Meet Sterility/Stability Requirements and Reduce Costs/Timelines With Compounded Batch IP
A research pharmacy meeting state, federal and USP 797 high risk standards is an acceptable alternative to GMP that has been approved by the FDA in batch investigational product (IP) production. As a result, a potentially cost-effective solution for sponsors is to employ a Phase I trial unit with an on-site pharmacy meeting those standards that is experienced in non-sterile to sterile compounding.
This webinar examines the certification requirements of such a research pharmacy and the options for sponsor companies to consider in protocol design and site selection. What are the right questions to ask? How can sponsors determine the capabilities and competency of service providers? The potential for sponsors to cut costs and accelerate timelines by using an on-site research pharmacy will be discussed. There will also be a live Q&A at the conclusion of the presentation.
DaVita Clinical Research is a Phase I clinical trial unit that has conducted more than 20 clinical protocols in which IP production has been accomplished by batch compounding conducted in their on-site pharmacy meeting state, federal and USP 797 high risk standards.
Register today to learn how Phase I clinical trial units with on-site pharmacy capabilities in non-sterile to sterile compounding may benefit your next trial.
Presented by
Harry Alcorn, PharmD,
Early Clinical Scientific Officer
Harry has 20+ years of leadership experience in clinical pharmacology and bulk compounding experience in meeting USP 797 High Risk certification, including process validation, clean rooms, and equipment. He oversees DCR’s two onsite, state-licensed USP 797 high risk certified pharmacies, and serves as an executive liaison with clients conducting trials at DCR’s Phase I trial units. Harry has faculty appointments at multiple universities.
John J. Koleng, Ph.D., R.Ph.,
Partner, AlphaVektor, LLC
Principal, Regulatory Compliance Initiatives, Inc.
John has 15+ years of experience in the scientific, operational, and business arenas of pharmaceutical drug delivery, product development and manufacturing. He is a co-founder and partner at AlphaVektor, LLC, a life sciences development consultancy focused on product development, manufacturing, scale up, commercialization, and supply chain management and is also a Principal in the consulting firm Regulatory Compliance Initiatives, Inc. (RCI).