William D. Schwieterman M.D.
Curriculum Vitae

3901 Point Road
Mobile, Alabama  36619
Phone: (251) 665-9224
wds@tekgenics.org

Personal:                                                                    Birthdate: January 16th, 1958
Birthplace:  Cincinnati, Ohio
Married (1991); 3 children

Education:                                                                   University of Cincinnati, College of Arts and Sciences
Bachelor of Science (Summa cum Laude with High College Honors) 1976-1980

University of Cincinnati College of Medicine
Medical Doctor
1980-1984

Postgraduate Positions:                                           Medical Internship- Mt. Sinai Hospital
New York, New York
1984-1985

Residency-Internal Medicine
Mt. Sinai Hospital, New York, New York
1985-1987

Medical Staff Fellow
Metabolism Branch-National Cancer Institute
National Institutes of Health
Bethesda, Maryland
1987-1990 

Senior Staff Fellow
National Institute of Arthritis and
Musculoskeletal Skin Disease
National Institutes of Health
Bethesda, Maryland
1990-1992

Appointments: 
Chief- Immunology and Infectious Disease Branch
Division of Clinical Trial Design and Analysis
Center for Biologics, Food and Drug Administration
June 1995-present 

Chief- Medicine Branch
Division of Clinical Trial Design and Analysis
Center for Biologics, Food and Drug Administration
November 1994-June 1995

Medical Reviewer
Division of Investigational New Drugs
Center for Biologics, Food and Drug Administration
July 1992-November 1994

Board Certification: 
1. Internal Medicine; Sept 15th, 1988 (#114658)
2. Rheumatology; 1992

Medical Licensure:
Maryland (D36419)

Honors/Societies:
1.  Phi Beta Kappa (May 10th, 1979)
2. Winner-Medical Student Research Competition }
   (June, 1982)
3. 11 individual or group and FDA "Award and Recognition Certificates"(1996-2001),
4. 1999 Center Director Award for “Managerial Excellence”

Past and Present FDA Review Responsibilities and Expertise

1.     Pulmonary medicine: biological therapies for treatment of cystic fibrosis, adult respiratory distress syndrome, chronic obstructive pulmonary disease, etc.
2.     Cardiology:  thrombolytic agents for treatment or coronary artery disease (co-primary reviewer of license application for GUSTO trial), imaging agents for ischemia, anti-inflammatory agents to preserve tissue function, etc.
3.     Neurology: biological therapies for treatment of multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer’s Disease, diabetic neuropathy, gene therapy for Parkinsons’s Disease, stroke, etc.
4.     Hepatology: interferon therapies for treatment of chronic hepatitis C and cirrhosis (supervised review of INTRON-A, ROFERON, WELLFERON, INFERGEN, PEG-INTRON license applications and supplements), liver assist devices, gene therapy for the treatment of Wilson’s Disease and other inherited metabolic disorders, cytokine therapy for alcoholic hepatitis and hemachromatosis, PCR assays for hepatitis C virus; planning committee--NIH hepatitis C consensus conference.
5.     Rheumatology: biological therapies for treatment of rheumatoid arthritis (supervised review of ENBREL, REMICADE license applications and supplements), systemic lupus erythematosus, vasculitis, Wegener’s granulomatosis, scleroderma, psoriatic arthritis, etc; provided CBER input for agency Guidelines for the Development of Therapies for Rheumatoid Arthritis.
6.     Infectious Disease: biological therapies for treatment of AIDS, sepsis, tuberculosis, imaging agents to detect appendicitis and osteomyelitis, and other infectious diseases, etc.
7.     Wound-Healing: cytokine agents to preserve tissue viability (supervised  review of REGRANEX license application, consultant to CDRH on applications for APLIGRAFT licensure); helped write agency draft guidance document on wound-healing. 
8.     Psoriasis/Treatment of Cosmetic Defects: biological therapies for treatment of psoriasis; helped draft agency Guidelines for the Development of Agents to Treat Psoriasis, somatic therapy to treat cosmetic defects; CBER representative to conference with National Psoriasis Foundation.
9.     Orthopedic Medicine: manipulated autologous structural cells (supervised review of CARTICEL license applications) bone morphogenic proteins, inhibitory cytokines (supervised review of ACTIMMUNE for treatment of osteopetrosis); principle author of agency guidance for the study of Manipulated Autologous Structural Cells (MAS cells)
10.  Renal and Hepatic Allograft Transplantation/xenotransplantation: immunosuppressive cytokine therapy to prevent rejection episodes following kidney (supervised review of SIMULECT and ZENAPAX license applications), liver, pancreatic and intestinal transplantation, in utero stem cell transplantation, and xenotransplantation protocols.
11.  IND Review:  principle author of Good Review Practices IV-draft agency guidance for reviewers of investigational new drug applications

Bibliography:      

 1.     Schwieterman W., Potter BJ, Kiang CL, Stump, D. and Berk, PD: Uptake kinetics of free    fatty acids into rat adipocytes. Clin. Res, 1987; 35,659A (Abstract).

2.     Potter BJ, Stump D, Schwieterman WD, Sorrentino D, Jacobs CN, Kiang CL, Rand J, Berk PD:  Isolation and partial characterization of plasma membrane fatty acid binding protein from myocyte and adipocyte preparations and their relation to analagous proteins in liver and gut.  BBRC 1987; 48: 1370-1376.

3.     Schwieterman W, Sorrentino D, Potter BJ, Rand J: Uptake of oleate by isolated rat adipocytes is mediated by a 40-kDa plasma membrane fatty acid binding protein closely related to that in liver and gut. PNAS, 1988; 85(2): 359-63.

4.     Nelson DL, Schwieterman WD, Notarangelo LD: The human immune response: molecular recognition and immunoregulation.  Proceedings of the International Symposium on Cyclosporin in Autoimmune Diseases and in Organ Transplantation.  Brescia, Italy, May 26-28, 1988. New York: Raven, 1988; 235-239.

5.     Notarangelo LD, Wagner DK, Schwieterman WD, Camerino G, Gleisher TA, Nelson DL:  Restriction fragment length polymorphism analysis of patients with X-linked agammaglobulinemia and isolated growth hormone deficiency.  In Albertine A. ed.  Molecular Probes:  Technology and Medical Applications.  New York: Raven, 1989; 143-148.

6.     Schwieterman WD, Wood GM, Scott DE, Steinberg, AD:  Studies of bone marrow progenitor cells in lupus-prone mice.  I.  NZB marrow cells demonstrate increased growth in Whitlock-Witte culture and increased splenic colony-forming unit activity in the Thy-1-, lineage-population.  J. Immunol, 1992.  148(8): 2405-2410.

7.     Schwieterman WD, Kleinman D. Steinberg AD:  Studies of bone marrow progenitor abnormalities in lupus-prone mice.  II.  Further studies of NZB Thy-1- lineage-bone marrow cells.  Clin. Immunol. and Immunopath, 1994; 72(1): 114-120. 

8.     Schwieterman WD:  Immunosuppression in Combination with Monoclonal Antibodies.  Proceedings:  Early Decisions in DMARD Development IV.  San Francisco, CA. March 2-4, 1995.  Atlanta, Georgia:  Arthritis Foundation, 1996: 291-296.

9.     Schwieterman WD, Roberts R: FDA Perspective on Study Designs for Therapies for Severe Sepsis, Sepsis, 1997, 1:1

10.   Schwieterman WD: FDA perspective on anti-TNF treatments. Ann Rheum Dis. 1999 Nov; 58 Suppl 1:I90-1.

11.   Schwieterman WD, Weiss KD, Tiwari J, Siegel JP: Changes in trial parameters. Lancet. 2001 Jan 27; 357(9252):314.

12.   Keane J., et al:  Tuberculosis Associated with Infliximab, a Tumor Necrosis Factor alpha-Neutralizing Agent.  New England Journal of Medicine.  2001 October 11; 345 (15): 1098.

Poster Presentations:

 Schwieterman WD, Zand MS, Plotz PH, Miller FW:  Misdiagnosis of Idiopathic Inflammatory Myopathy.  57th Annual Scientific Meeting of the American College of Rheumatology.  San Antonio, Texas; November 8, 1993

Invited Lectures/Presentations:

1.  Drug Information Association Annual Meeting; “Clinical Endpoints in Rheumatology Trials.”  Rockville, Maryland; June, 1993.

2.  Pharmaceutical Manufacturer’s Education and Research Institute Workshop on Drug Development in Rheumatology;  FDA Perspective on the Regulation of Biologics.” Chicago Illinois; June, 1993

3.  Japanese Government Conference on Gene Therapy;  “Animal Preclinical Studies and Human Clinical Protocol Considerations in Gene Therapy,” Tokyo, Japan; July, 1993.

4.  BioEast Annual Conference; “FDA Perspective on Clinical Trial Design.” Washington, D.C.; January, 1994.

5.  DIA Workshop: Safety of Investigational Drugs: Regulatory Requirements, Risk Assessment and Procedures for Implementation. “Special Issues Related to Biological Products,” Bethesda, Maryland; February, 1994.

6.  Cystic Fibrosis Research Symposia: “FDA Perspective on Clinical Trial Design for Studies of Cystic Fibrosis.” Arlington, Virginia; March, 1994.

7.  Gene Therapy Workshop-Paradigms for Success; “An FDA Perspective on Clinical Trial Design for Gene Therapy.” Washington, D.C.; May, 1994.

8.  International Business Conferences Workshop on Sepsis; “FDA Perspective on Clinical Trial Designs for Studies of Sepsis.” Philadelphia, Pennsylvania; July, 1994.

9.  FDA Science Forum: “Considerations for Clinical Trial Design for Gene Therapy.” Bethesda, Maryland; September, 1994.

10. DMARD Development IV-Biologic Agents in Autoimmune Disease; “Immunosuppression in Combination With Monoclonal Antibodies.” San Francisco, California; March, 1995.

11. Antirheumatic Drug Guidelines Meeting; “Outcome  Measures: Are Composite Indices Acceptable?”, Scottsdale, Arizona; May, 1995.

12. Commissioner’s Roundtable for Autologous Cells Manipulated ex vivo for Structural Repair; Proposed CBER Regulatory Policy for Clinical Development. Rockville, Maryland; March, 1996.

13. International Society for Rheumatic Therapeutics Fifth Biannual Congress;  “U.S. FDA Perspective on Clinical Trial Design for Rheumatic Therapies.” Paris, France;  May, 1996

14. Food and Drug Law Institute - Biologics Update ‘96; “Accelerated Approvals.”  Washington, D.C; July, 1996

15. Critical Care Medicine and Trauma Symposium, Sepsis Roundtable; “FDA Perspectives on Clinical Trial Design for Sepsis,” Toronto, Canada; October 1996

16. FDA Workshop; Good Review Practices Track VIII public workshop, panel discussion.  Rockville, MD; November 1996

17. 36th International Industrial Pharmacy Conference, Pharmaceutical Innovation-Incentives in Drug Development; Good Review Practices Track IV,” Austin, Texas, February 1997

18. Innovative Therapies in Autoimmune Diseases, planning committee; “FDA Introduction,” “Mock end-of-phase 2 meeting,” “FDA panel discussion on rheumatoid arthritis,” “FDA Perspective on Autologous Chondrocyte Transplantation for Structural Repair,” Washington, D.C., April 1997

19. Rounds--Center for Drugs, Evaluation and Research, FDA; "Development of Biologic Agents for the Treatment of Rheumatoid Arthritis," Rockville, MD, May 1998

20. National Institutes of Arthritis and Musculoskeletal Skin Disease Roundtable Discussion on Public-Private Partnerships in Arthritis Research; "Government Perspective on Partnerships to Foster Basic Science," Bethesda, Maryland; September 1997

21. National Psoriasis Foundation Conference on Psoriasis; "FDA Perspective on Clinical Trial Design and Safety of Biological Therapies for Studies of Psoriasis”, Friendship Heights, MD; August 1998

22. International Business Conference on Psoriasis;  "FDA Perspective on Clinical Trial Design for Studies of Psoriasis," Washington D.C.;September 1998

23. 1st International Conference: Gene Therapy of Arthritis and Related Disorders, "Regulatory Issues Surrounding the Gene Therapy of Arthritis and Related Conditions," Bethesda, MD; December 1998.

24. Preclinical and Clinical Development of Biological Therapeutics:  Focus on Pharmacokinetics and Pharmacodynamics, “FDA Perspective on Phase 1 Dose-Escalation,”Annapolis, MD; October 1999.

25. Antivirals Advisory Committee:  “Introduction to Meeting to Discuss Biological Therapies to Treat HIV,” Rockville, MD; October 2000

26. HIV Forum; “ FDA Perspective on the Development of Therapeutics to Treat HIV,” Washington, D.C., December, 2000