Dr. Mohammad A. (Mo) Heidaran, Ph.D. is Owner and Chief Regulatory Scientist at Cellx Inc., where he advises on regulatory strategy, product development, and FDA submissions for advanced therapies. With more than 35 years of experience spanning government, industry, and academia, he has held leadership roles at FDA/CBER, Celgene, Becton Dickinson, and Parexel, and most recently led translational and regulatory strategy at GC Therapeutics.

Dr. Heidaran spent nine years at FDA’s Center for Biologics Evaluation and Research (CBER), where he served as Acting Branch Chief in the Office of Tissues and Advanced Therapies and was recognized as a subject matter expert in CMC policy, GMP compliance, and regulatory review of cell and gene therapies. Earlier in his career, he conducted research at the National Cancer Institute, contributing to the understanding of growth factor signaling and oncology.

He is an active member of professional organizations including ISCT and USP, contributes to regulatory and legal committees, and has authored over 50 publications and more than 25 issued patents. A frequent invited speaker, Dr. Heidaran is recognized globally for his expertise in regulatory strategy, CMC development, and advancing cell and gene therapies from research to the clinic.

Professor of Pediatric Hematology-Oncology & Health Sciences. Areas of special interest include Immunotherapy and CAR-T cells, leading a major collaboration with Indian Institute of Technology at Powai (IIT-B) and National Cancer Institute, Bethesda that led to India’s first indigenously developed and approved CART-cell product. Principal Investigator at CAR T- & Cell Therapy Center (CTCTC) at TMC developing multiple cell & gene therapies for cancer and related indications. Leads multi-center randomized controlled trials of Indian Pediatric Hematology- Oncology Group (InPHOG) as core-member of ALL ICiCLe- Trial Group, and Study Chair of Multicentre RCT of Pediatric Hodgkin Lymphoma. Other areas of interest in research are Histiocytic Disorders, Cancer associated Thrombosis and Immunology in Malignancies. Senior member & past-Convener of Pediatric Hemato-lymphoid Group at Tata Memorial Center Mumbai that oversees a clinical program of 11-1200 new case of leukemia, lymphoma and histiocytic disorders in children annually and a DM Pediatric Oncology Training program that enrols 6 new students a year.

Dr (Lt Col) Pawan Kumar Gupta, is President – Medical & Regulatory Affairs, Stempeutics Research, Bangalore since October 2008, which is the first stem cell company in India focusing on clinical development of major unmet medical needs using allogeneic bone marrow derived Mesenchymal Stromal Cells.

Dr Pawan is a Hematologist & Medical Scientist and has worked in Armed Forces in India for 24 years. He has worked in Stem Cell Institute, University of Minnesota and trained in the field of stem cells. He was the former Dean of Manipal Institute of Regenerative Medicine, Bangalore. Under his leadership the product stempeucel® has progressed from pre-clinical to clinical trials and has been granted manufacturing and marketing approval for three indications in India.

  He has more than 100 publications and is the Asia Regional Vice President of International Society of Cell & Gene Therapy.  

Dr. Rahul Purwar is a professor at Department of Biosciences and Bioengineering at IIT Bombay. He

holds a Ph.D. in Molecular Medicine from Hannover Medical School, Germany. Dr. Rahul’s

professional journey spans various prestigious institutions and roles. He started his post-doctoral

fellowship at Harvard Medical School, Boston, USA. After his fellowship, he joined ImmunoGen,

Inc. (Boston, USA), as a scientist before returning to India as a faculty member at IIT Bombay.

His lab at IIT Bombay developed indigenous technology platform for CD19 CAR-T cell therapy, a

type of gene therapy. Based on his research at IIT Bombay, Dr Purwar founded ImmunoACT in 2018,

first cell & gene therapy company in India. Upon successful multiple clinical trials, ImmunoACT

received market authorization of the country’s first CAR-T cell therapy, and Honorable President of

India dedicated CAR-T cell therapy to the nation on April 4th, 2024. This is the first of many planned

milestones in democratizing access to advanced cell & gene therapies in India.

Dr. Purwar’s research work is well-recognized in the scientific community, with numerous

publications to his credit in esteemed journals. His contributions to the field of Biosciences & Bioengineering are commendable and his work continues to inspire many in the scientific community.

An esteemed leader in the biologics, cell and gene therapy industry with over two decades of expertise in developing molecules for the US and EU markets in the biologics space. In addition to a strong background in structural, biophysical, process development, analytical, and biological assays, Lakshmikanth has demonstrated expertise in cell and gene therapy programs using AAV and Lentiviral vector based therapies over last eight years. He has filed several patents in the field of product development in biologics and cell and gene therapies and been part of successful approvals of US IND’s, BLA’s and EU MAA’s for biosimilars. As the Chief Scientific Officer at Immuneel Therapeutics, Lakshmikanth oversees a team of professionals dedicated to the development of novel cell and gene therapy products and platforms. The key achievements of the same include technology transfer of antiCD19-CAR-T from HCB to Immuneel facility in India, resulting in a commercial approval of the first global CD19-CAR-T product (Qartemi®) in India, as well as successful development of a patented SIM-CAR-T platform resulting in both 3 and 7 day CAR-T product. Other notable achievements include development of an allogenic CAR-T platform and evaluation of novel humanized AntiCD19-gd CAR-T with established POC data for further studies. Prior to the current role, Lakshmikanth has served as Chief Scientific Officer of InnovaVector SRL a Gene therapy company based in Naples, Italy. He also served as Sr. Vice President, at Intas Pharmaceuticals handling R&D and Manufacturing Sciences for both Biologics and Cell and Gene therapy verticals, where he set up the R&D facility and programs for both Gene therapy and CAR-T cell therapies. Prior to that he has also served in various leadership roles in Biological Evans, Sanofi and Dr Reddy’s Laboratories.

Antonio Scatena is a member of the leadership team at Gateway Analytical, where he specializes in analytical testing for parenteral packaging and drug delivery systems. He partners with pharmaceutical and biotechnology companies to proactively address regulatory expectations and prevent compliance gaps during critical stages of development and commercialization. With expertise in container closure integrity, extractables and leachables, and particulate matter characterization, Antonio operates at the intersection of science and regulation to provide defensible data packages tailored for agency review and approval.

Dr. Ressler is the Vice President of Manufacturing Process Sciences at RoslinCT USA, where she leads the Analytical Development and Process Development teams to deliver robust, GMP-compliant processes and assays for cell and gene therapy (CGT) products. With leadership roles at Mustang Bio, Editas Medicine, and Duke University, Dr. Ressler has advanced multiple CGT products into clinical trials and contributed to three licensed therapies, including the successful BLA for RETHYMIC®. She is deeply committed to building high-quality data sets that drive decision-making and deepen product understanding. Dr. Ressler entered the CGT field when there was only one FDA-approved product available and continues to shape the industry’s growth. She holds a B.S. in Biomedical Engineering from Northwestern University and both an S.M. and Ph.D. in Mechanical Engineering from MIT.

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Dr. Antonio (Tony) Lee is the Global President & Executive Director of MEDIPOST Korea and serves as the Co-CEO of MEDIPOST Inc. (U.S.) and CEO of MEDIPOST K.K. (Japan), the wholly owned U.S. and Japanese subsidiaries of MEDIPOST, respectively. After earning his BSc (Hons) and MSc in Human Anatomy & Structural Biology and a PhD in Developmental Biology from the University of Otago in New Zealand, Dr. Lee held research positions in translational and regenerative medicine at the University of Sydney and the University of New South Wales, Australia.

Since joining MEDIPOST in 2011, Dr. Lee has led the company’s global commercialization and clinical development strategy for human umbilical cord blood-derived mesenchymal stem/stromal cell (hUCB-MSC) technologies and products, including the world’s first regulatory-approved allogeneic MSC product, CARTISTEM®, for knee osteoarthritis. He has overseen late-stage clinical trials in Japan and the U.S., and commercial manufacturing, CMC, and market access strategies across multiple jurisdictions, with over 33,000 patients treated with CARTISTEM® in South Korea since its market launch in 2012.

Masayo Takahashi is an ophthalmologist who completed her doctoral program (Visual Pathology) at the Graduate School of Medicine, Kyoto University. She served as the leader of the Laboratory for Retinal Regeneration, RIKEN Center for Biosystems Dynamics Research from 2006 to 2022, conducting groundbreaking clinical research using the world’s first induced pluripotent stem (iPS) cells in 2014. In 2017, she collaborated with the city of Kobe to establish the “Kobe Eye Center.” After leaving RIKEN in 2019, she became the CEO of Vision Care Inc. and subsequently founded two subsidiary companies dedicated to gene therapy development and cell therapy research.

John Ng joined DHC in 2023 as General Manager of Asia Pacific, responsible for growing and supporting the Asia-Pacific market. Before joining DHC, John served as CTO of Tessa Therapeutics. Tessa Therapeutics is a clinical-stage biotechnology company based in Singapore that is developing a portfolio of autologous and allogeneic cell therapy assets. 

John joined Tessa Therapeutics as a member of its executive leadership team in 2016 and grew the company from 30 people to more than 200 people. In 2021, he was asked by the Board of Directors to become the Acting CEO, where he led the company to complete a USD $126M fundraising round. He led the design, build, and validation of their multi-product integrated commercial cGMP facility (134,000 sq ft). The facility obtained the GMP certificate from the Health Authority of Singapore (HSA) to manufacture cell therapy products in early 2023.

As the CTO, John was responsible for the Operations organization, which includes Manufacturing, Process Development, Quality, Program Management, Engineering, and Global Supply Chain. Under his leadership, Tessa Therapeutics completed a phase 3 pivotal autologous cell therapy trial supplied by in-house manufacturing. He also led the translation of multiple programs with Tessa’s academic partners, executing successful tech transfers and comparability runs.

Before Tessa Therapeutics, John served in various leadership roles in Technical Operations in publicly listed companies. He spent ten years in China, responsible for Procurement, Global Supply Chain, and Program management.

Matthew Hewitt, B.A. Ph.D., currently serves as Vice President, CTO Manufacturing Business Division at Charles River Laboratories (CRL) playing a critical role in driving CGT strategic vision as well as leading multiple operational initiatives across CRL’s CGT CDMO, Biologics Testing, and Microbial Solutions global network.   Before joining CRL, he was Head of R&D and Clinical Development for Lonza’s Personalized Medicine Business Unit leading Cocoon platform development, a closed, automated, scalable cell therapy manufacturing solution. In addition, he executed numerous collaborations across academia and industry leveraging the Cocoon. Prior to Lonza, Matt led the Tumor Immunology and Microenvironment program at Bellicum Pharmaceuticals, focusing on improving cell therapy efficacy in solid tumors. He also led the Immunology group at the University of Pennsylvania’s Gene Therapy Program, leading and contributing to numerous AAV gene therapy programs.   Matt received his B.A. in Molecular Biology at Goucher College while playing Men’s Lacrosse, PhD in Biophysics and Physiology from the University of Alabama at Birmingham, and completed his postdoctoral fellowship at Johns Hopkins University within the Asthma and Allergy Division.

Dr Kilian Kelly has over 20 years’ experience in biopharmaceutical research and development, including almost 15 years focussed on the development of mesenchymal stem cell (MSC) based therapies. He joined Cynata in March 2014, initially as Vice President, Product Development, then Chief Operating Officer from May 2019, and since July 2023 has been CEO & MD. At Cynata, he has overseen all stages of the development of the Cymerus™ induced pluripotent stem cell (iPSC)-derived MSC technology, including the first completed clinical trial of any iPSC-derived product worldwide.

Dr Kelly previously held positions at Biota Pharmaceuticals, Mesoblast Limited, Kendle International, Amgen and AstraZeneca. He holds a Masters in Pharmacy degree from the Robert Gordon University, Aberdeen, a PhD in Pharmaceutical Sciences from Strathclyde University, Glasgow, and he is a Graduate of the Australian Institute of Company Directors (AICD), Melbourne. He is a member of the International Society for Cell and Gene Therapy (ISCT), the International Society for Stem Cell Research (ISSCR), the Royal Pharmaceutical Society and the AICD. Dr Kelly also serves on the ISCT Asia-Pacific Industry Committee, the ISSCR Best Practices Working Group for the Development of PSC-Derived Therapies and the Industry Interface Committee of the Center for Commercialisation of Regenerative Medicine (CCRM) Australia.