Nilufer (“Nilu”) Celenk has over 18 years of operational expertise in the clinical research and healthcare industries, across client services and project management. Nilu’s current responsibilities include partnering with Project Operations, Program Development, and Finance teams at Biorasi to maximize efficiencies and enable successful collaboration across the organization by leveraging her subject matter expertise in project operations. This includes bridging the gaps between different groups to provide visibility, alignment, and growth in operational success rates and ensuring successful financial planning, monitoring, and control of efficiency margins across projects. Previously, Nilu served as VP of Operations at Care Systems, Inc., building the company into a competitive organization and achieving significant revenue growth. She received her MBA/MIS from Loyola University and holds a BS in Environmental Engineering from Istanbul Technical University.

Brian Chaiken has over 25 years of legal and management experience across multiple industries, focusing on law, governance, strategy, and business planning. In his current role, Brian provides legal counsel to the Biorasi board of directors and senior leadership team on a broad range of legal matters affecting the company. Previously, he served as the Senior Executive Officer for Z Trim Holdings, a public biotechnology company, supporting equity and debt funding and establishing integral corporate policies. Brian received his JD from DePaul University and his BA in Accountancy from the University of Illinois, Champaign.

Cathy Gooch has over 25 years of experience in human resources, talent acquisition, resource management, and career development within clinical research and the CRO industry. In her current role, Cathy is responsible for the overall leadership and strategic direction for all matters concerning HR operations and talent acquisition, fostering a diverse workplace that enables all Biorasi employees to contribute at their full potential. Previously, Cathy served as Senior Vice President of Talent and Resource Management at Linical, where she was responsible for human resources, talent acquisition, and resource management. Cathy holds an MBA in Human Resource Management from Columbia Southern University and a BA in Human Resource Management from Georgia State University.

Alexandra (Alex) Dilis has over 25 years of quality and regulatory compliance experience across pharmaceutical, biotech, CRO industries, and all stages of biomedical product research and development. In her current role, Alex is responsible for strategic oversight of the Biorasi Quality Department, focusing on enabling regulatory and healthcare-related solutions for clinical trials and integrating Quality-By-Design into all aspects of Biorasi service delivery. Previously, Alex served as EVP and Chief Compliance Officer at SFJ Pharmaceuticals, where she spearheaded quality and research strategy and compliance with international legislature governing clinical development. Alex earned her JD from New England Law and received her BS in Business Administration from Providence College.

Becky Knockemus has more than 30 years of sales, operations, and executive management experience in the healthcare industry. Becky’s current responsibilities involve pipeline development and sales management, including leadership of the program development team and building short-term and long-term sales strategies for Biorasi’s continued growth. Previously, Becky served as Senior Vice President of Data and Analytics Sales for Decision Resources Group, a global company focused on data-based solutions for pharmaceutical and biotech companies. She received her BA in Political Science from the University of Alabama.

Dr. Sagar Patil has 20 years of experience in healthcare and pharmaceutical/biotechnology R&D, focusing on drug development and project management. In his current role as Executive Director of Asia Regional Operations, Dr. Patil is responsible for strategic development, business operations, project oversight, resource management, and business growth. Prior to his current role, Dr. Patil was Interim Country Head of India Operations for Amgen, a pioneer in the biotechnology industry. Dr. Patil received his MBA from the United Business Institutes in Brussels, Belgium, and holds a Medical degree from Mumbai University.

Evgeny Poltanov, MD, PhD brings over eighteen years of intensive experience in the fields of pre-clinical and clinical research, with a deep understanding of clinical development processes in the Eastern European regulatory environment. In his current role, Dr. Poltanov’s responsibilities are focused on developing growth strategies for operations and clinical research in Eastern Europe. Prior to joining Biorasi, Dr. Poltanov worked as a clinical operations director for Synergy CRO, providing strategic direction, leadership, and management across multiple company divisions to ensure the achievement of project goals within cost, time, and quality requirements. Dr. Poltanov received his MD from the Russian State Medical University with a PhD in Biology, focusing on antioxidants and photochemistry.

Kristen Reis brings over five years of administrative experience in supporting executive teams and their initiatives.  In her current role, Kristen’s responsibilities include managing the day-to-day operations of the executive leadership team, supporting projects in various branches from Human Resources to Marketing, planning company-wide events, and managing relationships. She received a BA in Sustainability from Florida International University.

Mike Rudolph brings over 18 years of experience in infrastructure, support, and IT operations for GxP companies. In his role as VP of Information Technology at Biorasi, Mike is responsible for IT strategy and operations, software development, and business intelligence. Previously, Mike served as Head of IT at Goodwin Biotechnology, and led a multi-year effort to launch a validated client server environment, including enterprise, quality, laboratory, and manufacturing management systems. Mike holds an MS in Information Systems and Operations Management from University of Florida.

Dr. Hartmut Schmied has over 25 years of experience in clinical research, with in-depth knowledge of regulatory compliance, safety, medical monitoring, project management, and clinical operations. In his current role, Dr. Schmied manages Biorasi’s presence in Europe, Ukraine, Russia, and India, and is responsible for all clinical operations outside of the U.S. Previously, Dr. Schmied held the position of Executive Director of European Operations at Jubilant Clinsys and Medifacts. Dr. Schmied received his medical degree from the University of Cologne and holds a EUCOR/ECPM in Pharmaceutical Medicine.

Roberto Silberwasser brings over 18 years of experience in the healthcare industry, focusing on program management, process improvement, and data analysis. His current role involves optimizing Biorasi’s unique approach to clinical data analysis, delivering data integrity and transparency through rigorous data management, biostatistics, and on-study analytics. Previously, Roberto held multiple leadership roles at Medtronic, a medical device manufacturer. He received his MBA from Harvard Business School and holds a BSc in Industrial Engineering and Management from the Technion (Cum Laude), Israel Institute of Technology.

Dr. Adjei is a consultant in Oncology, Professor of Oncology, and Professor of Pharmacology at the Mayo Clinic and Mayo College of Medicine in Rochester, MN. Dr. Adjei oversees oncology drug development as well as lung cancer research and treatment across all three Mayo Clinic sites, and is co-Leader of the Developmental Therapeutics program at Mayo Cancer Center. He has served as the PI on over 70 Phase I trials, as well as over 20 Phase II developmental trials for lung cancer therapy. Dr. Adjei received his MD from the University of Ghana and his PhD in Pharmacology from the University of Alberta, with an internal medicine residency at Howard University and a medical oncology fellowship at Johns Hopkins University.

Dr. Dwyer is a Professor of Medicine and Director of the Nephrology Clinical Trials Center at Vanderbilt University Medical Center. He is the current Chair of the Board, President, and Principal Investigator of the Collaborative Study Group, an international academic research organization. Dr. Dwyer is a practicing clinical nephrologist and has served on multiple Executive and Steering committees. Dr. Dwyer holds an MD with Distinction from Brown University Medical School and trained in Internal Medicine at Mayo Clinic Florida, and Nephrology and Clinical Research at Vanderbilt.

Dr. Isacson is a Professor of Neurology and Neuroscience at Harvard Medical School and Founding Director of the Neuroregeneration Institute at McLean Hospital. In this role, he is at the forefront of research into neurodegenerative disease and regenerative medicine for brain disorders. He has served as Executive Scientific Advisory Board Member for the Michael J. Fox Foundation and held memberships in the International Parkinson and Movement Society and the FDA’s Cellular, Tissues, and Gene Therapies Advisory Committee. He received his MD and PhD in Medical Neurobiology from the University of Lund in Sweden, completed his research fellowship in Neuroscience at the University of Cambridge, and holds honorary degrees from both Harvard University and University of Lund.

Dr. Negrin is a Professor of Medicine and former Chief of the Division of Blood and Marrow Transplantation at Stanford University. Dr. Negrin’s current research focuses on the fundamental understanding of graft vs. host and graft vs. tumor reactions, with an emphasis on immune regulatory mechanisms. He has previously served as the President of the International Society of Cellular Therapy and the American Society of Blood and Marrow Transplantation. Dr. Negrin received his MD from Harvard Medical School and trained in Internal Medicine and Hematology at Stanford University.