Project Manager Experience - 26 studies in patient populations

• Immunology / Inflammation (6 Phase II/III studies)

  • Wound healing

  • Soft tissue inflammation

• Endocrinology / Metabolism (4 Phase 1b/II studies)

  • Obesity

  • Growth hormone deficiency

  • Acromegaly

  • Pituitary/adrenal disorders

• Dermatology (4 Phase II/III studies)

  • Atopic dermatitis

  • Burn itch

  • Acne vulgaris

• Infectious Disease (2 Phase IIa studies)

  • Influenza vaccine

  • Oral warts

• Oncology (7 Phase I-IV studies)

  • Breast

  • Lung

  • Prostate

  • Melanoma

  • Kidney

• Pulmonary (2 Phase IIa studies)

  • Asthma (exercise and allergen induced)

• Genitourinary (1 Phase 1 study)

  • Erectile dysfunction

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Project / Program Oversight Experience - 79 studies in patient populations

• Immunology / Inflammation (1 Phase 1b study)

  • Rheumatoid Arthritis​

• Endocrinology / Metabolism (7 Phase Ib/IIa studies)​

  • Type II Diabetes​

  • Obesity

• Dermatology (3 Phase Ib/IIa studies)​

  • Atopic dermatitis​

  • Psoriasis

• Cardiovascular (3 Phase Ib, IV studies)​

  • Hypercholesterolemia​

  • Hear failure

• Neurology (13 Phase Ib/IIa studies)​

  • Anesthetic​

  • Pain (non-inflammatory)

  • Migraine

  • Alzheimer's Disease

  • Amyotrophic Lateral Sclerosis

  • Parkinson's Disease

• Psychiatry (8 Phase Ib/II studies)​

  • Schizophrenia​

  • Major Depressive Disorder

  • Generalized Anxiety Disorder

• Infectious Disease (1 Phase IIa study)​

  • Hepatitis C​

• Oncology (16 Phase I-III studies)​

  • Ovarian​

  • Sarcomas

  • Gastric

  • Hepatic

  • Adenoid Cystic Carcinoma

  • Solid tumors (various)

  • Melanoma

  • Pancreatic

  • Colorectal

  • Breast

• Gastroenterology / Hepatology (7 Phase Ib/IIa studies)​

  • Gastroparesis​

  • Inflammatory Bowel Disease

  • Irritable Bowel

  • NASH

• Pulmonary (9 Phase IIa/II studies)​

  • Tobacco - risk reduction​

  • Idiopathic pulmonary fibrosis

• Genitourinary (2 Phase IIa, IV)​

  • Chronic Kidney Disease​

  • Hyperphosphatemia

• Rare Diseases (7 Phase IIa/III)​

  • Mitochondrial Respiratory Chain Disease​

  • Tumor-induced osteomalacia

  • Epidermal Nevus Syndrome

  • X-linked Hypophasphatemic Osteomalacia

  • Gaucher's Disease

• Ophthalmology (2 Phase II/III studies)​

  • Age-related macular degeneration​

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Clinical Pharmacology Project Management / Oversight - 245 studies in healthy subjects

• Single Ascending Dose​​ (SAD)

• Multiple Ascending Dose (MAD)

• Human Absorption / Metabolism / Excretion (hAME) - 14C radiolabeled

• Drug-drug Interaction (DDI)

• Cardiac safety (including thorough QTc [TQT])

• Food Effect

• Gastric pH

• Renal Impairment

• Hepatic Impairment

• Bioequivalence (BE)

• Bioavailability (BA)

• Biocompatibility

• Age and gender

• Ethnic Bridging

• PK / PD (clinical pharmacokinetics / pharmacodynamics)