Tracks and Themes
TRACK 1: Advances in Therapeutic Development Across Modalities
Track Theme: Recent advances in therapeutic development across modalities, including gene therapy, cell therapy, and innovative therapies based on traditional modalities.
Theme 1: Recent Advances in Gene Therapy:
As the field of gene therapy expands in scope beyond orphan disease indications and learnings from ongoing clinical trials become available, the bioanalytical strategy to support this novel modality is developing. Discuss recent advances in this field, including biodistribution, pharmacodynamics, cellular immunogenicity, as well as how these fit into evolving regulatory guidance.
Theme 2: The Evolution of Cellular Therapy:
As cellular modalities expand across formats and indications, the technologies and practices for monitoring exposure, immunophenotyping, and clinical endpoints are rapidly advancing. Discuss these evolving strategies as well as considerations around allogeneic versus autologous therapies.
Theme 3: Innovation Based on Traditional Approaches:
Protein-small molecule hybrid (e.g., ADC), bi- and tri- specifics, oligonucleotides, and vaccine-based therapeutics are experiencing an exciting reemergence in innovation with new clinical findings. Discuss recent advances in biotransformation, PK/PD, and immunogenicity analyses to better assess safety and efficacy.
TRACK 2: Turbocharging Innovation in CMC -- Driving Back to Rational Drug Design
Track Theme: Beyond the innovation in drug discovery, pharmaceutical and biotechnology communities are embracing emerging opportunities and advancements in Chemistry, Manufacturing, and Controls (CMC) in all stages of the drug development life cycle. This track focuses on the emerging landscape of non-traditional platforms for drug delivery and novel modalities, such as cell and gene therapies. Discuss frontiers of drug and formulation design in biologics development, modern experimental, computational, intelligent analytics, regulatory perspective, and bioengineering.
Theme 1: Innovation Based on Non-Traditional Platforms
Innovative technologies have been harnessed to integrate cutting-edge resources with scientific expertise in shaping the next wave of medical interventions. Discuss breakthroughs with drug design and analytical tools for novel modalities, innovations in vaccine approaches, enhancing scope and coverage of modalities using AI and machine learning, as well as regulatory guidance and perspective on future innovations in biotechnology.
Theme 2: Next Generation Gene Therapies
Gene therapy advancements have revolutionized the treatment paradigm of a handful of rare disorders, from managing to curing the disease. The next wave of novel gene editing modalities will impact other therapeutic areas such as cancer, immune, and infectious diseases. Discuss coping with these advances in terms of improving patient stratification strategy, drug safety, and efficacy.
Theme 3: Explosion of Cell Therapy Beyond CAR-T
The next wave of cell therapies goes beyond the traditional Chimeric Antigen Receptor (CAR) T-cell immunotherapy (CAR-T). Newcomers include universal allogeneic CAR, tumor-infiltrating lymphocytes (TILs) and adoptive cell immunotherapy such CAR NK-cells. Discuss key advancements and challenges facing the adoption of these novel cell therapies, especially those related to drug design, safety, and supply chain.