Our Team

A Virtual Pharmaceutical Company
At Your Fingertips

Whether you are a startup looking for help to get off the ground or a medium sized company looking to grow your business, we offer an executive team and a network of seasoned professionals without bringing all those expenses in-house. Not many consulting firms offer you the experience we do under one roof. From commercial, regulatory, and business development to an advisory board or executive team on call to a virtual pharmaceutical network including market research, competitive intelligence, clinical research and formulation development as well as access to legal and compliance capabilities.

Executive Team

Larry Downey

Lifelong career in the pharmaceutical industry, holding leadership positions of increasing responsibility and ultimately serving as the President/CEO of the North America specialty medicines subsidiaries of a major multinational pharmaceutical company.

Developed and launched significant new products, many of which became leaders in their respective categories such as Multiple Sclerosis, Parkinson’s Disease, asthma emergency contraception, contraception, oncological diseases, Huntington’s Disease and Tardive Dyskinesia.

Created a people-focused work environment and culture that motivated the team to consistently achieve exemplary results year after year.

Michael McHugh

Extensive pharmaceutical experience, successfully led all Commercial functions, Strategic Planning, and Business Development. The last position he held in Pharma was Senior Vice President, GM, Women’s Health and Select Brands for a major multinational pharmaceutical company.

Exceeded his financial targets every year as General Manager of a variety of business units. His therapeutic areas of focus have been: Respiratory, Neurology, Psychology, and Women’s Health. Product lines targeted Primary Care, Institutional, Health Care Systems, and Consumers.

Has led Business Development function in-licensing and out-licensing of multiple Brand products. Michael has also been responsible for valuation and integration of US Brand M&A projects.

Mike Nicholas PhD

Innovative and analytical business partner with extensive experience developing and implementing regulatory strategy for specialty and generic drugs. Recognized for brand protection and life cycle management strategies across a wide swath of products, including drugs and biologics within multiple therapeutic categories.

Extensive FDA interactions (directing FDA meetings and communications) and the development of regulatory policy, including numerous Citizen Petitions.

Fully responsible for the North American Regulatory Affairs for a major multinational pharmaceutical company and oversaw the approvals of substantial brand products for the treatment of Multiple Sclerosis, Parkinson’s Disease and respiratory line extensions to name a few.

Also led the efforts for maximizing the life cycle of multiple products.

Additional Consultants

Kirk Hoffman PhD

Medical Affairs consultant with 30+ years of experience in building and implementing internal Medical Affairs functions and technologies in more than 30 small, medium, and large pharmaceutical companies. Areas of focus include medical information, medical writing (SRLs, slides), pharmacovigilance, MSL integration, publication planning, and supporting technologies.

Tom Gawlick

Accomplished marketing leader with demonstrated experience overseeing, leading and driving teams and strategic initiatives at a brand and portfolio level – through early development, launch and late lifecycle, that enhance pharmaceutical growth and revenue.

Proven track record of rebuilding underperforming brands and consistently exceeding financial targets. Strong market knowledge in areas of Neurology, Psychiatry and Endocrinology markets.

Scott Jenkins PhD

Dr. Scott Jenkins has 25 years of experience in the pharmaceutical industry. His doctorate is in Pharmacokinetics and Pharmaceutical Sciences from Auburn University. He has proven expertise in pre-clinical, Phase I and Phase IIa study design and analysis, Project Leadership of Development Teams, Life-Cycle Management, Portfolio Management, and Business Development.

He has held positions of Increasing responsibility at CRO’s, Speciality Pharma Companies, Multinational Pharmaceutical Companies and CMO’s. Scott has special interest and experience in the application of novel drug delivery technology and devices ranging from Transdermals, Nanotechnology, Orally Disintegrating Tablets, and Drug/Device combinations. He holds five issued patents and has more than 30 patent applications.

Imagine the Possibilities

We have a comprehensive network of experts who can provide a thorough package of services. This includes market research, pricing, contracting, competitive intelligence as well as clinical research and R&D. We can provide these services either virtually or on-site. We also provide services to European locations.

We can help evaluate business development deals from all aspects of due diligence and deal commercial evaluation. We can also help find buyers and sellers if needed and even help you secure funding if that's the stage you're in.

Experience That Counts