Past Event

Biosimilar Market Access and Commercialization Strategies Summit (EXL)

18–19 September 2017
Boston, MA 02210, United States
 

Biosimilar Market Access and Commercialization Strategies Summit (EXL)



The FDA’s approval of the first wave of biosimilars cleared the way for manufacturers to make lower-cost versions of expensive biologic drugs, saving patients money and improving access to important medications. There is a significant market opportunity ahead for biosimilar drugmakers; by 2020, leading biologic medicines worth more than $80 billion global annual sales will lose their patent protections, and biosimilars is the largest area for potential growth in the biotech sector. But with great rewards, there are also great risks that must be considered. In contrast to Europe, this is still an uncharted territory for the US market, and barriers to market access are not as low as they seem to be. From FDA approval to pricing and marketing strategies, there are risks and financial uncertainties. Therefore, the industry needs to know how to best address those challenges and optimize the biosimilar launch process.

Whether you are exploring your chances of tapping into the competitive biosimilars marketplace or are an expert in the field, the Biosimilar Market Access and Commercialization Strategies Summit will provide detailed presentations, intensive case studies and collaborative panel discussions relevant to your interests. Our talented faculty will address everything from navigating evolving regulations, analyzing optimal pricing models, accelerating market access strategies, and executing strategic decisions to mitigate risk and build for commercial success. In addition, designated lunches and networking breaks will enhance the exchange of knowledge and foster future business partnerships.

Conference Chair

John Coelho
Global Medical Strategy Leader
MERCK
Featured Speakers Include:


Bruce Leicher
Senior Vice President and General Counsel
MOMENTA PHARMACEUTICALS


Top Five Reasons to Attend

    Explore factors to consider before developing biosimilars — improve your chances on the road to approval and commercial success
    Hear best practices and case studies for a successful biosimilar product strategy from its conception to execution
    Stay up to date with FDA guidances and other regulatory guidelines and join the debate on nonproprietary naming of biological and biosimilar products
    Navigate biosimilar policies, regulations and compliance issues under the new administration
    Network with leaders in the industry and get tips on how to manage payer and provider considerations for market entry, engage with patients, and stay competitive

Who Should Attend

This conference is designed for biotech professionals responsible for:

    Biosimilars
    Biologics/Biotechnology/Biogenerics
    Biopharmaceuticals/Biotherapeutics
    Market Access Commercialization
    Marketing and Sales
    Strategic/Corporate Planning
    Pricing and Reimbursement
    HEOR and Outcomes Research
    Legal Affairs

    Intellectual Property
    Medical Affairs
    Manufacturing/Bioprocesses
    Clinical Affairs/Operations/Development
    Regulatory Affairs
    Medical Science Liaisons
    R&D
    Quality Control/Assurance

This event is also of interest to:

    CROs/CMOs/CMDOs
    Law Firms
    API Manufacturers
    Distributors
    Consulting Companies
    Market Access Providers

    Licensing Services
    Distribution and Logistics Services
    Packaging and Labeling Companies
    Preclinical/Nonclinical/Analytical Development Research Organizations

Agenda

Day One
Monday, September 18
PRE-CONFERENCE WORKSHOP

8:15AM – 9:00AM

Registration and Continental Breakfast for Workshop Participants

9:00AM – 12:00PM

WORKSHOP: UNCOVER MARKET ACCESS OF BIOSIMILARS IN THE U.S. MARKET

While the biosimilar market continues to develop, much remains unanswered to ensure the commercial success of biosimilars in the United States. It is essential for manufacturers of biosimilars and innovator products alike to understand the approval pathways and familiarize themselves with the major issues surrounding market access and evaluation of biosimilars.

This workshop will help stakeholders to identify some key issues related to the U.S. biosimilar landscape and review effective strategies for market access.

Firm up the basics of market access strategies of Biosimilars
Preparing to launch a biosimilar is expected to be much like preparing to launch a branded biologic
Walk through differences in biologic and biosimilar regulatory approval pathways
Analyze the issues, challenges and potential impact of unknowns on market access for biosimilars in the U.S. market
Assess issues in naming and labeling of biosimilars

There will be a half-hour networking break at 10:30.

12:00PM – 12:30PM
Luncheon for Workshop Participants
MAIN CONFERENCE

12:30PM – 1:00PM
Main Conference Registration

1:00PM – 1:45PM
Chairperson’s Welcome And Opening Remarks
John Coelho, Global Medical Strategy Leader, MERCK

1:45PM – 2:30PM
KEYNOTE: UNCOVER EMERGING TRENDS AND THE FUTURE OF BIOSIMILAR DRUG MARKET IN THE UNITED STATES
Chrys Kokino, Head Global Biologics Commercial, MYLAN

2:30PM – 3:15PM
ANALYZE THE BIOSIMILARS PIPELINE AND THE U.S. MARKET EVOLUTION
Ashish Dugar, Officer & Vice-President, Commercial Development, INTRA-CELLULAR THERAPIES

3:15PM – 3:45PM
Networking Break

3:45PM – 4:30PM
PANEL: REVIEW REGULATORY STRATEGIES AND INTERACT EFFECTIVELY WITH THE FDA
Bruce Leicher, Senior Vice President and General Counsel, MOMENTA PHARMACEUTICALS
Jennifer Horonjeff, Founder, Savvy Cooperative; Officer, Patient-Centered Outcomes Research, Columbia University Medical Center; Member of the Arthritis Advisory Committee and Consumer Representative, FDA

4:30PM – 5:15PM
Economics Impacts of Biosimilars
Joseph P. Fuhr, Ph.D., Adjunct Faculty, College of Population Health; Professor Emeritus of Economics, Widener University

5:15PM –
Day One - Closing Remarks

Day Two
Tuesday, September 19

8:15AM – 9:00AM
Registration and Continental Breakfast

9:00AM – 9:15AM
Chairperson’s Recap of Day One
John Coelho, Global Medical Strategy Leader, MERCK

9:15AM – 10:00AM
THE INTERCHANGEABILITY GUIDANCE AND THE OPPORTUNITY AND EFFICIENT APPROVAL OF INTERCHANGEABLE BIOLOGICS
Bruce Leicher, Senior Vice President and General Counsel, MOMENTA PHARMACEUTICALS

10:00AM – 10:45AM
CASE STUDY: KAISER PERMANENTE’S BIOSIMILAR EXPERIENCE
Ambrose Carrejo, Pharmaceutical Contracting Leader, KAISER PERMANENTE

10:45AM – 11:15AM
Networking Break

11:15AM – 12:00PM
BENCHMARK COMPLEX FACTORS TO DECIDE BETWEEN BIOBETTER VERSUS BIOSIMILAR DEVELOPMENT OPTIONS
Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety Assessment, MEDIMMUNE, ASTRAZENECA GROUP

12:00PM – 1:00PM
Luncheon
1:00PM – 2:00PM

REVIEW THE REGULATORY IMPACT OF BIOSIMILAR MARKET ENTRY: HOW GUIDANCE AND LEGISLATION IMPACTS APPROACH TO MARKET ENTRY
Patrick Lucy, Interim CEO and Chief Business Officer, PFENEX

2:00PM – 2:45PM
DISCUSS REIMBURSEMENT CONSIDERATIONS FOR BIOSIMILARS
Molly Burich, Associate Director Public Policy, BOEHRINGER INGELHEIM

2:45PM – 3:15PM
Networking Break

3:15PM – 4:00PM
UNDERSTAND THE IMPORTANCE OF PATIENT-CENTERED RESEARCH IN BIOSIMILAR DRUG DEVELOPMENT
Jennifer Horonjeff, Founder, Savvy Cooperative; Officer, Patient-Centered Outcomes Research, Columbia University Medical Center; Member of the Arthritis Advisory Committee and Consumer Representative, FDA

4:00PM –
Day TWO – Summit Closing Remarks

  • Bruce Leicher Senior Vice President and General Counsel MOMENTA PHARMACEUTICALSFind out more

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