Consultants from the Biologics Consulting Group (BCG) are actively involved with both academic and industry clients who are developing regenerative medicine products.
These novel medical products can consist of stem cells from a variety of sources (i.e. embryonic, adult, allogeneic or autologous) and often contain genetically modified cells and/or utilize biomaterials to provide structure and facilitate delivery into patients.  In some cases, regenerative medicine products are intended to integrate into the patient's own body or stimulate reservoirs of stem cells within the patient to become active and repair, replace, restore or regenerate the diseased tissue or organ. 

Working with BCG's consultants from the early stages of development can significantly shorten the time it takes to reach the clinic.  Our experience, gained from working at the FDA and in industry, allows us to quickly distinguish 'must do' from 'nice to know' activities.   We are also proactive in helping you anticipate the key product development steps you will need to undertake to achieve commercial success. 

If your regenerative medicine product contains growth factors, cells, genes, biomaterials, or a combination of these, BCG's consultants can undoubtedly help. 

Below are some examples illustrating our experience with regenerative medicine products.

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Copyright 2008 by the Regulatory Affairs Professionals Society (RAPS). Posted with permission on http://www.bcg-usa.com. Reprinted from the July 2008 issue of Regulatory Focus. This article may not be published, reposted or redistributed without express permission from RAPS (www.raps.org) and payment of appropriate fees when applicable. To obtain such permission, send a request to reprints@raps.org

Many of the requirements of the Good Tissue Practice (GTP) regulation will be familiar to those who work under Good Manufacturing Practice (GMP) or Quality Systems Regulations (QSRs). However, it is important to recognize that GTPs do have some unique requirements not found within existing GMP/QSR regulations. Thus, to ensure compliance with GTPs, a systematic assessment of current quality systems is essential to identify and fill any gaps. This article provides an overview of GTPs and offers considerations for assessing the state of compliance with GTP requirements.

What are GTPs?

GTPs are a comprehensive set of regulations enacted by the US Food and Drug Administration (FDA) to cover human cells, tissues or cellular or tissue-based products (HCT/Ps) intended for implantation, transplantation, infusion or transfer into a human recipient. These regulations govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps. The primary intent of GTPs is to ensure that HCT/Ps are manufactured in a manner designed to prevent the introduction, transmission and spread of communicable disease. In some cases, an HCT/P may be subject only to GTP requirements. In other cases, e.g., when an HCT/P is the starting material for creating novel cell- and tissue-based products, GTPs and additional regulatory requirements, such as GMPs, biological product standards and/or the medical device QSR, will be applicable. The criteria governing the specific level of regulatory oversight are described in 21 CFR 1271.10 and have been reviewed elsewhere. Figure 1 depicts how GTPs apply to different regulatory pathways for an HCT/P.

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Contact Dr. Darin Weber....

BCG consultants attend numerous conferences every year during which they are available to provide company information or consulting expertise. Below are some conferences that BCG consultants will be attending in the near future. Please feel free to contact the attending consultant either before, or during the conference for company information or to discuss a business opportunity.

Annual Conference & Exhibition

"Follow-on Biologics, (Biosimilars)” (Subbarao)

Speakers
Nanda Subbaro, Ph.D.

Lorianne Baranauskas
John Jessop, PhD
Reggie Neal
Kelly Reich, MS
Michael Trapani, MS, MBA
Holli Vaughan, MS, RAC
Keith Wells, Ph.D.

8th Annual Somatic Cell Therapy Symposium

"IND Overview"

"Problems in Product Development for Cell-Based Therapies"

Panelist for "Product Nomenclature" Session

Annual Meeting and TXPO

"Benchside to Bedside: Translation of CT Products into Clinic" - Weber

Ellen M. Areman, MS, SBB
(session chair)

Darin Weber, Ph.D.
(speaker)

Toronto, Canada

Nadine Ritter, Ph.D.(speaker)

29th Annual Meeting

Introduction of Biologics (Hartsough)  

John Jessop, Ph.D., MPH
Melanie Hartsough, Ph.D. (speaker)
David J. Pepperl, Ph.D.

Development and Regulation of Clinical Trial supplies