14th Biosimilars Congregation 2019

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

MARKET OVERVIEW & ANALYSIS

09:30 – Biosimilars : Concepts and Controversies

RISHI JAIN, Vice President, Medical, Clinical & Regulatory Affairs, India Business & ROW, Wockhardt

CHALLENGES & OPPORTUNITIES

10:00 – DISCUSSION WITH EXPERTS: Current landscape and policy updates for global biosimilars

•   Biosimilar companies ‘ market assessment – Where are we to ahead?
•   Establishing a prosperous biosimilar market for other nations around the globe in terms of accessibility, investment, competition, regulatory approach, and other facets.
•   Establishing similarity with the original medicine while finding the original molecular clone
•   Discussing on the development of biosimilar production capabilities along with overall high cost of development
•   Addressing rigorous and long regulatory paths in different nations
•   Discussing pricing approach and value management as a growing need
•   In the coming months, what topics will shape the sector, and how can players distinguish themselves?

Moderator
S.R.SALUNKHE, Former Assistant commissioner, FDA Maharashtra

Panellists
MAYUR PARMAR, Deputy Collector, Government Of Gujarat
OMPRAKASH S. SADHWANI, Former Joint Commissioner and controlling Authority, Food and Drug Administration (Maharashtra state)
HEMANT ZAVERI, General Manager Head Medical Affairs, Otsuka Pharmaceuticals
MUJTABA HUSSAIN NAQVI SYED, Team lead, Ideation, Medical Affairs, Dr. Reddy’s Laboratories
KAVYA KADAM, Consultant Global Clinical Trials

10:40 – Morning Coffee/Tea & Discussion

11:00 – DISCUSSION WITH EXPERTS: Current challenges in developing biosimilars

•   Scientific and strategic approaches taken for successfully developing of follow-on-biologics
•   Overcoming the difficulties of late clinical steps, drug safety factors and requirements for labelling
•   Focusing on multiple aspects of biosimilars product development to successfully deliver safe, potential and efficacious biologic products to the market
•   Does the industry have sufficient tools and technologies to partner and deliver services to the public sector?
•   What is the current stage of development and hindrances in fast-tracking translational research?
•   Opportunities – Models of business and investment
•   Portfolios of biosimilar products and business strategies

Moderator
PRASHANT BODHE, Director, CliniSearch

Panellists
ARUN BHATT, Consultant – Clinical Research & Development
SRIVANI MUKKAMALA, Independent Consultant
GAURAV AGARWAL, Biosimilars Program Manager, Wockhardt
HARSHAD RASANE, Associate Centralized Monitoring Lead, IQVIA
VINAYAKA SHAHAVI, Associate General Manager, Alkem Laboratories

11:50 - “Clinical strategies for global biosimilar development”

SANDEEP JAGTAP, Assistant General Manager (Global Clinical Development), Mylan Pharmaceutical

12:20 – Gateway of the Biosimilars to Puerto Rico

MAYRA GUZMAN-KASLOW, President & CEO, GK Pharmaceutical Contract Manufacturing, Operations (Puerto Rico, USA)

12:50 - Networking luncheon

13:50 – Biosimilars Perspective - Current Regulatory Scenario for Medical Devices

•   Current Market of Medical Devices
•   Why Separate regulation Required for Medical Devices?
•   Current Medical Devices Regulation of World wide.
•   Current Medical Devices Regulation in India.
•   Expectation from Govt related to Regulation.

CHIRAG BHATT, Head-Quality, MIV Therapeutics (India)

14:20 – DISCUSSION WITH EXPERTS: Discussing about the growth statistics of biopharmaceutical industry in India

•   Challenges faced in the development and production of biosimilars
•   Investigate whether pricing points are fulfilled or if other determinants need to be articulated
•   Planning of a biosimilar development project - what to consider from the very beginning?
•   Evaluate the financial development of biosimilars in the global healthcare marketplace
•   Mastering the present market movement to learn and cause biosimilar commercial success
•   Moving forward: strategies to optimise growth from a quality standpoint
•   Addressing the challenging perspectives where the development of biosimilars and generics should be addressed

Moderator
PRANJAL BORDOLOI, Vice President – Clinical, Medical Affairs & Pharmacovigilance, Veeda Clinical Research

Panellists
SAMIR KULKARNI, Director Innovation, Incubation and Linkages (Director, National Center for Nanoscience and Nanotechnology), University of Mumbai
RAJASHREE GADGIL JOSHI, Founder & CEO, ENERGYA - RSG Nutrition & Healthcare
THOMAS PHILIP, Senior Manager- Digital Strategy and Analytics, Cipla
RISHAB KAPOOR, Research Scientist, APAC Biotech
SAKHARAM GARALE, Head South-East Asia Operations ACMA & Managing Partner, RENOVARE Healthcare Solutions

15:00 – Afternoon Tea / Coffee

15:20 – Biosimilars : Hype, Hope and Beyond

•   Why Biosimilars?
•   Few must knows about Biosimilars
•   Challenges
•   The way forward
•   Conclusion

ASHOK KUMAR, President – Centre for Research & Development, Ipca Laboratories

REGULATORY

16:10 - DISCUSSION WITH EXPERTS: Biosimilars in India: Regulatory Scenario, Best foot forward

•   Biosimilars regulatory landscape: Indian perspective
•   Strategies for better regulatory expertise and cross-nation support for advance regulatory policy innovation
•   Leveraging regulatory landscape to launch biosimilars products in India
•   How the agency intends to move certain presently authorized biological products to be certified as biological products
•   Guidance and proposed rule to advance biosimilars policy framework
•   Guidelines for regulating the production process and the quality, security and effectiveness of comparable biologics
•   Aspect of Clinical Development and Safety surveillance aspects of Biosimilar
•   Key challenges in implementation of regulations

Moderator
VISHWAS SOVANI, Founder Director, Pharmawisdom

Panellists
RAHUL GUPTA, Vice President, Regulatory Affairs, USV
DEEPA ARORA, Director, CLINEXEL Life Sciences
MANISH MAHAJAN, Head- Medical Affairs, Cadila Healthcare (BU- Biologics)
ALAP GANDHI, Head, Medical Affairs, GSK
UJWALA V. SALVI, Founder & Chief Executive Officer, Nucleon Therapeutics
CHIRAG BHATT, Head-Quality, MIV Therapeutics (India)

16:50 - Chairperson’s closing remarks and end of conference