Registration is now closed. To comply with venue security policies, walk-in registrations will NOT be accepted. 

WHEN:
Thursday, April 17, 2025
5:30 PM - 8:00 PM EDT

WHERE:
Jacobs Offices, Copley Tower
Boston, MA 02116

PROGRAM DETAILS:
PFAS: Understanding “Forever Chemicals” and their potential impacts on pharmaceutical manufacturing
Join us for an informative evening program on Per- and polyfluoroalkyl substances (PFAS) and their potential impact pharma manufacturing. PFAS have been used industrially for decades, and due to their unique chemistry, they are resistant to degradation, leading to contaminated air, water, and soil. Certain PFAS have been detected in humans and animals through blood tests. While research on PFAS and their effects is ongoing, exposure to some PFAS has been linked to significant health concerns. Our speakers will discuss the science behind PFAS and share insights on how Takeda is accounting for the presence of these compounds in its operations.  

AGENDA:
5:30 PM - Arrival and Networking
6:45 PM - Presentations Begin
8:00 PM - Program Concludes

PRESENTATION 1*:
The Evolving PFAS Landscape: challenges and considerations for pharmaceuticals - Emily Pennoyer, PhD, MPH, Environmental Toxicologist
Per- and polyfluoroalkyl substances (PFAS) are synthetic fluorinated chemicals developed for their durability and water-resistant properties. Historically used in consumer goods, packaging, and industrial applications, many PFAS persist in the environment and accumulate in human serum. Some are bioaccumulative and toxic, with exposure linked to health effects such as increased cholesterol, immune system impacts, and cancer. PFAS regulations are evolving, with recent efforts to address them as a class rather than individually. However, broad PFAS definitions may include life-saving pharmaceuticals and other chemical products with essential uses, presenting challenges for regulation and environmental management. Understanding the evolving landscape of PFAS, their health effects, how they are defined and regulated is crucial for balancing environmental and public health concerns with the essential use of organofluorine containing pharmaceuticals. 

This session will provide an overview of PFAS, their uses, and their known health impacts. Using pharmaceuticals as an example, it will highlight differences across PFAS definitions used in regulatory and non- regulatory contexts and potential implications for pharmaceutical companies. Designed for professionals in bio/pharmaceutical manufacturing, environmental science, and policy, this talk will provide foundational knowledge about PFAS and their relevance to the pharmaceutical industry. 

PRESENTATION 2**:
Takeda’s Approach to Navigating PFAS Challenges - Kelly LaCarubba, Takeda Pharmaceuticals
This presentation delves into the impact of Polyfluoroalkyl substances (PFAS), known as ‘forever chemicals’ for their environmental persistence, on pharmaceutical manufacturing. With evolving global regulatory landscapes, such as the European Chemicals Agency’s (ECHA) proposed comprehensive ban on PFAS, the implications for bio/pharmaceutical manufacturing are significant. This presentation highlights how Takeda’s Global Material Qualification organization employs an agile, systematic approach to manage the risks associated with this evolving regulatory environment. Insights into Takeda’s comprehensive strategy are shared, focusing on data collection, digital tools, and a conceptual demonstration of the dashboard designed to tackle these challenges. 

This session provides actionable insights into how Takeda prepares for and responds to regulatory changes, ensuring the continued delivery of life-transforming products to patients. It is tailored for professionals in bio/pharmaceutical manufacturing, environmental scientists, regulatory affairs specialists and corporate sustainability officers. It is also relevant for senior executives responsible for strategic decision-making and suppliers involved in the bio/pharmaceutical sector who want to align with evolving regulations and data requirements.

SPEAKERS:

REGISTRATION FEES:

Registration by EOD Wednesday, April 9, 2025
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration Starting Thursday, April 10, 2025
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: $10 

**PLEASE NOTE: CANCELLATIONS RECEIVED ON/AFTER APRIL 9 ARE SUBJECT TO BILLING**