November 4-6, 2019 | North Bethesda, MD


Print Friendly, PDF & Email

Tuesday, November 5

8:00 – 9:00 a.m.

Rise + Shine Morning Breakfast

Day Two promises more insights and inspiration. After another mindfulness meditation and more stretching/dancing to get the blood pumping, we’ll engage in a creative interactive session where you’ll be challenged to provide new ideas and solutions to move our industry forward. We’ll crowd source the biggest problems/issues we’re facing and then encourage groups to brainstorm a fearless plans of attack. The bolder the better.

Nikhil Paul, Founder/Crowd Engagement Expert, We R Human 

9:00 – 10:00 a.m.

General Session – Salon D-H

OC/OGD/ OPQ  Keynote Address

Donald Ashley, JD
Director, Office of Compliance (OC), CDER, FDA

Sally Choe, PhD
Director, Office of Generic Drugs (OGD), CDER, FDA

Michael Kopcha, PhD, RPh
Director, Office of Pharmaceutical Quality (OPQ), CDER, FDA

10:00 – 10:30 a.m.

Networking Break

10:30 – 11:00 a.m.

General Session – Salon D-H

ORA Keynote Address

Alonza Cruse
Director, Office of Pharmaceutical Quality Operations
Office of Regulatory Affairs (ORA), CDER, FDA

11:00 – 11:30 a.m.

CDER Keynote Address

Patrizia Cavazzoni, MD
Deputy Director for Operations, CDER, FDA

11:30 – 12:00 p.m.

The USP of Today

Ronald Piervincenzi, PhD
Chief Executive Officer, United States Pharmacopeial Convention

12:00 – 1:30 p.m.

Ideas + Connections Networking Luncheon

This welcome midday break focuses on energizing the mind and body as well as delivering useful networking strategies. We’ll begin with full-body stretches and some light dancing, leading into cooperative conversations concentrating on reviewing your colleagues’ ideas and helping connect them to others at the conference who might be able to help.

Nikhil Paul, Founder/Crowd Engagement Expert, We R Human 

1:30 – 3:00 p.m.

GRx+Biosims Tracks

Federal Focus on Biosimilars: Policy and Politics
The U.S. government wields a great deal of clout when it comes to driving the drug pricing conversation. Officials often use biosimilars as a talking point on lowering prescription drug costs; however, their policies aren’t backing up what they’re telling America’s patients. Hear from a broad stakeholder group on how the executive and legislative branches can incentivize the use of biosimilars and increase adoption.

The Biologics Price Competition and Innovation Act (BPCIA) was designed to accelerate approval of biosimilars medicines and provide more treatment options, increase access to lifesaving medications and lower health care costs for U.S. patients. Unfortunately, the U.S. government isn’t following up and doing all it can to promote and bolster biosimilars.

Hear from a broad stakeholder group on how the executive and legislative branches can incentivize the use of biosimilars and increase adoption.

Moderator: Christine Simmon
Senior Vice President, Policy & Strategic Alliances, AAM
Executive Director, Biosimilars Council

Table Setter: Ronny Gal, PhD
Senior Analyst, Sanford C. Bernstein & Co

Molly Burich, MS
Director, Public Policy: Biosimilars and Reimbursement, Boehringer Ingelheim Pharmaceuticals, Inc.

James Carey
Executive Director, US Health Policy, Merck & Co., Inc.

Erika Satterwhite
Head of Global Biosimilars Policy, Mylan Inc.

Drug/Device Combination Products, Challenges and Opportunities
By definition, combination products are considered complex drugs. The dynamics of the review, as well as the information that must be included to support these applications, make them even more complicated and challenging. This session addresses how OGD, OPQ and CDRH work together to coordinate the review process and the challenges they face. In addition, we’ll review some of the key agency findings during the review process and how to better anticipate problems and concerns.

Moderator: Molly Ventrelli
SVP Regulatory Affairs, Fresenius Kabi USA

Henri Akouka 
Associate Director, R&D, Teva Pharmaceuticals

Lisa Bercu, JD 
Regulatory Counsel, Division of Policy Development (DPD), OGDP, OGD, CDER, FDA

Ashley Boam
Director, Office of Policy for Pharmaceutical Policy (OPPQ), OPQ, CDER, FDA

Michael Spagnola, M.D.
Medical Officer, Division of Clinical Review(DCR), Office of Bioequivalence (OB), OGD, CDER, FDA

Róisín Wallace
VP, Head of Global Device Development, Mylan Inc.

Panelist: Craig Kiester
Division Director, OPRO, OPQ, CDER, FDA

Panelist: Markham C. Luke, M.D., PhD
Director, Division of Therapeutic Performance (DTP), ORS, OGD, CDER, FDA

Controlled Correspondence: The Evolution and Opportunity
The Controlled Correspondence process has evolved over the years with the submission process becoming more structured and efficient, resulting in shorter turnaround times and improved predictability of response timing. However, in many aspects the process is more complex than ever and has created new challenges to obtaining necessary feedback.

This session brings together industry and FDA representatives to cover the spectrum of sponsor experiences with Controlled Correspondences and address common mistakes and issues and how they can be avoided.

Moderator: Charlie DiLiberti
President, Montclair Bioequivalence Services LLC

Janice Brown
Branch Chief, OPPQ, OPQ, CDER, FDA

Rosario LoBrutto, PhD
Head of Scientific Affairs, Sandoz, Inc. (A Novartis Division)

Robert Pollock, RPh, MS
Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.

Xiaohui (Jeff) Jiang, PhD
Deputy Director, DTP, ORS, OGD, CDER, FDA

Paramjeet Kaur, PhD
Bioequivalence Reviewer, Division of Bioequivalence II (DBII), OB, OGD, CDER, FDA

Panelist: Hee Sun Chung, PhD 
Lead Pharmacologist, Division of Bioequivalence I(DBI), OB, OGD, CDER, FDA

Panelist: Melissa Mannion, JD, PharmD
Regulatory Counsel, DPD, OGDP, OGD, CDER, FDA

Rebalancing U.S. Trade Policy
This panel brings together global IP and trade experts to explore how the generic and biosimilar industry can change U.S. trade policy and influence the on-going debate around trade, IP protection, access to medicines, and economic growth.

U.S. trade policy has too often reflected the interests of the branded pharmaceutical industry, eschewing a balanced approach that would both reward innovation and ensure a competitive marketplace for generic and biosimilar medicines.  This policy reflects a well-resourced, concerted effort by the branded industry to tie U.S. trade leadership and economic success directly to expanded intellectual property (IP) rights protections that extend far beyond World Trade Organization (WTO) obligations.  To counter this, the generic and biosimilar industry must develop a focused narrative that demonstrates the industry’s value to the U.S. economy and its healthcare system.

Moderator: Jonathan Kimball
Vice President, Trade & International Affairs, AAM

Tahir Amin
Co-Founder and Co-Executive Director, I-MAK

Timothy Keeler, JD
Partner, Mayer Brown LLP

Clark Packard, Esq
Trade Policy Counsel, R Street

3:00 – 3:30 p.m.

Networking Break

3:30 – 4:30 p.m.

GRx+Biosims Tracks

Biosimilar Product Development (BPD) Program: Experiences and Expectations
Here’s your opportunity to take an inside look at the FDA’s biosimilar regulatory approval process. This comprehensive program was designed to encourage biosimilar competition by developing policies to increase product options, provide more access and deliver more safe, effective and lower-cost biosimilar alternatives to patients. We’re bringing together FDA officials and industry experts for an in-depth discussion on real-world experiences with the BPD program and ways to more successfully navigate the approval process.

Welcome to an inside look at the FDA’s biosimilar regulatory approval process. This comprehensive program was designed to encourage biosimilar competition by developing policies to increase product options, provide more access and deliver more safe, effective and lower-cost biosimilar alternatives to patients. We’re bringing together FDA officials and industry experts for an in-depth discussion on real-world experiences with the BPD program and ways to more successfully navigate the approval process.

Topics include:

  • Data and study requirements necessary to prove a proposed product is “biosimilar” to a particular reference product
  • Unexpected observations and obstacles encountered during BPD programs and how they were addressed
  • Steps companies have taken to create a global dossier
  • Development of new types of biosimilars (e.g. super-orphan biosimilars, ophthalmic biosimilars)
  • Final interchangeability guidance and FDA regulatory expectations
  • Implications of the transition of certain therapeutic protein products from the 505 approval pathway to the 351 approval pathway

Gautier Sala
US Head Biopharmaceuticals Regulatory Affairs, Sandoz, Inc., a Novartis Division

Steven Kozlowski, M.D. (Invited)
Director, Office of Biotechnology Products, OPQ, CDER, FDA

Peter Stein, M.D.
Director, Office of New Drugs (OND), CDER, FDA

Cory Wohlbach
VP, Biosimilars Regulatory Affairs, Teva Pharmaceuticals

What’s Up with FDA’s Integrated Facility Evaluation Processes?
The quality and safety of drugs is of utmost importance; however, some of the changes FDA has made in its integrated facility evaluation processes have caused confusion with manufacturers. This informative session will provide plenty of answers as our panel delves into key topics related to drug inspections and FDA’s integrated approach to facility evaluations. In addition, we will wade further into inspection readiness to address some of the common inspectional issues including data integrity, investigations, CAPAs, quality agreements and aseptic processing..

Moderator: Robert Iser, MS
Vice President, PAREXEL Consulting

Goff Baker
Principal, American Pharmaceutical Consulting

Alonza Cruse
Director, OPQO, ORA, CDER, FDA

Francis Godwin (Invited)
Director, Office of Manufacturing Quality (OMQ), OC, CDER, FDA

Vidya Pai, PhD, MS
Facility Reviewer and Quality Assurance Lead (Acting), Division of Inspectional Assessment (DIA), Office of Process and Facilities, OPQ, CDER, FDA

Labeling Best Practice and Strategies for Reviews
Label development, maintenance and compliance are integral parts of the regulatory pre- and post-approval process. Understanding how FDA manages label review under GDUFA II can increase your odds of approval. Additionally, maintenance against RLD updates and compliance are very important in the post approval environment. This session sheds light on the FDA system for managing label review and provides effective strategies to prevent common errors.

Moderator: Marcy Macdonald, RAC
Consultant/President, MJM Regulatory Consulting, LLC

Courtney Canale, MS
Head of U.S. Labeling, Regulatory Affairs, Mylan Pharmaceuticals

Marshall Florence, PharmD
Labeling Reviewer, Division of Labeling Review (DLR), Office of Regulatory Operations (ORO), OGD, CDER, FDA

Huijeong (Ashley) Jung, PharmD, PhD, CPH
Labeling Reviewer, DLR, ORO, OGD, CDER, FDA

Charlene Peterson, PharmD
Labeling Reviewer, DLR, ORO, OGD, CDER, FDA

The Changing Landscape of Patents, Hatch-Waxman, and the BPCIA
Patents have been perhaps the hottest topic in Congress this year. This session is a can’t-miss opportunity for members of the biosimilars and generic manufacturing community to discuss the opportunities and challenges brought about by current legislation. We will cover patent settlements, the biosimilar patent dance, attempts to curb patent abuse, patent damages law, and the impact of potential changes to 180-day exclusivity on patent challenges.

Ali Ahmed, JD
Senior Vice President, Biosimilars, Fresenius Kabi USA

Karin Hessler, JD
Assistant General Counsel, AAM

William Jay, JD
Partner, Co-chair of Goodwin’s Appellate Litigation Practice, Goodwin Procter LLP

Teresa Rea, JD
Partner, Crowell & Moring LLP

3:30 – 5:30 p.m.

GRx+Biosims Exposition

An interactive knowledge sharing session that brings together multiple levels of scientific disciplines from diverse sectors, industry, academia and agency. The expo is geared toward facilitating one-on-one interaction among these sectors to increase understanding on a scientific level.

  • Office of Generic Drugs (OGD) – What’s Working Well?
  • Office of Regulatory Operations (ORO)/ Division of Project Management (DPM)
  • Office of Regulatory Operations (ORO)/ Division of Labeling Review (DLR)
  • Office of Regulatory Operations (ORO)/ Division of Filing Review (DFR)
  • Office of Research and Standards (ORS)
  • Office of Bioequivalence (OB)
  • Office of Pharmaceutical Quality (OPQ)/ Knowledge Aided Assessment and Structured Application (KASA)
  • Office of Regulatory Affairs (ORA)
  • Office of Management (OM)
  • Office of Business Informatics (OBI)
  • Drug Shortage
  • Best practices and robust strategies for DMF
  • Access to Medicine is Access to Hope
  • Challenges and Opportunities: Complex Products and Bioequivalence Studies
  • Risk Management Considerations for Combination Products
  • Orange you glad we know how to fix the Purple Book
  • Industry Feedback in Preparation for GDUFA 3
  • Quality Initiatives for ANDAs
  • Excipients
  • Serialization from a CMO Partnership Perspective
  • Combination Products – The Intersection of the 300 and 800s in your ANDA
  • Transfer of Assets in a Regulated Environment
  • The Sandoz Perspective on Biosimilar Interchangeability: A Designation Unique to the United States
  • Deficiency Trending – A Pharmaceutical Quality Tool
4:30 – 6:00 p.m.

Biosimilars Council Meeting

5:30 – 6:30 p.m.

Networking Reception

6:30 – 9:30 p.m.

Dinner & Entertainment

Delicious Dinner + Suspenseful Speakeasy

The Roaring Twenties – it was a time of lively flappers, notorious gangsters and secret speakeasies. Join us as we turn back the clock for an entertaining evening at GRx+Biosims, a speakeasy where attendees can get away from the clutches of prohibition for a few hours.

Learning Tracks

  • Generic Industry Outlook GDUFA III
  • Acquisitions/Mergers - Now What Do We Do
  • DMF
  • USP in Supply Chain       
  • Drug/Device Combination Products, Challenges and Opportunities    
  • Navigating the Q1/Q2 Letter Quagmire – Industry & FDA Experiences, and How Both Could Improve the Q1/Q2 Controlled Correspondence Process
  • What’s Up with FDA’s Integrated Facility Evaluation Processes?
  • Labeling  
  • Conducting Foreign Bioequivalence Studies Now and in the Future – an “Eyes Wide Open” Assessment of Risks, Challenges, and Opportunities
  • Post Approval
  • Developing Complex Generic Products, How to Ensure Success!
  • Emerging Tech   

  • Commercializing Biosimilars: Discussion with Biosimilars Industry Leaders
  • Biosimilars Action Plan Scorecard: Is FDA Helping Adoption?
  • The Importance of Global Regulatory Harmonization for Biosimilars
  • Payer Strategies to Drive Biosimilars Access & Savings
  • Federal Focus on Biosimilars: A Lot of Bark and No Bite
  • Biosimilar Product Development (BPD) Program: Experiences and Expectations
  • Progress and Challenges of BsUFA II
  • Biosimilars Education Evolution: Changing Perspectives in the Face of Increasing Costs

  • Emerging State Legal Issues
  • The Changing Landscape of Patents and Hatch-Waxman
  • Biosimilars at the Bar
  • Rebalancing U.S. Trade Policy

Stay Informed on Sciences and Regulatory Issues

Our science and regulatory affairs tracks will give you the insights you need to better navigate the regulatory landscape, and increase your understanding of how our industry can better manage the GDUFA II framework. Plus, be a part of in-depth discussions among diverse stakeholders - industry, academia and the FDA.

Breaking Through on Biosimilars

Take a deep dive into the policy and regulatory challenges facing the nascent biosimilars market in the United States. We will discuss the significant role biosimilars have played in increasing patient access to life-altering medicines and ensuring health system viability globally. Additionally, we will highlight the importance of stakeholder education as a crucial market river for these innovative medicines.

Legal Issues Currently Facing the Industry

Be a part of the discussions on a wide variety of emerging legal issues, including patent dance, drug pricing, state legislation, legal issues in GDUFA, FDARA and FDA competition proposals, as well as the latest issues in IP and Paragraph IV litigation.

Get Involved and Get Accredited

AAM will also be providing attendees with the opportunity for CEUs and CLE accreditations through our interactive general and breakout sessions. You’ll leave the conference with insightful up-to-date information and get your hours accredited based on your participation.


Receive the latest event information about key speakers,
sponsorship opportunities and exhibiting.