$1,689 – $5,989

FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, T...

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Irvine

Irvine, CA

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Description

Stem cells harness the power to differentiate into numerous cells upon stimulation. This has led to their wide exploration across all of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications.

This tutorial will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. It will also provide the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in industry on how such therapies should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

Upon completing this course participants should have an understanding of:

  • Fundamentals of stem cells
    • What is all the excitement about
    • How to control stem cell differentiation
    • Sources of stem cells
    • Incorporating stem cells into biomaterials
    • Avoiding immune system clearance of stem cells
  • FDA regulatory approvals for the use of stem cells in medicine
    • Currently approved use of stem cells in medicine
    • FDA guidance documents for stem cell technologies
    • Global approval of stem cell technologies
    • How the FDA regulates regenerative treatments and therapies
    • The use of human cells, tissues, and cellular and tissue-based product criteria and “Minimal Manipulation Standard”
    • The drug and biological approval process
    • Regenerative products as medical devices
    • How to design appropriate clinical trials
    • Applicable good manufacturing and good laboratory practices
    • Product labeling, marketing and advertising
    • FDA and other federal agency enforcement action
  • Future thoughts on approaches for regulatory approval of stem cell technologies
    • Remaining hurdles
    • Outlook for new technologies

Who will Benefit:

This course is designed for professionals in stem cell, biotech, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Labelers and private labelers
  • Contract manufacturers
  • Importers and custom agents
  • U.S. agents of foreign corporations
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Record retention specialists
  • Medical affairs
  • Legal professionals
  • Financial advisors and institutional investors
  • Patent lawyers
  • Graduate students
  • Academic faculty and professors
  • Clinicians
  • Entrepreneurs


Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Fundamentals of stem cells
    • Definitions
    • What is all the excitement about
    • How to control stem cell differentiation
    • Sources of stem cells
    • Incorporating stem cells into biomaterials
    • Avoiding immune system clearance of stem cells
    • Research examples pre-clinical approval
    • Research examples post-clinical approval
  • FDA regulatory approvals for the use of stem cells in medicine
    • Currently approved use of stem cells in medicine
    • FDA guidance documents for stem cell technologies
    • Global approval of stem cell technologies
Day 02(8:30 AM - 4:30 PM)
  • FDA regulatory approvals for the use of stem cells in medicine (continued)
    • How the FDA regulates regenerative treatments and therapies
    • The use of human cells, tissues, and cellular and tissue-based product criteria and “Minimal Manipulation Standard”
    • The drug and biological approval process
    • Regenerative products as medical devices
    • How to design appropriate clinical trials
    • Applicable good manufacturing and good laboratory practices
    • Product labeling, marketing and advertising
    • FDA and other federal agency enforcement action
  • Future thoughts on approaches for regulatory approval of stem cell technologies
    • Remaining hurdles
    • Outlook for new technologies
    • Strategies for commercializing stem cell technologies
  • Questions


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.



Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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