ABOUT

Northeastern University is home to the Asia-Pacific Economic Cooperation (APEC) Center of Excellence in Biotherapeutics.

Research in biotherapeutics is providing promising and innovative drugs that provide hope to millions of patients around the world. Yet these same drugs may pose risks if the challenges inherent in their production, distribution, and marketing are not properly understood and regulated.

New technologies are emerging that enable scientists and regulators to better analyze and characterize biotherapeutics. Industry, government regulators, and authorized health professionals need to be trained on these new technologies to maximize their potential, as well as minimize the risk of potential misuse or contamination. This training should involve theoretical science, clinical science, and physical hands-on skills.

A MESSAGE FROM THE DIRECTOR

Welcome to the Northeastern APEC LSIF RHSC Center of Excellence in Biotherapeutics. Northeastern University, along with the APEC Regulatory Harmonization Steering Committee, are committed to promoting regulatory convergence for Biologics across the Asia-Pacific region and the globe.  We are able to promote regulatory convergence through online learning, case studies, and providing experiential, hands-on, training to participants.  Through these learning experiences, participants are able to network with their colleagues from other agencies across the globe, as well as, with the Center’s faculty.  Through regulatory convergence, safe and effective drugs will be brought to market faster, thus benefiting patients.  Through all the activities performed at the Center, the patient is always the central focus.       

Jared Auclair, PhD
Director of Biotechnology Professional Science Masters and Training
Chemistry and Chemical Biology
Northeastern University

MISSION

• To become a premier international resource for training—online, in workshops, and through experiential learning—on the intricacies of regulatory considerations for biotherapeutics, including biosimilars.
• To serve as a facilitator of international collaboration and regulatory harmonization.

VISION

To apply modern online, experiential and case study learning to help scientists and regulators of all APEC nations increase their knowledge of biotherapeutics, and the unique regulatory aspects of biological therapies.