Pharmaceutical technology and innovation are advancing at an unprecedented pace, with biotherapeutics reshaping the current landscape of medicines, treatments, and global markets. Since the late 19th century, biological products such as vaccines and serum-based therapies have marked turning points in medical science—followed by the development of peptides, proteins, and monoclonal antibodies. Today, the field continues to expand rapidly, with new antibody formats emerging daily, including multispecific antibodies and antibody–drug conjugates receiving marketing authorization worldwide. In parallel, advanced therapies are redefining the purpose of medicine. Whereas medicines have traditionally been designed to prevent or treat disease, these innovative therapies now offer curative potential for conditions that previously had no treatment.

This scientific paradigm shift brings significant regulatory challenges. Companies must determine the most effective ways to design and submit regulatory dossiers for increasingly complex products. Regulators, in turn, must develop new frameworks to evaluate such therapies - often building the first sets of regulations only after reviewing pioneering products seeking market entry. Moreover, these products are frequently manufactured using novel technologies, leading to variations in review processes depending on the techniques involved.

This session aims to foster collaboration among academia, regulators, and industry to identify optimal regulatory approaches for addressing emerging technologies. It will explore how industry is planning and structuring dossiers for emerging technology products, as well as regulatory agency methods for navigating the challenges of oversight in a rapidly evolving landscape and using mechanisms (such as reliance) to streamline and accelerate product reviews to ensure patients have timely access to cutting-edge therapies.

Session Speakers:

From Pipeline to Product: FDA's Approach to Accelerating Gene and Cell Therapy Development and Commercialization

Timothy Kamaldinov, CBER, FDA

An Analysis of Advanced Therapy Medicinal Products Regulatory Landscape in ICH Member Countries: Opportunities and Challenges

Stuart Beattie, Biogen

Best Practices, Innovative Regulation, Challenges and New Opportunities in ATMP Review and Approval - ANVISA/Brazil Perspective

Joao Batista da Silva Junior, ANVISA

The Expanding World of Bioconjugate Therapeutics: Quality, Control, and Global Regulatory Considerations

Katie Duncan, GlaxoSmithKline

Regulating Advanced Therapy Medicinal Products (ATMPs) in Chile: Regulatory Foundations, Process Mapping, and Future Outlook

Jorge Canales, ISP - Public Health Institute of Chile

Timothy Kamaldinov

Appearances