Phlow was formed to manufacture low-cost, high quality, essential generic drugs for the United States.
To help our nation secure its own strategic drug reserve, Phlow will use novel and innovative methods in the drug manufacturing industry to support our customers, including the U.S. government and to reduce the U.S.’s dependency on foreign supply chains.
Executive Leadership
Our team has unmatched experience in research, development and commercialization of API, pharmaceuticals, and medical device products. Not only does our team have a deep understanding of the challenges of building world-class products and facilities, but we also recognize that quality, efficiency and affordability of medicines is paramount to a stable health care system.
Eric Edwards, M.D., Ph.D.
Dr. Eric Edwards is a seasoned pharmaceutical executive, entrepreneur, and inventor. He was previously co-founder of Kaléo, Inc. a pharmaceutical company in Richmond, VA, USA, developing novel medicines for the treatment of a variety of chronic and acute-care diseases. He is the co-inventor of several currently marketed products, including AUVI-Q, epinephrine for the treatment of allergic emergencies (anaphylaxis). Eric is named on over 215 issued and pending patent applications and is a published author on numerous scientific publications. During his 18 years at Kaléo, he held several executive management positions including chief science officer where he was responsible for overall scientific strategy and all pharmaceutical formulation development and manufacturing technology development programs, chief medical officer responsible for developing the medical affairs team and capability while operationalizing the company’s clinical program strategy, as well as vice president – innovation, overseeing Kaléo’s research and development pipeline and overall product strategy for the company. Eric obtained his B.S. in biology, Ph.D. in pharmaceutical sciences, and Doctor of Medicine degrees at Virginia Commonwealth University/Medical College of Virginia.
Eric Edwards, M.D., Ph.D.
Chief Executive Officer
Patricia Watson
Patricia Watson has over 40 years of pharmaceutical regulatory affairs experience with a demonstrated history of successful regulatory strategies and submissions (IND, NDA, DMF). She was previously the executive director of CMC Regulatory Affairs for Boehringer Ingelheim Pharmaceuticals, Inc., where she founded CMC regulatory affairs as a separate function within the company, and led a staff whose regulatory responsibilities encompassed the entire product lifecycle: development, registration and post-approval maintenance. Pat has extensive knowledge of current and emerging U.S., EU and ICH CMC regulatory requirements for clinical trials, marketing authorization applications, and post-approval changes. She has expertise with requirements for active pharmaceutical ingredients, and dosage forms including solid oral dosage forms and injections. She has been actively engaged in several PhRMA initiatives and working groups dealing with ICH and FDA guidelines and policy development. Since 2018, Pat has been a CMC regulatory consultant advising clients on a variety of topics, including EU clinical trials, combination products and 503A/503B compounding.
Patricia Watson, M.S.
Vice President, Regulatory Affairs
Andrew Stiles
Andrew Stiles has spent his career navigating the federal contracting and procurement process, including supporting companies with R&D programs funded by consortiums, the DOD, and HHS. As managing director of biodefense and government contracts for BDO, he helped lead over $10 billion for numerous government contract initiatives from contract development and negotiation to program management following award. Andrew is a certified fraud examiner and has helped manage compliance challenges associated with the Federal Acquisition Regulation (FAR), Cost Accounting Standards (CAS), OMB Circulars, and both Defense Contract Audit Agency (DCAA) and Defense Contract Management Agency (DCMA) Business System control requirements. Andrew has also designed and implemented numerous compliant cost accounting structures for companies and managed multiple challenges associated with navigating the government contract and private/public partnership process.
Andrew Stiles
Vice President, Government Initiatives
and Contract Compliance
Robby Demeria
Robby Demeria served as Virginia’s first deputy secretary of commerce and trade for technology and innovation, where he guided the administration’s policy and initiatives related to those focus areas and was the chief architect of the innovation-led entrepreneurship and tech-based economic development agency, the Virginia Innovation Partnership Authority. Prior to his appointment, Robby was a trade association executive for nearly 15 years, serving as the president of the Richmond Technology Council and vice president of Government Affairs for the Northern Virginia Chamber of Commerce. While overseeing the technology council, Robby founded its first foundation for technology education, launched one of the largest – and still running – women in technology conferences in the southeast U.S., and championed programs that highlighted and grew the region’s tech talent. Robby has served on many regional and statewide boards focused on issues from youth entrepreneurship to computer science education. He is a proud lifelong Virginian and graduate of George Mason University.
Robby Demeria
Chief of Staff
Glenn Gerecke, Ph.D.
Dr. Glenn Gerecke is an executive with operational leadership spanning the globe. Up until recently, Glenn was the senior vice president of operations for Teva Pharmaceuticals where he led end-to-end manufacturing operations for Europe. While in this role, Glenn provided oversight for all site and regional operations including manufacturing, quality, regulatory affairs, supply chain, engineering, EHS, as well as manufacturing science & technology. Glenn was also previously senior vice president of Asia Pacific Operations, where he led operations for Japan as well as India. Prior to his Teva experience, Glenn was global vice president of engineering and facilities for Bristol-Myers Squibb where he led all engineering, design, and strategic capital project governance for major infrastructure programs, including a $750 million biologics drug substance facility. At BMS, Glenn was also responsible for Latin America regional operations and served as vice president and general manager at three different manufacturing sites in Puerto Rico and the USA. Glenn received his B.S. in chemical engineering from Worcester Polytechnic Institute, MBA from Framingham State University, M.S. in management from Worcester Polytechnic Institute, and his Ph.D. in organization and management from Capella University School of Business and Technology. Glenn will be joining Phlow effective June 1, 2020.
Glenn Gerecke, Ph.D.
Chief Operating Officer
Wayne Motsek
Wayne Motsek has extensive domestic and international experience in developing, implementing, and maintaining pragmatic quality systems supporting operations qualification and validation activities, product scale-up, product transfer, process improvement, and technology identification and introduction. He previously led Pfizer’s North American Pharmaceutical External Supply Quality Assurance team directing quality staff, including U.S. leadership in support of contract manufacturing, packaging, and testing activities for assigned products and active pharmaceutical ingredients. Wayne was also in charge of establishing global standard workflows, ensuring sufficient contractor quality resources were allocated to support associated activities, compliance with company criteria/standards, and ensuring availability of products to markets. He also worked with Supply Chain and Business Technology resources in defining, establishing, and maintaining the global ERP model for 3Ps and defining the supporting quality assurance criteria.
Wayne Motsek
Vice President, Quality Assurance
Robert J. Mooney
Robert Mooney is a tireless champion of creativity and business acumen. As an entrepreneur and co-founder of New Richmond Ventures (NRV), Bob counseled startups and early stage companies on accounting and financial reporting, capital strategies, equity raising, project financing, milestones, business coaching, and IT strategies, including many healthcare start-ups. He has extensive accounting, financial information, and technology experience, including serving as a partner at Coopers & Lybrand (now PWC) for over 20 years, the chief financial officer and senior vice president of Ethyl Corporation, a $2 billion multinational petroleum and specialty chemicals company, as well as CFO of William & Mary’s Mason School of Business. Bob has also served as a board member of multiple large, national organizations.
Robert J. Mooney
Chief Financial Officer
Malcolm Rosenthal
Malcolm Rosenthal has over 40 years of experience in the pharmaceutical and chemical industries with a broad background in site management, business strategy, and growth and development activities. His previous experience includes active pharmaceutical ingredient sourcing, business development, facility acquisition and divestiture, as well as custom manufacturing for multiple companies, including Piramal, Cambrex, Flex and GSK. At GSK he was in charge of business development for GSK’s Global Manufacturing & Supply team, responsible for market, strategy, and business development for all pharmaceutical, synthetic, and API development and commercial supply to third parties in North American and Asia-Pacific Markets. Malcolm also has expertise in the areas of flow chemistry, drug delivery systems, and complex generics. He holds a B.Sc. degree in chemistry from the University of Akron and two M.B.A.s from Fairleigh Dickinson University.
Malcolm Rosenthal, M.B.A.
Vice President, Business Development
BOARD OF DIRECTORS
OUR PARTNERS
Civica Rx
A not-for-profit generic drug and pharmaceutical company founded in 2018 to combat drug shortages & affordability issues related to life-saving drugs. Civica is creating a public asset that is dedicated to ensuring that essential generic medications are accessible and affordable.
Medicines For All Institute
The Medicines for All Institute (“M4ALL”) was established in the Virginia Commonwealth University College of Engineering in July 2017 with the goal of reducing the high costs of pharmaceutical products. It is committed to improving access to safe, effective, and affordable medicines. With medicine prices rising, innovators and generic manufacturers have little incentive to reduce manufacturing costs for a wide range of medicines. M4ALL believes that its broad depth of novel chemical process technologies can lead to a step change reduction of excess costs. Undoubtedly, These processes will expand patient access both to existing and new medication at an overall lower cost. M4ALL was formed to pursue and deliver this vision with the support of the Bill & Melinda Gates Foundation. Improve access to safe, effective, and affordable medicines.
Ampac Fine Chemicals
AMPAC Fine Chemicals (AFC) is a custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Ampac’s integrated facilities are located in California, Texas, and Virginia and specialize in process development, scale-up, and cGMP compliant production from kilograms to multi-ton quantities.
With over 75 years of experience in mastering challenging chemistries, AFC has developed capabilities that support a wide range of processes and technologies. AFC has over 158,000 gallons (598 m³) of manufacturing capacity and is capable of handling all scales of production. AFC’s products are manufactured in full compliance with the U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practices (cGMP).