Miguel Forte, MD, PhD
ISCT President-Elect, CEO Kiji Therapeutics
Dr. Miguel Forte is a visionary leader shaping the landscape of cell and gene therapies. As the Chief Executive Officer at Kiji Therapeutics and a Professor at Lisbon University, Dr. Forte brings over two decades of expertise in operational and strategic management, revolutionizing the intersection of academia and industry. His groundbreaking work as the Founder and Managing Director of mC4Tx has propelled human medicinal product biotech companies forward, crafting innovative strategies for success.
Dr. Forte's leadership extends globally as the incoming President-Elect of the International Society for Cell & Gene Therapy, where he champions the development of safe and effective treatments to transform patient care worldwide. Holding an MD and a PhD in Immunology, along with a specialization in Infectious Diseases, Dr. Forte is also the Executive Chair of the Board of Directors for StemBond Technologies, which develops advanced materials for cell and gene therapy products.
His role in guiding human medicinal product biotech companies in strategy, business model development, and operations has been instrumental in shaping the industry landscape.
Panelist: Albert Ribickas
Assistant Director of Cell Therapy Facility Operations, Moffitt Cancer Center
Al Ribickas is the Assistant Director of Cell Therapy Facility Operations at the Moffitt Cancer Center in Tampa, Florida. 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. Al has worked on the production of various cellular therapies clinical trial products, and the implementation of commercial FDA approved products.
Panelist: Patrick Hanley, PhD
Director of the Cellular Therapy Program at Children’s National Hospital
Dr. Hanley, Chief and Director of the Cellular Therapy Program and Associate Professor of Pediatrics at Children's National Hospital and George Washington University, has 16 years of experience translating 550+ cellular therapy products across 25 protocols into clinical practice. He's VP-North America of ISCT, on its board, and co-founded the Early Stage Professionals committee. Dr. Hanley is the commissioning editor of Cytotherapy and a board member of FACT. He advises various cell and gene therapy biotech companies and, in his free time, engages with scientists and Bills fans on Twitter, enjoys soccer, cycling, cooking, and traveling.
Co-host: Tom Whitehead
Co-Founder of the Emily Whitehead Foundation
Tom Whitehead is a keynote speaker, author, and co-founder of the Emily Whitehead Foundation, which raises funds and awareness for pediatric cancer immunotherapy research. Tom and his wife Kari founded the Emily Whitehead Foundation in honor of their daughter Emily who was diagnosed at age five with an aggressive form of leukemia that failed to respond to chemotherapy. As a last hope, Emily was enrolled in a clinical trial and became the first pediatric patient in the world to receive CAR T-cell therapy. The therapy worked and Emily is now 11 years cancer free and considered cured.
Co-host: Olga Bukatova
Assoc. Dir, Biz Development CGT at Azenta Life Sciences
With a decade-long commitment to advancing GMP manufacturing technologies for Cell and Gene Therapies, Olga Bukatova’s expertise spans critical domains, including process automation, cryopreservation and thawing, isolator technologies, and aseptic fill & finish. Throughout her career, Olga focused on delivery of these transformative treatments to patients, working with start-ups, public organizations, pharmaceutical companies, and their CDMOs. As a member of the ISCT cold chain working group, she keeps on addressing the multifaceted challenges within the CGT landscape.
Kristen M. Hege, MD
Former SVP, Early Clinical Development, Hematology/Oncology & Cell Therapy, Bristol-Myers Squibb; Independent Board of Directors and Scientific Advisory Boards member
Dr. Kristen Hege, a retired Clinical Professor of Medicine specializing in Hematology/Oncology at UCSF and former Senior Vice President of Early Clinical Development at Bristol Myers Squibb, pioneered notable advancements in cellular therapy. A trailblazer in cancer immunotherapy, her collaborations with luminaries like Carl June and Bruce Levine have led to FDA-approved CAR T-cell therapies, notably Abecma for multiple myeloma. In 2023, Dr. Hege and her husband, Gib Biddle, embarked on a 2658-mile Pacific Crest Trail thru hiking adventure to commemorate and raise money to support advances in cellular immunotherapy research and, in particular, to support the next generation of early career women physicians and scientists working in this exciting field.
Also, special guest: Laurie Adami, Cancer Survivor, Member Board of Trustees, Leukemia & Lymphoma Society California Southland
The Patient’s Journey from Collection to Administration of a CAR-T Product
Presenter: Albert Ribickas, BMT laboratory and Patient Product Handling Team Manager, Moffitt Cancer Center
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Hospital Apheresis Considerations
Presenter: Lizette Caballero, Associate Director, Clinical Cell Therapy Lead, Janssen
For more than 24 years Lizette worked in the cellular therapy field, first managing the cellular therapy laboratory at Florida Hospital, Orlando, FL (1996-2011), and the Blood and Marrow Transplant (BMT) Laboratory at UCSF, San Francisco, CA (1996-2020). She joined Janssen Pharmaceuticals (Johnson & Johnson) as an Associate Director, Clinical Cell Therapy Lead (CTL). Lizette serves as a cross-functional, point of contact within Janssen for operational and technical aspects of collections and cryopreservation of apheresis cells used to manufacture chimeric antigen receptor T cells (CAR-T).
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Cryobiology & Formulation Considerations for Best In-Practice Allogenic Cell Therapy Manufacturing
Presenter: Katie Pollock, Associate Director, Head of Formulation and Cryobiology, Bristol Myers Squibb
Katie Pollock, PhD is a cryobiologist specializing in formulation, fill finish, container closure, and cryopreservation of cellular therapies. She currently serves as Associate Director, Head of Formulation and Cryobiology in the Cell Therapy Development Organization at Bristol Myers Squibb. During the last 6 years at Juno/BMS, she has contributed to cryopreservation development and support on 8 cell therapy commercial, clinical, and pre-clinical pipeline products.
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Labeling & Tracking Advanced Materials
Presenter: Karen Moniz, Technical Director, ICCBBA
Karen is a broad-spectrum blood bank specialist with decades of management experience in a variety of settings including donor centers, academic medical centers, community hospitals, reference laboratories, military settings, and information technology. She was an early advocate for the use of ISBT 128 labeling to support the globally unique identification of medical products of human origin (MPHO).
Dorothea Ledergerber
Chief Technical Officer, Tigen Pharma
Dorothea is a pharmacist with more than 20 years of experience in research, development, manufacturing and supply of pharmaceutical products. She received her PhD from the University of the Saarland, Saarbrücken, Germany.
While with Novartis, she led manufacturing sites in Switzerland, Germany and Ireland. A highlight in her career was the build-up and operational launch of the first commercial Cell & Gene manufacturing facility for Novartis in Europe.
In 2020, Dorothea moved on to Tigen Pharma, a Swiss biotech company in cell therapies to cure cancer. Tigen is a disruptive catalyst, combining a unique culture with a multidisciplinary set of clinical and technical capabilities and a long-term perspective to benefit patients and society. Dorothea is a firm believer in cross-cultural and -functional teams going beyond the beaten industry track.
Dr. Bruce Levine
Barbara and Edward Netter Professor in Cancer Gene Therapy, Founding Director, Clinical Cell and Vaccine Production Facility (CVPF), University of Pennsylvania
Dr. Bruce Levine is the Barbara and Edward Netter Professor in Cancer Gene Therapy at the University of Pennsylvania and is a distinguished figure in the field of immunology and cancer research. Dr. Levine's contributions include co-inventing the first FDA-approved gene therapy, Kymriah, and a remarkable 31 issued US patents with an extensive publication record. Dr. Levine continues to drive innovation as a Co-Founder of Tmunity Therapeutics and Capstan Therapeutics, both born out of the University of Pennsylvania. His accolades, such as the William Osler Patient Oriented Research Award and the Wallace H. Coulter Award for Healthcare Innovation, underscore his significant impact in advancing cell and gene therapy.
Phyllis Warkentin, MD
Chief Medical Officer of FACT (Foundation for the Accreditation of Cellular Therapy)
Dr. Phyllis I. Warkentin is a founding member and the chief medical officer of FACT (Foundation for the Accreditation of Cellular Therapy). Since the organization's inception in 1996, she has served as a board member. Dr. Warkentin has also been the director of the unrelated bone marrow transplantation program at the University of Nebraska Medical Center since 1988 and a professor of pediatrics and pathology/microbiology at the University of Nebraska Medical Center since 1994. A graduate of the University of Minnesota Medical School, Dr. Warkentin completed her residencies in pediatrics and pursued fellowships in pediatric hematology/oncology and blood banking. Her extensive contributions to the medical field, particularly in cellular therapy and bone marrow transplantation, showcase her dedication to advancing research and enhancing patient care.
Guest: Stephan Grupp, MD, PhD
Chief of the Cell Therapy and Transplant Section, Children's Hospital of Philadelphia (CHOP)
Dr. Stephan Grupp is the Chief of the Cell Therapy and Transplant Section and Director of the Kelly Center for Cancer Immunotherapy at the Children’s Hospital of Philadelphia (CHOP). He is a pioneer in CAR T-cell studies, overseeing many trials including the development of the FDA-approved CTL019 (Kymriah). Dr. Grupp's translational research in pediatric cancer cell therapy is shaping the future of treatment. He also serves as the Medical Director of the Stem Cell Lab, previously chaired the Stem Cell Committee of the national Children's Oncology Group and is a member of the National Academy of Medicine. Join us for his expert insights in the field of pediatric oncology.
