The Oncobiologics Team

Oncobiologics was formed by a team of accomplished scientists and engineers with over 100 years of experience in major pharmaceutical and biotech companies. The team brings senior management and technical experience from top-tier organizations, including; Amgen, Genentech, Eli Lilly, Bristol-Myers Squibb, Pfizer, Bayer, Merck, Johnson & Johnson, Schering-Plough and Medarex.

Oncobiologics combines the world-class know-how of leading discovery and development scientists with the agile, innovative culture of a start-up. We have also developed an expert advisory team and partnerships with leading institutions to complement our capabilities.

EXECUTIVE TEAM

Pankaj Mohan, Ph.D., M.B.A.

Founder and CEO

Dr. Mohan founded Oncobiologics in 2011 after a distinguished 20+ year career in the global biopharmaceutical industry.  Most recently, Dr. Mohan headed  Business Operations and Portfolio Management for a division of Bristol-Myers Squibb, where he was instrumental in expanding the business’ biologics pipeline.  He also held prior positions at Genentech and Eli Lilly and Company, where he led various bioprocess engineering functions.   Dr. Mohan also served as Assistant Professor (Lecturer/Fellow), at the Advanced Centre for Biochemical Engineering  at University College London.

During his career, Dr. Mohan played an important role in the development and manufacture of multiple blockbuster biopharmaceutical drugs. He planned, initiated and led a state of the art biologics R&D organization, and most recently led the acquisition of small biotech companies and multiple biologics molecule assets.

He earned his Ph.D. in Biochemical  Engineering at the School of Chemical Engineering, University of Birmingham, Birmingham, United Kingdom;  his MBA specializing in Finance Management from Middlesex University Business School, London, United Kingdom, and his Bachelor of Chemical Engineering at the Indian Institute of Technology in India.  Dr. Mohan also participated in the Executive Management program at the Fuqua School of Business, Duke University. He was a finalist in the 2014 Ernst & Young Entrepreneur of the Year program.

Dr. Mohan has authored a book on Pharmaceutical Manufacturing published by McGraw Hill and is the author of more than 30 publications.

 

Donald J. Griffith, C.P.A.

Chief Financial Officer

Don Griffith brings to Oncobiologics more than 30 years of experience in finance and accounting, including a partner position in the New Jersey accounting firm of Stolz & Griffith. Previously, his  roles included CFO and financial leadership positions  and more than 10 years in corporate finance with Exxon corporation. Don is a member of New Jersey Society of CPAs and the American Institute of CPAs.

 

Stephen J. McAndrew, Ph.D.

Senior Vice President, Business Strategy & Development

Dr. McAndrew is Vice President of Business Development and is responsible for the company’s revenue growth strategy and initiatives, establishing and managing all collaborative research and commercial product partnerships, and sourcing selected investment opportunities.

Prior to joining Oncobiologics, Dr. McAndrew served as Vice President, Business Development for Xenogen Biosciences, Caliper Life Sciences and Taconic Biosciences, where he was responsible for managing new business development, licensing and marketing functions. Previously, he served as Vice President, Pharmaceutical Business Development for Lexicon Pharmaceuticals and Director, Biotechnology Licensing for Bristol-Myers Squibb Company.  In each case, he was responsible for identifying, evaluating, negotiating and managing numerous preclinical compound collaborations and innovative platform technology alliances.  Prior to transitioning to Business Development/Licensing roles, Dr. McAndrew led applied research programs within Discovery-Oncology at Bristol-Myers Squibb, and exploratory research in the Roche Institute of Molecular Biology at Hoffmann La-Roche.

Dr. McAndrew earned his Ph.D. in Cellular and Molecular Biology from Ohio University, his Masters of Science in Molecular Genetics from SUNY at Albany and his Bachelors of Science from SUNY at Oswego.

 

Kenneth M. Bahrt, M.D., F.A.C.R.

Chief Medical Officer

Dr. Bahrt serves as Oncobiologics’ Chief Medical Officer and is responsible for the Clinical, Non-Clinical, and Pharmacovigilance functions.  A recognized expert in immunology, he brings over 30 years of clinical and pharmaceutical industry experience in both small molecule and protein therapeutics.   He previously served as the Vice President of US Medical Affairs at NPS Pharmaceuticals responsible for two orphan products.  He was part of the launch team for Natpara, the first replacement hormone therapy for hypoparathyroidism.  At Savient Pharmaceuticals, he was SVP and Chief Medical Officer and was the medical lead on the team that obtained European marketing approval for Krystexxa (pegloticase) for the treatment of chronic tophaceous gout.  Previously, Dr. Bahrt joined Genentech as part of the Roche acquisition and became the Therapeutic Head of Immunology Medical Affairs responsible for multiple products including Actrema, Rituxan, Xolair, and Pulmozyme.  While at Roche, he was the Global Medical Director for Immunology, leading both the US and Global Medical Affairs teams.

Dr. Bahrt is a board-certified Internist and Rheumatologist and a Fellow of the American College of Rheumatology. Dr. Bahrt holds a medical degree from Hahnemann University and a bachelor’s degree in biology from Muhlenberg College.

 

Claude Nicaise, M.D.

Deputy Medical Officer

Dr. Nicaise serves as Oncobiologics’ Deputy Medical Officer. A noted oncology specialist, he previously served as Senior Vice President of Strategic Product Development and Global Regulatory Affairs at Alexion Pharmaceuticals, where he was responsible for the company's regulatory activities worldwide in support of new product development  and preparation for entry into new markets. Prior to joining Alexion, Dr. Nicaise worked for Bristol-Myers Squibb for 24 years, where he held numerous senior management roles, including Vice President of Global Development; Vice President of Worldwide Regulatory Science and Global Regulatory Strategy; Vice President of Worldwide Regulatory Science and Strategy for Oncology, Infectious Disease and Neuroscience; Executive Director of Infectious Diseases Clinical Research; and Director of Clinical Cancer Research.

During his time with Bristol-Myers Squibb, Dr. Nicaise oversaw the approvals of numerous treatments for cancer, schizophrenia and infectious diseases, including Tequin (bacterial infections), Erbitux (cancer), Abilify (schizophrenia) and Reyataz (HIV). Dr. Nicaise is the author of more than 60 research articles published in peer-reviewed journals and is a member of several professional medical associations, including the American Society of Clinical Oncology, the European Society for Medical Oncology, the American Society for Microbiology and the American Society of Hematology. Dr. Nicaise holds a medical degree from the Université libre de Bruxelles in Belgium.

 

Scott Gangloff

Senior Vice President, Process Development and Manufacturing

Scott joined Oncobiologics in 2011 with more than 15 years of experience in biopharmaceutical process development and cGMP manufacturing. He previously spent over 12 years at Bristol-Myers Squibb, where he led multiple biologics programs through process development, scale-up, clinical manufacturing, and transfer to commercial manufacturing. Scott also spent time with Jacobs Engineering as a Process Engineer. Scott brings an accomplished track record of leadership in developing and scaling-up processes designed for production of mAbs, fAbs, and PEGylated proteins through both mammalian and microbial expression systems. By integrating process development with clinical manufacturing, an emphasis on process design for manufacture enables rapid progression of molecules from DNA to FIH. Scott earned his Master’s in Chemical Engineering from Lehigh University and his Bachelors in Chemical Engineering from Villanova University.

 

Elizabeth Yamashita

Vice President, Regulatory Affairs

Liz is Vice President of Regulatory Affairs and is responsible for Oncobiologics’ regulatory strategies and operations as well as clinical programs.  She brings over 30 years of pharmaceutical industry experience with 20+ years in the Regulatory Affairs arena. Prior to joining Oncobiologics, Liz served as Group Vice President, Regulatory Affairs at Savient Pharmaceuticals, Inc. In this role, she managed all aspects of the regulatory function, and recently led the Savient team to its first European marketing approval for Krystexxa® (pegloticase), a PEGylated enzyme for the treatment of severe gout.  Prior to this position, she served as Principal Fellow at ImClone, providing regulatory expertise across the ImClone and Eli Lilly biotech pipelines.  As Vice President at ImClone Systems, she was responsible for Regulatory CMC strategy and Operations for development and commercial monoclonal antibody projects.  Liz began her career at Bristol-Myers Squibb holding positions in Regulatory CMC, Process Chemistry, and global Oncology marketing.

Liz earned her Regulatory Affairs Certification from RAPS in 2002, and holds a B.S. degree in Chemistry from the University of Rochester.

 

Michael Kenville

Director, Quality Assurance

Mike brings over 25 years of experience in biopharmaceutical Manufacturing and Quality Assurance to Oncobiologics. Previously, he spent more than eight years at WuXi AppTec where he acted as Site Quality Lead, established the Validation department and helped start-up the facility in Philadelphia, PA.  Prior to WuXi, Mike held positions in Quality Assurance, Manufacturing and Process Development at two other start-up biotech companies; Biomira Inc. and the Liposome Company.  At the West Company, he managed Quality Assurance of sterile ophthalmic manufacturing and packaging.  Mike began his career working in Sterile Filling at Elkins and Sinn Pharmaceuticals after earning a BA degree in Biology from LaSalle University.

 

Jane Xiao, Ph.D.

Director, Analytical Sciences & Quality Control

Dr. Xiao joined Oncobiologics in 2011. She is Director of Analytical Sciences & Quality Control and is responsible for analytical characterizations, method development, qualification/validation, release and stability testing/reporting and specification development to support Process Development, Manufacturing, and Formulation.  Dr. Xiao brings more than 15 years of experience in Analytical and GLP. Prior to joining Oncobiologics, Dr. Xiao was Senior Scientist at Merck, where she managed a chromatography/mass spectrometry group to support pharmadynamics in early phase clinical trials for Clinical Pharmacology and Experimental Medicines. Previously, Dr. Xiao served as head of a proteomics lab at Johnson & Johnson.
 
Dr. Xiao earned her Ph.D. in Chromatography/Mass Spectrometry from University of Wales Swansea.  She was a postdoctoral fellow at University of the West of England, and at Mount Sinai School of Medicine.

 

Min Xu, Ph.D.

Director, Project Management

Dr. Xu joined Oncobiologics in April 2014 as Director of Project Management.  In this role, she is responsible for the Project Management and Alliance Management function at Oncobiologics.  Dr. Xu brings more than 16 years experience in the development of technology, process and commercial products for biotechnology and pharmaceuticals.  Prior to joining Oncobiologics, she was the Director of Program Management at Savient Pharmaceuticals, where she managed programs ranging from Process Development, Technology Transfer, Early Access, Regulatory Submissions, REMS and Post Marketing Commitments.  Previously, Dr. Xu held positions in the area of Technical Development, Marketing and Business Support with GE Healthcare, Orchid BioSciences and Schering-Plough.

Dr. Xu earned her Ph.D. at Tufts University, where her research focused on cell cycle regulation.  She was a postdoctoral fellow with Dana-Farber Cancer Institute at Harvard Medical School.  Dr. Xu received certification as a Project Management Professional in 2006.

 

Richard C. Gregory

Director of Marketing & Communications

Rick Gregory brings more than 20 years of strategic marketing experience to Oncobiologics. As an independent consultant, he has led dozens of life sciences strategy and execution engagements with leading firms such as GE Healthcare Life Sciences, Oncogene Sciences (OSI, now part of Astellas), CARR-Centritech, Xcellerex, Natrix Separations, FTS Systems, Sepracor, VWR International and Mayo Medical Laboratories.  He is also the author of the bestselling business book, The Dollarization Discipline, published by John Wiley & Sons in 2004.  Rick earned his B.A. in Economics from Amherst College.