Back

Pharma

4th Gene and Cell Therapy: Quality Developments, Manufacturing & Commercialization Summit

  • 8th – 9th June 2022
  • Germany flag Germany Berlin
  • Mövenpick Hotel Berlin Schöneberger Str. 3, 10963

The gene and cell therapy markets continue to grow in 2022, although companies are struggling to overcome new CMC, analytical, process development, and manufacturing constraints. The extended collaboration around gene and cell therapy science, technologies, manufacturing, and commercialisation is accelerated.

At the #VLGeneCell event on June 8-9, 2022, the cell and gene therapy experts will focus on the recent practical experiences and perspectives towards gene and cellular therapy-related advancements, while implementing and scaling up robust cost and quality efficient process development and manufacturing, and leveraging highly appropriate emerging technologies in the field.

Read more

About 4th Gene and Cell Therapy: Quality Developments, Manufacturing & Commercialization Event

The gene and cell therapy markets continue to grow, and gene and cell therapies clinical trials are expanding, although companies are struggling to overcome new CMC, analytical, process development, and manufacturing constraints.

What are the major challenges, opportunities and milestones facing the cell and gene therapy industry in 2022? Which steps can be taken to advance gene and cell therapies progress from preclinical to manufacturing and commercialisation? How to assure that production processes meet technical, regulatory, and cost-efficiency excellence for manufacturing safe products, and commercially viable CGTPs are delivered?

The cell and gene therapy (CGTs) developers in 2022 will continue facing unique difficulties and perspectives:

  • The extended collaboration around gene and cell therapy science, technologies, manufacturing, and commercialisation is accelerated
  • Gene and cellular therapy-related research and development continue to expand rapidly, with numerous products advancing in clinical development
  • Manufacturers produce and commercialise cell and gene therapy products faster, as a result of being supported by regulatory bodies cell and gene therapy approvals and fast-track product designations
  • Large-scale commercial production, especially viral vector manufacturing, is minimal because of insufficient flexibility, process control, speed, sustainability, and capital costs
  • Manufacturing process enhancements are required to advance production and to deliver cost-efficient CGTPs at a commercial scale
  • Numerous manufacturing platforms are developed, but the significant differences between GCT and traditional biopharmaceuticals are influencing the right choice of commercialisation strategy
  • Manufacturing decisions, being taken in partnership of various stakeholders, should be in line with the commercialisation objectives
  • The link between manufacturing and commercialisation of cell and gene therapy is strengthening, as strategies are planned and deployed from the earliest stages of development

At the 4th Gene and Cell Therapy: Quality Developments, Manufacturing & Commercialization Summit on 8-9 June 2022, while addressing manufacturing controls, cell and gene therapies experts will exchange valuable insights and expectations on:

  • Successful strategies to accelerate CGT process development from preclinical to manufacturing and commercialisation
  • Efficient enabling novel technologies and resources
  • Defining optimal regulatory pathways
  • Critical elements of establishing a robust CMC (chemistry manufacturing controls) strategy
  • Identifying and measuring of CQAs (critical quality attributes) and determining CPPs (critical process parameters)
  • Crucial factors in easing the complexity of vector development and production
  • Sophistication of production processes and performance of CGTP (cell and gene therapy products)
  • Achieving technical, regulatory, and cost efficiency for manufacturing safe gene and cell therapy products

At the #VLGeneCell in June 2022, the leading experts and advisers will focus on the recent practical experiences and perspectives towards implementing and scaling up robust cost and quality efficient process development and manufacturing, leveraging highly appropriate emerging technologies in the field.

Who should attend

  • Adenovirus
  • Adeno-Associated Virus (AAA)
  • Advanced Therapy Medicinal Product (ATMP)
  • Analytics
  • Analytical
  • Bioprocessing
  • Biotherapeutics
  • Chimeric Antigen Receptor T-Cells (CAR-T)
  • Cell Engineering
  • Cell Therapy
  • Cellular Immunotherapy
  • Cellular Therapy
  • Clinical Development
  • Chemistry, Manufacturing, and Control (CMC)
  • Commercialisation
  • Comparability
  • Compliance
  • Gene Therapy
  • GMP (Good Manufacturing Practices)
  • Gene Therapy Medicinal Products (GTMPs)
  • Cell-Based Medicinal Products (CBMPs)
  • Immuno-Oncology
  • Immunology
  • Immunology Chemistry
  • Immunotherapy
  • Lentivirus (LV)
  • Manufacturing
  • Market Access
  • Medical Affairs
  • Non-Viral Vectors
  • Oncology
  • Product Characterisation
  • Process Development
  • Production Engineering
  • Quality Assurance
  • Quality Control
  • Research and Development (R&D)
  • Regenerative Medicine
  • Regulatory
  • Safety
  • Scale Up
  • Stem Cell
  • Supply Chain
  • Viral Vector

Register by May 30 and get a 50% discount on the Standard Package

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

  • Advancing gene and cell therapies process development, manufacturing, cost, and quality efficiency
  • Enabling by emerging science and technologies cell and gene therapies maturing
  • Accelerating CMC, regulatory and quality progress of gene and cell therapies (GCT) products
  • Meeting consistent CGTP safety, efficiency, and GMP production standards
  • Optimising and scaling up vector manufacturing processes and performance
  • Matching novel technologies and processes with sophisticated CQAs
  • Enhancing analytical approaches while overcoming complexities
  • Creating a robust supply chain for gene, cell, and precision medicine therapies
  • Boosting the link between manufacturing and commercialisation of GCTP

Register by May 30 and get a 50% discount on the Standard Package

Zeb Khan, US

Director, Product Quality, Cell Therapies

Takeda

About Speaker

Dr. Rajiv Gangurde, US

Chief Technology Officer

SparingVision

About Speaker

Roberto Nitsch, SE

Director of the Gene Therapy

AstraZeneca

About Speaker

Margit Jeschke, CH

Ex-Global Head, Analytical Stewardship and CMC Correlational Sciences

Novartis

About Speaker

Dr. Roland Pach, CH

Global Expert Cell and Gene Therapy Analytics

Roche

About Speaker

Francesco Cicirello, US

Director, Quality Assurance

Evelo Biosciences

About Speaker

Dr. Matthias Bozza, DE

Associate Director

Vector BioPharma

About Speaker

Dr. Rahul Kaushik, DE

Ex-Head of AAV facility

DZNE

About Speaker

Jeremy Johnston, US

Director of Analytical Development

Asklepios Biopharmaceuticals

About Speaker

Matthew Li, US

Associate Director, Head of Cell Therapy Manufacturing Innovation

Vor Biopharma

About Speaker

Dr. Stefano Baila, IT

Director of Operation and BD

Anemocyte

About Speaker

Dr. Stephen Sullivan, UK

Program Manager and International Liaison Officer

Global Alliance for iPSC Therapies (GAiT)

About Speaker

Nick Timmins, US

Chief Development Officer

Artisan Bio

About Speaker

Dan Bright, US

Senior Global Project Manager

Ferring Pharmaceuticals 

About Speaker

Dr. Abhishek Srivastava, US

Vice President, Cell Therapy Development

Athenex

About Speaker

Dr. Lara Ionescu Silverman, US

Principal Consultant

LIS BioConsulting

About Speaker

Dr. Isabelle Gennart, BE

CMC & Process Dev Scientist

Celyad Oncology  

About Speaker

Dr. Hemant Dhamne, UK

Head, Process Development, GTVF, Research Management and Innovations Directorate

King's College London

About Speaker

Zeb Khan, US

Director, Product Quality, Cell Therapies

Takeda

Zeb Khan is a strategic leader supporting product quality within the cell therapies division for Takeda, oncology, responsible for supporting the development of cell therapy products from clinical to commercialisation.

She has over 25 years of experience in supporting development projects in the CMC space from pre-clinical to commercialisation with varying degrees of responsibility in product development, analytical laboratory, and quality assurance. In her tenure, she has contributed to developing phase appropriate quality systems for clinical development for CGT products. Zeb has coached multiple teams in the application of quality by design principles and delivered successful results-oriented strategies. She holds a master's in organic chemistry and a master’s degree in regulatory science and health safety.

Dr. Rajiv Gangurde, US

Chief Technology Officer

SparingVision

Dr. Rajiv Gangurde is chief technology officer at SparingVision, leading technical operation activities including process and analytical development, manufacturing, and quality assurance.

Rajiv has over 14 years of industry experience in biopharmaceutical development, harnessed in the biotechnology hub of Massachusetts, USA. Before joining SparingVision, Rajiv served as senior director and head of chemistry, manufacturing, and controls (CMC) at Voyager Therapeutics, a gene therapy company based in Cambridge, MA. In this role, he was responsible for CMC strategy and management of the company’s entire gene therapy portfolio. Prior to Voyager, Rajiv was director of bioprocess development and manufacturing at Genocea Biosciences, where he led upstream and downstream process development and biochemistry groups for early- and late-stage recombinant-protein-based therapeutic vaccines. Prior to Genocea, Rajiv served as head of protein sciences at LakePharma (now part of Curia), leading therapeutic protein production efforts for pre-clinical studies.

Rajiv obtained his PhD in life sciences from Mumbai University in India and did postdoctoral research at the department of biochemistry at the New Jersey Medical School, and at the department of molecular and cellular biology at Harvard University.

Rajiv is based in Massachusetts, USA.

Roberto Nitsch, SE

Director of the Gene Therapy

AstraZeneca

Roberto Nitsch graduated in medical biotechnology from the University of Naples (Italy), where he also obtained his PhD in molecular genetics. He later moved to Vienna, where he focussed on mouse genetics and cancer biology, and then recessive genetics. In 2014 he shifted his research topic to genome engineering with CRISPR/Cas9 and joined AstraZeneca, where he was responsible for the CRISPR mouse models for drug discovery and oncology. Since 2017, he has been associate director in the clinical pharmacology and safety sciences pioneering CRISPR safety assessments. Today, Roberto is the director of the gene therapy at AstraZeneca, and he is working towards the generation of safer CRISPR medicines.

Margit Jeschke, CH

Ex-Global Head, Analytical Stewardship and CMC Correlational Sciences

Novartis

Dr. Roland Pach, CH

Global Expert Cell and Gene Therapy Analytics

Roche

Dr. Roland Pach holds a PhD in molecular parasitology at the University Fribourg analyzing the intracellular trafficking of transgenic RNA in human pathogens.

Prior Roche, he was leading the Analytical Development department at Berna Biotech (former Swiss Vaccine and Serum Institute) and the QC department of Bio-Process Development at Merck Serono.

Roland is the global CMC Analytical Technical Lead in the cancer vaccines and cell- & gene therapy (CGT) area of Roche more than 10 years. In his assigned area, he represents Roche in external development projects, industrial consortiums like CGT BioPhorum and numerous due diligences of in-licensing candidates or companies in the CGT fields.

In his second role at Roche as global technical development leader, he had led successfully new formats like immunotoxins from pre-clinics into entry to human (EiH).

Francesco Cicirello, US

Director, Quality Assurance

Evelo Biosciences

Dr. Matthias Bozza, DE

Associate Director

Vector BioPharma

Until recently, Matthias Bozza was serving as senior member of the staff and had worked for the last seven years on the development of an autonomously replicating non-integrating DNA vector platform in Richard Harbottle’s division at the German Cancer Research Centre in Heidelberg. The aim of this research was to genetically modify cells while avoiding the risk of insertional mutagenesis or vector-mediated toxicity. For this work, he has received multiple awards from the American Society for Gene and Cell Therapy and was awarded in 2020 with the Scholar-In-Training Award from the American Association for Cancer Research. The DNA Vector Lab at the DKFZ are now implementing their vector platform into clinical pipelines.

Dr. Rahul Kaushik, DE

Ex-Head of AAV facility

DZNE

Dr. Rahul Kaushik is an experienced biochemist, molecular biologist, and cell biologist with 12+ years of preclinical research experience in neuroscience. He has a long-standing interest and experience in using viral vectors and their use in gene manipulation, editing, and potential therapies. As molecular biology unit and project leader at German Center for Neurodegenerative Diseases (DZNE), he designed several novel and innovative AAV and LV vectors and established a small-scale AAV production. Later he was working as a senior scientist at ViGeneron, with an aim to develop innovative gene therapy solutions for retinal disorders.

Jeremy Johnston, US

Director of Analytical Development

Asklepios Biopharmaceuticals

Jeremy is currently serving as the director of analytical development at Asklepios Biopharmaceuticals, Inc., in Chapel Hill, North Carolina (USA). He has more than 25 years of experience in the development and manufacturing of therapeutic proteins and has overseen analytical biopharmaceutical development for recombinant proteins at all stages of development and commercialisation. His group is working to update analytical methodology utilised in structural characterisation and GMP release of AAV vectors by developing HPLC, CE-SDS, ddPCR, and LC/MS assays for identity, purity, and potency of AAV products.

Matthew Li, US

Associate Director, Head of Cell Therapy Manufacturing Innovation

Vor Biopharma

Matthew Li is a biomedical scientist and engineer with over 12 years of experience across an array of areas in the biotech field including CGT R&D and manufacturing, translational medical device development, and clinical research. As an associate director at Vor Biopharma, he currently heads the cell therapy manufacturing innovation team that engages across the CGT value chain interfacing with research, development, manufacturing, quality, regulatory, clinical, business development, and commercial to holistically address and solve challenges across numerous stages across the life cycle of a therapy. Matthew holds a PhD in medical engineering and medical physics from the Massachusetts Institute of Technology.

Dr. 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. Stephen Sullivan, UK

Program Manager and International Liaison Officer

Global Alliance for iPSC Therapies (GAiT)

Dr. Sullivan is program manager and international liaison officer for the Global Alliance for iPSC Therapies (GAiT).

GAiT works to establish an HLA-homozygous haplobank network for clinical-grade-induced pluripotent stem cell (iPSC) lines [Barry et al. 2015, Sullivan et al. 2018]. Such cells would represent an appropriate starting material for allogeneic therapeutic development worldwide.

GAiT activity is funded by an international consortium of organisations: the French Institute of Health and Medical Research, INSERM (Paris, France), the University of Hong Kong (Hong Kong, Hong Kong), the Cell and Gene Therapy Catapult (London, UK), the Centre for Commercialisation of Regenerative Medicine (Toronto, Canada), the Korea HLA-Typed iPSC Banking Initiative (Seoul, Korea), and the New York Stem Cell Foundation (New York, USA). More information on GAiT and its sponsors is available at www.gait.global.

Stephen initially earned his PhD at the Roslin Institute (Edinburgh) under Professor Ian Wilmut and Dr. Jim McWhir, becoming one of the first researchers in Europe to culture human embryonic stem cells. His work focussed on pluripotency induction in human somatic cells.

Thereafter, Stephen worked as a research fellow at the University of Cambridge, Harvard University, and UCSD, deepening his expertise of other human stem-cell types (including induced pluripotent stem cells) and their medical applications.

While at Harvard, he read Dr. Paula Stefan's "How Economics Shapes Science", which stimulated his interest in the financial, as well as the scientific and clinical, hurdles that must be surmounted to bring stem-cell therapies to the clinic. Thereafter, he also worked for Novartis, dealing with clinical trial management and compliance, to better understand manufacturing, logistic, and regulatory challenges to bringing new therapeutics to market and earned an MBA at Trinity College Dublin focussing on risk mitigation during AMTP development.

Prior to his current position, Stephen was the chief scientific officer of the Irish Stem Cell Foundation, where, working with others, he facilitated the introduction of stem-cell legislation into the Irish Program for Government. He was also a project support officer for the Scottish National Blood Transfusion Service (2017-21). In March 2021, he founded Lindville Bio, an ATMP consultancy service specialising in scalable manufacture of pluripotent stem cells (PSC) and therapeutic development therefrom.

He is also a member of the steering committee for the International Stem Cell Banking Initiative (ISCBI), the Autologous iPSC Therapy Consortium, the Human Pluripotent Stem Cell Advisory Committee at University College Cork, Ireland, and is chief editor of "Human Embryonic Stem Cells – The Practical Handbook" published by Wiley & Sons.

Nick Timmins, US

Chief Development Officer

Artisan Bio

Nick is an experienced cell and gene therapy executive, innovator, and people leader. He has over 15 years' experience developing an assortment cell and gene therapies and associated technologies. Currently chief development officer at Artisan Bio, he previously held leadership roles at BlueRock Therapeutics, the Center for Commercialization of Regenerative Medicine (CCRM), and the Center for Advanced Therapeutic Cell Technologies. Nick's global experience includes time living and working in Canada, Switzerland, Australia, and New Zealand, engaging with a diverse assortment of partners, colleagues, and clients from industry and academia.

Dan Bright, US

Senior Global Project Manager

Ferring Pharmaceuticals 

Dr. Abhishek Srivastava, US

Vice President, Cell Therapy Development

Athenex

Abhishek Srivastava is vice president of cell therapy development at Athenex, overseeing early development, manufacturing, and technical operations of the autologous and allogeneic cell therapy programs. He has extensive clinical and translational research experience in the field of adoptive cell therapies serving both academia and industry. Most recently, he was an assistant professor (research) at the division of surgical oncology at the University of Pittsburgh, where he led the process development and manufacturing of tumor infiltrating lymphocytes (TIL) to support the multiple adoptive cell therapy Phase II clinical trials. He received his postdoctoral training from surgery branch at the National Cancer Institute and earned his PhD in immunology. He has authored numerous papers including research articles, abstracts, book chapter, and expert opinions.     

Dr. Lara Ionescu Silverman, US

Principal Consultant

LIS BioConsulting

Dr. Isabelle Gennart, BE

CMC & Process Dev Scientist

Celyad Oncology  

Isabelle Gennart is a biologist by training. She earned her PhD in 2018 at the University of Namur (Belgium), where she focussed on cancer development mechanisms using viral-induced lymphoma models in avian species. Since then, she has had experience with various CAR-T development and clinical manufacturing projects working as a QC specialist at Catalent. She joined Celyad Oncology in 2020 within the R&D team to setup new analytical tools to support innovative CAR-T cells product development and characterisation.

Dr. Hemant Dhamne, UK

Head, Process Development, GTVF, Research Management and Innovations Directorate

King's College London

Zeb Khan, US

Director, Product Quality, Cell Therapies

Takeda

Dr. Rajiv Gangurde, US

Chief Technology Officer

SparingVision

Roberto Nitsch, SE

Director of the Gene Therapy

AstraZeneca

Margit Jeschke, CH

Ex-Global Head, Analytical Stewardship and CMC Correlational Sciences

Novartis

Dr. Roland Pach, CH

Global Expert Cell and Gene Therapy Analytics

Roche

Francesco Cicirello, US

Director, Quality Assurance

Evelo Biosciences

Dr. Matthias Bozza, DE

Associate Director

Vector BioPharma

Dr. Rahul Kaushik, DE

Ex-Head of AAV facility

DZNE

Jeremy Johnston, US

Director of Analytical Development

Asklepios Biopharmaceuticals

Matthew Li, US

Associate Director, Head of Cell Therapy Manufacturing Innovation

Vor Biopharma

Dr. Stefano Baila, IT

Director of Operation and BD

Anemocyte

Dr. Stephen Sullivan, UK

Program Manager and International Liaison Officer

Global Alliance for iPSC Therapies (GAiT)

Nick Timmins, US

Chief Development Officer

Artisan Bio

Dan Bright, US

Senior Global Project Manager

Ferring Pharmaceuticals 

Dr. Abhishek Srivastava, US

Vice President, Cell Therapy Development

Athenex

Dr. Lara Ionescu Silverman, US

Principal Consultant

LIS BioConsulting

Dr. Isabelle Gennart, BE

CMC & Process Dev Scientist

Celyad Oncology  

Dr. Hemant Dhamne, UK

Head, Process Development, GTVF, Research Management and Innovations Directorate

King's College London

BROCHURE

Request the 4th Gene and Cell Therapy: Quality Developments, Manufacturing & Commercialization Summit brochure and find out the latest topics and ideas that will be shared.

Request

Please fill in your e-mail address below and we will process your request in a moment.

What our
participants
are saying

The conference was extremely well-organized! Thank you the Vonlanthen group for the efforts they take to bring on board the leading experts, who explore from practical perspectives the hottest topics in gene and cell therapies.

1
2
3
4
5

Past

Attendee

It has been a great event and it was lovely to be back in person.

1
2
3
4
5

Past

Attendee

I appreciated the conference a lot and especially liked the mixture of scientific talks with updates on the current technical development.

1
2
3
4
5

Past

Attendee

I appreciated the conference a lot and especially liked the mixture of scientific talks with updates on the current technical development.

1
2
3
4
5

Past

Attendee