FDA’s Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies: 2-day In-Person Seminar

By:Karl M. Nobert, Food and Drug Regulatory Attorney, Squire Sanders (US) LLP, Washington, DC
Coming soon.. Please contact customer care for new schedule
Course “FDA’s Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

We need the below information to serve you better

Course Description:

Regenerative medicine focuses on harnessing the power of one’s own stem cells and regenerative capabilities to restore function to damaged cells, tissues and organs. In April 2006, the U.S. Food and Drug Administration’s (“FDA”) implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products (“HCT/Ps”) 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 the industry on how such therapies should be regulated – by FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.

This 2-day interactive seminar on FDA regulations of regenerative medicine will cover:

  • How FDA is currently regulating regenerative therapies and products intended for both human and veterinary use.
  • The distinction being made between human regenerative products and their regulation as drugs, biologics, devices, and combination products.
  • The New Drug Application (“NDA”) and the Biologic License Application (“BLA”) review and approval processes including a discussion of available options, application components, relevant meetings, timing, costs and approval requirements.
  • The option for obtaining designation and approval as Orphan Drug Product.
  • Designing and conducting appropriate clinical trials to support the approval of regenerative therapies.
  • FDA’s regulation of some regenerative medicine products and accessories as Medical Devices.
  • The Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) being applied by FDA to human regenerative products.
  • The labeling and marketing of regenerative products and therapies.
  • The potential for enforcement action and recommendations for mitigating that risk.
  • The current regulation of veterinary cellular treatments including autologous, allogeneic and xenogeneic cellular products in the United States.

Learning Objectives:

Participants who attend this course on FDA regulation of regenerative medicines will leave with a comprehensive understanding of:

  • How FDA regulates regenerative treatments and therapies?
  • The HCT/P Criteria and “Minimal Manipulation Standard”.
  • The Drug and Biological Approval Process.
  • Regenerative Products as Medical Devices.
  • How to Design Appropriate Clinical Trials?
  • Applicable cGMPs and cGLPs.
  • Marketing Exclusivity and Patent Restoration.
  • Product Labeling, Marketing and Advertising.
  • FDA and other Federal Agency Enforcement Action.
  • The Regulation of Veterinary Regenerative Medicine.
  • The New Animal Drug Application (“NADA”) Process.
  • Veterinary User Fees and Waivers.

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
  • Consultants, Inspectors and cGMP Experts

Topic Background:

Regenerative medicine encompasses a broad category of advanced therapies that allow the body to repair, replace, restore and regenerate damaged cells, tissues, genes and organs. Regenerative medicine supports research in a variety of new biotech sectors including biomarker and growth factor identification, tissue and biomaterial engineering, and transplantation science.

The use and awareness of regenerative therapies is growing exponentially in the United States. It is no longer limited to test tubes, pilot studies and political debate … regenerative medicine has become reality and is increasingly becoming the future of medicine. This is demonstrated by reported use of stem cell therapies by Peyton Manning the quarterback for the Denver Broncos for a neck injury in November 2011, Governor Rick Perry of Texas in conjunction with spinal fusion surgery in early July 2011 and Well Armed, the American thoroughbred who won the 2009 Dubai World Cup which is the richest race horse racing.

Course Outline:

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

Introduction Human Regenerative Medicine: Science and the Law

  • FDA’s approval process for regenerative medicine products
  • FDA’s Regulation of Human Cells, Tissues or Cellular or Tissue-based Products (“HCT/P”)
    • The application of the FFDC Act and the PHS Act
    • The criteria for determining how a product will be regulated
    • The “Minimal Manipulation” Standard
  • Approval of Human Regenerative Treatments
    • FDA’s regulatory approval pathway for HCT/Ps
    • The new drug and biologic approval pathways
    • The various existing regulatory drug approval pathways (the “full” NDA v. the 505(b)(2) application) and the biologic approval pathways (BLA v. biosimilars) will be discussed.
    • The NDA and BLA review and approval processes including a discussion of available options, application components, relevant meetings, timing, costs and approval requirements.
  • Obtaining designation and approval as an Orphan Drug Product
    • Survey of the types of HCT/Ps and those indications receiving designation and approval as Orphan Drugs
    • The process for obtaining orphan drug designation and approval
    • The incentives accompanying orphan drug designation and approval
    • Available Marketing Exclusivity
  • Regulating Some Regenerative Treatments as Medical Devices
    • Products and accessories being regulated as medical devices
    • Identifying such products for regulatory purposes
    • Overview of FDA’s medical device clearance and approval pathways
    • Strategies for marketing and selling such products
  • The cGMPs and cGLPs Applied to Regenerative Treatments and Therapies
    • How to implement appropriate cGMPs and cGLPs applicable to the manufacturing, production, control, packaging and distribution of HCT/Ps
    • Some of the topics to be covered: material sourcing, characterization, manufacturing, sterility and quality controls
    • Standard Operating Procedures or SOPs

Bringing Regenerative Medicine Products to Market: Four Key Components

  • Conducting Clinical Trials to Support Product Approvals
    • Factors to consider when designing study protocols, engaging Clinical Research Organizations and investigators, and conducting clinical studies.
  • Labeling, Marketing and Advertising
    • Definitions and Regulation
    • Applicable Statutory and Regulatory Requirements
    • Federal Agency Shared Jurisdiction
    • Examples of Non-Compliance Labeling and Marketing
  • FDA Enforcement Action and Effective Strategies for Mitigating Such Risk
    • Types of enforcement action
    • A survey of recent FDA enforcement activities
    • Recommendations for mitigating the risk of FDA and FTC enforcement action
    • Strategies for preventing products from being deemed “adulterated” or “misbranded”
  • Intellectual Property Considerations
    • U.S. patent rules applicable to stem cells and other regenerative products
    • Relevant Patent Laws and Cases
    • A survey of past important legal cases A
    • Applicability of patent protection to drug marketing and commercialization, and the concept of Patent Restoration.
Day One (8:30 AM – 4:30 PM)

Introduction Veterinary Regenerative Medicine

  • The Center for Veterinary Medicine’s (“CVM”)
    • Regulatory Jurisdiction: FDA v. USDA
    • CVM’s Organization
    • USDA’s Organization
  • Statutory and Regulatory Overview
    • The Federal, Food, Drug and Cosmetic Act
    • The Virus, Serum and Toxin Act of 1913
    • Relevant Regulations
    • Guidance Documents and Policy Statements
  • The Regulation of Veterinary Cellular Products and Therapies
    • Regulatory Status
    • Definitions: Drug v. Biologic
  • The Veterinary Drug Approval Process
    • Approval Process
    • NADA Approval Process
    • User Fees and Waiver Request
    • Sections of an NADA
      • Product Characterization, CMC, Safety, Efficacy, etc
  • Managing Veterinary Clinical Trials
    • 7 Major Phases:
      • Planning
      • Study Initiation
      • In-life Activities
      • Site close-out
      • Data management
      • Biostatistical analysis
      • Report writing
  • Labeling, Marketing and Advertising
    • Definitions and Examples
    • Labeling
      • Immediate Container, Outer Packaging, Package Insert, Client Information Sheet, Shipping Label
    • Marketing Materials
      • Brochures, Leaflets, Press Releases, Flyers, Audio and Visual Pieces
  • Advertising
    • Written Media, Broadcast Media, Internet Media, Social Media
  • Standards to Avoid Misbranding
    • Truthful, Substantiated, and Not Misleading
    • Effective Communication, Risk Communications, Risks and Benefits
  • Timing of Review: NADA/ANADA Filing, Initial Publication/Broadcast, Disseminations Following Changes, Drug Experience Reports
  • Post Approval Surveillance: Traditional Media Surveillance, Internet and Social Media Surveillance, Industry and Professional Events, Internal Company Materials
  • Extra-Label Drug Use: Animal Medicinal Drug Use Clarification Act of 1994
  • Veterinary Drug User Fees and Fee Reductions and Waivers
    • Animal Drug User Fee Act (ADUFA) – Applies to Innovators Only
    • Animal Generic Drug User Fee Act (ADGUF) – Applies to Generic Manufacturers
    • Types of User Fees
    • Types of Fee Waivers and Reductions
    • Procedures, Timing and FDA Evaluation of Waivers or Reductions

Meet Your Instructor

Karl Nobert
Karl M. Nobert,
Food and Drug Regulatory Attorney, Squire Sanders (US) LLP, Washington, DC

Karl M. Nobert is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.

Venue

Location:
Irvine Marriott
18000 Von Karman Avenue
Irvine, California 92612 USA

July 24-25, 2014

Special Offer for the attendees of this seminar:

Rooms available at only $195 per night.

Call Hotel and Identify as part of the ComplianceOnline group

Please note: Hotel rooms are limited and based on availability



How to Reach

General Driving Directions:

From John Wayne Airport-Orange County – SNA: 0.8 mile(s) E

  • Straight across MacArthur street to Michelson.
  • Left on Von Karman Avenue. Hotel is on right.

From Long Beach Airport – LGB: 25 mile(s) SE

  • Take 405 South, exit Jamboree & turn right.
  • Turn right on Michelson, right on Von Karman.
  • Turn right on Quartz, then left into hotel.

From Los Angeles International Airport – LAX: 43 mile(s) S

  • Take 405 South, exit Jamboree and turn right.
  • Turn right on Michelson, right on Von Karman.
  • Turn right on Quartz, Turn left into hotel.

Other Transportation

Bus Station

  • Greyhound Lines: 7.5 mile(s) NW

Train Station

  • Amtrak Irvine: 6 mile(s) S
  • Metrolink: 6 mile(s) E
Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
Register Online

Register Online

$0
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-1-888-771-6965 or email at editor@grcseminars.com

Group Registrations

Send Your Team for Maximum Benefit Get your team up to speed!

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

  • 2 Attendees
  • 3 to 6 Attendees
  • 7 to 10 Attendees
  • 10+ Attendees
  • -
  • -
  • -
  • -
  • Get 10% off
  • Get 20% off
  • Get 25% off
  • Get 30% off
Call Toll Free +1-1-888-771-6965 if you have any queries.

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965


Download Registration Form

Yes, I want to attend "FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies: 2-Day In-Person Seminar"
Click here to Download Registration Form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
USA

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ editor@grcseminars.com

Payment:

Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future GRC Seminars event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:

After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:

By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

Media Partners

If you wish to partner with us for this event please contact us: partner@grcseminars.com or call us: +1-888-771-6965.
Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Sponsors

If you wish to sponsor this event please contact Ben Hobbs: benhobbs@grcseminars.com or call us: (650) 620-2941

Local Attractions:

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
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 is a very promising place to bring children.


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.

Disneyland
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.