November 4-6, 2019 | North Bethesda, MD

Agenda

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

Conference Program

Day 1

Monday, Nov 4

7:30 a.m.

Registration

7:30 – 8:30 a.m.

Networking Breakfast

8:30 – 9:00 a.m.

Welcome and Introduction

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

9:00 – 10:00 a.m.

General Session

Keynote Address

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

Commissioner Keynote Address

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

10:00 – 10:30 a.m.

Networking Break

10:30 – 12:00 p.m.

General Session

CDER Keynote Address

Patrizia Cavazzoni, M.D.
Deputy Director for Operations, CDER, FDA

Biosimilars Keynote Address

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

12:00 – 1:30 p.m.

Networking Luncheon

1:30 – 3:00 p.m.

GRx+Biosims Tracks

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.

 

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.

Generic Industry Outlook GDUFA III

Acquisitions/Mergers – Now What Do We Do

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.

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.

DMF

Siva Vaithiyalingam, PhD
Vice President Regulatory Affairs, Cipla LTD

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 presentation will cover the Study Data Guidance dates, the Study Data Technical Rejection Criteria, the Self-Check Worksheet, metrics and analysis of TRC error rates with a focus on the 70% error rate for ANDAs, Typical Errors seen during analysis and how to avoid them. It will also cover eCTD (guidance, metrics, common errors, and submission processing challenges) and introduce the 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.

Welcome Reception

Day 2

Tuesday, Nov 5

7:30 – 8:30 a.m.

Networking Breakfast

8:30 – 10:00 a.m.

General Session

OGD Keynote Address

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

OPQ Keynote Address

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

OC Keynote Address

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

10:00 – 10:30 a.m.

Networking Break

10:30 – 12:00 p.m.

General Session

ORA Keynote Address

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

The USP of Today

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

12:00 – 1:30 p.m.

Networking Luncheon

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.

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

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

Drug/Device Combination Products, Challenges and Opportunities

Molly Ventrelli
SVP Regulatory Affairs, Fresenius Kabi USA

Navigating the Q1/Q2 Letter Quagmire – Industry & FDA Experiences, and How Both Could Improve the Q1/Q2 Controlled Correspondence Process
Following the advent of Generic Drug User Amendments (GDUFA), today’s Controlled Correspondence process has turned out to be quicker, more efficient and has made it easier to predict response timelines than in the past. However, the system has become increasingly more complex and changes have created a host of new challenges particularly for those pertaining to Q1/Q2 inquiries. We’ve brought together experienced and knowledgeable insiders from both industry and the FDA to lend their insights on both the filing review and technical aspects of Controlled Correspondence submissions.

Today’s Controlled Correspondence process has turned out to be quicker, more efficient and has made it easier to predict response timelines than in the past. However, following the advent of Generic Drug User Amendments (GDUFA), the system has become increasingly more complex and changes have created a host of new challenges. For example, Q1/Q2 Controlled Correspondence requests no longer provide input on how formulations can be adjusted to meet requirements, which makes it much more difficult for generic sponsors to meet the Q1/Q2 goal.

This session will cover the spectrum of sponsor experiences with Controlled Correspondences, including Q1/Q2 requests (with specific case studies) and ways to achieve optimal results. Plus, FDA reprensentatives will address common mistakes/issues and how they can be avoided. We’ve brought together experienced and knowledgeable insiders from both industry and the FDA to lend their insights on both the filing review and technical aspects of Controlled Correspondence submissions. If you’ve got questions or concerns about the process, this is your chance to get up to speed.

Moderator: Charlie DiLiberti
President, Montclair Bioequivalence Services LLC

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.

Rebalancing U.S. Trade Policy
This panel will explore how our industry can develop a compelling narrative and advocacy efforts to rebalance U.S. trade policy in support of greater access to generic and biosimilar medicines.

Our country’s trade policy has too often put the interests of pharmaceutical monopoly owners over the needs of the larger U.S. health care sector. Current trade policy has tilted the playing field toward brand name, patent-based pharmaceuticals. In new bilateral or multilateral trade agreements, generic and biosimilars medicines are taking a backseat to the interests of big brands. Look at free trade agreements – they’re prioritizing exclusivity periods for biologics and new chemical entities and unbalanced patent linkage systems. The result? Diminished markets for U.S. generic companies. This panel will explore how our industry can develop a compelling narrative and advocacy efforts to rebalance U.S. trade policy in support of greater access to generic and biosimilar medicines.

 

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. (Invited)
Director, Office of New Drugs (OND), CDER, FDA

What’s Up with FDA’s Integrated Facility Evaluation Processes?
Perplexed by changes in the FDA’s integrated facility evaluation processes? This 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 to keep you from experiencing common pain points.

The FDA has made significant changes in its integrated facility evaluation processes to more efficiently and effectively ensure the quality and safety of drugs. However, these changes have caused some confusion with manufacturers. This 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 to keep you from experiencing common pain points. In addition, we’ll delve further into common inspectional issues such as data integrity, investigations, CAPAs, quality agreements and aseptic processing.

Moderator: Robert Iser, MS
Vice President, PAREXEL Consulting

Goff Baker
Principal, American Pharmaceutical Consulting

Labeling

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

The Changing Landscape of Patents and Hatch-Waxman
Destructive abuses of the system governing generic and biosimilar medicines are keeping affordable medicines from patients longer. This session is a can’t-miss opportunity for members of the biosimilars and generic manufacturing community to discuss the opportunities and challenges brought by changes to current legislation.

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 facilitation one-on-one interaction among these sectors to increase understanding on a scientific level.

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 The Bees Knees, a speakeasy where GRx+Biosims event attendees can get away from the clutches of prohibition for a few hours. It’s all fun and games until a patron runs into foul play. You and your dining companions will be called on to help solve the mystery and identify the culprit… if you can.

Day 3

Wednesday, Nov 6

7:30 – 8:30 a.m.

Networking Breakfast

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

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 P. 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 
Vice President and 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

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.

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

Post Approval

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

Billie Wiltison
Consultant, Wiltison Regulatory Consulting

12:30 – 1:30 p.m.

Networking Luncheon

1:30 – 2:30 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

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 – I & I and Biosimilars, Pfizer, Inc.

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.

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

Emerging Tech

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.

2:30 p.m.

GRx+Biosims Concludes

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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