MarketsandMarkets

Biosimilars Virtual Conference Time Zone - Central European Time (CET)

29th -30th September 2020

Revisiting a robust biosimilars market and following next steps towards improving biosimilars access and uptake

The Biosimilars industry is experiencing significant growth due to the rising incidence of chronic diseases and the increasing demand for biosimilars due to their cost-effectiveness.

The global biosimilars market size is expected to grow from USD 35.7 billion by 2025 from USD 11.8 billion in 2020, at a CAGR of 24.7%. However, with complexities in manufacturing and resistance from biologic manufacturers, such factors keeps adding to the hinderance in their development.

MarketsandMarkets Biosimilars- Digital Conference presents to you a virtual platform to keep your scientific exchange live. The online conference will hold discussions on key clinical attributes of biosimilars, perspectives from different stakeholders regarding opportunities for the biosimilar market, and how intense can the competition get.

The conference will also address the perspective on the global regulatory landscape and how partnerships can highly support R&D and the production of biosimilars.

Witness discussions on the importance of market access and marketing strategy and how should companies enhance their presence in the market.

WHAT TO EXPECT

  • Strategic framework and regulatory considerations
  • Key clinical attributes of Biosimilars
  • Expectations of biosimilars by different stakeholders
  • Market access and commercialization

CEO, CSO, CMO, Director, VP, Head, Manager, and Research fellows from pharmaceutical and biotech company working in:

  • Biosimilar Research
  • Biosimilar Development
  • Clinical Development Unit
  • Regulatory Affairs
  • Medical Affairs and information
  • Scientific Affairs
  • Legal Affairs
  • Market Access
  • Licensing
  • Pricing strategy
  • Clinical Pharmacology
  • Clinical affairs/clinical operations
  • Commercial Development
  • Bioanalytics

  • Learn about the recent trends and advancements affecting the biosimilars market
  • Learn about best practices for the commercial structure of a biosimilar from development to market access strategy
  • Engage in meaningful discussion with the most prominent industry experts and decision-makers from pharmaceutical and biopharmaceutical manufactures who will address most critical challenges in biosimilars upstream and downstream process
  • Opportunity to network and exchange scientific knowledge with expert speakers from leading manufacturers, global regulators, and solution providers

CONFERENCE AGENDA

Online Registration

 13:30 - 13:45

Welcome note from MarketsandMarkets

 13:45 - 13:50

Opening Remarks from the Chairperson

Michelle Bridenbaker

Michelle Bridenbaker, Senior Director, Global Medical Information Neuroscience and Biosimilars, Biogen

 13:50 - 14:00

Keynote Presentation - WHO Prequalification Process of Biotherapeutic Products and Similar Biotherapeutic Products (BTP & SBP)

Vimal Sachdeva

Vimal Sachdeva, Technical Officer (Senior Inspector), Regulation and Prequalification Department (RPQ), World Health Organization (WHO)

 14:00 - 14:30

CMC challenges in developing affordable Biosimilars

Venkata R Yeturu

Venkata R Yeturu, General Manager- Head, Analytical R&D and CMC, Lupin

 14:30 - 15:00

Biosimilar Development: Lessons Learned From Early Clinical Studies

Petra Struwe

Petra Struwe, Executive Director of Bioanalytical Services, Celerion

 15:00 - 15:30

Role of CQA assessment in streamlining biosimilar process development.

Shalini Sharma

Shalini Sharma, Senior Director, Kashiv BioSciences

 15:30 - 16:00

Understanding Biosimilar Guidance--A Fast to Market Approach

Sarfaraz K. Niazi

Sarfaraz K. Niazi, Professor Adjunct of Biopharmaceutical Sciences, University of Illinois at Chicago

 16:00 - 16:30

US Biosimilar Litigation in 2020 – Key Decisions and Trends

Tim Shea

Tim Shea, Director, Sterne Kessler

 16:30 - 17:00

General regulatory aspects of complex molecules

Sweety Mathew

Sweety Mathew, Regulatory Affairs, Biocon

 17:00 - 17:30

Biosimilar Regulations trends in LATAM - CL/PE/EC/AR

Eart J Cruz

Eart J Cruz, Senior Manager Regulatory Affairs, Teva Pharmaceticals (TBC)

 17:30 - 18:00

The Impact on Health Systems

Scott Soefje

Scott Soefje , Director, Pharmacy Cancer Care, Department of Pharmacy, Assistant Professor of Pharmacy, Mayo Clinic

 18:00 - 18:30

Closing remarks from the chairman

Michelle Bridenbaker

Michelle Bridenbaker, Senior Director, Global Medical Information Neuroscience and Biosimilars, Biogen

 18:30 - 18:35

One-to-one Networking break - virtual networking lounge

 18:35 - 19:00

End of Day 1

 19:00 - 19:00

Online Registration

 13:30 - 13:45

Welcome note from MarketsandMarkets

 13:45 - 13:50

Opening Remarks from the Chairperson

Scott Soefje

Scott Soefje , Director, Pharmacy Cancer Care, Department of Pharmacy, Assistant Professor of Pharmacy, Mayo Clinic

 13:50 - 14:00

Keynote Presentation- Role of scientific affairs and medical information supporting commercialization, value proposition and market uptake of biosimilar medicines

Michelle Bridenbaker

Michelle Bridenbaker, Senior Director, Global Medical Information Neuroscience and Biosimilars, Biogen

 14:00 - 14:30

A Comprehensive Therapeutic Strategy for COVID19 Management Through Biosimilars

Dr. Mrs. Villoo Morawala Patell

Dr. Mrs. Villoo Morawala Patell, Founder and CMD, Avesthagen Limited

 14:30 - 15:00

The Australian Early Phase Biosimilars Clinical Trial Landscape - How Agilex Biolabs and Nucleus Network Work Together

Dr Kurt Sales

Dr Kurt Sales, Director Immunoassay, Agilex Biolabs, Australia

 15:00 - 15:30

Biosimilar commercialization & legal hurdles

Kaushal Joshi

Kaushal Joshi, Director, Kashiv Biosciences

 15:30 - 16:00

Attractiveness and sustainability: Does Biosimilar market comply with these requirements?

Miguel Navarrete

Miguel Navarrete, Hospital & Biosimilars Commercial Director, STADA

 16:00 - 16:30

Attractiveness and sustainability: Does Biosimilar market comply with these requirements?

Rajesh Desikan

Rajesh Desikan, Vice President & Head, US Marketing, Oncology & Immunology Biosimilars, Fresenius Kabi, USA

 16:30 - 17:00

Panel discussion: Opportunities & Challenges for Biosimilars: Expectations from a manufacturing, regulatory & marketing standpoint

Rajesh Desikan

Rajesh Desikan, Vice President & Head, US Marketing, Oncology & Immunology Biosimilars, Fresenius Kabi, USA

 17:00 - 17:40

Solution provider presentation

 17:10 - 17:40

Closing remarks from the Chairperson

Scott Soefje

Scott Soefje , Director, Pharmacy Cancer Care, Department of Pharmacy, Assistant Professor of Pharmacy, Mayo Clinic

 17:40 - 17:45

One-to-one Networking break

 17:45 - 18:15

End of Conference

 18:15 - 18:15

SPEAKERS

Eart J Cruz

Eart J Cruz

Senior Manager Regulatory Affairs, Teva Pharmaceticals (TBC)

Kaushal Joshi

Kaushal Joshi

Director, Kashiv Biosciences

Michelle Bridenbaker

Michelle Bridenbaker

Senior Director, Global Medical Information Neuroscience and Biosimilars, Biogen

Miguel Navarrete

Miguel Navarrete

Hospital & Biosimilars Commercial Director, STADA

Rajesh Desikan

Rajesh Desikan

Vice President & Head, US Marketing, Oncology & Immunology Biosimilars, Fresenius Kabi, USA

Sarfaraz K. Niazi

Sarfaraz K. Niazi

Professor Adjunct of Biopharmaceutical Sciences, University of Illinois at Chicago

Scott Soefje

Scott Soefje

Director, Pharmacy Cancer Care, Department of Pharmacy, Assistant Professor of Pharmacy, Mayo Clinic

Shalini Sharma

Shalini Sharma

Senior Director, Kashiv BioSciences

Venkata R Yeturu

Venkata R Yeturu

General Manager- Head, Analytical R&D and CMC, Lupin

Dr. Mrs. Villoo Morawala Patell

Dr. Mrs. Villoo Morawala Patell

Founder and CMD, Avesthagen Limited

Vimal Sachdeva

Vimal Sachdeva

Technical Officer (Senior Inspector), Regulation and Prequalification Department (RPQ), World Health Organization (WHO)

Petra Struwe

Petra Struwe

Executive Director of Bioanalytical Services, Celerion

Sweety Mathew

Sweety Mathew

Regulatory Affairs, Biocon

Tim Shea

Tim Shea

Director, Sterne Kessler

Raja Selvam

Raja Selvam

AGM - Biosimilars Strategy, Market Intelligence & Commercial Performance, Mylan, India

SPONSORS

Celerion
Proteome Sciences
Serva
sternekessler

PARTNERS

Biosimilars Review & Report

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