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Developing a culture of quality: from early development of novel therapeutics to market

October 26 @ 11:00 AM 12:00 PM

Many innovative ideas for novel therapeutics come out of academia. While these small companies are generally founded on scientifically sound principles, they often lack the experience, especially with regards to quality systems, needed to translate their ideas into viable product candidates. This lack of experience often results in delays, or even failures, in development.

US Pharmacopeia (USP), an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, will host a panel discussion on challenges faced by developers of novel therapeutics. Experts will discuss how to develop a culture of quality necessary to translate scientific ideas into actual product development programs and recommend best practices to accelerate success.

 Michael Hidock, Principal Consultant, QCS Services, IQVIA
 Hynda Kleinman, Senior Science Advisor/Consultant, GTreeBNT, RegeneRx, ReGenTree, Lenus Therapeutics, Polaryx Therapeutics, and Oblato
 John F. Kokai-Kun, Director, External Scientific Collaboration, US Pharmacopoeia (Moderator)
 Piergiuseppe Nestola, Senior Platform Technology Consultant, Viral-based Therapeutics Segment, Sartorius Stedman Switzerland AG
 Nadine Ritter, President/Senior Analytics Advisor, Global Biotech Experts/CASSS Board
 Wesley Workman, Principal, Workman Biotech Consultants, LLC

 Developers of novel therapeutics who want to develop a culture of quality
Personnel of start-up biotech/pharma companies, up to senior leadership level
 Academics considering starting their own companies
 Quality professionals
 Those interested in USP and our role in supporting the development of quality medicines

 Why it is essential to consider quality from the beginning of product development
 Where to begin when developing a Quality Management System
 What is expected in terms of quality by contractors, partners and regulators
 Common quality focused mistakes that novel therapeutics developers make
 How USP can help develop a culture of quality