Clinical Research and Medical Affairs Expert Physician (MD)

Expertise

• Clinical research and medical affairs physician (MD) specializing in global drug and biologics development, approval of small molecules drugs and biologics.
• Commercial development, including Clinical Development Plans (CDPs) due diligence, business cases, and marketing support and protocols for Phase I-IV as well as post-marketing studies.
• Respected authority and resource working with key opinion leaders in a diverse range of pharmaceutical and medical specialties as well as interfacing with marketing, regulatory affairs, pre-clinical, toxicology and CMC.
• Clarify and synthesize clinical trial design processes to assure approval, developing strategic plans and budgets, BLAs, NDAs (505B1 and 505B2), and ANDAs.
• Preparation of orphan drug submissions, (and status).

Expert Witness Experience

• Legal consultation regarding diabetes.
• Medical records review and analysis.

Core Competencies

• Pain management drugs, primarily opiates and neuropathy
• Urology pharmaceuticals for bladder cancer and irritable bladder syndrome
• Cardiothoracic surgery/back Surgery - coagulation
• Irritable Bowel Syndrome (IBS) therapeutics
• Diabetes drugs
• Gastroenterology
• Coagulation / anti-coagulation mechanisms and drugs
• Perioperative bleeding
• Investigator sponsored studies
• Hereditary angioedema (HAE)
• Dupuytren's contractures
• Oral mucositis from chemotherapy
• Orphan drugs
• Clinical research
• Medical affairs
• Biologics
• Small molecules
• Translational research
• Oncology

Experience

Independent Consultant, Present

Undisclosed Company, 2006 - 2011

Global Medical Director-Critical Care/Coagulation

• Drove worldwide medical affairs in support of plasma-related products involved in coagulation and hereditary angioedema, maintaining a crucial role in global commercial development.
• Actively contributed to protocol development in warfarin reversal due to bleeding and urgent reversal of warfarin for critical surgical procedures.
• Analyzed the anticoagulant market to assess implications of new agents on warfarin usage.
• Spearheaded business development to ensure medical support for possible new acquisitions.
• Due diligence evaluation of drugs to treat bladder cancer (Urology), Sickle Cell Disease, Thalassemia, and iron overload, etc.
• Worked extensively with specialists such as hematologists, immunologists, cardiologists, cardiovascular and cardiothoracic surgeons, anesthesiologists, spine surgeons, hepatologists, interventional radiologists, ultrasound radiologists, and other clinicians.
• Structured business case scenarios, assembled international project teams, defined education and e-strategy initiatives, wrote publication and education plans, and facilitated clinical research, marketing, and regulatory affairs.
• Propelled development of key opinion leaders (KOLs), built scientific advisory boards and seminars, and oversaw investigator initiated studies.
• Delivered mission-critical support at medical meetings as well as supporting production of publications and posters.
• Launched investigator IND studies in cirrhosis for bleeding and reduction of INR to facilitate interventional radiology procedures.
• Secured U.S. approval of Fibrinogen concentrate to remedy bleeding in congenital afibrinogenemia.
• Proved integral to drug development of cardiothoracic operative indications, including protocol development, advisory board meetings, and investigator-initiated studies in aortic surgery and coronary bypass.
• Guided pdFactor XIII to final stages of submission of BLA to FDA for congenital Factor XIII deficiency. Hereditary angioedema agent is a C1esterase inhibitor to treat acute attacks in patients with C1INH deficiency (Hereditary Angioedema - HAE).
• Supported development, approval and marketing of Berinert (C1esterase inhibitor to for hereditary angioedema).
• Headed ClinCom, an internal IIS evaluation committee equivalent to an internal IRB to assess and approve global requests for investigator initiated studies.
• Pioneered fast track approval and orphan drug status of two drugs.

Auxilium Pharmaceuticals, Inc., Malvern, PA, Sr. Vice President, Clinical Development, 2005

• Steered Biometrics and Clinical Research Groups with oversight of all clinical development across multiple drug platforms, including topical, transmucosal, oral, injection, small molecule, and biologics.
• Achieved seamless support for the development of various testosterone-related products, pain products, and AA4500 (collagenase) for various orphan indications.
• Sharpened focus to emphasize urology, pain management, orphan diseases, and orthopedics.
• Accomplished successful development of a transmucosal film of testosterone.
• KOL development in prostate cancer.

McNeil Consumer and Specialty Pharmaceuticals, Inc., Fort Washington, PA, 2003 - 2005

Director of Medical Affairs

• Oversaw medical affairs in the areas of urology, pain management, gastroenterology, and oncology, including Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), traveler's diarrhea, interstitial cystitis, and oral mucositis.
• Formed scientific advisory boards, directed key opinion leader development, and attended scientific and medical meetings.
• Maintained awareness of trends in therapeutic areas, such as internal medicine, family practice, emergency medicine, rheumatology, orthopedics, pain medicine, urology, and women's health.

Biotrax Research, LLC, Chadds Ford, 1990 - 2003

CEO, President and Founder, 1990 - 1997

• Founded a niche CRO and guided rapid expansion to 35 employees within an 18-month period.
• Established start-up operations with oversight of staffing and recruiting, office space and equipment, payroll, invoicing, and SOP development.
• Designed nationwide safety surveillance programs such as Clozaril for possible aplastic anemia.
• Drove clinical research studies including CNS, PNS, wound healing in diabetics, diabetic neuropathy, and diabetes devices.
• Advised large and small pharmaceutical companies as a consultant.

Independent Consultant, 2001 - 2003

• Communicated insight and expertise as a consultant to pharmaceutical companies surrounding new drug development in therapeutic areas, including pain management, women's health, and nephropathy.
• Delivered leadership as interim Senior VP of Clinical and Medical Affairs for Endeavor Pharmaceuticals.
• Chief Medical Officer for Biostratum - Conducted studies to reverse renal impairment.
• Primary Consultant on pain management to AAI Pharma.

Endo Pharmaceuticals, Inc., Chadds Ford, PA, 1999 - 2001

Executive Director - Head of Clinical Research

• Directed all Phase I-III studies primarily in pain management as well as CNS/PNS in support of the development of drug delivery systems, such as extended release oral, transdermal, topical, patch, and buccal/transmucosal drugs.
• Charted programs involving NDAs (NCEs) as well as eANDAs (generic equivalents of marketed pain drugs).
• Spearheaded due diligence and study development and implementation in neuropathic pain (e.g., complex regional pain syndrome, postherpetic neuralgia, diabetic neuropathy, low back pain, inflammatory and nociceptive pain, cancer-related pain, postoperative (acute) pain, and abdominal surgeries).
• Oversaw execution of OxyContin generic at all four strengths under Paragraph IV and clinical development programs for Oxymorphone-ER and Oxymorphone-IR, now marketed as Opana.
• Played an essential role in determining potential new candidates and propelling market research and medical affairs as a member of the licensing committee.

Berlex Laboratories, Montville, NJ, Director - Pain Management and Orphan Drugs, 1997 - 1999

• Led the pain management group and orphan drug licensing, including design and implementation of multicenter trials in myofascial pain.

AstraZeneca, Wilmington, DE Sr. Director - Clinical Research & Medical Affairs, 1984 - 1990

• Supervised a 70-person team in CNS, anesthesia, and metabolism therapeutic area groups in addition to data management and PC support groups.
• Strategized worldwide clinical development in close partnership with European colleagues engaged in studies focused on various therapeutic areas, including diabetic neuropathy.
• Garnered three promotions to become one of two Senior Directors of Clinical Research and Medical Affairs, rising from the position of Associate Director of Clinical Research in Metabolism.

Pfizer Central Research, Groton, CT, 1981 - 1984

Associate Director - Head Endocrinology and Metabolism

• Planned and managed Phase I-III diabetes and diabetes complications studies and diabetes-related studies in glucose management.
• Originated the first multicenter diabetic neuropathy trials with Sorbinil, including successfully inventing many of the devices required to measure sensory responses.
• Started international scientific advisory boards featuring endocrinologists, neurologists, and cardiologists.

Honors & Publications

Credentials

• Medical licenses active in PA and DE
• Member of State and County Medical Societies in PA and DE
• Engineer in Training

Languages

• Italian: Worked with Italian and European investigators and researcher (in KOL's).

Academic and Professional Affiliations

• Fellow of the Global Health Economics Unit, Center for Clinical and Translational Science University of Vermont College of Medicine; Department of Surgery
• Faculty appointments at Brown University and the University of Delaware

Publications and Patents

• Multiple publications, abstracts and presentations at meetings covering a broad range of topics related to pharmaceutical development.
• Patents on devices to quantify neuropathy.

Education

• MBA Executive MBA, West Chester University, West Chester, PA
• M.D. University of Louisville School of Medicine, Louisville, KY
• B.S. Electrical Engineering, Polytechnic Institute of Brooklyn, Brooklyn, NY