Charles N. Durfor, Ph.D. 

Division of General, Restorative and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Rockville, MD

Background:

B.S., College of William Mary
Ph.D., University of Virginia

Research Interests:

Since 1994, Dr. Durfor has served within the Center for Devices and Radiological Health’s Office of Device Evaluation as Scientific Reviewer and IDE/PMA Team Leader in the Plastic and Reconstructive Surgery Branch.  In this role he performed and supervised the review of the first cellular medical devices to receive FDA approval as well as other products composed of protein, polysaccharide and biomimetic components that are used to treat a diverse array of indications (e.g., wound repair, surgical adhesion prophylaxis, and cosmetic correction of soft tissue defects). 

From 1988-1993 Dr. Durfor was a scientific reviewer in the Center for Biologics Evaluation and Research (CBER), which is the other component of the FDA involved in the regulation of cellular-derived products.  During this time he reviewed manufacturing, preclinical and clinical data for a variety of biotechnology products.  He also participated in the preparation of two CBER "Points to Consider" documents on Transgenic Animals and Monoclonal Antibodies.

Prior to government service, Dr. Durfor performed research in the private sector resulting in five patents and 12 publications in the fields of biochemical modification of electrode surfaces, metalloprotein enzymology, and monoclonal antibody catalysis.

Proposed Research Project for FDA Fellow:

FDA Fellows participating in this program will be responsible for mentored review of investigational studies and marketing applications in the area of responsibility of the mentor to develop an understanding of FDA regulations and how they are applied.  The fellow will develop a menu of all of the Federal and Standards Development Organizations combination product regenerative medicine documents that have published or are in preparation.  The fellow will review ongoing or past regenerative medicine combination product review projects in both CDRH and CBER and provide a summary of the products and the scientific/technical issues raised and how they were addressed.  This summary will include identification of guidance documents and standards that were leveraged. 

Selected Recent Publications:

1. Blackburn; G. F., Durfor; C. N., Powell; M.J. and , Massey; Richard J., "Catalytic antibodies as chemical sensors" U.S. Patent Number 6,846,654 (2005) and Canadian Patent Number 1,308,021
2. C.N. Durfor, R.J. Bolin, A.R. Schantz, and R.J.  Massey. "Interaction system comprising a surfactant-stabilized disperse aqueous phase containing an antibody or antibody fragment" U.S. Patent Number 5641865 (1997).
3. C. Witten, A. Batra, C.N. Durfor, S.L. Hilbert, D.S. Kaplan, D. Fink, D. Lavoire, E. Mahler and R. McFarland, "Overview of FDA Regulatory Process," in Principles of Regenerative Medicine, A. Atala, R. Lanza, J. Thomson and R. Nerem (editors), Amsterdam, Academic Press, Elsevier, 2008.
4. KJ.B. Hellman, R.R. Solomon, C. Gaffey, C. N. Durfor and J.G. Bishop.  Regulatory Considerations, pp 915-927, Principles of Tissue Engineering, 2nd Ed., R.P. Lanza, R. Langer and J. Vacanti (editors), San Diego, Academic Press, 2000.
5. K.B. Hellman, E. Knight, and C.N. Durfor.  Tissue Engineering: Product Applications and Regulatory Issues, pp. 341-366, Frontiers in Tissue Engineering, Charles W. Patrick, Antonio G. Mikos, and Larry V. McIntire (editors), Amsterdam, Elsevier Science, 1998.
6. C.N. Durfor.  Biotechnology Biomaterials: A Global Regulatory Perspective for Tissue Engineered Products: Summary Report and Future Directions.  Tissue Engineering, 3(1), 115-120, 1997.
7. C.N. Durfor, D.C. Turner, J.H. Georger, B.M. Peek and D.A. Stenger, "Formation and Napthoyl-Derviatization of Aromatic Aminosilane Self-Assembled Monolayers: Characterization by Atomic Force Microscopy and U.V. Spectroscopy," Langmuir, 10, 148-152 (1994).
8. C.L. Scribner, C.N. Durfor, D.M. Klinman and R.W. Kozak, "Clinical Uses of Biotechnology Derived Pharmaceuticals," In: E. Rubenstein, P. Leder and D. Clayton (eds.), Molecular Medicine.  Scientific American Medicine, New York, N.Y., p. 277 (1994).
9. R.W. Kozak, C.N. Durfor and C.L. Scribner, "Regulatory Considerations When Developing Biological Products," Cytotechnology, 9, 203-210 (1992).
10. C. N. Durfor and C. L. Scribner, "An FDA Perspective of Manufacturing Changes for Products in Human Use," Annals of the New York Academy of Sciences, 665, 356-363 (1992).

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Elias Mallis 

Acting Deputy Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Rockville, MD

Background:

B.S., Electrical Engineering, University of Maryland at College Park
FDA Experience - 15 years

Research Interests:

As the Branch Chief of the Cardiac Electrophysiology and Monitoring Branch (CEMB) in the Division of Cardiovascular Devices, Mr. Mallis is responsible for oversight of device review of a variety of cardiac diagnostic and therapeutic devices in the fields of electrophysiology, heart failure, and cardiac surgery.  This includes the class of device technologies designed for use with safe and effective delivery of gene therapy for treatment of cardiac disease.

Proposed Research Project for FDA Fellow:

FDA Fellows participating in this program would review (mentored) investigational studies and marketing applications to develop an understanding of FDA regulations and how they are applied.

Identify existing FDA Guidance and non-FDA Standards that pertain to the development of products in the area of regenerative medicine.

Data mine ongoing or past regenerative medicine combination products from both Centers and provide a summary of the products and the scientific/technical issues identified during the product’s regulatory review.

Write a white paper that summarizes current regenerative medicine products and development tools and that highlights opportunities for future standards and guidance development.

Select Recent Publications:

1. Am J.T. 2005 Update on regulatory issues in pancreatic islet transplantation. Nov-Dec;12(6):600-4.
2. Thornton, M., Worobec, A., Wonnacott, K., and Puri, R.2004. Regulatory Issues Affecting Tumor Vaccines. (Book Chapter) Handbook of Cancer Vaccines. Humana Press.
3. Sarah Kennett, Cynthia Porter, Eda Bloom, Keith Wonnacott. (Book Chapter) Cellular Therapy: Priniciples, Methods, and Regulations. (In Press)
4. INDs Submitted To FDA That Are Placed On Clinical Hold: Experience of the Office of Cellular, Tissue, and Gene Therapies.  Keith Wonnacott, Deborah Lavoie, Robert Fiorentino, Maritza McIntyre, Ying Huang, Steven Hirschfeld. Cytotherapy. (In press)
5. C. Witten, A. Batra, C.N. Durfor, S.L. Hilbert, D.S. Kaplan, D. Fink, D. Lavoire, E. Mahler and R. McFarland, “Overview of FDA Regulatory Process,” in Principles of Regenerative Medicine, A. Atala, R. Lanza, J. Thomson and R. Nerem (editors), Amsterdam, Academic Press, Elsevier, 2008
6. KJ.B. Hellman, R.R. Solomon, C. Gaffey, C. N. Durfor and J.G. Bishop.  Regulatory Considerations, pp 915-927, Principles of Tissue Engineering, 2nd Ed., R.P. Lanza, R. Langer and J. Vacanti (editors), San Diego, Academic Press, 2000.
7. K.B. Hellman, E. Knight, and C.N. Durfor.  Tissue Engineering: Product Applications and Regulatory Issues, pp. 341-366, Frontiers in Tissue Engineering, Charles W. Patrick, Antonio G. Mikos, and Larry V. McIntire (editors), Amsterdam, Elsevier Science, 1998.
8. C.N. Durfor.  Biotechnology Biomaterials: A Global Regulatory Perspective for Tissue Engineered Products: Summary Report and Future Directions.  Tissue Engineering, 3(1), 115-120, 1997.
9. C.N. Durfor, D.C. Turner, J.H. Georger, B.M. Peek and D.A. Stenger, "Formation and Napthoyl-Derviatization of Aromatic Aminosilane Self-Assembled Monolayers: Characterization by Atomic Force Microscopy and U.V. Spectroscopy," Langmuir, 10, 148-152 (1994).
10. C.L. Scribner, C.N. Durfor, D.M. Klinman and R.W. Kozak, "Clinical Uses of Biotechnology Derived Pharmaceuticals," In: E. Rubenstein, P. Leder and D. Clayton (eds.), Molecular >Medicine.  Scientific American Medicine, New York, N.Y., p. 277 (1994).

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Bruce S. Schneider, M.D. 

Clinical Evaluations Branch
Office of Cellular, Tissue and Gene Therapy
Center for Biologics Evaluation and Research
Rockville, MD

Background:

A.B., Harvard College
M.D., Harvard Medical School

Research Interests:

Dr. Schneider regulates clinical development of gene and cell therapies for a variety of indications. He has broad interests and experience in endocrinology and metabolism. His major focus at CBER is the clinical development of islet cell products for treatment of diabetes. Dr. Schneider also serves on the NIH-FDA Interagency Artificial Pancreas Working Group, as well as on the Metabolic Steering Committee of the Biomarkers Consortium.

Proposed Research Project for FDA Fellow:

FDA Fellows participating in this program would review (mentored) investigational studies and marketing applications to develop an understanding of FDA regulations and how they are applied.

Identify existing FDA Guidance and non-FDA Standards that pertain to the development of products in the area of regenerative medicine.

Data mine ongoing or past regenerative medicine combination products from both Centers and provide a summary of the products and the scientific/technical issues identified during the product’s regulatory review.

Write a white paper that summarizes current regenerative medicine products and development tools and that highlights opportunities for future standards and guidance development.

Selected Recent Publications:

1. Am J.T. 2005 Update on regulatory issues in pancreatic islet transplantation. Nov-Dec;12(6):600-4.
2. Thornton, M., Worobec, A., Wonnacott, K., and Puri, R.2004. Regulatory Issues Affecting Tumor Vaccines. (Book Chapter) Handbook of Cancer Vaccines. Humana Press.
3. Sarah Kennett, Cynthia Porter, Eda Bloom, Keith Wonnacott. (Book Chapter) Cellular Therapy: Priniciples, Methods, and Regulations. (In Press)
4. INDs Submitted To FDA That Are Placed On Clinical Hold: Experience of the Office of Cellular, Tissue, and Gene Therapies.  Keith Wonnacott, Deborah Lavoie, Robert Fiorentino, Maritza McIntyre, Ying Huang, Steven Hirschfeld. Cytotherapy. (In press)
5. C. Witten, A. Batra, C.N. Durfor, S.L. Hilbert, D.S. Kaplan, D. Fink, D. Lavoire, E. Mahler and R. McFarland, “Overview of FDA Regulatory Process,” in Principles of Regenerative Medicine, A. Atala, R. Lanza, J. Thomson and R. Nerem (editors), Amsterdam, Academic Press, Elsevier, 2008
6. KJ.B. Hellman, R.R. Solomon, C. Gaffey, C. N. Durfor and J.G. Bishop.  Regulatory Considerations, pp 915-927, Principles of Tissue Engineering, 2nd Ed., R.P. Lanza, R. Langer and J. Vacanti (editors), San Diego, Academic Press, 2000.
7. K.B. Hellman, E. Knight, and C.N. Durfor.  Tissue Engineering: Product Applications and Regulatory Issues, pp. 341-366, Frontiers in Tissue Engineering, Charles W. Patrick, Antonio G. Mikos, and Larry V. McIntire (editors), Amsterdam, Elsevier Science, 1998.
8. C.N. Durfor.  Biotechnology Biomaterials: A Global Regulatory Perspective for Tissue Engineered Products: Summary Report and Future Directions.  Tissue Engineering, 3(1), 115-120, 1997.
9. C.N. Durfor, D.C. Turner, J.H. Georger, B.M. Peek and D.A. Stenger, "Formation and Napthoyl-Derviatization of Aromatic Aminosilane Self-Assembled Monolayers: Characterization by Atomic Force Microscopy and U.V. Spectroscopy," Langmuir, 10, 148-152 (1994).
10. C.L. Scribner, C.N. Durfor, D.M. Klinman and R.W. Kozak, "Clinical Uses of Biotechnology Derived Pharmaceuticals," In: E. Rubenstein, P. Leder and D. Clayton (eds.), Molecular Medicine.  Scientific American Medicine, New York, N.Y., p. 277 (1994).

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Keith Wonnacott, Ph.D. 

Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene Therapy
Center for Biologics Evaluation and Research
Rockville, MD

Background:

B.S., Bringham Young Unversity
Ph.D., Pennsylvania State University

Research Interests:

Dr. Wonnacott is responsible for oversight of the review and regulation of cell therapy products, devices for manufacture of biological products, and combination products. He has a special interest in pancreatic islet cells and xenogeneic products.

Proposed Research Project for FDA Fellow:

FDA Fellows participating in this program would review (mentored) investigational studies and marketing applications to develop an understanding of FDA regulations and how they are applied.

Identify existing FDA Guidance and non-FDA Standards that pertain to the development of products in the area of regenerative medicine.

Data mine ongoing or past regenerative medicine combination products from both Centers and provide a summary of the products and the scientific/technical issues identified during the product’s regulatory review.

Write a white paper that summarizes current regenerative medicine products and development tools and that highlights opportunities for future standards and guidance development.

Selected Recent Publications:

1. Am J.T. 2005 Update on regulatory issues in pancreatic islet transplantation. Nov-Dec;12(6):600-4.
2. Thornton, M., Worobec, A., Wonnacott, K., and Puri, R.2004. Regulatory Issues Affecting Tumor Vaccines. (Book Chapter) Handbook of Cancer Vaccines. Humana Press.
3. Sarah Kennett, Cynthia Porter, Eda Bloom, Keith Wonnacott. (Book Chapter) Cellular Therapy: Priniciples, Methods, and Regulations. (In Press)
4. INDs Submitted To FDA That Are Placed On Clinical Hold: Experience of the Office of Cellular, Tissue, and Gene Therapies.  Keith Wonnacott, Deborah Lavoie, Robert Fiorentino, Maritza McIntyre, Ying Huang, Steven Hirschfeld. Cytotherapy. (In press)
5. C. Witten, A. Batra, C.N. Durfor, S.L. Hilbert, D.S. Kaplan, D. Fink, D. Lavoire, E. Mahler and R. McFarland, “Overview of FDA Regulatory Process,” in Principles of Regenerative Medicine, A. Atala, R. Lanza, J. Thomson and R. Nerem (editors), Amsterdam, Academic Press, Elsevier, 2008
6. KJ.B. Hellman, R.R. Solomon, C. Gaffey, C. N. Durfor and J.G. Bishop.  Regulatory Considerations, pp 915-927, Principles of Tissue Engineering, 2nd Ed., R.P. Lanza, R. Langer and J. Vacanti (editors), San Diego, Academic Press, 2000.
7. K.B. Hellman, E. Knight, and C.N. Durfor.  Tissue Engineering: Product Applications and Regulatory Issues, pp. 341-366, Frontiers in Tissue Engineering, Charles W. Patrick, Antonio G. Mikos, and Larry V. McIntire (editors), Amsterdam, Elsevier Science, 1998.
8. C.N. Durfor.  Biotechnology Biomaterials: A Global Regulatory Perspective for Tissue Engineered Products: Summary Report and Future Directions.  Tissue Engineering, 3(1), 115-120, 1997.
9. C.N. Durfor, D.C. Turner, J.H. Georger, B.M. Peek and D.A. Stenger, "Formation and Napthoyl-Derviatization of Aromatic Aminosilane Self-Assembled Monolayers: Characterization by Atomic Force Microscopy and U.V. Spectroscopy," Langmuir, 10, 148-152 (1994).
10. C.L. Scribner, C.N. Durfor, D.M. Klinman and R.W. Kozak, "Clinical Uses of Biotechnology Derived Pharmaceuticals," In: E. Rubenstein, P. Leder and D. Clayton (eds.), Molecular Medicine.  Scientific American Medicine, New York, N.Y., p. 277 (1994).

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