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Generics [clear filter]
Tuesday, June 25


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

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

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

Learning Objectives

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


William Gregory, PhD


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

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


Meredith Chuk

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

William Gregory

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

Tarek Hammad

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

Meredith Chuk

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

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


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

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

Learning Objectives

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


Felix Frueh, PhD


Mohammad Afshar, MD, PhD

Federico Manuel Goodsaid, PhD

avatar for Mohammad Afshar

Mohammad Afshar

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

Felix Frueh

Executive Partner, Opus Three LLC
avatar for Federico Goodsaid

Federico Goodsaid

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

Tuesday June 25, 2019 10:30am - 11:30am
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
Wednesday, June 26


#367: Model-Informed Drug Development (MIDD) and Complex Innovative Designs (CID) Programs: Where are We and What Have We Learned?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-691-L04-P; CME 1.25; IACET 1.25; RN 1.25

The PDUFA VI ‘goals letter’ identified MIDD and CID as enhancing regulatory decision tools. Starting in FY2018, the FDA committed to conduct pilot program for these. This session presents the experiences and learnings from the two pilot programs.

Learning Objectives

Discuss the status and share experience of the MIDD and CID programs; Summarize high level insights on the scope and process of the programs.


Rajanikanth Madabushi, PhD


Update on PDUFA VI MIDD Pilot Program
Rajanikanth Madabushi, PhD

Update on the PDUFA VI CID Pilot Program
Dionne Price, PhD

Issam Zineh, PharmD, MPH

Yaning Wang, PhD

Cristiana Mayer, DrSc, PhD

Brian Corrigan, PhD


Brian Corrigan

Global Head, Clinical Pharmacology, Pfizer Inc
Brian Corrigan is Vice President and Global Head of Clinical Pharmacology and Head of Clinical Pharmacology for Global Product Development at Pfizer in Groton, Connecticut. In these roles, Brian directly oversees the Global Clinical Assay Group, the Global Pharmacometrics Group, and... Read More →
avatar for Rajanikanth Madabushi

Rajanikanth Madabushi

Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER, FDA
Dr. Madabushi has 10 years of regulatory review experience as Pharmacometrics Review and as Team Leader in the Office of Clinical Pharmacology. He was predominantly involved in the application of quantitative clinical pharmacology approaches for regulatory decision making and addressing... Read More →
avatar for Cristiana Mayer

Cristiana Mayer

Director, Statistics and Decision Sciences, Janssen Research & Development, LLC
Cristiana Mayer is Director at Statistics and Decision Sciences, at Janssen R&D, Johnson & Johnson, with 20+ years of experience in the pharmaceutical industry. Cristiana is also the Head of the Adaptive Clinical Trials Center of Excellence at Janssen, and Vice-Chair of the DIA Adaptive... Read More →
avatar for Dionne Price

Dionne Price

Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER, FDA
Dr. Price is the Director of the Division of Biometrics IV providing leadership of analytical assessments in a regulatory setting. On the Senior Leadership Team and Statistical Policy Council, Dr. Price promotes collaborative efforts to advance the use of complex innovative trial... Read More →
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 →
avatar for Issam Zineh

Issam Zineh

Director, Office of Clinical Pharmacology, OTS, CDER, FDA
Dr. Zineh is Director of the Office of Clinical Pharmacology (OCP) at the U.S. FDA. He has held various leadership positions at FDA including Associate Director for Genomics in OCP (2008-2012), Co-Director of the CDER Biomarker Qualification Program (2009-2015), voting member of the... Read More →

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


#368: Global Rare Disease Town Hall
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-692-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA and international regulators will address unique regulatory complexities and challenges specific to orphan product development. It will provide key information and updates about programs available to expedite orphan drug development and include audience Q&A.

Learning Objectives

Identify unique regulatory complexities and challenges specific to orphan drug development; Describe FDA and EMA programs available to expedite the development of orphan products; Recognize new regulatory initiatives and policy developments related to orphan drug review.


James E. Valentine, JD, MHS


Ilan Irony, MD

Peter P. Stein, MD

Janet Maynard, MD, MHS

Agnès Saint-Raymond, DrMed, MD

avatar for Janet Maynard

Janet Maynard

Director, Office of Orphan Products, OC, FDA
Dr. Janet Maynard, as the Director of the Office of Orphan Products Development (OOPD), oversees legislatively mandated designation and grant programs intended to promote the development of products for rare diseases including, orphan drug, rare pediatric disease, and humanitarian... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

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

Peter Stein

Director, Office of New Drugs, CDER, FDA
Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related... Read More →
avatar for James Valentine

James Valentine

Attorney, Hyman, Phelps & McNamara, PC
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →
avatar for Ilan Irony

Ilan Irony

Deputy Director, DCEPT, OTAT, CBER, FDA
After training at UCSF and NIH and years of practice in Internal Medicine and Endocrinology, Dr. Irony joined FDA CBER in 2000 as a clinical reviewer. He also worked in the Endocrine Division in CDER as a reviewer and team leader. In 2011, he returned to CBER first as branch chief... Read More →

Wednesday June 26, 2019 2:00pm - 3:15pm
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Generics
  • Featured Topics Precision Medicine,Regulator Thinking,Rare Disease
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum


#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.


Amy Bertha


James Tyler

Andrew Kish, MS

avatar for Amy Bertha

Amy Bertha

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

Andrew Kish

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

James Tyler

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

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


#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.


Ruslan Horblyuk, PhD, MA


Sean Tunis, MD, MSc

EMA Perspective
Tânia Teixeira, PharmD

Industry Perspective
Cristina Masseria


Ruslan Horblyuk

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

Tânia Teixeira

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

Cristina Masseria

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

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


#403: Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-718-L04-P; CME 1.25; IACET 1.25; RN 1.25

With the advent of biosimilars on a global scale and thus the introduction of multi-source biological products, the importance of accurate pharmacovigilance and unique product traceability cannot be understated. Not only do these efforts support detection of adverse drug reactions, they give confidence to providers and patients in the safe and appropriate use of these medicines. Various approaches have been taken in attempts to facilitate unique product traceability and improve risk minimization.

This session will focus on some of these approaches and their effectiveness and will highlight the role of National Regulatory Authorities and evolving technology infrastructure to improve traceability and enable global harmonization in these approaches.

Learning Objectives

Describe the current state of pharmacovigilance efforts for biological products in various regions; Identify different approaches to unique product traceability and determine their effectiveness; Discuss how to help to identify opportunities for global harmonization to facilitate unique product identification.


Brad Jordan, PhD


Analysis of Biosimilars Approved in EU and US: Insights into Risk Minimization Strategies
Kalindi Hapani, MPharm

Biosimilars: Should They Have a ‘Similar’ System to the Originator?
Brian Edwards, DrMed

FDA Perspective
Lubna Merchant, PharmD, MS

Biologic and Biosimilar Nomenclature: How Important is Distinguishability and International Harmonization?
Philip J Schneider, MS, RPh

avatar for Brian Edwards

Brian Edwards

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

Kalindi Hapani

Assistant Manager, Pharmacovigilance, APCER Life Sciences
Kalindi is a Registered Pharmacist, having done Masters in Pharmacy. With stint as Lecturer for initial years (4 years in academics), she pursued Post Graduate Diploma in Clinical Research and Pharmacovigilance. She has 10 years of global experience with 6 years concentrated in pharmacovigilance... Read More →
avatar for Brad Jordan

Brad Jordan

Director, Global Regulatory and R&D Policy, Amgen
Dr. Brad Jordan is a Director of Global Regulatory and R&D Policy at Amgen where his role focuses on global technical regulatory policy relating to biologics and biosimilars. Dr. Jordan joined Amgen in 2006, and prior to his role in Policy, spent 10 years in the Discovery Research... Read More →
avatar for Lubna Merchant

Lubna Merchant

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

Philip Schneider

Chair, Advisory Board, Alliance for Safe Biologic Medicines
Philip J. Schneider is founder and principal of MediHealthInsight, which provides consultation to the industry and others on matters related to improving the use of medicines including the application of new technologies in healthcare. He is also Chair of the International Advisory... Read More →

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


#411: Recent CMC Changes in Emerging Regulatory Agencies
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-727-L04-P; CME 1.25; IACET 1.25; RN 1.25

The international regulatory landscape is changing rapidly as more regulatory agencies are maturing their regulatory systems, defining their regulatory expectations, and aligning with other regulators through organizations such as ICH and PIC/S. This session will focus on recent developments in Chemistry, Manufacturing and Controls (CMC) and inspections for emerging health authorities. Invited regulatory speakers are from China’s NMPA, South Korea’s MFDS, and Russia’s Ministry of Industry and Trade. Speakers will address current regulatory changes and harmonization efforts related to dossier content, inspections, and pharmacopeia alignment.

Learning Objectives

Discuss recent changes in regulations by emerging regulatory agencies; Identify efforts to harmonize regulatory systems for oversight of pharmaceutical quality.


Nirdosh Jagota, PhD


Perspective from Korea
YoungLim Kim, PhD

Russian Regulatory System in the Field of Medicines and its Potential Harmonization with International Requirements
Tatiana Nikolko

Industry Perspective on China
Chi-Wan Chen, PhD

avatar for Chi-Wan Chen

Chi-Wan Chen

Executive Director, Global CMC, Pfizer Inc
Dr. Chi-wan Chen is Executive Director in Global CMC, Pfizer, responsible for regulatory CMC policies and strategies with a focus on China and Asia Pacific. She has made numerous presentations on regulatory and CMC topics on China in these countries. Prior to joining Pfizer in 2008... Read More →
avatar for Nirdosh Jagota

Nirdosh Jagota

Vice President and Head, Regulatory CMC, Merck & Co., Inc.
Nirdosh Jagota serves as VP and Head of CMC, Global Regulatory Affairs at Merck. Nirdosh has 26 years of pharmaceutical industry experience including 21 years in global regulatory management. Prior to Merck, he was VP, Regulatory CMC at Genentech/Roche. Before joining Genentech/Roche... Read More →
avatar for YoungLim Kim

YoungLim Kim

Director, Ministry of Food and Drug Safety (MFDS)
Dr. Kim has been working at MFDS for more than 26 years. She is Director of the Gastroenterology and Metabolism Products Division, Drug Evaluation Department. Before that, Dr. Kim was Director of the Pharmaceutical Standardization Division, Deputy director and Reviewer of the Oncology... Read More →

Tatiana Nikolko

Deputy Head of Inspections Department, State Institute of Drugs and Good Practices

Thursday June 27, 2019 9:00am - 10:15am
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA