BIOSIMILARS CONGRESS INDIA 2018
Be the first one to think different In the market of Biosimilars
The impact of two key events- a phase of unprecedented patent expiration on many of the blockbuster biologics and financial crisis demanding significant and sustained cost reductions in the healthcare market is constantly changing the global Biosimilars landscape. The biosimilar is a lucrative sector owing to recent regulatory approvals and increasing opportunities. Biosimilars are at different stages of evolution across the globe. Developing a biosimilars demands huge investment, technical capabilities and clinical trial expertise. In order to unlock the biosimilars potential, the industry will entail focused strategies along the whole value chain, from optimizing the clinical development program to commercialization.
In this limelight, CPhI Conferences is pleased to announce the 3rd Annual Biosimilars Congress India 2018 conference on 23rd - 24th August 2018 in Hyderabad. This conference will congregate top industry stalwarts to discuss key challenges and best practices from development to launch of Biosimilars.
MEET THE ADVISORY BOARD MEMBERS AND SPEAKERS
Dr. Ajaz Hussain
National Institute for Pharmaceutical Technology and Education (NIPTE)
Dr. Arani Chatterjee
Senior Vice President, Clinical Research
Aurobindo Pharma Ltd.
Dr. Anjan Selz
Vice President – Head of Biosimilars
Darshan Koticha, Ph. D.
Director- R & D
Virchow Biotech Pvt. Ltd.
Dr. Devesh Bhardwaj
Head | Biotechnology
Dr. Gurpreet Sandhu
Dr. Hanmant Barkate
Vice President & Head-Medical affairs
Glenmark Pharmaceuticals Ltd.
Dr. Himanshu Gadgil
Whole-time director and CSO
Enzene Biosciences Ltd
Dr. Maharaj Sahib
Dr. Sanjeev Gupta
General Manager and Head- Advanced Biotech Lab (Biosimilar R&D)
Ipca Laboratories Ltd.
Sarfaraz K. Niazi, Ph.D., SI, FRSB, FPAMS, FACB
Karyo Biologics and Adello Biologics
Dr. Shrikrishna Dadke
Vice President, Biopharma
Vimta Labs Ltd.
Dr. Shubhadeep Sinha
Senior Vice President & Medical Director
Dr. Srinivas Pentyala
Professor & Director of Translational Research in Anesthesiology, SARAS Coordinator, Faculty member in Urology, Health Sciences, Physiology & Biophysics
Stony Brook University Medical Center, Stony Brook, NY, USA
Dr. Sundar Ramanan
Vice President and Head -Global Regulatory Affairs
Dr. Sunit Maity
Director, Product Development
KEY TOPICS OF DISCUSSION
Dynamics of Biosimilars and its Relevance-India
Overview on Biosimilars and Prospects for the Future
Regulatory Perspective: Biosimilars
Analytical Approaches for Efficient Upstream and Downstream Process Development
Clinical Development Strategies for Biosimilars
R&D, Manufacturing and Process Development
Pharmacovigilance of Biosimilars
"How Late is Too Late": Challenges for New Entrants
Global Development Strategy on Biosimilars: How to Win in the International Space
Product Development Alliances for Biosimilars
Managing Costs and Technology Adoption in Biosimilar Development
What's next for Biosimilars: New Biological Entity/ Bio-betters
Marketing of Biosimilars: Commodity versus Differentiated
Meet Regulatory Expectations
Understand the FDA expectations on Biosimilars interchangeability and updates on the EMA guidelines for approval of Biosimilars
Explore different statistical approaches to demonstrate biosimilarity with the reference product
Panel Discussion and Extended Q&A Sessions
Open forum to discuss your most critical questions around Biosimilars
National & International Speakers
Network with national and international industry stalwarts who will inspire, educate and engage.
Practical Case Studies
Gain insights and enhance your knowledge with practical case studies addressed at this esteemed summit.
CEO's and MD [Small-scale organizations], Vice Presidents, Associate Vice Presidents, Directors, Associate Directors, HOD, Deputy General Manager, General Manager, Senior Managers, Managers, Assistant Managers, Senior Executives, Executives, Scientists
Bioanalytical, Biosimilars, Biotech, Clinical research, Manufacturing - upstream, downstream, Regulatory, Quality Assurance, Quality Control, Production, R&D