[Webinar] The Evolution of Cell and Gene Therapies

Date: November 19, 2026 | Thursday | 5:30 PM, Manila Time

Cell and gene therapies have evolved from experimental laboratory concepts into a maturing class of clinical treatments that offer potential one-time cures for genetic disorders and cancers. This webinar will discuss the following major events:

Early Foundations (1960s–1980s)

  • DNA Discovery & Transformation: The field began with the recognition of DNA as the carrier of genetic code and early 1960s experiments demonstrating the transformation of human cells with genomic DNA.
  • Viral Vectors: In the 1980s, researchers like David Williams and David Nathan at Boston Children’s Hospital published the first studies showing that modified viruses could insert new genes into blood-forming stem cells.
  • Recombinant DNA: The rise of recombinant DNA technology allowed scientists to engineer vectors—such as retroviruses and adenoviruses—to carry therapeutic genetic material.

First Clinical Trials and Early Setbacks (1990–1999)

  • First Gene Therapy (1990): The first approved human gene therapy trial treated a young patient with adenosine deaminase (ADA) deficiency (a severe combined immunodeficiency).
  • The 1999 Setback: The field suƯered a major safety crisis during a clinical trial in 1999, leading to a temporary halt in many studies and forcing a complete re-evaluation of vector safety, immune responses, and patient conditioning.

The Rise of Cell Immunotherapy (1989–2010s)

  • Genetically Modified T-Cells (1989): The first clinical trial involving genetically modified cells used engineered T-cells to treat a patient with advanced melanoma.
  • CAR-T Revolution: Developed through the 1990s and 2000s, Chimeric Antigen Receptor (CAR) T-cell therapy modified patient T-cells with synthetic receptors to hunt down cancer cells.
  • First FDA Approvals: In 2017, the FDA approved the first CAR-T cell therapy for pediatric acute lymphoblastic leukemia (ALL), followed by expansions into lymphomas and multiple myeloma (such as therapies from Gilead’s Kite Pharma and Bristol-Myers Squibb).

Precision Gene Editing and Modern Era (2012–Present)

  • CRISPR & RNAi Discoveries: The invention of CRISPR-Cas9 in 2012 (alongside RNA interference technologies) provided unprecedented, letter-by-letter precision to rewrite or silence genomic sequences.
  • In Vivo & Ex Vivo Breakthroughs: Therapies expanded from rare single-gene conditions—like Zolgensma for spinal muscular atrophy (SMA)—to landmark CRISPR-based treatments like Casgevy, approved by the FDA in 2023 for sickle cell disease and beta-thalassemia.
  • Current Expansion: The pipeline now spans over 400 active ATMPs (Advanced Therapy Medicinal Products), moving into targeted in vivo gene delivery (such as AAV-based vectors for renal and metabolic disorders), custom N=1 therapies, and systemic frameworks by regulatory bodies like the FDA Rare Disease Drug Development Framework.

About the Speaker:

Shirley M. Bartido, PhD, MBA | Principal Consultant | CELLiCONsultant | Cell & Gene Therapy Expertise

Dr. Shirley Bartido has recently retired as Takeda’s Director of Global Regulatory Affairs in Cell Therapy Oncology. Dr. Bartido holds a PhD in Immunology and an MBA in Pharmaceutical Management from Rutgers University. She completed her doctoral studies at New York University elucidating an alternative Class II processing and presentation pathway utilizing a viral antigen. Her postdoctoral work at Memorial Sloan Kettering Cancer Center involved the development of DNA vaccines for the treatment of melanoma using the melanosomal antigen tyrosinase. Following her postdoctoral work, she joined the Carl Icahn Institute of Gene Therapy and Molecular Medicine as an Assistant Professor to serve as the Assistant Director of the Gene Therapy Immunology Core Laboratory. In this role, she developed several immunomonitoring tools for assaying efficacy of adenoviral directed immunotherapies using AdV-IL-12 vectors targeting metastatic liver cancer. This was followed by an 11-year role as the Senior Quality Manager of the Cell Therapy and Cell Engineering Facility at Memorial Sloan Kettering Cancer Center. In this role, she developed the QA program for the development and GMP manufacturing of autologous CD19 Chimeric Antigen Receptor T-cell therapies for several clinical trials which targeted several indications in leukemia and prostate cancer as well as gene therapy for the treatment of B-Thalassemia using lentiviral transduced CD34+ HPSCs. She was an integral member in the design and construction of a state-of-the art GMP facility at MSKCC. She then proceeded to become the Director of Regulatory Affairs at Cellectis Inc, a French based company. The company’s platform consists of incorporating gene editing TALEN based technology in the development of allogeneic CAR T-cells targeting hematological malignancies. At Takeda, she was the global regulatory lead in several cell-gene therapy projects that seek to broaden the impact of immunotherapy in cancer treatment by focusing on mechanisms that leverage the innate immunity. She has authored several peer-reviewed publications in several well cited scientific journals and has been invited as speaker in many well attended international and regional conferences. This included recent presentations on “Targeting Cancer: Hitting the Bullseye with Cell and Gene Therapies” and “Gene Editing in Cell Therapy and Its Regulation” and on “Viral vectors manufacturing: Chemistry, Manufacturing, Control and Regulatory Aspects”, at the APEC Pilot CoE in Advanced Therapies at Seoul, Korea and at the 25th PIC/S Expert Circle Meeting on Human Blood, Tissues, Cells and ATMPs in Djakarta, Indonesia, respectively. She is currently a principal consultant on cell and gene therapies at CELLiCONsultant.

Register

This webinar is free and open to the public.

For questions, email us at:

[email protected]