13th Biosimilars Congregation 2019

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.

09:20 – Chairperson opening remarks

LOUIS BOON, CSO, Bioceros

PATIENT VIEWPOINT

09:30 – How to make Research& Healthcare better; The patient viewpoint

•   Market Overview & Current Trends.
•   Process Intensification and Accelerating Time-to-Market.
•   Novel Assay Approaches to Establish Bio-similarity

ROBERT A. JOHNSTONE, Board Member, International Alliance of Patients Organisations

10:10 – “Biosimilars and policies that help uptake or not”

SUE NAEYAERT, VP Global Government Affairs, Policy and Pharmacoeconomics, Fresenius Kabi SwissBioSim

10:50 – Morning Coffee/Tea & Discussion

BUSINESS MODELS

11:20 – Biosimilars: Are biologics becoming a commodity? A medical perspective.

•   What is needed (efficacy, safety), how to differentiate?
•   The challenges of not being the first biosimilar on the market: how to tackle?
•   Interchangeability, Education of physicians, Real world evidence data generation, Tender dossiers
•   Strategic thinking: biosimilars, a final destination or the beginning of the journey?

CHRISTIAN AGBOTON, Sr Global Brand Medical Director - Global Medical Affairs, Takeda
JOSEPH SALAMEH, Medical Lead, Alnylam Pharmaceuticals

12:10 – The Biosimilar uptake of biosimilars in Denmark. What’s the secret?

•   The uptake in Denmark of biosimilars has been both very high and also extremely quick.
•   Involvement of many different stakeholders has played a very important roll.
•   What can anybody learn from Denmark and will it be possible to copy?

DORTHE BARTELS, Senior Strategic Advisor, Amgros

12:50 - Networking luncheon

CLINICAL

14:00 – What Physicians’ want to know about Biosimilars

•   Current level of understanding of biosimilars among different Specialities of physicians
•   Need gap of understanding Biosimilars among Physicians
•   Understanding of Chemical vs Biologics/Biosimilars, Biosimilarity: Totality of Evidence, Rationality of extrapolation of data, Interchangeability, Regulatory approval process etc.

HANMANT BARKATE, Vice President & Head Medical Services, (India, MEA), Glenmark (India)

14:40 – Using SPOT™ and SLIM™ technology and upstream process modulation to reduce cost of goods of biosimilars

•   Increase specific productivity using SPOT™
•   Increase specific productivity and biosimilar product quality using upstream process modulation
•   Reduce process issues using SLIM™
•   Reducing cost of goods of biosimilars

LENNEKE DE WINTER, USP Director, Bioceros

15:20 – Afternoon Tea/Coffee

REGULATION OVERVIEW & UPDATE

15:40 - Panel Discussion: The developing regulatory frame work in advanced and developing markets

•   Market and regulatory developments in the Europe and globally
•   Predicting the post Brexit changes in biosimilars regulation in UK
•   EMA’s act on switching & interchangeability?
•   How regulators, payers and policy makers take initiatives to make healthcare more sustainable
•   Collaboration with HTA’s for patients benefit
•   CMC regulatory considerations for Biosimilar products development
•   Regulatory changes necessary to maximize biosimilars potential
•   The way forward

Moderator
LOUIS BOON, CSO, Bioceros

Panellists
CORNELIA ULM, Independent Consultant, Biotec Regulatory Consulting
LIZ POLLITT, Director, BPCRCS
GEORGIA GAVRIILIDOU, Counsel, Food, Drug Medical Device Regulatory Life sciences, Sidley Austin LLP

16:20 - 16:30 – Chairperson’s closing remarks and end of 13th Biosimilars Congregation 2019 conference