2025 ISPE Biotechnology Conference Announces Keynote Speakers
The 2025 ISPE Biotechnology Conference will take place 2 – 3 June in Boston, Massachusetts, USA and virtually
ISPE has announced its keynote speakers at the 2025 ISPE Biotechnology Conference, taking place Monday, 2 June, through Tuesday, 3 June, in Boston, Massachusetts, USA and virtually. This conference will focus on digital transformation in biopharmaceutical manufacturing holistically.
Biotech is advancing at an unprecedented pace, and the only way to stay ahead is through continuous learning and adaptation. The emergence of AI, automation, and digital twins means that we must rethink traditional approaches to manufacturing and quality. At the same time, global regulatory landscapes are evolving, requiring us to stay informed and agile. Beyond staying current with technical advancements, professional growth is about building a network of peers and mentors who challenge us to think differently and inspire new ways of working. Conferences like this provide an essential space for that kind of learning and collaboration.
Michelangelo Canzoneri, PhD, 2025 ISPE Biotechnology Conference Chair and Global Head of Group Smart Manufacturing at Merck KGaA Darmstadt, Germany.
The conference will feature a diverse array of professionals from throughout the biotech ecosystem, with case studies showcasing how companies are applying technologies in real-world scenarios, related to process control, regulatory compliance, next-generation manufacturing, and more. Key discussions will include how AI and automation are accelerating biopharmaceutical manufacturing (based on the ISPE Baseline® Guide: Pharma 4.0™ approach), how regulatory expectations are evolving in a digital age, and how to embed sustainability into process design.
Confirmed Keynote Sessions and Speakers:
- “AI as an Enabler for a Sustainable Quality Transformation,” presented by Magaly Aham, Senior Vice President Head of Global Quality Compliance and Systems, Takeda – Boston
- “Data Management Requirements for Sterile Manufacturing Processes,” presented by Ronald Bauer, PhD, Head of Institute Surveillance, Austrian Agency for Health and Food Safety (AGES)
- “Thriving in Expansion: Compliance and Improvement Blueprint,” presented by Eamonn Warren, Senior Vice President of Global Parenteral Manufacturing, Eli Lilly and Company
- “Addressing Current Challenges in Biomanufacturing with Reliability, Efficiency, Agility, and Differentiation,” presented by Oliver Thiel, Vice President Operations Commercialization, Amgen
- Global Harmonization of the Drug Approval Process (official title to be confirmed), presented by Timothy Watson, Vice President of CMC Regulatory Affairs, Gilead Sciences, and a speaker from the Paul-Ehrlich Institute in Germany
Session tracks will feature presentations focused on accelerating biopharma with AI and machine learning and implementing digital initiatives in the biopharma industry. They will also delve into opportunities for enhancing quality initiatives such as cleaning validation and biologics via analytics, future-proofing the biomanufacturing facility lifecycle, driving operational readiness and cultural excellence, and pursuing process intensification, continuous manufacturing, and sustainability.
For a limited time, registrants to the 2025 ISPE Biotechnology Conference are eligible to receive one of the following two printed ISPE Guides outlined below.*
- Use code BIO25AUTOLOG to request the ISPE Guide: Advanced Therapy Medicinal Products – Autologous Cell Therapy at checkout
- Or use code BIO25BIOPDM to request the ISPE Guide: Biopharmaceutical Process Development and Manufacturing at checkout
*Restrictions apply. This offer is valid for In-Person or Virtual All Access Pass registrants who use the designated promo code at checkout by 11 April 2025, while supplies last. Guidance documents are available in printed format only and will be sent in the weeks following conference registration.
About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 22,000+ members of ISPE provide solutions to complex pharmaceutical industry challenges through innovation, member and workforce development, and technical, regulatory, and compliance collaborations in more than 120 countries worldwide. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. For more information, visit ISPE.org.