The Rondaxe Team

Members and Managers

Jeffrey M. Evans, Ph.D.

Dr. Evans joined Rondaxe in January 2005 and is responsible for Business Development and Licensing programs. Jeff supports our clients with strategic product development planning, chemical synthesis improvement, clinical trial material sourcing, due diligence preparation and product out-licensing management. Prior to joining Rondaxe, Dr. Evans was responsible for Chemical Development Sourcing at Bristol-Myers Squibb leading a cross divisional Development Sourcing Team. In addition to his responsibilities in sourcing, Jeff led the evaluation of CMC aspects of late phase licensing opportunities concentrating on COGs, security of supply and contract evaluations. Jeff joined Bristol-Myers Squibb in 1994 as a project chemist and assumed roles of increasing responsibility during his 10 years at BMS. Jeff earned his B.Sc. in Chemistry at the State University of New York at Oswego and his Ph.D. in Organic Chemistry at Syracuse University. [curriculum vitae]

Ann P. Kich

Ms Kich has been with Rondaxe Pharma since its inception in 2003 and leads our Finance and HR functions. Ann provides our clients support in the areas of chemical and fermentation manufacturing operations, process engineering, facility evaluations, supply chain development, COGs projections and supply contract negotiations. Prior to joining Rondaxe, Ms. Kich was an executive at Bristol-Myers Squibb where her 20 year career started as a process development engineer at Bristol-Myers. Through her tenure at BMS, Ann held increasingly responsible positions in manufacturing technical support, environmental, and plant engineering. As an executive at BMS, Ann was the leader of Global Manufacturing Network and Supply Chain Planning organizations incorporating a "cradle to grave" strategy for manufactured products. Ann earned her B.Sc. in Chemical Engineering at the University of Maine. [curriculum vitae]

Kenton Shultis

Mr. Shultis joined Rondaxe in 2008 and is responsible for our Software Development group. Ken offers our clients an extensive array of services including product development planning, quality systems design, API and formulation COGs evaluations, technology transfer support, process and facility engineering and supplier negotiations. He previously was Vice President of Operations and General Manager of Organichem for AMRI after founding American Advanced Organics where he served as President for 2 years. Ken spent 14 years at Bristol-Myers Squibb as Director of Pilot Plant Development where he led several multiple site plant introduction programs. Ken also worked in Process R&D at Merck and in Fermentation Development at Abbott Laboratories. Ken earned his B.Sc. in Chemical Engineering from the University of Wisconsin and his M.Sc. in Chemical Engineering from the University of Minnesota. [curriculum vitae]

Wilhelm Stahl, Ph.D.

In 2009 Dr. Stahl became President, Rondaxe Deutschland, OHG, with responsibilities for Sales and Marketing Operations for all Rondaxe entities. Beyond his internal responsibilities, Willie also helps Rondaxe clients with market and product viability assessments, strategic operations evaluations and international supply chain development. Dr. Stahl began his career as a scientist with Hoechst AG in Germany in 1991. Starting in medicinal chemistry, he became a group leader in Natural Product Screening and advanced to the Head of Global Screening after the company became HMR (and finally Aventis). He later joined Bayer AG, where he headed up a Medicinal Chemistry Department and moved on to become Head of Life Sciences at Bayer's Central Research Units. In his most recent positions Willi was responsible for R&D/Marketing at Lanxess' Fine Chemicals business unit and subsequently became Head of Saltigo's Pharma Custom Manufacturing business. Willi earned both his undergraduate and Ph.D. degrees from the Institute for Organic Chemistry and Biochemistry at the University of Bonn, in Germany, and did his post-doctoral work with Prof. K.C. Nicolaou at the Research Institute of Scripps Clinic, Department of Chemistry, La Jolla, CA. Additional Languages: German. [curriculum vitae]

Quality & Regulatory

Karl Hofmann, Jr.

Mr. Hofmann first joined Rondaxe in 2006, and was promoted in 2008 to President, Rondaxe Quality L.L.C. Karl manages all quality system design programs, Pre-Approval Inspection preparations, cGMP audits and quality agreement negotiations for our clients. Mr. Hofmann brings to Rondaxe nearly 40 years of both hands-on involvement and managerial oversight of pharmaceutical manufacturing and quality assurance operations. While at Ayerst and Bristol-Myers Squibb, through increasingly more demanding quality and manufacturing assignments, he developed a specialization in GMP and regulatory matters associated with manufacturing small molecule and biologic API's, sterile manufacturing, plant design, technology transfer and pre-approval inspections by the FDA. Karl received his B.A. in Chemistry from Middlebury College and his M.Sc. in Biochemistry from the State University of New York at Plattsburg. [curriculum vitae]

William Regan

Mr. Regan joined Rondaxe's senior advisors team in 2009. He has been sharing his unique skills and experiences with the life sciences industry as a consultant since 2006. Prior to that he had worked within the industry for over 20 years, most recently with Bristol-Myers Squibb, where he was Head (VP) of Global Regulatory Affairs, Medical Imaging. During his 15 years there Bill also had responsibility at various times for regulatory due diligence associated with M&A activities, for implementing major synthetic changes, and consolidating CMC regulatory functions for 25+ global facilities after the Bristol-Myers and Squibb merger. Bill received his B.A. in Chemistry from Rutgers University, has a Resource Manager Certification from and is a graduate of Tufts University Program for Pharmaceutical Development. [curriculum vitae]

William Winter, Ph.D.

Dr. Winter became affiliated with Rondaxe in early 2009. Prior to becoming a consultant on quality assurance and systems issues for our clients, Bill was with Bristol-Myers Squibb for a total of 26 years. His most recent position was as Vice President/Senior Director, Analytical Development in New Brunswick, NJ, where he led that organization for seven years. There he established a new Global Analytical Development organization and oversaw the timely and effective completion of approximately 250 analytical transfers to QC labs each year. Prior to that, Bill progressed from Senior Director, Chemical Development, to Vice President, Bulk QA and Worldwide QC. Bill earned his Ph.D. in Organic Chemistry at The Ohio State University, and was a postdoctoral research fellow at Texas Christian University. He received his B.A. in Chemistry with honors from the State University of New York at Potsdam. [curriculum vitae]

Formulation/Device Development and Sourcing

Robert Davis, Ph. D..

Before joining Rondaxe as a Sr. Advisor in 2005, Dr. Davis spent 36 years in the pharmaceutical industry. He worked with oral solids and liquid manufacturing in ever-increasing positions of responsibility at Bristol-Myers Squibb, concentrating on formulation and process development, scale-up and commercialization. He has led successful tech transfers on over 45 products, both within the same company and between international alliance partners. Bob received both his B.S. in Pharmacy and his Ph.D. in Pharmaceutics from the University of Mississippi. [curriculum vitae]

Sandra Sims, Ph. D..

Dr. Sims began working with Rondaxe in 2007 as a Sr. Advisor for formulation development and project management. Most recently Sandi was in charge of solid oral dosage form development, supply chain and all CMC activities for multiple IND's at Meditrina Pharma. Prior to that, she spent 16 years with Pfizer, Inc. in roles of increasing responsibility in formulation development. She led the formulation development for Zyvox IV from discovery, pre-clinical and clinical development through registration and commercial launch. Sandi also held positions as Team Leader and Associate Director for groups responsible for formulation development of sterile, oral solid, ophthalmic and topical products, as well as leading Pfizer's veterinary products group. Sandi received her B.S. in Pharmacy from West Virginia University and her Ph.D. in Pharmaceutics from the University of Utah. [curriculum vitae]

Judit Bartis, Ph.D..

Dr. Bartis joined Rondaxe in 2010. Dr. Bartis is a pharmaceutical professional, trained as an inorganic chemist, with broad experience in drug development, especially in analytical and formulation development. Her previous experience includes Associate Director, Pharmaceutical Development for Praecis Pharmaceuticals; Manager, Product Development for Arquale, Inc.; and Director, CMC for Pear Tree Pharmaceuticals. She also held various roles of increasing responsibility at Bristol-Myers Squibb, formerly DuPont Pharmaceuticals, Medical Imaging Division and Millenium Pharmaceuticals. Dr. Bartis earned her MBA in the High Technology Program from Northeastern University, her Ph.D. in Analytical/Inorganic Chemistry from City University of New York and her BS from University Babes-Bolyai, Cluj, Romania. [curriculum vitae]

Chemistry/Fermentation Development and Sourcing

David Dodds, Ph.D.

Dr. Dodds has been affiliated with Rondaxe since shortly after its inception. After working as a biochemist at Sepracor, where he was responsible for a new biocatalytic process which earned several million dollars in royalties, he joined Schering-Plough's Research Institute as a Manager of its Biotransformations Group. There he successfully introduced biocatalysis in over a dozen projects, including the approved antifungal POSACNAZOLE. David was then Director of Fermentation and Biocatalysis Development at Bristol-Myers Squibb. There he worked on pressing problems associated with enzymatic processes and the development of processes for chiral intermediates for HIV therapeutics. He has served on due-diligence teams, worked with regulatory groups on commercial processes, and supported legal groups defending patents. David received his B.S., M.Sc. and his Ph.D. in Organic Synthesis from the University of Toronto, and his PDF in Molecular Biology from the University of Colorado. [curriculum vitae]

Brian James, Ph.D., M.B.A.

Dr. James joined Rondaxe as Director, CMC Strategic Development, in 2006. Brian provides project management, API synthesis design and API/formulation sourcing support to our clients. He manages projects ranging from pre-IND chemistry development to pre-launch validation and material sourcing for late-stage clinical trials. Prior to joining Rondaxe, he was with Bristol-Myers Squibb for 7 years, where he honed his skills and expertise in API synthesis and sourcing strategies. Brian received both his Ph.D. in Chemistry from University of California, his M.B.A. from Le Moyne College, and performed his post-doctoral fellowship at Colorado State University. [curriculum vitae]

Shu-Jen D. Chiang, Ph.D.

Dr. Chiang joined Rondaxe's senior advisors team in 2009. Prior to affiliating with Rondaxe, he had over 35 years of experience in recombinant DNA technology, genetics and biochemistry, including industrial experience in R&D, fermentation and product purification process development. He was most recently Associate Director with Bristol-Myers Squibb, where he was responsible for API manufacturing technologies, strain engineering and recombinant protein expression for fermentation and biotransformation projects, and external technology transfer. Before that, Shu-Jen was with Abbott Laboratories and SDS Biotech Corporation. Shu-Jen received his B.S. in Biology from Fu-Jen Catholic University, and his M.S. and Ph.D. in Molecular Biology from the University of Texas at Dallas. Shu-Jen is fluent in Mandarin. [curriculum vitae]

Manufacturing and Supply Chain Management

Brendan Carey

Mr. Carey joined Rondaxe in 2008 as Director, Process/Product Development. Brendan provides our clients project management expertise and supports our Software Development group for implementation and training. He has nearly 20 years of pharmaceutical manufacturing experience in Ireland, the UK and the US. His positions with Swords Laboratories, Church and Dwight, and Bristol-Myers Squibb have allowed him to become an expert in all facets of API and formulation manufacturing operations, including process engineering, supply chain management, project management, SAP implementation, contract manufacturing and software development. Brendan is a graduate of University College (B.S., Chemical Engineering) and Trinity College (Post Graduate Diploma, Computer Science), both in Dublin, Ireland. [curriculum vitae]

Life Science Legal Services

David Reed, J.D.

Mr. Reed became affiliated with Rondaxe in early 2009, after nearly 20 years of providing international legal services to life sciences companies. As in-house counsel for Bayer, ImClone, Osteotech and Bristol-Myers Squibb, Dave advised their international operations on all manner of compliance and contracting issues associated with pharmaceutical and medical device manufacturing. In his career he has been lead counsel for an international audit and procurement departments; he has also led multi-disciplinary teams focused on licensing, product life cycle and governmental enforcement. While in private practice, Dave's clients have included Pfizer, J&J and Boehringer-Ingelheim. Dave earned his B.A. at Dartmouth College and received his Juris Doctorate from Syracuse University. He is admitted to practice law in the states of Florida, Massachusetts and New York, as well as in the Northern District of New York (U.S. Second Circuit) and in the Court of Appeals (U.S. First Circuit). [curriculum vitae]

International Sourcing and Business Development

Joel Lirot

Mr. Lirot joined Rondaxe in 2008 as Vice President of Business Development. Prior to joining Rondaxe Joel spent 13 years in international sourcing, business development, sales and technology transfer management for KNC Laboratories, IRIX Pharma Services and Summit Pharmaceuticals. Over that time he developed an understanding and expertise in pharmaceutical business operations in Asia, particularly Japan where he completed numerous scholastic and professional assignments. Joel received his B.S. degree in Social Sciences from Michigan State University in 1991. Additional Languages: Japanese. [curriculum vitae]

Licensing, Market Intelligence and Financing

Katie MacFarlane, Pharm.D.

Dr. MacFarlane began working with Rondaxe in 2008 supporting Licensing and Market Intelligence projects for our clients. Katie brings a truly unique set of skills and experiences to those already available to Rondaxe's clients. Before entering the world of consulting, Katie had been president and CEO of Xintria Pharmaceutical Corp, a start-up focused on dyslipidemia and Type II diabetes. Before that she was Vice President of Women's Healthcare and Product Planning for Warner Chilcott, Inc. While there Katie not only managed the sales and marketing teams, she also led the launch of several products and participated in the due diligence and deal negotiations for the acquisition of products from Lilly, BMS and Pfizer. She has also held sales and marketing positions in Pfizer and Warner-Lambert, where she was responsible for the launch of Lipitor®. Katie received both a B.S. in Pharmacy and her Doctor of Pharmacy from Purdue University; she completed her postdoctoral fellowship in Industrial Clinical Pharmacy at Rutgers University. [curriculum vitae]

Allan Shaw

Mr. Shaw first became associated with Rondaxe in 2008, working on Rondaxe Licensing and Financing efforts. He has been a member of Navios' board of directors since 2005 and has over 20 years of financial management experience. Allan is the Founder and Senior Managing Director of Shaw Strategic Capital LLC, an international financial advisory firm currently serving as a strategic advisor to an International bank (in NYC). Prior to that he was the Chief Financial Officer and Executive Management Board Member at Serono International S.A., the then-third largest biotechnology company in the world. Allan has also been CFO and Director for Viatel Inc., an international telecommunications company, and a manager with Deloitte & Touche. He has structured, directed, negotiated and closed over $4 billion in public an dprivate financings. Allan is a CPA and received his B.Sc. from the State University of New York at Oswego. [curriculum vitae]

Software Development and Implementation

Daniel Moss

Mr. Moss started as Lead Application Developer with Rondaxe in 2008 and was recently promoted to Director of Software Development, based in the Clifton Park, NY office. Dan has been developing software for nearly a decade, focusing on the integration of computer technologies into client projects. His past projects included the development of the FDNY and NYPD electronic command board management system for Emergency Response. Dan has a B.A. from Bennington College and a Masters in Professional Studies from NYU. [curriculum vitae]