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02: ClinTrials -ClinOps [clear filter]
Monday, June 24
 

2:15pm

#152: Making Data Meaningful: Using Data Visualization to Drive Efficiency in Safety Analysis
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-550-L04-P; CME 1.00; IACET 1.00; RN 1.00

Data visualization can transform and advance clinical trial safety analysis. Discover the latest data visualization use cases for safety and how dynamic data exploration yields meaningful data review, better patient outcomes and trial efficiency.

Learning Objectives

Discuss various data visualization examples that can be applied to the area of clinical trial safety analysis; Outline key benefits and efficiencies statisticians, medical monitors, and others in charge of safety can achieve through data visualizations that are being used in this area of clinical trials today.

Chair

Demi Niforos, MS

Speaker

Summary of Safety Visualization Efforts
William Wang, PhD

Panelist
Nathan Bennett, PhD, MA



Speakers
DN

Demi Niforos

Vice President, Biostatistics and Statistical Programming, eClinical Solutions
Demi Niforos is VP, Biostatistics and Statistical Programming for eClinical Solutions and has more than 20 years of drug development experience in both the CRO and Pharmaceutical/Biotech environments. Prior to joining eClinical Solutions she held leadership roles in biostatistics... Read More →
avatar for William Wang

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →


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

3:30pm

#158: Enhancing Patient-Focused Outcome Assessment in Medical Product Development
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-568-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the evolution of patient-focused outcome assessment and how current FDA efforts and resources support measuring what matters most to patients in medical product development. Join the Study Endpoints Community for a follow up Round Table discussion on Tuesday, June 25, 9:30-10:30AM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Describe FDA's activities to promote patient voice in outcome measurement; Describe FDA resources to support the science of patient input in medical product development.

Chair

Elektra Johanna Papadopoulos, MD, MPH

Speaker

Update from CDRH
Michelle Tarver, MD, PhD

Panelist
Telba Irony, PhD

Industry Perspective
Robyn T. Carson, MPH

Patient Perspective
Bray Patrick-Lake, MS



Speakers
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 Michelle Tarver

Michelle Tarver

Director of Patient Science and Engagement, OST, CDRH, FDA
The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies. Under her leadership, CDRH is making... Read More →
avatar for Robyn Carson

Robyn Carson

Head, Patient-Centered Outcomes Research, Global Evidence and Value Development, Allergan
Robyn T. Carson has worked in the pharmaceutical industry for 12 years and leads the Patient-Centered Outcomes Research (PCOR) function at Allergan. In this role, Robyn is responsible for the development of innovative strategies to evaluate meaningful outcomes to patients and consumers... Read More →
avatar for Telba Irony

Telba Irony

Deputy Director, Office of Biostatistics and Epidemiology, CBER, FDA
Telba is Deputy Director of the Office of Biostatistics and Epidemiology at CBER. She joined FDA to implement the use of Bayesian statistics for the regulation of medical devices and led the Decision Analysis initiative including Bayesian statistics, benefit-risk determinations, and... Read More →
avatar for Bray Patrick-Lake

Bray Patrick-Lake

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


Monday June 24, 2019 3:30pm - 4:30pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#162: Precision Medicines in Clinical Trials: Understanding and Overcoming Barriers to Adoption
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-559-L04-P; CME 1.00; IACET 1.00; RN 1.00

Precision Medicines in Clinical Trials (PMCT) are demonstrably impactful in drug development yet are not widely adopted by industry. This forum explores reasons for low adoption from the viewpoints of scientists, drug developers and regulators and explores solutions.

Learning Objectives

Describe the value of precision medicine trials (PMCT) as an innovative approach to drug development; Identify the regulatory, scientific, operational and technical challenges and barriers to the execution of these trials.; Explain key considerations for precision medicine trial design and execution.

Chair

Anita Nelsen

Speaker

Academic Perspective from Korea
Yeul Hong Kim, MD, PhD

Panelist
Edward Abrahams, PhD

Panelist
Rebecca Blanchard, PhD



Speakers
avatar for Edward Abrahams

Edward Abrahams

President, Personalized Medicine Coalition
Edward Abrahams, Ph.D., is the President of the Personalized Medicine Coalition. Representing innovators, scientists, patients, providers and payers, PMC promotes the understanding and adoption of personalized medicine concepts, services and products for the benefit of patients and... Read More →
avatar for Rebecca Blanchard

Rebecca Blanchard

Vice President, CRISPR Therapeutics
Dr. Blanchard’s career in academia and industry has spanned basic, translational, and clinical research. She is currently responsible for Clinical Biomarkers and Exploratory Research, Assay Development and Pharmacology/Toxicology at CRISPR Therapeutics. After receiving her Ph.D... Read More →
avatar for Yeul Hong Kim

Yeul Hong Kim

Professor, Section of Medical Oncology, Department of Internal Medicine, Korea University Anam Hospital
Yeul Hong Kim, MD, PhD, is a Professor in the Department of Internal Medicine at the Korea University College of Medicine in Seoul. He is actively involved in cancer genomic research, using circulating tumor DNA, for lung and gastrointestinal cancers. His primary area of interest... Read More →
avatar for Anita Nelsen

Anita Nelsen

Vice President, Translational Medicine, Parexel
Anita has more than 20 years of experience in the pharmaceutical industry and 29 years of experience in pharmacogenetic, human and molecular genetics research in roles including bench scientist, manager, and business leader. As Head of Translational Medicine Services, Anita leads... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Artificial Intelligence,Regulator Thinking,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum
 
Tuesday, June 25
 

8:00am

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

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

Learning Objectives

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

Chair

Bob Brindle, MA

Speaker

Enforcing Better Standards in Protocol Development
Bob Brindle, MA

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

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

Protocol Development of the Future
Robert A. DiCicco, PharmD



Speakers
avatar for Bob Brindle

Bob Brindle

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

Robert DiCicco

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

Nate Root

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

Rachael Song

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


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

8:00am

#205: Driving Enrollment with a Patient-Centric Focus to Artificial Intelligence
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-587-L04-P; CME 1.25; IACET 1.25; RN 1.25

Artificial intelligence, blockchain, natural language processing and real world evidence have been all the rage lately in industry news. Hear perspectives on these new technologies from a panel of experts from sponsor, technology vendor, patient advocacy group, and patients on what's working and what's not.

Learning Objectives

Describe how to drive patient enrollment in clinical studies with a patient-centric approach, allowing patients to pre-screen themselves and retargeting them if excluded; Identify how to address patient recruitment issues associated with pre-screening, screening and dropout to reduce the current average conversion ratio from 10:1; Discuss how to reduce pre-screening burden via mining of EMR records.

Chair

Rob Wynden, PhD

Speaker

Introduction to Patient-Facing Trial Technology
Rob Wynden, PhD

A Bulls-Eye Clinical Trial via Patient's Point- of-View
Abhit Singh, MD, MHA

User-Driven Markets Data that Help Clinicians Assess Treatments and Cure Diseases
Collin Powell, MBA

Turning Clinical Trial Recruitment on its Head Using EHR-Connected Applicants
Scott Cressman

Pragmatism and AI in Research
Mike Nolte, MBA



Speakers
avatar for Scott Cressman

Scott Cressman

Business Development and Strategic Partnerships, Human API
Scott Cressman leads business development & strategic partnerships in clinical research and digital health for Human API. He spends much of his time working at the intersection of life sciences + digital technologies with startups and Fortune 500s alike. His focus is on improving... Read More →
avatar for Mike Nolte

Mike Nolte

Chief Executive Officer, Signant Health
Mike Nolte is the CEO of CRF Bracket. Mike is a seasoned operational leader in healthcare and technology who is passionate about the patient experience. Before CRF Bracket, Mike was CEO at Influence Health, President and COO at MedAssets, and he held several leadership roles in healthcare... Read More →
CP

Collin Powell

Founder, Chief Executive Officer, The Health Exchange Market (THEM)
The Health Exchange Market (T.H.E.M.) is an online marketplace for de-identified healthcare data that allows organizations to realize new revenue streams through data commercialization, while also being able to obtain access to prospective and retrospective data from a variety of... Read More →
avatar for Abhit Singh

Abhit Singh

Chief Medical Advisor, Medical Advisory Board, WeHeal Foundation
Dynamic (Global) Physician Leader, Speaker and Visionary- specializing in the Medical Advisory, Transactional and Transformational management of Healthcare Advisory, Biotech & Biopharma organizations. Among many, a Medical Advisor for WeHeal Inc, a 'CrowdHealing' Therapeutic Options... Read More →
avatar for Rob Wynden

Rob Wynden

Chief Executive Officer, Aloha Health Network
Rob has been a computer scientist and programmer for over 30 years in the scientific programming, e-commerce, biotech, and health care industries. He implemented study startup and CTMS functionality at 9 bay area biotech companies, and invented a method that allows medical and biotech... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#215: Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational, and Patient Enrollment Challenges
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-589-L04-P; CME 1.25; IACET 1.25; RN 1.25

Global clinical trials conducted with GMOs pose unique regulatory, logistical and strategic challenges. This session will presents case studies addressing lessons learned and perspectives from regulatory authorities, investigators and patients.

Learning Objectives

Describe strategies to optimize the conduct of clinical trials with GMOs, in order to facilitate approval across multiple layers and regulatory bodies; Discuss efforts among different stakeholders (Sponsor, CRO, vendors) to enable adequate IP management; Identify how to implement educational plans to overcome cultural barriers (patients, families and site staff) and facilitate enrolment completion.

Chair

Esther Mahillo, PhD

Speaker

Clinical Research with GMOs: Regulatory, Ethical, and Biosafety Challenges
Daniel Kavanagh, PhD

Operational and Logistical Aspects of Working with GMOs
Esther Mahillo, PhD

Patient Perspective
Kathleen Higgins



Speakers
avatar for Daniel Kavanagh

Daniel Kavanagh

Senior Scientific Advisor, Gene Therapy, WIRB-Copernicus Group (WCG)
Dr. Kavanagh is Senior Scientific Advisor, Gene Therapy at WIRB-Copernicus Group (WCG). Prior to joining WCG, he was Assistant Professor of Medicine and Institutional Biosafety Committee Vice Chair at Harvard Medical School, Assistant Immunologist at the Massachusetts General Hospital... Read More →
avatar for Esther Mahillo

Esther Mahillo

Customer Relationship Executive, Oncology and Hematology, Syneos Health
I have been working for 24 years in the clinical research arena. Over the past 20 years, I have conducted 47 phase I-III clinical trials enrolling more than 13,000 patients at over 1,000 sites in 50 countries.I obtained my PhD with a research on the role of multicatalytic proteinase... Read More →
avatar for Kathleen Higgins

Kathleen Higgins

Director of Community Outreach, Li Fraumeni Syndrome Association


Tuesday June 25, 2019 8:00am - 9:15am
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next,Patient Focused,Advanced Therapies
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

2:00pm

#257: Clinical Trial Diversity: Moving from Admiring the Problem to Solving it
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-624-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will take discussions about clinical trial diversity to the next level, focusing on practical solutions and strategies for strengthening diversity in clinical trials. A panel of multi-stakeholder experts will provide their perspectives.

Learning Objectives

Describe strategies for increasing diversity in clinical trial research; Discuss examples of innovations in enrollment and recruitment of diverse patients as well as challenges overcome.

Chair

Jane E. Myles, MS

Speaker

Inclusive Trial Participation: Imperative or Nice to Have?
Jane E. Myles, MS

FDA Perspective
Richardae Araojo, PharmD, MS

Panelist
Fabian Sandoval, MD

Panelist
Madeline Geday

Patient Perspective
Mindy Leffler



Speakers
RA

Richardae Araojo

Associate Commissioner and Director, Office of Minority Health and Health Equity, FDA
CAPT Richardae Araojo serves as the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at the U.S. Food and Drug Administration. In this role, she provides leadership, oversight, and direction on minority health and health disparity... Read More →
avatar for Madeline Geday

Madeline Geday

Director, Patient Innovation and Engagment, Global Clinical Trial Operations, Merck & Co., Inc.
avatar for Jane Myles

Jane Myles

Head, Operational Intelligence and Innovation, Genentech, A Member of the Roche Group
Jane is the Head, Operational Intelligence and Innovation for Roche, working at Genentech. Her passion is driving innovation into the way we design and execute trials to get medicines to patients faster. She's worked at Genentech for 17 years in many roles, including line manager... Read More →
FS

Fabian Sandoval

Chief Executive Officer and Research Director, Emerson Clinical Research Institute
Dr. Sandoval has over 20 years of bench to bedside research experience. His diversified research career has been in academia, healthcare systems and the public sector. He received his Bachelors of Science in molecular and cellular biology from Marymount Unv. and his Doctorate of Medicine... Read More →
ML

Mindy Leffler

Rare Disease Parent; Partner, Casimir


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

4:15pm

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

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

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

Learning Objectives

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

Chair

Susan Callery-D'Amico, BSN

Speaker

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

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



Speakers
avatar for Susan Callery-D'Amico

Susan Callery-D'Amico

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

Penelope Manasco

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

Gregg Larson

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


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

4:15pm

#290: The Responsibility Industry, Agencies, and Early Education own in Cure-Model Based Therapeutics
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-632-L04-P; CME 1.25; IACET 1.25; RN 1.25

In today’s pharmaceutical and biotech industry we are at an inflection point with regard to the future of therapeutic development. In this forum the focus will be to explore how industry, agencies, and academic institutions collaborate to drive innovative technologies to speed therapeutic development. Specifically, the forum will explore how we are leveraging STEM (Science, Technology, Engineering, Mathematics) programs both independently and interactively to enable current and future entrepreneurial opportunities. The goal is to foster an environment where we best take advantage of the opportunities presented by advances in life sciences and technology.

Learning Objectives

Evaluate the quality of interaction among various stakeholders in cure-based drug development; Assess the quality of those interactions in their own environments; Recognize the importance of fostering an environment where creativity and an entrepreneurial spirit is nurtured. Determine how STEM (Science, Technology, Engineering, Mathematics) programs are put to use to address the aforementioned objectives.

Chair

Dan Tierno, MA, MBA

Speaker

Industry Perspective
Yaron Drucker, MBA

Student Perspective
Advaita Chandramohan

Panelist
Melanie Matheu, PhD



Speakers
avatar for Advaita Chandramohan

Advaita Chandramohan

Undergraduate Research Associate, University of Southern California
Advaita Chandramohan is a first year student at the University of Southern California studying Biomedical Engineering with an Electrical emphasis. She is an Undergraduate Research Associate at USC's International Center for Regulatory Science, where she studies the dissemination and... Read More →
avatar for Yaron Drucker

Yaron Drucker

Staffing Lead, Cloud Partners, Google
Yaron has a Bachelor's Degree in Electrical Engineering, and an MBA from Baruch College. In his early career, Yaron worked in aerospace and defense as an EMC/EMI Engineer, and at SAP for a year. He then worked at Microsoft for 7 years in various roles in digital media on the advertising... Read More →
avatar for Dan Tierno

Dan Tierno

Associate Director, Global Clinical Data Sciences and Analytics, Bayer
Mr. Dan Tierno has over 20 years of experience in the pharmaceutical and biotech industry, specializing in drug development, data sciences and analytics for clinical trials, and commercialization of novel small molecule and cell based therapeutics. Mr. Tierno has spoken on training... Read More →
MM

Melanie Matheu

Founder and Chief Executive Officer, Prellis Biologics, Inc.


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

8:00am

#303: Disruptive Technology Transforming Clinical Trials: The Case for Artificial Intelligence, Blockchain, and Mobile Tech/Wearables
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-659-L04-P; CME 1.25; IACET 1.25; RN 1.25

Artificial Intelligence, machine learning, blockchain, and mobile devices are all disruptive technologies that promise to transform research. Expert panelists will discuss each technology and its current and future relevance to research.

Learning Objectives

Describe the way disruptive technologies including artificial intelligence and machine learning, bockchain and mobile/wearables can be applied to clinical research; Discuss examples and case studies of how these technologies are currently being used in clinical research; Analyze which of these technologies offer the most potential benefit to clinical research.

Chair

Sam Anwar

Speaker

Industry Perspective on Artificial Intelligence and Machine Learning
Jeffrey Blaine Smith, MS, PMP

Understanding the Promise, Risk, and Requirements for Using Blockchain Technology in Clinical Trials
Karin Beckstrom

Mobile Tech and Wearables
Joseph Dustin



Speakers
avatar for Karin Beckstrom

Karin Beckstrom

Innovation Lab, ERT
Karin Beckstrom is responsible for discovering common ground among technologists, scientists and clinical trial leaders, transforming ideas into solutions that enhance the patient and investigator experience during clinical trials. She has over 20 years’ experience driving software... Read More →
avatar for Sam Anwar

Sam Anwar

Chief Technology Officer, eClinical Solutions
I have spent that past 20 years of my career in leveraging cutting edge technologies to revolutionize clinical trials. In my current role as CTO at eClinical Solutions, I harness the power of software development, big data, AI and machine learning to help advance the technology innovations... Read More →
JD

Joseph Dustin

Solutions Director, Mobile Health / eCOA, Medidata Solutions
Since 2002, I have been immersed in the world of eClinical. I came in as the new guy, with new ideas, and new perspectives in an industry that still needs help when using technology to facilitate clinical research. Past companies include Medidata, CRF Health, and etrials. www.joedustin.com... Read More →
JS

Jeffrey Smith

Senior Director, Analyst, GARTNER
Jeffrey Smith is a Senior Director Analyst on Gartner's Healthcare and Life Sciences Industry Research team. Mr. Smith's research is focused on clinical development activities within pharmaceutical and medical device companies, helping CIOs and R&D IT leaders to better navigate strategic... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Artificial Intelligence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

8:00am

#317: Designing Clinical Trials with the Right Endpoints: Applying ICH-E9(R1) - Getting the Questions Right (GTQR),Estimands and Handling Missing Data
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-657-L04-P; CME 1.25; IACET 1.25; RN 1.25

Industry and FDA experts will share how to operationalize ICH E9(R1) to design trials with clinically meaningful endpoints. Forum will include a summary from the DIA Stats Community GTQR Series, the Oncology Drug Development Working group on Estimands, and Tipping Point analysis to account for missing data.

Learning Objectives

Discuss key elements of ICH E9(R1) and GTQR; Define estimands and ongoing efforts for implementation; Identify how to apply estimands in oncology with time-to-event endpoint; Describe an overview and examples of applying tipping point analysis to explore the impact of missing data assumptions on study results, along with key considerations during the planning stage of these sensitivity analyses.

Chair

Munish Mehra

Speaker

Estimand Framework and its Impact on Oncology Drug Development: Findings From An Industry-Wide Working Group
Yi Liu, PhD

Assessment of Tipping Point Analysis for Handling Various Types of Missing Data
Martin Clancy, MSc

Estimands for Efficacy Analyses
Thomas J. Permutt, PhD



Speakers
MC

Martin Clancy

Senior Statistician, PHASTAR
I'm a Senior Statistician at PHASTAR, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services by providing expert consultants and delivering in-house projects. Working in a Contract Research Organisation (CRO) for the past 4 years... Read More →
avatar for Yi Liu

Yi Liu

Director Biostatistics, Nektar Therapeutics
Yi Liu got her Ph.D. degree in Statistics from the department of Statistics at The Ohio State University. She is currently a director at Nektar Therapeutics responsible for clinical trials in collaborations with external partners and CMC and biomarker related statistical analyses... Read More →
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
Dr. Munish Mehra, is a drug development expert with Tigermed, providing services to Pharmaceutical and Biotechnology companies to design, analyze and report on Phase 2 and 3 studies. He has represented several sponsors at pre-IND, End of Phase 2 and pre-NDA meetings. He is a frequent... Read More →
avatar for Thomas Permutt

Thomas Permutt

Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA
Tom Permutt is Associate Director for Statistical Science and Policy, Office of Biostatistics, Center for Drug Evaluation and Research at FDA. Tom’s contributions to causal inference in clinical trials date from 1989 when he proposed an instrumental-variable estimator of the effect... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 11B 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 Forum

10:30am

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

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

Learning Objectives

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

Chair

Adama Ibrahim, MBA

Speaker

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

Panelist
Tina Barton, PhD, MBA



Speakers
TB

Tina Barton

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

Adama Ibrahim

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

Alexis Normand

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


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

10:30am

#344: Meaningful Patient-Focused Drug Development for Rare Disease and Personalized Medicine
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-672-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide a platform to discuss measurement challenges and practical considerations for selection of fit-for-purpose clinical outcome assessments (COAs) to support endpoints in rare disease drug development programs.

Learning Objectives

Discuss practical considerations for utilizing clinical outcome assessments (COAs) to support clinical trial endpoint(s) in drug development; Identify the measurement challenges and recommendations for the selection of COAs for rare disease drug development.

Chair

Michelle Campbell, PhD

Speaker

Generalized Pairwise Comparisons for Benefit/Risk Assessment in Personalized Medicine
Marc E. Buyse, DrSc

Endpoint Selection and Use of Clinical Outcome Assessments (COAs) in Rare Disease Drug Development: A Regulatory Perspective
Lili Garrard, PhD

Selection of Fit-for-Purpose COAs to Support Endpoints in Rare Disease
Jean Paty, PhD



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 →
MC

Michelle Campbell

Division of Neurology Products, Office of New Drugs, CDER, FDA
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes for the Division of Neurology Products, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a... Read More →
LG

Lili Garrard

Mathematical Statistician, Office of Biostatistics, OTS, CDER, FDA
Lili Garrard is a statistical reviewer on the Clinical Outcome Assessment (COA) Statistical Support Team at the Division of Biometrics III, Office of Biostatistics (OB), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration... Read More →
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 10:30am - 11:30am
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

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

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

Learning Objectives

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

Chair

Serge Bodart, MS

Speaker

Panelist
Jenny Ly, PhD

Panelist
Patricia DeLong, MS

Panelist
T.J. Sharpe, PMP

Panelist
Jessica Branning



Speakers
avatar for Serge Bodart

Serge Bodart

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

Patricia DeLong

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

Jenny Ly

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

T.J. Sharpe

Patient Advocate, Starfish Harbor LLC
T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in the Patient #1 Blog.  He was diagnosed in August 2012 with melanoma tumors in multiple organs, only four weeks after his second child was born. Since then, he has undergone six surgeries and four... Read More →
avatar for Jessica Branning

Jessica Branning

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


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

3:30pm

#378.1 SB: On the Soapbox: Good for People and Good for Research - Individuals as Research Partners
Component Type: Forum
Level: Basic
CE: ACPE 0.50 Knowledge UAN: 0286-0000-19-737-L04-P; CME 0.50; IACET 0.50; RN 0.50

The intersection of data privacy and an acknowledgement that research data lacks depth, diversity, and real-world information are driving new health database models. The benefits of promoting people from subjects to research partners will be covered.

Learning Objectives

Identify new models in patient engagement and data stewardship towards richer research; Analyze how patient privacy and data connectivity can co-exist; Explore the benefits of patients as partners in research versus research subjects.

Chair

Dawn Barry, MBA


Speakers
avatar for Dawn Barry

Dawn Barry

President and Co-Founder, LunaPBC
Dawn Barry is President and Co-founder of Public Benefit Corporation, LunaPBC. LunaPBC launched LunaDNA, the first people-powered health data sharing platform owned by its community of data donors. LunaDNA members share in the value created by the platform through the offering of... Read More →


Wednesday June 26, 2019 3:30pm - 4:00pm
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

4:15pm

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

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

Learning Objectives

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

Chair

Jamie Wilkins, PharmD

Speaker

Panelist
James Nickas, PharmD

Panelist
Christine Brown, MS

Moderator
Elaine Morrato, DrPH, MPH



Speakers
avatar for Christine Brown

Christine Brown

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

James Nickas

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

Jamie Wilkins

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

Elaine Morrato

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


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

4:15pm

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

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

Learning Objectives

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

Chair

Penny Randall, MD

Speaker

Panelist
Laura Byrnes Podolsky, JD, MPH

Panelist
Gail Adinamis

Panelist
Michael O'Brien, CPA



Speakers
avatar for Gail Adinamis

Gail Adinamis

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

Michael O'Brien

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

Laura Podolsky

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

Penny Randall

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


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

4:15pm

#380: Incorporating Patient Input into the Design and Conduct of Clinical Trials
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-712-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will outline efforts, best practices, and key considerations to enhance the incorporation of patient input into the design and conduct of clinical trials.

Learning Objectives

Outline current efforts and opportunities to incorporate patient input into the design and conduct of clinical trials (CT); Discuss approaches, best practices, and key considerations to facilitate patient recruitment, enrollment and retention, and minimize the burden of patient participation in CTs; Identify opportunities to enhance patient engagement and ensure patient input informs CTs.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
Alexis Reisin Miller, JD

Panelist
Michelle Tarver, MD, PhD

Panelist
Marilena Flouri, PhD

Panelist
Mary Elmer, BSN, MSN, RN

Panelist
T.J. Sharpe, PMP



Speakers
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 →
AM

Alexis Miller

Senior Director, Regulatory Science and Policy, Sanofi
Alexis is a Senior Director for Sanofi Global Regulatory Science & Policy, helping to shape the regulatory and policy environment on topics like patient-focused drug development, digital health technology regulation, and various PDUFA initiatives and FDA program implementation. Prior... Read More →
avatar for Michelle Tarver

Michelle Tarver

Director of Patient Science and Engagement, OST, CDRH, FDA
The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies. Under her leadership, CDRH is making... Read More →
avatar for Mary Elmer

Mary Elmer

Executive Director, Patient, Caregiver and Consumer Experience, Patient Engagement Operations, Merck
Mary Elmer is the Executive Director, Patient, Caregiver, and Consumer Experience, Patient Engagement Operations at Merck. This group seeks to create an experience that engages consumers and patients in optimizing their health, wellbeing, and healthcare outcomes.She also leads a team... Read More →
MF

Marilena Flouri

Mathematical Statistician, OTS, CDER, FDA
Marilena is a statistical reviewer supporting the Division of Dermatology and Dental Products (DDDP) in the Center for Drug Evaluation and Research (CDER) at the FDA. Marilena joined the FDA in 2016 immediately after receiving her Ph.D. in Statistics from the University of Maryland... Read More →
avatar for T.J. Sharpe

T.J. Sharpe

Patient Advocate, Starfish Harbor LLC
T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in the Patient #1 Blog.  He was diagnosed in August 2012 with melanoma tumors in multiple organs, only four weeks after his second child was born. Since then, he has undergone six surgeries and four... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Thursday, June 27
 

9:00am

#405: eSource and the Sites: Have They Bonded?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-726-L04-P; CME 1.25; IACET 1.25; RN 1.25

In an era where technology has taken over almost every form of information dissemination and data collection; at the clinical investigative site level, there still remains a divided and skeptical attitude towards the most efficient way to collect data. While most pharmaceutical and biotech companies have adopted the use of EDC, eCRFs and almost every type of electronic capture of clinical trial data, clinical trial sites are still struggling between using the standard patient chart in a manila folder or three ring binder as the repository of their source documents versus the use of electronic source documents or EMR.

In this session, pros and cons, issues and challenges, opportunities and solutions will be discussed and debated. Current trends and status of adoption of technology by different site models, as an ideal way of improving efficiency of collecting data will likewise be reviewed.

Learning Objectives

Identify advantages and disadvantages of using eSource; Discuss the ways of transitioning use of paper source to eSource.

Chair

Nadina Jose, MD

Speaker

Panelist
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 →
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 →


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