Madhusudan Peshwa is a seasoned life sciences executive, entrepreneur, and investor with a track record of guiding biopharmaceutical innovations from early concept to commercial success. With leadership roles spanning private startups to public enterprises, he has driven FDA approvals, global partnerships, and strategic licensing agreements across the U.S. and Asia. Dr. Peshwa’s expertise spans cellular therapies, biologics, and vaccines, with deep experience in process and product development, regulatory strategy, manufacturing operations, and fundraising.

He has served as CEO of MKC Biotherapeutics, held CTO roles at Tessera Therapeutics, Mana Therapeutics, and GE Healthcare, and is an elected Fellow of the American Institute for Medical and Biological Engineering (AIMBE). Known for building high-performing teams and forging impactful collaborations with academia, government, and industry, Dr. Peshwa remains at the forefront of therapeutic innovation—driven by a passion for advancing science to improve global health.

Stephan Kadauke, M.D., Ph.D.

Director of the Cell-Based Therapy Laboratory (CBTL) at the Children's Hospital of Philadelphia (CHOP)

Martin Bonamino, Ph.D.

Head of the Cell and Gene Therapy Program at the Brazilian National Cancer Institute

Tim joined Alliance for Regenerative Medicine (ARM) as CEO in 2022 with more than 20 years of experience in the biotechnology industry. A company-builder with a focus on corporate culture, he has helped early-stage organizations create internal cohesion and advance strategic initiatives. As chief executive, Tim divides his time between managing ARM and its global staff of nearly 30 employees and serving as an external advocate on behalf of ARM’s membership and the broader cell and gene therapy sector.

Tim was most recently the Chief Culture and Corporate Affairs Officer at Xilio Therapeutics, a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer. Prior to that, he was the Chief Corporate Affairs Officer at CRISPR gene-editing pioneer Editas Medicine, where he led the company’s global policy and government affairs, bioethics, communications, market development and human resources initiatives. He also served in executive public affairs roles at Cubist Pharmaceuticals and Biogen.

Tim was an Advisory Group member of the Value-Based Payments for Medical Products consortium at the Duke-Margolis Center for Health Policy. He also has been a member of the Board of Directors of the non-profit organization Life Science Cares and has chaired the Ethics Committee of the American Society of Gene and Cell Therapy (ASGCT). Tim is also no stranger to the ARM network. He previously served as a member of ARM’s Gene Editing Task Force and on the Biotechnology Innovation Organization’s Gene Editing Working Group. Tim received a B.A. in history and philosophy from Boston College and a J.D. from the Columbus School of Law at the Catholic University of America. He lives in Boston with his wife and children and is a passionate fan of the Boston Celtics.

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.

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.

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.

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.

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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.

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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

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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.

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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.

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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.

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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.

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