Join Us for the Bridging the Gap Webinar Series
A monthly panel discussion on emerging topics that are changing the field of cell and gene therapy
Cell and Gene Therapy Discussion Panel
The expanding use of advanced therapy medicinal products (ATMPs) is presenting a new set of challenges for staff and infrastructure at point of care centers. Our “Bridging the Gap” webinar series opens a platform to discuss industry questions, address pressing issues, hear from cell and gene therapy leaders, and network with peers.
Featuring prominent guest speakers spanning fields from scientific discovery to clinical introduction of cell and gene therapies, this webinar series roundtable is created by leaders in the field for their peers. Join us to hear discussions of hot topics, address critical areas of need, and share insights not being discussed anywhere else. Attendees will have the opportunity to ask questions and get answers from the live panel.
Sign up for the series. You’ll receive a webinar log-in code several days before each event. You can unsubscribe (or resubscribe) at any time by emailing: bridgethegap@azenta.com
Sponsored by Azenta Life Sciences and the Emily Whitehead Foundation with industry-leading guest hosts and speakers.
READ THE RECAP BLOGS LISTED BELOW
Monthly Virtual Panel Discussion
Who: Industry leaders, providers of cell and gene therapies, and all interested stakeholders
What: Various featured panelists from clinic and industry, along with host Tom Whitehead of the Emily Whitehead Foundation
Why: Address emerging challenges around implementation of cell and gene therapies, and raise awareness of clinical trial opportunities
Where: Online via GoTo Webinar
When: First Friday of each month at 8 am PST / 11 am EST / 4 pm GMT / 5 pm CET. Days and times may change so make sure you register to receive updates.
NEXT WEBINAR
Date: Friday, October 4, 2024
Time: 8 am PST/11 am EST/ 5 pm CET
Guest Speaker: TBD
Topic: TBD
With Panelists: Dr. Patrick Hanley, Professor and Director of the Cellular Therapy Program at Children’s National Hospital, and Al Ribickas, Assistant Director of Cell Therapy Facility Operations, Moffitt Cancer Center.
Upcoming Guest Speaker
Equity of Access to Advanced Therapies: Considerations and Best Practices
Friday, September 6, 2024
Jacqueline Barry, Ph.D.
Chief Clinical Officer, Cell and Gene Therapy Catapult
Jacqueline Barry is a senior business leader with over 20 years of experience in biologics and advanced therapies. Her career has focused on supporting the translation of research from the laboratory bench through to gaining regulatory approval and then clinical delivery. She possesses a blend of expertise across the areas of regulation, quality, Good Manufacturing Practice, science, strategy, commercial development and management.
Jacqueline holds an executive position at the Cell and Gene Therapy Catapult, where she leads a specialist team that is dedicated to developing regulatory and translational strategies for advanced therapy products, as well as working to ensure that the wider ecosystem supports the development and adoption of these therapies in the UK and beyond. She also leads a network of advanced therapy treatment centres in the UK that aim to accelerate patient access to these transformative therapies.
Jacqueline sits on a number of national and international advisory boards. She feels passionately about making advanced therapies more widely available for patients and over her career she has worked closely with industry partners and policy makers to support the adoption of these therapies by healthcare systems.
Prior her time at Cell and Gene Therapy Catapult, Jacqueline worked at the Scottish National Blood Transfusion Service where amongst other activities she designed the Regulatory strategy for the Cellular Therapies for the Blood Transfusion Service and acted as Qualified Person for their release.
HOSTS AND PANELISTS
Meet Our Hosts and Panelists
Hosts and Panelists
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, Ph.D.
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.
Sept. 2024 - Dr. Barry - Equity of Access to Advanced Therapies: Considerations and Best Practices
Jacqueline Barry, Ph.D.
Chief Clinical Officer, Cell and Gene Therapy Catapult
Jacqueline Barry is a senior business leader with over 20 years of experience in biologics and advanced therapies. Her career has focused on supporting the translation of research from the laboratory bench through to gaining regulatory approval and then clinical delivery. She possesses a blend of expertise across the areas of regulation, quality, Good Manufacturing Practice, science, strategy, commercial development and management.
Jacqueline holds an executive position at the Cell and Gene Therapy Catapult, where she leads a specialist team that is dedicated to developing regulatory and translational strategies for advanced therapy products, as well as working to ensure that the wider ecosystem supports the development and adoption of these therapies in the UK and beyond. She also leads a network of advanced therapy treatment centres in the UK that aim to accelerate patient access to these transformative therapies.
Jacqueline sits on a number of national and international advisory boards. She feels passionately about making advanced therapies more widely available for patients and over her career she has worked closely with industry partners and policy makers to support the adoption of these therapies by healthcare systems.
Prior her time at Cell and Gene Therapy Catapult, Jacqueline worked at the Scottish National Blood Transfusion Service where amongst other activities she designed the Regulatory strategy for the Cellular Therapies for the Blood Transfusion Service and acted as Qualified Person for their release.
Aug. 2024 - Laura Alquist - Breaking Bottlenecks: Enhancing Autologous Cell Therapy Manufacturing
Laura Alquist
Vice President and Head of Global Manufacturing, Kite, a Gilead Company
Laura Alquist is Vice President and Head of Global Manufacturing at Kite, a Gilead Company, where she leads a multi-site, global network of T-cell therapy and viral vector facilities responsible for manufacturing Kite’s cell therapy products.
Employees at Kite manufacturing locations ensure successful production and delivery of innovative CAR T-cell therapies to patients around the world with industry-leading turnaround times. The team works collaboratively with other Technical Operations functions (i.e., Process Development, Quality, Supply Chain), as well as Clinical Operations, Commercial, and IT to anticipate and meet patient demand for Kite’s cell therapy products.
Laura joined Kite in 2016, serving in a variety of positions where she helped design and optimize end-to-end operations and processes. She was instrumental in shaping and scaling Kite’s global operations as the company’s reach and network expanded, and as the number of regulatory geographies and demand for commercial products grew. Most recently, Laura led the Global Supply Chain organization in managing logistics, labeling, and packaging engineering, inventory management, sourcing and procurement, supply and operations planning, master data governance, sales and operations, and business systems.
Prior to joining Kite, Laura spent 20 years at Amgen in a range of global and operational roles of increasing responsibility across Supply Chain, Manufacturing, Quality, and IT.
Laura holds a Bachelor of Science in Business Management from California Lutheran University and is APICS certified in Supply Chain operations.
July 2024 - Dr. Puri - Attacking Solid Tumors: TIL Revolution and Next Generation Advanced Therapies
Raj Puri, M.D., Ph.D.
Executive Vice President, Regulatory Strategy and Translational Medicine, Iovance Biotherapeutics
Dr. Puri joined Iovance Biotherapeutics in March 2022, bringing decades of experience in evaluating and regulating advanced therapies such as cell and gene therapy, cancer vaccines, and cellular immunotherapy. He spent 33 years at the FDA, including over 19 years as Director of the Division of Cellular and Gene Therapies in the office of Tissue and Advanced Therapies in Center for Biologics Evaluation and Research (CBER), FDA. He also participated and supervised development of FDA policies and guidance documents for advanced therapies. Dr. Puri has published over 300 articles, participated in 220+ speaking engagements, and holds numerous patents, many of which are licensed for further development. Dr. Puri has received several prestigious awards, including the FDA Award of Merit, FDA CBER’s Scientific Achievement Award, FDA Commissioner’s Special Citations and the SITC Collaborator Award. He trained at the Surgery Branch of the National Cancer Institute (NCI), where he worked in the laboratory of Dr. Steven Rosenberg on adoptive immunotherapy approaches including Tumor Infiltrating Lymphocytes (TIL) therapy for cancer. Dr. Puri was trained at the Mayo Clinic, Rochester, MN and holds an M.D. from the University of Juarez Medical School and a Ph.D. from the Central Drug Research Institute in India.
June 2024 - Dr. Mukherjee - Bridging the Global Access Gap to Advanced Therapies
Siddhartha Mukherjee, M.D.
Pulitzer Prize-Winning Author, Hematologist, Oncologist, Professor of Medicine at Columbia University
Dr. Siddhartha Mukherjee, a distinguished hematologist and oncologist, born in New Delhi, India, holds degrees from Stanford University, Oxford University (as a Rhodes Scholar), and Harvard Medical School. He completed his medical training at Massachusetts General Hospital and currently serves as a professor of medicine at Columbia University and as a staff cancer physician at the university’s medical center.
Renowned for his groundbreaking studies into the composition and behavior of cancer cells and his work in cancer research, Dr. Mukherjee has authored several best-selling books including the Pulitzer Prize-winning, "The Emperor of All Maladies: A Biography of Cancer," adapted into a PBS documentary. Elected to the National Academy of Medicine in 2023, his contributions extend to numerous publications in prestigious journals. For his contributions to science, Dr. Mukherjee was awarded the 2014 Padma Shri, one of India's highest civilian honors.
May 2024 - Dr. Forte - Shaping Tomorrow’s Standards of Care: Improving Patient Access to Advanced Therapies
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.
April 2024 - Dr. Hege - Trailblazing Paths in Cancer Immunotherapy
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
March 2024 - Dr. Lederberger - Off the Beaten Path: Lessons in Decentralized CGT Manufacturing
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.
Feb. 2024 - Dr. Levine - What's Next in CGT: Anticipating the Next Advanced Therapy Breakthroughs
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.
Dec. 2023 - Dr. Warkentin - The Journey Toward Standardization in the Advancement of Cell 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.
Nov. 2023- Dr. Grupp - Reflecting on the Past Decade of Treating Patients with Advanced Therapies
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.
About this Webinar Series
This webinar series began organically in 2020 as a monthly virtual panel discussion called “First Fridays” to raise awareness and invite open dialogue between the creators of cell and gene therapies and those administering them.
The original series has been re-launched and expanded as “Bridging the Gap” and continues as a monthly virtual panel discussion sponsored by Azenta Life Sciences and the Emily Whitehead Foundation.
It is hosted each month by Tom Whitehead of the Emily Whitehead Foundation, along with a featured guest and host from the cell and gene therapy space. These discussions focus on receipt, storage, and handling of cryogenically preserved therapies, SOP challenges, and solutions that can move the industry forward.
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