In 1997, the FDA proposed a comprehensive regulatory program for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/Ps) outlining the registration and listing procedures for HCT/Ps. This program also differentiates between HCT/Ps that will be regulated via the traditional pathway and those that will undergo approval as new drugs, biologics or devices.

In this seminar, we'll discuss the historical context for the use of HCT/Ps in medicine as well as how the HCT/P market is evolving. You will be shown examples of the FDA-approved use of HCT/Ps and what is required for successful product development. This course will also provide an overview of the health authority regulating HCT/Ps, discuss the regulations that govern HCT/Ps, discuss potential product development strategies and provide an overview of product development in the United States.

Learning Objectives:

Upon completing this course, participants will better understand:

  • The FDA’s regulatory approval process for HCT/Ps
  • Keys to successful product development of HCT/Ps
  • Application of “Minimal Manipulation,” “Homologous Use” and “Chemical Action”
  • Currently approved use of HCT/Ps in medicine
  • The drug and biologic approval process
  • Nonclinical requirements to support product development
Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
  • Challenges of product characterization and specifications with respect to HCT/Ps
  • Requirements for compliance with good tissue practice, good manufacturing practice and good laboratory practice
  • FDA enforcement actions
  • The global regenerative medicine market
  • The One Health Initiative and its impact
  • HCT/Ps and translational medicine
  • Future approaches for regulatory approval of HCT/Ps in regenerative medicine

Who will Benefit:

This course is designed for professionals in biotechnology, regenerative medicine, HCT/P, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

  • Graduate students
  • Academic faculty and professors
  • Clinicians
  • Entrepreneurs
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing professionals
  • Quality Control professionals
  • Contract manufacturers
  • Foreign corporations in the regenerative medicine field
  • Financial advisors and institutional investors
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • FDA regulatory oversight of HCT/Ps
    • Historical Perspective
    • Laws and Regulations
    • Definitions
    • Jurisdiction
      • Tissue Reference Group
      • Office of Combination Products
        • Request for Designation
  • FDA regulatory approval process
    • HCT/Ps as drugs/biologics
    • HCT/Ps as medical devices
  • Compliance
    • Good tissue practice
    • Good manufacturing practice
    • Quality system regulations
    • Good laboratory practice
    • FDA enforcement actions
    • Adverse event reporting
Day 02(8:30 AM - 4:30 PM)
  • FDA regulatory guidance regarding HCT/Ps
    • Minimal manipulation
    • Homologous use
    • Same surgical procedure
    • Adipose tissue
  • Overview of FDA Public Workshop on Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval
    • Product development
    • FDA viewpoint
    • Views from professional societies
    • Patient experiences
  • Overview of FDA Part 15 Hearing on Draft Guidance Relating to the Regulation of HCT/Ps
    • Industry perspective
    • Professional society perspective
    • Patient perspective
    • HCT/Ps and translation medicine
    • One Health Initiative
  • Approaches for regulatory approval of HCT/Ps in regenerative medicine
    • FDA expedited review programs
    • Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
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Debra Webster

Debra Webster,
Principal Scientist, Regulatory Affairs and Product Development, Cardinal Health Regulatory Sciences | Ex-FDA Professional (Reviewing Pharmacologist)

Debra Webster, PhD, is Principal Scientist, Regulatory Affairs and Product Development, for Cardinal Health Regulatory Sciences. She began her regulatory career at the FDA and has more than 25 years of experience in drug development, focusing on nonclinical toxicology and proof-of-concept. Dr. Webster is responsible for nonclinical and regulatory consulting to guide products from pre-Investigational New Drug (pre-IND) application interactions with the FDA to New Drug Application (NDA) and Biological License Application (BLA) approval.

Prior to joining Cardinal Health, Dr. Webster was a medical writer at Quintiles, where she authored clinical study reports and nonclinical sections of INDs. Previously, she was in private practice, where she authored summaries of nonclinical data to support due diligence and regulatory submissions. Dr. Webster worked for the FDA in the Center for Food Safety and Nutrition, where she evaluated color and food additive petitions. Subsequently, she was a pharmacology/toxicology reviewer in the FDA Division of Antiviral Drugs in the Center for Drug Evaluation and Research, where she received the Commissioner Frank E Young Appreciation recognition for her role in the approval of Foscarnet.

Dr. Webster received a doctorate degree in pharmacology and toxicology at Virginia Commonwealth University, Medical College of Virginia. She received a bachelor’s degree in biology from Virginia Polytechnic and State University, where she graduated with honors and worked as a research associate in the anaerobic microbiology laboratory.

David A. Cummings

David A. Cummings,
RAC, Director, Scientific and Regulatory Consulting

David A. Cummings is Director, Chemistry, Manufacturing and Controls (CMC), for Cardinal Health Regulatory Sciences. He is responsible for scientific and regulatory consulting activities associated with pharmaceutical and biological product development, regulatory affairs strategy development, participation in FDA meetings, preparation of investigational and marketing applications for small molecules and biologics, good manufacturing practice qualification audits and good laboratory practice audits.

Cummings has more than 24 years of experience with development and regulatory affairs of small molecule and biologic products. His biologic experience includes viral antigens, enzymes, monoclonal antibodies, gene therapy products and therapeutic proteins. Prior to joining Cardinal Health in 2008, Cummings worked in several product development and regulatory affairs roles with Chiron Corporation, Gen-Probe, Collateral Therapeutics and Peregrine Pharmaceuticals.

Cummings received a bachelor’s degree in molecular, cellular and developmental biology from the University of Colorado and worked in the laboratory of Dr. Richard G. Ham. Cummings received regulatory affairs certification (RAC) in 2001.

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Hilton Irvine/Orange County Airport,
18800 MacArthur Blvd.,
Irvine, CA, 92612, USA
Tel: +1-949-833-9999

July 13-14, 2017

How to Reach

General Driving Directions:

Driving directions from John Wayne Airport/Orange County - 0.25 miles:
  • Depart ramp toward Self-Parking/Valet / Departures
  • Keep right onto road
  • Keep left toward Airport Way
  • Keep straight onto Airport Way
  • Turn right onto MacArthur Blvd
  • Turn left onto Douglas
  • Turn left onto road
  • Turn right onto road
  • Hotel is on the right
Driving directions from Long Beach Airport – 21 miles:
  • Freeway 405 South, continue for 25 miles
  • Exit on MacArthur Blvd
  • Turn left on MacArthur
  • Hotel is 2 lights down on left side at corner of MacArthur and Douglas

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Local Attractions of Irvine, CA

The Irvine Museum

The Irvine Museum

The Irvine Museum collects and preserves California Art, with an emphasis on landscapes and Impressionist work. The Museum itself is a lovely hacienda style building, reminiscent of the Golden Land's early days.

Tanaka Farms

Tanaka Farms

Located in the heart of sunny Irvine, Tanaka farms provides fun, educational activities for kids and families. Seasonal tours of the Pumpkin Patch and Strawberry Fields, plus elaborate cook-outs and entertainment are among the delights offered at Tanaka farms.

Pretend City Children's Museum

Pretend City Children's Museum

Pretend City Children's Museum is a very promising place to bring children.

Orange County Great Park

Orange County Great Park

The Orange County Great Park is a vital center that brings together some of the southern California's exciting, diverse communities with educational workshops, farmer's markets, concerts and exhibits. The Park is currently expanding and will soon have an elaborate sports field as well.

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One of the largest and most popular Orange County attractions is just a short trip away. See Mickey, Minnie, Peter Pan, Winnie the Pooh, Alice in Wonderland and many of the world's most beloved characters and rides during a visit to the Magic Kingdom.

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