Angeliki Grammenos is a physicist by training and has a PhD in biophysics specialized in cell biology. 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. From 2018-22, Angeliki led the regulatory department of Celyad Oncology, a biopharmaceutical company developing allogeneic and autologous CAR-T cell therapy candidates for cancer patients. Additionally, she was acting as a program management team chair for the company. Since 2022, she has been working at Debiopharm, an independent biopharmaceutical company based in Switzerland aiming to develop innovative therapies that target high unmet medical needs.

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 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.

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.

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.

Dr. Gregory Fiore is a co-founder and is the President and CEO of Exacis Biotherapeutics. He is a pharmaceutical/biotechnology executive and entrepreneur and is a co-founder and former CEO of Sollis Therapeutics, a clinical-stage pharmaceutical company. As CEO of Sollis, he led fundraising efforts and raised up to $50M to perform a pivotal trial for the company’s lead asset.

Before this, Gregory provided senior medical support as consultant and acting CMO for several early-stage biotechnology companies through two successful consultancies he founded, SSI Strategy and Fiore Healthcare Advisors. He was the first CMO of The Medicines Company and held leadership roles at Merck and Abbott Laboratories, and previously he had been a management consultant at McKinsey and Company.

Gregory completed an internal medicine residency and received clinical pulmonary/critical care training at Harvard Medical School following graduation as class valedictorian with an MD degree from New York Medical College. He serves on several medical and business advisory committees/boards. He is on the executive board of the Institute of Neuromodulation, the scientific advisory board for Advera Health Analytics, the business advisory board for the Advanced Group of Companies, and the editorial advisory board of the industry publication Clinical Leader. He serves as an advisor to several biotechnology companies.

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.

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 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). 

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 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 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 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 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.