June 20-22 2017

Boston, MA

2 weeks to go!

 

Pre-Conference Workshop A
Tuesday June 20, 2017

09:00 - 17:00

Outsourcing, Technology Transfer, & CMO-Client Relationships


Workshop Leader: Firelli Alonso, Senior Director, Biotherapeutics & Vaccines Outsourcing, Pfizer Workshop Leader: Jon Crate, President & Senior Chemist, FAI Testing Workshop Leader: Kim Hejnaes, CEO, Hejnaes Consult


A Full Day Workshop


As potent compounds continue to increase in prevalence, an ever-increasing number of drug developer companies are investing in outsourcing partners for the development and manufacture of potent compounds for clinical studies and commercial supply.

The CMC section of a biopharmaceutical project is typically on a time-critical path, which can prove a challenge for both the client (contract giver) and the CMO (contract acceptor). To ensure a successful collaboration and outcome, client expectations must be aligned with the contracted CMO, a factor particularly relevant in the highly potent space, where containment facilities and expertise are of paramount importance. This workshop will allow you to ‘wear the hat’ of a big pharma sponsor in a safe, educational and entertaining environment, allowing you to explore a multitude of outsourcing situations in one day, gaining expertise that would usually take years to develop. Immerse yourself in interactive, hands-on sessions covering every aspect of the outsourcing journey, including:

CMO SELECTION PROCESS
Take part in an interactive case study, giving you a handson experience in selecting CMOs in different geographies and with different experiences, to ensure a successful outsouring process.

TECH TRANSFER
Ensure that the key process and analytical factors are communicated and transferred effectively to external manufacturers.

EXECUTION OF CONTRACT
Learn effective vendor-management tools to create a sense of ‘co-ownership’ of the project, to facilitate a seamless contract execution and completion.

Firelli Alonso, Senior Director, Biotherapeutics & Vaccines Outsourcing, Pfizer

Firelli Alonso

Jon Crate, President & Senior Chemist, FAI Testing

Jon Crate

Kim Hejnaes, CEO, Hejnaes Consult

Kim Hejnaes cropped

Pre-Conference Workshop B
Tuesday June 20, 2017

09:00 - 12:00

Successful Multifunctional Approaches to Managing Risks Associated with Manufacturing and Quality


Workshop Leader: Patricia Weideman, President & Principal, Sakari Consultants


A Half Day Workshop


Development, manufacturing, and delivery of safe and high-quality pharmaceutical products require input and cooperation of multiple functions throughout the product’s life cycle within a company or an organization.  This workshop will focus on identification and discussion of internal and external operational challenges that companies experience and expect to experience in changing regulatory and fast-paced development environments.

Attendees will discuss:

  • Impact of toxicology on selection of controls for cross-contamination and worker protection
  • What teams and their roles are needed in implementation of effective programs to ensure delivery of safe and high-quality products with timely manufacturing schedules
  • How to align a company product quality program with regulatory expectations-what are the basics that every regulator wants to see
  • Define the similarities and differences between cGMP and worker safety programs-how can we synergize the efforts

Patricia Weideman, President & Principal, Sakari Consultants

Patricia Weideman - Photo

Pre-Conference Workshop C
Tuesday June 20, 2017

13:00 - 16:00

Effective Occupational Health Categorization & Banding


Workshop Leader: Bob Sussman, Managing Director, SafeBridge


A Half Day Workshop


This workshop will improve industry consistency by defining and maintaining categorization. This session will provide a general overview of handling recommendations and basic descriptors of safe work environments based on categorization. Qualitative health-based approaches have been developed to assess and communicate the potential health hazards of these novel compounds to workers.

Attendees will discuss:

  • Aligning hazard assessment classifications
  • Understanding the toxicological criteria of a potent compound
  • Assigning banding classifications and creating an industry standard
  • Ensuring equipment meets requirements and development demands

Bob Sussman, Managing Director, SafeBridge

Robert Sussman