November 4-6, 2019 | North Bethesda, MD

Agenda

Monday, November 4th

7:30 a.m.

Registration

7:30 – 8:30 a.m.

Welcome Breakfast + Morning Meditation

What a way to start the day. We’ll kick things off with a brief-but-invigorating mindfulness meditation complete with Yoga at Work-inspired stretches to get your blood flowing. Next up is a fun and interactive welcoming session designed to inspire friendly, get-to-know-you conversations.

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

8:30 – 10:30 a.m.

General Session

Commissioner Keynote Address

Norman (Ned) Sharpless, M.D.
Acting Commissioner, FDA

Keynote Address

The Honorable Alex Azar, II (Invited)
Secretary, United States Department of Health and Human Services

Biosimilars Keynote Address

Sarah Yim, M.D.
Acting Director for Therapeutic Biologics, Office of New Drugs
Therapeutic Biologics and Biosimilars Team, CDER, FDA

Welcome and Introduction

Chester “Chip” Davis, Jr., JD
President & CEO, AAM

10:30 – 11:00 a.m.

Networking Break

11:00 – 12:00 p.m.

GRx+Biosims Tracks

Emerging Technologies: How Can the Generic Industry Participate and Benefit?
What does the new emerging technology landscape and usage of continuous processing for pharmaceutical manufacturing look like today? FDA has published several guidances to encourage and facilitate the adoption of emerging technologies, all part of the Agencies efforts to advance new innovations. This session will describe what some of the technologies being utilized today are, how industry can participate in these initiatives and how the generic industry can benefit from the adoption of these processes as well as engage with FDA.

Judy Murrah
Chief Information Officer, Applied DNA Sciences

Developing Complex Generic Products, How to Ensure Success!
The FDA has provided several ways for companies to interact to fast-track development, submission, approval and accessibility of complex generic products. Engage with our knowledgeable panel on key topics, discuss common challenge and learn the most important factors when developing a complex generic product.

Moderator: Robert Iser, MS
Vice President, PAREXEL Consulting

Gregg DeRosa, MS
SVP, Generic Clinical R&D and Internal Clinics, Teva Pharmaceuticals

Robert Lionberger, PhD (Invited)
Director, Office of Research Standard, OGD, FDA

Bing Li, PhD (Invited)
Director (Acting), Office of Bioequivalence, OGD

The Importance of Global Regulatory Harmonization for Biosimilars
This session discusses how global regulatory authorities, including the World Health Organization (WHO), European Medicines Agency (EMA) and FDA, are moving to adopt global harmony to help expand patient access and bring down drug costs.

Policies and regulations regarding biosimilars medicines differ from country to country, leading to confusion over biosimilars integrity. Global regulatory harmonization – the process by which technical guidelines are developed to be uniform across participating authorities – ensures consistency and affordability of biosimilars and their safety and reliability. Find out how these factors affect global development with a session that discusses how global regulatory authorities, including the World Health Organization (WHO), European Medicines Agency (EMA) and FDA, are moving to adopt global harmonization of regulatory standards to help expand patient access and bring down drug costs.

Suzette Kox, MSc, Pharm
Secretary General, International Generic and Biosimilar medicines Association

Biosimilars Education Evolution: Changing Perspectives in the Face of Increasing Costs
What do stakeholders actually think about biosimilars? Attitudes continue to evolve as the body of data on their safety, efficacy and savings grows. Hear from a panel of stakeholders representing patients, physicians and pharmacists on where the biosimilar industry currently stands.

While provider education on biosimilars presents a hurdle for health systems worldwide, making sure patients have access to correct information about biosimilars is crucial to adoption.

Surveys show that fewer than half of patients are familiar with biosimilars, and a substantial number haven’t heard the term “biosimilar” before. Attitudes continue to evolve as the body of data on their safety, efficacy and savings grows. Hear from a panel of stakeholders representing patients, physicians and pharmacists where the biosimilar industry currently stands.

Sameer Awsare, M.D.
Associate Executive Director, The Permanente Medical Group

12:00 – 1:30 p.m.

Energize + Socialize Networking Luncheon

There’s no time for an afternoon lull. This revitalizing post-lunch break employs rejuvenating full-body stretches and light dance movement to provide a boost of energy as well as the opportunity to get to know fellow attendees a little more.\

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

1:30 – 3:00 p.m.

GRx+Biosims Tracks

Progress and Challenges of BsUFA II
Looking to get up to speed on BsUFA II? We’re gathering industry and FDA representatives to evaluate of the progress and challenges of BsUFA II, which authorizes the FDA to collect fees and use them for the review of biosimilar biological product applications.

We’re gathering industry and FDA representatives to evaluate of the progress and challenges of BsUFA II, which authorizes the FDA to collect fees and use them for the process for the review of biosimilar biological product applications.

Topics include:
• Evaluation of metrics used for adhering to BPD meeting timing commitments
• Review cycle of BPD programs; feedback provided to sponsors;
• FDA staffing goals; FDA’s commitment to education related to biosimilars, status of guidance’s for which commitments were made.

This session will include an evaluation incorporating a “score card” of FDA commitments as well as a discussion of the financial health. If you’ve got questions about BsUFA II, this is the place to find answers.

 

Hillel Cohen, PhD
Executive Director, Scientific Affairs, Sandoz Inc., a Novartis Division

Andrew Kish, MSPPM (Invited)
Office Director, Office of Program and Strategic Analysis (OPSA), CDER, FDA

Brian McCormick, JD
Vice President & Chief Regulatory Counsel, Teva Pharmaceuticals

Sarah Yim, M.D.
Acting Director for Therapeutic Biologics, Office of New Drugs, Therapeutic Biologics and Biosimilars Team, CDER, FDA

Payer Strategies to Drive Biosimilars Access & Savings
Manufacturers employ all kinds of anti-competitive market access tactics to block biosimilars adoption. The good news is that many major U.S. payors and pharmacy benefit managers (PBM) have begun preferring biosimilars to their branded reference products. Hear representatives from the payor community discuss how they’re overcoming obstacles and realizing significant savings for patients and the health care system.

Brand-name drug companies are using every tool at their disposal to protect and extend the monopolies of biologic medicines. Their anti-competitive tactics are effectively blocking biosimilars adoption and denying access to affordable, lifesaving medicines to patients who desperately need them. The good news is that many major U.S. payors and pharmacy benefit managers (PBM) have begun preferring biosimilars over their branded reference products, and their voices are driving real change in the industry. Hear representatives from the payor community discuss how they’re overcoming obstacles and realizing significant savings for patients and the health care system.

Amy Gutierrez, PharmD
Senior Vice President and Chief Pharmacy Officer, Kaiser Permanente National Pharmacy Programs and Services

Imminent Approvals – Enhancing Access
As industry and FDA work together to streamline processes, this session focuses on how determinations are made on imminent approval/tentative approval applications. Learn from FDA subject matter experts and industry colleagues about best practices regarding imminent approvals within the GDUFA II commitment letter to facilitate patient access to more affordable generic medicines.

Edward (Ted) Sherwood (Invited)
Director, Office of Regulatory Operations, OGD, CDER, FDA

Acquisitions/Licensing and Mergers – What Are the Regulatory Requirements and Strategies to Consider?
Hardly a day goes by when we don’t hear about another acquisition, merger or licensing agreement in our industry. With all this change, managing the complex regulatory environment is key to preventing drug shortages, maintaining compliant submissions and ensuring smooth transitions. This session addresses key regulatory considerations, including due diligence, ownership/site transfers, compliance issues, ensuring product supply and more.

Moderator: Kiran Krishnan, PhD
Senior Vice President, Global Regulatory Affairs, Apotex Inc.

Donal Parks, MBA, MPM
Division Director, Division of User Fee Management and Budget Formulation (DUFMBF), Office of Management(OM), CDER, FDA

Scott Tomsky
VP, Regulatory Affairs, Generics, North America
Teva Pharmaceuticals

3:00 – 3:30 p.m.

Networking Break

3:30 – 4:30 p.m.

GRx+Biosims Tracks

Biosimilars Action Plan Scorecard: Is FDA Helping Adoption?
Success in this industry means understanding how The Food and Drug Administration (FDA) thinks, communicates and operates. We’re bringing together experts to discuss the impact of FDA policy on the U.S biosimilar market and implications globally.

A better understanding of how the FDA communicates and operates could mean the difference in getting new biosimilars medicines approved or having them languish in development. We’re bringing together a seasoned group of FDA experts to lead a discussion on ways FDA policy is affecting both the U.S. and global biosimilars markets.

Biosimilars at the Bar
There’s never been a more meaningful moment for biosimilars. We’ll explore the themes that will shape the industry in the coming months and years. This session provides an update on legislation, litigation and the curiosities and complexities of the patent dance, as well as other current obstacles and opportunities for bringing more biosimilars to market.

Biosimilars have the ability to give patients much-needed access to lower-cost complex therapies. This session takes a deep dive on the themes that will shape the industry in months and years to come. Get the latest on legislation, litigation and the curiosities and complexities of the patent process, as well as other obstacles and opportunities for bringing more biosimilars to market.

Robert Cerwinksi, JD
Partner, Goodwin Procter LLP

Joe Franklin, JD, PhD (Invited)
Policy Director for the Principal Deputy Commissioner, FDA

Scott Lassman, JD
Principal, Lassman Law+Policy

Brian McCormick, JD
Vice President & Chief Regulatory Counsel, Teva Pharmaceuticals

Drug Substance and Drug Product Manufacturers – Partnering to Improve the Process
Agency guidance and information available to industry has improved the quality, submission and review of DMFs. However, deficiencies resulting from the Agency review of those DMFs, multiple ANDA references to the same DMF and basic communication between API manufacturers and ANDA holders still may create challenges in timely ANDA approval. In this session, industry and the Agency will discuss common challenges and deficiencies and ways to address them to ensure ANDA approvals meet GDUFA goals.

Siva Vaithiyalingam, PhD
Vice President Regulatory Affairs, Cipla LTD

Martin Ehlert, PhD
VP, Research & Development, Apotex Pharmachem

Panelist: Aloka Srinivasan, PhD
Vice President, Regulatory Practice, Lachman Consultant Services, Inc.

Office of Business Informatics: FDA Study Data Standard for Submissions and Electronic Submissions Update What Sponsors Need to Know
This highly useful presentation covers a wide range of issues, including study data guidance dates, study data technical rejection criteria and the self-check worksheet. It will also address metrics and analysis of TRC error rates, with an emphasis on the 70% error rate for ANDAs as well as typical errors seen during analysis and the best way to avoid them. We’ll cover eCTD (guidance, metrics, common errors and submission processing challenges) and introduce a new way of requesting pre-assigned application numbers via the CDER NextGen Portal (pre-assignment process, ease of use, automated confirmation and historical records).

Heather Crandall
Operations Research Analyst, OBI, OSP, CDER, FDA

Susanne Lenk
Computer Scientist, OBI, OSP, CDER, FDA

Jonathan Resnick
Project Management Officer, OBI, OSP, CDER, FDA

Jiang Xu
Business Informatics Specialist, OBI, OSP, CDER, FDA

5:00 – 6:30 p.m.

Shake + Connect Welcome Reception

Join us for a networking event that thinks it’s a dance party! We’re turning up the music and encouraging you and your fellow attendees to loosen up and be part of a fun, festive and surprisingly productive group activity. It’s time to get movin’, groovin’ and improvin’ (your network, that is).

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

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.