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Real World Evidence [clear filter]
Monday, June 24
 

11:00am

#105: Addressing Heterogeneity of Real World Evidence in Drug Safety
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-522-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session addresses the concern of inconsistent real world evidence in drug safety by presenting 1) epidemiological approaches for assessing inconsistent findings in observational studies, 2) lessons learned from observational studies in a distributed research network and 3) challenges using methods that synthesize findings from observational studies.

Learning Objectives

Identify possible study factors contributing to heterogeneity of real world evidence using claims databases; Discuss lessons learned from observational studies in a distributed research network regarding heterogeneity of RWE; Describe methods for synthesizing findings from observational studies and their limitations.

Chair

Michael Blum, MD, MPH

Speaker

Epidemiological Approaches for Assessing Inconsistent Findings in Observational Studies
Huei-Ting Tsai, PhD, MS

Minimizing Heterogeneity in Distributed Research Networks: Examples from the Canadian Network for Observational Drug Effect Studies
Adrian Levy, PhD, MSc

Challenges with Methods Used to Synthesize Findings from Observational Studies
Alicia Gilsenan



Speakers
avatar for Michael Blum

Michael Blum

Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER, FDA
Michael Blum, MD, MPH is currently Deputy Director, Office of Pharmacovigilance and Epidemiology in FDA CDER. He is a pediatric infectious diseases specialist. Dr. Blum worked as a medical reviewer in the CDER Division of Anti-Infective Drug Products, followed by over 20 years in... Read More →
avatar for Alicia Gilsenan

Alicia Gilsenan

Senior Director and Head, Epidemiology, RTI Health Solutions
Alicia Gilsenan, PhD, is Senior Director and Head, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI... Read More →
avatar for Huei-Ting Tsai

Huei-Ting Tsai

Epidemiologist, Office of Surveillance and Epidemiology, CDER, FDA
Huei-Ting Tsai, Ph.D., is an Epidemiologist in the Office of Surveillance and Epidemiology in FDA CDER. Prior to joining FDA, she was an Assistant Professor at the Georgetown University Medical Center and served as the principle investigator of multiple grants to assess effectiveness... Read More →
avatar for Adrian Levy

Adrian Levy

Professor, Department of Community Health and Epidemiology, Dalhousie University
Adrian R. Levy PhD is Professor in the Department of Epidemiology and Community Health at Dalhousie University. He is author of over 150 peer reviewed publications (https://bit.ly/2CBWeI5) and is the co-editor of two volumes in the Springer Handbook of Health Services Research entitled... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:00am

#109: When Disaster Strikes: Developing a Proactive Plan to Address Challenges Brought on by Large Scale Natural Disasters
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-536-L04-P; CME 1.00; IACET 1.00; RN 1.00

We are faced with many challenges in drug development and clinical trial continuity, one that we must all be prepared for is how to manage your trial and team in the face of a natural disaster. Often we do not think about this until disaster strikes.

Learning Objectives

Discuss the importance of having a natural disaster management plan; Describe factors to consider when developing a natural disaster management plan; Identify key aspects of staff, site and patient support and how to be proactive and reactive in face of a natural disaster.

Chair

Mark Summers

Speaker

Panelist
Jennifer Sheller, MPH

Panelist
Raymond Policare, MPH



Speakers
JS

Jennifer Sheller

Regional Head, NA, Global Clinical Trial Operations, Merck & Co, Inc.
Jennifer Sheller joined Merck in 2017 as an Associate Vice President and the North America Regional Head of Global Clinical Trials Organization. In this role she is responsible for all aspects of Merck Research Laboratories clinical trial operations in the United States and Canada... Read More →
avatar for Mark Summers

Mark Summers

President, Patient Engagement Division, WIRB-Copernicus Group (WCG)
Mark Summers currently serves as President of the Patient Engagement Division at WCG, a division which includes all business units within WCG that provide services that directly interface with patients. Prior to his role at WCG he founded ThreeWire, Inc., a patient recruitment, enrollment... Read More →
RP

Raymond Policare

Senior Director, Clinical Operations, PRA


Monday June 24, 2019 11:00am - 12:00pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:00am

#110: Automation with Intelligence: Transformation From Human Resource to Artificial Intelligence in Risk Management
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-524-L04-P; CME 1.00; IACET 1.00; RN 1.00

Learn 1) challenges in adapting AI in risk management; 2) approaches in proactively managing clinical operation risk and in streamlining the process for automation; 3) a automation model to transform resource based monitoring into risk based approach

Learning Objectives

Discuss challenges in adapting artificial intelligence in risk management; Discuss innovative approaches in leveraging real-time access to clinical data and analytics in proactively managing clinical operation risk and in streamlining the process for automation in risk assessment and mitigation; Discuss automation maturity model to transform resource based monitoring into risk based approach.

Chair

Hanming H Tu, MSc

Speaker

Using Artificial Intelligence to Centralize, Standardize, and Ensure Data Integrity in Clinical Trial Monitoring
Michelle Marlborough

Artificial Intelligence in Risk Management
Susan Olson, PhD, MS

Utilizing AI to Transform Drug Safety Case Processing
Christina J Wocosky



Speakers
avatar for Susan Olson

Susan Olson

Chief Operating Officer, edj
Susan is Chief Operating Officer at EdjAnalytics and manages operations and innovates advanced analytics solutions in life sciences. Edj is a Louisville, Kentucky company that offers advanced analytics for healthcare providers, pharmaceutical companies, government organizations, payers... Read More →
avatar for Hanming Tu

Hanming Tu

Vice President, IT, Frontage Laboratories, Inc.
* MS, MCRP * VP, Clinical IT & Database Administration (DBA) at Frontage * Manager, DBA in Accenture Life Science Cloud * Director, Clinical IT in Octagon Research * Over 20 years of pharmaceutical and clinical IT experience * Oracle Certified Professional (OCP) and DBA Master from... Read More →
avatar for Christina Wocosky

Christina Wocosky

Industry Principal, Innovation and Though Leadership, Accenture
Chris Wocosky is an Industry Principal in Accenture’s Life Sciences R&D practice, and is based in San Diego, CA. She served as the Product Manager for an AI Platform, PV First, for case intake and pre-case processing, and was instrumental in developing and bringing the platform... Read More →
MM

Michelle Marlborough

Chief Product Officer, AiCure
As Chief Product Officer at AiCure, Michelle Marlborough is responsible for the product direction, definition and delivery of the company’s award-winning artificial intelligence platform. With over 23 years of experience in life sciences and software development, Michelle has been... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 1AB 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

3:30pm

#161: Making Trials Work for Special Populations
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-558-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session discusses a variety of ways to address patient needs that help recruit and retain special populations in clinical trials.

Learning Objectives

Identify useful guidelines and regulations regarding special populations in various countries; Discuss useful models of patient engagement that focus on special populations; Discuss case studies that show how some clinical trials have attracted special groups of patients.

Chair

Deborah E. Collyar

Speaker

Therapeutic Needs of Older Patients in the Era of Mobile Health
Dinah Duarte, MSc

Implementation of a Peer Advocate Model to Optimize Trial Enrollment, Diversity, and Retention
Caroline Donovan, MPH

Site Awareness and Best Practices for Inclusion of Diverse Populations in Research
Diana Foster, BSN, PhD, MSN



Speakers
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR)
Deborah Collyar has been a patient engagement leader since her first cancer diagnosis. She founded Patient Advocates in Research (PAIR) international communication network in 1996, "where research meets reality." Deborah infuses hundreds of patient advocates into research programs... Read More →
avatar for Caroline Donovan

Caroline Donovan

Manager of Patient Engagement, LuCIN, Lupus Therapeutics, LLC
Caroline Donovan, MPH is the Manager, Patient Engagement for Lupus Therapeutics, an affiliate of Lupus Research Alliance. She is responsible for the development and implementation of a peer education program in which prospective lupus clinical trial patients are matched with a trained... 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 Diana Foster

Diana Foster

CEO, Society For Clinical Research Sites
Dr. Foster serves as a consultant to the Society for Clinical Research Sites as the Vice President of Strategy and Development. In her role she is responsible for building relationships with industry that help amplify the voice of the clinical research site. She has been integrally... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

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

#204: Protocol Developments of the Future
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-586-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will discuss specific areas in the protocol development process and the use of emerging technologies.

Learning Objectives

Identify where and how technology can be applied to improve or transform traditional protocol development processes: Describe best practices for creating, managing and implementing templates, and standard re-usable content; Discuss how consistently drafted protocols can lead to better success in a regulatory submission and aligned global transparency: Explain how to succeed developing protocols and managing amendments for complex study designs including master protocols.

Chair

Bob Brindle, MA

Speaker

Enforcing Better Standards in Protocol Development
Bob Brindle, MA

Objectives, Endpoints, and Outcome Measures: Developing Protocols to Achieve Consistency Between Documents and Registrations
Nate Root, MSc

Using Technology Innovations to Navigate Substantial Protocol Amendments for Studies with Complex Innovative Design
Rachael Cui Song, MBA

Protocol Development of the Future
Robert A. DiCicco, PharmD



Speakers
avatar for Bob Brindle

Bob Brindle

Venture Leader and Associate Director, Life Sciences R&D Practice, Cognizant
After graduating in Biochemistry from Cambridge University, Bob spent more than 20 years working at a major pharmaceutical company. Starting his career in Data Management, he progressed to become Head of Technology for Clinical Operations, and has extensive expertise in clinical trials... 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 →
avatar for Nate Root

Nate Root

Associate Director, Disclosure and Transparency, Ionis Pharmaceuticals
Nate is a disclosure and transparency professional, with over 6 years of experience in the environment, working for and with CROs, Big Pharma, Non-Profit, and Small Biotech. He is a member of the DIA Disclosure Community Core Team, PhUSE CTD initiatives, and creator of the West Coast... Read More →
avatar for Rachael Song

Rachael Song

Associate Director - Global Project Management, PPD
Rachael is currently global Project Leader for Oncology clinical trials with focus on Immuno-Oncology and master protocol studies. She has experiences in compound-level clinical planning and design, study-level operational planning and strategy development, and program implementation... Read More →


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

8:00am

#219: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-584-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will present examples evaluating real world endpoints using electronic health records, current application, and challenges. A panel of experts will provide interpretation, discuss approaches to increase its reliability and acceptability. Join the Study Endpoints Community for a follow up Round Table discussion on Wednesday, June 26, 9:30-10:30AM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Describe opportunities and challenges utilizing real world endpoints in health care; Discuss examples and approaches to increase objectivity and reliability of real world endpoints; Explain implications for regulatory and payer decision-making.

Chair

Natalia Sadetsky, MD, PhD

Speaker

Panelist
Natalia Sadetsky, MD, PhD

Real World Data in 2019: What's New
Michelle Hoiseth

Real World Data Model with Visualization for Value and Access
Sharon Hensley Alford, PhD, MPH

Panelist
Ronald Cantrell, PhD, MPH

Panelist
Gillis Carrigan, PhD, MS



Speakers
avatar for Michelle Hoiseth

Michelle Hoiseth

Senior Vice President and Chief Data Officer, Parexel
Michelle has been working in the drug and device development industry for 30 years. She has enjoyed a variety of positions that allowed her to create product development plans, run study operations, and support product commercialization objectives. Michelle presently leads PAREXEL’s... Read More →
avatar for Natalia Sadetsky

Natalia Sadetsky

Senior Scientist, Genentech, A Member of the Roche Group
Natalia Sadetsky, is an medical doctor and epidemiologist by training. She has over 18 years of academic and industry experience in oncology. She joined Genentech, a member of a Roche group in 2013 and currently a Senior Data Scientist in Personalized Health Care Data Science, RWD... Read More →
avatar for Sharon Hensley Alford

Sharon Hensley Alford

Offering Management, IBM Watson Health
Sharon Hensley Alford, PhD is Associated Chief Health Officer for Data & Evidence within the Life Science (LS) pillar of IBM Watson Health. Dr. Alford has been working on data and analytic strategy for life science clients since she joined IBM 2+ years ago. Prior to IBM, she worked... Read More →
RC

Ronald Cantrell

Senior Director and Principal Data Scientist, Verana Health
Ronald Cantrell leads clinical data science at Verana as Senior Director and Principal Data Scientist. He has over a decade of experience working with and analyzing real world data in the life science industry. He previously served as Principal Data Scientist at Genentech, where he... Read More →
GC

Gillis Carrigan

Director, Epidemiology, Covance Market Access
Dr. Carrigan has over 20 years of experience in observational studies with a focus on study design and methodology. He is experienced with the use of electronic medical records (EMR), administrative claims data, and registry data. He has worked with observational data in a number... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 14B 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

#240: Harmonizing Regulatory Science Through the International Council for Harmonization (ICH)
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-599-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of the ICH Association and offer insight into strategic, long-term views on advancing global convergence of regulatory science through ICH.

Learning Objectives

Identify the value and benefits of global regulatory harmonization and the ICH; Discuss opportunities to advance regulatory science through ICH; Describe the current harmonization initiatives that are currently underway and the impact on global drug development.

Chair

Camille Jackson

Speaker

FDA Update
Theresa Mullin, PhD

EMA Update
Agnès Saint-Raymond, DrMed, MD

MHLW Update
Naoyuki Yasuda, MS



Speakers
CJ

Camille Jackson

Associate Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Camille Jackson is currently Associate Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she manages PhRMA’s international regulatory policy initiatives including engagement in the International Council for Harmonization (ICH) and the APEC Regulatory Harmonization... 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 Agnès Saint-Raymond

Agnès Saint-Raymond

Head of Division International Affairs, European Medicines Agency
Agnes is an MD and qualified French Paediatrician. She worked as a paediatrician in a paediatric Hospital in Paris, France, then in pharmaceutical industry, and then moved to the French Medicines Agency. In 2000 she joined the European Medicines Agency (EMA) and was responsible for... Read More →
avatar for Naoyuki Yasuda

Naoyuki Yasuda

Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW)
Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 6F 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

#256: Wearables and Patient Technologies Utilized in Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-623-L04-P; CME 1.25; IACET 1.25; RN 1.25

Explore an initiative which seeks to facilitate and accelerate progression towards a future where patients have access to innovative technologies that enhance the patient experience and reduce their burden in clinical trials. Describe lessons learned from 3 "smart" trials executed for top 5 pharma companies. Explore the use of technology, devices, and virtual visits in a pediatric clinical trial setting and help to alleviate some of the questions and concerns sponsors and regulators have when endpoints or key outcome measures come from personal devices, wearables, or other patient controlled technology.

Learning Objectives

Define opportunities and challenges with use of patient-facing technology in clinical trials; Discuss how to complement eClinical platform with new technologies; Demonstrate how technology and virtual visits are being utilized to ease burden of participation and increase compliance.

Chair

Margareth Dimitrov-Kuhl, MA

Speaker

Patient-Driven Digital Platform: The Need to Integrate eClinical Technologies, Wearables, RPA, and AI/Machine Learning
Isabelle M de Zegher, DrMed, MD, MS, MSc

Making Pediatric Clinical Trials Fun (and Easy?): Virtualization, Wearables, and Other Technologies Utilized in Clinical Trials
Gina Calarco, BSN, MPH

Implementing Patient-Facing Technology in Clinical Trials: How to Overcome the Industry’s Greatest Challenges
Margareth Dimitrov-Kuhl, MA



Speakers
avatar for Gina Calarco

Gina Calarco

Director of Pediatric Strategy and Planning, Covance
Gina Calarco is Director of Operational Strategy and Planning for the Rare Disease and Pediatric Team at Covance. She is a nurse and received her MPH from the University of Kansas. She is an affiliate member of the American Academy of Pediatrics Section on Advances in Therapeutics... Read More →
MD

Margareth Dimitrov-Kuhl

Clinical Development Function Head, Novartis Pharmaceutical
Margareth Dimitrov-Kuhl is a Clinical Director Function Head at Novartis Pharmaceuticals. She is also a Sponsor-company representative serving on TransCelerate BioPharma’s Patient Technology Initiative focused on developing tools for study teams utilizing patient-facing technologies... Read More →
avatar for Isabelle de Zegher

Isabelle de Zegher

Vice President, PAREXEL Informatics
Isabelle de Zegher is Vice President, Integrated Solutions at PAREXEL Informatics where she is responsible for engineering strategy around Big Data, BI and Advanced Analytics. She has 25 years’ experience in Life Sciences, including extensive work on cross-industry forum on integration... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#283: Let's Talk Risk-Based Monitoring
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: Let's Talk Risk-Based Monitoring; CME 1.25; IACET 1.25; RN 1.25

Let’s face it, Risk Based Monitoring (RBM) has been in the forefront of our industry for more than 10 years. From the beginning, RBM challenged the belief that 100% source document verification (SDV) would yield quality data in clinical trials. Regulators responsible for making decisions based on reliable data were also challenging industry as to the utility of this monitoring methodology as a way to identify and manage issues in clinical trials. It took some time for the focus of RBM to shift risks in a clinical trial that would include identification and assessment, ongoing monitoring, mitigation as well as even prevention. We are now in an epoch of understanding that it’s about the management of risks in clinical trials that could impact the reliability of patient data, patient safety and patient rights and welfare. In March of 2019, FDA has provided a draft guidance to augment the 2013 guidance relating to risk based-monitoring whereby FDA is making recommendations for planning a monitoring approach, developing content for monitoring plans, and the monitoring of results. Since regulations establish the expectations, it remains up to the sponsor to determine the how in order to achieve the expectation.

RBM has come a long way however sponsors may still struggle with certain aspects in the multi-prong processes needed to be successful with RBM. This forum will present various approaches to RBM, and give the opportunity to learn from experts, so Let’s Talk Risk-Based Monitoring!

Learning Objectives

Describe what is comprehensive RBM , with an understanding of key components to achieve goals of Risk-Based Monitoring in Clinical Trials; Develop a risk-based approach to monitoring of clinical trials that will achieve the expectations for quality clinical data; Identify how to determine best approach based on risks within the clinical trial and consider how to best monitor ongoing risks.

Chair

Susan Callery-D'Amico, BSN

Speaker

A Comparison of SDV to MANA Method: A Risk-Based Monitoring Approach
Penelope K. Manasco, MD, MS

Holistic Approach to Risk-Based Management of Studies and Monitoring of Investigators
Gregg Larson, PhD



Speakers
avatar for Susan Callery-D'Amico

Susan Callery-D'Amico

Vice President, R&D Quality Assurance, AbbVie, Inc.
Susan Callery D’Amico is a pharma leader with extensive experience in quality assurance and clinical development. She is the VP, R&D Quality Assurance, AbbVie, with the mission to drive quality excellence and continuous improvement as a strategic advantage across the lifecycle of... Read More →
avatar for Penelope Manasco

Penelope Manasco

Chief Executive Officer, MANA RBM
Dr. Manasco has conducted clinical research for over 30 years at the NIH and as an executive at GSK. She has spent 10 years in the area of clinical trial technology. Since starting MANA RBM, her focus has been on enhancing the processes of clinical research to rapidly identify and... Read More →
avatar for Gregg Larson

Gregg Larson

Vice President, Development Operations, AbbVie
Gregg’s career over 25+ years has spanned medical affairs, clinical research, and clinical operations. Gregg assumed his current role as VP, Development Operations in October 2017, which includes Site Management and Monitoring, Clinical Program Development, Strategic Clinical Operations... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#294: Update From the US FDA on Progress and Topics of Current Interest in US Biosimilar Policy, Regulation, and Outreach/Education
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-636-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will include an update from members of the US FDA on progress and topics of current interest in US biosimilar policy, regulation, and outreach/education.

Learning Objectives

Discuss topics of current interest in US biosimilar policy.

Chair

Sarah Yim, MD

Speaker

FDA Update
Joseph B. Franklin, JD, PhD

FDA Update
Sarah Crowley-Ikenberry, MA

FDA Update
Christopher Downey, PhD



Speakers
avatar for Sarah Yim

Sarah Yim

Director (Acting), Office of Therapeutic Biologics and Biosimilars, FDA
Sarah Yim, M.D. is acting Director of the Office of Therapeutic Biologics and Biosimilars in CDER's Office of New Drugs (OND). Prior to joining the Biosimilars group in March 2019, she was director of the Division of Clinical Review in the Office of Generic Drugs (OGD) for 2 years... Read More →
avatar for Sarah Crowley-Ikenberry

Sarah Crowley-Ikenberry

Senior Communication Advisor, OTBB, OND, CDER, FDA
Sarah Ikenberry is Senior Communication Advisor for the Office of Therapeutic Biologics and Biosimilars (OTBB), in the Food and Drug Administration’s (FDA), Center for Evaluation and Research (CDER) where she provides communication advice and support to senior leaders and the agency... Read More →
avatar for Christopher Downey

Christopher Downey

Review Chief, OBP, OPQ, CDER, FDA
Christopher (Chris) Downey is a Review Chief in FDA/CDER’s Office of Biotechnology Products (OBP). He was been with FDA since 2012, and currently oversees CMC reviews of therapeutic proteins, including new molecular entities and biosimilars. He received his PhD in Biochemistry from... Read More →
JF

Joseph Franklin

Policy Director for the Principal Deputy Commissioner, FDA
Joe Franklin is the Policy Director for the FDA Principal Deputy Commissioner. Until April 2019, Dr. Franklin was the Director of the Policy Staff in the Office of Therapeutic Biologics and Biosimilars at FDA. Previously, Dr. Franklin was an Associate Chief Counsel in FDA’s Office... Read More →


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

8:00am

#304: Operationalizing Master Protocols
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-660-L04-P; CME 1.25; IACET 1.25; RN 1.25

The modernization of clinical trials is driven by the need to address important clinical questions more efficiently while decreasing costs. Master protocols (including basket, umbrella, and platform trials) provide a method to answer multiple questions in one overarching trial structure. Although these trials require more intentional planning, coordination and upfront investment in creating an infrastructure for execution, they provide an opportunity to more efficiently address a broader set of objectives than would be possible in an independent trial.

In this session, we consider this emerging family of clinical trial designs within the context of broader efforts to increase efficiency, effectiveness, and quality in the development paradigm.

Learning Objectives

Analyze different trial designs that can be described and executed under a master protocol (including umbrella, basket and platform); Describe considerations and challenges for master protocol development; Discuss a case example for using the common protocol template basket studies; Identify critical elements around data collection, analysis, and interpretation;

Chair

MaryAnn Morgan-Cox, PhD

Speaker

Master Protocols; Design and Execution Considerations
Meredith Buxton, PhD, MPH

Utilizing the TransCelerate Common Protocol Template for Novel Clinical Trial Designs, Such as Platform Trials
Mitzi Allred, PhD

Statistical Analysis Opportunities and Challenges with Master Protocols
Karen Lynn Price, PhD, MA



Speakers
avatar for Mitzi Allred

Mitzi Allred

Director Clinical Operations; Head, Clinical Content Standards, Merck Sharpe & Dohme, Co., Inc.
Mitzi Allred is a Director at MSD where her focus is on Structured Content Management. She has over 20 years of experience in the biopharmaceutical industry in Regulatory & Clinical Operations. Mitzi uses process improvement through information design and structured content reuse... Read More →
avatar for Meredith Buxton

Meredith Buxton

Chief Operating Officer, Global Coalition For Adaptive Research
Meredith provides operational leadership for the Global Coalition for Adaptive Research (GCAR), a nonprofit research organization founded to expedite the discovery and development of cures for patients with rare and deadly diseases, and home of GBM AGILE, an international, seamless... Read More →
avatar for MaryAnn Morgan-Cox

MaryAnn Morgan-Cox

Senior Director, Immunology Design Hub, Eli Lilly and Company
MaryAnn Morgan-Cox is a Sr Director and Leader of the Immunology Design Hub at Eli Lilly and Company, where she focuses on innovative approaches to drug development, clinical research, commercialization, and portfolio management.
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 →


Wednesday June 26, 2019 8:00am - 9:15am
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#308: Identifying High-Value Patient Engagement Opportunities: A Collaborative Three-Step Process for Sponsors and Patient Groups
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-649-L04-P; CME 1.25; IACET 1.25; RN 1.25

This workshop brings together sponsors and patient groups for facilitated discussion of high-value engagement opportunities. Using evidence-based resources, attendees apply a simple prioritization process to identify new activities and evaluate ROI.

Learning Objectives

Discuss how to apply a straightforward process for identifying engagement opportunities with high value for both sponsors and patient groups; Describe the diverse factors that sponsors and patient groups consider in evaluating the benefits and investments associated with engagement opportunities; Identify new patient engagement and relationship opportunities & new ways to partner across the R&D continuum.

Chair

Jaye Bea Smalley, MPA

Speaker

Facilitator
Linda Brennan, MPH



Speakers
avatar for Linda Brennan

Linda Brennan

Director, Community Partnerships, Cystic Fibrosis Foundation
Linda Brennan is Senior Director, Community Partnerships at the Cystic Fibrosis Foundation (CFF), which brings the perspectives of people affected by cystic fibrosis (CF) into all the Foundation’s activities, including research and clinical development, and provides opportunities... 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 →


Wednesday June 26, 2019 8:00am - 9:15am
Room 5AB 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

#328: Risk-Based Monitoring: Best Practice Today and Technology for Tomorrow
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-673-L04-P; CME 1.00; IACET 1.00; RN 1.00

Organizations have faced challenges when implementing risk-based monitoring (RBM) and there is no one size fits all approach to overcome these challenges. Sharing best practices and implementing new facets of technology are opportunities to take RBM from the present to the future.

Learning Objectives

Discuss experiences and best practices on risk-based monitoring implementation including central monitoring; Demonstrate how technology enablement such as process automation and artificial intelligence can enhance the risk-based monitoring experience.

Chair

Suzanne Lukac

Speaker

The Keys to Successful Risk-Based Monitoring Implementation
Suzanne Lukac

Ahead of Curve in Risk-Based Monitoring Through Process Automation and Artificial Intelligence
Zabir Macci, MBA

Central Monitoring: Best Practices
Hadley Stinson



Speakers
avatar for Suzanne Lukac

Suzanne Lukac

Senior Account Director, CluePoints
Suzanne has nearly 20 years experience in the pharmaceutical industry including hands-on experience with RBM implementation. She is currently Senior Account Director at CluePoints where she is responsible for managing enterprise-level accounts and working with customers to lay the... Read More →
avatar for Hadley Stinson

Hadley Stinson

Associate Director, Clinical Monitoring Services, Premier Research
I am currently the Associate Director of Clinical Monitoring Services at Premier and oversee the NA CRA division. Prior to that I have worked in CRA Line Management and CRA positions and have global experience in multiple therapeutic areas including Oncology, Cardiovascular and R... Read More →
ZM

Zabir Macci

Centralized Monitoring Manager, IQVIA
Zabir is a Process Design & Analytics Manager for IQVIA focused on their approach to risk-based monitoring (RBM), Data-driven Trial Execution. He brings expertise spanning risk-based monitoring, business analysis, continuous process improvement, and analytics for clinical trials... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#329: Global Clinical Trials: Make Them Really Global and Involve Africa
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-674-L04-P; CME 1.00; IACET 1.00; RN 1.00

Changing how we do global clinical trials, with the inclusion of emerging markets in this development process, is imperative. A panel of experts will discuss how to plan and involve pharma/biotech and technology providers.

Learning Objectives

Describe ways in which to integrate emerging markets in global clinical trials using innovative technologies;Discuss approaches to process optimization, mobile health digitalization, blockchain, and change management on how to undertake clinical trials within Africa as the process model: Identify challenges and solutions from actual cases and experience.

Chair

Adama Ibrahim, MBA

Speaker

Next Generation Real World Evidence with Blockchain
Alexis Normand, MPA, MSc

Panelist
Tina Barton, PhD, MBA



Speakers
TB

Tina Barton

Chief Operating Officer, Emerging Markets Quality Trials (EMQT)
Tina Barton is an experienced Board member and Chair, with a BSc, PhD in cancer research and MBA, and has held Senior Management roles in large global through mid-size to small emerging organisations, working in partnership to lead for success, as a customer-focused clinical research... Read More →
avatar for Adama Ibrahim

Adama Ibrahim

Associate Director, Clinical Operations| WIN UK Chapter Co-Lead, Biogen
An innovation award winning operational strategy collaborator, blockchain advocate, eCOA and patient engagement thought leader with over 17 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON and Biogen). An R&D transformation change champion... Read More →
avatar for Alexis Normand

Alexis Normand

Head of Blockchain for Health Consortium, Embleema
Alexis Normand is head of the Embleema Blockchain Consortium bringing together patients, their advocacy groups, life sciences companies (and regulators, ie FDA to set a new digital standard for sharing Real World Evidence (RWE), to have new treatments approved faster, while ensuring... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 10 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

#359: Training for the Electronic Capture of PRO Data in Clinical Trials: Views from ePRO Vendors, Sponsors, Sites, and Patients
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-698-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum presents the ePRO Consortium’s best practices recommendations for training subjects and sites on technology use in clinical trials. Sponsor, ePRO vendor, site, and patient perspectives will be shared on training challenges and solutions.

Learning Objectives

Discuss best practice recommendations from the Consortium for training on the use of technology to collect PRO data in clinical trials; Identify challenges associated with training subjects and study sites from a vendor, sponsor, site, and patient perspective.

Chair

Serge Bodart, MS

Speaker

Panelist
Jenny Ly, PhD

Panelist
Patricia DeLong, MS

Panelist
T.J. Sharpe, PMP

Panelist
Jessica Branning



Speakers
avatar for Serge Bodart

Serge Bodart

Senior Advisor, Outcomes Science, CRF Bracket
Serge has extensive experience working in patient outcomes and new technologies. With Dr Bruno Pornel, he founded SYMFO, a European based ePRO provider in 2000. After he sold his company, he acted as the eCOA Subject Matter Expert at Biomedical Systems. Serge is currently Senior Advisor... 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 →
avatar for Jenny Ly

Jenny Ly

Clinical Science Advisor, ERT
Jenny Ly is currently a Clinical Science Advisor at ERT. She is a neuropsychologist with over 10 years of experience in the management and design of clinical trials. She has extensive experience developing training content for site staff, study participants, and caregivers that align... Read More →
avatar for T.J. Sharpe

T.J. Sharpe

Patient Advocate, Starfish Harbor LLC
T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in his Patient #1 Blog.  He was diagnosed in August 2012 with metastatic melanoma, weeks after his second child was born. He has undergone six surgeries and four immunotherapy treatments over two different... Read More →
avatar for Jessica Branning

Jessica Branning

Owner and Co-Founder, ClinCloud
Jessica Branning is the Co-Founder and Owner of ClinCloud, LLC, a Florida based clinical research site. She has nearly 5 years of clinical research experience in multiple therapeutic areas including Alzheimer's disease, Parkinson's disease, migraine, osteoarthritis, diabetes, and... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Thursday, June 27
 

9:00am

#406: Electronic Submissions Update
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-719-L04-P; CME 1.25; IACET 1.25; RN 1.25

See the latest electronic submission metrics for regulatory submissions and conformance with study data standards. Learn about FDA's current challenges with building upon existing automation in submission processing and how you can help.

Learning Objectives

Discuss the status of electronic submissions and validation at the FDA; Identify key components of lifecycle management for electronic submissions; Apply proposed best practices for handling daily submissions and ensuring validation standards are followed.

Chair

Tessa Brown, BSN, DrSc, MPH, RN

Speaker

FDA Study Data Standards Submission Update
Heather Crandall, MA

FDA Electronic Submissions Update
Jonathan Resnick, PMP



Speakers
avatar for Tessa Brown

Tessa Brown

Deputy Director, Office of Business Informatics /OSP / CDER, FDA
CAPT Tessa Brown DHSc, MPH, BSN, RN began her career as a Commission Corp Officer of the U.S. Public Health Service (USPHS) in 2001. She has held positions in various organizations to include the Bureau of Prisons, Health Resources and Services Administration, and the Food and Drug... Read More →
avatar for Heather Crandall

Heather Crandall

Operations Research Analyst, OBI, OSP, CDER, FDA
Heather Crandall has been with the FDA for over 6 years, working in CDER’s Office of Business Informatics. She currently focuses on standards and processes around electronic submissions.
avatar for Jonathan Resnick

Jonathan Resnick

Project Management Officer, OBI, OSP, CDER, FDA
Jonathan Resnick is a member of CDER’s Electronic Submissions Team, with a focus on eCTD and has been with FDA for eight years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.


Thursday June 27, 2019 9:00am - 10:15am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA