Connecting Pharmaceutical Knowledge

Commissioning & Qualification in Cell Therapies

The CQV Benelux organises it’s very first webinar. Get to know the new CoP, learn about the Cell Therapies landscape and find out what challenges these technologies bring to the field of commissioning and qualification.

Speakers:

  • Tim Vertongen (Chair ISPE CoP Benelux / Managing Director Sales & Finance at Trevalco): introduction ISPE CQV COP
  • Markwin Velders (Managing Director and Owner at Prime Life Science): introduction to the cell therapy landscape
  • Philip Foley (Director of Quality Engineering (EU) at Kite Pharma: C&Q challenges in cell therapy
  • Q&A

Attending the webinar is free for ISPE members. Non-members have to pay a fee of only €10,-. Registration is required.

Special thanks to our sponsors:

  • Trevalco
  • Adryan Consulting

Event Properties

Event Date 20-Jan-2022 15.00
Capacity 100
Registered 63
Individual Price €10.00

Agendas

15:00

Welcome & Introduction

15:05

Tim Vertongen – Introduction ISPE CQV COP

The ISPE CQV COP Benelux was founded in 2021 and this webinar is the first event presented. Tim will provide more insight in the CQV COP, it’s function within ISPE and the goals the steering committee has set forward.

15:30

Dr. Markwin Velders – Introduction to the cell therapy landscape

Dr Velders will provide an overview of the current status of the cell therapy with a focus on cancer. The CAR-T therapy that is most advanced and some are even approved for commercial treatment will be highlighted as well as its efficacy in patients. The amazing results also bear challenges for improvements. These challenges will be discussed together with the future opportunities and developments in the field of cell therapy.

16:00

Philip Foley – C&Q challenges in cell therapy

Philip will focus on the challenges encountered during the process of upscaling to manufacturing. Many challenges are common with other industries while others are specific to the new technology.

16:30

Q&A

17:00

Closure

Speakers

Tim Vertongen

Chair ISPE CoP Benelux / Managing Director Sales & Finance at Trevalco

Tim Vertongen is a passionate life science professional with almost 20 years of experience. He started his career at Alcon (now part of Novartis) before entering consultancy. Tim has performed multiple projects in Belgium and the Netherlands at several clients with extensive periods at Pfizer and Prothya BioSolutions. He’s an all-round professional with experience in CSV, Engineering, CQV and QA. Currently Tim is Managing Director Sales & Finance at the life science consultancy company Trevalco and he uses his network and knowledge to support the sector as Board Member of the ISPE Belgium Affiliate vzw and Chair of the ISPE CQV COP.

Dr. Markwin Velders

Managing Director and Owner at Prime Life Science

Markwin Velders is an independent entrepreneur and consultant with 25 years of experience, working in the fields of research, development, operations and management. He was awarded a PhD in Molecular Immunology from Leiden University in the Netherlands. After transferring from the US academical to the Dutch biopharmaceutical sector Dr Markwin Velders served, among several other management positions, as Chief Scientific Officer at Dutch biotech company AM-Pharma, with responsibility for R&D and pre-clinical development. In 2013 he consulted to the Dutch biotech T-Cell Factory (TCF) where he played a key role in the acquisition of the company to form Kite Pharma EU B.V. Markwin joined Kite, now a Gilead company, as VP Operations and managing director in 2015. He managed the research and development of novel immune receptors against tumors alongside managing the realization of Kite’s new manufacturing facility for cell therapy in the Netherlands. Markwin was chairman of the board of HollandBio, the branch association for Biotech in the Netherlands. He serves as supervisory board member at ISA Pharmaceuticals and Amarna Therapeutics, advisory board member at Achilles Therapeutics, Thuja Capital and Necstgen BV and he is an Entrepreneur in Residence at Oncode.

Philip Foley

Director of Quality Engineering (EU) at Kite Pharma

Philip Foley is the Quality Engineering Director at the Kite Pharma T-Cell Factory (TCF04) based in Hoofdorp. Originally an electronics and software engineer Philip began his career in Pharma Validation/Quality in 2007 working for Johnson and Johnson and MSD in Ireland. In 2012 Philip moved to the Netherlands where he worked on a broad range of projects for Abbot, Sanquin, Uniqure, and Kiadis before joining Kite Pharma as QE Director in 2018. In his role as QE Director Philip was responsible for Quality oversight during the commissioning, qualification and validation phase of the TCF04 factory build. Subsequently he has developed the QE team at TCF04 to support ongoing operations and projects with a focus on Quality Risk Management at the site.

Sponsors

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