November 4-6, 2019 | North Bethesda, MD


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Wednesday, November 6

7:30 – 8:30 a.m.

Build + Inspire Morning Breakfast

Let’s make our last day together something special. We’ll begin with a few minutes of mindfulness meditation, morning Yoga at Work stretches and light, wake-up-your-body dancing. Once the juices are flowing, we’ll roll into an invigorating interactive session that will focus on some the most popular crowd sourced topics from our previous sessions. Get ready to further the conversation through group ideation, problem-solving and personal commitments, especially by drawing upon what you’ve learned and the connections you’ve made at the conference.

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

8:30 – 10:30 a.m.

General Session – Salon D-H

Healthcare Innovation and The Political Economy

Scott Gottlieb, M.D.
Former Commissioner, FDA

Quality of Pharmaceuticals Discussion

Scott Gottlieb, M.D.
Former Commissioner, FDA

Carol Lynch
President, Sandoz US, Head of North America

Jeff Watson
President & Chief Executive Officer, Apotex, Inc.

10:30 – 11:00 a.m.

Networking Break

11:00 – 12:30 p.m.

GRx+Biosims Tracks

Commercializing Biosimilars: Discussion with Industry Leaders
What’s the current state of biosimilars? Hear from insightful industry leaders on practical approaches to biosimilars commercialization and how this burgeoning pharmaceutical market offers increased competition and patient access.

What’s the current state of biosimilars? There’s plenty of promise with a growing number of U.S. launches that could lead to more than $54 billion in savings over the next decade, providing access to needed medicines for 1.2 million patients. But there are troubling signs on the horizon as well, including rebate and contracting tactics, IP, and regulatory issues that could block future progress. Finding your way in the biosimilars industry means understanding all the factors that come into play, recognizing the obstacles/pitfalls and adopting the practices that will give you the best chance to succeed. That’s why we’re bringing together insightful biosimilar industry leaders to lead a beneficial discussion on practical approaches to commercialization and how this burgeoning pharmaceutical market is a unique opportunity.

Moderator: Stan Mehr
Director of Content, Biosimilars Review & Report

Sang-Jin Pak, M.D., MSc
Senior Vice President and Head of Commercial Division, Samsung Bioepis

Chrys Kokino
Head Global Biologics & Insulins Commercial, Mylan, Inc.

Carol Lynch 
President, Sandoz US, Head of North America

Juliana M. Reed
Vice President, Corporate Affairs Lead – Immunology, Inflammation (I & I) and Biosimilars, Pfizer, Inc.

Emerging State Legal Issues
Increasingly, states are wrestling with ways to address drug pricing in order to maintain a sustainable health care system. Most legislative proposals will impact generics and biosimilars. Unfortunately, many of the solutions offered at the state level focus on “price transparency” or price limitations with no recognition of the important differences between the brand industry that drives higher prices and the generic industry that drives savings. Additionally, policymakers often emphasize percentage increase when looking at prices while neglecting to consider true costs and the overall deflationary pricing trend—price decreases—for the vast majority of generic medicines. Finally, new legislative concepts appear each year that, if enacted, will have a greater impact on reducing access to and delaying market entry of generic and biosimilar medicines.

This panel offers a frank and insightful discussion of state legislative proposals.

Moderator: Tara Ryan, JD
Vice President, State Government Affairs, AAM

Robert Cerwinski, JD
Partner, Goodwin Proctor

Jack Conway, JD
Former Attorney General of Kentucky

Stephanie Trunk, JD
Partner, Arent Fox LLP

Assessment of Risks, Challenges and Opportunities in Conducting Foreign Bioequivalence Studies
The regulatory world is becoming more connected, and it’s changing the way our industry operates in expansive and critical ways. Today bioequivalence (BE) studies supporting U.S. ANDAs are being conducted all over the globe. This session can help you navigate the challenges and risks of contracting overseas studies, comparing scenarios of pharmacokinetics-based and clinical endpoint-based BE studies, and hear the ins and outs of conducting foreign BE studies.

With the increasing globalization of the drug industry, how biosimilars are tested and regulated in different countries can drastically affect access and costs. That’s one of the reasons it’s more important than ever to come up with standard global development strategies that allow generic companies to save time and costs in research and development and which allows them to offer better prices for their products. This session can help you navigate the challenges and risks of contracting overseas studies, comparing scenarios of pharmacokinetics-based and clinical endpoint-based BE studies and hear the ins and outs of conducting foreign BE studies.

Moderator: Charlie DiLiberti
President, Montclair Bioequivalence Services LLC

Kumar Ramu, PhD
Sr. Vice President & GM, QPS Holdings LLC

Nageshwar Thudi, PhD
Senior Director, Global Gx Clinical R&D- PD/CE Studies, Teva Pharmaceuticals

Panelist: Juan He, MSc.Phm.,BSc.Phm.
Senior Director, Pharmacometrics, BioPharma Services, Inc.

Post Approval Changes: Best Practices and Strategies

Today’s post-approval world is complex. There are many business decisions such as new equipment and technology, facility build outs, product transfers due to the relocation of manufacturing facilities or even revisions for older products due to changes in manufacturing and analytical technology that result in the need for global complex post approval changes. This session delivers some best practices and effective strategies in working with FDA for guidance and approval of complex changes.

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

Billie Wiltison
Senior Director, Regulatory Affairs, Vertice Pharma

Olugbenga (Gbenga) Okubadejo, PharmD
Branch Chief (Post Approvals), Office of Program and Regulatory Operations (OPRO), OPQ, CDER, FDA

Paul Schwartz, PhD

12:30 – 1:30 p.m.

Collaborate + Motivate Networking Luncheon

The conference may be wrapping up, but there’s still time to get in one last midday energizing networking break. Join us as we refresh mind, body and spirit with some invigorating immersive stretches and light dancing while focusing on gaining a deeper understanding of the motivations of your fellow attendees and connecting with the underlying mission that drives us all. We promise it’ll be time well spent.

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

Complex Product Workshop  (separate registration required)

The availability of generic drug products can mitigate the risk of drug shortages, help make prescription drugs more affordable, and enhance patient access to medicines. However, there may be substantial uncertainty about how to approach the development of complex generic drug products (CGDPs). The complexity of CGDPs may be associated with the active pharmaceutical ingredient (API), the formulation, the dosage form, the route of delivery, and/or the nature of the drug-device combination product. To encourage CGDP development, the Food and Drug Administration (FDA) is actively engaging with prospective developers of CGDPs through pre-ANDA meetings to discuss specific issues of scientific or regulatory complexity, and to clarify the FDA’s bioequivalence (BE) standards and recommendations.

This practical, active-participation workshop will help participants learn how to approach development of CGDPs and how to engage with the FDA during the development of a CGDP. Workshop participants will learn how to efficiently de-risk CGDP development, increase certainty about regulatory decision making, and enhance patient access to high-quality CGDPs. Workshop participants will gain hands-on experience discussing CGDP development approaches with FDA experts in mock pre-ANDA meetings. The meetings will be structured as fun, simulated experiences where all workshop participants can interact directly with FDA experts. Each breakout session will hold a mock pre-ANDA meeting for the hypothetical CGDP they will have developed with their mentors, and the participants from the other breakout sessions will observe as FDA experts answer questions and provide constructive, critical feedback.

Kris Andre, MS
Associate Director for Regulatory Affairs, ORS, OGD, CDER, FDA

Andrew Babiskin, PhD
Team Lead, Division of Quantitative Methods and Modeling (DQMM), ORS, OGD, CDER, FDA

Bing Cai, PhD
Division Director, Division of Liquid-based Drug Products (DLBP), OLDP, OPQ, CDER, FDA

Sneha Dhapare, PhD
Reviewer, DTP, ORS, OGD, CDER, FDA

Kairui (Kevin) Feng, PhD

Dhaval Gaglani, MS

Priyanka Ghosh, PhD
Reviewer, DTP, ORS, OGD, CDER, FDA

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

Darby Kozak, PhD

Robert A. Lionberger, PhD
Director, ORS, OGD, CDER, FDA

Markham C. Luke, M.D., PhD
Director, DTP, ORS, OGD, CDER, FDA

Bryan Newman, PhD
Acting Team Lead, DTP, ORS, OGD, CDER, FDA

Pahala Simamora, PhD

Eleftheria Tsakalozou, PhD

Ross Walenga, PhD

1:30 – 5:00 p.m.

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

What are Complex Drugs and Why Generic Drug Focus

Robert Lionberger, PhD
Director, ORS, OGD, CDER, FDA

Logistics for Pre-ANDA Meetings
Kris Andre, MS
Associate Director for Regulatory Affairs, ORS, OGD, CDER, FDA

Complex Product Workshop Breakout Session Intros
Session Leads

Complex Product Workshop Breakout Sessions:

Session 1: Liposomal Ophthalmologic Suspension

Session 2: Orally Inhaled Drug-Device Combination Product

Session 3: Topical Dermatologic Cream

Complex Product Workshop Breakout Session Recap
Session Leads

Questions and Closing Statement
Robert Lionberger, PhD

Director, ORS, OGD, CDER, FDA

Xiaohui (Jeff) Jiang, PhD
Deputy Director, Division of Therapeutic Performance, Office of Research and Standards, OGD, CDER, FDA


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.


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