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3rd Gene and Cell Therapy: Quality Developments to Commercialization Online Summit

  • 6th – 7th October 2021
  • Hopin flag Hopin
  • ONLINE

Addressing cellular and gene therapy-related developments and manufacturing controls, cell and gene therapies experts and advisers will exchange practical insights and expectations on:

  • Successful strategies to accelerate CGT process development from preclinical to manufacturing and commercialization
  • Enabling new technologies and resources
  • Critical elements of establishing a robust CMC strategy
  • Key factors in easing the complexity of vector development and production
  • Production processes meet technical, regulatory, and cost-efficiency excellence for manufacturing safe products
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About Gene and Cell Therapy: Quality Developments to Commercialization Event

While the global gene and cell therapies markets are evolving and the number of clinical trials investigating gene and cell therapies is increasing, companies continue facing hurdles with CMC, analytical, process development, and production difficulties.

What are the greatest challenges and opportunities facing the cell and gene therapy industry in 2021? And what are the strategies to accelerate gene and cell therapies progress from preclinical to manufacturing and commercialization?

The emerging field of cell and gene therapies (CGTs) offers unprecedented perspectives, as well as barriers:

  • The true partnership of science, technologies, manufacturing and commercialization is crucial as we move forward in 2021, and into the future.
  • Cellular and gene therapy-related research and development continue to grow at a fast rate, with a number of products advancing in clinical development.
  • Cell and gene therapy approvals and fast-track product designations have high support from regulatory bodies, encouraging manufacturers to produce and commercialize these products rapidly.
  • Wide-scale commercial manufacture, especially in viral vector production, is limited by lack of flexibility, process control, speed, sustainability, capital costs.
  • Improvements to the production processes are required to remove manufacturing hurdles and to deliver cost-efficient CGTP at a commercial scale.
  • Even various manufacturing platforms are developed, the significant differences between GCT and traditional biopharmaceuticals are influencing the right choice of commercialization strategy.
  • Collaboration of variety stakeholders should keep manufacturing decisions in line with commercialization goals.
  • The link between manufacturing and commercialization of gene and cell therapy is becoming more visible, since strategies are planned and implemented from the earliest stages of development.

At the 3rd Gene and Cell Therapy: Quality Developments to Commercialization Online Summit on 6-7 October 2021, while addressing manufacturing controls, cell and gene therapies experts and advisers will exchange practical insights and expectations on

  • Successful strategies to accelerate CGT process development from preclinical to manufacturing and commercialization
  • Enabling new technologies and resources
  • Critical elements of establishing a robust CMC (chemistry manufacturing controls) strategy
  • CQAs (critical quality attributes)
  • CPPs (critical process parameters)
  • Key factors in easing the complexity of vector development and production
  • Critical considerations on the sophistication of production processes and performance of CGTP (cell and gene therapy products) in order to assure:
    • Production processes meet technical, regulatory, and cost-efficiency excellence for manufacturing safe products
    • Commercially viable CGTPs are delivered

The leading experts and consultants will share their practical experience and perspectives towards achieving and scaling-up robust cost and quality efficient manufacturing and vector process development, exploring emerging technologies in the field.

Join #VLGeneCell to explore gene and cell therapy development standards and advancements on October 6-7, 2021.

Who should attend

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

  • Adenovirus
  • Adeno-associated Virus (AAV)
  • Advanced Therapy Medicinal Product (ATMP)
  • Analytics
  • Analytical
  • Bioprocessing
  • Biotherapeutics
  • Cancer Immunotherapy
  • Chimeric antigen receptor T cells (CAR-T)
  • Chimeric antigen receptor macrophages (CAR-M)
  • Cell Engineering
  • Cell Therapy
  • Cellular Immunotherapy
  • Cellular Therapy
  • Clinical Development
  • Chemistry, Manufacturing, and Control (CMC)
  • 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
  • Ocular Gene Therapy
  • 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

Key Practical Learning Points

  • Enhancing cell and gene therapies process development, manufacturing, cost, and quality efficiency
  • Powering by emerging science and technologies, cell and gene therapies maturing
  • Accelerating CMC & quality progress of gene and cell therapies (GCT) products
  • Meeting consistent CGTP safety, efficiency, and GMP manufacturing standards
  • Optimizing and scaling vector production processes and performance
  • Coupling new technologies and processes with sophisticated CQAs
  • Advancing analytical approaches while overcoming complexity challenges
  • Designing a robust supply chain for gene, cell, and precision medicine therapies
  • Strengthening the link between manufacturing and commercialization of GCTP

Dr. Angeliki Grammenos, BE

Senior Regulatory Manager

Celyad Oncology SA

Angeliki Grammenos is a physicist by training and has a PhD in biophysics specialized in cell biology. She has held positions in academia and biopharma, with a special focus in cell therapy. In 2012, she left her teaching position at the University of Liège to join the international office of Doctors Without Borders, where she assisted the ethical review board as well as the quality assurance department of the organization. In 2015, she left to lead the regulatory department at Bone Therapeutics S.A, a biopharmaceutical company dedicated to the development of cell therapy products based on autologous and allogeneic adult stem cell technology to treat unmet medical needs in the field of bone disease. In 2018, Angeliki joined Celyad Oncology, a biopharmaceutical company developing a diversified pipeline of allogeneic and autologous CAR-T cell therapy candidates for cancer patients with hematological malignancies and solid tumors.

Albert Ribickas, US

BMT/QC Laboratories Manager, Cell Therapies Facility

Moffitt Cancer in Tampa Florida

Al Ribickas is the BMT/QC Laboratories Manager in the Cell Therapies Facility at the Moffitt Cancer in Tampa Florida. Al has provided leadership for cellular therapy facilities for over eighteen years. He attended the University of South Florida receiving a degree in Clinical Laboratory Sciences. He is board certified by the American Society of Clinical Pathology as a Medical Technologist, a Specialist in Blood Banking, and as a Hemapheresis Practioner. He has been at the Moffitt Cancer Center since it’s opening in 1987. He initially worked as a blood bank technologist in the transfusion service until 2001. During his time in the transfusion service, he was trained in extracorporeal photopheresis for the treatment of Sezary syndrome, and for the treatment of graft versus host disease. This inspired him to explore, and move to the apheresis collection and processing laboratories of the blood and marrow transplant program to enhance his skills, and contribute to the emerging area of cell therapies. Al has worked on the production of various cellular therapies clinical trial products, and the implementation of commercial FDA approved products.

Dr. Pinar Cicalese, US

Director, CMC Commercial Strategy

Immatics Biotechnologies

Dr. Pinar Cicalese is the Director of CMC Commercial Strategy at Immatics US Inc. in Houston, TX, for Immatics’ adoptive cell therapies for various solid cancers in collaborations with University of Texas MD Anderson Cancer Center. Pinar has nearly 20 years of experience in process development, GMP manufacturing, and supply of biopharmaceuticals and cell and gene therapies at various companies. Before joining Immatics, she was responsible for GlaxoSmithKline cell and gene therapy platform manufacturing and supply strategy. Prior to this she led a manufacturing science and technology group in GlaxoSmithKline, delivering many late-stage clinical and commercial biopharmaceutical assets to the patients. Pinar has experience in early-stage development through launch and growth of biological assets in companies of various sizes. She holds a PhD in chemical engineering from Drexel University and was a Fulbright scholar during her PhD studies.

Dr. Yin Lai, US

Director/Principal Scientist of Chemistry, Manufacturing & Controls

Cardinal Health Regulatory Sciences

Yin Lai has extensive experience in the pharmaceutical industry working in biologics and gene and cell therapy development. In her current role at Cardinal Health Regulatory Sciences, she focuses on providing CMC regulatory consulting and strategy in the gene and cell therapy area.  Her role includes helping clients in FDA meeting preparation (INTERACT, pre-IND, end of phase), authoring Module 3 quality sections, preparation of information request (IR) responses, and authoring of biologics master files.

Dr. Monica Commerford, US

Head of Viral Vector Services Regulatory Affairs

Thermo Fisher Scientific

Monica M. Commerford, Ph.D., is the Head of Regulatory Affairs at Thermo Fisher Scientific Patheon Viral Vector Services. She is an expert in the microbial control, product quality microbiology, and sterility assurance of Investigational New Drug Applications and Biological License Applications and performed pre-license inspections of biological product manufacturing facilities. She previously worked as a Microbiologist and Consumer Safety Officer in Branch IV in the Division of Microbiology Assessment, Office of Process and Facilities, Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the Food and Drug Administration. In addition, she has participated in writing policies and a draft guidance document for the Office of Pharmaceutical Quality. Dr. Commerford earned her B.S. in Biochemistry and Molecular Biology from Michigan State University and her Ph.D. in Microbiology and Molecular Genetics from Harvard University. In addition to her regulatory experience, she was also a Sallie Rosen Kaplan post-doctoral research fellow in the Laboratory of Molecular Biology at the National Institutes of Health.

Gregory Fiore, US

Chief Executive Officer

Exacis Biotherapeutics

Riccardo Biavasco, US

Scientist II

bluebird bio

Riccardo obtained his PhD in cellular and molecular biology in 2018, working at the Telethon Institute for Gene Therapy, where he designed and generated a humanized mouse model for myeloid inflammatory neoplasms and characterized the effects of aberrant cellular senescence in hematopoietic stem and progenitor cells. In 2019 he joined bluebird bio analytical development group, where he coordinates the development of characterization assays for hematopoietic stem cell drug products. Riccardo is responsible for the interactions with regulatory agencies regarding drug product characterization assays.

Dr. Hemant Dhamne, IN

Head, Vector and CAR-T Cell Process

Immuneel Therapeutics Pvt Ltd

Hemant Dhamne obtained his Ph. D from the ACTREC, Mumbai (2014) in Applied Virology. His Ph.D. thesis was on the Lentiviral Vector Mediate Long Term Expression of Therapeutic Proteins. He completed his doctoral work in the labs of Dr. Robin Mukhopadhyaya and Dr. Rajiv Kalraiya. His doctoral studies mainly focused on developing the novel LV platform using the inhouse HIV-1 derived vector system and its application for cell engineering and tumor targeting in pre-clinical models. From 2014 to 2015, he was a postdoctoral fellow in the laboratory of Dr. Amit Dutt in the same institute, working on functional genomics aspects spanning novel miRNA discovery and novel mutations in cancer-causing genes and associated pathways. Thereafter, he joined Gene Therapy Division at Intas Pharmaceuticals, Ahmedabad. He worked on early-stage product development of AAV mediated gene therapy for diseases such as hemophilia, neuronal and eye disorders. He successfully developed the pilot-scale manufacturing platforms using suspension cell lines in upstream and chromatography in downstream processes. He also contributed to assay development. He served as Research Scientist from 2015 to 2017 and as Senior Research Scientist from 2017 to 2019. He also developed early-stage designs and assays for CAR-T research. 

From 2018 to 2019, he completed a Diploma in International Business Management from Ahmedabad Management Association in affiliation with California State University. 

In 2019, he joined Immuneel Therapeutics as Head of Vector & CAR-T Manufacturing. His work encompasses the process development and GMP grade manufacturing of autologous CAR-T cells for clinical trials. The disease areas mainly include leukemias and lymphomas. 

He has 7 peer-reviewed publications in the field of gene therapy and functional genomics.

Dr. Houria Bachtarzi, UK

Associate Director, Regulatory Affairs - CMC - Gene and Cell Therapies

ProPharma Group

Dr. Houria Bachtarzi is an Associate Director, Regulatory Affairs - CMC - Gene and Cell Therapies, with 15 years of experience in the scientific and regulatory CMC aspects of advanced biological therapies including virally vectored gene therapy, in vivo and ex vivo gene editing, cell-based immunotherapy, genetically modified cells for tissue regeneration, genetically engineered immune cells targeting cancer cells, and stem cell-based therapies. Houria started her career by first training and registering as a pharmacist in the UK, before embarking into a unique journey in gene therapy and regenerative medicine. She completed her PhD in cancer gene therapy at the University of Oxford, department of oncology (previously department of clinical pharmacology). She subsequently followed up with additional post-doctoral work in AAV-based gene therapy and shRNA therapeutics for degenerative neuro-muscular disorders at the Centre for Biomedical Sciences, Royal Holloway – University of London, in collaboration with Benitec Biopharma, Inc. and the Institute of Myology at the Pitié-Salpétrière Hospital in Paris, France.  In 2013, Houria was appointed as a lecturer in biopharmaceutics and biotechnology at the School of Pharmacy and Biomolecular Sciences, University of Brighton.

Prior to joining Diamond BioPharm Ltd., a ProPharma Group Company, Houria was a senior consultant in gene and cell therapies at other product development and regulatory consultancies: ERA Consulting (UK) Ltd., NDA Group and Dark Horse Consulting, where she provided technical scientific, CMC, and regulatory/development strategic advice in relation to different complex gene and cell therapy technologies. She also provided expert advice on matters related to genetically modified organisms (GMOs). 

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. 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).

John Taylor, US

Process Development Scientist

MilliporeSigma

John Taylor is a field-based Process Development Scientist at MilliporeSigma based in Philadelphia, Pennsylvania, USA. John is focused on robust process design, optimization, and scale-up of MilliporeSigma bioprocessing technologies used in biotherapeutics purification. John's current role has allowed him to support cell and gene therapy companies as they navigate through the challenges associated with process development and implementation. Prior to joining MilliporeSigma, he was an Assistant Scientist at Janssen R&D, where he focused on the process development of quick-to-market monoclonal antibodies. John received his M.S. in Biochemical Engineering from Villanova University in 2020 and his B.S. in Biological Engineering from NC State University in 2015. 

Dr. Magdi Elsallab, US

Head of Clinical Development and Regulatory Affairs & Head of GMP Production

University of Southern California

Dr. Magdi Elsallab is currently the head of Clinical Development and Regulatory Affairs at the joint USC/CHLA Cell Therapy program. He also serves as the head of GMP production at the CHLA GMP Lab. His goals include facilitating the clinical translation of cell and gene therapies through evidence-based approaches. Magdi’s experienced with clinical trial designing, preparing investigational new drug (IND) applications, regulatory submissions, GMP production and regulatory compliance, as well as quality control. His research focus is novel trial designs, regulatory science, meta-analyses, the development of immunotherapies, and computational text mining for clinical evidence generation.

Dr. Robin Ng, US

Strategy Lead for Technology and Manufacturing

CBMG

Dr. Robin Ng joined CBMG as Strategy Lead for Technology and Manufacturing in June 2018. In this role, Robin is responsible for supply chain and operational management, CMC program management, as well as external collaboration management at CBMG. He is also the program lead for the tech transfer of the first CAR-T product in the world, Kymriah™, from Novartis to CBMG Shanghai. Prior to joining CBMG, Robin held a position as a process science fellow for the bioproduction division of Thermo Fisher Scientific, where his team oversaw the cell culture and cell therapy technical team in Asia Pacific. Prior to that, he was the senior bioengineer at Takeda (previously Shire Human Genetic Therapy), where he led the tech transfer of the world’s first 2,000L disposable bioreactor system.

Robin started his career as the senior scientist at Goodwin Biotechnology, where he led the upstream process development lab. He got his PhD in chemical and biomolecular engineering from Ohio State and an MSc in technology commercialization from D’Amore-McKim School of Business at Northeastern University. Robin received his BSc in chemical and biomolecular engineering at National Central University in Taiwan.

Dr. Angeliki Grammenos, BE

Senior Regulatory Manager

Celyad Oncology SA

Albert Ribickas, US

BMT/QC Laboratories Manager, Cell Therapies Facility

Moffitt Cancer in Tampa Florida

Dr. Pinar Cicalese, US

Director, CMC Commercial Strategy

Immatics Biotechnologies

Dr. Yin Lai, US

Director/Principal Scientist of Chemistry, Manufacturing & Controls

Cardinal Health Regulatory Sciences

Dr. Monica Commerford, US

Head of Viral Vector Services Regulatory Affairs

Thermo Fisher Scientific

Gregory Fiore, US

Chief Executive Officer

Exacis Biotherapeutics

Riccardo Biavasco, US

Scientist II

bluebird bio

Dr. Hemant Dhamne, IN

Head, Vector and CAR-T Cell Process

Immuneel Therapeutics Pvt Ltd

Dr. Houria Bachtarzi, UK

Associate Director, Regulatory Affairs - CMC - Gene and Cell Therapies

ProPharma Group

Dr. Stefano Baila, IT

Director of Operation and BD

Anemocyte

Dr. Roland Pach, CH

Global Expert Cell and Gene Therapy Analytics

Roche

John Taylor, US

Process Development Scientist

MilliporeSigma

Dr. Magdi Elsallab, US

Head of Clinical Development and Regulatory Affairs & Head of GMP Production

University of Southern California

Dr. Robin Ng, US

Strategy Lead for Technology and Manufacturing

CBMG

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