Agenda

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

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.

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.

Siva Vaithiyalingam, PhD
Vice President Regulatory Affairs, Cipla LTD

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

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

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.

Molly Ventrelli
SVP Regulatory Affairs, Fresenius Kabi USA

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.

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

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

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

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

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

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.

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

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

Billie Wiltison
Consultant, Wiltison Regulatory Consulting

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.

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

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.