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2nd Annual Gene and Cell Therapy: Quality Developments to Commercialization Virtual Summit

  • 26th – 27th October 2020
  • Zoom flag Zoom
  • ONLINE

We are excited to be hosting the 2nd edition of our Gene and Cell Therapy: Quality Developments to Commercialization Virtual Summit and look forward to meeting you online in the fast-growing center for knowledge, research, and innovation.    

This is the perfect place to take part in exciting presentations while networking and connecting online with speakers and delegates. Together you can address the key burning issues and innovative approaches. Learn more about the delivery of cost and quality efficient process development, manufacturing and commercialization of cell and gene therapies, and much more. 

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About

This premier B2B event provides the appropriate platform to engage and discuss ideas with your fellow peers while facilitating a professional atmosphere and environment for good company representation and development. The Summit will shed light on the delivery of cost and quality efficient process development, manufacturing, and commercialization of cell and gene therapies. It is an honor and privilege to invite you to participate in this Summit.

Who Should Attend

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specializing in: 

  • Advanced Therapy Production
  • Analytical
  • Biotherapeutics
  • Cell Engineering
  • Cellular Immunotherapy
  • Clinical Development
  • Gene Therapy
  • GTMPs (Gene Therapy Medicinal Products)
  • Health Economics
  • Immuno-Oncology
  • Immunology Chemistry
  • Legal/IP
  • Market Access
  • Oncology
  • Pricing
  • Quality Control
  • Regenerative Medicine
  • Safety
  • Stem Cell
  • Tissue Therapy
  • ATMP (Advanced Therapy Medicinal Product)
  • Bioprocessing
  • CAR-T
  • Cell Therapy
  • Cellular Therapy
  • CMC
  • GMP
  • CBMPs (Cell-Based Medicinal Products)
  • Immune Deficiencies
  • Immunology
  • Immunotherapy
  • Manufacturing
  • Medical
  • Precision Medicine
  • Process Development
  • R&D
  • Regulatory
  • Sales
  • Supply Chain

Reserve your seat!

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

Key Practical Learning Points

  • Optimized cell and gene therapies process development, manufacturing, cost, and quality efficiency towards successful commercialization
  • CMC technical and regulatory compliance to empower cell and gene therapy products development roadmap
  • Emerging science and technologies to enhance cell and gene therapies development
  • Robust supply chain design for precision medicine therapies
  • Advanced analytical approaches to improve quality control and real-time release

Reserve your seat!

Dr. Rajesh Thangapazham, US

Head of Regulatory Strategy & Innovation, Cell & Gene Technologies

Lonza Pharma Biotech & Nutrition

Dr. Rajesh Thangapazham is a regulatory affair professional with over 10 years of experience and specialisation in regenerative medicine and cell and gene therapies. He is currently the head of regulatory strategy and innovation at the cell and gene technologies unit of Lonza Pharma Biotech & Nutrition.

Raj has a bachelor’s in pharmacy, a Master of Engineering, and a PhD in biotechnology. His training includes postdoctoral fellowship, staff scientist tenure, and research assistant professorship at the US Department of Defence, where he advanced regenerative medicine and was actively involved in the preclinical development of cell and gene therapies. 

With a background in biotechnology commercialisation, intellectual property creation and considerable experience in orphan drug development, Raj joined and has supported sponsor’s CMC sections of regulatory filing, regulatory briefing documents, registration/licenses for Lonza’s establishments as well as lifecycle management of drug master files for facilities, cell banks, and donor programs. 

Raj has also provided regulatory support to Lonza’s innovative technologies, such as induced pluripotent stem cell technology, automated and closed-cell processing systems, and single-use disposables.  

Chaminda Salgado, UK

Scientific Leader Cell & Gene Therapy Platform CMC Platform Technology & Sciences

GSK

Alex Klarer, US

Head of Cell Therapy Development

Biocentriq

Alex Klarer is Head of Cell Therapy Development in Biocentriq. He was a senior engineer in Hitachi Chemical Advanced Therapeutic Solutions’ (HCATS) innovation and engineering group. The mission of the I&E group is to investigate new technologies and capabilities across the bioscience landscape with the goal of increasing patient access to cell and gene therapies. Since joining HCATS in 2017, Alex has worked on a wide array of projects including T-Cell culture platforms with a focus on dynamic 3D methods, novel transfection methods, label-free selection methods, supply chain security, and GMP assay qualification. Prior to joining the team at HCATS, Alex worked at Genentech on their tocilizumab and rituximab products.

Dr. James Wang, US

Global Quality Auditor, Cell & Gene Therapy

Novartis

Since 2018, Dr. James Wang has been the global quality auditor in cell and gene therapy at Novartis. From 2011-18, he worked in QA and operation management, cell therapy and MSKCC. James received his PhD from the Hebrew University of Je­rusalem.

Dr. Peter de Haan, NL

CSO & Co-Founder

Amarna Therapeutics BV

Peter has a biology background and has been active in R&D for thirty years. His aca­demic career started as a Virologist at the Wageningen University in The Netherlands, where he obtained his PhD in 1991. In 1991 he joined Novartis Seeds where he held several research management positions in the field of plant biotechnology. He is a co-founder of Phytovation B.V., formerly active in biopharmaceuticals and vaccine production, and of its subsidiary Viruvation B.V., which was active in developing a therapeutic AIDS vaccine. Peter is founder and CSO of Amarna Therapeutics a gene and immunotherapy company based in Leiden, the Netherlands. He developed Ama­rna’s SVac viral gene delivery vector platform derived from the macaque polyomavirus SV40. Because of its non-immunogenicity in humans the SVac platform is unique in its capacity to develop effective treatment for genetic disorders and degenerative/in­flammatory/autoimmune diseases. Throughout his career Peter has worked on appli­cations of virus-associated technologies. He has a long-standing expertise in virology, molecular biology, immunology, cell biology and is highly experienced in molecular cloning activities, tissue culture of mammalian cells and production of (recombinant) virus particles in mammalian cell systems. Peter has an H-index of 35, wrote more than fifty peer reviewed scientific articles and is (co-) inventor of more than fourteen different awarded patents and patent applications.

Sarah Thomas, US

Vice President of Quality

REGENXBIO

Sarah Thomas is the VP of quality at REGENXBIO, responsible for the quality as­surance and analytical development/quality control organisations. She has over 30 years’ experience in pharmaceutical and biotech quality. She has experience working with products at all phases of development, from early clinical phases to commercial distribution. She has led quality teams through the transition from clinical to commer­cial operations, and multiple product approvals. Sarah received an MBA from George Washington University and a BSc in chemistry from Butler University.

Dr. Wenliang Dong, NL

Chief Operational Officer

ORCA Therapeutics BV

Wenliang Dong has over 15 years of life science experience. He has worked 10-plus years in the pharmaceutical industry in R&D, manufacturing, preclinical development and management. As COO at ORCA Therapeutics BV, he manages internal and ex­ternal operational activities related to the development of ORCA’s technology from R&D to clinical development. Wen holds a PhD from the University of Leiden, and he previously worked at the German Cancer Research Centre (DKFZ, Heidelberg) as well as the International Agency for Research on Cancer (IARC, WHO, Lyon). He worked at Sanquin Plasma Products BV as project leader at the CMO division and was a member of the management team of pharmaceutical services.

Dr. Christiane Niederlaender, UK

Director

AMBR Consulting Ltd

Christiane Niederlaender has spent more than 12 years in medicines tissue, cell and gene therapy regulation. She spent eight years with the MHRA, where she worked until August 2019, assessing all groups of biological medicines and managing the biologicals unit.  

Christiane was the UK representative at the EMA committee for advanced therapies (CAT) and the rapporteur/co-rapporteur/CMC assessor for several ATMPs. She acted as the rapporteur for the EMA gene therapy guideline and was drafting group member for many other CAT guidelines.   

Prior to joining the MHRA, Christiane worked for the UK competent authority responsible for the European tissues and cells directive as an assessor and inspector. She has a PhD and research background in cell-signalling, cancer, and stem cells and obtained a law degree in 2005. 

Karsten Hendriks, DE

Business Development Manager

SCIEX, CE EMEAI

Karsten Hendriks obtained his Diploma in Chemistry and Biotechnology at the Niederrhein University of Applied Sciences in Germany in 1994. He has worked for Beckman Coulter™ in various customer supporting roles for over 19 years. In 2014 he started to work for SCIEX as a Sales Support Specialist for Capillary Electrophoresis. He has over 24 years’ experience in supporting analytical solution.

Karsten is currently the EMEA CE Business Development Manager of SCIEX. He provides technical advice and supports the development of new applications in the area of CE and CE-MS.

Dr. Simon Briggs, CH

Sr. Technical Product Steward, Cell & Gene Therapy

Dr. Simon Briggs is the senior technical product steward for Kymriah, at Novartis, sup­porting the successful launch of Kymriah for PedALL and DLBCL patients in Europe, as well as global manufacturing data and process analytics initiatives. Simon entered the world of cell and gene therapy nearly 20 years ago through PhD and postdoctoral research on polymeric materials for viral and non-viral gene therapy vectors at the Uni­versity of Oxford. However, after 6 years as an academic researcher, it was clear that these technologies were not mature enough to penetrate into the commercial space so Simon made the switch from academic research to industry. He started his indus­trial journey at UCB Pharma in the process analytics team supporting high throughput biologics process development and novel analytics to support late and early phase projects. Simon continued to extend his experience in the commercial drug product manufacturing of biologics and small molecule-based products at Biogen, where he was responsible for setting up in the process analytics data platform supporting OPV for external manufacturing.

Dr. Jef Pinxteren, BE

VP Operations

Promethera Biosciences

Dr. Jef Pinxteren obtained his PhD in biochemistry at the University of Antwerp in 1994. With a long-term EMBO fellowship he moved to the UK to study the role of G-proteins in secretion from granulocytes. This was in the group of Bastien Gomperts and Peter Tatham at University College London. After his fellowship he obtained further funding from the Medical Research Council (MRC) and the Wellcome Trust. In both 1999 and 2000, he received a UCL Bogue fellowship to work in the US with Vytas Bankaitis, first at UAB in Alabama, later at Chapel Hill in North Carolina. In this project a mouse ES cell model was used to establish a role for phosphoinositol transfer protein (PITP) in secretion from granulocytes. In 2000, he returned to Belgium and he joined the group of Jean Plum and Bart Vandekerckhove at the University of Gent for a project on cord-blood derived stem cells. He started work on human MAPC and collaborated with Catherine Verfaillie in Minneapolis. In 2004, he started to perform proteomics on human MAPC and moved to the VIB (Flemish Institute of Biotechnology), where he joined the group of Joel Vandekerckhove and Kris Gevaert. In 2006, he moved to the newly formed Stem Cell Institute Leuven under Catherine Verfaillie and worked with Athersys (Cleveland, Ohio) to set up the daughter company ReGenesys. In May 2007, he started to work as head of R&D at ReGenesys. With support from the EU Framework Program and IWT, the R&D support agency of the Flemish government, he built out ReGenesys to a 17-person research team. The focus of the team is de­veloping a xeno-free version of the MultiStem® product and alternative, compact and more economical ways of expanding the product for clinical production. In November 2016, he moved to Promethera Biosciences, where cell therapies for liver diseases are being developed. He started as director of preclinical and product development in the R&D department and then became director of process development in the operations department and later took the whole operations responsibility worldwide.

Alfred Luitjens, NL

Global Technical Director

Batavia Biosciences

Alfred Luitjens has a profound background in development and production of vac­cines, with more than 30 years of experience. He worked for research & development at Solvay, DSM Biologics and Crucell. He had a management position at the Animal Science Group and was senior manager process architecture at GSK.

Jørn Remi Henriksen, NO

Field Application Manager

ArcticZymes Technologies

Jørn Henriksen has more than 15 years of experience in Life Science. Since 2011 he has worked at ArcticZymes Technologies both as a scientist and leading internal teams when developing methods for enzymatic purification of various biological materials. He also has extensive experience in guiding external partners in implementing enzymatic purification methods in their processes and platforms. Over the last year he has focused on how enzymes with novel features can be used to simplify purification of protein-based products in bioprocessing, e.g. viral vectors, vaccines and other biomolecules.

 

Dr. Nicolas Brauckhoff, DE

Head of Biotherapeutical Analytics

Protagen Protein Services GmbH

Stefano Baila, IT

Director of Operation and BD

Anemocyte

Stefano Baila received his PhD in 2007 based upon translational research and development of gene therapies for hemophilia at the Children’s Hospital of Philadelphia.  Since that time he has been actively involved in the process development and manufacturing of advanced therapeutic medicinal products through business development and strategic marketing roles at Areta International, a CDMO, and by leading field implementation and commercialization activities for the cell processing unit of Terumo BCT.  Stefano also worked as Industrialization Manager at Celyad where he led process development and automation efforts for CAR-T. Now he serves as Director of Operation and BD for Anemocyte 

 

Dr. Rajesh Thangapazham, US

Head of Regulatory Strategy & Innovation, Cell & Gene Technologies

Lonza Pharma Biotech & Nutrition

Chaminda Salgado, UK

Scientific Leader Cell & Gene Therapy Platform CMC Platform Technology & Sciences

GSK

Alex Klarer, US

Head of Cell Therapy Development

Biocentriq

Dr. James Wang, US

Global Quality Auditor, Cell & Gene Therapy

Novartis

Dr. Peter de Haan, NL

CSO & Co-Founder

Amarna Therapeutics BV

Sarah Thomas, US

Vice President of Quality

REGENXBIO

Dr. Wenliang Dong, NL

Chief Operational Officer

ORCA Therapeutics BV

Dr. Christiane Niederlaender, UK

Director

AMBR Consulting Ltd

Karsten Hendriks, DE

Business Development Manager

SCIEX, CE EMEAI

Dr. Simon Briggs, CH

Sr. Technical Product Steward, Cell & Gene Therapy

Dr. Jef Pinxteren, BE

VP Operations

Promethera Biosciences

Alfred Luitjens, NL

Global Technical Director

Batavia Biosciences

Jørn Remi Henriksen, NO

Field Application Manager

ArcticZymes Technologies

Dr. Nicolas Brauckhoff, DE

Head of Biotherapeutical Analytics

Protagen Protein Services GmbH

Stefano Baila, IT

Director of Operation and BD

Anemocyte

What our
participants
are saying

“I like the format and the idea of speed networking. I especially like the mix of compliance / regulatory / CMC / academia / company presentations. I think there is a need in Europe for such a meeting which will focus on GT from a perspective of developers / manufacturers to exchange views and opinions.”

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Jacek Lubelski

uniQure

“Meeting was really great - content but also networking opportunities especially your initiation to bring people together was really fantastic. The organisation was really super top!! And the onsite team so perfect!!”

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Carmen Brenner

BONE THERAPEUTICS S.A.

“It was my pleasure to meet peers and having the opportunity for this high quality networking.”

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Catherine Cancian

GenSight Biologics

“We have enjoyed your summit a lot. It was a nice network opportunity.”

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Dr. Markus Kaymer

Beckman Coulter GmbH

“I think the event was a great success to connect on the ongoings in this young field, and I would love to join again next year. “

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Daniela Woide

ProJect Pharmaceutics GmbH

“It has been a pleasure for me to participate to this meeting. It had been well organized and full of interesting contents. “

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Manuela Cota

Molmed