Ben Locwin, PhD, MBA, MS, MBB is Head of Clinical Quality at Karyopharm Therapeutics, and a member of several pharma and biotech Boards of Directors and Advisory Boards. He has been featured in The Wall Street Journal, Forbes magazine, USA Today, and other top-tier media outlets. Dr. Locwin is widely published in the healthcare arena, his work extending to improving patient care, hospital practice, and infection reduction. He has participated as a futurist for new treatment modalities and medical devices, and has also been a consultant for drug pricing in the current climate. Some of these paradigms have also extended to work with ICH as well as FDA on forward-thinking metrics for the future of the pharmaceutical industry. Ben is also an active Board member for the Genetic Literacy Project, an internationally-acclaimed organization for the critical thinking and publication of clear science on the future of genetics and genomics, and technologies therein to enhance conditions for humanity.
Brian Hasselbalch is currently acting Deputy Director in CDER OPQ’s Office of Policy for Pharmaceutical Quality. OPPQ is responsible for the development and implementation of regulations, policies, and programs governing the quality ‘lifecycle’—pre-market through commercialization. Brian been with FDA since 1990, when he began his career in FDA’s San Francisco District Office inspecting drug operations there and overseas. Brian transferred to CDER’s Office of Compliance in 1995 to work on enforcement actions and related drug quality policies, and then transitioned into OPQ in his current position when CDER reorganized in 2015. Brian has led the development of many compliance (i.e., inspection) programs, several regulation changes, helped with many guidance, led the team that developed the first site selection model in 2005, served as an agency member of the team that collaborated with industry to create the first generic drug user fee program of 2013, proposed FDA membership into PIC/S, and strives to develop clear and effective drug quality policies.
Lieutenant Jogy George is an Active Duty commissioned Regulatory Officer with the United States Public Health Service (USPHS) and a GDUFA Drug Investigator for the U.S. Food & Drug Administration. He conducts foreign and domestic inspections of various FDA-regulated entities and serves as a SME for Process Validation, Cleaning Validation, Equipment Qualification, and Data Integrity audits. Prior to joining the FDA, he has 12+ years of experience in the pharmaceutical industry where he managed process engineering projects and commercial lifecycle management for a wide range of commercial dosage forms. LT George holds a B.S. degree in Chemical Engineering from New Jersey Institute of Technology, and a M.S. degree in Pharmaceutical Sciences from Long Island University.
Paul McGuirk is Senior Sourcing Manager for small molecule drug product at Pfizer. He has broad responsibilities that include Drug Product Manufacturing oversite, vendor management, and sourcing strategy. He has been instrumental in developing Pfizer R&D’s vendor database, which is utilized to capture relevant information required to support outsourcing activities. Paul has 10+ years of experience in various supply chain roles for both the consumer goods and pharmaceutical industries including SC Quality, Manufacturing/Packaging and Procurement. Paul holds a Bachelor of Science degree in Molecular and Cell Biology from the University of Connecticut as well as an MBA from the University of New Haven.
Dave Windley is a managing director and founding member of Jefferies’ Healthcare Equity Research team. Over a 20-year career in investment research, Mr. Windley has covered a broad range of healthcare product and service sectors, including managed care, healthcare information technology, pharmaceutical services, and specialty pharmaceuticals. Dave is a five-time Wall Street Journal Best on the Street honoree and a 6-time Starmine award recipient. Dave is involved in the Nashville financial and healthcare community, having served as an officer and board member of the CFA Society of Nashville, an Alumni Board Member of the Owen Graduate School of Management, and a member of Leadership Healthcare.
Robert Marohn is Director of Computer System Validation in Quality Engineering at Kite Pharma, a leader in engineered T cell therapy. Kite Pharma is transforming cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago. Robert has consulted with organizations on all aspects of developing and implementing comprehensive quality information technology policy/procedures, frameworks, computer system validation, and data integrity plans and programs. He has worked in the life science industry for over twenty years. He served as the Chief Information Officer of Worldwide Clinical Trials for eight years. He holds a Master of Science in the Management of Technology from Georgia Institute of Technology.
John Moser is currently the Associate Director of Laboratory Information Systems at Gilead Sciences. He has experience spanning 30 years overseeing validation and manufacturing for commercial and clinical pharma and biopharma operations. Unique to his experience is leading the startup of large-scale GMP manufacturing facilities and helping to craft data integrity governance practices. John has technical expertise in commissioning, qualification, risk management, economic analysis and data presentation. For his leadership approach, John believes firmly that individuals flourish when immersed in an environment of autonomy and opportunity. John has a MBA from Johns Hopkins and a BA in business communications. In 2012, he authored the book, LiNK: The Fascinating Ways Our Minds Connect, a book about improving organizational collaboration and was an Amazon business best-seller.
José Jusino is a Senior Manager, Computer Systems Validation for Kite Pharma. He has been Global lead of a Data Integrity program for a Worldwide Pharmaceutical Company. He has implemented the structure for Data Integrity GAP assessments and mitigations plans around the world for dozens of laboratory, manufacturing and IT systems. José worked closely with Local and Global Operations multidisciplinary groups taking leadership in the closure of a 3 years Data Integrity Program which resulted in the development and implementation of a world class Data Integrity Compliance Initiative integrated as a day to day activity. José has a BS in Chemistry from the Catholic University of Puerto Rico and an MBA in Technology Management from the University of Phoenix. José has 30 years of QA/CSV/IT/GAMP/FDA/MHRA experience in the small molecule and large molecule pharmaceutical industry as well as biotechnology and medical devices industries.
Juan is a principal statistician with R&D in Centralized and Point of Care Solutions at Roche Diagnostics. She is experienced in clinical studies’ design and implementation in the medical device industry. She has made key contributions to studies from different disease areas such as infectious diseases, women’s health, heart disease, and specialty drug testing. Those studies include testing in large analyzers at central laboratories as well as point of care devices at patient’s bedside. Previously she has held positions in software validation and verification, algorithm development, and software development in Diabetes Care R&D at Roche. She was a key functional lead in the development and launch of their unlabeled vial release system.
John Avellanet gives practical, compliance solutions to data integrity challenges for clients around the world. Winner of the 2009 & 2011 Best of Business Services award by the Small Business Commerce Association, Mr. Avellanet has earned international acclaim for his business-savvy, pragmatic FDA compliance advice. He most recently served as the industry expert reviewer for the international standard, BSI 10008 Evidential Weight and Legal Admissibility of Electronic Information (2015). He is the lead expert for the ISPE GAMP Data Integrity Working Group. He regularly trains FDA andHealth Canada officials and investigators on advanced data integrity topics. In 2014, he co-authored the book, “Pharmaceutical Regulatory Inspections,” with several current and former regulatory agency officers, and his industry classic, “Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (2010),” was originally featured at BIO 2011 and garnered multiple five-star reviews from industry publications, blogs, Amazon.com readers, and former FDA officials. He has a breadth of experience designing, implementing, and being accountable for quality systems and compliance programs for FDA, DEA, ICH, GHTF/IMDRF, and ISO. For more than 15 years, John was directly accountable for regulatory compliance, records management, and information technology, most recently as a C-level executive for a Fortune 50 combination device firm. In 2006, Mr. Avellanet founded his independent lean compliance consulting and training firm, Cerulean Associates LLC.
Donna Gulbinski is Vice President in the Compliance Practice at Lachman Consultants who has more than 30 years of experience in pharmaceutical and biopharmaceutical companies where she served as a global quality leader. Her expertise and experience spans worldwide regulatory, quality, compliance, and operations across vaccine, biological, pharmaceutical and medical device technologies. She has provided strategic quality leadership to worldwide manufacturing and supply organizations by establishing systems and processes while engaging others to achieve superior business performance.
Jim is currently the principal of Spavins Consulting and is the former SVP of Pfizer’s industry leading Pharmaceutical Sciences organization. He has experience spanning 36 years developing and bringing to patients innovative new medicines. Unique to his experience is leading global groups across all the technical disciplines of CMC development, as well as regulatory, quality, clinical supply, commercial manufacture, CI, statistics, environmental impact and economic analysis. For his leadership approach, Jim brings a strong focus beyond the necessary technical disciplines and regulations, looking at the interplay of culture, teamwork and behavior for successfully advancing programs in an effective and efficient manner. Jim has a M.A. in analytical chemistry and M.S. in chemical engineering, both from SUNY Buffalo. When not consulting, Jim is a highly-engaged grandfather.
Following retirement as Vice-President in charge of External Affairs and Biosimilar Strategy for the Biotherapeutics Pharmaceutical Sciences organization of Pfizer Worldwide R&D, Dr. Bose practices business and technology strategy advising as the sole partner of AbiologicsB, LLC. At Pfizer, Arin’s group was responsible for biopharmaceutical product development outsourcing, competitive intelligence and external influencing in addition to developing and executing Pfizer’s entry strategy for biosimilars. His long biopharmaceutical industry career has included assignments in bioprocess development, clinical supply manufacturing, corporate biotechnology strategy and advocating for science-based regulations for biologics, including biosimilars. Dr. Bose’s outstanding professional accomplishments have been recognized by his election as Fellow of three leading professional organizations: American Chemical Society, American Institute of Chemical Engineers and American Institute of Medical and Biological Engineering.
Marazban Sarkari, PhD is Director of Pharmaceutical Operations with Teva’s Global Branded Products R&D group. He is a Chemical Engineer by training and has more than 15 years’ experience in outsourced pharmaceutical drug product manufacturing, and formulation and analytical development covering both large and small molecules. His teams have been involved in vendor selection, contract negotiation, project management and process scale-up and optimization. Previously he has held positions in technical operations, process and formulation development and engineering at Cephalon, Endo Pharmaceuticals and RxKinetix gaining a broad experience in the outsourcing of formulation and analytical development as well as the manufacture of clinical and commercial API and drug products. He has presented and published in the areas of new process development, vaccine formulation, novel drug delivery technologies, process optimization and monitoring.