INTRATAB LABS INC.

 

 

                                                THERAPIES WHEN TIME MATTERS™

 

 

Company Leadership and Scientific Advisors

 

Rudy J. Emmelot 

CEO

 

Rudy J Emmelot is an experienced executive & leader in the pharmaceutical development, biotech, diagnostics, lab services & life sciences fields.

 

Rudy began his career at the Chicago Board of Trade at a market maker firm in index arbitrage with Stafford Trading.  Soon Rudy moved to the equity side of Stafford Trading & became the portfolio manager of public & privately held biotechnology & life science firms while serving on several of their boards.  Rudy then relocated to Europe & opened trading offices & served as Managing Director for Stafford in Amsterdam in a joint venture with ABN-Amro.  Rudy returned to the US & with Stafford established 2 startup healthcare technology companies, Clinical Micro Sensors, Inc. & Xencor (XNCR) serving as director of operations and vp of finance respectively. Rudy then joined Nventa Pharma Inc., PharmaForm & Akela Pharma, Inc. serving as CEO, president & member of the board of directors of the latter two. Recently Rudy was CEO, president & founder of Formex.

 

 

John A. McCarty

President & Chief Scientific Officer

 

John McCarty has been developing pharmaceutical dosage forms for over thirty years. He started his career as a Quality Control Manager for a cardiac heart pacer manufacturer. His career in pharmaceutics started at KEY Pharmaceuticals developing transdermal patches, controlled release oral dosage forms and inhalation products. He held management positions at Key Pharmaceuticals, Schering–Plough, and Pharmavene (acquired by Shire). As Vice President of Formulation Sciences and Drug Delivery at Azopharma Contract Pharmaceutical Services, his leadership resulted in the development of over 200 clinical products in three years.  Some of the commercial products which he helped launch include NITRO-DUR (transdermal nitroglycerin), UNI-DUR (once-a-day oral theophylline), CARBATROL (once-a-day oral carbamazepine), THALOMID® (oral thalidomide).

 

John is an inventor on over 20 U.S. and foreign patents, a National Institute of Health Grant  Reviewer, on PharmTech Experts Panel Member, on Elsevier editorial staff for Journal of Control Release, on Tablet & Capsules  Editorial Advisory Board and contributor to Eye on Excipient Column and JRS Pharma Member of the Prosolv Advisory Board. His affiliations include American Association of Pharmaceutical Scientists, Controlled Release Society, American Chemical Society, American Association for the Advancement of Science, Parenteral Drug Association, International Society of Pharmaceutical Engineers and Society for Research on Nicotine and Tobacco. He received Bachelors in Chemistry and Microbiology from Florida Atlantic University in 1977.

 

 

Christine de los Reyes Pharm. D., MBA 

Vice President, Business Development & Licensing

 

Christine has over 25 years of pharmaceutical experience and most recently was founder and Managing Director of BiotechPartnering Solutions, a business development consulting firm that advises life science companies on partnering strategy, search for potential partners, coordination of technical evaluation and due diligence, deal structure and transaction negotiation.  In this capacity, she has had numerous clients and executed several licensing transactions.  She is also on the advisory board of the Neurotechnology Industry Organization, a non-profit trade association that represents companies involved in neuroscience, academic neuroscience research centers and brain-illness advocacy groups.

 

Prior to starting BiotechPartnering Solutions Christine served as Executive Director of Licensing & Development at Pfizer.   At Pfizer Christine spent twelve years in their licensing group with a focus on in-licensing in several therapeutic areas including neuroscience, infectious diseases, immunology, dermatology, and ophthalmology. Having completed numerous in-licensing and one out-licensing transactions, she also was responsible for external search activities for new opportunities and led multidisciplinary teams conducting technical evaluation, due diligence, and financial valuation for licensing, co-promotion and M&A transactions with biotech and pharma companies. Also while at Pfizer, Christine held several senior positions in the US and international marketing and medical groups.

 

Christine began her career as Assistant Professor of Pharmacology teaching undergraduate and graduate level courses in clinical pharmacy at the University of Texas. From there she became Director of Clinical Research at Mt. Sinai Medical Center in New York, before joining Pfizer in 1989.

 

Christine earned her Doctorate in Clinical Pharmacy from the University of Texas, a Master’s in Business Administration from St. Joseph’s University, and a Bachelor of Science in Pharmacy degree from Wayne State University.

 

 

Angus McLean, Ph.D.

Director of Pharmacology and Kinetics

 

Dr. McLean graduated with a Ph.D. in Chemistry from the University of Strathclyde in 1972. He initially worked at Marie Curie Research Institute and at The University of Surrey and Imperial College. 1981 he worked at the University of Texas investigating interactions of apomorphine with rat brain and receptor model proteins. This work was published in the Journal of Medicinal Chemistry.

 

On leaving Texas, he entered the pharmaceutical industry with Adria Laboratories in Columbus, Ohio. He worked in Analytical Research and Development on 3 NDA submissions concerned with hypertension, fungal infections and inflammation. Following the sale of Adria to Erbamont in 1985 he moved to Florida and joined Key Pharmaceuticals, where he met John McCarty, and worked on biopharmaceutics product development support of transdermal and modified release products. Following the merger with Schering Plough he moved to NJ as a Senior Research Scientist researching the physical and chemical properties of cyclodextrins.

 

In 1992 he moved to Maryland and joined a venture capital drug delivery company Pharmavene working on the product development of modified release drug formulations including Carbatrol (NDA approved 1997) and osmotic and transmucosal drug delivery systems. Pursuant to the sale of Pharmavene to Shire he worked on the NDA approval of Adderall XR (ADHD) and Fosrenol (Cardiorenal).

 

In the year 2000 he became an independent pharmaceutical consultant at BioPharm Global, Inc. Over the last 14 years he has worked with ~ 50 different companies on issues relating to pharmaceutical development and drug registration. Involvement in approved New Drug Applications (NDA) include Adderall XR®, Equetrol®, Fosrenol®, Daytrana®, Lusedra® and Moxatag®. In summary Angus has 18 years within the pharmaceutical industry and 14 years as a consultant to the industry. 

 

 

Scientific Advisory Board

 

Jed Rose, Ph.D.

Chair, Scientific Advisory Board

 

Dr. Rose is the Director of the Duke Center for Smoking Cessation and a Professor in the Department of Psychiatry and Behavioral Sciences at Duke University Medical Center.  

 

Under his direction, the Center is focusing on personalized and adaptive treatment approaches, in which genomic and phenotypic markers are used to tailor treatment to the individual smoker, and the initial treatment can be modified based on early indicators of therapeutic outcome.  His primary research goals are to elucidate the biological mechanisms underlying tobacco addiction and to promote the development of more effective treatments. 

 

Dr. Rose is also the President and CEO of the Rose Research Center. The Rose Research Center is a premier clinical research facility, leading the way in clinical trials to eliminate smoking addiction.

 

Dr. Rose began work in the area of tobacco addiction research as a NIMH Postdoctoral fellow at the University of Caifornia at Los Angeles. A main focus of his research program has been the elucidation of the role of sensorimotor cues and the CNS effects of nicotine in reinforcing cigarette smoking behavior.

 

He is most known for co-inventing the nicotine skin patch with the late Murray Jarvik, M.D. , Ph.D. and K. Daniel Rose in the early 1980s.  Rose et al. published the first study of the pharmacokinetics of a transdermal nicotine patch in humans in 1984 and the subsequently filed US Patent 4920989, which was upheld in a priority decision in 1993.  This work helped pave the way for the development of commercial nicotine skin patches.  Dr. Rose also developed novel methods for reaerosolizing selected constituents of tobacco smoke in cigarette-sized devices, a forerunner of modern e-cigarettes.  His first NIDA funded grant, "Scaling the Reinforcing Value of Cigarette Smoke" (1981-2000), measured the role of nicotine in tobacco dependence, by selectively varying nicotine concentrations in smoke while holding tar yield constant, using a two-barreled smoke-mixing device.  This method was employed in research cited in the 1988 U.S. Surgeon General's Report on nicotine addiction.

 


R. Christian“Chris” Moreton, M.Sc., Ph.D., M.R.Pharm.S., MRSC.

Scientific Advisory Board Member


Dr. Moreton has almost 40 years’ experience in the pharmaceutical sector. He is a Partner at FinnBrit Consulting. Prior to the founding of FinnBrit, Dr. Moreton worked mainly as a formulation scientist in the UK, Sweden, Canada and the US for both innovator and generic companies. In addition he has also worked in QA/QC and Regulatory Affairs for an excipient and drug delivery company. Dr. Moreton’s most recent full-time position was as Vice president of Pharmaceutical Sciences at Idenix Pharmaceuticals.


Dr. Moreton has worked in all areas of drug development from preformulation through formulation and process design, development and scale-up, to technical transfer into commercial manufacture. His formulation design and development experience includes tablets, capsules, powders for reconstitution, ointments, creams, suppositories, oral liquids and parenteral products.


Dr. Moreton received his B.Pharm. from the Nottingham University (UK), his M.Sc. in pharmaceutical analysis from the Strathclyde University (UK), and his Ph.D. in pharmaceutica from the University of Wales, College of Cardiff (UK) (now Cardiff University). He is a past Chair of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas)



Raymond S. Niaura, Ph.D.

Scientific Advisory Board Member

 

Dr. Niaura is known opinion leader in the area of tobacco addiction. Currently he  is Associate Director for Science at the Schroeder Institute for Tobacco Research and Policy Studies at Legacy®. Dr. Niaura also holds an appointment as Professor in the Department of Health, Behavior and Society in The Johns Hopkins Bloomberg School of Public Health. Dr. Niaura’s research interests lie in studying combined pharmacological and behavioral treatments for smoking cessation, and cessation in disadvantaged populations.

 

Dr. Niaura has received numerous grants from the National Institutes of Health (NIH), several foundations, and industry for his work. Dr. Niaura has published over 250 peer-reviewed papers, and has authored numerous book chapters, as well as a book titled The Tobacco Dependence Treatment Handbook: A Guide to Best Practices. He is Past President of the Society for Research on Nicotine and Tobacco (SRNT). He is also a Fellow of the American Psychological Association, the Society for Behavioral Medicine, and the American Academy of Health Behavior.

 

Dr. Niaura was educated at McGill University and at Rutgers University. 


Dr. Niaura oversees the Pre- and Post-doctoral Training Program at the Schroeder Institute.

 

 

John M. "Jay" Sisco, Ph.D.

Scientific Advisory Board Member

 

With more than 35 years experience in pharmaceutical R&D, Dr. Sisco is the founder and president of JM Sisco Pharma Consulting, LLC, which provides consulting services in the chemistry, manufacturing, and controls (CMC) arena of drug product development from preclinical through post-marketing product enhancement.  

 

Jay's most recent industrial position was Senior Vice President of Pharmaceutical and Preclinical R&D at King Pharmaceuticals responsible for discovery, preclinical and all CMC aspects of product development.  Prior to his role at King he held scientific positions of increasing responsibility at Schering-Plough, Boehringer Ingleheim and Glaxo, followed by senior management positions at Parke-Davis/Warner Lambert, Pfizer and Nektar Therapeutics.  

 

The majority of Jay's experience is CMC-based with contributions to over 100 INDs and 15 NDAs.  In addition to his development experience, Jay also worked on the research side of the industry with responsibilities for discovery and IND enabling preclinical activities.  He pioneered one of the first discovery/development interface groups responsible for advancing "druggable" lead compounds.  Jay is a long-time member of the American Association of Pharmaceutical Scientists serving 7 years in leadership positions of the organization as Member-at–Large to the AAPS Executive Council (Board of Directors) and as AAPS President.  He received his BS in chemistry from the University of Scranton, MS in physical chemistry from Rutgers University, and PhD in pharmaceutical chemistry from the University.



Adam Urbach, PhD

Scientific Advisory Board Member


Dr. Urbach is Professor of Chemistry at Trinity University in San Antonio, Texas.  His research group studies the fundamental science of intermolecular interactions (solubility, binding) in water and focuses on the molecular recognition of peptides and proteins by synthetic receptors, including the first such receptor for human insulin and human growth hormone.  Dr. Urbach's research has been funded continuously by numerous grants from the National Science Foundation, the Welch Foundation, Research Corporation for Science Advancement, the Camille and Henry Dreyfus Foundation, and the American Chemical Society.

Dr. Urbach received his BS in chemistry from the University of Texas at Austin (research advisor Prof. Jonathan Sessler), his PhD in organic chemistry from Caltech (under Prof. Peter Dervan), and his NIH postdoctoral fellowship training at Harvard University (under Prof. George Whitesides).  Dr. Urbach was a Visiting Associate in Chemical Engineering at Caltech 2011 to 2012.  Dr. Urbach began his independent career at Trinity University in 2004 and recently served an elected term as Vice-Chair and then Chair of the Faculty Senate.



Frank Vocci, Ph.D.

Scientific Advisory Board Member

 

Dr. Vocci as over 30 years' experience in medications development and clinical trials.  His work includes 11 years at the FDA in the Drug Abuse Section, reviewing medications for the treatment of alcohol and substance abuse disorders.  Frank also worked for 19 years at the National Institute on Drug Abuse (NIDA) where he administered the medications development program.  During his NIDA tenure, four medications developed in this program were approve for marketing by the FDA; Levomethadyl Acetate, Buprenorphine and Buprenorphine/naloxone, and the depot naltrexone formulation, marketed as Vivitrol.  In 2010 Vivitrol received a second indication for the treatment of opioid dependence.

 

As a recognized expert in Clinical Trials, Dr. Vocci has supervised multi-center trials and provided managerial oversight to over a dozen other multisite trials. He is well versed in the myriad operations that must be successfully coordinated to conduct clinical trials.  As well, Dr. Vocci is a recognized expert in the field of treatment development for psychostimulant disorders, having published on multiple clinical trials and written review articles that summarize the state of the science in this important area.

 

Dr. Vocci currently serves as the president of Friends Research Institute and supervises a team of 14 investigators whose primary research focus is on substance abuse and treatment.