17th Biosimilars Congregation 2022

WHY SHOULD YOU ATTEND?

Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.

Event Speakers

SUYAMBURAM S

Sun Pharma(UAE)

SAMIR KULKARNI

Institute of Chemical Technology

SHAHU INGOLE

Wockhardt

MOHIT AGARWAL

Sun Pharma

VENKAT N

Pfizer

HARSHAD K

Merck KGaA

DEEPA ARORA

CLINEXEL Life Sciences

MILIND ANTANI

Nishith Desai Associates

SANTOSH J

Bharat Serums and Vaccines

PANKAJ THAKUR

Hetero Labs

SHALU KASLIWAL

Dr. Reddy’s Laboratories

SWEETY MATHEW

Novo Nordisk

SEEMA B

Biocon

APARNA P

Wockhardt

VISHWAS SOVANI

Pharmawisdom

PRASHANT B

CliniSearch

SAKHARAM G

Renovare Healthcare

ROSHAN PAWAR

Alkem Laboratories

GAURAV A

Abbott

“Uniting industry leaders to analyze advanced commercial developments & to identify successful management strategies of Biosimilars”

Event Schedule

Meet and to network with your conference colleagues.

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

CHALLENGES & OPPORTUNITIES

09:30 – Future of Biopharma industry

KETAKI SABNIS-PRASAD, Assistant Director & Head Development Quality Assurance Biotech, Lupin

10:00 – DISCUSSION WITH EXPERTS: Biosimilars 2022 Analyzing the potential challenges

•   Biosimilars manufacturing – Expectations Vs reality
•   Future of Interchangeability – What has to be done?
•   Real world challenges in implementation of Biosimilars
•   Clinical trials and Pharmacovigilance for biosimilars – What are recent developments?
•   Reference product and the biosimilars – How to maintain the relationship?
•   Biosimilars in rare diseases: An opportunity

Moderator

VISHWAS SOVANI, Founder Director, Pharmawisdom

Panellists
SHALIGRAM RANE. Vice President & Site Head Quality, Lupin
PANKAJ THAKUR, GM, Clinical Project Management - Drug Discovery, Biologics, Hetero Labs

SHAHU INGOLE, General Manager, Head Medical Affairs, Wockhardt
ROSHAN PAWAR, Associate General Manager, Alkem Laboratories
KAVYA KADAM, Consultant Global Clinical Trials

10:50 – Morning Coffee/Tea & Discussion

MARKET ACCESS & IMPLEMENTATION

11:10 - DISCUSSION WITH EXPERTS: Unique challenges to market access for Biosimilars

•   What are the current market trends affecting the biosimilar?
•   Addressing the challenges of market implementation in biosimilar especially under post-pandemic
•   Entry strategies, countermeasures to economic impact & marketing channels
•   Key factors that impacting market and economic growth
•   New product and existing product strategies to maintaining sustainability in biosimilars

Moderator
PRASHANT BODHE, Director, CliniSearch

Panellists
RAJKUMAR MALAYANDI, Head Biopharmaceutics & Clinical Pharmacokinetics, Abbott
MOHIT AGARWAL, Head of Emerging Markets – SFE, Sun Pharma
VENKAT NATARAJAN, Heading Access Initiatives, Pfizer
SHALU KASLIWAL, Group Lead- Medical Sciences, Biologics, Dr. Reddy’s Laboratories
SEEMA BHANDARKAR, Global Program Manager Biosimilar Operations, Biocon
GAURAV AGARWAL, New Product Introduction Project Manager, Abbott

12:00 – Designing and Conducting Clinical Trials of Biosimilars - Building Operational & ScientificEfficiency

•   Evolution of the Biosimilar Regulatory Framework - Past & Future
•   Understanding Phase 3 Trial Designs
•   Biosimilar to biosimilar switching- Rationale & current experience
•   Streamlining regulatory approvals of biosimilars

DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences

12:30 – Networking luncheon

PRODUCT DEVELOPMENT

13:50 – DISCUSSION WITH EXPERTS: Future direction for product development in Biosimilars

•   Analytics - How will it help to make things better?
•   Upstream processing & Downstream processing – Risk and benefits
•   Risk of adverse effects related to new drug development. How to overcome that?
•   How to keep ensuring the balance between product development and patient safety?
•   How to speed up the process of development and reduce costs of production?
•   Product compatibility and regulatory aspects

Moderator
DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences

Panellists

MUKESH KUMAR,Senior Vice President & Head, Clinical R&D, Cipla
SUYAMBURAM SATHASIVAM, Associate Vice President, Sun Pharma(UAE)
GODHULI CHATTERJEE, Senior Medical Advisor, India – South East Asia Cluster, Sanofi

SAMIR KULKARNI, Head, Biological Sciences and Biotechnology, Institute of Chemical Technology
SAKHARAM GARALE, Founder & CEO, Renovare Healthcare Solutions

14:40 – Device and its component testing for drug device combination products

SANTOSH JADHAV, Deputy General Manager - Quality Control, Bharat Serums and Vaccines

15:10 – Afternoon Tea / Coffee

15:30– Overview of the Regulatory considerations for Novel and Biosimilar product development

•   Overview of novel and biosimilar molecule development
•   Current biosimilar landscape
•   Overview of regulatory requirements & interchangeability

SWEETY MATHEW, Regulatory Professional- Global Regulatory Affairs: CMC Rare Diseases, Novo Nordisk

REGULATORY

16:00 - DISCUSSION WITH EXPERTS: Overview of regulatory guidelines for Biosimilars

•   What are the recent developments in regulatory that impact the biosimilar industry?
•   Regulatory requirements for approval of biosimilars
•   Interchangeability and switching biosimilar: Regulatory’s view
•   Clinical-phase-appropriate regulatory compliance in the development of biosimilars
•   FDA and EU regulatory – What can be learnt from that side towards our market?

Moderator
MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates


Panellists

RAHUL GUPTA, Sr.Vice President, Regulatory Affairs, USV
DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences
HARSHAD KOTHAWADE, Director, Head of Regulatory Management & Trade Compliance India, South East Asia, ANZ, Merck KGaA
AKSHAYA ODAK, Head - Regulatory (Biotech), Lupin
APARNA PRABHUNE, Asst General Manager Regulatory Affairs, Wockhardt

16:50 – Chairperson closing remarks and end of the conference

Event Sponsors & Partners

We wouldn’t be able to host our conferences without help from these amazing companies. A huge thanks to all our sponsors and partners!

Virtue Insight

CONCEPTUALISED BY

Clocate

SUPPORTED BY

Townscript

SUPPORTED BY

Testimonials

A huge thanks to all our sponsors, attendees and partners!

Venue Details

Venue:

Hotel Kohinoor Continental

Address: Andheri Kurla Road, Andheri ( E ),
             Mumbai – 400059
             Maharashtra, India
            Phone: 022 6769 3500

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Attendee List

No attendee found
  • Date : 13 December 202223 May 2025
  • Time : 9:30 am - 5:30 pm (Asia/Kolkata)

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