IriSys Leadership Team
Gerald J. Yakatan, Ph.D.
Chairman, CEO & Founder
Prior to founding IriSys in 1996, Dr. Yakatan served as President & CEO of Avanir Pharmaceuticals where he was responsible for the development, regulatory approval and commercialization of Abreva®, and he led development efforts resulting in the NDA submission for Nuedexta®. Dr. Yakatan has also served as Pharmaceutics Chair at the University of Texas at Austin; Vice President for Product Development Worldwide at Warner Lambert/Parke Davis; and Founder and CEO at Tanabe Research Labs, USA. He has served on the Boards of numerous not-for-profit organizations and received distinguished alumnus awards from Temple University and from the University of Florida.
Dr. Yakatan received his B.S. in Pharmacy and M.S. in Pharmaceutical Chemistry from Temple University in Philadelphia, Pennsylvania. His Ph.D. was earned in Pharmaceutical Sciences from the University of Florida, in Gainesville, Florida.
Robert “Bob” Giannini, Ph. D.
Vice President & Chief Technical Officer
Dr. Giannini has more than 30 years of pharmaceutical industry experience. His breadth of knowledge includes development of a wide range of dosage forms such as controlled/extended release solids, oral liquids, and injectables. He has been responsible for all aspects of dosage form development and manufacture: preformulation, formulation development, analytical methodology, stability, process validation, regulatory compliance/submissions, and day- to-day production for currently marketed products. Dr. Giannini joined IriSys in 2004 and has been the primary author and principal investigator on most of the Company’s proposals that resulted in NIH development and manufacturing contracts.
From 1981 to 1985 Bob served as a Senior Scientist – Solid Dosage Forms, and then as Unit Supervisor – Novel Drug Delivery Systems at Wyeth Laboratories. In 1985 he joined Key/Schering Plough as Section Head – Solid Dosage Form Development. This was followed by a position as Vice President – Pharmaceutical Research and Development at a small venture capital funded firm called Himedics. In 1991, he joined Watson Laboratories as Director of Product Development where he was responsible for the development of generic products from formulation to ANDA submission.
Dr. Giannini was awarded a Ph.D. in Industrial Pharmacy from the University of Maryland at Baltimore for research in the area of solid dosage form design.
Jin Jean Wang, Ph.D.
Vice President, Quality Assurance and Quality Control
Dr. Wang has 20 years of experience in analytical chemistry and the pharmaceutical industry. She has been responsible for strategic leadership in analytical methodology development and implementation; execution of quality systems; and cGMP compliance for pharmaceutical product development and manufacturing. Dr. Wang joined IriSys in 2009 and her responsibilities include providing technical and quality guidance via directly overseeing quality assurance functions and all quality control testing including chemistry tests, stability study, and microbiological assays. Dr. Wang has planned, managed, and executed a variety of successful projects such as approval strategies to ensure compliance with cGMP regulations and the execution of internal/external audits.
Dr. Wang was awarded a Ph.D. in Analytical Chemistry from McGill University, Montreal, Canada. She had her post-doctoral training with the U.S. National Research Council Fellowship for two years and was a NIH Fellow for three years. Dr. Wang has published many peer-reviewed journal articles.
Vice President, Business Development
Mr. Scotti joined IriSys in 2015 after previously serving on its Board of Directors from 2007 until 2012. He has headed business development, marketing, new products and investor/public relations functions during a long career in the bio/pharma industry both in the U.S. and internationally. His responsibilities at IriSys include business development, commercial planning and managing contracts with clients and partners.
Mr. Scotti’s previous appointments include Chief Business Development Officer (Druggability Technologies), Vice President Commercial/Business Development/Marketing (Arena Pharmaceuticals) and Executive Director Licensing (Ligand Pharmaceuticals). During the course of his career, he identified, negotiated and closed more than 25 partnerships, R&D collaborations, licenses and commercialization agreements for biotech and pharmaceutical companies.
Executive Director Manufacturing Operations
Mr. Cavallino joined IriSys in 2015 and is responsible for manufacturing operations . He is a multitalented business leader with more than 20 years experience in all phases of cGMP manufacturing, facilities operations, purchasing and procurement, inventory control, supply chain management, and new product and business development. His diverse background and experience in multiple fields include the pharmaceutical, telecommunications, electronics, defense/aerospace and real estate industries.
Mr. Cavallino has been responsible for the planning, developing and establishment of corporate headquarters, manufacturing facilities, distribution centers, training, research and development hubs, and customer service capacities domestically and worldwide. Locations he has served in include China, Brazil, Mexico, Canada, Korea, India, Puerto Rico, and Europe. He has also directed Operations Research with the implementation of optimization algorithms covering entire supply chain network and individual operational cells.
Mr. Cavallino earned his Bachelor of Science in Industrial Engineering degree from Northeastern University in Boston, Massachusetts.
Victoria Smith Karpinski
Director of Human Resources and Administration
Ms. Karpinski joined IriSys in 2014. During 2003-2013, she and her husband relocated to an island in the western Caribbean, and established successful businesses in land development, restaurant, internet café, as well as a vacation rental business.
Ms. Karpinski joined AVANIR Pharmaceuticals, San Diego, California in 1998 as Director of Human Resources, was appointed Executive Director of Administrative Affairs in 2000, and became Vice President of Administration in 2001. During this time, she successfully facilitated the build-out of the Company’s former San Diego corporate offices and tripled the number of employees.
Victoria also previously served as Vice President, Administration at Inspired Arts Digital Media Group. Prior to Inspired Arts, she served for six years at Tanabe Research Laboratories, first as Manager of Research and Development Administration and Human Resources, and later as Director of Administrative Affairs. Among other achievements, Ms. Karpinski was project manager for Tanabe’s new $15 million biomedical laboratory and office facility, and developed the Scientific Management Program for directing scientists to become better managers, which subsequently was adopted industry-wide by the Biomedical Industry Council, San Diego. For the previous seven years, she held similar administrative management positions at Immunetech Pharmaceuticals and Scripps Clinic & Research Foundation.
Ms. Karpinski received a Master of Arts degree in Organizational Management and holds a Bachelor’s degree in Communications.
Igor Nikoulin, Ph.D.
Director of Research and Development
Dr. Nikoulin has 14 years of academic and 16 years of drug discovery and development experience serving as a project leader and team leader/principal investigator, as well as experience working in cGMP and GLP compliant labs.
Prior to joining IriSys in 2013, Dr. Nikoulin directed research and development projects in the areas of cardiovascular, inflammatory, and metabolic diseases at Avanir Pharmaceuticals. He initiated and advanced a research and development project from concept to the filing of an IND. His varied responsibilities ranged from setting up and supervising the laboratories to coordinating the efforts of cross-functional teams, and academic and industry partners.
Dr. Nikoulin has extensive knowledge and experience in small molecule, peptide, and protein formulation development, and lipid- / polymer-based micro- and nanoparticle targeted drug delivery systems. He established the R&D and manufacturing capabilities for nanoparticle-based drug delivery systems at IriSys.
Igor Nikoulin was awarded a Ph.D. in Biochemistry from the Moscow Institute of Medical Enzymology.
Prior to joining IriSys in 2014, Mr. Xie held various management level positions during his 18 years in diverse industries including food distribution, telecommunication, investment management, accounting and tax services. He has direct experience in the areas of accounting, finance and tax.
Mr. Xie is in charge of the Company’s finance, accounting and tax functions. He is responsible for financial planning and reporting, budgeting, cash management, payroll, internal control and tax filing and reporting.
Mr. Xie has a Master in Accounting degree from the University of Texas at Arlington, and is a Certified Public Accountant.
Director of Quality Assurance and Regulatory Affairs
Mr. Brooke Yakatan joined IriSys in 2014. His Quality Assurance experience includes the overseeing and maintaining of cGMP compliance in both small- and large-scale manufacturing campaigns ranging from Phase I/II to commercial products. Brooke’s Regulatory Affairs experience includes the filing of annual reports for NDA/ANDA submissions and facility annual product reviews.
Brooke was awarded a Master of Business Administration degree with distinction from Keller Graduate School of Management, a Bachelor of Science degree from Coleman University, and a Bachelor of Arts degree from the University of Florida. He also completed specialized certificate programs in Quality Assurance, Regulatory Affairs and Biotechnology Manufacturing from the University of California, San Diego.
Eli Shefter, Ph.D.
Chairman of the Scientific Advisory Board
Dr. Shefter has served as Chief Scientific Director and Senior Science Fellow at IriSys since the Company’s founding in 1996. He has extensive experience in the strategic and tactical planning for the development of medical products. He has knowledge of the regulatory formulation and manufacturing requirements for drugs, biologics and devices (therapeutic and diagnostic).
Dr. Shefter has been a member of the faculty at the State University of New York at Buffalo from 1966 to 1981; the University of Colorado from 1990 to 1992, and served as Adjunct Professor at the University of Colorado from 1993 to 2000. More recently, he was a Professor in the School of Pharmacy at the University of California, San Diego.
His industrial experience in product development included positions at E.I. DuPont Nemours, Genentech, Access Pharmaceuticals, and Cytel Corporation.
Dr. Shefter served as an elected member on the Committee of Revision of The United States Pharmacopoeia from 1985 to 2010. In addition, he has served on the Boards of a number of scientific journals in pharmaceutics. Dr. Shefter is a Fellow of the American Pharmaceutical Association (APA) and of the American Association of Pharmaceutical Scientists (AAPS).
Dr. Shefter was awarded a Ph.D. from the University of Wisconsin.