November 4-6, 2019 | North Bethesda, MD

Agenda

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

Keynote Address

Scott Gottlieb, M.D.
Former Commissioner, FDA

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

Sang-Jin Pak, M.D., MSc
Chief Operating Officer, 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
Numerous states wrestling with the issue of drug pricing and our nation’s opioid crisis have considered or enacted legislation that would affect generics and biosimilars. This panel offers a frank and insightful discussion of far-reaching new state law proposals in Maryland, California and Nevada and the arguments against them.

Unfortunately, many of the solutions proposed at the state level have focused only on “price transparency” or pricing limitations with no recognition of the differences between the brand industry that drives higher prices and the generic industry that drives savings. In addition, some policymakers emphasize isolated price spikes in terms of percentage increase, while neglecting to mention the overall deflationary pricing trend—price decreases—for the vast majority of generic medicines.

Jack Conway, JD (Invited)
Former Attorney General of Kentucky

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

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

Apurva Shah
Founder and Director, Veeda Clinical Research Pvt Ltd.

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

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
Consultant, Wiltison Regulatory Consulting

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, Division of Therapeutic Performance (DTP), ORS, OGD, CDER, FDA

Kairui (Kevin) Feng, PhD
Reviewer, DQMM, ORS, OGD, CDER, FDA

Dhaval Gaglani, MS
Branch Chief, Division of Modified Release Products (DMRP), Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, CDER, FDA

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

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

Darby Kozak, PhD
Team Lead, DTP, ORS, OGD, CDER, FDA

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
Branch Chief, DLBP, OLDP, OPQ, CDER, FDA

Eleftheria Tsakalozou, PhD
Reviewer, DQMM, ORS, OGD, CDER, FDA

Liang Zhao, PhD
Director, DQMM, ORS, OGD, CDER, FDA

Ross Walenga, PhD
Reviewer, DQMM, ORS, OGD, CDER, FDA

1:30 – 5:15 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

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

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

Questions and Closing Statement
Robert Lionberger, PhD

Director, ORS, OGD, CDER, FDA

Xiaohui (Jeff) Jiang, PhD
Deputy Director, DTP, ORS, 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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Get Started + Register

Whether you are an AAM member, general attendee, speaker or exhibitor, you can be part of the premier scientific and regulatory conference for the U.S. generics and biosimilars industry.