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Regulator Thinking [clear filter]
Sunday, June 23
 

9:00am

SC27: #27: eCOA 101: The What, Why, and How of eCOA to Reduce Barriers to Adoption in Clinical Studies
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-507-L04-P; CME 3.25; IACET 3.25; RN 3.25

Evidence suggests that capturing clinical outcome assessment data electronically (eCOA) has many benefits over paper. However, barriers to adoption still remain. Poor adoption is in part attributable to unfamiliarity with benefits, but also poor experiences during study start-up, absence of clear expectations among sponsors and vendors, and misalignment among all stakeholders. This is also an area where no formal training exists for sponsors or eCOA providers. This short course is designed to introduce participants to key eCOA topics including:
  • Benefits of and barriers to eCOA adoption
  • Regulatory guidance applicable to eCOA vendors
  • Key measurement science and design principles applicable when using eCOA
  • Considerations when choosing a solution for your study based on study design and patient population
  • Start-up processes and considerations for migrating from paper to electronic modes of data collection, developing specification documents, and conducting user acceptance testing
  • Role of sponsors and sites in the trial technology implementation process and in optimizing quality of data collected with eCOA
  • Best practice recommendations for training site staff and study subjects on eCOA data collection in clinical trials
  • Considerations for the use of bring your own device (BYOD) in clinical trials
The interactive short course, created in collaboration with the Critical Path Institute’s ePRO Consortium, will provide real world examples and case studies including challenges and proposed solutions for the audience to work through in small groups.
An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for individuals in the clinical operations, digital technologies, procurement, clinical science or outcomes research areas at pharmaceutical companies who are considering collection of eCOA data or evaluating eCOA technology providers for their clinical studies. eCOA provider staff and developers new to the field would also benefit from this course.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Review benefits and challenges of capturing eCOA data in clinical trials;
  • Identify measurement science principles applicable to eCOA data capture and considerations for measurement comparability;
  • Discuss roles and responsibilities of eCOA providers, sponsors and sites in the implementation/deployment of clinical trials collecting electronic COA data.



Speakers
avatar for Paul O'Donohoe

Paul O'Donohoe

Scientific Lead, eCOA and Mobile Health, Medidata Solutions
Paul O’Donohoe is Scientific Lead, eCOA and Mobile Health at Medidata Solutions, a clinical software platform provider. He is responsible for developing the company's scientific expertise for electronic clinical outcome assessments and mobile health in clinical trials, and supports... Read More →
avatar for Susan Vallow

Susan Vallow

Executive Director, Patient-Centered Outcomes Research, Worldwide Clinical Trials
Susan Vallow, VP, Patient Centered Outcomes Strategy, MedAvante-ProPhase, is an experienced outcomes researcher with a specialty in the strategy, development and implementation of PROs. Sue previously was Senior Director & Head, Patient Focused Outcomes at GSK, where she managed the... Read More →
avatar for Patricia DeLong

Patricia DeLong

Manager, Patient-Reported Outcomes, Janssen Global Services, LLC
Patricia (Trish) Shepherd Delong has worked in the PRO and eCOA fields for more than ten years in both contract research and pharmaceutical organizations. She currently holds the role of PRO Process expert within the PRO team at Janssen. In this role Trish represents the PRO functional... Read More →


Sunday June 23, 2019 9:00am - 12:30pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Monday, June 24
 

11:00am

#107: Emerging Technologies in Clinical Research
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-534-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will present innovative uses of technology to collect data from and about patients in clinical research studies, including an update on Bring Your Own Device (BYOD) technology, the use of in-home monitoring for patients with neurological disorders, and the use of technology for expression detection. An EMA regulatory perspective will also be presented. Join the Study Endpoints Community for a follow up Round Table discussion on Monday, June 24, 1:15-2:15PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the current state of BYOD and how it may evolve in the future; Discuss new approaches to patient assessment in neurological disorders including passive data collection and use of the artificial intelligence; Describe the use of expression detection as a clinical outcome assessment tool. Discuss a regulatory perspective on emerging technologies.

Chair

Sonya L. Eremenco, MA

Speaker

BYOD: The Current State of Play and Future Potential for Electronic Clinical Outcome Assessments (eCOA)
Chris David Watson, PhD

Using Passive In-Home Monitoring and Artificial Intelligence to Quantify Patients with Neurological Disorders
Dina Katabi, PhD, MS

The Face is a Mirror of the Mind: The Potential of Expression Detection for New Clinical Outcome Measures
Bill Byrom, PhD

EMA Perspective
Anthony Humphreys, MPharm



Speakers
avatar for Bill Byrom

Bill Byrom

Vice President, Product Strategy and Innovation, Signant Health
Bill leads product strategy and innovation, and the ePRO Science team at Signant Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →
avatar for Sonya Eremenco

Sonya Eremenco

Associate Director, PRO Consortium, and Acting Director, ePRO Consortium, Critical Path Institute
Sonya Eremenco is Associate Director of the Patient-Reported Outcome (PRO) Consortium at the Critical Path Institute. Sonya has over 20 years of experience in PRO (and other clinical outcome assessment) instrument development, with a focus on multicultural development, linguistic... Read More →
avatar for Anthony Humphreys

Anthony Humphreys

Head of Scientific Committees Regulatory Science Strategy, European Medicines Agency (EMA)
He is the Head of Scientific Committees Regulatory Science Strategy Division (SciRS). He is responsible for providing leadership in the Agency in the areas of Scientific Committees Coordination and Regulatory Science Strategy in support of delivering the EMRN 2020 Strategy. He chairs... Read More →
avatar for Dina Katabi

Dina Katabi

Andrew and Erna Viterbi Professor of Electrical Engineering and Computer Science, Massachusetts Institute of Technology (MIT)
Dina Katabi is the Andrew & Erna Viterbi Professor of Electrical Engineering and Computer Science, and the director of the MIT center for wireless networks and mobile computing. Katabi is a MacArthur Fellow, a member of the National Academy of Engineering. She received the ACM Grace... Read More →
avatar for Chris Watson

Chris Watson

Director of Product Strategy - Digital Patient, ERT
Chris has a PhD in Behavioural Neuropharmacology and is an experienced product strategist with over 19 years’ experience in the delivery of innovative business and consumer solutions. Chris’ career started in the financial services and for the last 10 years, Chris has been translating... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:00am

#111: PhactMI Benchmarking Survey Highlights: How are the Twenty Seven Member Companies Executing on Medical Information Initiatives
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-525-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the phactMI benchmarking survey that was conducted in an effort to assess twenty seven member companies in the US through nine overall topics, such as company background, inquiry management, content development, decision makers, technology and website.

Learning Objectives

Discuss how twenty seven member companies are executing on medical information activities; Identify which technologies are currently being used, how medical content is being created and how inquiries coming from health care providers, patients and caregivers across the nation are being managed; Describe medical information executes on managed care situations and how medical information websites are being created and maintained.

Chair

Rania Gaspo, PhD

Speaker

Structure and Organization of Medical Information Services: Insights from a Survey of 27 US Pharmaceutical Medical Information Departments
Kirstie Marasigan, PharmD

How Do Twenty Seven Medical Information Departments Execute on Healthcare Decision Making Materials for Payer Inquiries: A PhactMI(TM) Benchmarking Survey
Andrew Gazo, PharmD, MS

What is Happening Through Product Support, Key Performance Indicators, and Other MI Services: Insights from a PhactMI(TM) Survey of Twenty Seven US Pharmaceutical MI Departments
Meera Patel, PharmD

How Do We Create Medical Content? Fulfilling Customers’ Medical Information Needs: Insights from a PhactMI(TM) Survey of Twenty Seven US Pharmaceutical Medical Information Departments.
Teresa Flowers, MBA, MS, RPh



Speakers
avatar for Teresa Flowers

Teresa Flowers

Senior Director, Medical Communications, Medical Affairs, Astellas Pharma Inc.
Teresa Flowers is Senior Director, and Global Medical Information Lead at Astellas Pharma Inc. She leads a co-located team of subject matter experts responsible for creating medical Information global core content. She has over 20 years of experience across multiple therapeutic areas... Read More →
avatar for Rania Gaspo

Rania Gaspo

Director, Global Therapy Area Team Lead, External Medical Communications, Pfizer Inc
Rania Gaspo earned her Pharmacy Degree and her PhD at University of Montreal, Faculty of Pharmacy. She served as a Post-Doctoral fellow at Montreal Heart Institute before moving into industry in 1998 as a Senior Scientist. Rania joined Pfizer in 2003 where she held positions in medical... Read More →
avatar for Andrew Gazo

Andrew Gazo

Head of CHC Global Content, Medical Information, Sanofi
Andrew Gažo is currently Head of Global Content for Consumer Healthcare in the Sanofi Medical Information Department and is a Board member of phactMI. Andrew has been active in all aspects of Medical Information, including content globalization, compliance monitoring, business development... Read More →
avatar for Kirstie Marasigan

Kirstie Marasigan

Post-Doctoral Fellow, US Medical Affairs and Medical Communications, Genentech, A Member of the Roche Companies
Kirstie Marasigan is a first year US Medical Affairs Post-Doctoral Fellow at Genentech within the Rutgers Pharmaceutical Industry Fellowship Program. In May 2018, she graduated with a PharmD from the University of the Sciences, Philadelphia College of Pharmacy. During her last year... Read More →
avatar for Meera Patel

Meera Patel

Associate Dierctor, Medical Information and Knowledge Integration, Janssen Pharmaceuticals
Meera has 15+ years of experience in Medical Information in the pharmaceutical industry. She is an Associate Director in Medical Information at Janssen Pharmaceuticals where she has oversight of products in infectious diseases. Prior to joining Janssen, she was a Medical Information... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:00am

#112: Collecting Better Patient Experience Data: Lessons Learned from Patient Organizations
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-526-L04-P; CME 1.00; IACET 1.00; RN 1.00

We will present methods and success stories from three rare disease patient organizations that have collected meaningful patient experience data. Panelists will share their insights and challenges for data collection including surveys and patient registries.

Learning Objectives

Describe the importance of participating in registries and the methods by which data is collected; Identify strategies for overcoming the challenges of patient engagement to help provide pathways towards accelerating rare disease research.

Chair

Laura Trutoiu, PhD

Speaker

Panelist
Monica Weldon

Panelist
Pamela Mace, RN



Speakers
PM

Pamela Mace

Executive Director, Fibromuscular Dysplasia Society of America
At the age of 37, Pam Mace was diagnosed with a rare disease called Fibromuscular Dysplasia (FMD). She struggled with her health for the first few years after her diagnosis and realized that medical professionals had no real understanding of the disease. Pam became an advocate for... Read More →
LT

Laura Trutoiu

Director of Research, The Association For Creatine Deficiencies
Laura is a computer scientist and the Director of Research for the Association for Creatine Deficiencies. She holds a PhD in Robotics from Carnegie Mellon University and she has conducted research in several top industry labs including Disney Research, Industrial Light and Magic... Read More →
avatar for Monica Weldon

Monica Weldon

President/Chief Executive Officer, Bridge the Gap - SYNGAP Foundation
In November of 2012, Monica's twin son, Beckett, was the first to be diagnosed at Texas Children's Genetics Clinic with the gene mutation SYNGAP1 (6p21.3). When Beckett was 4 months old, she noticed he was not meeting the same milestones as his twin sister. Monica then began a journey... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:00am

#119: Making Value-Based Contracting Stick
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-532-L04-P; CME 1.00; IACET 1.00; RN 1.00

Value-based contracting between payers, providers and manufacturers is an evolving space. Finding approaches that will can both scale and succeed long term have been challenging. The first speaker will describe a set of examples that focus on the payer-pharma relationships. The second two speakers will describe a new approach to using provider clinical outcomes in specialty conditions as the level of measurement.

Learning Objectives

Describe the current state of value-based contracting; Discuss examples of success and failure in value-based contracting; Identify a new approach to using provider clinical outcomes.

Chair

Richard Gliklich, MD

Speaker

Trends and Practices of Applying Real World Evidence to Market Access and Value-Based Care
Robert A. DiCicco, PharmD

Medical Scores to Enable Value-Based Care
Richard Gliklich, MD

Industry Update
Thomas Michael Renshaw, MBA, RPh



Speakers
avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, OM1
Dr. Richard Gliklich is the CEO of OM1, Inc., an outcomes and technology company focused on real world evidence and measuring and predicting outcomes. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale... Read More →
avatar for Thomas Renshaw

Thomas Renshaw

Senior Director, Business Solutions, Acentrus Specialty (Vizient)
Tom currently functions as the Senior Director of Business Solutions for Apexus with responsibility for innovative business strategies and development. Tom has served as a subject matter expert in the areas of transitional care, population health management, bioinformatics, 340B... Read More →
avatar for Robert DiCicco

Robert DiCicco

Deputy Chief Health Officer, IBM Watson Health
Rob DiCicco is a Deputy Chief Health Officer for IBM Watson Health where he focuses on Life Sciences. Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years. His area of expertise includes clinical pharmacology and experimental medicine, clinical... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:00am

#120: FDA Payer Communication Guidance, Twenty Years in the Making: Now What?
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-533-L04-P; CME 1.00; IACET 1.00; RN 1.00

The FDA Payer Guidance released in 2018 has provided some clarity to industry and payers. The FDA explicitly noted the important difference between information required for medical product approval and what is needed by payers to make decisions about population-based coverage and reimbursement. The FDA Payer Guidance is largely pragmatic regarding HCEI communications and advances industry’s proactive dialogue with payers. However, there remains areas of uncertainty within the guidance. A panel composed of the relevant stakeholders will have an open dialogue on the intention of the guidance, the challenges with developing a guidance for industry and payers, the practical challenges of operationalizing aspects of the guidance, the remaining informational needs of payers from industry to inform access decisions.

Learning Objectives

Discuss how to decrease the anxiety in proactively communicating relevant coverage and reimbursement information from industry to payers for population-based coverage decisions.

Chair

Sissi Pham, PharmD

Speaker

FDA Perspective
Sheila Ryan, MPH, RAC

Panelist
Chris Leo Pashos, PhD

Panelist
Mitchell Higashi, PhD

Panelist
Denise Sanchez, JD, MPH, MS



Speakers
avatar for Mitchell Higashi

Mitchell Higashi

Vice President, Health Economics and Outcomes Research, Bristol-Myers Squibb
Mitch is the Vice President of HEOR at Bristol-Myers Squibb. Prior to joining BMS, he was the Chief Economist for GE Healthcare, where he led global efforts in health economics, pricing, reimbursement, and health policy. Mitch is a published author, including JAMA, and his work in... Read More →
avatar for Chris Pashos

Chris Pashos

Vice President, Global Evidence Strategy, AbbVie Inc.
Dr. Pashos oversees AbbVie’s Real-World Evidence Generation and Patient Centric Research Center of Excellence, demonstrating the value of medicines in addressing needs perceived by regulators, health technology assessment agencies & payers, the medical community and patients. He... Read More →
avatar for Sissi Pham

Sissi Pham

Chief Executive Officer, AESARA
Sissi Pham is a founder and CEO of AESARA, Inc. and AESARA Foundation, both established in 2016. AESARA, Inc. was established with the commitment to absorb the administrative cost of the AESARA Foundation to enable the charity to give 100% of the donations to directly to humanitarian... Read More →
SR

Sheila Ryan

Acting Director, Division of Supply Chain Integrity, Fda/cder/Office Of Compliance/Office of Drug Security, Integrity and Response
Sheila Ryan, PharmD, MPH, RAC is currently the Acting Director of the Division of Supply Chain Integrity in the Office of Drug Security, Integrity and Response within CDER's Office of Compliance at FDA. She has over 15 years of FDA regulatory experience, including over 10 years in... Read More →
avatar for Denise Sanchez

Denise Sanchez

Executive Director, Commercial Regulatory Affairs, Allergan
Denise is a leader in the commercial regulatory space with 15 years of combined industry, government and law firm experience. Industry roles include Regulatory overview of commercial promotion and practices at Allergan Aesthetics, Ironwood, Celgene, & Cubist. At the law firm of Hughes... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:15pm

#142: Show Me the Money! Patient and Caregiver Roles and Compensation in Research, Development, and Innovation
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-542-L04-P; CME 1.00; IACET 1.00; RN 1.00

With advancements in stakeholder engagement prompted most recently by the 21st Century Cures Act, PCORI, and FDA’s Patient-Focused Drug Development initiatives, patients and caregivers have increasingly shifted from being passive subjects to more active partners in research and healthcare innovation. Groups like the Clinical Trials Transformation Initiative have established best practices for how and when to engage patients in research and development, NIH’s NCATS has created toolkits to support patient engagement in therapy development, and PCORI has put forth recommendations that patients be included as valued research team members who are appropriately compensated for their time. However, no framework to date has put a spotlight on patient and caregiver motivations and expectations around involvement and compensation nor mapped competencies and support needs from their standpoint. As we work towards embracing patients and caregivers as valued partners, it is important to understand challenges as well as best practices to ensure we can pave a path forward.Through our research we will illustrate the motivations, needs and expectations of patient and caregiver involvement in research and healthcare innovation.

Learning Objectives

Discuss the types of roles patient/caregivers serve in research, development, and healthcare innovation; Describe the various mechanisms for patients and caregivers to get engaged and their respective barriers/facilitators to involvement from the patient/caregiver perspective; Discuss patient/caregiver views on ethics, competency, and support required for each role; Illustrate patient/caregiver motivations and expectations around involvement and compensation.

Chair

Sarah Krug, MS

Speaker

Panelist
Bray Patrick-Lake, MS

Panelist
Veronica Todaro, MPH

Panelist
Jaye Bea Smalley, MPA



Speakers
avatar for Sarah Krug

Sarah Krug

Chief Executive Officer, CANCER101
Sarah Krüg is the CEO of CANCER101, a patient advocacy organization whose mission is to help patients and caregivers navigate the cancer journey and partner with their healthcare team to make informed decisions. Sarah is also Founder of the Health Collaboratory, a global innovation... Read More →
avatar for Bray Patrick-Lake

Bray Patrick-Lake

Director of Stakeholder Engagement, Duke Clinical Research Institute
Bray Patrick-Lake supports efforts to actively engage patients, health advocacy organizations, and other stakeholders in Duke Clinical Research Institute’s local and national research programs. She has led extensive efforts through the CTTI to incorporate patient voice into clinical... Read More →
avatar for Jaye Bea Smalley

Jaye Bea Smalley

Director, Global I and I Patient Advocacy and Life Cycle Management, Celgene Corporation
Jaye Bea joined Celgene as Global Director, Patient Advocacy and Life Cycle Management, Inflammation & Immunology in March 2018. Her twenty-five-year career in health care includes extensive experience in the public and private sector focused on advancing the needs and interests of... Read More →
avatar for Veronica Todaro

Veronica Todaro

Chief Operating Officer, Parkinson's Foundation
Veronica (Ronnie) Todaro, M.P.H., has led the national programs of the Parkinson’s Disease Foundation (PDF) since joining the organization in 2004. In this role, she has pioneered national programs focused on patient engagement both at PDF and in the broader community. She has advocated... Read More →
avatar for Veronica Todaro

Veronica Todaro

Chief Operating Officer, Parkinson's Foundation
Veronica (Ronnie) Todaro, M.P.H., has led the national programs of the Parkinson’s Disease Foundation (PDF) since joining the organization in 2004. In this role, she has pioneered national programs focused on patient engagement both at PDF and in the broader community. She has advocated... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:15pm

#143: Opportunities and Challenges with First-In-Human Multiple Expansion Cohort Designs in Oncology
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-543-L04-P; CME 1.00; IACET 1.00; RN 1.00

Use of the multiple expansion cohort design in oncology trials offers advantages and challenges. This session presents views on the success and hurdles of this design by regulators and industry. Implications for global development are also raised.

Learning Objectives

Discuss the important differences between phase 1 FIH studies and the FIH multiple expansion cohort design; Identify key safety challenges and risk mitigation steps; Discuss ethical consideration with oncology studies involving expansion cohorts; Identify examples of implementation challenges and opportunities of this design; Describe lessons learned from industry and regulators.

Chair

Sherry Leonard, RAC

Speaker

The Use of Expansion Cohorts in First-in-Human Clinical Trials to Expedite Oncology Drug Development
Pamela Balcazar, MS

Implementation Challenges and Opportunities with FIH Multiple Expansion Cohorts
Sherry Leonard, RAC

Ethical Considerations in Oncology Studies Involving Expansion Cohorts
Lindsay McNair, MD, MPH, MSc



Speakers
PB

Pamela Balcazar

Regulatory Health Project Manager, OHOP, CDER, FDA
Pamela Balcazar is Regulatory Project Manager in the Office of Oncology and Hematology Products (OHOP) at the FDA. In OHOP, her responsibilities include developing policies and overseeing regulatory initiatives related to the review of oncology products including guidances and process... Read More →
avatar for Sherry Leonard

Sherry Leonard

Director, Regulatory Affairs, Celgene Corporation
Sherry A. Leonard, RAC, Director, Regulatory Affairs, Celgene Corporation Sherry joined Celgene Corporation in 2014 where she is a Director Regulatory Affairs within the Hematology/Oncology Franchise. She is the global regulatory lead for new chemical entities and biologic products... Read More →
avatar for Lindsay McNair

Lindsay McNair

Chief Medical Officer, WCG
Lindsay McNair, MD, MPH, MSBioethics is the Chief Medical Officer for the WIRB-Copernicus Group. She oversees the physician team within the WCG IRBs, and provides consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol design, regulatory... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:15pm

#145: Examining Essential Elements of Vendor Governance and Comparing Perspectives of Large and Emerging Biopharma
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-545-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will present pillars of effective vendor oversight and governance. A panel of experts will provide perspectives on benefits, lessons learned and challenges of various models.

Learning Objectives

Discuss the importance of comprehensive and transparent vendor oversight in light of increasing partnerships and outsourcing; Identify and review real life examples of issues and how to effectively address in both new and ongoing vendor relationships; Discuss ways to improve and accelerate trust in relationships.

Chair

Leo Dodds, MBA

Speaker

Panelist
Judith Sernatinger, MA

Panelist
Albert Cosenza, MS



Speakers
avatar for Albert Cosenza

Albert Cosenza

Head, Vendor and Capacity Management, Johnson & Johnson
A Pharmaceutical executive with a passion for building successful partnerships between vendors and corporations. As the cross-sector head of vendor and capacity management, he is responsible for providing strategic leadership for vendor management and oversight, as well as capacity... Read More →
avatar for Leo Dodds

Leo Dodds

Partner, Triradial Solutions
A biopharma executive and management consultant with a background in statistics and business operations. Leo helps clients accelerate their success strategies through leading practice and experience-based methods. His experience spans both commercial and R&D operations and his focus... Read More →
avatar for Judith Sernatinger

Judith Sernatinger

Vice President, Global Head of Quality, Prothena Biosciences Inc
Judith is a Quality Management Executive recognized for her ability to collaborate to build quality organizations and processes that drive patient safety and product quality. As VP, Global Head of Quality at Prothena Biosciences, she is responsible for Quality strategic planning and... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#154: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-555-L04-P; CME 1.00; IACET 1.00; RN 1.00

The forum will cover latest developments on CIOMS XI from the perspective of patients, regulators, and industry. Current thinking in more closely involving patients throughout the medicines lifecycle will be presented and audience feedback sought. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Tuesday, June 25, 2:00-3:00PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Discuss the latest developments in patient involvement and engagement in the medicinal product lifecycle from development to post-marketing, pharmacovigilance and risk management; Describe current progress of the CIOMS XI WG in terms of involving patients and patient groups or associations more closely with medicines addressing medical needs.

Chair

Judith Zander, MD

Speaker

An Introduction to CIOMS and the CIOMS XI Initiative on Patient Involvement in the Medicinal Product Lifecycle
Herve Le Louet, DrMed, DrSc, MD, PhD, MS

FDA Perspective
Theresa Mullin, PhD

The Role of Patients in Drug Development and Lifecycle Use
Marc M. Boutin, JD

An Overview of the CIOMS XI Initiative
Kerry Leeson-Beevers

Using Patient Data to Evaluate the Benefits and Risks of Medicines
Meredith Y. Smith, PhD, MPA



Speakers
avatar for Marc Boutin

Marc Boutin

Chief Executive Officer, National Health Council (NHC)
Marc M. Boutin, JD, is the Chief Executive Officer of the National Health Council. He has been a leading voice for greater patient involvement at every stage of the health care continuum. Boutin has been actively involved in patient advocacy organization management, health advocacy... Read More →
KL

Kerry Leeson-Beevers

National Development Manager, Alström Syndrome UK
I joined Alström Syndrome UK (ASUK) in 2003 when my son was diagnosed with the condition. I am now the National Development Manager responsible for overseeing the Family Support Service and I work closely with our medical teams in Birmingham, UK to support the highly specialised... Read More →
avatar for Herve Le Louet

Herve Le Louet

President, Head of PV Coordination, CIOMS and APHP
Herve Le Louet is Professor of Clinical Pharmacology. He is currently head of Pharmacovigilance department of Paris University Hospitals (AP-HP). He is an hepatologist by training and has a PhD in Pharmacogenetic from the Paris University. He is the President of CIOMS and immediate... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Programs, CDER, FDA
Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She leads Patient-Focused Drug Development which includes implementation of the 21st Century Cures Act. She leads the CDER International program and heads the FDA delegation to ICH, IPRP and other... Read More →
avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →
avatar for Judith Zander

Judith Zander

Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER, FDA
Judy Zander is the Director of the Office of Pharmacovigilance and Epidemiology (OPE), in the Office of Surveillance and Epidemiology (OSE), in the Center for Drug Evaluation (CDER) at the U.S. Food and Drug Administration (FDA).She oversees the Divisions of Pharmacovigilance 1 and... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#157: A Large Academic Medical Center’s Perspective on Using Precision Medicine to Find Patient Disease Subgroups at Scale
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-567-L04-P; CME 1.00; IACET 1.00; RN 1.00

Hear how scientists and physicians at Johns Hopkins Medicine in Baltimore and Microsoft collect and tap vast amounts of data from clinical care, genomics, and wearable devices, to better predict disease progression and pinpoint individual treatments.

Learning Objectives

Describe using data analytics, machine learning, and precision medicine, how to distinguish, analyze, and reclassify disease based on subgroups; Identify the best prognosis for patients using these tools; Describe how to better predict disease progression and pinpoint individual treatments.

Chair

David Meyers

Speaker

Academic Perspective
Dwight Raum



Speakers
avatar for David Meyers

David Meyers

National Director, US Life Sciences, Microsoft
Dave Meyers is National Director - US Life Sciences at Microsoft; focused on strategy, business development, and the solutions portfolio in pharma, genomics and precision medicine. He joined Microsoft in 1997 - held various technical, program management, and product development positions... Read More →
avatar for Dwight Raum

Dwight Raum

Vice President and Chief Technical Officer, Johns Hopkins
Dwight Raum is Vice President and Chief Technology Officer of Johns Hopkins Health System and Johns Hopkins University. His passion lies in challenging the status quo, mobilizing teams to harness technology and championing change. Since 2016, Dwight has helped lead a precision medicine... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Featured Topics Real World Evidence,Artificial Intelligence,Precision Medicine,Student Programming
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

3:30pm

#163: Strategic Integration: Is Anyone Getting it Right?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-560-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166060YI7; RN 1.00

Despite the regularity of asset or company acquisitions, integration into an existing portfolio is rarely straightforward. This forum will discuss successful (and less successful) strategies for integration across various healthcare organizations.

Learning Objectives

Describe the different components that lead to the successful integration of acquired assets or companies; Compare and contrast different strategies for strategic integration and discuss best practices from a business development, project and portfolio management perspective to promote streamlined integration of an asset or company.

Chair

Erin Mulrooney, MSc

Speaker

Industry Perspective
Vijayalakshmi Agnani, MBA, MS

Industry Perspective
Erin Mulrooney, MSc

Integration of Cultures and Teams in a Hospital Setting
Elizabeth Somers, MS



Speakers
avatar for Vijayalakshmi Agnani

Vijayalakshmi Agnani

Associate Director, Transactions, Global Business Development and Licensing, Sanofi
Vijayalaksmi (Viju) Agnani is currently Associate Director, Transactions in the Global Business Development and Licensing team at Sanofi. In this role, she engages throughout all phases of business development and licensing activities to lead and manage the execution of strategic... Read More →
avatar for Erin Mulrooney

Erin Mulrooney

Associate Director, Project Management, Merck & Co., Inc.
Erin Mulrooney joined the Global Project and Alliance Management group at Merck in 2016 as an Associate Director. She specializes in the management of large-scale, complex collaborative projects in Discovery and Early Development. Prior to her transition to Project Management, she... Read More →
avatar for Erin Mulrooney

Erin Mulrooney

Director, Portfolio Management and Operations, Biocelerate
Erin Mulrooney joined the Global Project and Alliance Management group at Merck in 2016 as an Associate Director. She specializes in the management of large-scale, complex collaborative projects in Discovery and Early Development. Prior to her transition to Project Management, she... Read More →
avatar for Elizabeth Somers

Elizabeth Somers

Executive Director of Infectious Disease, Global Project and Alliance Management, Merck & Co., Inc.
Liz is an Executive Director of Infectious Diseases in Global Project and Alliance Management at Merck. In addition to accountability for the ID TA, she manages a team focused on Discovery collaborations which leverages her experience managing complex cross functional drug development... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#165: Drug Development Tools in a Digital Era
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-562-L04-P; CME 1.00; IACET 1.00; RN 1.00

Explore opportunities and challenges ahead for digital drug development tools (DDTs) from an EMA, consortium, and industry perspective. Analyze how existing regulatory frameworks apply to the emerging field of digital health technologies including case examples, and discuss issues to be addressed to promote advancement of digital DDTs.

Learning Objectives

Describe the EMA, industry, and consortium views on digital drug development tools (DDTs); Discuss the growing value of digital health tools as part of the drug development process including key learnings from sponsor experience; Evaluate case example(s) in the development of digital DDTs.

Chair

Lauren Oliva, PharmD, RPh

Speaker

Critical Path Update
Stephen Joel Coons, PhD

EMA Update
Zahra Hanaizi, PharmD, MPharm

Industry Update
Josh Cosman, PhD



Speakers
avatar for Josh Cosman

Josh Cosman

Associate Director, Digital and Quantitative Medicine, Biogen
Dr. Cosman has 15 years’ experience exploring novel markers of cognition, motor function, and quality of life in healthy aging and neurological disorders. His work has focused on the development of functional measures using scalable research-grade tools and consumer devices in a... Read More →
avatar for Zahra Hanaizi

Zahra Hanaizi

Scientific officer, PRIME Coordinator, Scientific and Regulatory Management Dept, European Medicines Agency (EMA)
Zahra Hanaizi joined EMA in 2007 as Product Team Leader, managing centralised medicinal products initial marketing authorisation applications, maintenance and life-cycle activities, mostly in the therapeutic area of Oncology. Since 2015, she has been working on the creation, implementation... Read More →
avatar for Lauren Oliva

Lauren Oliva

New Technologies Global Regulatory Policy Lead, Biogen
Lauren Oliva is Global Regulatory Policy Lead for New Technologies at Biogen. She oversees the development and execution of R&D’s policy roadmap for digital health tools and gene therapy to enable Biogen’s neuroscience portfolio. In her time at Biogen she launched a widely used... Read More →
avatar for Stephen Joel Coons

Stephen Joel Coons

Executive Director, PRO Consortium, Critical Path Institute
Stephen Joel Coons is Executive Director of the Patient-Reported Outcome (PRO) Consortium at Critical Path Institute (C-Path). C-Path, an independent nonprofit organization, established the PRO Consortium in cooperation with the U.S. Food and Drug Administration and the pharmaceutical... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#166: Updates on China Regulatory Reform
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-563-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this forum, experts from government, academia and industry will present and discuss updates in NMAP's regulatory reform and progress in drug review and approval, and development of Chinese pharmacopeia 2020.

Learning Objectives

Discuss and understand the latest progress in NMPA’s regulatory reform and the impacts on Chinese pharmaceutical regulation and drug development; Recognize China’s evolving regulatory environment and future development.

Chair

Ling Su, PhD

Speaker

Regulatory Reform Enhancing Drug Review and Approval
Xiao Yuan Chen, PhD

Regulatory Reform: Industry EWxoerience and Perspective
Wendy Yan, MD, MBA

Brief Introduction on Chinese Pharmacopoeia 2020
Xiaoxu Hong



Speakers
avatar for Ling Su

Ling Su

Professor, Shenyang Pharmaceutical University
Ling Su, PhD, is Professor in Shenyang Pharmaceutical University, and a Venture Partner with Lilly Asia Ventures. Dr. Su has over 25 years of experience in drug regulatory and development. He had worked in the Chinese regulatory agency and US FDA, as well as in various R&D management... Read More →
avatar for Xiao Yuan Chen

Xiao Yuan Chen

Office Director, Tsinghua University
XH

Xiaoxu Hong

Deputy Division Director, Chinese Pharmacopoeia Commission
avatar for Wendy Yan

Wendy Yan

Senior Vice President, Head of Regulatory Affairs, BeiGene (Beijing) Co., Ltd.
Wendy Yan is Senior Vice President, Global Head of Regulatory Affairs, for BeiGene, a commercial-stage biotechnology company focused innovative molecularly-targeted and immuno-oncology drugs for treatment of cancer. She has more than two decades of regulatory affairs experience, having... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#169: How Statistics Can Help Improve Data Quality: ICH E6 R2
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-564-L04-P; CME 1.00; IACET 1.00; RN 1.00

ICH E6 (R2) guidance stresses the importance of centralized monitoring, especially by leveraging statistical analyses in order to assess data quality. This session will discuss how statistical methodology fits in the overall quality risk management strategy for the trial portfolio.

Learning Objectives

Discuss centralized statistical monitoring approaches and their impacts to data quality and integrity.

Chair

Cheng Su, PhD

Speaker

Using Appropriate Count-Based Statistical Models for KPIs, Risk Metrics, QTLs, etc.
Michael Farnum, PhD, MS

ICH E6 R2: How Statistics Can Help Improve Data Quality
Stephen Young, MSc

Centralized Statistical Monitoring: A Large Pharma's Approach
Taras Carpiac, MBA



Speakers
avatar for Taras Carpiac

Taras Carpiac

Director, Head of Innovation and Process Improvement, Amgen, Inc.
MF

Michael Farnum

Senior Director, Covance
Michael Farnum is a Senior Director for Covance Informatics. In 5+ years working at Covance, he has helped to create the Xcellerate platform, consisting of data integration, analytics, and decision support tools that enable Risk-Based Monitoring, Medical Review, Statistical Review... Read More →
CS

Cheng Su

Executive Director, Data Sciences and Analytics, Biomarin Pharmaceutical
Cheng got his Ph.D. in statistics from NCSU and has 22 years of experiences in both nonclinical and clinical areas. Cheng has a broad interpest in applying statistical thinking and analytics to support drug research and development. His specific areas of expertise include high throughput... Read More →
avatar for Stephen Young

Stephen Young

Chief Scientific Officer, CluePoints
As Chief Scientific Officer for CluePoints, Steve oversees the research and development of advanced methods for data analytics, data surveillance and risk management, along with providing guidance to customers in RBQM methodology and best practices. Steve worked for three bio-pharmaceutical... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

8:00am

#202: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-573-L04-P; CME 1.25; IACET 1.25; RN 1.25

Following the initial success of an unprecedented collaboration between nineteen sponsors to address major pharmacovigilance challenges with regulators, this session will provide lessons learned and an update on an increasing scope of collaborative work. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Tuesday, June 25, 3:15-4:15PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Identify expert perspectives on the future of the field of clinical safety and pharmacovigilance, with a focus on trends, challenges, and how collaborations can work to advance the industry in this space; Discuss strategies to address pharmacovigilance challenges in the long-term.

Chair

Jose Vega, MD

Speaker

The European IV Iron PASS Consortium: Experiences from Coordinating a Multi-Company, Multi-Registry PASS
Michael Forstner, PhD

Regulator Observations and Feedback
Gerald J. Dal Pan

Advancing Safety Analytics
Paul Chang, MD

Intelligent Automation in Pharmacovigilance
Songlin Xue, MD, PhD



Speakers
PC

Paul Chang

Chief Safety Officer, Janssen Pharmaceuticals
Dr. Paul Chang is the Chief Safety Officer at Janssen, the Pharmaceutical Companies of Johnson & Johnson, where he is responsible for all aspects of patient safety and pharmacovigilance. Paul joined J&J in 2006, and has held various leadership positions including the Head of Cardiovascular... Read More →
avatar for Michael Forstner

Michael Forstner

Senior Vice President, Head of Risk Management and Pharmacoepidemiology, PrimeVigilance
Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis methodologies in... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →
avatar for Jose Vega

Jose Vega

Vice President, Chief Safety Officer, Merck & Co., Inc.
José M. Vega is Vice President, Global Clinical Safety and Pharmacovigilance (GCS&PV) and Chief Safety Officer at Merck Research Laboratories (MRL). He also serves as Chair of the TransCelerate Pharmacovigilance Steering Committee and as Merck's representative on the Clinical Trials... Read More →
avatar for Songlin Xue

Songlin Xue

Executive Vice President and Global Head of Pharmacovigilance, Astellas
Songlin Xue, M.D., Ph.D., is Executive Vice President and Head of the global Pharmacovigilance in Astellas. In this position, he leads a global pharmacovigilance organization that includes pharmacovigilance operation and processes, medical safety, risk management, and epidemiology... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#201: To Err is Human: Progress and Challenges in the Prevention of Medication Errors
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-572-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will look at progress in the reduction of medication errors due to name confusion. A panel of experts, representing major health authorities and WHO will provide a concise summary of guidelines these bodies have developed to minimize these errors, discuss differences in their approaches and what they see are the challenges that remain.

Learning Objectives

Discuss progress in the reduction of medication errors due to the development of regulations surrounding the development of drug names; Evaluate progress and identify challenges in the development of guidance by FDA, Health Canada, and EMA for proprietary names development and challenges with name confusion in the development of INNs; Describe best practices in the development of acceptable proprietary and non-proprietary names.

Chair

Tony E. Catka, PhD

Speaker

ISMP Perspective
Michael R. Cohen, DrSc, MS, RPh

FDA Perspective
Lubna Merchant, PharmD, MS

WHO Perspective
Raffaella Giovanna Balocco Mattavelli, PharmD, PhD



Speakers
avatar for Tony Catka

Tony Catka

Senior Director, Regulatory Affairs, Addison Whitney, A Syneos Health Company
As the Lead of Addison Whitney's Center for Regulatory Guidance, Tony ensures that Addison Whitney stays abreast of changes that affect drug naming worldwide. He provides analysis of regulatory guidance, precedents, and the emerging environment and collaborates with team members in... Read More →
MC

Michael Cohen

President, Institute for Safe Medication Practices
Michael Cohen, RPh, MS, ScD, is president of The Institute for Safe Medication Practices, a non-profit healthcare organization that specializes in understanding the causes of medication errors and providing error-reduction strategies to the healthcare community, policy makers, and... Read More →
RB

Raffaella Balocco Mattavelli

Group Lead, International Nonproprietary Name Programme, World Health Organization (WHO)
Dr. Raffaella Balocco is a pharmacist Doctor and has a PhD in Pharmacology. She worked at the "Mario Negri Institute for Pharmacological Researches" in Milan before joining the World Health Organization in 1993. From 1993 until 2001 she worked in the regulatory support Unit within... Read More →
avatar for Lubna Merchant

Lubna Merchant

Deputy Office Director, OMEPRM, OSE, CDER, FDA
Dr. Merchant currently serves as the acting Director of the Division of Medication Error Prevention and Analysis. She is also the Deputy Director of the Office of Medication Error Prevention and Risk Management in FDA’s Center for Drug Evaluation and Research’s (CDER) where she... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#203: eConsent Done Right
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-585-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will present real world case studies from sponsor companies that have already begun piloting eConsent.

Learning Objectives

Explain how eConsent can improve patient understanding of clinical trials, enable better informed decision-making and increase patient participation; Describe eConsent implementation best practices from real world case studies; Discuss where and how eConsent is utilized around the globe.

Chair

Carrie Guglielmo

Speaker

Enabling the Future of eConsent: An Overview of the TransCelerate Initiative and Real-World Implementation
Carrie Guglielmo

How eConsent will Support Increased Insights and Future Enhancement of Informed Consent Content and Processes
Bill Byrom, PhD

Utilizing Mobile Apps and eConsent in Global Research Registries: Ethical and Legal Considerations
Robyn Shapiro, JD

Moving the Needle: Improving the Clinical Trial Informed Consent Process with Tools to Increase Understanding
Lauren McCormack, PhD, MPH



Speakers
avatar for Bill Byrom

Bill Byrom

Vice President, Product Strategy and Innovation, Signant Health
Bill leads product strategy and innovation, and the ePRO Science team at Signant Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →
avatar for Lauren McCormack

Lauren McCormack

Vice President, Public Health Research Division, RTI International
Lauren McCormack, PhD, MSPH is Vice President of RTI’s Public Health Research Division and Adjunct Associate Professor in the UNC Gillings School of Global Public Health. Her research bridges the fields of health communication and health policy, and involves developing, testing... Read More →
avatar for Robyn Shapiro

Robyn Shapiro

Founder and Partner, Health Sciences Law Group LLC
Robyn Shapiro is Founder and Attorney at Health Sciences Law Group LLC. She represents clients in research and healthcare compliance issues, bioethics issues, health information privacy issues, and corporate and commercial issues faced by pharma and device manufacturers. Her past... Read More →
avatar for Carrie Guglielmo

Carrie Guglielmo

eConsent Initiative Lead, Novartis Pharmaceuticals Corporation
Carrie Guglielmo Novartis eConsent Initiative Lead Carrie has been in the pharmaceutical industry for over 20 years. She has held various roles in clinical operations including Trial Management, Resource and Performance Management, and Process and Training. Carrie has been leading... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#206: Single Source of Truth, Integrations, or IoT (Internet of Things): Exploring Ways to Improve Connectedness of Clinical Data
Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-574-L04-P; CME 1.25; IACET 1.25; RN 1.25

This panel discussion will explore ways to improve connectedness of clinical data in today's CDM world and talk about if Single Source of Truth, Integrations or IoT (Internet of Things) are the best ways to move forward.

Learning Objectives

Describe why, what, where, when and how of data integrations between clinical systems; Describe recent technologies in CDM world and how these technologies are increasing the need for efficient integrations; Identify current challenges in data integrations between clinical systems; Discuss ways to improve efficiency of integrations and use cases where technology has improved integration.

Chair

Joby John, DDS

Speaker

Panelist
Nick Neri, MS

Panelist
Kelly Ritch, MBA, MS

Panelist
Jennifer Price



Speakers
avatar for Joby John

Joby John

Senior Director, Technology Operations, Bioclinica
Dr Joby John is a versatile Clinical Research executive with over 16 years of experience in managing end to end clinical services like EDC, CDM, SDTM, SAS, IWRS, eTMF to name a few. She has worked with a wide array of global Pharma companies, CROs and FSPs in setting up and managing... Read More →
avatar for Nick Neri

Nick Neri

Director of Data Services & Integration, ERT
Mr. Neri has over 20 years of industry experience, and has established himself as a thought leader in the industry for applying next generation concepts and technologies to the clinical research space. He currently serves as Director, Data Integration and Services, CoE at ERT. Previously... Read More →
avatar for Jennifer Price

Jennifer Price

Senior Director, Clinical Data Management, Paidion Research
Jennifer has 25+ years of pharmaceutical industry experience with Biometrics, Data Management and related technologies. Jennifer currently is the head of Data Management for Paidion Research, a Pediatric CRO. In this role, Jennifer is responsible for the collection and management... Read More →
KR

Kelly Ritch

VP, Clinical Trial Solutions, ArcheMedX
Dynamic and innovative executive with 20 years experience creating, managing, and driving high-performance, outcomes, and long-term value. Strategic thinker with strong analytical skills as well as a proven ability to affect positive change and significantly improve business processes... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#228: Emerging Safety Challenges in New Oncology Treatments
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-591-L04-P; CME 1.00; IACET 1.00; RN 1.00

Immuno-oncology (IO) agents are emerging as essential tools to treat a wide range of solid tumors and their indications for use continue to expand. However, the antitumor immune activity of these agents can also be a threat to healthy tissue, resulting in novel presentations of adverse reactions, sometimes with highly undesirable outcomes. Early recognition and intervention can have a dramatic effect outcomes, particularly for very rare events that are progressive. However, presentation can mimic other less serious conditions that do not require early intervention. Thus, these immune-mediated phenomena have become the focus of intense exploration.

This session will provide a very brief conceptual overview of these agents, followed by two presentations. the first presentation will include methodological considerations for identifying potential predictors, such as transcriptomic biomarkers or specific interleukins, etc., that might aid prevention, facilitate early detection, or predict mortality. The second presentation will provide regulatory considerations in ensuring that benefits of these products outweigh their risks. Both presentations will include examples to illustrate key points. The session will conclude with an opportunity for Q&A.

Learning Objectives

Outline basic mechanistic aspects related to the efficacy and safety of immuno-oncology agents; Describe methodological considerations when identifying utility of markers that can help in the prevention or early diagnosis of IO-associated adverse events; Discuss considerations in benefit-risk assessment and communication for these agents.

Chair

William Gregory, PhD

Speaker

Checkpoint Inhibitor-Associated Myocarditis: Prevention or Early Detection?
Tarek Hammad, MD, PhD, MS, MSc, FISPE

Regulatory Challenges in Benefit/Risk Assessment and Labeling of Immuno-Oncology Agents
Meredith K. Chuk, MD, MHS



Speakers
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
avatar for William Gregory

William Gregory

Senior Director, Safety and Risk Management, Pfizer Inc
He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well... Read More →
avatar for Tarek Hammad

Tarek Hammad

Therapeutic Area Strategy Lead, Global Pharmacovigilance, Sanofi Genzyme
Dr. Hammad joined Sanofi-Genzyme, in 2019, as a Therapeutic Area Strategy Lead in the Global Pharmacovigilance group. Prior to this, he served as the Head of Signal Detection and Benefit-Risk Assessment in Merck KGaA/EMD Serono. Previously, he was an Executive Director of Pharmacoepidemiology... Read More →
MC

Meredith Chuk

Acting Associate Director for Safety, OOD, OND, CDER, FDA
Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Oncologic Diseases in OND/CDER at the FDA.


Tuesday June 25, 2019 10:30am - 11:30am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#229: An Industry Collaboration on Pharmacovigilance Analytics
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-592-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss an initiative and how it is facilitating biopharmaceutical companies to enable earlier and systematic identification of potential safety issues to help minimize harm to patients, improve quality of analytic methods to improve product development, and deliver accelerated method development through collaboration and piloting. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 12:45-1:45PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Discuss methods for collaborating and innovating in analytics to improve patient safety; Identify how to build awareness of opportunities for greater alignment across the industry in signal detection and management; Describe industry best practices of current and future signal detection and management.

Chair

Andres Gomez, PhD, MPH

Speaker

Panelist
John Van Stekelenborg, PhD, MBA, MSc

Panelist
Neal Grabowski, MS



Speakers
AG

Andres Gomez

Vice President, Head of Epidemiology, Safety Science, and Analytics, Bristol-Myers Squibb
Dr. Gomez joined at Bristol Myers Squibb Company as an Associate Director of Pharmacoepidemiology in the Global Pharmacovigilance and Epidemiology department in 2003. He currently heads the epidemiology, safety science and analytics groups which is accountable for the real world research... Read More →
NG

Neal Grabowski

Director, Pharmacovigilance & Patient Safety, AbbVie
Prior to joining AbbVie, Neal held multiple roles in Patient Safety and Clinical Operations at Amgen, Genzyme and Sanofi. He holds a MS in biomedical engineering and MBA from Pepperdine University.
avatar for John Van Stekelenborg

John Van Stekelenborg

Director, Group Lead, Methods and Analysis, Johnson & Johnson
John van Stekelenborg is the Head of the Methods & Analysis group in the Global Medical Safety department of Janssen, the Pharmaceutical Companies of Johnson & Johnson. John has been with J&J since 2002 and assumed leadership of the M&A group in 2011 where he leads a group of data... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#233: Creating Clarity: Changes at CDISC to Make Standards Implementation Easier for all Stakeholders
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-593-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the recommendations of the Blue-Ribbon Commission, an overview of CDISC 2.0, the innovation initiative CDISC is currently undertaking to and what benefits these efforts will bring for all stakeholders.

Learning Objectives

Describe CDISC 2.0 and how this initiative and what benefits these efforts will bring for all CDISC stakeholders; Describe how beginning to end connected standards can streamline clinical data management make and data sharing easier.

Chair

Kit Howard, MS

Speaker

CDISC 360 and CDISC Library: Continuing the Journey Toward Beginning-to-End Automation
Bess LeRoy, MPH

SEND: What's New Today and on the Horizon for CDISC's Standard for Nonclinical Research
Lou Ann Kramer

CDISC Primer: Making CDISC Easier: A Collaboration Between CDISC and PhUSE
Kit Howard, MS



Speakers
avatar for Kit Howard

Kit Howard

Senior Director, Standards Development & Education, CDISC
Kit Howard has over 30 years’ experience in many areas of research and development, including developing data and process standards for exploratory through post-marketing human clinical research, pharmacogenomics and non-clinical research. She is CDISC's Senior Education Expert... Read More →
LK

Lou Kramer

Senior Director, Standards Development, CDISC
Lou Ann Kramer is a Senior Director of Standards Development at CDISC. Prior to joining CDISC, she had over 30 years experience at a major pharmaceutical sponsor company where she held roles in IT, early phase Clinical and non-clinical regulatory. She managed non-clinical submissions... Read More →
BL

Bess LeRoy

Head of Standards Development, CDISC
Bess LeRoy has over 15 years of experience working in public health research. She is currently the Head of Standards Development at CDISC. She has been a CDISC team member since 2011 and has been involved in the development of over 16 CDISC Therapeutic Area User Guides. Bess has a... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#241: PMDA Town Hall
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-600-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this forum, PMDA will share the latest details regarding its policies and initiatives and other related strategic directives.Three senior level representatives from PMDA and MHLW will introduce the latest situations regarding scientific review systems, regulatory capacity building activities, and the current international collaboration.

Learning Objectives

Discuss the latest information regarding PMDA and Japanese regulations; Describe how to foster dialogue between participants and senior PMDA officials concerning drug/device regulatory concerns.

Chair

Nobumasa Nakashima, PhD

Speaker

Regulatory Updates: Facilitating Early Patient Access
Kazuhiko Mori, MSc

The Future of PMDA
Yasuhiro Fujiwara, MD, PhD

Current Initiatives of PMDA Regulatory Science Center
Hiroyuki Arai, PhD



Speakers
avatar for Yasuhiro Fujiwara

Yasuhiro Fujiwara

Chief Exective, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. FUJIWARA Yasuhiro has been Chief Executive, PMDA since April 2019. He is a medical oncologist, specializing in breast cancer. He was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National... Read More →
avatar for Hiroyuki Arai

Hiroyuki Arai

Director of Center for Product Evaluation and Center of Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. ARAI Hiroyuki is currently Executive Director and Director of Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA). He oversees all aspects of medical product evaluation including review, scientific advice and standard compliance of pharmaceuticals... Read More →
avatar for Kazuhiko Mori

Kazuhiko Mori

Councilor for Pharmaceutical Affairs, Minister’s Secretariat, Ministry of Health, Labour and Welfare (MHLW)
Kazuhiko Mori, MSc., is currently Councilor for Pharmaceutical Affairs, Minister’s Secretariat of the Ministry Health, Lobour and Welfare (MHLW). Mr. Mori has led many of MHLW/PMDA’s drug initiatives. He contributed to introduce new approaches to drug safety regulation including... Read More →
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs and Asia Training Centre, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Nakashima holds the position of Associate Executive Director for International Programs and Asia Training Centre (ATC) at PMDA since January 2020. Before this position, he had joined MHLW in April 1992, where he worked as Director of Office of International Regulatory Affairs... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#242: Use of Real World Evidence to Support Regulatory Decision-Making: First-Year Findings From the RCT-DUPLICATE Project
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-601-L04-P; CME 1.00; IACET 1.00; RN 1.00

The Cures Act and the PDUFA IV mandated that the US FDA develop rules to guide industry on the use of real world evidence (RWE) for drug approvals. The session will bring together researchers and regulators to discuss the role of real world evidence.

Learning Objectives

Describe the DUPLICATE project replicating RCTs with real world data (RWD) analyses and provide an interim update on the findings from the first year; Discuss key considerations in implementing non-randomized studies using real world data to ensure valid and unbiased findings; Facilitate discussion how real world evidence may be used in regulatory decision-making.

Chair

Jeremy Rassen, DrSc, MS

Speaker

Initial Learnings From the RCT DUPLICATE Project
Jessica Franklin, PhD

Industry Perspective
Brande Yaist, MHS

Overview of the DUPLICATE Real World Evidence Demonstration Project
David Martin, MD, MPH



Speakers
avatar for Jessica Franklin

Jessica Franklin

Biostatistician, Div of Pharmacoepidemiology & Pharmacoeconomics;Asst Professor, Brigham and Women's Hospital and Harvard Medical School
Jessica Franklin, PhD, is an Assistant Professor of Medicine at Harvard Medical School and biostatistician in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Her research focuses on developing and applying statistical methods for the study... Read More →
avatar for David Martin

David Martin

Associate Director for Real World Evidence Analytics, OMP, CDER, FDA
David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions... Read More →
avatar for Jeremy Rassen

Jeremy Rassen

President and Chief Science Officer, Aetion
Jeremy A. Rassen, ScD is a pharmacoepidemiologist with 25 years of academic and industry experience. He is co-founder, president, and chief science officer at Aetion, a health care technology company that delivers real-world evidence for life sciences companies, payers, and regulatory... Read More →
avatar for Jessica Franklin

Jessica Franklin

Assistant Professor of Medicine, Div of Pharmacoepidemiology and Pharmacoeconomi, Brigham and Women's Hospital and Harvard Medical School
Jessica Franklin, PhD, is an Assistant Professor of Medicine at Harvard Medical School and biostatistician in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Her research focuses on developing and applying statistical methods for the study... Read More →
avatar for Brande Yaist

Brande Yaist

Senior Director, Global Patient Outcomes & Real World Evidence, Eli Lilly and Company
Mrs. Yaist is the Senior Director of the Center of Expertise in Global Patient Outcomes and Real World Evidence at Eli Lilly and Company. She leads and develops the research talent and capabilities needed to provide scientific services/expertise and support across an array of core... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#245: Artificial Intelligence Enhanced Data Analytics for Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-602-L04-P; CME 1.00; IACET 1.00; RN 1.00

Artificial Intelligence (AI) enhanced drug development is becoming increasingly important in the era of precision medicine.This session illustrates with examples how AI can impact and facilitate modern drug development.

Learning Objectives

Recognize the benefit of using artificial intelligence (AI) approaches in modern drug development; Identify the regulatory paths using biomarker-based, AI-enhanced strategies in clinical trials; Outline how to incorporate advanced analytics into trial analyses and future trial designs.

Chair

Felix Frueh, PhD

Speaker

Panelist
Mohammad Afshar, MD, PhD

Panelist
Federico Manuel Goodsaid, PhD



Speakers
avatar for Mohammad Afshar

Mohammad Afshar

Chief Executive Officer, Ariana Pharma
Mohammad founded Ariana® to accelerate the development of novel drugs with the help of computational decision support technologies. It has developed KEM®, for rapid & exhaustive analysis of multi-parametric/multi-objective data for biomarkers, drug discovery, clinical and early... Read More →
FF

Felix Frueh

Executive Partner, Opus Three LLC
avatar for Federico Goodsaid

Federico Goodsaid

Associate Partner, Biomarkers and Regulatory Affairs, Opus Three LLC
B.A. was in Biochemistry and Biophysics from the University of California at Berkeley and his Ph.D from Yale University, New Haven, in Molecular Biophysics and Biochemistry. He was a Postdoctoral Fellow at Cornell University in Ithaca, New York and at Washington University in St... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#246: How Employers are Reinventing Healthcare and What it Means for Research Participation and Evidence
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-603-L04-P; CME 1.00; IACET 1.00; RN 1.00

Employers are contracting directly with vendors to provide innovative healthcare services for their employees. Featuring patients, advocates and vendors, this panel shows how to engage employers and measure their impact in drug development.

Learning Objectives

Explain the experience of patient/employee balancing career, health care and benefits; Describe how employer benefits are changing; Identify collaborative opportunities between payers, providers, employers and advocates to facilitate employee/patient access to quality, affordable care; Illustrate how stakeholders can align on data requirements to capture and report key metrics to support care quality and cost management in hemophilia.

Chair

Mary Stober Murray, MBA

Speaker

Improving Collaboration and Data Reporting for Integrated Hemophilia Care: Metrics for Quality Improvement/Cost Management
Kollet Koulianos, MBA

Personalized Care Management
Marc M. Boutin, JD

Patient Perspective
Jacqueline Smith



Speakers
KK

Kollet Koulianos

Senior Director Payer Relations, National Hemophilia Foundation
avatar for Mary Murray

Mary Murray

Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb Company
As an Associate Director for Diversity and Patient Engagement at Bristol-Myers Squibb, Mary facilitates collaborations with disease-specific and community-based organizations to bring relevant clinical trial options to patients and representative populations. Mary has co-chaired the... Read More →
JS

Jacqueline Smith

Associate Director, Oncology Advocacy and Policy, Bristol-Myers Squibb
avatar for Marc Boutin

Marc Boutin

Chief Executive Officer, National Health Council (NHC)
Marc M. Boutin, JD, is the Chief Executive Officer of the National Health Council. He has been a leading voice for greater patient involvement at every stage of the health care continuum. Boutin has been actively involved in patient advocacy organization management, health advocacy... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#255: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-610-L04-P; CME 1.25; IACET 1.25; RN 1.25

Machine Learning is one approach in the fast-paced field of artificial intelligence that is positioned to address many key issues in pharmacovigilance. However, it presents several challenges which must be addressed by both industry and regulators. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 3:15-4:15PM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Review updated developments in machine learning in PV; Discuss risks and challenges; Describe updates on regulatory landscape and areas of future development and collaboration.

Chair

Bruce Donzanti, PhD

Speaker

Chapter Two: Implementing Automation, Machine Learning, and Analytics in Pharmacovigilance - Case Study
Lisa George, RPh

FDA Perspective
Robert Ball, MD, MPH, MSc

MHRA Perspective
Mick Foy



Speakers
avatar for Robert Ball

Robert Ball

Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA
Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug risks and promoting the safe use of drugs by the American... Read More →
avatar for Bruce Donzanti

Bruce Donzanti

Senior Group Director, Global Pharmacovigilance Innovation Policy, Genentech, A Member of the Roche Group
Bruce has a PhD in pharmacology/neuroscience with almost 30 years of experience in the pharma/biotech industry. Prior to industry, he performed research on mechanisms of neuronal degeneration and neurotoxicology and lectured in neuropharmacology to graduate and medical students while... Read More →
avatar for Mick Foy

Mick Foy

Head of Pharmacovigilance Strategy, Vigilance Intelligence, and Research Group, Medicines and Healthcare Products Regulatory Agency (MHRA)
Mick Foy is Head of Pharmacovigilance Strategy at the MHRA. Among is responsibilities is the running of the UK ADR reporting system and signal detection activities. Mick is also leads the MHRA's work with WHO and the Bill and Melinda Gates Foundation on capacity building in low and... Read More →
avatar for Lisa George

Lisa George

Advisor, Global Patient Safety, Case Management, Eli Lilly and Company
Lisa George has a B.S. in Pharmacy from Butler University, Indianapolis IN. Lisa started in the pharmaceutical industry in 1998 with Eli Lilly and Company's Global Patient Safety (GPS) department. During her time in GPS, she has worked with case management in various capacities. Lisa... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#264: Immuno-Oncology Product Development: Overcoming Scientific and Regulatory Challenges
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-19-615-L04-P; CME 1.25; IACET 1.25; RN 1.25

The development of immuno-oncology products has spanned decades, culminating in approvals for the use of immune modulating cytokines, monoclonal antibodies, fusion proteins, genetically modified T cells, cancer vaccines and oncolytic vectors, for the treatment of cancer. Currently there are hundreds of immuno-oncology products in clinical trials.

This session will provide an overview of immuno-oncology products, highlighting the relevant preclinical safety regulations and potential safety concerns ascribed to different categories of products. Preclinical development challenges, such as, selecting the relevant pharmacology and toxicology models, distinguishing pharmacologic from toxicologic responses, and justifying first in human dose, will be discussed. Case examples highlighting the preclinical testing strategies that are being applied to evaluate the pharmacology and safety of immuno-oncology drugs will also be presented.

Learning Objectives

Describe immuno-oncology products, including the potential safety concerns ascribed to different immunotherapeutic modalities; Identify the regulatory requirements (and/or challenges) associated with preclinical safety evaluation for different modalities of immuno-oncology drugs; Discuss the preclinical testing strategies that are being applied to evaluate the pharmacology and safety of immuno-oncology products through case study presentations.

Chair

Laurie Iciek, PhD

Speaker

New Challenges for Developing HER2-Targeted Cancer Immunotherapeutics
Karin Staflin, PhD

Strategies for Preclinical Safety Assessment of Immune-Oncology Biologics
Simone Nicholson, PhD

Challenges in Predicting Animal-to-Human Safety for Immune-Stimulatory Agents from Toxicology Studies
Theresa Sweeney, PhD



Speakers
avatar for Laurie Iciek

Laurie Iciek

Senior Consultant, Nonclinical, Biologics Consulting
Laurie is currently a Sr. Nonclinical Consultant for Biologics Consulting. Previously she spent 17 years in industry as a lead Toxicologist for MedImmune/AstraZeneca, Abbott Laboratories, and Bristol-Myers Squibb. Her academic training is in cellular and molecular immunology and her... Read More →
SN

Simone Nicholson

Toxicologist, AstraZeneca
Simone is a Toxicologist at MedImmune/AstraZeneca, she supports the safety assessment of multiple biologics modalities at all stages of development. Prior to her time at MedImmune, Simone performed in vivo pharmacology and safety studies at Dyax, the antibody library company. She... Read More →
KS

Karin Staflin

Senior Scientist, Genentech, A Member of the Roche Group
Dr. Karin Staflin, PhD., DABT., is a Development Toxicologist within the Safety Assessment Group at Genentech. She is responsible for the safety assessment of early- to late-stage large and small molecule therapeutics, within a range of disease areas. Before joining the Development... Read More →
avatar for Theresa Sweeney

Theresa Sweeney

Vice President, Safety Assessment, Nektar Therapeutics
Dr. Sweeney is currently the Vice President of Safety Assessment at Nektar Therapeutics where she leads a team responsible for evaluating the safety of both large and small molecule drugs. She has more than 25 years of drug development experience at Nektar and Genentech. Her professional... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#269: Driving Complex Generics to Approval: What are the Keys to Success
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-620-L04-P; CME 1.25; IACET 1.25; RN 1.25

GDUFA II provides new regulatory processes designed to accelerate access to generic versions of complex products. In thisforum, FDA and industry provide examples on how to effectively use these processes.

Learning Objectives

Explain how the FDA review of ANDAs for complex generics has been improved under GDUFA II; Describe current regulatory and scientific considerations for generic combination products; Develop strategies to communicate more effectively with FDA during development of a complex product intended for submission under an ANDA.

Chair

Robert A. Lionberger, PhD

Speaker

Industry Perspective
Michelle Lee-Bourner, MSc

FDA Update
Martha Nguyen, JD



Speakers
avatar for Martha Nguyen

Martha Nguyen

Director, Division of Policy Development, OGD, CDER, FDA
Martha Nguyen is the Director of the Division of Policy Development in FDA CDER's Office of Generic Drugs, where she provides strategic leadership and direction on broad policy issues affecting generic drugs and oversees the development and clearance of regulations, guidance documents... Read More →
avatar for Michelle Lee-Bourner

Michelle Lee-Bourner

Head Global Respiratory and Biologics Regulatory Sciences, Mylan Pharma UK Ltd
Michelle Lee-Bourner has 30 years’ experience of drug pharmaceutical research and development, focused mainly on NCE’s and more recently generics, biosimilars and biologics. At Pfizer Michelle’s career spanned drug discovery, early clinical research and Regulatory Affairs. Michelle... Read More →
avatar for Robert Lionberger

Robert Lionberger

Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA
Robert Lionberger, Ph.D. serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the GDUFA science and research commitments including internal research activities and external research grants... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#271: Master Protocols: Applications in Oncology
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-19-621-L04-P; CME 1.25; IACET 1.25; RN 1.25

Future advances in medicine depend on our ability to leverage complex innovative designs of clinical trials. Master protocols, including basket, umbrella, and platform trials, as one type of complex innovative designs, provide a method to answer multiple questions in one overall trial structure. In this session, the concept of master protocols, some case studies using real world examples in oncology, and the advantages and challenges of designing and implementing master protocols will be discussed. Join the Statistics Community for a follow up Round Table discussion on Wednesday, June 26, 3:15-4:15PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Explain the concept of master protocols; Discuss case studies in master protocols with applications in oncology; Describe opportunities and challenges in applying master protocols as an innovative approach in oncology drug development.

Chair

Amy Xia, PhD

Speaker

FDA Update
Yuan-Li Shen, DrPH

Industry Update
Scott M Berry, PhD, MS

Industry Perrspective About Platform Trials
Karen Lynn Price, PhD, MA



Speakers
avatar for Scott Berry

Scott Berry

President and Senior Statistical Scientist, Berry Consultants LLC
Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests... Read More →
avatar for Karen Price

Karen Price

Research Fellow, Statistical Innovation Center/Design Hub, Eli Lilly and Company
Karen received her Ph.D. in Statistics from Baylor University in 2001, and joined Eli Lilly and Company at that time. She is currently Research Fellow at Eli Lilly and Company where she leads the Statistical Innovation Center, a team that focuses on innovative design and analysis... Read More →
avatar for Amy Xia

Amy Xia

Vice President, Biostatistics, Design & Innovation, Amgen Inc.
Amy Xia is Vice President, Biostatistics, Design & Innovation at Amgen. Amy has worked on designing, implementing, and analyzing Phase I-IV clinical trials as well as observational studies in the past 22+ years. Currently, she heads up the Biostatistics and Design & Innovation organizations... Read More →
YS

Yuan-Li Shen

Acting Associate Director, Office of Biostatistics, OTS, CDER, FDA
Yuan-Li is the acting Associate Director in Division of Biometrics V, Office of Biostatistics, Office of Translational Science, CDER, FDA. The teams that she is associated with support all statistical aspects of regulatory submissions in Gastrointestinal, Lung/Head and Neck, Neuro-oncology/Rare... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#272: Aligning Facilitated Regulatory and Access Pathways: Observations from the North American Experience
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-622-L04-P; CME 1.25; IACET 1.25; RN 1.25

The purpose of this session is for agencies, industry, and other organizations to present their observations around the types of facilitated pathways that are available in North America to speed access to medicines that address an unmet medical need.

Learning Objectives

Describe initiatives that the US and Canada has implemented to streamline the process for approval of and access to therapies that address unmet medical need (UMN); Illustrate opportunities and challenges with aligning regulatory and access pathways; Discuss if these pathways may have a broader remit than just for therapies for UMN.

Chair

Lawrence Eugene Liberti, PhD, RPh, RAC

Speaker

Market Access on the Two Sides of the Atlantic: Barriers and Opportunities
Maria Isabel Manley, LLM

Aligning Approval and Access: The US Experience
Sean Tunis, MD, MSc

Patient Perspective
Julie Eller



Speakers
avatar for Lawrence Liberti

Lawrence Liberti

Head, Regulatory Collaborations, Centre for Innovation in Regulatory Science (CIRS)
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →
avatar for Maria Manley

Maria Manley

Partner, Head of the UK Life Sciences, Sidley Austin LLP
Marie Manley leads is Partner and Head of Sidley’s UK life sciences practice. She is a distinguished thought leader and adviser on EU and UK regulatory law and acts as Chairperson of the DIA Legal Affairs Community. Marie advises clients before both national and European courts... Read More →
avatar for Julie Eller

Julie Eller

Manager, Grassroots Advocacy, Arthritis Foundation
Julie leads a patient network of more than 100,000 patient Advocates as they share their story to effect change. Julie has had arthritis since she was seven years old and the Arthritis Foundation has helped her foster a passion for translating the patient experience into advocacy... Read More →
ST

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMPT)


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#281: Structured Evidence Planning, Production, and Evaluation (SEPPE): A “Quality-Based” Framework for Drug Development
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-627-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will convene experts from the regulatory authority, payer, industry, and patient communities to discuss how a new type of strategic “quality by design” framework for drug development.

Learning Objectives

Describe a comprehensive framework for evidence generation to support optimal drug development and more efficient pathways to product approval; Identify pragmatic approaches for integrating this framework into regulatory authority and pharmaceutical company organizational structures.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

SEPPE Framework and Implications for Regulators
Robyn R. Lim, PhD

Implications for Patients
Marc M. Boutin, JD

Pragmatic Lessons Learned from Implenting Within a Pharmaceutical Company
Meredith Y. Smith, PhD, MPA

EMA Perspective
Anthony Humphreys, MPharm



Speakers
avatar for Marc Boutin

Marc Boutin

Chief Executive Officer, National Health Council (NHC)
Marc M. Boutin, JD, is the Chief Executive Officer of the National Health Council. He has been a leading voice for greater patient involvement at every stage of the health care continuum. Boutin has been actively involved in patient advocacy organization management, health advocacy... Read More →
avatar for Anthony Humphreys

Anthony Humphreys

Head of Scientific Committees Regulatory Science Strategy, European Medicines Agency (EMA)
He is the Head of Scientific Committees Regulatory Science Strategy Division (SciRS). He is responsible for providing leadership in the Agency in the areas of Scientific Committees Coordination and Regulatory Science Strategy in support of delivering the EMRN 2020 Strategy. He chairs... Read More →
avatar for Robyn Lim

Robyn Lim

Senior Science Advisor, Health Products and Food Branch, Health Canada
Dr Lim’s focus is modernizing Canada’s federal drug regulatory system, developing the benefit-harm-uncertainty evidence standard for Canada’s amended Food and Drugs Act. Her interests are scientifically and socially-responsible patient-focussed and life-cycle approaches for... Read More →
avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#282: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-628-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum-style enquiry session is designed as a panel discussion driven by audience participation. Speakers will present prepared summary comments on effective communication of safety and risk concepts in reference safety information (RSI). These short, introductory statements will prepare the audience for discussion of the evolving product labeling landscape, using Japan and Asia as examples. Additional comments will describe the existing regulatory guidance from Canada, the EU, and the US that supports simplification of suspected adverse reactions in RSI. To facilitate convergence of several independent efforts aimed at grouping near-synonymous medical concepts, CIOMS has formed an exploratory working group to assess the feasibility of developing internationally harmonized consensus principles for “MedDRA® Labeling Groupings” (MLGs). If developed, these principles could be available for consideration when the existing MedDRA hierarchy does not support the desired groupings. Practical examples of current challenges will be discussed in the context of enhancing understandability of medical concepts by the health care community. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 2:00-3:00PM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Describe regional safety labeling requirements in Japan and Asia and their international implications (for the benefit of patients); Identify existing regulatory guidance that supports simplification of RSI; Define practical examples of medical concepts that are nearly synonymous from a clinical perspective and which might be appropriate candidates for application of MLGs; Explain the new CIOMS initiative that is exploring feasibility of developing principles for MLGs.

Chair

Judith Jones

Speaker

Dynamic Trends for Value and Meaningful Product Safety Labeling in Asia, Including Japan
Rie Matsui, RPh

A Perspicacious CIOMS View of a Sometimes Tangled Mass of Adverse Reaction Communication Challenges
William Gregory, PhD

MedDRA Labeling Groupings (MLGs): A New CIOMS Initiative
Sonja Brajovic, MD

MedDRA Labeling Groupings (MLGs): Practical Examples Underscore Feasibility
Ilona Grosse-Michaelis, MD, PharmD



Speakers
avatar for William Gregory

William Gregory

Senior Director, Safety and Risk Management, Pfizer Inc
He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well... Read More →
avatar for Judith Jones

Judith Jones

Principal Consultant, Pharmacovigilance, Epidemiology, and Risk Management, PharmaLex
Dr. Jones is a clinical pharmacologist/pharmacoepidemiologist trained in geriatrics and internal medicine with a longstanding interest in the study of adverse drug reactions, drug utilization, and drug development and regulation. She received her medical training at Baylor College... Read More →
avatar for Rie Matsui

Rie Matsui

Senior Director, Regional Labeling Head for APAC, Pfizer R&D
Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group(ILG), Global Regulatory Affairs, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer. The Asia Labeling Hub has created various... Read More →
avatar for Sonja Brajovic

Sonja Brajovic

Medical Officer, OSE, CDER, FDA
Sonja Brajovic is a Medical officer in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for coordination of projects related to the Medical Dictionary for Regulatory Activities... Read More →
avatar for Ilona Grosse-Michaelis

Ilona Grosse-Michaelis

Senior Medical Dictionary Expert, Bayer AG
Dr. Große-Michaelis is a clinical pharmacologist trained in internal medicine and pharmacology/ toxicology with a longstanding interest in the risk-benefit profile of drugs, and drug development. She obtained her medical degree from the Humboldt University of Berlin, Germany. The... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#286: The Machines are Here! Learn About Real Uses of Machine Learning and Artificial Intelligence in Pharma
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-629-L04-P; CME 1.25; IACET 1.25; RN 1.25

Artificial Intelligence (AI) and Machine Learning ML) have become buzzwords in every industry. While most of AI's potential is yet to be reached, pharma is starting to see tangible benefits that can be applied across the industry. This session will discuss new technologies and methods leveraging AI and ML to transform aspects of MedDRA coding, WHO drug coding, and data quality.

Learning Objectives

Explain and contrast the definitions of Artificial Intelligence and Machine Learning; Describe how AI has impacted MedDRA coding; Discuss how to review ways in which AI has been implemented to improve the efficiency and accuracy of WHO drug coding and the challenges experienced along the way; Identify how pharmaceutical companies and CROs have leveraged machine learning technology to improve data quality and overall drug submission success.

Chair

Stacey Yount, MA

Speaker

Introduction to Artificial Intelligence and Machine Learning: Application for MedDRA Coding
Cartic Ramakrishnan, PhD

How Can We Optimize the Use of Machine Learning for Increased Efficiency in Drug Coding?
Malin Jakobsson, MPharm, RPh

The Use of Machine Learning to Transform Clinical Trial Data Quality and Efficiency
Stacey Yount, MA



Speakers
avatar for Malin Jakobsson

Malin Jakobsson

Product Strategy Manager, Uppsala Monitoring Centre
Malin is Product Strategy Manager for WHODrug at Uppsala Monitoring Centre (UMC). She is a pharmacist by training and she has been working with WHODrug in different roles for twelve years, from data validation to production and now she is involved in the strategic development of the... Read More →
avatar for Cartic Ramakrishnan

Cartic Ramakrishnan

Senior Technical Staff Member, Lead Cognitive Scientist, Life Sciences, IBM Watson Health
Cartic Ramakrishnan is a research scientist with a background in NLP and Machine Learning. He serves as lead scientist at IBM Watson health developing solutions to problems in the biomedical and healthcare domain. Cartic's recent work has focused on the development of NLP systems... Read More →
avatar for Stacey Yount

Stacey Yount

Vice President, Product, Medidata Solutions
As Vice President of Product at Medidata, Stacey Yount is the leader for the CTMS and Risk Based Monitoring platform. With 20 years of experience in clinical research, Stacey is an expert in data management, pharmaceutical efficiency, clinical development, CRO operations, and innovation... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#296: Informing Development and Authorizations Using Real World Evidence/Artificial Intelligence
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-645-L04-P; CME 1.25; IACET 1.25; RN 1.25

The evolution of actionable insights on how medicines are used, generated from real world evidence and artificial intelligence will be discussed. This session will focus on knowledge management, regulatory intelligence, and learning healthcare systems.

Learning Objectives

Discuss the potential for artifical intelligence and real world evidence to inform both development and authorization; Identify the opportunities and barriers and how AI and RWE in conjunction with knowledge management can enable better development and regulatory decisions.

Chair

Lawrence Eugene Liberti, PhD, RPh, RAC

Speaker

How Do Companies View Knowledge Management as a Decision-Making Tool?
Magda Bujar, PhD, MSc

Learning Healthcare Systems: Managing Real World Evidence/Knowledge - How Can This Transition Healthcare Data to Actionable Information?
Andrea Julsing Keyter, MS

Potential Uses of AI for Regulatory Intelligence: How Can This be Used Practically and What are the Barriers and Opportunities?
Mukesh Singhal, MBA



Speakers
avatar for Magda Bujar

Magda Bujar

Manager, Strategic Development, Centre For Innovation In Regulatory Science (CIRS)
Dr Magda Bujar is the Manager of Strategic Development at CIRS. In her current role, she is responsible for developing and executing strategies for engaging with CIRS stakeholders - pharmaceutical companies as well as major regulatory authorities. Magda also initiates and coordinates... Read More →
avatar for Lawrence Liberti

Lawrence Liberti

Head, Regulatory Collaborations, Centre for Innovation in Regulatory Science (CIRS)
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →
avatar for Andrea Keyter

Andrea Keyter

Deputy Director, Medical Devices, South African Health Products Regulatory Authority
Andrea is a pharmacist and has 10 years of experience within the field of regulatory affairs, quality assurance, quality risk management, pharmaceutical production, complementary medicines manufacture and risk-based inspection planning. In her current role, Andrea is responsible for... Read More →
avatar for Mukesh Singhal

Mukesh Singhal

Senior Manager, Deloitte
Mukesh is a Senior Manager in Deloitte Consulting's life science R&D practice. He has spent over 15 years of his career between industry and Consulting. He focuses on helping R&D organizations at biotech and pharmaceutical companies address strategic and operational challenges with... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

8:00am

#301: So Much Data, So Little Time: Hot Topics in Benefit-Risk Assessment
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-646-L04-P; CME 1.25; IACET 1.25; RN 1.25

Both regulators and sponsors are increasingly using structured frameworks to assess the benefit-risk profile of medicinal products. Such frameworks can accommodate a variety of data sources and can be supplemented by an array of graphical presentations. As experience with using structured benefit-risk assessment (SBRA) frameworks in both the pre- and post-market context accrues, a number of important questions remain, including: 1) What has been learned by FDA and EMA in regard to using a structured benefit-risk assessment framework for new drug application assessments? 2) How are these regulatory authorities continuing to train and support their reviewers in conducting such assessments? 3) What are the challenges involved in incorporating real world data into structured benefit-risk assessment analyses? 4) What are good practices in terms of evaluating the impact of different types of uncertainty on the quality of the benefit-risk assessment decision?

Learning Objectives

Describe the FDA’s and EMA’s experiences to date in implementing structured approaches to benefit-risk assessment, including the use of the Effects Tables and other tools; Discuss the key considerations in evaluating the impact of uncertainty on the quality of the benefit-risk assessment decision; Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

FDA's Experience to Date Using the Structured Benefit-Risk Assessment Framework to Support Regulatory Decision-Making
Graham Thompson

Use of Real World Evidence in Personalized Benefit-Risk Assessment: Closing the Knowledge Gap
Tarek Hammad, MD, PhD, MS, MSc, FISPE

EMA Perspective
Douwe Postmus, PhD, MSc



Speakers
avatar for Tarek Hammad

Tarek Hammad

Therapeutic Area Strategy Lead, Global Pharmacovigilance, Sanofi Genzyme
Dr. Hammad joined Sanofi-Genzyme, in 2019, as a Therapeutic Area Strategy Lead in the Global Pharmacovigilance group. Prior to this, he served as the Head of Signal Detection and Benefit-Risk Assessment in Merck KGaA/EMD Serono. Previously, he was an Executive Director of Pharmacoepidemiology... Read More →
avatar for Douwe Postmus

Douwe Postmus

Researcher, University Medical Center Groningen
Dr Douwe Postmus is employed as a researcher at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory, reimbursement... Read More →
avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →
GT

Graham Thompson

Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER, FDA
Graham Thompson joined FDA in 2012 and currently serves as an operations research analyst for the Decision Support and Analysis Team (DSAT) in FDA’s Center for Drug Evaluation and Research (CDER). He works on CDER projects and initiatives related to benefit-risk assessment and supporting... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#306: Methods for Integrating EHR Data into EDC and eSource Databases
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-647-L04-P; CME 1.25; IACET 1.25; RN 1.25

Panelists will share experience and methods that make the integration of EHR and clinical trial electronic data capture a reality that can be repeated – and without protocol-specific custom coding.

Learning Objectives

Describe the difference between electronic medical record (EMR) systems and electronic health record systems (EHR); Define the key principles and methods for integrating medical record data with electronic data capture; Evaluate integration feasibility, scalability and costing for EHR and EDC/eSource data integrations.

Chair

Gene Vinson

Speaker

Sponsor Perspectives on EHR to EDC Integration
Len Rosenberg

Technology Innovations for EHR Data Integrations
Hugh Levaux, PhD

Operational Lessons Learned for EHR to EDC Integrations
Gene Vinson



Speakers
avatar for Hugh Levaux

Hugh Levaux

Founder & CEO, Protocol First
Dr. Hugh Levaux is Founder and CEO of Protocol First. The company offers innovative software solutions for clinical research such as Protocol First eProtocol, eSource and EDC integrated platform or Clinical Pipe -- industry’s first system-agnostic EHR-to-EDC connector application... Read More →
avatar for Len Rosenberg

Len Rosenberg

Head of Clinical Operations, Beat AML/Leukemia and Lymphoma Society
Dr. Rosenberg is a 30 plus year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical and contract research organization sectors. With his diverse background which includes executive management, clinical... Read More →
avatar for Gene Vinson

Gene Vinson

Executive Director, Global Data Technologies, Biometrics, Syneos Health
Gene Vinson has over 15 years’ experience in a clinical research organization (CRO) and is currently the Senior Director of Global Data Technologies in Biometrics at Syneos Health. Gene has lead the implementation of multiple EDC Systems and is an expert in the implementation of... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#310: Project Planning 101: Turning Strategy into Execution
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-651-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166RVVC1X; RN 1.25

A successful project starts with good planning. This session will provide tool agnostic best practices for creating a credible, realistic timeline that will help your project team achieve its deliverables on time.

Learning Objectives

Describe fundamental components of at least one project management methodology for managing a project; Compare and contrast differences between project management approaches; Describe the various roles and responsibilities of project managers either in non-drug development projects or in junior roles.

Chair

Matthew Curin, PharmD

Speaker

Best Practices for Project Planning
Ken Hays, MBA



Speakers
avatar for Ken Hays

Ken Hays

Senior Project Management Consultant, Independent Consultant
Ken has been engaged in Project Management since 1992, with experience in IT, Data Communications, Medical Device R&D and manufacturing, Drug Development and Process Improvement initiatives. He has driven key changes to large and small Project Organizations globally. As a PMP and... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#314: Medical Devices: EU Medical Device Regulation, PMDA Updates, and US MDUFA IV – Where Are We Now?
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-655-L04-P; CME 1.25; IACET 1.25; RN 1.25

Since 2017 we have analyzed the new EU Medical Devices Regulations, the enabling acts (still to come!) and MDUFA IV. Now one more year on, we examine what has improved, where action is still required and what to do now to keep products on the market and review new initiatives in Japan.

Learning Objectives

Describe how your own organization is managing the change to the new EU regulations; Assess what changes the MDUFA IV regulations have already made and how things might change further; Discuss the changes happening in Japan; Identify areas where your organization still needs to move forward to comply with the new regulations; Interpret the new regulations and guidance to benefit their own working environment.

Chair

Angela Stokes, MSc

Speaker

The Medical Device Regulation: Less Than a Year to Go! Where Are We Now?
Angela Stokes, MSc

Recent Progress of Balancing Between Risk/Benefit Assessment and Patient Access to Medical Devices in Japan
Nobuhiro Handa, DrMed, MD

MDUFA IV: Another Year has Passed! What are the Highlights?
LeeAnn L Chambers, MS



Speakers
LC

LeeAnn Chambers

Principal Research Scientist, Global Regulatory Affairs, CMC - Devices, Eli Lilly and Company
LeeAnn Chambers has been a Regulatory Affairs professional at Eli Lilly and Company for 22 years. She assists teams in developing global registration strategies for medical devices and drug / device combination products. She has guided the preparation of device content in US IND... Read More →
avatar for Nobuhiro Handa

Nobuhiro Handa

Principal Reviewer, Office of Medical Device, Pharmaceuticals and Medical Devices Agency (PMDA)
I graduated the University of Tokyo, Faculty of Medicine in 1985. Since then I had been a cardiovascular surgeon over 28 years. I was trained in the US for 4 years at Mayo clinic as well as Massachusetts General Hospital. I changed my career at age of 52 from clinical physician to... Read More →
avatar for Angela Stokes

Angela Stokes

Vice President, Head Global Regulatory Consulting, Syneos Health
Angela has almost 30 years of experience in medicinal product and medical device development. Her strengths include regulatory and strategic advice, authorship of regulatory submissions, regulatory writing, regulatory research, and compliance with relevant guidelines and standards... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#313: Model Integrated Evidence as Pivotal Information for Drug Regulatory Decision Making: When, Where, and Why
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-654-L04-P; CME 1.25; IACET 1.25; RN 1.25

The use of advanced quantitative methods and computational modeling has become part of modern drug development and assessment. Model Integrated Evidence (MIE) is an approach for generating evidence of bioequivalence via modeling and simulation.

Learning Objectives

Identify the core modeling and simulation capabilities (PBPK and QCP) that a generic drug manufacturer must posses; Evaluate lessons learned from the use of a model informed drug development process for new drugs, and apply common processes to generic drug development programs; Define and prepare for the future use of model informed evidence (MIE) in a generic drug submission and identify the value.

Chair

Liang Zhao, PhD

Speaker

Industry Update
Michael A. Eldon, PhD, RPh

FDA Update From New Drugs Perspective
Yaning Wang, PhD

FDA Update from Generic Drugs Perspective
Liang Zhao, PhD



Speakers
avatar for Yaning Wang

Yaning Wang

Director, Division of Pharmacometrics, OCP, OTS, CDER, FDA
Dr. Yaning Wang is the Director of the Division of Pharmacometrics in the Office of Clinical Pharmacology at FDA. Before joining FDA, Dr. Wang received his Ph.D. in Pharmaceutics and master’s degree in Statistics from the University of Florida from 1999 to 2003. He also obtained... Read More →
LZ

Liang Zhao

Director, Division of Quantitative Methods and Modeling, OGD, CDER, FDA
Dr. Liang Zhao has been serving as Director of the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS) in Office of Generic Drugs, CDER since 2015. He initially joined FDA as a clinical pharmacology reviewer in the Office of Clinical Pharmacology... Read More →
avatar for Michael Eldon

Michael Eldon

Expert Consultant, NDA Partners LLC
Dr. Eldon has more than 37 years of experience in clinical pharmacology, pharmacokinetics/ pharmacodynamics and pharmacometrics in the pharmaceutical industry. He is an Expert Consultant at NDA Partners and as VP of Clinical Pharmacology at Nektar Therapeutics he was responsible for... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#316: Implementation of Innovative and Adaptive Designs in Clinical Trials
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-656-L04-P; CME 1.25; IACET 1.25; RN 1.25

The use of innovative designs and possible adaptations can help reduce the number of patients required for trial recruitment, thereby shortening drug development time. Experts from FDA and the industry will provide feedback on the complex innovative designs and how they inform regulatory decision making.

Learning Objectives

Outline the advances in adaptive designs; Utilize newly developed innovative designs in clinical trials.

Chair

Aloka Chakravarty, PhD

Speaker

Recent Advances in Group Sequential and Adaptive Designs for Unblinded Sample Size Re-estimation and Seamless Phase 2/3 Pivotal Trials
Sandra Bihary-Waltz, BSN, MSN

EMA Update
Andrew Thomson, PhD, MA, MS

FDA Update
Meiyu Shen, PhD



Speakers
MS

Meiyu Shen

Expert Mathematical Statistician, Office of Translational Sciences, CDER, FDA
A team leader and a senior statistical reviewer at the Center of Drug Evaluation and Research, Food and Drug Administration (FDA). She obtained her Ph.D. in statistics from Statistics Program of Department of Mathematics at University of Maryland at College Park in 2015 and her Ph.D... Read More →
AT

Andrew Thomson

Statistician, Biostatistics and Methodology Support Office, European Medicines Agency
Andrew Thomson is a statistician in the Office of Biostatistics & Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics subgroup of ICH... Read More →
SB

Sandra Bihary-Waltz

Senior Director, Global Regulatory Affairs, PRA Health Sciences
Sandra joined Idis as the Global Head of REgulatory Affairs in 2012, after spending over 24 years in the pharmaceutical industry, predominantly in regulatory affairs. She has extensive experience in all phases of drug development, through post-approval activities, including EAP p... Read More →
SB

Sandra Bihary-Waltz

Senior Director, Global Regulatory Affairs, PRA Health Sciences
Sandra joined Idis as the Global Head of REgulatory Affairs in 2012, after spending over 24 years in the pharmaceutical industry, predominantly in regulatory affairs. She has extensive experience in all phases of drug development, through post-approval activities, including EAP p... Read More →
avatar for Aloka Chakravarty

Aloka Chakravarty

Deputy Director, Office of Biostatistics, Office of Translational Sciences, CDER, FDA
Dr. Chakravarty joined CDER in 1992. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development and has presented and published widely on it. Dr. Chakravarty received the FDA Award of Merit in 2008 and... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#327: Digital Risk Minimization: The “Next Generation” Risk Management Tools
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-664-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will describe the process of conceptualizing, implementing, and evaluating digital risk minimization tools, using several real world examples. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 4:15-5:15PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the process of developing a digital risk minimization tool; Outline considerations for the effective implementation and evaluation of a digital risk minimization tool.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

Leveraging Digital for Effective Risk Minimization Tools: Operational and Policy Considerations
Simon Ingate, PhD, MBA

One Company's Perspective on Implementing Digital Risk Minimization Tools Globally
Sarah A. Frise, PhD, MS

Applying the Diffusion of Innovaton Theory Framework to the Implementation of Innovative Digital Risk Minimization Measures
Carmit Strauss, PharmD



Speakers
avatar for Simon Ingate

Simon Ingate

Director, Huron Consulting Group
Simon Ingate is a Principal Consultant at Huron Consulting Group (Formerly Pope Woodhead) where he develops and implements risk management/minimisation (RM) strategy and programmes. Simon leads teams developing new approaches for disseminating and evaluating risk minimisation measures... Read More →
avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →
avatar for Carmit Strauss

Carmit Strauss

Global Benefit Risk Management Scientist, Safety Management, Amgen Inc.
Carmit Strauss, PharmD, is currently a Benefit Risk Management Scientist at Amgen. Dr. Strauss obtained her PharmD at the University of Southern California and completed her industry Post-Doctoral fellowship in medical affairs at Baxter Bioscience. Dr. Strauss has a global medical... Read More →
avatar for Sarah Frise

Sarah Frise

Global Director Risk Management, AstraZeneca
Sarah holds a Masters Degree in Physiology and Phd in Epidemiology. Sarah holds the position of the Global Director, Risk Management at AstraZeneca and a faculty position in Epidemiology at the University of Toronto. She is an active member of many Pharmacovigilance working groups... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#340: Digital Technology Advances Labeling Management and Patient Access
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-671-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will update the labeling management across regions in the EU and the Asia Pacific, in particular, the NMPA and PMDA will elaborate on current labeling management in China and Japan and envisage digital/electronic labeling management in the future. Also, the industry will share some industry initiated eLabeling pilot activities, finally, all will discuss the opportunities and hurdles of introducing digital/electronic labeling

Learning Objectives

Explain digital/electronic labeling policy and its pilot activities across different regions; Discuss the advantages of digital/electronic labeling and benefit to patients and prescribers; Describe the latest eLabeling policy and future trends in EU and the Asia Pacific, particularly in Japan and China

Chair

Vicky (Fengyun) Han

Speaker

Labeling Management Update from the PMDA
Mariko Tsukuda, MSc

NMPA Labeling Management and Envisage of Electronic Labeling Trends in China
Xiao Yuan Chen, PhD

Digital Labeling Innovation in Europe
Shimon Yoshida, PhD

Trends of eLabeling and its Innovation Pilot Activities in Asia Pacific
Vicky (Fengyun) Han



Speakers
avatar for Vicky (Fengyun) Han

Vicky (Fengyun) Han

Senior Director, Asia Pacific Regulatory Policy Group Lead, Asia Pacific, Johnson & Johnson Pte. Ltd.
Vicky Han is Senior Director at Janssen Pharmaceuticals in charge of Asia Pacific Regulatory Policy since 2016. Her experiences spans in Asia & Europe, she dedicated 18 years in GSK, wherein 12 years in GSK China for leading regulatory affairs. In 2008, she moved to Belgium for dealing... Read More →
avatar for Mariko Tsukuda

Mariko Tsukuda

Reviewer, Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency (PMDA)
Mariko Tsukuda is Reviewer at Pharmaceuticals and Medical Devices Agency since 2014. Mrs.Mariko Tsukuda worked for implementation of ICH E2B(R3), which is electronic standard for ICSRs, in Japan as an ICH E2B member since 2014.
avatar for Shimon Yoshida

Shimon Yoshida

Executive Director, International Labeling, Pfizer Inc
Dr Shimon Yoshida is Executive Director at Pfizer, and heads the International Labeling Group in Global Regulatory Affairs. Dr Yoshida obtained a PhD in Chemistry from Reading University, UK, and held postdoctoral positions at Durham University before joining the Royal Society of... Read More →
avatar for Xiao Yuan Chen

Xiao Yuan Chen

Office Director, Tsinghua University


Wednesday June 26, 2019 10:30am - 11:30am
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#356: Involving Patients in Medicinal Product Benefit-Risk Communication: How're We Doing?
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-732-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will explore the state-of-the-science in regard to patient involvement in benefit-risk communication for medicinal products. Interactive audience engagement will occur throughout the session to stimulate dialogue on implications for advancing the science and practice in this area. Questions will include: • What steps are regulators taking to involve patients in benefit-risk communication? • What new tools are being developed to educate patients about the benefits and risks of drugs, and how effective are they? • What are the current challenges and barriers that impede greater patient involvement in benefit-risk communication of medicinal products? How can they be addressed? • What are promising avenues for further advancing the science of patient involvement in benefit-risk communication?

Learning Objectives

Describe the state-of-the-science in terms of patient involvement in benefit-risk communication of pharmaceutical products; Discuss challenges and solutions for enhancing patient involvement in benefit-risk communication and for improving how such information is provided to them; Identify pragmatic scientific approaches for enhancing patient involvement in benefit-risk communication and the role of new types of interactive digital educational tools for patients.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

Trends in the Use of Interactive Digital Tools to Educate Patients Regarding Safe and Appropriate Use of Drugs: What Has Been Learned to Date?
Meredith Y. Smith, PhD, MPA

Patient Engagement in Pharmacovigilance and Benefit-Risk Communication: Update from EMA
Tânia Teixeira, PharmD

Involving Patients in Benefit-Risk Communication: What are the Opportunities? What are the Challenges?
Marc M. Boutin, JD



Speakers
avatar for Marc Boutin

Marc Boutin

Chief Executive Officer, National Health Council (NHC)
Marc M. Boutin, JD, is the Chief Executive Officer of the National Health Council. He has been a leading voice for greater patient involvement at every stage of the health care continuum. Boutin has been actively involved in patient advocacy organization management, health advocacy... Read More →
avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →
avatar for Tânia Teixeira

Tânia Teixeira

EMA Official at the FDA, European Medicines Agency
Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#360: Identification of Medicinal Products: FDA's Perspective and Approach
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-684-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will discuss FDA's perspective on the five ISO standards for Identification of Medicinal Products and its approach to conformance, as well as its collaboration with industry and other regulatory agencies.

Learning Objectives

Identify the five ISO IDMP Standards; Describe FDA's approach to IDMP conformance; Explain the current scope of the FDA's IDMP approach.

Chair

Ron D. Fitzmartin, PhD, MBA

Speaker

FDA Update
Ta-Jen Chen, MS

Defining Substances for the IDMP Using the GSRS
Lawrence Nicholas Callahan, III, PhD



Speakers
avatar for Ta-Jen Chen

Ta-Jen Chen

Project Management Officer, OSP, CDER, FDA
TJ is a project management Officer at Office of Strategic Programs, CDER, FDA, where he is responsible for the development, testing, and implementation of electronic data standards for CDER regulatory review. As a FDA delegate to ICH E2B Expert Working Group and ISO TC 215 WG 6, he... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of the Director, CBER, FDA
Ron Fitzmartin is Senior Informatics Advisor, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →
LC

Lawrence Callahan

Chemist, OCS, OCPP, Office of the Commissioner, FDA
Larry Callahan obtained his Ph.D. in Chemistry from the University of Chicago. He was previously employed at FDA, NIH and the United States Pharmacopiea (USP). He has been involved in Nucleic Acid, HIV, tuberculosis research and the development of analytical methods for biotechnology-derived... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#363: Neurodegenerative Diseases: Early-Stage Challenges and Optimal Models in Drug Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-687-L04-P; CME 1.25; IACET 1.25; RN 1.25

Intense research on the multiple fronts advanced our understanding of neurodegenerative diseases. Many disease-specific animal models have been used to test emergent medicines in neurology. Genetics and mechanism of neuronal pathogenesis contributed greatly and has created a wealth of knowledge and became the bases for novel technologies and multiple therapeutic targets for these neurodegenerative diseases. There is however substantial difficulty in choosing/accessing an optimal model or choosing measurements which would be truly informative of the product’s efficacy in neurodegenerative rare diseases or more prevalent diseases like pediatric neurodegenerative diseases and Alzheimer’s. This session will discuss nonclinical models supporting efficacy in rare neurodegenerative conditions, looking also at the challenges in early development in pediatric neurodegenerative diseases and highlight successes and failures in the development of treatments for dyslipidemia that may be applicable to the treatment of neurodegenerative diseases like Alzheimer’s disease.

Learning Objectives

Describe the importance and value of nonclinical in vivo models in rare neurodegenerative conditions and share highlights on the challenges in early development in pediatric neurodegenerative diseases; Identify optimal strategies for testing putative Alzheimer therapies; Recognize how to select and qualify biomarkers to identify patient and measure relevant drug activity; Define how to apply lessons from development of drugs to prevent Alzheimer Dementia.

Chair

Dinah Duarte, MSc

Speaker

Rare Neurodegenerative Diseases: Early-Stage Challenges and Optimal Animal Models in Orphan Drug Development
Dinah Duarte, MSc

Alzheimers Disease Prophylaxis: Lessons from Lipid Therapeutics
Richard Scheyer, MD

The Challenges in Early Development in pediatric Neurodegenerative Diseases
Scott Demarest, MD



Speakers
SD

Scott Demarest

Assistant Professor, Departments of Pediatrics and Neurology, University of Colorado School of Medicine; Children's Hospital Colorado
Scott Demarest received a Bachelor of Science in biology from the University of Texas at Austin before going on to medical school at the University of Texas Health Science Center in San Antonio. He completed his residency in Pediatrics and child neurology at Children's National Health... Read More →
avatar for Dinah Duarte

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →
avatar for Richard Scheyer

Richard Scheyer

Vice President, Medical, Medpace
Dr. Richard Scheyer is VP Medical at Medpace. Prior to Medpace, he led Experimental Medicine, BM, and PGx functions at Daiichi Sankyo. He served in leadership roles at Sanofi-Aventis and CMO at Neurotrope Bioscience. Dr. Scheyer received his BS Physics from Stanford, MD from SUNY... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#369: User-Fee Programs Myth Busting: General Financial Principles Explained
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-693-L04-P; CME 1.25; IACET 1.25; RN 1.25

With preliminary user-fee reauthorization discussions underway, it is important to refresh on the financial principles behind a user-fee program and hear an update on the PDUFA VI, GDUFA II, and BSUFA II resource management commitments. Don't miss this fantastic educational opportunity to learn more about FDA's financial management.

Learning Objectives

Explain how the FDA financials operate beyond the collection of user-fees; Describe and name the general financial principles behind a user-fee program; Describe how FDA utilizes its resources, and discuss the restrictions FDA is under being part of the federal government; Summarize FDA’s progress in implementing the PDUFA VI, GDUFA II, and BSUFA II resource management related commitments.

Chair

Amy Bertha

Speaker

Panelist
James Tyler

Panelist
Andrew Kish, MS



Speakers
avatar for Amy Bertha

Amy Bertha

Senior Director, Regulatory Policy, Bayer
Amy Bertha is currently Senior Director, Regulatory Policy at Bayer. Prior to joining Bayer in 2018, Amy worked 14 years at the FDA's Center for Drug Evaluation and Research in various offices, including the Regulatory Affairs Team in the Office of New Drugs and the Special Projects... Read More →
avatar for Andrew Kish

Andrew Kish

Director, Office of Planning and Strategic Analysis, OSP, CDER, FDA
Andrew is the Director of the Office of Strategic Programs and Analysis (OPSA) in the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA). Andrew oversees projects that span the application of economics, program evaluation, decision science... Read More →
avatar for James Tyler

James Tyler

Chief Financial Officer, Office of Operations, OC, FDA
Jay Tyler has 31 years of federal financial management experience serving at multiple federal agencies with diverse missions having broad national and international impact. He joined the U.S. Food and Drug Administration (FDA) in October of 2012 as the Chief Financial Officer (CFO... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#379: From Trials to Real World: How Safety Protocols Impact REMS
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-700-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will present the approach for evaluation of interventions and/or protocol amendments in trials, and how these interventions impact the determination of the need for a REMS, and its design. Presentation will use an approved REMS.

Learning Objectives

Describe how safety interventions/trial protocol modifications are evaluated to ensure pre- and post-market continuity in safety management planning and the need for a REMS; Discuss evaluation of safety interventions in trials and their impact on REMS design; Discuss an example of the evaluation of trial protocol modifications and safety intervention considerations effecting an approved REMS.

Chair

Jamie Wilkins, PharmD

Speaker

Panelist
James Nickas, PharmD

Panelist
Christine Brown, MS

Moderator
Elaine Morrato, DrPH, MPH



Speakers
avatar for Christine Brown

Christine Brown

Executive Director, National PKU Alliance
Christine Brown is the first Executive Director of the National PKU Alliance, a non-profit organization working to improve the lives of individuals with PKU and pursue a cure. Christine has more than 30 years of experience in building and leading non-profit organizations at the local... Read More →
JN

James Nickas

Vice President, Pharmacovigilance and Clinical Medical Writing, Biomarin
James (Jim) Nickas is currently Vice President of Pharmacovigilance & Clinical Medical Writing at BioMarin in San Rafael, California. He joined the company in October 2010 bringing with him 12 years of academic experience at UCLA Medical Center and 18 years of drug development and... Read More →
avatar for Jamie Wilkins

Jamie Wilkins

Deputy Director, Division of Risk Management, OSE, CDER, FDA
Jamie Wilkins, Pharm.D. is the Deputy Director for the Division of Risk Management (DRISK) in the Office of Surveillance and Epidemiology (OSE) in the Center for Drug Evaluation (CDER) at the U.S. Food and Drug Administration (FDA). DRISK provides risk management expertise on development... Read More →
avatar for Elaine Morrato

Elaine Morrato

Professor Health Systems, Management and Policy, Colorado School of Public Health
Elaine Morrato, DrPH MPH is a Professor in Health Systems, Management and Policy and Associate Dean for Public Health Practice at the Colorado School of Public Health. Her research focuses on accelerating the translation of drug warnings into practice, and she has contributed her... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#381: A New Path Forward for Using Decentralized Clinical Trials
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-713-L04-P; CME 1.25; IACET 1.25; RN 1.25

Barriers are hindering the widespread use of decentralized clinical trials. However, new recommendations developed by CTTI offer new approaches to improve recruitment and retention, participant diversity, and the research experience for patients.

Learning Objectives

Describe proven methods for executing decentralized clinical trials through telemedicine and mobile healthcare providers; Discuss actionable recommendations for navigating state medical licensing laws and issues with drug supply chain of custody; Identify the broad continuum of hybrid protocol designs possibilities for implementing decentralized clinical trials.

Chair

Penny Randall, MD

Speaker

Panelist
Laura Byrnes Podolsky, JD, MPH

Panelist
Gail Adinamis

Panelist
Michael O'Brien, CPA



Speakers
avatar for Gail Adinamis

Gail Adinamis

CEO, GlobalCare Clinical Trials, LLC
Ms Adinamis has >35 yrs of global clinical trials experience including tenures at Abbott and Astellas. She established & headed clinical trials divisions for 3 national home infusion companies then started an independent ambulant care service company for clinical trials in 2004 where... Read More →
avatar for Michael O'Brien

Michael O'Brien

Chief Strategy Officer, The Avoca Group
Michael brings more than 30 years of executive management experience in the life sciences and information technology industries. Michael is currently the Chief Strategy Officer for The Avoca Group. For the prior 5 years, Michael has been an early pioneer in the development and support... Read More →
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Laura Podolsky

General Counsel, Science 37, Inc.
Laura is a health care lawyer focusing on novel healthcare technologies. She has served as Science 37's General Counsel since its founding, assisting the company in navigating legal and regulatory issues surrounding decentralized clinical trials. She earned her JD from the UCLA School... Read More →
avatar for Penny Randall

Penny Randall

Vice President and Head, CNS Center of Excellence, IQVIA
Dr. Randall is Vice President and Head of the CNS Center of Excellence at IQVIA. Her scientific focus is on optimizing trial design and implementation to minimize the risk of inconclusive trials. She is also interested in leveraging disruptive technologies to modernize and accelerate... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#385: The Importance of Human Translation for Successful Preclinical Drug Discovery and Cardiac Safety
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-704-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how human-focused translational technologies help ensure the safety and efficacy of novel therapies, reduce product development costs, shorten time to market and provide an unprecedented opportunity to unlock new possibilities for preclinical drug discovery.

Learning Objectives

Discuss the importance of human cells and/or tissue in early drug discovery for success in clinical trials; Identify strategies for using human cells and/or tissue in every stage of preclinical research (i.e., from target identification to lead optimization and into phase 1; Identify from case studies that describe how data from human cells/tissues can be more predictive than in vivo animal studies.

Chair

Christopher Mathes, PhD, MBA

Speaker

Industry Perspective
Andre Ghetti, PhD

PMDA Update
Satoshi Tsunoda

Translation of Safety Pharmacology Testing to Human Trials: What Do We Know?
Hugo M Vargas, PhD



Speakers
avatar for Andre Ghetti

Andre Ghetti

Chief Executive Officer, AnaBios
Andre Ghetti, PhD, is our Chief Executive Officer. During the last several years, Dr. Ghetti focused on the creation of new tools and strategies to advance biomedical sciences, with special emphasis on enabling the direct study of human biology and pharmacology to accelerate the rate... Read More →
avatar for Christopher Mathes

Christopher Mathes

Chief Commercial Officer, AnaBios
As Chief Commercial Officer (CCO) of AnaBios, Dr. Chris Mathes provides leadership in business development & contributes to strategic direction. Previously, Mathes acted as CCO of Icagen. led the North American business development team for Discovery Services at Charles River & was... Read More →
avatar for Satoshi Tsunoda

Satoshi Tsunoda

Deputy Specialist, Office of New Drug IV, Pharmaceuticals and Medical Devices Agency (PMDA)
avatar for Hugo Vargas

Hugo Vargas

Executive Director, Amgen Inc.
I am an Executive Director at Amgen, and lead the Safety Pharmacology & Animal Research Center (SPARC) department. My team includes 60+ staff (Thousand Oaks, San Francisco, Burnaby BC) and we contribute actively and extensively to the entire drug discovery and development pipeline... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#391: Real World Evidence and Artificial Intelligence to Inform Post-Authorization Studies
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-717-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will discuss SENTINEL and other databases and how they are being mined for important signals. How is AI being used to assess real world effectiveness? Can AI inform a risk-based approach to lifecycle management?

Learning Objectives

Discuss how Sentinel and other databases are being mined for important signals; Identify how real work evidence and artificial intelligence is being used to inform post-authorization activities; Identify if artifical intelligence is a risk-based approach to lifecycle management.

Chair

Sudip Parikh, PhD

Speaker

The New World of Post-Authorization Knowledge Building
Mary Jo Lamberti, PhD, MA

SENTINEL and Other Databases: How Are These Being Mined for Important Safety and Effectiveness Signals?
Gerald J. Dal Pan

The Potential for Real World Data/Real World Evidence to Inform Postmarketing Safety Surveillance
Jose Vega, MD



Speakers
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Associate Director of Sponsored Research, Research Assistant Professor, Tufts Center for the Study of Drug Development
Mary Jo Lamberti leads multi-company sponsored research studies at the Tufts Center for the Study of Drug Development (CSDD). She has extensive experience conducting research on biopharmaceutical industry practices and trends affecting contract research organizations and investigative... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →
avatar for Sudip Parikh

Sudip Parikh

Senior Vice President and Managing Director, DIA Americas, DIA
Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial... Read More →
avatar for Jose Vega

Jose Vega

Vice President, Chief Safety Officer, Merck & Co., Inc.
José M. Vega is Vice President, Global Clinical Safety and Pharmacovigilance (GCS&PV) and Chief Safety Officer at Merck Research Laboratories (MRL). He also serves as Chair of the TransCelerate Pharmacovigilance Steering Committee and as Merck's representative on the Clinical Trials... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#389: Transparency, Expanded Access Navigator, Right to Try: Helping Patients Get Access to Investigational Medicines?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-708-L04-P; CME 1.25; IACET 1.25; RN 1.25

Numerous steps have been taken to increase access to investigational medicines for patients with serious and life-threatening diseases. This session will explore whether these initiatives have had the desired impact.

Learning Objectives

Describe changes to expanded access programs, including Right to Try; Assess the impact of these changes to the patient; Discuss ways to improve access to investigational medicines for patients.

Chair

Kim Quaintance-Lunn

Speaker

Patient Perspective on Preapproval Access
Melinda Bachini

Innovating Compassionate Use Request Processes with CompAC
Beverly L Harrison

Assessment of Progress
Alison Bateman-House, PhD, MA, MPH



Speakers
avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, NYU Langone Health
Alison Bateman-House, PhD, MPH, MA, is an assistant professor in the Division of Medical Ethics at NYU Langone Health's School of Medicine. She is co-chair of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies ethical issues concerning... Read More →
avatar for Beverly Harrison

Beverly Harrison

Head, Patient Support, Janssen Pharmaceutical Companies of Johnson & Johnson
Leading the Patient Support Group @ Janssen R&D (a J&J Co.), reporting directly to the Chief Medical Officer, Beverly focuses on developing strategies for patients’ needs by working with internal/external stakeholders & engaging patient advocacy organizations. She is a R&D & nonprofit... Read More →
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Vice President and Head, Regulatory Policy, North American Regulatory Affairs, Bayer
Kim Quaintance-Lunn serves as Vice President and Head, Regulatory Policy, North American Regulatory Affairs, at Bayer. Kim joined Bayer in February 2014 to establish and lead the US regulatory policy function for the organization. She works with colleagues to analyze regulatory policy... Read More →
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Melinda Bachini

Advocacy Coordinator, Cholangiocarcinoma Foundation


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#396: Challenges to Access: Bringing Payers to the Table
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-711-L04-P; CME 1.25; IACET 1.25; RN 1.25

While the FDA and EMA avail themselves for early engagement with pharmaceutical manufacturers, non-binding joint consultations with regulators and payers have been to-date available to manufacturers primarily in Europe. With the moving target of paradigm shift from volume-based to value-based healthcare delivery in the US, the question remains if viable avenues for engagement with payers exist in the fragmented market place. Traditional engagement opportunities through payer advisory boards and standing panels have proven moderately effective and with the growing focus on health technology assessment in the US that spans comparative effectiveness, short-term affordability and long-term value for money assessments, a dialogue may be warranted to explore more formal ways to engage manufacturers, regulators and payers. A panel composed of the relevant stakeholders will have an open dialogue on the topic offering a forum for generating potential concepts for testing to enable formal early payer engagement in the medicine development process in the US.

Learning Objectives

Identify potential innovative ways of early engagement with payers in the US to enhance medicine development programs and produce a “reimbursable file” at the time of regulatory approval.

Chair

Ruslan Horblyuk, PhD, MA

Speaker

Panelist
Sean Tunis, MD, MSc

EMA Perspective
Tânia Teixeira, PharmD

Industry Perspective
Cristina Masseria



Speakers
RH

Ruslan Horblyuk

Chief Strategic Consulting Officer, AESARA
Ruslan Horblyuk started his career in international health policy consulting over 20 years ago working in the countries of former Soviet Union as part of the US Agency for International Development funded Health Policy Reform Initiative. He transferred to the industry in 2003 and... Read More →
avatar for Tânia Teixeira

Tânia Teixeira

EMA Official at the FDA, European Medicines Agency
Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product... Read More →
CM

Cristina Masseria

Vice President, Patient and Health Impact, Vaccines, Pfizer Inc
ST

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMPT)


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA