Medical Safety

CURRICULUM VITAE

KARL GALLEGOS, MD, MPH, CPI, ABAM

**** ****** ******* *****

Kennesaw, GA 30152

770-***-**** (Office)

770-***-**** (Fax)

404-***-**** (Cell)

**********@**********.***

Brief Summary:

Dr. Gallegos has been an investigator, and a medical monitor in numerous clinical trials, phase 1 through 4. His experience spans a range of therapeutic areas including CNS, analgesia and pain relief and trials in diabetes and metabolism.

He also has extensive background drug safety and has expertise in the preparation of literature reviews, intelligence reports, signal detection reports, aggregate reviews, protocols, Investigator Brochures, informed consents, data safety monitoring committee charters, clinical study reports, regulatory approval submissions (e.g. IND, SBLA and NDA), product labeling (e.g. PI, CCDS, etc.), RiskMAPs, Benefit Risk Reassessments, Risk Evaluation and Mitigation Strategies (REMS), etc. He as participated in development implementation and continuance of several EU-RMPs and REMS.

Dr Gallegos’s clients have included pharmaceutical, biotechnology and medical device companies, contract research organizations; private and public research institutions, public health organizations and non-profit organizations and the NIH. He has assisted with the streamlining, integration and harmonization and organization of the pharmacovigilance systems for growing, pharmaceutical and biotech companies and after mergers and downsizing. His interests include transforming scientific findings into clinical treatments, promoting global and domestic pharmaceuticals, cooperation, communication, and business development.

EDUCATION:

1973 B.S., Biology

Massachusetts Institute of Technology

Cambridge, Massachusetts

1977 Doctor of Medicine

Harvard Medical School

Boston, Massachusetts

1984 - 1986 Epidemiology and Statistics courses (non-degree)

Emory University School of Medicine

Atlanta, Georgia

2008 Masters of Public Health

University of North Carolina at Chapel Hill

Gillings School of Global Public Health

Chapel Hill, North Carolina

REFERENCES: Upon Request

PHARMACEUTICAL/BIOTCHNOLOGY INDUSTRY EXPERIENCE:

5/11/11 – Present Medical Monitor and Safety Consultant

Vifor Pharmaceutical / Vifor Pharma Ltd.

Drug Safety and Medical Review support of clinical trials.

2/20/12 – 4/3/12 Medical Safety Consultant

Otsuka Pharmaceutical

9/6/11 - 12/31/11 Drug Safety Contractor

Biogen Idec

Drug Safety and Medical support of clinical trials, and other activities related to filing of NDA.

2/22/11 – Present Medical Consultant National Institute of Drug Abuse

Rockville, MD

NIDA CTN-0052 Protocol review consultant and DSMB Member.

12/22/10 – 3/1/11 Safety Consultant

Cardiokine Biopharma, LLC

Drug Safety and Medical support of clinical trials.

02/16/10 – 1/31/11 Medical Consultant

Sepracor Inc. became Sunovion Pharmaceuticals

Drug safety, risk management – supported clinical development and post marketing drug safety.

6/2006 – 12/31/2010 Consultant Drug Safety and Medical Monitor

Aspreva Pharmaceuticals, Inc.

Victoria, British Columbia, Canada

Drug Safety and Medical support of clinical trials.

11/20/08 – 5/25/09 Pharmacovigilance consultant

Celgene Corporation

Review of Safety and provide medical input for filing of a cancer therapy for a new indication.

10/20/08 – 10/15/09 Pharmacovigilance consultant

Millennium: The Takeda Oncology Company

Responsibilities: Provide medical expertise and assist with aspects of drug safety harmonization of the Millennium pharmacovigilance / drug safety system, after the merger with Takeda and Millennium.

5/06/08 – 10/19/08 Medical Consultant Drug Safety / Risk Management

Ferring Pharmaceuticals Inc.

Support development and maintenance of product benefit-risk profile; provide medical-scientific content for ad hoc and routine product safety reports and com-municate product safety recommendations to internal and external stakeholders.

6/16/08 – 6/30/08 Pharmacovigilance Auditor

NephroGenex, Inc.

Provide external medical review and evaluation protocol and other study related documents, and performed the pre-study CRO pharmacovigilance audits..

3/07/08 – 11/01/08 Medical Consultant Drug Safety / Risk Management

Johnson & Johnson and Centocor Research & Development Inc.

Responsibilities (Oncology, Immunology and Rheumatology) Risk assessment of Eprex and Procrit and Remicade

9/12/2007 – 8/23/08 Medical Consultant Drug Safety / Risk Management

Alkermes Pharmaceuticals Inc.

Responsibilities: Provide product safety medical expertise for safety activities related to Vivitrol.

4/2007 – 8/1/2007 Consultant Drug Safety Evaluation

Ocera Therapeutics, Inc.

Provide due diligence/safety evaluation a product already approved in Japan for renal failure, but being developed globally for a new indication.

4/2006 – 9/2006 Consultant, Risk management Plan development

Solvay Pharmaceuticals, Inc.

Risk Management Plan for Merinol, and assisted in the development, regulatory and marketing strategy development of Merinol for global development.

10/2005 – 4/1/2008 Consultant

Marion Weinreb & Associates, Inc.

Provided medical leadership and review for several Modules 5 prior to submission. Performed GCP pharmacovigilance audits.

12/2003 – 10/1/2007 Medical Consultant Drug Safety / Risk Management

Biogen Idec Inc.

Responsibilities: Provided product medical safety expertise of serious adverse events for clinical trials and post marketed products.

10/2005 – 5/2006 Consultant Medical Monitor

UCB, Inc.

Position Purpose/Summary: Medical monitor for study of a product being tested for its utility in the treatment of neuropathic pain. I also assisted with the statistical analysis plan development, reviewing the line listings, and tables, and writing the Clinical Study Report.

9/2005 – 4/2006 Consultant Medical Monitor

Vasogen, Inc.

Toronto, Canada

Position Purpose/Summary: Review end of study data at the closure of 2 pivotal studies, participate in writing the end of study reports and the Biological Licensing Agreement (BLA).

6/2005 – 11/2005 Contract Physician Postmarketing Safety Evaluations (PSE)

Abbott Laboratories

Responsibilities: Triage and medical review and evaluation of serious adverse events for the postmarketing group in Global Medical Services.

7/2003 – 3/2005 Medical/Safety Consultant

US WorldMeds, LLC

Position Summary: Medical monitoring - oversee the clinical/medical development and FDA strategy for the Phase 3 clinical development for a product (for relief of symptoms in opiate withdrawal) approved in Great Britain but not yet approved in the US. Responsibilities included the medical and scientific direction of the clinical development program including protocol writing, meetings with the FDA and NIDA, site selection, and medical and safety monitoring of the trials. GCP Compliance Audits.

9/2003-12/2004 Medical Consultant

Enzon Pharmaceuticals, Inc

Author/developed post marketing protocols for ABELCET® for Investigator Initiated Studies

2/2002 – 5/2004 Consultant Medical Monitor

Clinical Trials Management

SCIREX Corporation

Medical monitoring and safety surveillance program for human clinical trials for SCIREX.

1/2003 – 8//2003 Consultant Medical Monitor/Post-marketing Drug Safety

Serono, Inc.

Responsibilities: Medical review of serious adverse events for products in clinical development and post marketed products. Provide medical direction an input for Medical Information after initial launch of Rebif® (interferon beta-1a). Medical Input into post marketing safety studies, interaction with KOLS and prescribing physicians with respect to Rebif® and Novantrone®.

2002 – 6/1/2003 Consultant Safety Monitor/ DRUG Safety

UCB Pharma

Position Purpose/Summary: (Pediatric Epilepsy) To ensure the medical safety of an antiepileptic medication being developed for a pediatric population (formulation change). In the role I was responsible for the management and safe conduct of the clinical studies. I was also involved in the daily review of serious adverse events for post marketed products, and products in clinical development.

8/2001 – 2/2002 Safety Consultant/Consulting Project Physician

Schering-Plough Research Institute

Responsibilities: Provided assessment and review of the Safety reports related to filing of Noxafil (posiconazole) and worked with the Anti-infective/CNS/Endo/ Dermatology Division at SPRI. Reviewed, updated, and prepared annual reports, Investigator Brochures, managed signal detection, and managed other clinical safety information for all products within the clinical development Anti-infective/CNS/Endo/Dermatology Division.

1/2001-9/2001 Consultant Endocrine Product Development

Pharmacia Inc.

Responsibilities: Functioned as the medical director of a PPAR drug being developed of type 2 diabetes. Wrote the protocols and the phase 3 development plan. Assisted with Regulatory, marketing, sales strategy development, choosing study sites, FDA interactions, etc.

2/2001-10/2001 Consultant/Lead Physician

Cardiovascular/Metabolic Division

Pharmacia Inc.

Assisted with integration and harmonization of the Searle and Pharmacia drug safety system, after the merger.

9/2000 –12/2000 Consultant

Cardiovascular Safety

G.D. Searle and Co.

Responsibilities: Maintained worldwide responsibility for surveillance and management of safety for all cardiovascular, metabolic and hematologic products in clinical development. Served as a member of the clinical development team(s) and was accountable for the medical aspects of drug safety surveillance and pharmacovigilance for drug, biologic, and device products in all phases of development. This included providing analysis and summary of safety data for the purposes of worldwide regulatory submission and commercial support.

4/1998 – 4/2001 President (Owner And Founder Of This CRO /SMO)

Peachtree Clinical Research Group, Inc. Atlanta, Georgia

Founder, and President of the Peachtree Clinical Research Group (PCRG), an independent, dedicated, multi-specialty clinical research organization (CRO), and clinical research site management organization (SMO). As President, I oversaw the Clinical Research, Pharmaceutical Data, Analytics, Outcomes, Epidemiological/Safety, Health Education, and Strategic Consulting business.

4/1997 – 4/1998 Safety Monitor

WorldWide Clinical Trials, Inc.

Kennesaw, Georgia

Coordinated and supervised all medical product safety and surveillance activities for the organization. Assisted with protocol review, protocol development for the management of safety information, safety monitoring, safety data interpretation, and assisted in safety report writing.

MEDICAL LICENSE: Georgia Medical License 031247

CONSULTING THERAPEUTIC EXPERTISE:

Analgesia and Pain Relief

Diabetes and Metabolism

CNS and Psychiatry

Monoclonal Antibodies

PRIVATE PRACTICE

1985 - 1996 Attending Physician, Adult & Young Adult Chemical Dependence

Ridgeview Institute

Smyrna, Georgia

1995 - 1996 Service Director, Addiction Medicine

Inpatient, Partial Hospitalization and Outpatient Services

Charter Behavioral Health Systems of Atlanta at Peachford

Atlanta, Georgia

1991 - 1995 Medical Director, Adult Addiction Medicine

Inpatient, Partial Hospitalization and Outpatient Services

C.P.C. Parkwood Hospital

Atlanta, Georgia

1985 - 1995 Director, Medical Intervention Unit

South Fulton Medical Center

East Point, Georgia

1983 - 1992 Director of Research / Medical Director, Caduceus Foundation

Clinical and Epidemiological Research Institute

Atlanta, Georgia

1988 - 1991 Attending Physician, Adult & Adolescent Chemical Dependence

Inpatient & Outpatient Services, Talbott-March Recovery Systems

Anchor Hospital

College Park, Georgia

TRAINING:

1985 - 1987 Clinical Fellowship, Adult & Adolescent Chemical Dependence

Ridgeview Institute

Smyrna, Georgia

1981 - 1983 Research Fellowship, Rheumatology & Orthopedics

Division of Rheumatology and Orthopedics

The Hospital for Special Surgery/Sloan Kettering Memorial Hospital

Sloan Kettering/New York Hospital Medical Center

Cornell Medical Center

New York, New York

1979 - 1981 Orthopedic Resident

Columbia Presbyterian Medical Center

The New York Orthopedic Hospital

Columbia-Presbyterian Medical Center

New York, New York

1978 - 1979 General Surgery Junior Resident

Roosevelt Hospital

St. Luke’s-Roosevelt Hospital

New York, New York

1977 - 1978 General Surgery Intern

Roosevelt Hospital

St. Luke’s-Roosevelt Hospital

New York, New York

PROFESSIONAL MEMBERSHIPS:

Volunteer: Cobb (Georgia) Medical Reserve Corps - Directpr

Volunteer: Cobb County Emergency Management Agency (CEMA)

Volunteer: The Cochrane Collaboration - Cochrane Consumer Network

National Alliance for Hispanic Health

MIT Alumni Advisory Group on Human Rights and Justice

MIT Institute Career Assistance Network

MIT Alumni Group of Atlanta

Academy of Pharmaceutical Physicians and Investigators

Education Committee - Past

Public Affairs Committee - Past

Annual Conference Committee - Past

American Society of Addiction Medicine

President, Georgia ASAM, 1995-1997

Certification Exam Development Committee - Past

Public Policy Committee - Past

State Chapter Presidents’ Committee - Past

Membership Task Force – Current

Pharmaceuticals and therapeutics Committee - Current

Impaired Physicians Committee - Past

Board of Trustees (Georgia Chapter) - Past

Research and Science Chairman (Georgia Chapter) - Past

Drug Information Association

Harvard Medical School Alumni Association

UNC – Gillings School of Public Health Alumni Association

AWARDS/HONORS:

100 Best Doctors - Atlanta Magazine, 1995 & 1996

AMA Physicians Recognition Award 1984, 1988, 1992, 1996

American Medical Association Education Research Foundation Award, 1984

Orthopaedic Research Foundation Fellowship Award, 1983

American Rheumatism Association Travelling Fellowship Award, 1982

Merck, Sharp and Dohme Research Fellowship Award, 1981

National Medical Fellowship Award, 1973-1977

Student Research Fellowship Award, American Society of Anaesthesia, 1976

Sloan-NIH Research Summer Fellowship, 1972

PUBLICATIONS/ABSTRACTS:

Talbott GD, Gallegos KV: The Pilot Impaired Physicians Epidemiologic Surveillance System (P.I.P.E.S.S.) Rationale for Improved Peer Review. Quality Review Bulletin 1999; 14(4):116-122.

Talbott, G. D., Gallegos, K. V., & Angres, D. H. (1998). Impairment and recovery in physicians and other health professionals. In A. W. Graham & T. K. Schultz (Eds.), Principles of Addiction Medicine (2nd ed.), (pp. 1263-1279). Chevy Chase, MD: American Society of Addiction Medicine.

Gallegos, K.V. and Talbott, G.D. 74 Physicians and Other Health Professionals. In J.H. Lowinson, P. Ruiz, R.B. Millman, and Langrod, J.G. (Eds.), Substance Abuse: A Comprehensive Textbook. Baltimore: Willliams & Wilkins, pp. 744-754, 1997.

Gallegos KV, Lubin B, Bowers C, Blevins J, Talbott GD: Relapse and Recovery; five to ten year follow-up study of chemically dependent physicians- the Georgia experiment. MD Med J 1992; 41:325-329.

Gallegos KV, Talbott GD, Angres D, Bettinardi-Angres K, Collins J: The Model Medical Marriage. Med Assoc Ga Med J 1991; 80:191-195.

Galanter M, Talbott GD, Gallegos KV, Rubenstone E: Combined Alcoholics Anonymous and Professional Care for Addicted Physicians. Am J Psychiatry 1990; 147:64-68.

Gallegos KV, Kelly JM: Trends in Physicians Drug Abuse: Prevention and Control. Addiction and Recovery 1990; 10(3):28-32.

Talbott GD, Gallegos KV: Intervention with Health Professionals. Addiction and Recovery 1990; 10(3):13-16.

Gallegos KV, Bettinardi-Angres K, Talbott GD: The Effects of Physicians Impairment on the Family. Maryland Med J 1990; 39:1007-1011.

Gallegos KV, Keppler JP, Wilson PO: Returning to Work After Rehabilitation: Aftercare, Follow-Up, and Worker Reliability, In Rehabilitation of the Alcoholic: Occupational Medicine, State of the Art Reviews, 1989; 4(2); 357-71.

Talbott GD, Gallegos KV: A Treatment Program for Physicians. EAP Digest 1989; 4(2); 357-370.

Galanter M, Talbott GD, Gallegos KV: AA and Professional Care for Impaired Physicians Am J Psychiatry 1989 (Abstract).

Gallegos KV, Browne CH, Veit FW, and Talbott GD: Addiction In Anesthesiologists, Drug Access and Patterns of Substance Abuse: A Case-Control Study. Quality Review Bulletin 1988; 14(4):116-122.

Gallegos KV, Veit FW, Wilson PO, Porter T, and Talbott GD: Differences in Patterns of Substance Abuse Among Impaired Health Professionals. Maryland Medical J 1988; 27:191-197.

Talbott GD, Gallegos KV, Porter and T, Wilson PO: The Medical Association of Georgia’s Impaired Physicians Program, Review of the First 1,000 Physicians: Analysis of Specialty. JAMA 1987; 257: 2927-2930.

Gallegos KV. The Pilot Impaired Physicians Epidemiological Surveillance System (P.I.P.E.S.S.) J Maryland State Med Soc 1987; 36:264-266.

Gallegos KV, Morrison MA: Substance Abuse In adolescents: Implications For the Year 2000. Proceedings of Youth 2000. Looking Toward the Future. Proceedings of the 1987 Region IV Conference on Adolescent Health and Social Issues, 1987.

Gallegos KV: Development of a National Database for the study of Impairment among Physicians. Proceedings of the Sixth National AMA Conference on the Impaired Physician,1986.

Robinson EL, Fitzgerald JS, Gallegos KV: Brain Functioning and Addiction: Neuropsychological Studies of Chemically Dependent Physicians- Patients. J Med Assoc Ga 1985; 74:374-379.

Gallegos KV, Norton MA, and Talbott GD: Computerized Approach to the Staging of the Disease of Chemical Dependence. J Med Assoc Ga 1985; 74:06-310.

Gallegos KV, Norton MA, Talbott GD, and Farley WJ: Data Collection of Georgia Impaired Health Professional Program. Alcoholism Clin and Exp Research 1984; 8:144 (Abstract).

Gallegos KV, Norton MA: Statistical Analysis of the Patient Population of the Impaired Physicians Program. J Med Assoc Ga 1984; 73:755-58.

Inman RD, Gallegos KV, Brause BD, Christian CL: Clinical and Microbiologic Features of Prosthetic Joint Infection (PJI). Annals of Int. Med 1984.

Gallegos KV, Inman RD, Brause BD, Christian CL: Histopathologic Study of Prosthetic Joint Infection (PJI). Arthritis Rheum 1983; 26:523. (Abstract).

Gallegos KV, Vigoritta VJ, Inman RD, Brause BD, Christian CL: Histopathologic Study of Prosthetic Joint Infection (PJI). Arthritis Rheum 1983; 26:547. (Abstract).

Christian CL, Gallegos KV, Brause BD: Management of Infections Associated with Joint Replacement and on the Immunosuppressed: Prophylaxis and Treatment. Medical Council, Merck Sharp and Dohme International, Proceedings of Meeting, 13-15 June 1982, Paris, France.

Gallegos KV, Inman RD: Antibody Response on Patients with Prosthetic Joint Infection. Orthopedic Transactions 1982; 9(3):118. (Abstract).

Gallegos KV, Inman RD, Brause BD, Fitzgerald TE, Redecha PB: Diagnostic and Therapeutic Implications of Antibody Response in Patients with Prosthetic Joint Infection. Arthritis Rheum 1982; 25:539. (Abstract).

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