Time to market: when clinical trial time can be decreased, what is the new time critical factor?

21/11/19

To get approval of a new biopharmaceutical drug, much time, effort and costs are spent to gather the necessary clinical trial results. However, in order to obtain regulatory approval also the chemistry, manufacturing and control (CMC) module (Module 3 – The Quality section of the CTD) is of vital importance. What should you consider at what stage during drug development? How to prevent delays in regulatory approval as a result of incomplete CMC sections? On November 21st 2019, Progress- PME will organize an event in collaboration with HollandBIO where multiple speakers will share their lessons learned on gathering the required CMC data.

Save your seat!

Speakers

• Kees Groen  (ORCA Therapeutics) Kees is a well-known biotech entrepreneur. He is co-founder and CEO of DGr Pharma, Chaiman of the supervisory board of Micreos and of Matisse Pharmaceuticals and CEO of ORCA Therapeutics.
• Pieter-Jan Vos  (Batavia Biosciences) Pieter-Jan is Sales Director Northern Europe and USA East Coast at Batavia Biosciences. Earlier he was, amongst others, acting in the field of Business Development at Julius Clinical, PCI Pharma Services and Sharp Packaging Solutions in Europe. He is specialized in developing and executing sales and marketing strategies in the biopharmaceutical contract service industry.
• Karin Hoogendoorn (ATMP expert) Karin has over 20 years of experience in the pharmaceutical industry, predominantly in the field of mAbs, (viral-based) vaccines, and cell and gene therapy products. Currently, she holds a position as scientist ATMP product development at the Leiden university medical centre, The Netherlands. Before joining the LUMC, she was senior CMC RA consultant at Quality RA and she has held several management positions in the field of regulatory CMC at Novartis, Janssen Biologics and Centocor.

Practical info

• Date: November 21st
• Time: 14.30 doors open, 15.00 program 17.00 drinks
• Venue: Centraal museum, Utrecht
• Registration: Registration is free via this link