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by: Consultants from 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. Human Embryonic Stem Cells (hESCs) We have represented clients in multiple meetings with the FDA to define requirements specific to a given therapy Umbilical Cord Blood Adult Stem Cells We have worked with clients developing therapies across a broad spectrum of clinical applications. A few examples include:
BCG consultants have worked with clients in establishing appropriate product release specifications, identifying contract manufacturing organizations (CMO), designing appropriate preclinical safety studies and developing first in human clinical protocols. Related activities have included conducting quality audits for compliance with GTPs, GMPs, GLP and GCPs. Gene Therapy We have assisted multiple academic and industry clients from around the world in the development of gene-based therapies. BCG consultants have expertise with multiple vector systems including non-viral and virus (DNA and RNA)-based vectors. Our clients include groups developing both in vivo and ex vivo gene therapies, using a variety of cells types including stem cells and somatic cells. BCG consultants have had key input in the design of preclinical safety studies for gene-based therapies, taking into consideration the unique issues related to these products, including species and cell-type specificity and biodistribution.
Gene-based therapies have additional oversight, requiring protocol review by the NIH/RAC. BCG consultants have had first hand experience with both the FDA and NIH/RAC regulatory processes and have assisted clients in the preparation of submissions to both agencies, as well as in attendance at key agency meetings. Biologic-Device Combination Products (Tissue Engineering) Tissue engineered constructs consisting of combinations of cells and natural or synthetic biomaterials require a unique skill set for efficient and successful product development. BCG consultants with both FDA Center for Biologics (CBER) and Center for Devices (CDRH) experience will work together as a team to help you clearly define the applicable regulatory requirements and develop a focused product development strategy that will allow you to reach the clinic sooner. Examples of combination products BCG has worked on include:
BCG’s Regenerative Medicine Experts Below is a listing of the BCG consultants actively involved in assisting clients who are developing medical technologies used in regenerative medicine. We are here to help. Contact any of the consultants listed below to ask a question or discuss how we can assist you. Depending upon your needs, we can identify other BCG preclinical, clinical and facility consultants with expertise in this area. For further information about the background and qualifications of each consultant simply click on his or her name. Ellen Areman, MS, SBB Angela Blackwell, MS Andra Miller, PhD Stuart Portnoy, MD Darin Weber, PhD |
