Biotech start-ups and groups working on translational projects start out with great ideas. However, with an overall success rate of less than 5% for drug discovery projects to ever make it to the market, there are several challenges including the formal demand on quality and CMC, the obligation to comply with regulatory agencies, as well as the lack of sector-specific business knowledge and network. Also, the scalability of lab solutions is often not well understood, laboratory scientists’ interpretation of what ‘scalable’ means may be magnitudes short of what is needed for clinical production.
This event aims to address some of these challenges, generate awareness for possible pitfalls start-ups and translational groups might encounter during their exciting journey.
Several industry experts are invited to share their experience and knowledge. We are looking forward to meet you at this virtual event!
Program
14:00 – 14:25 + 5 min Q&A
Twilight Zone: Product Development by Researchers: IvD and active ingredient development from academic research – funding grants in universities and research institutes
Marcus Luther, Charité
14:30 – 14:50 + 5 min Q&A
Experience from: Prime vector technologies
Ferdinand Salomon, PVT
14:50 – 15:10 + 5 min Q&A
Experience from: THT-Biomaterials
Johannes Hackenthal, THT Biomaterialien
15:10 – 15:35 + 5 min Q&A
Process development and the landscape of Cell therapy
George White, Cytiva
20 min Bio break
16:00 – 16:25 + 5 min Q&A
Introduction into Regulatory, cGMP and aspects to consider
Melanie Sorensen & Limin Wang, Cytiva
16:30 – 16:55 + 5 min Q&A
The Future of Disease, Biotherapeutics & Biomanufacturing
Günter Jagschies, Gemini Bioprocessing
17:00 – 17:30 + 5 min Q&A
Process considerations in Downstream
Henrik Ihre, Cytiva
17: 30 – 18:00
Joint round table, final Q&A
Host: Günter Jagschies & Key notes