Conference Program


Day 1

8.30 - 9.30

Registration & Refreshment

9.30 - 9.40

Chairperson's opening remarks
Dr Shelley Gandhi - Chairperson
Director - Pharmacovigilance and Drug Safety
NDA Group AB

9.40 - 10.25

Chronicles of a Biosimilar Production Facility
Dr Sébastien Ribault
Director Provantage Biodevelopment/ End to End Delivery,
Merck, France

10:25 - 10:55

The challenges in developing monoclonal biosimilars

  • The key characteristics of monoclonals

  • Risk assessment of differences in quality attributes

  • Challenges in clinical development

  • Dr.Cecil Nick

    Vice President,Parexel

    10:55 - 11:15

    Morning Coffee/Tea & Networking

    11:15 – 11:45

    Role of Medical Affairs in Biosimilars

  • Brief overview of the role of Medical Affairs in innovative pharma

  • Differences and specific challenges for Medical Affairs in biosimilars

  • Will there be a role to play for Medical Affairs in biosimilars in 3 years?

  • Dr Karsten Kissel

    Head Global Medical Affairs Biosimilars, Boehringer Ingelheim Germany

    11:45 – 12:15

    Designing Effective Structural & Physicochemical Biosimilar Comparability Studies
    Dr. Richard Easton
    Technical Director - Structural Analysis, BioPharmaSpec

    12:15 – 12:45

    Challenges in Pharmacovigilance for Biosimilars: Where are we?

  • Focus on current regulatory requirements/guidance on pharmacovigilance

  • Hot topics: Interchangeability, Immunogenicity, Traceability

  • Safety monitoring of biosimilars: During Clinical Development and Postmarketing phases

  • Dr Niraj Chhaya

    Boehringer Ingelheim GmbH

    12:45 – 13:45

    Networking luncheon

    13:45 – 14:15

    PV in Biologics

  • Unique properties of biologics and how they influence the safety profile

  • Importance of Traceability

  • Making it work – legislation and guidance

  • Catherine Akers,

    Senior Regulatory Affairs Manager,

    AMGEN

    14:15 – 15:15

    Panel Discussion - Biosimilars - Safety and Clinical Aspects, Market
    Considerations and Development of Biosimilars

  • How safe are Biosimilars: Current Positive Trends in Biosimilars,

    Development and Medical Experience

  • Biosimilars Growth: Implications for Safety and Risk Management

  • Important Development of Biosimilars over the next two years

  • European & US Market Considerations and Guidelines:

    State of Today’s US & European Biosimilars Market Impact on the Future of Biosimilars

  • Dr.Shelley Gandhi, Director, NDA Regulatory

    Dr.Steinar MADSEN, Director, Norwegian Medicines Agency

    Dr.Karsten Kissel, Head Global Medical Affairs Biosimilars, Boehringer Ingelheim

    Dr.Gopalan Narayanan, Vice President, Disruptive Biologics, VCLS

    15:15 – 15:45

    Time to treat Biosimilars as Biogenerics
    Dr Steinar Madsen
    Medical Director, Norwegian Medicines Agency

    15:45 – 16:15

    Afternoon Tea/Coffee

    16:15 – 16:45

    The last hurdle? : Management and strategies for preparing a biosimilar dossier

  • General strategies for the dossier and approaching the centralised procedure

  • Structure and function: biosimilarity, comparability and the abbreviated dossier

  • Supporting indications and extrapolation

  • Dr. Christopher Mann Ph.D,

    Scientific & Regulatory Affairs Manager,
    Asphalion

    16:45 – 17:00

    Chairperson’s closing remarks
    Dr Shelley Gandhi - Chairperson

    Director - Pharmacovigilance and Drug Safety
    NDA Group AB

    17:00 - 18:30

    Networking Reception

    Day 2

    8.30 - 9.30

    Registration & Refreshment

    9.30 - 9.40

    Chairperson's opening remarks
    Dr Shelley Gandhi - Chairperson
    Director - Pharmacovigilance and Drug Safety
    NDA Group AB

    9.40 - 10.25

    Development Strategies

    Biosimilars - Opportunities and Challenges from a Market- and Patient Access Perspective

  • What are the areas of differentiation amongst biosimilars?

  • What are the potential barriers for switching?

  • Does differentiation vs originator make sense?

  • Dr Thomas Hasmann Ph.D

    Vice President and Solution Lead Market Access,

    HighPoint Solutions, Switzerland

    10:25 - 10:55

    Harnessing the power of the network to deliver biosimilar clinical trials within the NHS

  • Exploring the clinical research landscape within the NHS

  • Insight into the NIHR clinical research network (CRN) research delivery arm of NHS England

  • Understand the breath and depth of the free services available to companies delivering trials

  • Divya Chandha Menak

    Head of Business Development

    NIHR Clinical Research Network Coordinating Centre UK

    10:55 - 11:15

    Morning Coffee/Tea & Discussion

    11:15 – 11:45

    10 year Perspective: Science and Commercial Power - Battle of the Giants in Biosimilars
    Dr. Richard Littlewood
    Chief Executive Officer
    Applied Strategic

    11:45 – 12:15

    Clinical Trial Strategies and New Guidelines
    Dr Mourad Farouk Rezk MD
    Global Head Medical Affairs Biosimilars Biogen Idec, Switzerland

    12:15 - 12:45

    Challenges of Signal Detection in Biosimilars

  • Signal management in Biosimilars - Is it different?

  • Challenges in Data Mining

  • Qualitative Vs Quantitative Assessments

  • What to monitor as DME, TME in Biosimilars

  • Dr Pipasha Biswas

    Vice President, Pharmacovigilance/

    pharmacoepidemiology & Late Phase RWE, Symogen

    12:45 – 13:30

    Networking luncheon

    13:30 – 14:30

    Panel Discussion:-
    Why does the biosimilar market fail to meet the expectations? Hurdles and way forward

  • Regulatory and Legislative barriers,

  • Limited number of players in the field

  • Reasons for low commercial success

  • Meeting commercial requirements

  • Competition with established drugs and biologics

  • Suspicious patients- how to gain the confidence of patients

  • The challenges of safety monitoring

  • Dr Thomas Hasmann Ph.D

    Vice President and Solution Lead Market Access,

    HighPoint Solutions

    Dr Beat Flühman

    Global Regulatory Science Leads & Director

    Vifor Pharma

    Dr Pipasha Biswas,

    Vice President, Pharmacovigilance/

    pharmacoepidemiology & Late Phase RWE, Symogen

    14:30 – 15:00

    Interchangeable Biosimilars and Biobetters

    Benefits and Concerns of Interchangeable Biosubstitutes and Post Authorization Monitoring.
    Dr Devrim Satik
    Country Regulatory Head
    SANOFI Turkey

    15:00 – 15:30

    Challenges in Assessing Therapeutic Equivalence of Nano-Similars

    Dr Beat Flühmann
    Global Regulatory Science Leads & Director
    Vifor Pharma, Switzerland

    15:30 – 16:00

    Afternoon Tea/Coffee

    16:00 – 16:45

    Challenges in Biosimilar development: Safety perspective
    Dr Oleksandr Karpenko
    Managing Director, Olexacon

    16:45 - 17:00

    Chairperson’s closing remarks and end of conference
    Dr Shelley Gandhi - Chairperson
    Director - Pharmacovigilance and Drug Safety
    NDA Group AB