Loading…

Sign up or log in to bookmark your favorites and sync them to your phone or calendar.

09: Regulatory [clear filter]
Monday, June 24
 

11:00am

#116: Harnessing Power of Advanced Technologies for Digital Transformation in Regulatory Affairs
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-530-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide the insight to future of regulatory affairs in the digital world and how companies need to embrace advanced technology to disrupt the traditional way of handling regulatory information and submission.

Learning Objectives

Describe Regulatory 2.0 and the future of regulatory affairs and impact of advanced technology such as artificial intelligence and machine learning; Discuss how to build a regulatory intelligence system using voice assistant and machine learning; Illustrate how real world evidence ( RWE) gives a new paradigm shift for more predictable, effective, and value-based patient care and the use of RWE in regulatory affairs.

Chair

Susant Mallick, MBA

Speaker

Regulatory 2.0 and Digital Tranformation in Regulatory Affairs Using Advanced Technology
Susant Mallick, MBA

Impact of Artificial Intelligence and Machine Learning in Regulatory Affairs
Hans van Bruggen, MSc

Automated Risk Detection using Machine Learning in Clinical Trials
Francois Torche, MBA



Speakers
avatar for Hans van Bruggen

Hans van Bruggen

Senior Regulatory Affairs Consultant, Qdossier B.V.
Hans van Bruggen is Director of and Senior Regulatory Affairs Scientist at Qdossier and eCTDconsultancy. He has an MSc in Pharmaceutical Medicine from the University of Surrey (UK) and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European... Read More →
avatar for Susant Mallick

Susant Mallick

Leader and Evangelist, Healthcare and Life Sciences, EMEA, Amazon
Susant Mallick is leading Amazon AWS HCLS professional services for EMEA region. He comes up with 20+yrs of Pharma and IT background on building disruptive solutions/products in Clinical and Regulatory space. He is technology evangelist on cutting edge technology like (Artificial... Read More →
avatar for Francois Torche

Francois Torche

Chief Executive Officer, CluePoints
François holds a Master in Business Administration from the ICHEC School of Management, Brussels. Over the past 20 years in the pharmaceutical industry, he has held positions as statistical programmer, developer and IT project leader for companies such as GSK, UCB and IDDI. During... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Real World Evidence,Artificial Intelligence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

2:15pm

#146: Communications with Regulators Beyond Formal Meetings
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-546-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA and industry experts share best practices when seeking advice via Critical Path Innovation Meetings (CPIM), parallel scientific advice, and the Initial Targeted Engagement for Regulatory Advice on CBER products (INTERACT).

Learning Objectives

Identify when you should seek advice beyond formal meetings with FDA; Discuss best practices in obtaining parallel scientific advice from FDA and EMA; Discuss best practices in obtaining advice via a Critical Path Innovation Meeting (CPIM); and, discuss the impact to regulatory strategies and timelines.

Chair

Khyati Roberts, PharmD, RPh

Speaker

Overview of FDA-EMA Parallel Scientific Advice
Sandra L. Kweder

Seeking Advice from EMA
Tânia Teixeira, PharmD

Overview of Critical Path Innovation Meetings
Chekesha Clingman, PhD, MBA

Industry Perspective on Communications Beyond Formal Meetings
Nicole Mahoney, PhD

Overview of INTERACT Meetings
Christopher Joneckis, PhD



Speakers
avatar for Chekesha Clingman

Chekesha Clingman

Associate Director for Strategic Partnerships, OTS, CDER, FDA
Dr. Chekesha Clingman is a Commander in the US Public Health Service and the Associate Director for Strategic Partnerships in the Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). Dr. Clingman manages the... Read More →
CJ

Christopher Joneckis

Associate Director for Review Management, CBER, FDA
*
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA Office of International Programs. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research, where she actively led numerous... Read More →
avatar for Nicole Mahoney

Nicole Mahoney

Senior Director, Regulatory Policy, Flatiron Health
Nicole Mahoney is the Senior Director of Regulatory Policy at Flatiron Health, helping advance the use of real world evidence for regulatory decision making. Prior to her current role, she was a Director of Global Regulatory Policy at Merck, advocating for incentives to spur antibiotic... Read More →
avatar for Khyati Roberts

Khyati Roberts

Head US/Canada, Regulatory Policy and Intelligence, AbbVie, Inc.
Khyati leads regulatory policy advocacy efforts for the U.S. and Canada and coordiantes international harmonization efforts. She joined AbbVie in 2012 and has over 25 years of regulatory experience. Khyati has also provided regulatory advice to the biopharmaceutical industry on product... Read More →
avatar for Tânia Teixeira

Tânia Teixeira

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


Monday June 24, 2019 2:15pm - 3:15pm
Room 6B 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

#149: Hype Versus Reality: Artificial Intelligence and Drug Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-554-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss maturation of the development of artificial intelligence (AI) over time and how AI has matured more for R&D and signal detection and less so for regulatory support.

Learning Objectives

Discuss how artificial intelligence has matured over time.

Chair

Ranjini Prithviraj

Speaker

Results of DIA (Tufts) Survey of 1000+ Members About Their Ideas About Digital Health
Mary Jo Lamberti, PhD, MA

Artificial Intelligence in Regulatory Affairs
Patrick Brady, PharmD

What is Believed Can Be Done Versus What is Now Being Done
David Meyers



Speakers
avatar for Patrick Brady

Patrick Brady

Vice President, Regulatory Affairs Head, Regulatory Policy and Intelligence, Bayer AG
Dr. Patrick Brady is Vice President, Regulatory Affairs at Bayer. In this role, he leads Bayer’s global regulatory policy and intelligence activities. He has more than 10 years of experience in Regulatory Affairs. Prior to joining Bayer, Patrick led international science and regulatory... Read More →
avatar for Mary Jo Lamberti

Mary Jo Lamberti

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

Ranjini Prithviraj

Global Associate Director, Content Collaboration, DIA
Dr. Ranjini Prithviraj is Global Associate Director, Content Collaboration, at DIA. She provides strategic thought leadership and delivers content that advances DIA’s mission through various media, including traditional journal publications. Prior to DIA, she was a Managing Editor... Read More →


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

3:30pm

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

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

Learning Objectives

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

Chair

Lauren Oliva, PharmD, RPh

Speaker

Critical Path Update
Stephen Joel Coons, PhD

EMA Update
Zahra Hanaizi, PharmD, MPharm

Industry Update
Josh Cosman, PhD



Speakers
avatar for Josh Cosman

Josh Cosman

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

Zahra Hanaizi

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

Lauren Oliva

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

Stephen Coons

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


Monday June 24, 2019 3:30pm - 4:30pm
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

8:00am

#214: Global Pediatric Policy Update: Are You Ready to Implement FDARA Section 504?
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-582-L04-P; CME 1.25; IACET 1.25; RN 1.25

The new requirements in FDARA Section 504 represent a significant paradigm shift in pediatric oncology development. This session will review these requirements and their likely global impacts, as well as possible mitigation strategies.

Learning Objectives

Describe and explain the new provisions in FDARA Section 504 that will impact pediatric oncology development in the US within the context of the EU requirements; Analyze the implications and assess the impact of these new provisions on global pediatric oncology development; Describe the use of Master Protocols as a possible mitigation strategy.

Chair

Melodi J McNeil, MS, RPh

Speaker

Industry Perspective: Industry Perspective: Master Protocols as an Option to Design and Conduct Pediatric Oncology Studies under FDARA, Sec 504
Pamela Simpkins, MBA

FDARA 504 Overview/Implementation Planning
Gregory Reaman, DrMed, MD

Lessons Learned from Two Public-Private Partnership Master Protocols
Stacey J. Adam, PhD



Speakers
avatar for Stacey Adam

Stacey Adam

Director, Cancer Reserach Partnerships, Foundation for the National Institutes of Health (FNIH)
Dr. Stacey Adam is the Director of Cancer Research Partnerships at the Foundation for the National Institute of Health (FNIH). She oversees major partnerships, including the Partnership for Accelerating Cancer Therapies (PACT), the Lung Master Protocol (Lung-MAP) clinical trial, and... Read More →
avatar for Melodi McNeil

Melodi McNeil

Director, AbbVie, Inc.
Melodi J. McNeil, R.Ph., M.S. Ms. McNeil is currently a Director in AbbVie’s Rockville, Maryland Regulatory Policy and Intelligence office. She identifies, assesses, and comments on proposed regulatory policies, and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
avatar for Gregory Reaman

Gregory Reaman

Associate Director for Pediatric Oncology , OCE, OC, FDA
Dr. Gregory Reaman is a pediatric oncologist with a long career in clinical investigation and translational research. Prior to joining the FDA in 2011, he was the inaugural Chair of the Children's Oncology Group and was previously the Associate Chair for Scientific Affairs and the... Read More →
avatar for Pamela Simpkins

Pamela Simpkins

Senior Director & Strategy Lead, Child Health Innovation Leadership Dept. (CHILD, Johnson & Johnson
Pamela L. Simpkins, MBA is a biopharmaceutical business leader with 20+ years of experience in leading strategic initiatives and departments across R&D, corporate strategy, regulatory, marketing, business development and finance. She leads internal and external innovation programs... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Precision Medicine,Advanced Therapies,Rare Disease,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

8:00am

#216: Identifying the Reference Listed Drug for ANDA Submission, Overview of FDA’s Orange Book, and Exclusivities for NDAs and ANDAs
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-590-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA’s Orange Book and other information resources are essential to potential applicants in developing their generic submissions. This session will provide an overview of these resources and the different information that each contains.

Learning Objectives

Describe the content of FDA’s Orange Book; Identify and understand drug product, patent, exclusivity, and therapeutic equivalence information in the Orange Book; Explain FDA’s process for making exclusivity determinations. Describe the process to qualify for Paragraph IV and Competitive Generic Therapy 180-day exclusivities as well as events which may result in exclusivity forfeiture. Understand which applicants are blocked by these exclusivities and triggering events.

Chair

Kendra Stewart, PharmD, RPh

Speaker

Orange Book Overview
Kendra Stewart, PharmD, RPh

Identifying the Reference Listed Drug for ANDA Submissions
Martha Nguyen, JD

Understanding Exclusivities for ANDAs: 180-Day Exclusivity and Competitive Generic Therapy Exclusivity
Martin Shimer



Speakers
avatar for Martha Nguyen

Martha Nguyen

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

Martin Shimer

Deputy Director, Division of Legal and Regulatory Support, FDA
Captain Martin Shimer is the Deputy Director of the Division of Legal and Regulatory Support within the Office of Generic Drugs Policy (OGDP) at the Food and Drug Administration (FDA). He was commissioned as an officer in the US Public Health Service in July 2000 and joined the Office... Read More →
avatar for Kendra Stewart

Kendra Stewart

Supervisor, Orange Book Staff, Office of Generic Drug Policy, CDER, FDA
Captain Kendra Stewart is the Supervisor of the Orange Book Staff within the Office of Generic Drugs Policy (OGDP) at the Food and Drug Administration (FDA). She began her career in 2001 as a pharmacist for the Veterans Affairs Hospital. In 2003, she was commissioned as a Lieutenant... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Featured Topics Generics,Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

8:00am

#218: Real World Data to Real World Evidence
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-583-L04-P; CME 1.25; IACET 1.25; RN 1.25

We discuss the advantages and disadvantages of real world data and real world evidence compared to other sources. Join the Clinical Research Community for a follow up Round Table discussion on Wednesday, June 26, 9:30-10:30AM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the importance of real world data for answering regulatory questions; Discuss the benefits and challenges of evidence derived from real world sources compared to clinical trials.

Chair

Richard Zink, PhD

Speaker

Real World Data to Real World Evidence: A Case Study of Direct-Acting Antivirals for the Treatment of Hepatitis C Infection
Richard Zink, PhD

Machine Learning 2.0: Causal Models and Big Data in the Era of Real World Evidence
Andrew Wilson, PhD, MS

Matching with Replacement: The COLLECTION of ‘Personal’ EFFECTs Should be Handled with Care
Sarah Anselm Short, MPH



Speakers
SS

Sarah Short

Sr. Statistical Mgr, RWE - Biostats & Medical Writing, ICON plc.
Sarah has over ten years’ experience in health related statistical analysis, primarily in disease or product registries and other prospective observational studies. Her experience encompasses a wide array of therapeutic areas and study designs. As a Senior Statistical Manager, she... Read More →
avatar for Andrew Wilson

Andrew Wilson

Director, Pharmacoepidemiology and Statistics RWDS, PAREXEL
I lead the pharmacoepidemiology & statistics initiatives within Real World Data Services at PAREXEL. To be part of the real world evidence movement, it is essential we embrace the data generation process, and keep data context as all-important. Real world data typically comes from... Read More →
avatar for Richard C. Zink

Richard C. Zink

Senior Director, Data Management and Statistics, TARGET Pharmasolutions Inc
Richard C. Zink is Senior Director of Data Management and Statistics at TARGET PharmaSolutions. He is the 2019 Chair of the Biopharmaceutical Section of the American Statistical Association, host of the Biopharmaceutical Section Statistics Podcast, and Associate Editor for the DIA... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

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

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

Learning Objectives

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

Chair

Camille Jackson

Speaker

FDA Update
Theresa Mullin, PhD

EMA Update
Agnès Saint-Raymond, DrMed, MD

MHLW Update
Naoyuki Yasuda, MS



Speakers
CJ

Camille Jackson

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

Theresa Mullin

Associate Director for Strategic 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 →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
Head of International Affairs, Head of Portfolio Board MD and qualified Paediatrician. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio... Read More →
avatar for Naoyuki Yasuda

Naoyuki Yasuda

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


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

10:30am

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

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

Learning Objectives

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

Chair

Jeremy Rassen, DrSc, MS

Speaker

Initial Learnings From the RCT DUPLICATE Project
Jessica Franklin, PhD

Industry Perspective
Brande Yaist, MHS

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



Speakers
avatar for Jessica Franklin

Jessica Franklin

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

David Martin

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

Jeremy Rassen

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 →
avatar for Jessica Franklin

Jessica Franklin

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

Brande Yaist

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


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

2:00pm

#263: Drug Development for Ocular Disease, New Therapies, Regulations, and Patient Perspectives
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-614-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will highlight recent advances and review challenges and opportunities in rare disease ocular therapies. New therapeutic approaches have emerged including promising gene and cell-based therapies in retinal diseases. Relevant case studies and special considerations will be discussed. We will explore the regulatory and scientific issues with experts to provide insights from the FDA and different sponsors.

Learning Objectives

Identify recent advances in in ocular drug development therapies; Discuss the existing regulatory framework; Describe challenges and opportunities in ocular rare disease drug development highlighting what has been done and what might be done in the future.

Chair

Nita Ichhpurani, PMP

Speaker

Gene Therapy for Inherited Retinal Diseases
Melissa Shiao Hui Liew, MD

FDA/CBER Perspective on the Development of Gene Therapy Products for Retinal Disorders
Wei Liang, PhD

Changing What it Means to be Blind: We're All in This Together
Kristin Smedley



Speakers
avatar for Wei Liang

Wei Liang

Pharmacologist, OTAT, CBER, FDA
Dr. Liang is a Pharmacology/Toxicology Reviewer in the Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). She joined OTAT in 2006. Her primary focus is the review of preclinical testing... Read More →
avatar for Nita Ichhpurani

Nita Ichhpurani

Consultant, Phase One Forward
At Pharmacia (now Pfizer), Nita was a discovery Chemist and then PM in Clinical Pharmacology in oncology and CNS research. At MDS PS, she managed Global Central lab teams and later become the Latin American Lab Manager. At MDS PS and Celerion, she managed drug development consulting... Read More →
KS

Kristin Smedley

President, Curing Retinal Blindness Foundation
Kristin Smedley is President and Co-Founder of the Curing Retinal Blindness Foundation, the only patient organization in the world for her two sons’ blindness, CRB1 LCA/RP. Kristin has led the CRBF to raise over $1.3 Million, introduced the first ever legislation in the United States... Read More →
avatar for Melissa Liew

Melissa Liew

Global Head of Translational Medicine-Opthamology, Novartis Institutes of Biomedical Research
Melissa is Vice President and Global Head of Translational Medicine-Ophthalmology, at Novartis Institutes of Biomedical Research, based in Cambridge Massachusetts. In her role, she is working to translate cutting edge basic science discoveries into transformative novel medicines for... Read More →


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

2:00pm

#268: Current Status of FDA Framework for the Evaluation of Real World Evidence
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-619-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA issued a framework for a program that will evaluate the use of real world evidence (RWE) to help support the approval of new indications for an approved drug or to help support or satisfy drug post approval study requirements. During this session, FDA will share their takeaways from public comments about the RWE framework and provide participants with an update on the current status of the FDA RWE Program.

Learning Objectives

Identify three topic areas included in the FDA real world evidence program; Identify and discuss two FDA takeaways from the analysis of public comments to the real world evidence framework; Identify one area of interest for real world evidence guidance development.

Chair

M. Khair ElZarrad, PhD, MPH

Speaker

FDA Update
Jacqueline A. Corrigan-Curay, JD, MD

Update from CBER
Steven A. Anderson, PhD

FDA Update
David Martin, MD, MPH



Speakers
MK

M. Khair ElZarrad

Deputy Director, Office of Medical Policy, CDER, FDA
Dr. ElZarrad is the Deputy Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads... Read More →
avatar for Steven Anderson

Steven Anderson

Director, Office of Biostatistics and Epidemiology, CBER, FDA
Steven Anderson, Ph.D., M.P.P., is currently the Director of the Office of Biostatistics and Epidemiology (OBE) at the FDA Center for Biologics Evaluation and Research (CBER). He provides leadership for all CBER statistical, epidemiological and risk assessment programs. He was previously... Read More →
avatar for Jacqueline Corrigan-Curay

Jacqueline Corrigan-Curay

Director, Office of Medical Policy, CDER, FDA
Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). Dr. Corrigan-Curay... Read More →
avatar for David Martin

David Martin

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


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

4:15pm

#295: Prescription Drug Labeling: New Guidances from the US FDA
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-643-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will provide updates from the US FDA on the latest developments regarding prescription drug labeling (i.e., Prescribing Information). Topics will include overviews of recently published FDA guidances, including Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products -- Content and Format, Pediatric Information Incorporated into Labeling, Product Title and Initial US Approval in the Highlights of Prescribing Information, and Labeling for Biosimilar Products.

Learning Objectives

Discuss labeling updates from the US FDA: Describe recommendations for prescription drug labeling outlined in recently published FDA guidances; Identify labeling information that is relevant for your organization.

Chair

Barbara Chong, PharmD

Speaker

Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products: Content and Format
Iris Masucci, PharmD

Labeling for Biosimilar Products
Stacey Ricci, DrSc

Pediatric Information Incorporated into Labeling; Product Title and Initial US Approval in the Highlights of Prescribing Information
Eric Brodsky, MD



Speakers
avatar for Eric Brodsky

Eric Brodsky

Associate Director, Labeling Development Team, Office of New Drugs, CDER, FDA
Dr. Brodsky [as the Associate Director of the Labeling Development Team in the Office of New Drugs at the Center for Drug Evaluation and Research at the FDA] oversees OND’s implementation of Prescribing Information (PI) regulations, guidances, and policies to help promote consistency... Read More →
BC

Barbara Chong

Special Assistant for Labeling, Office of Medical Policy, CDER, FDA
Dr. Chong, Special Assistant for Labeling, joined the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research (CDER/FDA) in 2016. Her current position is primarily focused on policy and guidance development for prescription drug labeling. She works with various... Read More →
IM

Iris Masucci

Special Assistant for Labeling, Office of Medical Policy, CDER, FDA
Dr. Masucci joined FDA in 1998 and has been focusing on professional labeling and related policy since 2002. In CDER’s Office of Medical Policy, she serves as the Office lead on professional labeling policies. She leads Office efforts on the development and implementation of labeling... Read More →
SR

Stacey Ricci

Director, Scientific Review Staff, Therapeutic Biologics and Biosimilars, Office, FDA
Dr. Ricci has worked in CDER/FDA for over 11 years and is currently the Director of Scientific Review in the Office of Therapeutic Biologics and Biosimilars OTBB. OTBB works collaboratively with CDER Offices and Review divisions responsible for providing scientific and regulatory... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 6B 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

4:15pm

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

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

Learning Objectives

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

Chair

Lawrence Eugene Liberti, PhD, RPh, RAC

Speaker

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

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

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



Speakers
avatar for Magda Bujar

Magda Bujar

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

Lawrence Liberti

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 Andrea Keyter

Andrea Keyter

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

Mukesh Singhal

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


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

4:15pm

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

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

Learning Objectives

Discuss topics of current interest in US biosimilar policy.

Chair

Sarah Yim, MD

Speaker

FDA Update
Joseph B. Franklin, JD, PhD

FDA Update
Sarah Crowley-Ikenberry, MA

FDA Update
Christopher Downey, PhD



Speakers
avatar for Sarah Yim

Sarah Yim

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

Sarah Crowley-Ikenberry

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

Christopher Downey

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

Joseph Franklin

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


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

8:00am

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

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

Learning Objectives

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

Chair

Meredith Y. Smith, PhD, MPA

Speaker

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

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

EMA Perspective
Douwe Postmus, PhD, MSc



Speakers
avatar for Tarek Hammad

Tarek Hammad

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

Douwe Postmus

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

Meredith Smith

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

Graham Thompson

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


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

8:00am

#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

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

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

Learning Objectives

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

Chair

Angela Stokes, MSc

Speaker

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

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

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



Speakers
LC

LeeAnn Chambers

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

Nobuhiro Handa

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

Angela Stokes

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


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

8:00am

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

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

Learning Objectives

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

Chair

Liang Zhao, PhD

Speaker

Industry Update
Michael A. Eldon, PhD, RPh

FDA Update From New Drugs Perspective
Yaning Wang, PhD

FDA Update from Generic Drugs Perspective
Liang Zhao, PhD



Speakers
avatar for Yaning Wang

Yaning Wang

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

Liang Zhao

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

Michael Eldon

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


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

10:30am

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

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

Learning Objectives

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

Chair

Vicky (Fengyun) Han

Speaker

Labeling Management Update from the PMDA
Mariko Tsukuda, MSc

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

Digital Labeling Innovation in Europe
Shimon Yoshida, PhD

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



Speakers
avatar for Vicky (Fengyun) Han

Vicky (Fengyun) Han

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

Mariko Tsukuda

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

Shimon Yoshida

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

Xiao Yuan Chen

Office Director, Tsinghua University


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

10:30am

#339: Hot Topics in Quality and Regulatory Affairs for Combination Products
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-670-L04-P; CME 1.00; IACET 1.00; RN 1.00

Combination products are a hot topic in healthcare. These products combine two areas of medicine: medical devices and drugs/biologics. While these products open doors to exciting new possibilities in the medical world, they also bring new challenges.

This session will discuss the importance of promoting a culture of compliance to build a compliant lifecycle management infrastructure around combination products to ensure appropriate cGXPs and Quality System regulations are enforced throughout the franchise. Open discussions, case studies and dialogue will be included.

Learning Objectives

Discuss clinical trial to launch including regulatory expectations and differences for devices and drugs, how to manage parallel development programs and minimize risks for regulatory submissions; Outline best practice of handling adverse effects, usability concerns and complaints throughout drug/ device lifecycle; Describe how to establish an on-going and rigorous post-market surveillance strategy to identify product, design, and process improvement.

Chair

Rachel SW Turow, JD, MPH

Speaker

FDA Update
Melissa B. Burns, MS

Industry Perspective
James Wabby, MHS

Industry Perspective
Jim Kershner, MSc



Speakers
MB

Melissa Burns

Senior Program Manager, Office of Combination Products, FDA
Melissa Burns is a Senior Program Manager in FDA’s Office of Combination Products (OCP). In this role, she is responsible for coordinating activities related to combination product review and regulation including development and review of guidance documents, regulations, and procedures... Read More →
avatar for Rachel Turow

Rachel Turow

Executive Counsel, Regulatory Law, Teva Pharmaceutical Industries Ltd.
Rachel Turow is Executive Counsel – Regulatory Law at Teva Pharmaceuticals Ltd. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination products and digital health projects... Read More →
avatar for James Wabby

James Wabby

Executive Director, Regulatory Affairs, Devices and Combination Products, Allergan
James Wabby is the Executive Director of Regulatory Affairs (Device and Combination Products) at Allergan in Irvine, California. He has over 15 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining... Read More →
avatar for Jim Kershner

Jim Kershner

Human Factors Engineering Technical Lead, Eli Lilly and Company
Jim Kershner is a senior technical lead in the Human Factors group at Eli Lilly and Company. In this role, Jim was responsible for establishing the HF group at Lilly, and continues to drive human factors technical input in accordance with regulatory guidance, consensus standards... Read More →


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

10:30am

#343: Efficient Preparation of Global CMC Dossiers
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-676-L04-P; CME 1.00; IACET 1.00; RN 1.00

Preparation and maintenance of dossiers for a global market is exceedingly complex, due to different expectations for regulatory agencies across the globe. Efficiently creating a dossier to effectively meet worldwide requirements requires careful planning. This session will provide some practical and pragmatic approaches for managing the complexity of global CMC dossiers.

Learning Objectives

Describe the key regulatory considerations for preparation of a global CMC dossier; Discuss some of the global harmonization efforts that are underway.

Chair

John Smart, PhD

Speaker

Global CMC Dossiers: Preparation is Key
Angela McGillivary, PhD

Regulatory CMC Roadmaps for Fast-Evolving Global Markets (Brazil, China, India, Russia and Turkey)
Monika Jain, PhD



Speakers
avatar for Monika Jain

Monika Jain

Manager , Regulatory Affairs CMC, Regulatory Development Solutions, PPD
Monika Jain, Ph.D. joined the pharmaceutical industry in 1996. She is an internationally accomplished regulatory Chemistry, Manufacturing and Controls (CMC) scientist, with a long- standing background in pharmaceutical research and development of small molecule drug products.Since... Read More →
avatar for Angela McGillivary

Angela McGillivary

Principal Consultant, PAREXEL
Angela is a Principal Consultant at PAREXEL and is an Emerging Markets Regulatory Affairs Professional with over 20 years’ experience in the Pharmaceutical Industry. Angela McGillivary PAREXEL, Principal Consultant Angela has worked with global cross functional teams to develop... Read More →
avatar for John Smart

John Smart

Senior Director and Group Manager, Regulatory CMC, AstraZeneca
John has a PhD in Chemistry and over 20 years’ experience of CMC development within AstraZeneca including roles in Analytical & Product Development and Project Management. John is currently a Senior Director in Regulatory CMC with responsibility for regulatory submissions from Phase... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

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

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

Learning Objectives

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

Chair

Amy Bertha

Speaker

Panelist
James Tyler

Panelist
Andrew Kish, MS



Speakers
avatar for Amy Bertha

Amy Bertha

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

Andrew Kish

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

James Tyler

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


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

4:15pm

#388: Convergence of the Regulatory Pathways for Advanced Therapy Medicinal Products
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-707-L04-P; CME 1.25; IACET 1.25; RN 1.25

Advanced Therapy Medicinal Products (ATMPs) include gene therapy, somatic-cell therapy, and tissue-engineered products. Collectively, these products are being developed in an evolving landscape and are associated with unique developmental challenges because of distinct manufacturing, clinical trial, and regulatory requirements. A 75-minute session is proposed facilitating the presentation and discussion of perspectives from several experienced regulatory agencies. An objective would be to provide a global overview of the various frameworks in place for the development of ATMPs, making note of ongoing and planned harmonization and cooperation projects.

This session will include collective short talks by CBER (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, and possibly a representative from Alliance for Regenerative Medicine (ARM) on the nature and importance of regulatory convergence with ATMPs. This would be followed by a interactive session with the speaker panel and the audience.

Learning Objectives

Describe the regulatory pathway for advanced therapy medicinal products in various global regions.

Chair

Peter W. Marks, MD, PhD

Speaker

EMA Update
Anthony Humphreys, MPharm

PMDA Update
Nobumasa Nakashima, PhD



Speakers
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... 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 Nobumasa Nakashima

Nobumasa Nakashima

Senior Director for International Programs, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Nakashima joined Pharmaceutical and Food Safety Bureau of Ministry of Health, Labor, and Welfare (MHLW) in 1992. He spent his career in the international field such as at WHO and OECD, not only in the domestic field. He worked as International Planning Director since September... Read More →


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

4:15pm

#392: Breakthrough Therapy and PRIME Expedited Regulatory Pathways: Experience, Analysis, and Reflections from EMA, FDA, and Industry
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-735-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will compare recent hands-on experience with expedited regulatory pathways in EU and US (PRIME and Breakthrough Designation) both from the regulators’ and sponsor’s viewpoint. It will also include analysis of data comparing each program’s utilization and scope. A panel debate will be structured around statements that both panelists and the audience will be able to vote upon with the aim of inspiring honest discussion on the real benefits, drawbacks and future opportunities of these regulatory tools in the EU, US, and globally.

Learning Objectives

Describe Breakthrough Therapy and PRIME program aims, parameters, and regulatory agency experience in implementation; Discuss the sponsor perspectives on utilization of PRIME or Breakthrough Therapy pathways and how decisions about timing of engagement of FDA and EMA are made; Review utilization data of Breakthrough Therapy and PRIME pathways and concurrent and discordant decisions on sponsor applications for these designation.

Chair

Shannon Thor, PharmD, MS

Speaker

Experience with Breakthrough Therapy Applications: Viewpoints on Progress, Potential, and Lessons Learned
Sandra L. Kweder

Experience with PRIME Applications: Viewpoints on Progress, Potential, and Lessons Learned
Zahra Hanaizi, PharmD, MPharm

FDA Update on Breakthrough Therapies
Christopher Joneckis, PhD

Breakthrough Therapy and PRIME Expedited Regulatory Pathways: Industry Perspective
Samuel Rigourd, PharmD



Speakers
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA Office of International Programs. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research, where she actively led numerous... Read More →
avatar for Zahra Hanaizi

Zahra Hanaizi

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

Christopher Joneckis

Associate Director for Review Management, CBER, FDA
*
avatar for Samuel Rigourd

Samuel Rigourd

Senior Director Regulatory Affairs, Alnylam Pharmaceuticals
Samuel Rigourd joined Alnylam Pharmaceuticals in 2016 as Senior Director of Regulatory Affairs, where he leads the global registration strategy of a new class of medicines, RNA interference therapeutics. He has over 15 years of experience in regulatory affairs, in various roles both... Read More →
avatar for Shannon Thor

Shannon Thor

International Policy Analyst, Office of Global Policy and Strategy, European Off, FDA
Lieutenant Commander Shannon Thor is a pharmacist and officer in the United States Public Health Service, serving as an international policy analyst in FDA's Europe Office. LCDR Thor’s FDA career began when she joined the Office of Health and Constituent Affairs in 2014, serving... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

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

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

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

Learning Objectives

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

Chair

Ruslan Horblyuk, PhD, MA

Speaker

Panelist
Sean Tunis, MD, MSc

EMA Perspective
Tânia Teixeira, PharmD

Industry Perspective
Cristina Masseria



Speakers
RH

Ruslan Horblyuk

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

Tânia Teixeira

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

Cristina Masseria

Methods and Capabilities Lead, Pfizer Inc
ST

Sean Tunis

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


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Thursday, June 27
 

9:00am

#410: Advancing Benefit-Risk Assessment to Support FDA’s Regulatory Review of Human Drugs and Biologics
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-724-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA currently uses a structured, qualitative framework for benefit-risk assessment of human drugs and biologics. This session will cover FDA’s efforts to enhance this qualitative framework and explore more advanced benefit-risk assessment methods.

Learning Objectives

Describe FDA’s approach to benefit-risk assessment under PDUFA V and VI; Discuss efforts to continue enhancing FDA’s methodological approach to benefit-risk assessment; Summarize findings from analysis of BRFs in 2017 novel drug approvals.

Chair

Graham Thompson

Speaker

Implementation of a Structured Benefit-Risk Framework into FDA's Human Drug Review
Leila Grace Lackey, MHS, PhD

CBER’s Experience with Benefit-Risk
Hong Yang, PhD

Planning and Assessing Benefit-Risk Quantitatively in the Next Decade
Susan Duke, MSc

Best Practices for Quantitative Benefit-Risk Assessments
Tommi Tervonen



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 →
avatar for Leila Lackey

Leila Lackey

Operations Research Analyst, OPSA, OSP, CDER, FDA
Dr. Lackey has a Master of Health Science from Johns Hopkins in Environmental Health Sciences and a doctorate from UCLA in Environmental Science and Engineering. Professionally, she has worked for the Environmental Protection Agency and for the Food and Drug Administration leading... Read More →
avatar for Tommi Tervonen

Tommi Tervonen

Research Scientist, Evidera, PPD
Tommi Tervonen, PhD, is an Associate Director of Patient Preferences and Research Scientist at the Patient-Centered Research team of Evidera in London, UK. Dr. Tervonen joined Evidera in September 2015 after leaving his position of Assistant Professor at the Erasmus School of Economics... Read More →
GT

Graham Thompson

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

Hong Yang

Biologist, Office of Biostatistics and Epidemiology, CBER, FDA
Dr. Hong Yang is a senior regulatory scientist in the Office of Biostatistics and Epidemiology, CBER, FDA. She holds Ph.D. degree in Biological Engineering. Dr. Yang has expertise in benefit-risk assessment of biological products. She has been devoted in regulatory review, as well... Read More →


Thursday June 27, 2019 9:00am - 10:15am
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA