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02: ClinTrials -ClinOps [clear filter]
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

#108: Innovation in Enrollment, Recruitment, and Retention
Component Type: Session
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-535-L04-P; CME 1.00; IACET 1.00; RN 1.00



Speaker

Patient Video: A Powerful Tool for Clinical Trial Recruitment
Paul Ivsin

Optimizing Social Media Ads for Enrollment and Using Social Analytics Insights to Inform Strategy
Neil Weisman

Myth, Urban Legend, and an Element of Truth: Unwrapping Innovation in Enrollment, Recruitment, and Retention
Matthew Kibby, MBA



Speakers
avatar for Paul Ivsin

Paul Ivsin

Managing Director, Clinical Trial Strategy, The Patient Experience Project
Paul leads the Clinical Trial Strategy and Patient Enrollment practice at The Patient Experience Project (PEP). He provides strategic planning services to both large pharma companies and biotechs, with an emphasis on patient engagement, clinical trial awareness, and performance a... Read More →
avatar for Matthew Kibby

Matthew Kibby

Principal, President, BBK Worldwide
Matt is president and principal of BBK Worldwide, the industry leader in patient recruitment and engagement. Matt leads the company in its commitment to the industry’s adoption of patient-centric recruitment best practices and is a vocal advocate for efforts to enhance the patient... Read More →
avatar for Neil Weisman

Neil Weisman

President, Continuum Clinical
Neil Weisman, President of Continuum Clinical, helps pharmaceutical and biotech companies bring new therapies to market faster and more efficiently by solving critical communication challenges that impact the clinical development process. With nearly 20 years of experience, Neil leads... Read More →
avatar for Jennifer Burgess

Jennifer Burgess

Executive Director of Engagement, TransCelerate BioPharma Inc.


Monday June 24, 2019 11:00am - 12:00pm
Room 9 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

#118: Statistical Considerations for Trials Using Surrogate Endpoints for Accelerated Approval
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-531-L04-P; CME 1.00; IACET 1.00; RN 1.00

For slowly progressed diseases, it may take years, if not decades, to observe clinical outcomes, such as mortality. Owing to the regulatory agencies’ accelerated approval pathway, drug developers can now consider applying for a drug approval based on surrogate endpoints. In this session, many surrogate endpoints adopted in various diseases and statistical methods for determining the validity of the surrogacy will be discussed, including their implementation in real case examples.

Learning Objectives

Describe cases that utilize the accelerated approval and what good surrogate endpoints are for common and rare diseases; Identify how to apply appropriate statistical methods for assessing the association between surrogate endpoints and clinical outcomes.

Chair

Yeh-Fong Chen, PhD

Speaker

FDA Update
Aloka Chakravarty, PhD

Statistical Assessment of Potential Surrogate Endpoints: Is the Bar too High?
Marc E. Buyse, DrSc

Using the Biomarker Endpoint for Accelerated Approval
Stephanie O. Omokaro, MD



Speakers
avatar for Marc Buyse

Marc Buyse

Chief Scientific Officer, International Drug Development Institute (IDDI)
Marc Buyse holds master’s degrees from Brussels University (Belgium), the Cranfield School of Management (UK) and a doctorate degree from the Harvard School of Public Health (USA). He had worked for 12 years at the EORTC in Brussels and for 2 years at the Dana Farber Cancer Institute... Read More →
avatar for Aloka Chakravarty

Aloka Chakravarty

Acting Director, Office of Biostatistics, Office of Translational Sciences, CDER, FDA
Dr. Chakravarty joined CDER in 1992. She served as an Adjunct Faculty in Depart. of Statistics, Foundation for Advanced Education in the Sciences, NIH. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development... Read More →
avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Dr. Chen is the Acting Associate Director of the Division of Biometrics II within CDER of FDA, supervising reviewers for the Division of Metabolism and Endocrinology Products and Division of Anesthesia, Analgesia, and Addiction Products. She joined FDA in 2000 after receiving her... Read More →
avatar for Stephanie Omokaro

Stephanie Omokaro

Lead Medical Officer, Office of New Drugs, CDER, FDA
Dr. Omokaro is a Lead Medical Officer in the Division of Gastroenterology and Inborn Errors Products in the Center for Drug Evaluation and Research at FDA. She was educated in Biochemistry at Cornell University, and in medicine at Boston University. She completed a pediatric residency... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:15pm

#130 RT: Round Table Discussion: Emerging Technologies in Clinical Research
Component Type: Session
Level: Basic

Round table discussion tied to session #107: Emerging Technologies in Clinical Research (Monday, June 24, 11:00AM - 12:00PM). Seating is limited. To include special guests from the session: Anthony Humphreys, Sonya Eremenco.

Chair

Keith W. Wenzel


Speakers
avatar for Keith Wenzel

Keith Wenzel

Senior Director, Business Opeartions, Scientific Data Organization, Parexel
Mr. Wenzel holds the position of Senior Director within PAREXEL Informatics’ Solution Incubator, a team that brings innovation to clinical trials. He is responsible for advising clinical trial sponsors and consults with regulatory authorities and industry organizations to advance... Read More →


Monday June 24, 2019 1:15pm - 2:15pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:15pm

#135: Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and Post-Market Continuity
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-538-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss proactively planning and pilot-testing high-quality safety monitoring programs in the pre-marketing phase to ensure timely implementation of monitoring programs and post-marketing safety studies.

Learning Objectives

Describe the role of real world data in active safety monitoring, strengths, and limitations of real world data, and basic pharmacoepidemiological study design considerations; Recognize analytic and logistical considerations in planning and testing a safety monitoring program based on use case examples and translate lessons learned to your own pharmacovigilance team.

Chair

Jeremy Rassen, DrSc, MS

Speaker

Academia Perspective
Noelle Cocoros, DrSc, MPH

Industry Perspective
Kimberly Brodovicz, DrPH



Speakers
KB

Kimberly Brodovicz

Executive Director of Global Epidemiology, Boehringer Ingelheim
Kim Brodovicz is Executive Director, Late Stage Cardiometabolism Team Lead in Global Epidemiology and Real World Evidence at Boehringer Ingelheim. Kim has supported drugs and vaccines from early development to post-approval in a variety of therapeutic areas and has conducted numerous... Read More →
NC

Noelle Cocoros

Research Scientist, Department of Population Medicine, Harvard Medical School
Noelle Cocoros is an epidemiologist with a broad background in public health surveillance, pharmacoepidemiology, and infectious disease epidemiology and has expertise in the use of claims, electronic health records, and registry data for surveillance (FDA's Sentinel System; ESPhealth.org... Read More →
avatar for Jeremy Rassen

Jeremy Rassen

Co-Founder, President and Chief Science Officer, Aetion
Jeremy A. Rassen, MS, 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 →


Monday June 24, 2019 2:15pm - 3:15pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Real World Evidence,Regulator Thinking,Innovative Trial Design,Generics,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

2:15pm

#137: Emerging Technology to Improve Sponsor-Site Interactions
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-547-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will include updates on the growth of functionality, adoption, and engagement initiatives to further strengthen Sponsor-Site collaboration. This session will also describe the value and benefits of SIP being open for adoption across the industry, which means that realized benefits would be further multiplied across participating sponsors and sites.

Learning Objectives

Discuss how Sponsors, technical partners, and Investigators collaborated in an unprecedented way to create a first of its breed technology platform that will enable a seamless investigator experience; Describe the value, benefits, and latest system updates from the Shared Investigator Platform being available for adoption across all interested Sponsors and respective vendors.

Chair

Lisa Bartoli Moneymaker

Speaker

An Evolution of Sponsor-Site Collaboration in the Planning and Execution of Clinical Trials
Lisa Bartoli Moneymaker

Chatbot Implementation for Improving Site-Sponsor Relationship: A Lean Start-up Approach
Johan Chaparro



Speakers
avatar for Johan Chaparro

Johan Chaparro

Lead Clinical Data Manager, Merck, Sharp and Dohme
Passionate for the use of new technologies Chemical Engineer and Data Manager with 2+ years of experience in oncologic clinical trials. Specialized in Innovation Management, the main motivation is to bring disruption considering to the highly regulated pharmaceutical industry. Strong... Read More →
avatar for Lisa Moneymaker

Lisa Moneymaker

Principal Architect, Clinical Trial Management Systems, Amgen Inc.
Lisa is a Principal Architect within the Development Information Systems organization at Amgen, specializing in Clinical Trial Management ecosystems. She additionally supports TransCelerate in both the Investigator Registry and Shared Investigator Platform initiatives, and is the... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:15pm

#139: Developing Standard Core Clinical Outcome Assessments and Endpoints: FDA Perspective and Plans
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-549-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an opportunity for stakeholders to hear about FDA’s effort to advance the development of a publicly available core set(s) of clinical outcomes assessment measures and endpoints.

Learning Objectives

Describe FDA efforts, including plans and progress on an anticipated new FDA extramural grants program, to advance the development of a publicly available core set(s) of clinical outcomes assessment (COA) measures and endpoints for specific disease indications; Discuss the opportunities for key stakeholders including, academia, Health Technology Assessors, payers, health care providers, and regulated industry.

Chair

Meghana Chalasani, MHA

Speaker

FDA Update
Theresa Mullin, PhD

FDA Update
Laura Lee Johnson, PhD

FDA Update
Elektra Johanna Papadopoulos, MD, MPH

Industry Update
Tara Symonds, PhD

Industry Update
Anton Hoos, MD, PhD, MBA



Speakers
avatar for Anton Hoos

Anton Hoos

Executive Team, Patient Focused Medicine Development
Tony is a founding member of the non-profit, multi-stakeholder alliance ‘Patient Focused Medicines Development’ (www.pfmd.org); members include many patient groups, industry and others; Tony currently serves on PFMD’s executive team. He has 30 years of professional experience... Read More →
avatar for Meghana Chalasani

Meghana Chalasani

Senior Research Analyst, Office of the Center Director, CDER, FDA
Meghana Chalasani currently serves as a senior research analyst for the Patient-Focused Drug Development (PFDD) Program in FDA’s Center for Drug Evaluation and Research (CDER). She works closely on CDER’s various PFDD initiatives and provides strategic, regulatory, program, and... Read More →
LL

Laura Lee Johnson

Director Division III, Office of Biostatistics, OTS, CDER, FDA
Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, OCD, CDER, FDA
Principal advisor on strategy including CDER international cooperation and harmonization, application of decision science, and other initiatives. Leads FDA Patient Focused Drug Development, and heads the FDA delegation to ICH. Previous work includes leading FDA negotiations for 2002... Read More →
EP

Elektra Papadopoulos

Associate Director, Clinical Outcome Assessments Staff, OND, CDER, FDA
Dr. Papadopoulos serves as the Associate Director of the Clinical Outcome Assessments Staff in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The staff provides consultation to CDER’s Review Divisions as well as other FDA Centers on clinical outcome... Read More →
avatar for Tara Symonds

Tara Symonds

Chief Science Officer, Clinical Outcomes Solutions
Tara Symonds is Strategic Lead at Clinical Outcomes Solutions providing advice on COA strategy from development to dissemination. Tara has 25+ years of experience in the COA field both negotiating labelling and in disseminating results effectively with payers. She has worked in numerous... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

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, WIRB-Copernicus Group (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

3:30pm

#155: Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-570-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss how to complement existing activities and regulations, we propose an additional approach blending evidence derived from pharmacological and organizational science which addresses human factors and transparency to enhance organizational learning and continuous improvement. This systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future.

Learning Objectives

Identify evidence-based techniques for better defining causal factors in system failure; Recognize that those techniques which can be used now; Appraise how we should best develop these concepts, identify best practice and engage all stakeholders; Discuss how to volunteer to join the team aiming to improve the safety of the system for clinical research.

Chair

Brian Edwards, DrMed

Speaker

Applying CAUSAL Analysis System Theory to the TGN1412 First-In-Human Clinical Trial
Brian Edwards, DrMed

Innovation in First-in-Human Safety
Howard Greenberg, DrMed, MD, MBA, MS

Investigators from the Warfarin-Stimulated Frail Hospitalized Patients Project
Nichola Crust, MSc



Speakers
NC

Nichola Crust

National Investigator, Healthcare Safety Investigation Branch
Nichola has worked at a strategic level in a variety of healthcare settings spanning primary and secondary care. Her roles have included professional nurse leadership and mentoring of nursing teams, mobilisation of new services including service and workforce redesign, and training... Read More →
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
avatar for Howard Greenberg

Howard Greenberg

Medical Safety Officer, Janssen Research and Development, LLC
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next,Patient Focused
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

3:30pm

#156: Clinical Research in Emerging Regions
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-566-L04-P; CME 1.00; IACET 1.00; RN 1.00

Changing times, technology and a surge in activities in the emerging regions have prompted the global clinical research industry to further enhance capabilities by building capacity and developing talent. Outsourcing services to emerging regions continue to grow especially in the realm of risk based monitoring, data management, clinical trial management and site management. On the scientific arena, innovative research activities in countries like Korea, China, and Singapore to name a few have developed biomedical, biotech and clinical research infra structures with the ultimate goal of attracting big pharma to partner with them to co-develop their discoveries. However, capability, capacity, credibility and overall quality remain to be sticking points.

In this session, current trends, issues, challenges and opportunities will be discussed by experts who work in these emerging regions. Their hope is that by sharing experiences and information the global pharma and biotech industry would have better understanding of the huge opportunities and untapped potential these emerging regions can provide. Join the Good Clinical Practices & Quality Assurance Community for a follow up Round Table discussion on Tuesday, June 25, 3:15-4:15PM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Discuss the current environment of clinical research in emerging regions; Identify strategic advantages in conducting clinical trials in emerging regions; Identify solutions to challenges in conducting clinical research activities and trial management in these emerging regions.

Chair

Nadina Jose, MD

Speaker

What is the Best Collaborative Model to Deliver Pivotal Clinical Trials in Developing Countries
Asita De Silva, MD, PhD, FRCP

Strategic Inclusion of Regions in Multi-Regional Clinical Trials
Eunyoung Kim, PharmD, PhD

An Integrated Mobile eSource-EDC Solution to Streamline Clinical Trial Data Management for Large Global Trials
Avik Kumar Pal, MBA



Speakers
avatar for Nadina Jose

Nadina Jose

Assistant Professor, Clinical Trial Sciences, BioPharma Educational Initiative, Rutgers, The State University of New Jersey
Rejoined academia on Oct 2016 and is currently Assistant Professor at Rutgers University, Department of Health Informatics, Biopharma Education Initiative, School of Health Professions MS in Clinical Research Management. Dr. Jose is the Founder and President of Anidan Group Pte. Ltd... Read More →
EK

Eunyoung Kim

Professor, College of Pharmacy, Chungang University
avatar for Avik Pal

Avik Pal

Chief Executive Officer, CliniOps
Avik is the CEO of CliniOps, a mobile, cloud-based, digital solutions company, for the clinical trial industry & global health research. Prior to that, he worked with two successful startups and is a Founding Board member at iKure, a healthcare startup. He is passionate about Global... Read More →
AD

Asita De Silva

Professor of Pharmacology, University of Kelaniya
Professor Asita de Silva has held many positions in academic medicine over the last 25 years. He is a Clinical Pharmacologist, and is currently Senior Professor of Pharmacology at the Faculty of Medicine, University of Kelaniya, Sri Lanka. He is also Director of the Clinical Trials... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 9 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
 
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

9:30am

#224 RT: Round Table Discussion: Enhancing Patient-Focused Outcome Assessment in Medical Product Development
Component Type: Session
Level: Basic

Round table discussion tied to session #158: Enhancing Patient-Focused Outcome Assessment in Medical Product Development (Monday, June 24, 3:30-4:30PM). Seating is limited. To include special guests from the session: Elektra Papadopoulos, Telba Irony, Michelle Tarver.

Chair

Emuella Flood


Tuesday June 25, 2019 9:30am - 10:30am
Community Zone Sails Pav 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

Worldwide Medical and Safety, 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, OHOP, CDER, FDA
Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Hematology and Oncology Products in 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

#230: Assessing Opportunities to Improve Outsourcing Oversight and the Vendor Qualification Assessment Process
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-604-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session reviews original benchmark research and experiences with outsourcing practices to identify opportunities to optimize the management, execution and performance of CRO relationships.

Learning Objectives

Identify benchmarks characterizing outsourcing practices and identifying opportunities to improve outsourcing effectiveness and efficiency; Describe risk-based quality management and monitoring practices to improve effectiveness; Discuss data-driven insights to inform improvement in the vendor qualification assessment process.

Chair

Kenneth A. Getz, MBA

Speaker

Risk-Based Quality Management and Monitoring; How to Perform Oversight
Liz Wool, BSN

Benchmarking the Oversight and Vendor Qualification Assessment Process
Kenneth A. Getz, MBA



Speakers
avatar for Kenneth Getz

Kenneth Getz

Director of Sponsored Research Programs and Associate Professor, Center For the Study of Drug Development, Tufts University School of Medicine
Kenneth A. Getz, MBA, is the Director of Sponsored Research and an Associate Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the... Read More →
avatar for Liz Wool

Liz Wool

President, Wool Consulting Group Inc.
Liz Wool CCRA, CID, CMT, is President, Wool Consulting Group. Inc. Liz possesses 28 years in the product development with expertise in CRO-Vendor Oversight, GCP compliance, SOP gap analyses and development, development and delivery of training programs (live, webinar, virtual classroom... Read More →


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

10:30am

#231: Outcomes, Endpoints, and Methods Supporting Oncology and Alzheimer Therapies
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-605-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of past challenges and future opportunities for outcomes research in the Oncology and Alzheimer therapy areas. This will include an update on the state of eCOA and the use of connected devices inside oncology clinical trials as well as a review of existing and future endpoints that could be relevant for immunotherapies. The session will also discuss the eCOA led methodological improvements that are positively supporting Alzheimer clinical trials.

Learning Objectives

Describe the use of eCOA and connected health devices inside oncology clinical trials, areas of controversy and opportunity; Discuss current challenges in Alzheimer clinical trials - traditional approaches to eCOA implementation with central oversight; Identify Current challenges associated with measuring c the effects of immunotherapies with existing metrics and proposed metrics to measure outcomes into the future.

Chair

Brad Sanderson, MHS

Speaker

eCOA and Connected Devices for Supporting Oncology Patients in Clinical Trials
Brad Sanderson, MHS

Measuring and Understanding the Outcomes of Immunotherapies in Oncology
Imad Al-Dakkak, DMD, MPA, MPH



Speakers
IA

Imad Al-Dakkak

Director, Huron Consulting Group
Imad is a clinical epidemiologist with over 14 years of experience from government, industry, and academia across multiple disease areas. His areas of expertise include research methodology, epidemiology, study designs, database analytics, and evidence-based medicine. Imad is based... Read More →
BS

Brad Sanderson

Senior Scientific Advisor, Signant Health
Brad is a physiologist and researcher with over 15 years of industry experience. Brad is currently Senior Scientific Advisor - Head of Health Outcomes at CRF Bracket where he leads the Health Outcomes discipline and seeks to advance the company’s scientific and technical expertise... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#232: Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-606-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will explore new approaches to quality risk management implemented by stakeholders since the adoption of ICH E6 (R2) and the vital role of critical thinking and metrics in bridging from risk assessment to centralized monitoring.

Learning Objectives

Discuss and compare your organization’s approach with leading practices shared in the session; Describe some of the gaps in standard approaches to risk assessment and ways to overcome them; Explain the importance of metrics in risk assessment and risk control.

Chair

Linda B. Sullivan, MBA

Speaker

Panelist
Sherry Merrifield

Panelist
Ann McCabe

Panelist
Suzanne Lukac



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 Ann McCabe

Ann McCabe

Director, Process Excellence and Risk Management, Daiichi Sankyo Inc
Ann E. McCabe Director, Process Excellence & Risk Management Ann McCabe is Director, Process Excellence & Risk Management at Daiichi Sankyo. She has worked in clinical research for over 20 years at various global pharma, biotech, medical device and consulting companies. She has worked... Read More →
avatar for Sherry Merrifield

Sherry Merrifield

Senior Director, Global Operations Management, Syneos Health
Sherry Merrifield has over 20 years of clinical operations experience. In her current role she is Senior Director of the Global Operations Management group focused on the optimization of Syneos Health’s data-driven RBM solution and application of ICH E6 R2. Her experience in this... Read More →
avatar for Linda Sullivan

Linda Sullivan

Executive Director, Metrics Champion Consortium
Ms. Sullivan is the Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has... Read More →


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

10:30am

#235: Walking the Talk: Using Home Nursing as a Patient-Centric Service in Clinical Trials - From Multiple Perspectives
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-595-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session examines the use of home trial support services from the perspectives of the study sponsor, CRO partner and the potential patient participant. During this session we will discuss the logistics of home trial support, its benefits and pitfalls, when it is most appropriate to use and the patient perception of the service and how it may affect their willingness to participate.

Learning Objectives

Describe the benefits of use of home nursing (specifically, home trial support) in clinical trials from the sponsor, CRO and patient perspectives; Identify barriers to implementation of home trial support; Discuss scenarios where the greatest return on investment for home trial support is realized.

Chair

Ellyn Getz

Speaker

Academic Perspective
Ellyn Getz

Industry Perspective
Todd McGrath

Study Sponsor Perspective
Nour Ziyadeh, MS

Patient Perspective
Mary Koestler

CRO Perspective
Kelly Franchetti, RN



Speakers
MK

Mary Koestler

Assistant Professor, Clinical Trials Adminstrator, Memory and Aging Center, University of California San Francisco
avatar for Nour Ziyadeh

Nour Ziyadeh

Clinical Trial Oversight Lead, Alnylam Pharmaceuticals
Nour Ziyadeh is a Clinical Trial Oversight Lead ensuring compliance for Alnylam’s outsourced clinical trials. She has 15 + years of industry experience including third party auditing for the FDA, CRO , SMO and Pharma. She has held roles including Clinical Research Coordinator, Clinical... Read More →
avatar for Kelly Franchetti

Kelly Franchetti

RN, CCRN, CEN Vice President, Global Head Patient Insights & Engagement, ICON plc.
Kelly has a diverse background comprised of nursing, advocacy & clinical research. She is also the mother of a child with a rare disease. This gives her a unique 360 degree view of patients’ & caregiver’s perspectives in the realm of disease management, treatment and burden. As... Read More →
avatar for Ellyn Getz

Ellyn Getz

Associate Director, Development and Community Engagement, CISCRP
Ellyn Getz is the Associate Director of Development and Community Engagement at CISCRP. She is responsible for directing CISCRP’s educational and outreach initiatives, including AWARE for All: Clinical Research Education Days, MT Pharmacy and Journey to Better Health mobile experiential... Read More →
TM

Todd McGrath

Vice President Operations A/O, Medical Research Network
Todd has over 15 years' experience in the clinical trial and life science industry; beginning his career in pharmaceutical and biotech consulting and then holding operational positions at a clinical research organization. As Vice President Operations Americas Oceania at MRN, Todd... Read More →


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

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 & 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

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

#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

Senior Research Advisor, Statistical Innovation Center, 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 Senior Research Advisor 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

Executive Director, 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 advises on a broad spectrum of matters, both contentious and non-contentious, that arise in the conduct of a bio pharmaceutical business. Marie represents pharma companies before UK and EU institutions (EMA, MHRA, NICE, PMCPA DOH and the European Commission). Marie is Chairperson... Read More →
avatar for Julie Eller

Julie Eller

Manager of 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

#284: Virtual Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-640-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how virtual clinical trials represent a relatively new method of collecting safety and efficacy data from clinical trial participants, from study start-up through execution to follow-up.

Learning Objectives

Discuss the concept of assessing a protocol visit by visit to identify opportunities to minimize patient burden of participation; Discuss how to appraise and choose the right visit location, data collection method, patient support service or technology for each visit; Design and plan trials that consider patient burden enabled by utilizing relevant technology or patient support services.

Chair

Lucas Garmon

Speaker

A Patient-Centric Approach to Study Visits and Data Collection: What if I'm not Ready for 100% Virtual Trial?
Lucas Garmon

Research Passport: Ethics Review and Regulatory Implications for Participants in Virtual Trials
David Babaian, JD, LLM

Back to the Future with Virtual Clinical Trials
Juliana Nino Ortegón



Speakers
avatar for Juliana Nino Ortegón

Juliana Nino Ortegón

Senior Clinical Data Manager, Merck, Sharp and Dohme
Senior Clinical data management at Merck Sharp and Dohme. Microbiologist and Biomedical Engineer interested in research and development in pharmaceutical industry. I've got three years of experience in Data management of different Oncology trials working in data cleaning to achieve... Read More →
DB

David Babaian

Senior Consulant and Senior Regulatory Attorney, Advarra
David Babaian leverages his expertise in regulatory affairs, healthcare law, and project management to provide consultation on U.S. and international research compliance and data privacy law. David graduated cum laude from The John Marshall Law School in Chicago and earned an LL.M... Read More →
LG

Lucas Garmon

Recruitment Manager, Patient Recruitment Solutions, ICON plc.
Lucas has over 10 years of experience supporting recruitment and retention of clinical trials with techniques in the digital space. He has a creative agency background and works at the forefront of integrating patient-centric research insights into the campaigns he implements. His... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

4:15pm

#285: Using Mobile Sensors in Clinical Trials and Evidentiary Considerations for Electronic Submissions
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-641-L04-P; CME 1.25; IACET 1.25; RN 1.25

We will review the current work of the Study Endpoint Community wearables group. Specifically three areas: how to select a clinical endpoint derived from mobile sensor data; how to select a fit for purpose device and how to provide evidence to support its use; considerations regarding the positioning of endpoints derived from mobile sensor data alongside other clinical endpoints in the endpoint hierarchy.

Learning Objectives

Identify the format and content of an evidence dossier to support clinical endpoints derived from wearable devices in regulatory drug submissions; Outline key considerations in the practical implementation of wearables to measure intervention effects in clinical trials; Discuss endpoint hierarchy considerations when including new objective sensor-based clinical endpoints.

Chair

Bill Byrom, PhD

Speaker

Practical Considerations for the Implementation of Mobile Sensors for Measurement in Clinical Trials
Jennifer Goldsack, MA, MBA, MS

Developing an Evidence Dossier to Support the Use of Mobile Sensors to Collect Clinical Endpoints in Regulatory Submissions
Bill Byrom, PhD

Endpoint Hierarchy Considerations When Including New Objective Sensor-Based Clinical Endpoints
Emuella Flood



Speakers
avatar for Jennifer Goldsack

Jennifer Goldsack

Interim Executive Director, Digital Medicine Society (DiMe)
Jen Goldsack is the Interim Executive Director of the Digital Medicine (DiMe) Society and is Vice President of Digital Measurement at monARC Bionetworks.
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 Emuella Flood

Emuella Flood

Director, Patient-Reported Outcomes, AstraZeneca
Emuella Flood is co-chair of the DIA Study Endpoints Community and has been working in the field of patient-centered outcomes for over 20 years. She recently joined AstraZeneca as PRO Director, with a focus on PRO strategy and implementation in women's cancer. Prior to joining AstraZeneca... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#298: Clinical Safety Assessment: What’s a Statistician Got to Do with It?
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-637-L04-P; CME 1.25; IACET 1.25; RN 1.25

Statistical attention to safety data is often times left to routine, basic calculations and tabulations. Absent statistical input, the data run the risk of being presented in ways that are unintuitive, uninformative, or in the worst case, deceptive. Speakers in this session will present examples where statisticians are collaborating with clinical colleagues and data scientists to more effectively analyze and clinically interpret safety data.

Learning Objectives

Recognize the importance of statistical engagement in the assessment of clinical trial safety data; Apply appropriate statistical methods in the analysis of safety data; Identify the need to work collaboratively with clinicians and data scientists.

Chair

Mat Soukup, PhD

Speaker

Improving Analyses and Displays for Clinical Trial Safety Data
Mary Nilsson, MS

ASA/DIA Safety WG Presents: Finding Safety Signals During Clinical Development with R Shiny
Susan Duke, MSc

FDA Perspective
Matthew Guerra, PhD



Speakers
avatar for Susan Duke

Susan Duke

Mathematical Statistician, OB, OTS, CDER, FDA
Susan became involved in safety related industry-wide graphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG. She is currently a Mathematical Statistician reviewer in CDER and member of a cross-functional safety monitoring WG co-sponsored by DIA and ASA Biopharm... Read More →
MG

Matthew Guerra

Mathematical Statistician, OB, OTS, CDER, FDA
Matthew is a senior statistical reviewer supporting the Division of Dermatology and Dental Products (DDDP) in the Center for Drug Evaluation and Research (CDER) at the FDA. Matthew joined the FDA in 2011 immediately after receiving his Ph.D. in Biostatistics from the University of... Read More →
avatar for Mary Nilsson

Mary Nilsson

Statistician, Eli Lilly and Company
Mary received a MS degree in statistics from Iowa State University in 1989. She has been employed at Lilly since 1989 and is currently a research advisor in the Safety Analytics group within the Statistical Sciences function. She consults with compound teams on safety analysis planning... Read More →
MS

Mat Soukup

Deputy Div. Director, Div. of Biometrics VII, Office of Biostatistics, OTS CDER, FDA
Following his educational endeavors in statistics at the University of Minnesota-Morris and the University of Virginia, Mat joined FDA/CDER in September 2004. His first 6 years were spent reviewing dermatology and dental products before joining the Division of Biometrics 7 as Team... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session
 
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 & 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

Senior Research Advisor, Statistical Innovation Center, 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 Senior Research Advisor 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

#305: Demystifying Technology Selection in Mobile Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-661-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will describe CTTI resources that support the adoption of mobile technologies into clinical research by 1) eliminating redundant feasibility testing, and 2) promoting streamlined, informative studies where there are knowledge gaps.

Learning Objectives

Describe how feasibility testing can reduce the risk of conducting mobile clinical trials; Identify how to initiate their own feasibility studies, where appropriate; Describe how to access and utilize the consortium's database of feasibility studies available as a resource summarizing current knowledge.

Chair

Thomas Switzer, MEd

Speaker

FDA Perspective
Isaac R. Rodriguez-Chavez, MHS, PhD, MS

Industry Update
Barry Peterson, PhD

Panelist
Aaron Coleman



Speakers
AC

Aaron Coleman

Founder and Chief Executive Officer, Fitabase
In 2012 Aaron Coleman founded Fitabase, forming an early partnership with Fitbit and creating a software platform to connect consumer devices to the needs of researchers and data scientists. Fitabase has been used by over 500 research studies, clinical care pilots, and pharma trials... Read More →
avatar for Barry Peterson

Barry Peterson

Wearable Devices, Independent Consultant
Dr. Peterson has extensive experience with the application of actigraphy and physiological measurements in pharmaceutical clinical trials. After 20 years of academic research on acute lung injury and respiratory measurement techniques, he joined Pfizer's Clinical Technology group... Read More →
avatar for Isaac Rodriguez-Chavez

Isaac Rodriguez-Chavez

Clinical Research Methodology, Reg Compliance and Policy Development, OMP, CDER, FDA
Dr. Isaac R. Rodriguez-Chavez serves as a FDA, CDER Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development. He is a biomedical leader with expertise in Virology, Microbiology, Immunology, Vaccinology, and Oncology. Past positions in the last 20 years... Read More →
avatar for Thomas Switzer

Thomas Switzer

Business Ops Leader, Digital Health Platforms, Genentech, A Member of the Roche Group
Tom is a Business Operations Lead in the Roche PHC Center of Excellence supporting Digital Health Platforms.  His current focus is on developing technology platforms supporting molecule teams across the Roche late-stage organization.  Tom has over 18 years of clinical development... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

8:00am

#309: Neoantigen-Based Cancer Therapies: Regulatory Challenges and Opportunities
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-650-L04-P; CME 1.25; IACET 1.25; RN 1.25

Neoantigen-based cancer therapy is an approach based on the specific genetic information unique to individual tumor(s) of an individual patient. Such information can be utilized in many ways for cancer treatment, e.g., to generate antigens for vaccination or specific T-cells. Results from earlier clinical trials have shown that this approach is feasible, able to elicit the intended immune response, and in some cases generating anti-tumor activities that may mediate the tumor regression. However, this approach has many scientific and regulatory challenges, for example, optimal ways / algorithms in identifying and selecting neoantigens, and regulatory framework for regulating such products given that drug product and indications are not explicitly defined. This session is intended to address these challenges and discuss the opportunities for the neoantigen-based cancer therapies.

Learning Objectives

Describe the concepts of cancer immunoediting and neoantigen;Discuss the recent advances in neoantigen-based novel cancer therapy, e.g., vaccine and cell-based therapies;Discuss scientific and regulatory challenges, focusing on pre-clinical studies and early clinical trials; Identify opportunities in facilitating and accelerating the development.

Chair

Peter F. Bross, MD

Speaker

CMC Considerations: Regulatory Perspective
Elena Gubina, PhD

CMC Considerations: Industry Perspective
Karin Jooss, DrSc

Clinical Consideration for Early-Phase Trials: Academic Perspective
Aaron M. Miller, MD, PhD

Clinical Consideration for Early-Phase Trials: Regulatory Perspective
Peter F. Bross, MD

Panelist
Alyssa K. Galaro, PhD



Speakers
avatar for Alyssa Galaro

Alyssa Galaro

Biomedical Engineer, DCEPT, OTAT, CBER, FDA
Dr. Galaro joined the Office of Tissues and Advanced Therapies in 2018 as a Pharmacology and Toxicology Reviewer. Prior to joining CBER, she completed her PhD in biomedical engineering at the Johns Hopkins School of Medicine where her research focused on engineering nanoparticle-based... Read More →
PB

Peter Bross

Medical Team Leader, OTAT, CBER, FDA
Peter Bross is a clinical oncology team leader in the FDA Center for Biological Evaluation and Research (CBER), Office of Tissue and Advanced Therapies (OTAT) and previously worked as a clinical reviewer in the Division of Oncology Drug Products in the Center for Drug Evaluation and... Read More →
avatar for Elena Gubina

Elena Gubina

Expert Biologist, OTAT, CDER, FDA
KJ

Karin Jooss

Executive Vice President of Oncology and Chief Scientific Officer, Gritstone Oncology
Dr. Karin Jooss serves as executive vice president of research, chief scientific officer at Gritstone and interim head of manufacturing. She joined Gritstone from Pfizer, where she was head of cancer immuno-therapeutics, was a member of the vaccine immuno-therapeutics leadership team... Read More →
AM

Aaron Miller

Medical Oncologist, Assistant Professor of Medicine, University of California San Diego
Dr. Miller is a board-certified medical oncologist who specializes in diagnosing and treating gastrointestinal cancers. He is an assistant professor in the Department of Medicine, where he instructs medical students, residents and fellows at UC San Diego School of Medicine. He holds... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking,Advanced Therapies
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

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 (EMA)
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

Acting Director, Office of Biostatistics, Office of Translational Sciences, CDER, FDA
Dr. Chakravarty joined CDER in 1992. She served as an Adjunct Faculty in Depart. of Statistics, Foundation for Advanced Education in the Sciences, NIH. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development... 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

9:30am

#323 RT: Round Table Discussion: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine?
Component Type: Session
Level: Basic

Round table discussion tied to session #219: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine? (Tuesday, June 25, 8:00-9:15AM). Seating is limited.

Chair

Emuella Flood


Wednesday June 26, 2019 9:30am - 10:30am
Community Zone Sails Pav 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

#330: The Analytics Revolution: Opportunities and Threats for Disrupting Clinical Development Operations
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-675-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss advanced analytics techniques such as machine learning and AI and how they bring enormous opportunity for improving clinical development operations, but also significant process and cultural challenges that must be addressed head on.

Learning Objectives

Discuss some immediate term and future possibilities for transforming clinical development operations through application of advanced analytics; Share key process and cultural considerations that may threaten the success of this transformation – and how to address head on.

Chair

Jacqueline Gough, MS

Speaker

Industry Perspective
Gary Thompson, MS

Industry Perspective
Jacqueline Gough, MS



Speakers
JG

Jacqueline Gough

Director, Central Monitoring and Data Surveillance, Astellas
Jackie Gough is the Director for Central Monitoring and Data Surveillance at Astellas. Previously she led the RBM team at Lilly. Jackie began her career as a statistician – first in the academic world, then at a CRO and for the last 15 years on the sponsor side. She has been a member... Read More →
GT

Gary Thompson

Vice President, Strategic Consulting, Medidata Solutions
Gary Thompson, MS, is the VP of Strategic Consulting at Medidata Solutions, focused on helping clients maximize value from the Medidata platform and achieve transformative business goals. Gary has over 24 years of experience in clinical research in a variety of CRO, pharma, and technology... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Artificial Intelligence,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

10:30am

#331: A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Trials from eICF to Database Lock
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-680-L04-P; CME 1.00; IACET 1.00; RN 1.00

The paperless clinical trial is a paradigm shift that must occur to enable the clinical trial enterprise to embrace the modern era. We will share our experience partnering, planning, and implementing these trials to assure that there is no compromise on patient safety, data integrity, trial efficiencies and regulatory review.

Learning Objectives

Describe the elements of the paperless clinical trial and how it differs from paper-based studies; Discuss the paradigm shift and its impact on the clinical trial stakeholders; Identify how to plan and implement the paperless clinical trial.

Chair

Jules T Mitchel, PhD, MBA

Speaker

Paperless Clinical Trial
Michelle Eli

Paperless Clinical Trial
Thomas Haag



Speakers
avatar for Michelle Eli

Michelle Eli

Clinical Project Management Advisor, Chorus, Eli Lilly and Company
Michelle Eli has worked in the pharmaceutical industry for 28 years with positions primarily in Clinical Project Management and Pharmacokinetics. She started her career at the former Upjohn Company (now Pfizer) and is currently a Clinical Project Management Advisor within the Chorus... Read More →
avatar for Thomas Haag

Thomas Haag

Principal Consultant, Cardinal Solutions Consuting, LLC
Tom Haag has a truly innovative vision for quality in clinical research that is focused on delivering outcome data that justifies therapeutic costs. Formerly the Global Head of Digital Development and Transformation QA with Novartis, Tom led on end-to-end quality and data integrity... Read More →
avatar for Jules Mitchel

Jules Mitchel

President, Target Health, Inc.
Dr. Mitchel is President and co-founder of Target Health Inc., a New York City-based full service eCRO dedicated to all aspects of Drug and Device Development. He also leads the team at Target Health developing software tools to enable the “Paperless Clinical Trial.” Dr. Mitchel... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

10:30am

#336: Exploring the Evolving Requirements for the Clinical Assessment of Abuse and Dependence Potential of CNS-Active Drugs
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-678-L04-P; CME 1.00; IACET 1.00; RN 1.00

Drug scheduling is implemented by regulatory agencies to mitigate the risk of drug abuse. Learn about the pivotal clinical studies required to evaluate the abuse and dependence potential of CNS-active drugs and the evolving regulatory requirements.

Learning Objectives

Describe the most recent FDA recommendations for the clinical evaluation of abuse and physical dependence of CNS-active drugs; Discuss how this data is used to determine drug scheduling and the implications of controlled substances;Evaluate the best strategies to design robust abuse/dependence potential clinical trials.

Chair

Beatrice Setnik, PhD

Speaker

Panelist
Jack Henningfield, PhD

Panelist
Beatrice Setnik, PhD



Speakers
avatar for Jack Henningfield

Jack Henningfield

Vice President, Research, Health Policy, and Abuse Liabiliy, Pinney Associates
Professor Adjunct, Johns Hopkins School of Medicine, past chief Abuse Potential and Clinical Pharmacology, NIDA. 400+ articles and books related to drug abuse & regulation, public health, and neuropharmacology. My PinneyAssociates focus is on drug development, risk management, and... Read More →
avatar for Beatrice Setnik

Beatrice Setnik

Dept of University of Toronto; VP, Scientific and Clinical Strategy, Early Phase, Syneos Health
Dr. Setnik has been working in the area of CNS research and clinical drug development for over 16 years and is an expert in the area of abuse and dependence potential evaluation of drugs. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and oversees... Read More →
avatar for Beatrice Setnik

Beatrice Setnik

Dept of University of Toronto; VP, Scientific and Clinical Strategy, Early Phase, Syneos Health
Dr. Setnik has been working in the area of CNS research and clinical drug development for over 16 years and is an expert in the area of abuse and dependence potential evaluation of drugs. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and oversees... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next,Regulator Thinking,Innovative Trial Design,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

2:00pm

#357: Accelerating Drug Development via Structured Content Reuse: Introducing the TransCelerate Clinical Template eSuite
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-696-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will include presentations to introduce the new Common SAP and CSR templates, describing how these were designed and the key guiding principles in their structure, content, and format. Attendees will hear learnings from early case studies.

Learning Objectives

Describe the Clinical Template Suite (CPT-SAP-CSR) developed by an industry member consortium; Analyze the new Common Statistical Analysis Plan and Clinical Study Report templates; Explain how this technology enabled edition allows for content use across the protocol, statistical analysis plan and clinical study report.

Chair

Stacy Tegan

Speaker

Panelist
Vivian Combs, MS

Panelist
Kelly Lengyel, MS

Panelist
Yihua Gu, MS



Speakers
VC

Vivian Combs

Advisor/Process Owner, Clinical Information and Process Automation, Eli Lilly and Company
Vivian Combs currently leads the TransCelerate workstream responsible for the development of the TransCelerate Clinical Template eSuite. She is the acting rapporteur for the ICH M11 CESHarP (Clinical Electronic Structured Harmonized Protocol) Expert Working Group, and is a full-time... Read More →
avatar for Yihua Gu

Yihua Gu

Director of Statistics, Abbvie
Yihua has dedicated 22 years of career in Abbott/Abbvie. Her experience spans across immunology, neurology, infectious diseases, and analgesia. Her combined statistical knowledge, scientific insights, the ability to look beyond statistics and the operation excellence have made her... Read More →
avatar for Kelly Lengyel

Kelly Lengyel

Director of Medical Writing, Allergan
Kelly Lengyel is a Director of Medical Writing at Allergan and oversees the medical writing team for multiple therapeutic areas. Kelly has nearly 15 years of regulatory affairs and medical writing experience across multiple pharmaceutical companies. Over the course of her career in... Read More →
avatar for Stacy Tegan

Stacy Tegan

Senior Program Manager, Transcelerate Biopharma Inc.
Stacy Tegan is a Sr. Program Manager at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

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

#371: Efficient Pediatric Drug Development: Incorporating Innovative Techniques Using Extrapolation and Historical Information
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-694-L04-P; CME 1.25; IACET 1.25; RN 1.25

Pediatric drug development for adult indications is mandated. Yet children should be protected from unnecessary risks. This session discusses innovative techniques using extrapolation from adult data as an efficient way to study drugs in children.

Learning Objectives

Explain the regulatory and ethical context of pediatric drug development; Discuss the role, assumptions, and data needed for using extrapolation from adult data; Identify innovative approaches using Bayesian methodologies to demonstrate the efficacy of drugs in pediatrics; Discuss ways to integrate pediatric into adult drug development.

Chair

Robert Meland Nelson, MD, PhD

Speaker

The Use of Extrapolation in Pediatric Drug Development
Robert Meland Nelson, MD, PhD

Using Historical Data to Establish More Efficient Clinical Trials
Jeen Liu, PhD

Design and Analytic Strategies for Incorporating External Data in a Global Pediatric Trial
Margaret Gamalo-Stiebers, PhD



Speakers
MG

Margaret Gamalo-Stiebers

Principal Research Scientist, Eli Lilly and Company
JL

Jeen Liu

Associate VP, Biostatistics, Allergan Inc.
I have worked in the Pharma industry for 20+ years as a statistician, currently responsible for biostatistics support of all the ophthalmology products for the company. Prior to joining Allergan, I have worked for Novartis, Astellas and Eisai. My experience in clinical trials covers... Read More →
avatar for Robert Nelson

Robert Nelson

Senior Director, Pediatric Drug Development, Johnson & Johnson
Robert “Skip” Nelson, MD, MDiv, PhD. is currently Senior Director, Pediatric Product Development at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics, Office of the Commissioner at the U.S. Food and... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Beginner
  • Featured Topics Patient Focused,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

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

#390: Clinical Trial Innovation: Pathways for Selecting and Developing Novel, Fit-for-Purpose, Technology-Derived Study Endpoints
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-709-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will cover regulatory and research perspectives on challenges and opportunities for selecting, developing and implementing fit-for-purpose digital technology tools for to derive study endpoints to support drug development.

Learning Objectives

Describe the regulatory and practical consideration for successfully selecting, developing, and implementing patient-focused digital technology tools for use to derive study endpoints (e.g., accelerometer or mobile technology derived endpoints) that are fit for purpose for use in clinical trials to support drug development.

Chair

Ebony Dashiell-Aje, PhD

Speaker

What Can Technology-Derived Endpoint Tell us About the Patient’s Experience?
Jean Paty, PhD

Fit-for-Purpose in the Digital Era: Digital Measurement Tools in Clinical Trials
Jennifer Goldsack, MA, MBA, MS

Fit-for-Purpose Digital Health Technology Driven Study Endpoints: Regulatory Considerations for Implementation
Ebony Dashiell-Aje, PhD



Speakers
avatar for Ebony Dashiell-Aje

Ebony Dashiell-Aje

Clinical Outcome Assessments Reviewer, COA Staff, OND, CDER, FDA
Dr. Dashiell-Aje is a reviewer with the Clinical Outcome Assessments (COA) Staff in the Center for Drug Evaluation and Research (CDER) at the FDA. She serves as an expert consultant to CDER and other FDA Centers (e.g., CDRH, CBER), advising on COAs, study endpoint issues and regulatory... Read More →
avatar for Jennifer Goldsack

Jennifer Goldsack

Interim Executive Director, Digital Medicine Society (DiMe)
Jen Goldsack is the Interim Executive Director of the Digital Medicine (DiMe) Society and is Vice President of Digital Measurement at monARC Bionetworks.
avatar for Jean Paty

Jean Paty

Vice President, Patient-Centered Endpoints, IQVIA
Dr. Paty is an acknowledged leader in the effective strategies and practices of capturing patient perspective data for use in the clinical development of new medical products. He has published extensively in the areas of Patient Reported Outcomes (PRO) and electronic PRO (ePRO), as... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Patient Focused,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

4:15pm

#395: Utilization and Evaluation of Innovative Approaches for Efficient Drug Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-716-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how to promote utilization of innovative methodologies such as M&S and Bayesian approach for efficient drug development. Regulators will present their recent activities for reviewing/qualifying innovative methodologies and share their experiences.

Learning Objectives

Identify how to recognize innovative methodologies recently applied for efficient new drug development and related activities in regulatory agencies aiming at accelerating drug development; Discuss how to consider the use of such methodologies in drug development through better communication between industry and regulatory agencies.

Chair

Yuki Ando, PhD

Speaker

Utilization and Evaluation of Innovative Methodologies: PMDA Perspective
Yuki Ando, PhD

Extrapolation: Recent European Regulatory Considerations
Andrew Thomson, PhD, MA, MS

Model-Based Bayesian Methods in Pharmaceutical Clinical Trials
Neal Thomas, PhD



Speakers
YA

Yuki Ando

Senior Scientist for Biostatistics, Office of New Drug I, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. She received a master’s degree in Engineering from Tokyo Science University, and PhD in Health Science from Osaka University. Currently she is responsible for the... Read More →
avatar for Neal Thomas

Neal Thomas

Executive Director, Biostatistics, Pfizer Inc
Neal Thomas joined Pfizer in 2002, and has been a member of the Statistics Research and Innovation center since 2004 where he has worked on clinical and non-clinical applications in many therapeutic areas. He received a PhD in Statistics from the University of Chicago, and he was... Read More →
AT

Andrew Thomson

Statistician, Biostatistics and Methodology Support Office, European Medicines Agency (EMA)
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 →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session
 
Thursday, June 27
 

9:00am

#404: Investigational Medicinal Products: eLabeling Initiative, Supply Forecasting Strategies, and Patient-Centric Technology for Medicine Adherence
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-725-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss three key aspects in digitally supporting Investigational Medicinal Product (IMP) management and adherence. The topics include a cross-industry patient-centric eLabeling initiative, next generation clinical supply forecasting, and a case study of patient centric technology supporting medication adherence.

Learning Objectives

Discuss concepts of eLabeling and digitally supported, patient-centric clinical supply chains; Describe the clinical forecasting landscape and evaluate the role of technology to support supply strategies; Describe a case study of patient-centric technology supporting medical adherence.

Chair

Mark Paul, MBA

Speaker

Leveraging Real World Evidence and Patient-Centric Technology to Drive a Virtual Study of Treatment Adherence: A Case Study
Mark Paul, MBA

Evolving Clinical Supply Forecasting Strategies to Drive Supply Chain Efficiency
Jan Pieter Kappelle, MS

eLabels: A Cross-Industry Perspective on Managing IMP with Patient-Centric Technology
Jennie Deem, BSN, RN



Speakers
JD

Jennie Deem

Regulatory Consultant, Clinical Trial Labeling and Supplies, Eli Lilly and Company
Jennie Deem is a Regulatory Consultant, Clinical Trial Labeling and Supplies, at Eli Lilly and Company.  She has over 15 years of experience in international regulatory affairs, global clinical supplies and pharmacovigilance spanning multiple therapeutic areas.  In her current role... Read More →
JP

Jan Pieter Kappelle

Vice President, Strategy, 4G Clinical
Jan Pieter (JP) Kappelle, 4G Clinical Vice President of Strategy, is a Supply Chain Executive with 30 years of industry experience, of which 15 years were spent leading clinical trial supplies departments in global pharmaceutical and biotech companies. JP has a strong financial background... Read More →
MP

Mark Paul

Customer Success Manager, Medable Inc.
Mark Paul has served in progressive management positions in the clinical trials industry for over 25 years. Mr. Paul began his career in clinical research at Quintiles as a clinical programmer and project manager. Mr. Paul was Project Director for several global clinical programs... Read More →


Thursday June 27, 2019 9:00am - 10:15am
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Real World Evidence,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session