Course Overview

This course provides a brief history of biologics and follow-on biologics (also known as biosimilars) and how they are regulated, describes the key aspects of chemistry, manufacturing and controls (CMC) for various types of biologic products, defines principles underlying biologics safety and clinical trial assessments, and aids in developing a planning strategy for toxicology and clinical studies supporting biological drug development. Participants will gain a broad multidisciplinary understanding of the scientific, management and regulatory decision points in the development of new biologics.

Benefits of Attendance

  • Learn the history of biologics and how they are regulated
  • Walk away with an understanding of the preclinical studies used to support the phases of clinical trials
  • Work with peers to develop a strategy for developing new biologics, from first in human to product launch
  • Learn from FDA and industry experts about biologics and biosimilars

Download the current agenda for this comprehensive course on Biologics and Biosimilars.

  • Discuss the difference between small molecules and biologics in terms of regulatory pathways to approval
  • Describe the differences between biologics and biosimilars
  • Define manufacturing process of biologics
  • Describe key components of pre-clinical packages required for Regulatory approval of biologics
  • Describe key pharmacovigilance concepts including safety risks
  • Discuss the utility of biomarkers in the development of biologics including oncology products
  • The History of Biologics
  • The IND/BLA Regulatory Procedure
  • Chemistry, Manufacturing and Controls (CMC)I: Biologic Bulk Drug Substance
  • Chemistry, Manufacturing and Controls (CMC) II: Specified Biotechnology Drug Program
  • Biotech Toxicology
  • Special Topics in Toxicology
  • Overview of Clinical Trial Design
  • Immunogenicity
  • Getting your Biologic into Humans Workshop
  • Perspective on Preventive Vaccine Trials
  • Managing the Development Process through Multidisciplinary Project Teams
  • Marketing Authorization Application (MAA)
  • Clinical and Nonclinical Professionals
  • Manufacturing Personnel
  • Regulatory Affairs Professionals
  • Seasoned drug developers transitioning into biologics

Continuing Education Credit
Pharmaceutical Education & Research Institute, Inc. (PERI) is pleased to make continuing education credit available to you for attendance at this program. To receive credit, you must attend the entire program and submit the Continuing Education Application form directly to a PERI on-site coordinator. Additional $35 fee applies for students who are applying for continuing education credit.

ACPE Statement:
Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider f continuing pharmacy education. ACPE Universal Activity Number is 0708-0000-17-003-L01-P. 1.0 continuing education units (CEUs) are available for this program. Initial Release Date: 04/27/17. This is a knowledge based CPE Activity.

ACCME Statement:
PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. PERI, Inc. designates this live activity for a maximum of 10 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Course Director: Paul Beninger, MD, MBA

2d472fa Dr. Beninger is Assistant Professor of Public Health & Community Medicine at Tufts University School of Medicine, where he is the Director of the MD/MBA and MBS/MBA Programs. He began his career in drug development in 1987 at the US Food and Drug Administration, first as a reviewer and manager for drugs against HIV/AIDS and opportunistic infections and then as a division director for medical devices. He joined Merck & Company in 1995 and developed experience in regulatory affairs, medical affairs and drug safety in the areas of anti-infective drug and biological products, vaccines, anti-diabetic drug products and oncology drug products, before joining Genzyme as vice-president of pharmacovigilance in 2006; Genzyme was acquired by Sanofi in 2011. Dr. Beninger retired from Genzyme-Sanofi in April, 2017. Dr Beninger trained in internal medicine and infectious diseases. He received his MD from the University of California, Davis, his BA from Claremont McKenna College in Claremont, California, his MBA from St Joseph’s University in Philadelphia, Pennsylvania, and his graduate certificate in epidemiology from Tufts. He has published and spoken extensively on regulatory science, drug and vaccine safety, and pharmacovigilance, and he is a fellow of the American College of Physicians and the Infectious Disease Society of America.

Confirmed Course Faculty

Christopher Ellis
Pharmacologist, CDER/Division of Anti-Viral Products, US Food & Drug Administration

Martin Green, PhD
Supervisory Toxicology, CBER/Division of Vaccines and Related Product Applications, US Food & Drug Administration

Jaw Horrow, MD, MS, FACC
Executive Director, Global Clinical Development, Merck & Co.
Professor of Anesthesiology & Perioperative Care, Drexel University College of Medicine, Philadelphia, PA

Orest Hurko, MD
Senior Clinical Consultant, Rare Disease Unit, Pfizer

Jinhua Lu, PhD
Pharmacology/Toxicology Reviewer, CBER/Office of Tissues and Advanced Therapies, US Food & Drug Administration

Chandrasekha Natarajan
Chief Scientific Officer, ViNa Pharma Consultants LLC

Gillian Woollett, MA, DPhil
Vice President, FDA Regulatory Policy, Avalere Health

Event Details

Date: April 27 – 28, 2017
Location: PERI Training Facility
Fairfax, VA 22031
Course Rate: $1595
Early Bird Rate: $1395
Early Bird Deadline: 03/24/17

Recommended Hotel

Hyatt House Falls Church/Merrifield
8296 Glass Alley
Fairfax, VA 22031

Request a Proposal

Interested in bringing this course to your company? Request a proposal and a PERI team member will be in touch about hosting this course as a Corporate Education program.

Request Proposal

Request Proposal

Your Name (required)

Your Title (required)

Your Company (required)

Your Email (required)

Your Phone(required)

Subject of Interest(required)

Additional Information
(# Attendees, Location, Live/Online Learning, etc.)

How did you hear about us?

Course Director

Paul Beninger, MD
VP Global Patent Safety and Risk Management, Genzyme

Course Information

Jo Ann Zoul
Email Question