Back

Live Event

Gene and Cell Therapy: Regulatory CMC, Quality Development and Manufacturing

  • 23rd June 2020
  • Zoom flag Zoom
  • ONLINE

Hosted by the leading experts, Gene and Cell Therapy LIVE Webinar will provide an opportunity to participate in the interactive discussion on the recent strategies, perspectives and expectations in the field.

Learn more about successful process development, manufacturing, quality, CMC technical and regulatory requirements for ATMPs (advanced therapy medicinal products), featuring gene and cell therapy. The brochure contains the additional info and key insights of the live event.

Read more

About

Preserving rapidly increasing complexity and growing concerns related to cell & gene therapies, and meeting emerging challenges in the process development, quality / CMC (Chemistry Manufacturing and Controls) technical and regulatory requirements for CGT, best practices to be assessed, novel approaches to be taken, and new paths to be defined.

Gene and Cell Therapy LIVE webinar on 4 June 2020, affiliated with the 2nd  Gene and Cell Therapy: Quality Developments to Commercialization Summit, leading by experts with many years of experience in ATMPs, will deliver an interactive approach to:

  • learn from subject-specific case studies,
  • exchange professional knowledge and expectations, featuring cell & gene therapy medicinal products,
  • get guidance and competent advice, addressing critical issues and uncertainty in development, manufacturing, and control of CGT, as well as clarification of regulatory guidelines

Join virtually an interactive discussion and practical presentations, exploring industry standards and advancements to:

  • accelerate gene and cell product development,
  • get more gene and cell therapy products successfully approved,
  • have a controlled manufacturing process,
  • deliver safe and commercially viable CGT products.

After the event, you will receive a digital certificate of attendance.

Who should attend

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

  • Advanced Therapy Medicinal Product (ATMP)
  • Analytical
  • Bioprocessing
  • Biotherapeutics
  • CAR-T
  • Cell Engineering
  • Cell Therapy
  • Cellular Immunotherapy
  • Cellular Therapy
  • Clinical Development
  • Chemistry, Manufacturing, and Control (CMC)
  • Compliance
  • Gene Therapy
  • GMP
  • Gene Therapy Medicinal Products (GTMPs)
  • Cell-Based Medicinal Products (CBMPs)
  • Immuno-Oncology
  • Immunology
  • Immunology Chemistry
  • Immunotherapy
  • Legal/IP
  • Manufacturing
  • Market Access
  • Medical Affairs
  • Oncology
  • Process Development
  • Production Engineering
  • Quality Assurance
  • Quality Control
  • Research and Development (R&D)
  • Regenerative Medicine
  • Regulatory
  • Safety
  • Stem Cell
  • Supply Chain

KEY PRACTICAL LEARNING POINTS

  • CMC technical and regulatory compliance to empower cell and gene therapy products development roadmap
  • Optimised cell and gene therapies process development, manufacturing, cost and quality efficiency 

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. Axel Ståhlbom, SE

Principal Consultant / Biologics & Preclinicical

ProPharma Group

Axel is a principal consultant in biologics at Propharma. Before joining in 2017, he had positions at the Swedish medical products agency for 16 years as a pharmaceutical assessor of biological products and also as a preclinical assessor. He has experience from clinical trials, scientific advice, and marketing authorisations for biological products, including recombinant products and advanced therapy products, as well as oligonucleotide-based medicines. As a long-time member of gene therapy working groups at EMA and EDQM, he has long experience from writing EU guidelines and pharmacopoeia texts. At Propharma, he is involved in drug-related development projects as an expert in biological products in particular and non-clinical issues in general.

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. 

Karen Magers, US

Regulatory Affairs Scientist

Head of Regulatory Affairs, Cell and Gene Technologies 

Karen Magers is a Head of Regulatory Affairs Scientist with over 25 years of experience in the biopharmaceutical industry in the areas of biologics regulatory strategy and science, Chemistry, Manufacturing, and Controls (CMC) and technical team management of regulatory and product development groups. Karen has expertise in the areas of cell and gene therapy, vaccines (recombinant and live/attenuated viral and bacterial), biologics manufacturing and design, and conduct of clinical and nonclinical safety and efficacy studies.    

Karen joined Lonza in January 2018 as the Head of Regulatory Affairs for the Cell and Gene Technologies Business Unit. Karen joined Lonza after several years at Dynport Vaccine Company, a GDIT Company where she held a number of positions, including Director, Regulatory Affairs.   

In addition, Karen was a product development team leader supporting the advanced development of medical countermeasures for the US Department of Defense. Prior to working with Dynport Vaccines, Karen held the position of Senior Manager, Biologics Development at AVANT Immunotherapeutics Inc. (now Celldex Therapeutics.)     

Karen holds Bachelor's and Master's degrees in Animal Science, awarded by the University of Rhode Island, Kingston, RI. 

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.  

Dr. Ali Mohamed, US

VP CMC

Immatics Biotechnologies

Ali Mohamed, PhD, VP of CMC, Immatics US Inc. in Houston TX leading the development and manufacturing of Adoptive Cell Therapies for various solid cancers in collaborations with University of Texas MD Anderson Cancer Center.  

Dr. Mohamed has nearly 20 years of experience in process development and GMP manufacturing of regenerative medicine, cell and gene therapy products at various CMOs and clinical-stage companies. 

Before joining Immatics, Dr.  Mohamed was the senior director of manufacturing operations/ manufacturing development at PCT (now HCATS), helping their clients manufacture cell & gene therapy products. Before joining PCT, Dr. Mohamed led the development of AlloCure’s MSCs for acute kidney injury, and previous to that, he helped Lonza clients develop various cell therapy products. 

Dr. Mohamed holds a PhD in Molecular Pharmacology from Medical College of Ohio and postdoctoral fellowship in neuroscience and neurobiology from the Georgetown University Institute of Cognitive and Computational Sciences (GICCS).

Dr. Alessandra Gatti, IT

Cell Process Development Manager

MolMed

Alessandra Gatti is the Cell Process Development Manager of Molmed. She is a Biology by education with a long and strong experience in Virology and Gene therapy field. After her first experience as a researcher in the “San Raffaele Scientific Institute,” she was involved at various levels of responsibility in a number of projects on HIV-1 and joined MolMed in 2001. She worked as a supervisor in the Cell Biology Quality Control Unit, acquiring competence and skills in aseptic manipulations under GMP conditions as well as in the development, qualification, and validation of cellular biology analytical methods. After about 13 years, she moved into the development department with growing responsibilities in Cell Process Development Unit. She has main experiences in the development and industrialization of T- and haematopoietic cells transduction processes with lentiviral and retroviral vectors in the different scales from feasibility in small scales to engineering runs in large scale and close systems.

Dr. James Wang, US

Global Quality Auditor, Cell & Gene Therapy

Novartis

Dr. Axel Ståhlbom, SE

Principal Consultant / Biologics & Preclinicical

ProPharma Group

Dr. Christiane Niederlaender, UK

Director

AMBR Consulting Ltd

Karen Magers, US

Regulatory Affairs Scientist

Head of Regulatory Affairs, Cell and Gene Technologies 

Dr. Rajesh Thangapazham, US

Head of Regulatory Strategy & Innovation, Cell & Gene Technologies

Lonza Pharma Biotech & Nutrition

Dr. Ali Mohamed, US

VP CMC

Immatics Biotechnologies

Dr. Alessandra Gatti, IT

Cell Process Development Manager

MolMed

What our
participants
are saying

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

1
2
3
4
5

Daniela Woide

Director Sales and Marketing at ProJect Pharmaceutics GmbH

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

1
2
3
4
5

Manuela Cota

Upstream Vector Development Supervisor at Molmed

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.

1
2
3
4
5

Jacek Lubelski

VP, Global Process Development at uniQure