SUMMARY
Why Knowledge Management is Important for Virtual Companies
A 60-minute panel discussion of cross-industry experts will share their unique perspectives on WHY and HOW virtual companies need to understand and manage the details of their product and process development, even when outsourcing the development activities to a CDMO/CMO.
Drug sponsors, practitioners, regulatory professionals, pharmaceutical executives, academics, and other interested parties will gain an understanding of the activities you need to manage as the sponsor, what information is important to capture and manage, and how to manage the overall “data” relationship with your CDMO/CMO.
PERSPECTIVES BY
Attendees will learn:
How structured data frameworks simplify the process of communication and the exchange of data with your CMO
Best practices for sharing and receiving information from CMO
Practical tips for making CMO relationship management easier
BIOS
Meet the Moderator
Adam Lambert, PhD
Vice President, Product & Process Development, Pharmatech Associates
Dr. Lambert has 20+ years of experience in drug and device development. His experience includes device/drug combination products, vaccines, monoclonal antibodies, recombinant proteins, peptides and small molecules for parenteral, pulmonary, solid oral, topical and transdermal dosage forms.
He has expertise in Quality by Design with specific emphasis on designing and leading Risk Based QBD activities for ANDA, NDA, BLA, PMA and MDD applications. He has executive leadership experience and expertise in CMC strategies small, large, and complex large molecule modalities and in developing, formulations, processes (upstream and downstream) and analytical methods for products at all phases of drug and device development lifecycle.
Dr. Lambert’s participation in academic/industry/regulatory agency collaborations throughout his career has resulted in multiple grant awards supporting the development of novel products and therapeutics. He has unique experience in having supported both development and commercial manufacturing on the drug/product sponsor side of the development process as well as from a contract service provider’s perspective.
BIOS
Meet the Speakers
Bikash Chatterjee
CEO, Pharmatech Associates
Mr. Chatterjee, Chief Executive Officer for Pharmatech Associates, has more than 30 years of experience
in the pharmaceutical, biosciences, medical device/diagnostic, and nutraceutical/dietary supplement
industries.
He has guided the successful approval of over a dozen products across U.S. and Europe and is
a frequent speaker at industry events.
Mr. Chatterjee is a regular contributor to various internationally
recognized industry journals and sits on several scientific advisory boards for pharmaceutical and
medical device companies.
Yash Sabharwal, PhD
CEO and President, CherryCircle Software
Yash Sabharwal is co-founder, President, and CEO,of CherryCircle Software. He is a successful serial entrepreneur. He has over 20 years of experience in the life science industry.
He was previously co-founder and Chief Operating Officer at Xeris Pharmaceuticals. It was in this role that he crafted the vision for CherryCircle Software and the development of the QbDVision platform.
Yash has a B.S. in Optics from the University of Rochester and a M.S. and Ph.D. in Optical
Sciences from the University of Arizona.
WEBINAR
Why Knowledge Management is Important for Virtual Companies
WEBINAR
Why Knowledge Management is Important for Virtual Companies
April 6th, 2021 | 1:00pm EDT | 05:00pm GMT
Format: Panel Discussion