Tuesday, 25 February 2014

08:00

Registration


Round Table Discussion - Looking Forward with Confidence to Regulatory and Commercial Success - Moderator : Dr. Ajaz Hussain

09:30

Looking Forward with Confidence to Regulatory and Commercial Success
Ajaz Hussain, Consultant, Insight Advice & Solutions LLC, United States of America

09:31

Looking Forward with Confidence to Regulatory and Commercial Success
Anthony Crasto, Principal Scientist, Glenmark Generics Limited, India

09:32

Looking Forward with Confidence to Regulatory and Commercial Success
Bharata Parayitam, Biotechnology Professional, Dr. Reddy’s Laboratories Ltd, India

10:10

Tea Break and Networking in Exhibition Area


Plenary Talk

10:30

Girish SahniKeynote Presentation

Emerging Opportunities in Bio-Therapeutics- Converting Biosimilars into Bio"Leaders"
Girish Sahni, Director, CSIR-Institute of Microbial Technology, India


Session 1 - Development of Biologics

11:10

Physical, Chemical and Biological Characterization and Similarity in Biologics
Ajaz Hussain, Consultant, Insight Advice & Solutions LLC, United States of America

11:50

Recommendation for Best Practices in Developing Bioanalytical Assays For Biologics Production, Preclinical and Clinical Programs
Arumugam Muruganandam, Mananging Director & Chief Scientific Officer, Affigenix Biosolutions Pvt Ltd, India

12:20

Taking Similar Biologics from Development to their Marketing Authorization: Technical and Regulatory challenges
Sanjay Sonar, Director, BioGenomics Limited, India

12:50

Discussion

13:00

Lunch Break and Networking in Exhibition Area


Session 2 - Biosimilars: Future Perspective

14:00

Maharaj SahibKeynote Presentation

Biosimilar Product Development- Challenges and Opportunities
Maharaj Sahib, Director, Wockhardt Ltd, India

14:40

Similar Biologics / Biosimilars : An Indian Perspective
Suresh Jadhav, Executive Director, Serum Institute of India Ltd, India

15:10

Tea Break and Networking in Exhibition Area


Session 3 - Regulatory Challenges for Biologics

15:30

US FDA Guidance and Regulatory Compliance for Biosimilars
Arvind Mishra, Joint President, Cadila Pharmaceuticals Ltd, India

16:00

US FDA Guidance and Regulatory Compliance for Biosimilars
Shrivathsa Achar, Manager, Biocon Limited, India

16:30

Closing Remarks & End of the Conference