Chief Scientific
Adviser
Dr. Lefer is currently a
Professor of Surgery at the Emory University School of
Medicine and is Director of the Cardiothoracic Surgery
Research Labs in the Division of Cardiothoracic Surgery.
His research is focused on the investigation and
translation of the cardioprotective therapies for the
treatment of acute myocardial infarction and congestive heart
failure. Dr. Lefer has performed seminal research in the areas
of statin-mediated and nitric oxide mediated cardioprotection
in the setting of myocardial infarction and heart failure. Dr.
Lefer is an expert in the field of nitric oxide and nitrite
physiology and cytoprotection and his research team was among
the first to demonstrate the profound cardioprotective effects
of sodium nitrite in ischemia-reperfusion injury in
preclinical model systems. Dr. Lefer has also served as
a cardiovascular consultant for Merck and Company, Pfizer
Global Research, Syngenta, Forest Research Institute, Cytel,
Genentech, Texas Biotechnology, Biopure, Ikaria, Adolor,
Astra-Zeneca, Genetics Institute, Schwarz Pharma, and
Boehringer Ingelheim.
Douglas Flanagan, Ph.D.
Chief
Formulation Adviser
Dr. Flanagan is a Professor of
Pharmaceutics and Chemical & Biochemical Engineering and
former Division Head of the Pharmaceutics Division in the
College of Pharmacy at the University of Iowa. With
nearly 90 publications and over 100 presentations at
scientific meetings, Dr. Flanagan has 40 years experience
teaching about and developing drug formulations and
biopharmaceutics. He has had numerous collaborative grants
with government agencies and partnerships with pharmaceutical
companies such as Bristol-Myers Squibb, Abbott Laboratories,
Axonyx, and over 25 other firms, working on controlled drug
delivery systems and formulations. Many of these
collaborative efforts and partnerships have come through his
over 30 year relationship with the University of Iowa
Pharmaceuticals (UIP). UIP is a FDA-registered clinical
manufacturer which has provided to formulation development and
production services to the pharmaceutical industry and
government agencies for over 40 years.
Brian H. Annex,
M.D.
Chief Clinical Adviser
Dr. Annex has
had a long standing clinical and basic research interest in
area of angiogenesis (the growth of new blood vessels) in
peripheral arterial disease (PAD). PAD is caused by blockages
in arteries to the leg. His group conducts a series of
translational studies in PAD which include investigations on
the causes of lower extremity atherosclerosis, the mechanisms
that regulate the control of collateral blood vessel
formation, the impact that diabetes mellitus plays in PAD,
computational modeling of growth factor pathways, as well as
genetic influences. There are several clinical studies such as
those testing the mechanism of exercise training as well as
gene or cell based clinical investigation to promote blood
vessel growth in patients with PAD. Finally, Dr. Annex is a
well known thought leader in the PAD and clinical trials. Dr.
Annex currently serves as the Chief of the Division of
Cardiovascular Medicine at the University of Virginia.
Amol Soin, M.D.,
M.B.A.
Clinical
Advisor
Dr. Soin is chairman and
founder of The Ohio Pain Clinic- a network of free-standing
chronic pain management facilities in southwestern Ohio
focused on non opioid based treatments for chronic pain. He
brings a wealth of experience in research, development,
biotech angel investing, and regulatory matters to TheraVasc.
Currently, he is a physician representative to Medicare via
the Clinical Advisory Committee for Ohio and West Virginia.
Additionally, he has held several key leadership positions in
various statewide and national medical societies. Dr. Soin has
authored several papers, textbook chapters, abstracts, and
served as a primary investigator for clinical research. He is
also the founder and CEO of a biotech angel investment firm
and has experience creating viable medical products from bench
research. Dr. Soin serves as a Clinical Assistant Professor of
Surgery at Wright State University Medical School and was
selected as one of America's Top Doctors in Pain Management
for 2006, 2007, 2008, and 2009. He has also won the "Patients
Choice Award" in 2008 and 2009 and the “Top Doctors and
Patient Choice Award" for 2010. Dr. Soin trained at the
Cleveland Clinic, and currently he is an active practicing
physician who sees patients that suffer from painful
peripheral artery disease and poor wound healing on a daily
basis. He is also an observer on the board of directors.
Michael Gill
Regulatory
Advisor
Mr. Gill is a Regulatory, QA,
QC Compliance Consultant with an extensive knowledge of
quality assurance, cGLP, cGMP quality control systems,
chemistry, manufacturing and controls requirements, and an
expert in general FDA Regulatory requirements with 26 years of
experience in the U.S. pharmaceutical industry working for
international pharmaceutical companies. Mr. Gill began his
career as an analytical chemist for Boots Pharmaceuticals,
Inc., then transitioned into the Regulatory Affairs department
where he worked in the R&D group managing INDs for the
cardiovascular and anti-depressant drug product portfolios.
Mr. Gill then worked as a Regulatory and Compliance Manager
for BASF Corportion, the US subsidiary of the German chemical
company and subsequently as a Regulatory and Compliance
Manager for Dr. Reddys Laboratories, Inc., an Indian based
generic drug leader in the world generic market. Mr. Gill
successfully lead transition teams for the introduction of
foreign manufactured drug product and transfer of the
manufacturing of those products from foreign plants to US
manufacturing facilities for the US market for oral solutions,
creams and solid oral dosage forms. Mr. Gill has had extensive
experience in managing US FDA, EU and German regulatory
authority inspections for US manufacturing facilities.