PRINCIPAL INVESTIGATOR

CHARLES FRANCIS DIEDERICH, M.D.

EDUCATION

FELLOWSHIP

University Health Center Hospitals, Fellowship, Critical Care Medicine, Pittsburgh, Pennsylvania 1985-1987

RESIDENCY

Wayne State University Affiliated Hospitals, Residency, Internal Medicine, Detroit, Michigan, 1983-1985

INTERNSHIP

Wayne State University Affiliated Hospitals, Internship, Internal Medicine, 540 E. Canfield, Detroit, Michigan, 48201, 1982-1983

FIFTH PATHWAY

University of Medicine and Dentistry of New Jersey, One Medical Center Drive, Stratford, NJ 08084, Fifth Pathway, Jersey Shore Medical Center, Neptune, NJ 1981-1982

MEDICAL DOCTOR

Autonomous University of Guadalajara, 110 Gallery Circle, San Antonio, TX 78258, M.D., 1981

BACHELOR OF ARTS

University of Pittsburgh, Pittsburgh, PA 15260, B.A., Economics, 1976

ASSOCIATE IN SCIENCE

Community College of Allegheny County, Route 885, West Mifflin, PA, Associate Science, 1971

THERAPEUTIC EXPERIENCE

Circulatory: Coronary Artery Disease, Hypertension

Metabolic Endocrine: Diabetes Mellitus, Hypercholesterolemia, Dyslipidemia, Hyperlipidemia

Infections/Parasitic Infections: Respiratory Tract Infections

Nervous System/Sense Organs: Fibromyalgia, Tendonitis/Bursitis

Vaccines: Pneumococcal

PROFESSIONAL EXPERIENCE

BANKSVILLE MEDICAL PITTSBURGH, PA APRIL, 1998 –May, 2017

PRINCIPAL INVESTIGATOR:

Functioned as Principal Investigator in multiple and various Phase II, III, and IV clinical trials. I was the primary person responsible for protecting rights, safety, and welfare of study subjects. I ensured that the trial at my site was conducted according to the investigator statement, that informed consent was obtained from each subject and that consent was ubderstood by the subject. I made sure that study staff received adequate training regarding their delegated tasks and provided oversight of their activities in conducting the trial. I made sure that any medical care needed by a subject due to a study related or non-related event was obtained.

BANKSVILLE MEDICAL, P.C PITTSBURGH, PA July 1990 to August 2017

PRESIDENT AND PHYSICIAN,

UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE PITTSBURGH, PA

July 1987 to June 1990

ASSISTANT PROFESSOR,

MONTEFIORE HOSPITAL PITTSBURGH, PENNSYLVANIA 1987 to1990 ASSISTANT DIRECTOR, SURGICAL INTENSIVE CARE UNIT

MERIT MEDICAL NETWORK MARS, PA 1996-2000

BOARD OF DIRECTORS

HEALTH SYSTEMS ALLIANCE MARS, PA 1997-2000

BOARD OF DIRECTORS, CHAIR, CONTRACTING COMMITTEE

LICENSURE

Pennsylvania MD 034292 E

Michigan (inactive)

PROFESSIONAL ACTIVITIES

University of Rochester School of Medicine and Dentistry and Western Institutional Review Board (WIRB), “Investigator Training for Medical Research”, March 15, 2007

Associate of Pittsburgh Critical Care Medicine Grand Rounds, “Digitalis and Supraventricular Tachyarrhytharia in the Postoperative Open Heart Surgical Patient”, October, 1987

University of Pittsburgh School of Nursing, Nurse Anesthesia School, “Acid-Base Balance”, Montefiore Hospital, November 30, 1988

University of Pittsburgh Critical Care Medicine Grand Rounds, “Toxicity of Interleukin II”, May 1988

Three Rivers Chapter AACN Annual Meeting, “Inatrogenic Complications in the Intensive Care Unit”, October, 1988

University of Pittsburgh School of Nursing, Nurse Anesthesia School, “Respiratory Physiology and Mechanical Ventilation”, September, 1989

University of Pittsburgh Critical Care Medicine Grand Rounds, “Thyroid Storm”, October 1989

University of Pittsburgh School of Nursing, Nurse Anesthesia School, “Acid Base Balance and Arterial Blood Gas Interpretation”, Montefiore Hospital, November, 1989

Montefiore Hospital ICU Nurse Conference, “Withholding and Withdrawal of Life Support”, November, 1989

COMPUTER EXPERIENCE

Proficient in Windows, iOS, Word, Excel, EDC (Medidata, Oracle, Inform)

LANGUAGES

Native English Speaker, mildly proficient in Spanish

SERVICE

Interviewer, Medical School Admissions Committee, University of Pittsburgh, 1987-1988

Member, Infectious Disease Committee, Montefiore Hospital, 1987-1990

Member, Standards Committee, Montefiore Hospital, 1987-1990

Member, Utilization Review Committee, Montefiore Hospital, 1989

Member, Library Committee, St. Clair Hospital, January 1998 to January 2000

Member Ethics Committee, St. Clair Hospital, January 2000-2004

RESEARCH PUBLICATIONS

“Evaluation of Hewett Packard End Tidal CO2 Module During Patient Weaning From Mechanical Ventilation”, Poster Presentation, American Thoracic Society, Cincinnati, May, 1989

“Hemodynamic Effects of Interleukin II”

“Evaluation of a Double Lumen High Frequency Jet Ventilation Endotracheal Tube”

“The Natural History of Pherenic Nerve Injury Occurring During Open Heart Surgery”

“Swallowing Function Following Prolonged Orotracheal Intubation”

“Swallowing Function Following Tracheostomy”

CLINICAL RESEARCH

CIRCULATORY: “A Multicenter, Randomized, Double-blind, Placebo-Controlled, 8 week Study to Evaluate the Safety and Efficacy of XXXXXX and Valsartan Given as a Fixed-Dose Combination in Patients with Stage 1 or 2 Essential Hypertension. Forest Research Institute, Inc. NAC-MD-01. November 2011 to December 2012.

CIRCULATORY: “A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous XXXXXX in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP”, Novartis, CACZ885M2301, May 2011 to September 2012.

CIRCULATORY: “Phase II multi-center, double-blind, randomized, parallel group, placebo-controlled, clinical trial for dose-finding and safety study of RVX000222 in subjects with stable coronary artery disease. ResVerlogix, ASSERT, January 2010 to August 2010.

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CIRCULATORY: “A Phase 3b, Double-Blind, Randomized, 12-Week Efficacy and Safety Study Comparing the TAK-491 Plus Chlorthalidone Fixed-Dose Combination vs Olmesartan Medoxomil-Hydrochlorothiazide in Subjects With Moderate to Severe Hypertension” Takeda TAK-491CLD_303. December 2009 to January 2011.

CIRCULATORY: “A Phase 3, Double-Blind, Randomized, Efficacy and Safety Study of the XXXX Plus Chlorthalidone Fixed-Dose Combination Compared With XXXX and Hydrochlorothiazide Coadministration Therapy in Subjects With Moderate to Severe Essential Hypertension. Takeda XXXXX. January 2009 to October 2009.

CIRCULATORY: “A 10 week, randomized, double-blind, parallel group, multi-center study to evaluate the efficacy and safety of once daily dosing of XXXXX (300 mg qd) to twice daily dosing of XXXXX (150 mg bid) in patients with essential hypertension.” Novartis, February 2008 to September 2008.

CIRCULATORY: “Follow up Of Clinical Outcomes: The Long-term XXXXXX plus Usual Care Study (FOCUS). Atherogenics, Inc. August 2006 to June 2007.

CIRCULATORY: “XXXXXX” Cardiovascular Treatment Assessment Versus Enalapril”, Bristol-Myers Squibb CV 137-120 (OCTAVE), December 2000, Phase III

CIRCULATORY: “A Prospective, Randomized, Double-Blind, Multi-Center Study Comparing the Effects of [Investigational Product] Versus Placebo on the Reduction of Cardiovascular Events in Patients with Coronary Artery Disease”. Atherogenics, Inc., AGI-1067-042, February 2004 to May 2007, Phase III. Sub-Investigator.

VACCINE: “A Phase 3, Open-Label,Single-Arm Trial Evaluating the Safety, Tolerability, and Reactogenicity of a 13-Valent Pneumococcal Conjugated Vaccine in Ambulatory Elderly Adults Aged 68 Years and Older Who Received 1 or More Doses of 23-Valent Pneumococcal Polysaccharide Vaccine At Least 3 Years Before Study Enrollment.” Wyeth 6115A1-3000. April 2008 to June 2009.

NERVOUS SYSTEM/SENSE ORGANS: “A Multi-Center, long-term, open-label extension study of [S,S] xxxxxx (PNU-165442G0 Administered once daily in patients with Fibromyalgia.” Pfizer, March 2008 to June 2009.

NERVOUS SYSTEM/SENSE ORGANS: “A 14-week, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of [S,S] XXXXX (PNU-165442G) Administered Once Daily in Patients with Fibromyalgia.”Pfizer, January 2008 to June 2009.

NERVOUS SYSTEM/SENSE ORGANS: “A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase III Study of the Efficacy, Tolerability and Safety of XXXXXX Topical Patch, 20% (KTP) in the Treatment of Pain Associated with Tendonitis or Bursitis of the Shoulder, Elbow or Knee.” Endo Pharmaceuticals, Inc. November 2007 to July 2008.

ENDOCRINE/METABOLIC: “A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of XXXXXX on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus”, 28431754DIA4003, Phase 4, Dec. 2013 – Feb. 2017

ENDOCRINE/METABOLIC: “A Multicenter, Controlled, Open-label Extension Study to Assess the Long-term Safety and Efficacy of XXXXXX”, 20120138, June 2013 to March, 2017

ENDOCRINE/METABOLIC: “A Double-blind, Randomized, Placebo and Ezetimide Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of XXXXXX on LDL-C in combination with Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia, Amgen, September 2012 to March 2014.

ENDOCRINE/METABOLIC: “A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of XXXXXX. Amgen 20110110, Dec. 2011 to Mar. 2017

ENDOCRINE/METABOLIC: “LAPLACE TIMI 57 – A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficay of XXXXXX on LDL-C in Combination With HMG-CoA Reductase Inhibitors in Hypercholerolemic Subjects. Amgen, 20101155, October 2011 to April 2012.

ENDOCRINE/METABOLIC: “A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of XXXXXX in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy”, Johnson & Johnson Pharmaceutical R & D, XXXXXX, Phase 2, June 2011 to April 2012.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of XXXXX Compared to Glipizide When used in Combination with Metformin in Subjects with Type 2 Diabetes. Takeda SYR-322_305. February 2009 to May2012.

ENDOCRINE/METABOLIC: “An 8-week, Multicenter, Randomized, Double-blind, Four-arm, Parallel-group Study Comparing the Safety and Efficacy of XXXXX to Simvastatin in Subjects with Hypercholesterolemia”. Abbott XXXXXX. December 2008 to July 2009.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind, Plecebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Effficacy of XXXXX in Combination with Thiazolidinedione Therapy in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Thiazolidine Theapy Alone.” Bristol-Myers Squibb XXXXX July 2008 to August 2009.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of XXXXX in Combination with Atorvastatin and Ezetimide to Atorvastatin in Combination with Ezetimibe in Subjects with Combined (Atherogenic) Dyslipidemia”. February 2008 to September 2008.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind, Placebo-Conrolled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of XXXXX as Monotherapy in Subjects with Type 2 Diabetes Who Have Inadeguate Glycemic Control with Diet and Exercise.” Bristol-Myers Squibb MB102013. September 2007 to November 2009.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind, Placebo-Conrolled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of XXXXX in Combination with Metformin in Subjects with Type 2 Diabetes Who Have Inadeguate Glycemic Control on Metformin Alone.” Bristol-Myers Squibb MB102014. September 2007 to May 2010.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of XXXXX (dosed as coadministered XXXXX and Simvastatin Tablets) Versus Atorvastatin in Patients With Mixed Hyperlipidemia.” Merck & Co., Inc. Phase 3. May 2006 to March 2008.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of XXXXX as Monotherapy with Titration in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and Exercise.” Bristol-Myers SquibbXXXXX Phase 3. March 2006 to June 2008.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of XXXXX in Combination with Glyburide in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Glyburide Alone.” Bristol-Myers Squibb XXXXX. Phase 3. March 2006 to March 2008.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of XXXXX in Combination with Thiazolidinedione Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidine Therapy Alone.” Bristol-Myers Squibb XXXX Phase 3. February 2006 to March 2008.

ENDOCRINE/METABOLIC: “A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Study of Rosuvastatin 20 mg in the Primary Prevention of Cardiovascular Events Among Subjects with Low Levels of LDL-Cholesterol and Elevated Levels of C-Reactive Protein”. Jupiter. Phase 3. September 2005 to May 2008.

ENDOCRINE/METABOLIC: “A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of XXXXX 50 mg, 100 mg or Placebo When Co-Administered with Rosuvastatin 10 mg or 20 mg in Subjects With Primary Hypercholesterolemia.” Protocol XXXXX Phase 3. September 2005 to March 2007.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of XXXXX in Combination with Metformin in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone.” Bristol-Myers Squibb CV181-014. Phase 3. June 2005 to November 2009.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of XXXXX as Monotherapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and Exercise.” Bristol-Myers Squibb CV181-011. Phase 3. June 2005 to August 2009.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind, Placebo-controlled Comparison Study to Determine the Efficacy and Safety of XXXXX in Patients with Type 2 Diabetes, Who are Either Receiving No Current Treatment or Currently Treated with Diet and Exercise, a Sulfonylurea, Metformin, or a Combination of a Sulfonylurea and Metformin”. Development Partners,LLC XXXXX. Phase II. March 2005 to November 2005.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind Study to Evaluate the Lipid-Altering Efficacy and Safety of the Ezetimibe/Simvastatin Combination Tablet Versus Rosuvastatin in Patients with Primary Hypercholesterolemia.” Merck Protocol 058-00. Phase III. April 2004 to January 2005.

ENDOCRINE/METABOLIC: “A Phase 3, Randomized, Three-Arm, Double-blind, Active Controlled, Parallel Group, Multicenter Trial to Evaluate the Safety and Efficacy of XXXXCX in Combination with Metformin Compared to Glimepiride in Combination with Metformin in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone”. Bristol-Myers Squibb Protocol XXXXX. March 2004 to February 2006.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel Study to Determine the Effect of Pravastatin 20 mg on LDL-C when Administered Once Daily to Subjects with Moderately Elevated Primary Hypercholesterolemia”. Bristol-Myers Squibb Protocol XXXX. Phase III. March 2004 to November 2004.

ENDOCRINE/METABOLIC: “A Randomized, Double-blind, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of [Investigational Product] in Combination with Metformin Compared to Pioglitazone in Combination with Metformin in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone”. Bristol-Myers Squibb XXXXX, October 2003 to April 2005, Phase III.

ENDOCRINE/METABOLIC: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of [Investigational Product] as Monotherapy in Subjects with Type 2 Diabetes Mellitus Who have Inadequate Glycemic Control. Bristol-Myers Squibb XXXXX, April 2003 to May 2004, Phase II

INFECTIONS/PARASITIC DISEASES: “Randomized, Open Label, Multicenter Trial of the Safety and Effectiveness of INVESTIGATIONAL PRODUCT] and Amoxicillin/Clavulonic Acid in Outpatients with Respiratory Tract Infections in Usual Care Settings”, Aventis, October 2001to March, 2002 Phase III

INFECTIONS/PARASITIC DISEASES: “An Open-Label Multicenter Non-Comparative Study of Oral Gatifloxacin in the Treatment of Community-Acquired Respiratory Tract Infections”, February 2000 to July, 2000, Phase IV.

INFECTIONS/PARASITIC DISEASES: “The Allegra Research on Gaining Experience Trial ”, (T.A.R.G.E.T.), April 1998, Phase IV.

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