The Athenex team includes a deep bench of professionals with experience in pharmaceutical research, product development, manufacturing and quality assurance.
Executive Vice President – Athenex Pharmaceutical Division
James M. (“Jim”) Hussey has been a President or CEO of various health care and advanced technology related companies over the past +20 years. After graduating from Pharmacy School at Butler University in 1982 and getting his MBA from University of Illinois – Chicago in 1984, Jim joined Bristol Myers Squibb, a global pharmaceutical company. During his 11 years at BMS, Jim held positions of increasing responsibility within the US business reaching the position of General Manager – US in 1992. He left BMS in 1994 to start the first of his many start-up ventures. Over the next 20 years, Jim served as CEO, President or Founder at Physicians Quality Care, NeoPharm Pharmaceuticals (NEOL: NASDAQ), NanoInk, Inc., Sagent Pharmaceuticals (SGNT: NASDAQ) and now Athenex Pharmaceutical Division, a global pharmaceutical company. He also served on the leadership team at Ovation Pharmaceuticals. Jim has served on many different Board of Directors both as CEO/President or as an Independent Director. Jim served on the board of Option Care, a public (OPTN: NASDAQ) specialty pharmacy business. He has been an angel investor for biotech and served as an advisor to many biotech and health care startups. Jim has served on government boards and on the boards of charitable organizations. Jim currently is Chairman of the Board at Symbria, a National Long Term Care Health Care Service Provider based in Chicago. He serves as Independent Director on the Power Wellness Board, a Global Wellness Center Management Company and on the Board of Vidasym, a biotech startup. Jim serves as a Consultant to the health care, biotech, nanotech, compound pharmacy and branded and generic pharmaceutical industries in addition to his role as Executive Vice President at Athenex Pharmaceutical Division.
Teresa Bair, ESQ
Vice President, Corporate Development & Legal Affairs
Teresa is a seasoned commercial attorney who has extensive experience handling complex business matters in both the board room and court room. Prior to joining Athenex, she served as a partner at Harris Beach PLLC, a nationally recognized law firm. Teresa successfully represented business clients, including Fortune 500 companies, in matters involving mergers and acquisitions, intellectual property, international law, equity investments, corporate governance, and contract transactions. Teresa has been consistently recognized by peer journals as a “Super Lawyer” in Business Litigation and Intellectual Property. Teresa received her law degree (JD) from University at Buffalo School of Law, and a Bachelor of Science in Business Administration from Bowling Green State University.
E. Douglas Kramer, MD
Vice President, Clinical, Regulatory Affairs & Pharmacovigilance
Doug has over 20 years of experience in drug development, regulatory affairs and pharmaceutical risk management. He has been involved in successful approvals of treatments for addiction (including nicotine replacement and buprenorphine for opioid dependence), opioid analgesics, and IV Temodar for glioblastoma. His work has included international drug regulatory issues and strategy and development of risk management plans for post marketing drug safety. Doug holds a Doctor of Medicine (MD) degree from Columbia University and a Bachelor of Arts degree in Chemistry from Vassar College.
Gerald Fetterly, PhD
Vice President, Clinical Pharmacology & Regulatory Affairs
Jerry is a leader in the field of Clinical Pharmacology and drug development. As Vice President of Clinical Pharmacology and Regulatory Affairs, he brings to Athenex over fifteen years of experience with successful regulatory submissions for INDs, Dossiers and NDAs across the globe, and formulating dose selection through all phases of the oncology drug development process. Before joining Athenex, Jerry was the Director of the Pharmacokinetics and Pharmacodynamics Core Resource at Roswell Park Cancer Institute, where he led a multidisciplinary translational and bioanalytical team supporting preclinical and clinical testing, as well as IND submissions for cytotoxic and targeted oncology drugs. Prior to his work at Roswell Park, Jerry developed expertise in population PK/PD modeling at Cognigen, where he acted as a consultant for commercial and academic clients in pharmacokinetics and the PK/PD relationships for efficacy and safety. His analyses led to the successful dose selection for cytotoxic drugs including Yondelis®, novel formulations of paclitaxel, and targeted therapy in the fields of mTOR, VEGF, and immunomodulation. During his work at Roswell Park and Cognigen, Jerry led interdepartmental projects that provided clinical pharmacology services for regulatory strategy, and assisted in the interpretation of preclinical data and extrapolation of the implications for human clinical development. Early in his career, Jerry worked at the FDA as a clinical pharmacology and biopharmaceutics reviewer of IND and NDA regulatory submissions. Jerry obtained his PhD in the Pharmaceutical Sciences from the University at Buffalo where he focused on developing novel delivery systems and PK/PD models for paclitaxel that led to optimal dose selection.
Tracey Burr, PhD
Chief Scientific Officer, Active Pharmaceutical Ingredients
Tracey has been engaged in leading product development, portfolio management and lifecycle management for nearly 20 years, including over 10 as a successful executive in the international pharmaceutical industry. Tracey is the CSO of our API manufacturing platform, with significant pharmaceutical product and regulatory experience in worldwide markets. She has been instrumental in successfully filing numerous ANDA/NDAs/Dossiers and has actively contributed to the development of over 20 products through the drug development process, from target identification, R&D, regulatory approval, product launch and post-commercialization support. Under her leadership, pharmaceutical companies have seen dramatic increases in R&D scope, regulatory approvals, sales, and global production. She now brings her characteristic combination of discipline, vigor and vision to the development and commercialization of Athenex products.
Prior to joining Athenex as CSO, Tracey worked for 15 years as a CSO for pharmaceutical companies in the USA, China, Switzerland and Germany. Tracey received an MSc in Organic Chemistry from the California Institute of Technology (Caltech), and a PhD at the Massachusetts Institute of Technology (MIT) in Materials Science and Engineering.
Lorin J. Drake
Vice President, Sales – Athenex Pharmaceutical Division
Lorin J Drake is the Vice President of Sales for Athenex Pharmaceutical Division. Mr. Drake has a wealth of experience in both the generic and brand name pharmaceutical businesses. His +30 year track record of success is well known in the pharmaceutical industry.
Mr. Drake was one of the founding members of Sagent Pharmaceuticals in 2005 and served as its Executive Vice President, Sales and Marketing. Prior to Sagent, from 1998 through 2004, Mr. Drake was the Vice President of Sales for the start-up of American Pharmaceutical Partners (now Fresenius). Mr. Drake also held positions of Regional Sales Director, Director of Trade Relations and Western Business Unit Manager in the pharmaceutical sector.
Mr. Drake holds a Bachelor of Science degree in Business and Economics from Manchester University.
Tony Gulczynski, RPh
Vice President, Alternative Customer Channels – Athenex Pharmaceutical Division
Tony Gulczynski is the Vice-President of Alternative Customer Channels at Athenex Pharmaceutical Division. Mr. Gulczynski leads the Athenex Pharma Solutions business at APD. Mr. Gulczynski practice pharmacy for many years in the Chicago area before he took a job with Schering Plough in Sales. After leaving Schering Plough, Mr. Gulczynski took a position with Premier, one of the largest healthcare group purchasing organization (GPO) in the country. After leaving Premier, he joined Sagent Pharmaceuticals as Vice-President of Corporate Development where he continued his long track record of success.
He earned his BS in Pharmacy from the University of Illinois College of Pharmacy and holds and active pharmacist license in the State of Illinois.
Vice President, Marketing – Athenex Pharmaceutical Division
Joe Mase is Vice President of Marketing at Athenex Pharmaceutical Division. Mr. Mase has been in the pharmaceutical and medical device industry for over 25 years. He has a wealth of unique experiences that make him one of the industry’s top experts on IV drug delivery technologies.
Prior to joining Athenex, he served as the Vice President of Marketing and Business Development at Sagent Pharmaceuticals. Mr. Mase started his career as global engineer with DePuy a (Johnson and Johnson company), which is a leading orthopedic implant medical device manufacture. He also worked for Baxter Healthcare, for 12 years in which he has held a succession of positions with increasing responsibility in the areas of engineering and global marketing.
Mr. Mase has a Bachelor of Science degree in Engineering from Michigan State University, and a Masters of Business Administration (MBA) from Kellogg School of Management, Northwestern University.
Vice President, Quality Assurance – Athenex Pharmaceutical Division
Sheila Moran is Vice-President of Quality Assurance at Athenex Pharmaceutical Division. Ms. Moran has 28 years of successful management experience in Quality Assurance, Facility Compliance, Validation, Manufacturing/Operations and Research & Development within a FDA registered cGMP environment. Her expertise spans both pharmaceutical drug products and drug substances and she is recognized globally for her expertise in Quality Assurance. Ms. Moran started her career at Northfield Laboratories and over her career worked for Cardinal Health, Regis Technologies, Sagent Pharmaceuticals in positions of increasing responsibility. Most recently, she was Vice-President of Global Quality Assurance at Sterigenics International.
Ms. Moran has a B.S in Biology from Roosevelt University in Chicago, Il.
Vice President, Regulatory Affairs – Athenex Pharmaceutical Division
Tom Moutvic has worked in Regulatory Affairs in the medical industry for 32 years. Mr. Moutvic has significant RA experience with pharmaceuticals and medical devices on a global basis having submitted applications in over 60 countries. He has developed and implemented systems for global electronic submissions and eCTD. Tom worked at Baxter, Abbott Laboratories, Hospira and Sagent holding several RA positions of increasing responsibility. Tom is well recognized as a leading Regulatory expert in the global pharmaceutical business.
Tom Moutvic received his BS degree in Microbiology from the University of Wisconsin at Madison in 1985.
Bert Patterson, RPh
Vice President, National Accounts, Contracting & Supply Chain – Athenex Pharmaceutical Division
Bert Patterson is currently Vice-President of National Accounts, Contracting and Supply Chain at Athenex Pharmaceutical Division. Prior to his current position he was Executive Vice President at Sagent Pharmaceuticals responsible for National Accounts, Contracting, Supply Chain and Corporate Development. Mr. Patterson spent nearly 30 years as a Pharmacist with the U.S. Department of Veterans Affairs serving in local, regional and national positions. He was at the Premier, a national healthcare Group Purchasing Organization as Vice President of Pharmacy for 6 years. Mr. Patterson’s experience includes roles in executive management, research, clinical practice, consulting, strategy and business development, negotiations, relationship management, advocacy and government relations.
Mr. Patterson received his B.S. in Pharmacy from the University of Illinois, College of Pharmacy. He has served in faculty positions at the University of Illinois, University of Wisconsin and Purdue University Pharmacy Schools and was a member of the Dean’s committee at Midwestern University, Chicago College of Pharmacy, and Roosevelt University, College of Pharmacy, Dean’s Advisory Committee.
Raymond Yeung MBA, MSc, BSc (Econ), FIBMS
Senior Director and Deputy Head, Clinical Research & Regulatory Affairs – Asia-Pacific Athenex (Hong Kong)
Raymond has over 30 years of experience in the pharmaceutical and healthcare industries, holding senior positions in Preclinical & Clinical CROs, GMP manufacturing facilities, as well as hospital and community medical laboratories. In his previous role as General Manager of Fortune Pharmacal in Hong Kong, Raymond oversaw all aspects of GMP Manufacturing, Quality Assurance, Quality Control, Plant Engineering, Sales & Marketing, as well as warehousing and distribution. Fortune Pharmacal is one of the largest and most advanced GMP plants in Hong Kong. Previously, Raymond was the Managing Director of AMRI (Albany Molecular Research Inc. USA)’s Singapore operation. AMRI Singapore is one of the largest chemistry-focused preclinical CRO in South East Asia, specializing in Medicinal Chemistry and other early Drug Discovery services. Prior to AMRI, Raymond worked for MDS Pharma Services as its Director (Asia Pacific) in Singapore, supervising the operations of Central Laboratories, Centralized ECG services, and Clinical Development. MDS Pharma Services was one of the major global Contract Research and Contract Manufacturing Organizations during the first decade of this century. Raymond’s expertise includes GCP, GLP, GMP Pharmaceutical Manufacturing, Central Laboratories, Clinical Trials, Preclinical studies, Microbiology, and Clinical Pathology Laboratory Services.
Raymond holds an MBA from the State University of California at Hayward (now East Bay) and an MSc in Medical Microbiology from the University of the West of England at Bristol, UK. Raymond is also a BSc (Econ) graduate from the University of London, and he is currently a Fellow of the Institute of Biomedical Sciences of the United Kingdom.
Michael Smolinski, PhD
Director, Preclinical Operations
As the Company’s primary chemist since 2008, Michael has contributed substantially to the development of Athenex’s clinical pipeline, operations, and platform technologies, including the Optimized PhotoAffinity Labelling (OPAL) platform technology which is a keystone to Athenex’s drug discovery efforts today. He has made significant contributions to Athenex’s clinical pipeline through hands-on research and management of IND-enabling studies including many aspects of drug substance, product, and process development.
Prior to joining Athenex, Michael completed a postdoctoral position at Scripps Florida where he focused on the drug discovery of kinase inhibitors, which resulted in several patent applications and publications. Michael obtained his PhD from SUNY University at Buffalo, and his multi-disciplinary PhD thesis on the “Thermodynamics of Molecular Recognition” contained breakthrough findings for the biotechnology industry.
Robert F. Keem
Vice President, Quality Assurance
Rob, an analytical chemist, has implemented effective quality management systems for over 20 years. Prior to joining Athenex, in his role as Global Quality Leader for Thermo Fisher Scientific, Rob oversaw 13 regulated manufacturing sites around the world. He has extensive experience in Quality Assurance and Validation, having led large teams in pharma, biotech and medical device companies, including Bristol Myers Squibb and Fujisawa, and assuming roles in R&D, Project Management, QC and QA/QC. Rob is proficient in execution of compliance to GMP 21 CFR 210/211/820 and has experience with lean manufacturing, six sigma training, and risk management. Early in his career, Rob focused on method development and quality control testing for biomedical companies. He received a Bachelors in Chemistry and a Master in Analytical Chemistry from Buffalo State College, State University of New York.
Stephen A. Panaro, PhD
President – QuaDPharma
Stephen has over 12 years of experience in the pharmaceutical industry. His experience spans from drug discovery and API synthesis, to large-scale commercial production of finished products across many different dosage forms and packaging configurations.
Throughout his career, Stephen has overseen personnel in nanotechnology, quality control (QC) chemistry, QC microbiology, customer service, project management and production, to name a few. Most recently, Stephen founded QuaDPharma based on his experience with clinical and commercial manufacturing. He wanted to create a company unlike the large-scale contract manufacturing organizations of today and focus on projects, and products, that require small to mid-scale manufacturing. The clients that sponsor these products require a unique blend of customer service and technical expertise. QuaDPharma provides just the right environment for development and commercialization of these innovative pharmaceutical products.
Director, Clinical Manufacturing & Supply Chain
Mark Seep is a seasoned professional with extensive experience in the pharmaceutical, biotechnology and medical device industries with Wyeth Pharmaceuticals, Progenics Pharmaceuticals, Athenex and Life Technologies. His experience includes cell culture, large and small molecule products of sterile liquid, powder, capsule and tablet formats. Mark has held positions in product development, manufacturing, regulatory compliance, quality assurance, systems development, project management, engineering as well as purchasing and supplier management.
Mark is a graduate of the State University of New York at Buffalo in Chemistry and Economics.
Benjamin Lee, PharmD
Hong Kong Research & Product Development Leader
Benjamin is the President of Comprehensive Drug Enterprises Ltd, an award winning, technology-driven company that provides innovative solutions for drug delivery system. Founded in 2005 and located in HK Science Park, it has products from the pre-clinical to the clinical stage of development. Benjamin was also an adjunct member of the Faculty of Medicine at the Chinese University in Hong Kong School of Pharmacy. He holds a Doctorate from the University of Kentucky College of Pharmacy. He trained under Drug Development and Clinical Research Fellowships at Glaxo Wellcome and the University of North Carolina, School of Pharmacy. Upon completion of his Fellowships, Benjamin joined Glaxo Wellcome as a Senior Research Scientist, rising to Lead Scientist and group manager in Clinical Development Center at GlaxoSmithKline. He has participated in the development of several of the GlaxoSmithKline respiratory drugs development, regulatory approval and marketing, and has also participated in product development and registration in neurology and pain management.
Xiaodong Wang, MBA
General Manager – Chongqing Taihao Pharmaceutical
Xiaodong has served as General Manager of Chongqing Taihao Pharmaceutical since August 2012. He participated in the establishment, development, and restructuring of the Chongqing Taihao Pharmaceutical from 2004 to 2012, and served as Vice President of Supply, Marketing and Sales. Xiaodong served as Manager of Administration, Marketing and Sales of Chongqing United Pharmaceutical, later merged to Holley Pharmaceutical (SSE: 600607) from 1997 to 2004. He has over 18 years experience in pharmaceutical and chemistry.
Xiaodong has his MBA from Chongqing University in China.
Li Shen, MBA, CPA
Vice President, Financial Planning & Treasury
Li has extensive experience in financial capital markets including 17 years of financial analysis, planning, accounting and auditing, asset management and risk management for both public and private companies. Prior to joining Athenex, Li worked in the audit and assurance services for PricewaterhouseCoopers in New York City, leading audit engagements in the capital market area. Her clients included key US banks, investment companies, the depository trust company and large insurance companies. She has a proven record of implementing procedures to promote financial excellence, optimizing company structure while serving as business partners to operational managers to improve financial results. Li graduated with an MBA in professional accounting from Rutgers University and she is a certified public accountant in New York State.
Prior to coming to the U.S., Li resided in Hangzhou, China working for a leading import and export company. Attending international expositions and travelling the world extensively, she has considerable experience with international business and trade. She received her BA in English Language and Literature from Shanghai International Studies University.
Xiaoli Yu, MBA
Chief Financial Officer – Chongqing Taihao Pharmaceutical
Xiaoli has served as Chongqing Taihao Pharmaceutical’s Vice General Manager of administration and Chief Financial Officer since August 2012. Xiaoli served in Chongqing Xiyong Microelectronics Industrial Park, a Chongqing Municipal key state-owned enterprises, engaged in the establishment of finance department from 2011 to 2012. She served as Audit Manager, CFO of Chongqing Holley Pharmaceutical, which is a listed pharmaceutical company in China (SSE: 600607) and has more than 20 domestic and overseas subsidiaries, from August 2004 to October 2011. Xiaoli served as Audit, Project Evaluation Manager of Chongqing Kanghua Accounting Firm from January 2000 to July 2004.
Xiaoli held various certificates, such as CPA, Certified Real Estate Appraiser in China. She also has her MBA from Chongqing University.
Edward Chan, CPA
Chief Financial Officer – Comprehensive Drug Enterprises
Edward has over 15 years of experience in accounting, auditing, financial management, corporate finance and risk management. Prior to joining Athenex, Edward was the Financial Controller of Hong Kong listed companies. Prior to that, Edward was a Finance Manager of a US listed energy company and an audit manager of KPMG Hong Kong.
Edward graduated with a Bachelor of Business Administration major in professional accounting and he is also a member of The Hong Kong Institute of Certified Public Accountant.
Vice President, Human Resources
Mary has more than 20 years’ experience in human capital management and organizational transformation. She has a proven record of building company capabilities and executing strategic change initiatives. Prior to joining Athenex, Mary held various human resource positions with Contract Pharmaceuticals Limited Niagara and Bristol-Myers Squibb. Mary has a BS in Business from Canisius College.
James L. Clements, PhD
James received his PhD from the University of Vermont (Cell and Molecular Biology) and pursued postdoctoral training at the Universities of Iowa and Pennsylvania. After an 8 year appointment in the Department of Immunology at Roswell Park Cancer Institute, James joined Athenex in 2008 to complement and expand existing expertise in the pre-clinical research programs. Prior to joining Athenex, James led active research programs in lymphocyte development, activation, and immune system function. Since joining the Athenex team, James has focused on advancing pre-clinical programs related to the main Athenex platforms, including conversion of intravenous to oral dosing formats for multiple drugs. These efforts include a broad range of activities, from designing in vitro assays to the management of GLP-compliant toxicology studies. James plays an active role in Athenex research operations based in Hong Kong and China, including the preparation of multiple successful grant applications to support Athenex R&D initiatives in Asia.
Director, Business Development – QuaDPharma
With an academic background in Biology and Chemistry, Ryan began a successful career in the life science industry working for pharmaceutical manufacturers Fujisawa and Astellas in Quality Control with responsibilities ranging from analytical method development and technology transfer to audit support and team leadership. Assisting in the laboratory compliance efforts for the commercial launch of drugs like Protopic prepared him for a career that extended outward from the laboratory into comprehensive development and management of pharmaceutical quality systems. Experience gained in another leadership role in laboratory compliance at Contract Pharmaceuticals Limited prepared Ryan for his next challenge where he, along with current colleagues Dr. Stephen Panaro and Leanne Kisicki, established QuaDPharma as a new Contract Manufacturing Organization. Today, Ryan manages all aspects of Business Development at QuaDPharma by engaging new clients and connecting them with the deep pool of subject matter experts to secure new business opportunities.
Director, Quality – QuaDPharma
Leanne oversees all aspects of Quality Control Laboratory operations at QuaDPharma. Leanne has been with the company since its inception and has used her extensive experience in analytical services to develop and maintain a GMP analytical service offering to our customers. Leanne has over fifteen years of experience helping customers to understand their product data. With tenure at APP Pharma and Contract Pharmaceuticals Ltd., Leanne has developed a wide range of laboratory management skills which augment the efficiency of laboratory operations at QuaDPharma.