Manufacturing issues can delay drug approvals and complicate the relationship between drug firms and their contract suppliers. Following an FDA post, it was established that in 2016 the primary deficiency of several new drug applications was a failure to comply with the FDA’s current Good Manufacturing Practice (cGMPs) regulations that were designed to control product quality.
In this webinar we help you prepare for clinical manufacturing by identifying the major reasons why projects get delayed and ways to avoid them. Dr David Brett will provide tactical insights on this issue including, establishing a plan to choose primary packaging and materials, how to prepare legal documents, and guidelines for choosing a development and manufacturing partner that can offer the quality necessary for filing for approval on time.
Participation in this webinar will help you attain a practical ‘road map’ that can help shorten time to clinic while maintaining high product quality, safety and efficacy.
Dr David Brett
Product & Service-Manager
Dr David Brett, Team Leader, Product and Service Management Vetter Pharma International GmbH
Dr David Brett studied Biological sciences at the University of East Anglia in the UK. He earned an MBA at the University of Bayreuth, Germany, and a PhD in Biochemistry at Imperial College in London.
After postdoctoral positions at the Institute of cancer research, he trained at Bioinformatics with a focus on pharmaceutical drug target screening. In the Siemens Healthcare strategy and innovation department, he worked on a number of topics including protein target molecules for cancer & diabetes, e-health, personalized medicine, and molecular imaging.
David joined Vetter in 2010 as product and service manager with a focus on innovation in injectable drug-delivery systems, clinical development and commercial manufacturing. He became Team leader of Product and Service Management in 2015, and is responsible for the development of Vetter’s service offering to optimally fit customer requirements.
- Planning steps characteristic in clinical manufacturing
- Creating a plan to choose the right packaging and materials
- Getting the legal aspects right the first time
- Choosing a high-quality CDMO for clinical and scale up manufacturing
- Head of Primary Packaging Development
- Head of Drug Product Development
- Sourcing Manager Research Outsourcing
- Head of Research and Development
- Clinical Research Manager
- Manager Strategic Outsourcing
