About

Scientific Advisors

Lawrence Blob, M.D. Safety/ Medical Director
Culley Carson, M.D. Urology
Robert Fielding, M.S. Pharmacokinetics
Thomas Hochadel, Pharm.D CRO Clinical Operations
Sally Look, Ph.D. Chemistry, Manufacturing and Controls
Frances Mielach, Ph.D., R.Ph., D.A.B.T. Toxicology and Regulatory Affairs
George Nadackal, MS, Ph.D. Preclinical Development

Lawrence Blob, M.D.
Safety/ Medical Director

Dr. Blob is Board Certified in Internal Medicine and Emergency Medicine and an expert on tyramine challenge studies associated with the use of MAO inhibitors. Dr. Blob consults with pharmaceutical companies to develop and conduct difficult Phase I trials. Previously, Dr. Blob served as Medical Director of Somerset Pharmaceuticals and consequently held a prominent role in the NDA approval in Major Depressive Disorders (MDD) by the FDA of selegiline, the first MAO inhibitor antidepressant without food restrictions. Dr Blob is an expert on the design and clinical execution of dietary tyramine challenge studies. He has authored a number of scientific publications and has participated as guest speaker at national and international conferences. Before joining Somerset, Dr. Blob spent 20 years practicing and teaching Emergency Medicine and running two healthcare companies.

 

Culley C. Carson III, MD
Urology

Dr. Carson is Rhodes Distinguished Professor of Urology and Chief of Urology at the University of North Carolina. Previously, he was Professor of Urology at Duke University Medical Center. Dr. Carson has published more than 300 peer review articles and 14 textbooks. He is author of Textbook of Erectile Dysfunction that was awarded the 2000 Book Prize by the Royal College of Medicine. He received the David Cristol Award (Mayo Alumni Association) and the Distinguished Contribution Award from the American Urological Association in 2011. Dr. Carson served on the American Board of Urology Examination Committee from 2001-2004. He was named US Air Force Command Flight Surgeon of the Year in 1974. Dr. Carson is past-president of the Sexual Medicine Society, Society of Urologic Prosthetic Surgeons and Southeast Section of the American Urological Association.

 

Robert Fielding
Pharmacokinetics

Mr. Fielding has over 25 years experience in pharmaceutical and biotech clinical research, including formulation evaluation, preclinical pharmaco-kinetics/toxico- kinetics, pharmacology and safety, and clinical pharmacokinetic studies for more than 40 products now approved or in clinical trials, including 4 of the 5 marketed liposomal drug products. He has directed in-house, collaborative, and contract studies in the above areas, and contributed over 90 articles, abstracts and reviews on the subjects of liposomal antibiotics, liposomal bronchodilators, liposomal antineoplastics, hemoglobin- based oxygen carriers, proteins and oligonucleotides, inhalation delivery, and sustained release injectables. He is a member of the American Association of Pharmaceutical Scientists, the American Society for Microbiology and the Society of Toxicology.

 

Thomas Hochadel, Pharm.D.
CRO Clinical Operations

Dr. Hochadel has over 18 years of experience in the planning, management, and conduct of clinical research trials. He is the Chief Operating Officer of Cognitive Research Corporation. Previously, Dr. Hochadel was the President of Advanced Research Corporation where he was responsible for the overall management and financial health of a full-service Contract Research Organization. Prior to that he was Senior Director, Psychiatry and Neurology, with SCIREX Corporation and Director of Clinical Operations CNS Center with Covance Inc, where he actively managed senior Project Managers, cross-functional project teams, and all clinical aspects of CNS studies. Dr. Hochadel also has six years of experience as Director of Clinical Research at Somerset Pharmaceuticals, Inc., where he was responsible for the generation of preclinical-to-post-marketing development plans and regulatory submissions. Dr. Hochadel was Somerset’s responsible party for two Investigational New Drug Applications (IND) and conducted more than 30 Phase I clinical studies.

Dr. Hochadel’s Phase I clinical trial experience has included multiple dose studies in healthy elderly subjects, tyramine challenge pressor tests, and extensive evaluations of transdermal systems including pharmacokinetic and wearability assessments. His expertise in Phase II-IV development is highlighted by his work in dementia, including a 48-week chronic dosing study in Alzheimers disease subjects and Nursing Home based studies targeting behavioral signs and symptoms of dementia. He also has experience with depression, mania, attention deficit/hyperactivity disorder, Tourettes syndrome, schizophrenia, Parkinson’s disease, and sleep disorder trials. Dr. Hochadel was also the responsible party for an anti-osteoporosis compound IND and development program.

 

Sally Look, Ph.D.
Chemistry, Manufacturing and Controls

Dr. Look is a natural products chemist with over 20 years experience in CMC regulatory work for FDA submissions. She is President of Regulatory Interlinx where she provides regulatory consulting services to a broad clientele that includes companies of all sizes, ranging from small start-up biopharmaceutical firms to major multi-national and foreign corporations. Previously, Dr. Look was a reviewing chemist at the FDA Center for Drug Evaluation and Research (CDER) Division of Oncology and Pulmonary Drug Products. Prior to joining the FDA, she held research positions at the Frederick Cancer Research Facility, Allergan Pharmaceuticals, Columbia University and UCSD.

 

Frances Mielach, Ph.D.
Toxicology and Regulatory Affairs

Dr. Mielach is a toxicologist with over 30 years experience in pharmaceutical regulations and development. She is president of Aspen Biomedical Consulting where she provides regulatory, scientific, safety, due diligence, and legal consulting services to several pharmaceutical/ biotechnology companies, venture capital firms, academic institutions, and law firms. Previously, Dr. Mielach was a VP of Scientific and Regulatory Affairs at Myriad Pharmaceuticals. Prior to joining Myriad, she was a Supervisor and Reviewer at the FDA Center for Drug Evaluation and Research (CDER) Division of Antiviral Drug Products and Expert Consultant to the five FDA Centers and other U.S. Government Agencies.

 

George Nadackal, MS, Ph.D.
Preclinical Development

Dr. Nadackal has over 20 years of leadership in drug discovery and development at West Coast Pharmaceutical companies. He has extensive experience in regulatory submissions and licensing processes for marketed products and drugs in development. Through his work at large pharmaceutical and biotechnology companies he has authored preclinical and clinical sections of several IND’s.