The present management team for Nanotherapeutics comprises extensive experience in the areas of pharmaceuticals, cGMP manufacturing, material science, business and financial operations, and technology development and commercialization. The profiles of the principal executives are provided as follows:
Prasad S. Raje, Ph.D., President and Chief Executive Officer
Dr. Raje was appointed CEO and Member of the Board of Directors of Nanotherapeutics in November 2016 Dr. Raje comes to the company with over 20 years of experience as a recognized global leader with deep experience forging business alliances that help companies increase sales and revenue growth through market expansion. Prior to joining Nanotherapeutics, Dr. Raje was Senior Vice President and Head of the Life Sciences Division of EAG Laboratories, a Contract Research Organization serving, among other sectors, pharmaceutical drug development. Prior to EAG, Dr. Raje was a business owner, the President and Managing Director, AMRI India PVT. LTD – Mumbai, India and held executive positions with several CRO/CMO companies where his excellent short and long term strategic planning abilities and operational expertise repeatedly produced revenue and EBITDA growth in dynamic and changing markets. Dr. Raje brings experience of managing private equity backed, privately owned and publicly traded businesses. Dr. Raje received his undergraduate degree and Master of Science degree from Gujarat University, Gujarat India and his Ph.D. from Auburn University, Auburn Alabama. Dr. Raje’s academic credentials include 9 patents and 16 peer-reviewed published papers.
James M. Matthew, Chief Financial Officer
Mr. Matthew joined the Nanotherapeutics Board of Directors in February 2008 and became the Chief Financial Officer of the Company in March 2011. Mr. Matthew is a member of the Board of Managers of NANO ADM, LLC, a wholly-owned subsidiary of the Company. He became President and Chief Executive Officer in May 2016. Mr. Matthew has over 30 years of financial experience, including more than 10 years as the Chief Financial Officer of public and private companies with responsibilities for accounting, finance, information management, investor relations, procurement and facility services. In addition, he has 20 years of experience with KPMG where he was responsible for a variety of transactions and financings for the Health Care and Life Sciences Industry Group. Mr. Matthew received an MBA from Michigan State University and a B.S. in Accountancy from the University of Illinois at Springfield.
Ron Cobb, Ph.D., Chief Scientific Officer
Dr. Cobb joined Nanotherapeutics in 2011. As Chief Scientific Officer, Dr. Cobb is responsible for the development of novel vaccines, biologics, and medical devices. He also works to help procure outside funding for the company’s strategic programs. During his tenure at Nanotherapeutics, Dr. Cobb led project teams focused on recombinant protein based drug and vaccine development as well as medical device development. Prior to joining Nanotherapeutics, he was Director of Research and Development at RTI Biologics. Under his leadership over 20 new products and line extensions were launched and a stem cell based technology was initiated. He also spent 7 years as Head of Protein Expression and Purification Group at Berlex Biosciences (subsidiary of Schering, AG).
Dr. Cobb has over 20 years of experience in biopharmaceutical and medical device Research and Development and has provided molecular biology expertise to numerous projects ranging from early stage research to supporting protein expression and purification for a Phase II clinical program. He has over 40 peer-reviewed publications and book chapters and has been a reviewer for several different journals for over 10 years.
Bärbel Eppler, Ph.D., Sr. VP, Quality and Regulatory
Dr. Eppler joined Nanotherapeutics in April 2001 as Director of the Bioanalytical Department, promoted to VP of Preclinical Development and QA in 2006, Sr. VP of Preclinical Development and Quality Assurance in 2008, and to Chief Quality Officer (CQO) in 2015. Prior to joining Nanotherapeutics she held a Postdoctoral Traineeship from 1999 to 2001 at the University of Florida. Dr. Eppler received a B.S. in Zoology and a Ph.D. in Pharmaceutical Sciences from the University of Florida. During her tenure at Nanotherapeutics, Dr. Eppler created and fully implemented from ground zero a robust Quality Assurance and Compliance program that has been successfully audited by several biologic, pharmaceutics and medical device companies as well as regulatory agencies such as FDA. She lead the quality team to obtain ISO 13485 and 9001 certification in 2012. Dr. Eppler provides leadership and technical contributions at Nanotherapeutics directing preclinical and analytical departments to complete tasks for contracts and grants and regulatory submissions for biologic medical devices and pharmaceutics.
Peter Khoury, Ph.D., MBA, Senior Vice President & Chief Commercial Officer
Dr. Khoury joined Nanotherapeutics in 2016 as Senior Vice President and Chief Commercial Officer bringing over 20 years of experience in strategy, business development, marketing and sales in the biologics and vaccines markets. In this role, he leads the global corporate efforts in commercial expansion and business development. Before joining Nanotherapeutics, Dr. Khoury was with the Bill & Melinda Gates Foundation, serving as Senior Program Officer, Life Sciences Partnerships, Office of the President for Global Health. Among his responsibilities, he spearheaded the expansion of industry engagement with the developing country manufacturer (DCM) industry sector, including relationship management at the “C” level for strategically important and complex DCMs focused on life-saving initiatives including vaccines, biologicals, medical diagnostics and generic products. Prior to his tenure with the Gates Foundation, from 2002 to 2012, Dr. Khoury was Vice President, Global Marketing at Baxter International, where he led the development and implementation of the company’s vaccines business strategies, product management, business plans, and ex-European vaccine sales. Before Baxter, Peter spent 10 years at Merck and Co., Inc. in positions of growing responsibilities in the areas of business development, marketing and sales. Dr. Khoury earned his Bachelor’s degree in Biology and a Ph.D. in Microbiology from Syracuse University, and received his MBA in Management/Marketing from Cornell University’s Johnson Graduate School of Management.
Robert V. House, Ph.D., FATS, PMP, Senior Vice President, Government Contracts
Dr. House joined Nanotherapeutics in 2014. Previously, Dr. House worked for more than 11 years at DynPort Vaccine Company, where he held the positions of President and Chief Scientific Officer. He also worked at Covance Laboratories and IIT Research Institute in Chicago where he managed highly successful programs in immunotoxicology assessment.
Dr. House has nearly 30 years of experience in basic and applied biomedical research and development, specializing in the assessment of inadvertent and therapeutic immunomodulation. Dr. House earned his B.A. in Zoology, M.S. in Public Health and Ph.D. from the University of North Carolina. He is the author, co-author or editor of more than 100 journal articles, book chapters and books in the fields of immunomodulation, immunotoxicology, host defense, cytokine biology and biodefense.
Dr. House is an Adjunct Professor at George Mason University where he teaches medical countermeasure development. He is a certified Project Management Professional (PMP), a Fellow of the Academy of Toxicological Sciences, and President of the Biotechnology Specialty Section of the Society of Toxicology.
William Hensler, Ph.D., Senior Vice President, Global Head of Operations
Dr. Hensler joined Nanotherapeutics in 2013 as VP and Global Head of Operations, bringing him over 25 years of development, manufacturing and management experience in the biopharmaceutical and vaccine arena. In this role, he oversees the Company’s Advanced Development and Manufacturing (ADM) program in Alachua, FL, and Bohumil’s commercial scale vaccine manufacturing facility in the Czech Republic. A biochemical engineer by training, Dr. Hensler began his career at Schering-Plough (now Merck), assuming increasingly responsible roles in the development and GMP commercial manufacturing of alfa-2b interferon (INTRON-A), one of the first recombinant biopharmaceuticals approved by the FDA in the US. He subsequently moved to the life sciences division of Raytheon Engineers, as Sr. Director of Technology, where managed the design, construction, startup, commissioning and qualification of biopharmaceutical and vaccine production facilities. With his development and manufacturing expertise and engineering background, he later started Consulting Group Alantra Biotech Services, Inc., serving major biopharmaceutical and vaccine corporations internationally, including Merck, Sanofi, Bristol-Myers Squibb, Novartis, Regeneron, Biogen, Green Cross and TEVA. Dr. Hensler holds BS, MS and Ph.D degrees in BioChemical Engineering from Rutgers and Cornell University.
Andrew Graham, M.Sc., Vice President, Manufacturing
Mr. Graham joined Nanotherapeutics in 2013 with over 25 years experience building and leading teams in the development and manufacture of human vaccines and biologics. He worked for over 16 years at Sanofi Pasteur at both the Toronto and Swiftwater sites in various roles including Director, Cell and Viral Culture in Product Development and as Senior Director of Industrialization in Industrial Operations. At Sanofi he worked on the development and manufacture of numerous viral and bacterial vaccines, including vaccines for the prevention of polio, pertussis, tetanus, meningitis and RSV (respiratory syncytial virus). In 2004, Mr. Graham moved to AlphaVax to become the Vice President of Development and Technical Operations. At AlphaVax he was responsible for the development and manufacture of vaccine candidates using an alphavirus vector derived from VEE (venezuelan equine encephalitis) virus. In 2013, he joined Nanotherapeutics as Senior Director of Manufacturing Operations and in January 2015 was promoted to Vice President of Manufacturing and Head of Operations for the Nanotherapeutics Advanced Development and Manufacturing (NAN0-ADM) program, which is funded by the U.S. Department of Defense (DoD). Mr Graham earned his BS degree in Biochemistry at McGill University and his MS degree in Chemical Engineering at the University of Waterloo.
Eugene B, Johnston, CQE/CQA, Vice President, Quality Assurance
Mr. Johnston joined Nanotherapeutics in 2015. Prior to joining Nanotherapeutics Mr. Johnston worked for more than seven years with the Biologics Consulting Group, Inc. (BCG) as North Carolina Office Head and Senior Consultant. While at BCG, Mr. Johnston specialized in Quality Management and Regulatory Compliance consulting. Mr. Johnston also held senior Quality Management positions at Biolex Therapeutics, Biogen and Pharmacia. Mr. Johnston has over 40 years QA/QC and validation experience in FDA regulated industry. Mr. Johnston has a BS in Biology from the University of Dayton and is an ASQ Certified Quality Engineer and Certified Quality Auditor.
Gary A. Ascani, Vice President, Business Development
Mr. Ascani joined Nanotherapeutics in 2011 and has more than 35 years of experience in the biotechnology and medical products industries. He served in senior level positions at Hyland Labs, a Division of Baxter - Travenol, Monoclonal Antibodies, Inc., Molecular Analysis, Inc., T Cell Diagnostics, Diamedix, Inc. a division of Ivax Corp., and Banyan Biomarkers, Inc. Mr. Ascani also co-founded Vulcan Medical Ventures, Inc., a venture capital firm focused on seed stage venture financing. In 2001, VMV closed a Series A Preferred Stock Financing for PNP Therapeutics, Inc. (PNP Inc.) at which time Mr. Ascani became PNP's Chairman and Chief Executive Officer.
Doris Snow, Ph.D., Vice President, Global Regulatory Affairs
Dr. Doris Snow has more than 25 years of experience in the field of biochemistry with expertise in new product development. Dr. Snow’s global regulatory experience in biomedical products comprises biologics, drugs, and devices. She advises and leads the development of innovative regulatory strategies for project teams. She has significant experience with managing complex regulatory issues, including the development of regulatory strategies for combination products (drug/device) and the development of products using the FDA Animal Rule. Since 2013, Dr. Snow has been the regulatory lead for the NANO-ADM, a domestic manufacturing facility with capabilities for medical countermeasures and commercial biologics. She represents global companies as a US Agent for the FDA. Dr. Snow has contributed to regulatory strategy for an extensive list of product types (BLA/NDA/ANDA/510K/CTA/DMF/IND), with management of numerous regulatory applications within the last 15 years. She has successfully developed regulatory approval strategies for US and global markets, facilitating clinical development and market entry.
Prior to joining Nanotherapeutics, Dr. Snow held leadership positions in CMC, quality assurance and regulatory affairs overseeing the development of plasma products, cancer therapeutics and biodefense vaccines. Dr. Snow received her Ph.D. in Biological Chemistry from Johns Hopkins University School of Medicine.