Leadership & Scientific Advisors
One team, passionate about faster trials
Chris O’Brien
CEO
About Chris →
Chris O’Brien
CEO
Chris O’Brien brings over 20 years of experience in building operational excellence across regulated industries. In his role as CEO, his responsibilities include setting the business strategy for Biorasi, as well as recruiting and coaching extraordinary people and developing a culture of high performance. Previously, Chris served as President and COO at Decision Resources Group and was responsible for operating a 1000+ person healthcare data and insights business. Chris holds an MBA from the Amos Tuck School at Dartmouth College and received his BA in English Studies from Middlebury College in Vermont.
Nilu Celenk
VP Operations, Commercial and Financial Affairs
About Nilu →
Nilu Celenk
VP Operations, Commercial and Financial Affairs
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
General Counsel
About Brian →
Brian Chaiken
General Counsel
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.
Alex Dilis
Senior VP, Quality Development
About Alex →
Alex Dilis
Senior VP, Quality Development
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.
marc Gas, PH.D.
VP, Program Development and Partnerships, Head of the Rare Disease Center of Excellence, Biorasi
About Marc →
marc Gas, PH.D.
VP, Program Development and Partnerships, Head of the Rare Disease Center of Excellence, Biorasi
Marc M. Gas, Ph.D., is the VP of Program Development and Partnerships and the Head of the Rare Disease Center of Excellence at Biorasi. Marc has an active and instrumental role in the design, development, and optimization of Sponsor projects and oversees various programs including: rare disease, oncology, hematology, and nephrology, in addition to Biorasi’s many clinical trial rescues. He has been involved in research for over twelve years in multidisciplinary fields such as materials science, proteomics, complex systems simulations, and late-phase clinical research. Dr. Gas brings his scientific and operational expertise to support global and complex clinical trials to drive optimal clinical trial success for Biorasi’s partners.
Prior to joining Biorasi, Dr. Gas had an extensive academic research career at the University of Barcelona (Spain), Florida State University, and the National High Magnetic Field Laboratory, where his work in material science, proteomics, and molecular simulations have been published in multiple peer-reviewed publications (i.e., Nature Commun, J. Am. Chem. Soc.). Dr. Gas holds a Ph.D. in Chemical Science and Technology.
Cathy Gooch, MBA
Senior VP, People and Culture
About Cathy →
Cathy Gooch, MBA
Senior VP, People and Culture
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 People Operations, Talent Acquisition, and Biorasi Culture – 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, a global CRO, where she was responsible for Human Resources, Talent Acquisition, and Resource Management. Prior to Linical, Cathy worked with Chiltern, a global CRO, serving as the Executive Director of Talent Acquisition, Human Resources, and Resourcing Solutions (FSP). Cathy holds an MBA in Human Resource Management from Columbia Southern University and a BA in Human Resource Management from Georgia State University.
Jimmy El Hokayem, Ph.D.
VP, Program Development and Medical Insights, Head of the Neurology and Regenerative Medicine Centers of Excellence
About Jimmy →
Jimmy El Hokayem, Ph.D.
VP, Program Development and Medical Insights, Head of the Neurology and Regenerative Medicine Centers of Excellence
As Head of Biorasi’s Neurology and Regenerative Medicine Centers of Excellence and VP of Program Development and Medical Insights, Dr. Jimmy El Hokayem oversees clinical projects related to neurological indications and therapies. His unique expertise in the basic, translational, and clinical research spectrum provides critical insights at strategic, operational, and managerial levels. He is an expert clinical trial decentralizer and an early adopter of digital technologies and digital therapeutics.
With over twenty years’ experience in both academia and clinical research, Dr. El Hokayem has focused his research on rare neurological diseases. He currently serves on the Scientific Advisory Board of the Foundation for Angelman Syndrome Therapeutics (FAST). Dr. El Hokayem has published over twenty peer reviewed papers and received multiple awards from international foundations and entities.
Dr. El Hokayem received his Ph.D. from University of Miami, Miller School of Medicine, in Biochemistry and Molecular Biology. He continued his training with post-doctoral work at the University’s Hussman Institute for Human Genomics.
Becky Knockemus
Senior VP, Commercial Operations
About Becky →
Becky Knockemus
Senior VP, Commercial Operations
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.
Nancy Newark
VP, Project Management
About Nancy →
Nancy Newark
VP, Project Management
Nancy Newark has worked in clinical research for over 25 years and is an accomplished project management and clinical operations executive. She has extensive experience leading complex multi-faceted research programs and global teams. Her research expertise, combined with her experience as a registered nurse, has provided a broad range of therapeutic experience including but not limited to cardiovascular (acute coronary syndromes, heart failure, PAH, hypertension), metabolic (diabetes, obesity), acute and chronic renal failure, rare diseases, liver disease, and gene and cell therapy. Prior to joining Biorasi, Nancy served as an Executive Director of Project Management at Worldwide Clinical Trials. Additionally, she previously worked at the Duke University Medical Center as a registered nurse for 11 years with 14 years at the Duke Clinical Research Institute.
Sagar Patil
Executive Director, Asia Regional Operations
About Sagar →
Sagar Patil
Executive Director, Asia Regional Operations
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.
Dipali Patel, MD
VP, Medical and Scientific Affairs
About Dipali →
Dipali Patel, MD
VP, Medical and Scientific Affairs
Dr. Dipali Patel has over seven years of experience in the pharmaceutical and CRO industries, across therapeutic areas including rare disease, neurology, oncology, and hematology. As the VP and Head of the Medical and Scientific Affairs (MSA) team, Dr. Patel’s current responsibilities include serving Biorasi and sponsors by providing precise medical and scientific support with patient safety at its core. This includes establishing Biorasi MSA methodology and best practices for medical monitoring, clinical development, medical writing, pharmacovigilance (PV), and post-market PV surveillance. Prior to this role, Dr. Patel launched medical monitoring solutions at Biorasi and was instrumental in forming the current Scientific Advisory Board. Dr. Patel received her MD from International American University, College of Medicine.
EVGENY POLTANOV, MD, PHD
DIRECTOR, EASTERN EUROPEAN OPERATIONS
About Evgeny →
EVGENY POLTANOV, MD, PHD
DIRECTOR, EASTERN EUROPEAN OPERATIONS
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.
Paige Queen
VP, Clinical Operations
About Paige →
Paige Queen
VP, Clinical Operations
Paige Queen has over 18 years of experience in clinical monitoring, clinical operations, and project management across the pharmaceutical and CRO industry. As Head of Clinical Operations, Paige is responsible for quality delivery of clinical activities on all Biorasi projects, global leadership of the clinical team, resource management, performance oversight, and training strategies. Previously, Paige served as VP of Clinical Operations at Total Clinical Trial Management and was instrumental in the long-term growth and development of the company. She received her BS in Biology from Texas Tech University.
Kristen Reis
Chief of Staff
About Kristen →
Kristen Reis
Chief of Staff
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
Senior VP, Data Sciences and Technology
About Mike →
Mike Rudolph
Senior VP, Data Sciences and Technology
Mike Rudolph brings over 18 years of experience in infrastructure, support, and IT operations for GxP companies. In his role as Senior VP, Data Sciences and 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.
Hartmut Schmied, MD
Senior VP, Head of Regional Operations
About Hartmut →
Hartmut Schmied, MD
Senior VP, Head of Regional Operations
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.
Chetan Tadvalkar
Senior VP of Clinical Delivery and Corporate Strategy
About Chetan →
Chetan Tadvalkar
Senior VP of Clinical Delivery and Corporate Strategy
Chetan Tadvalkar has over 15 years of experience in professional services, operations management, and M&A in the healthcare industry. In his role as Senior VP of Clinical Delivery and Corporate Strategy at Biorasi, Chetan oversees project delivery, leading global project management and clinical teams. In addition, Chetan is responsible for developing external partnerships and alliances to support Biorasi’s clients. Prior to joining Biorasi, Chetan served as Senior VP & GM at Decision Resources Group, a global pharma services business. Earlier in his career Chetan advised life sciences companies while a consultant at BCG. Chetan holds an MBA from the Wharton School at the University of Pennsylvania and a BA in Economics from Yale University.
Sara Vaidya
Vice President, Data Sciences and Biometrics
About Sara →
Sara Vaidya
Vice President, Data Sciences and Biometrics
Sara Vaidya has over 16 years of experience in clinical data management, including EDC systems, CDISC standards, Alliance management, statistical programming, and biostatistics oversight. As VP of Data Sciences and Biometrics, Sara is responsible for providing advanced data solutions to improve healthcare outcomes with a focus on developing partnerships routed in quality, efficiency, and transparency, end-to-end data sciences management, global leadership of the Data Sciences team, and metrics-driven performance oversight. Prior to joining Biorasi, Sara served at SIRO ClinPharm CRO in an Alliance management role responsible for end-to-end data services, customer engagement, project management, statistical programming, and key areas of medical writing. She received her MS in Biotechnology from the University of Mumbai.
Mike Vitek, CPA
Chief Financial Officer
About Mike →
Mike Vitek, CPA
Chief Financial Officer
Mike Vitek is a senior financial executive who brings over 30 years of experience in all aspects of accounting, auditing, and financial management. As CFO, Mike’s role involves overseeing finance and accounting functions at Biorasi. Prior to his current position, Mike has held CFO, Board Advisor, and General Manager posts with both public and private companies. These include private equity portfolio companies in oilfield services, consumer goods, manufacturing, gaming, and hospitality industries. Mike received his BS in Business Administration in the field of Accounting from the Ohio State University.
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Scientific advisors
Biorasi’s Scientific Advisory Board (SAB) represents the best and brightest in clinical leadership – across key industry focus areas and around the world. Our SAB team brings new perspectives and fresh ideas to your clinical trial solutions.
Alex A. ADJEI, MD, PHD, FACP
Oncology
Chairman of the Taussig Cancer Institute at Cleveland Clinic
About Dr. Adjei →
Alex A. Adjei, MD, PhD, FACP
Oncology
Chairman of the Taussig Cancer Institute at Cleveland Clinic
Dr. Adjei is Chairman of the Taussig Cancer Institute at Cleveland Clinic. Dr. Adjei has served as the PI on over 70 Phase I trials, as well as over 20 Phase II developmental trials for lung cancer therapy. Previously, Dr. Adjei held the position of professor of oncology and professor of pharmacology at Mayo Clinic and Mayo Clinic College of Medicine and Science in Rochester, MN. 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. He is a recent recipient of the Adi F. Gazdar Merit Award from the International Association for the Study of Lung Cancer for Distinguished Achievement in Lung Cancer Research and Mentorship, and a recipient of the European Society for Medical Oncology’s Lifetime Achievement Award. He is a member of the National Cancer Institute’s Board of Scientific Counsellors.
JAMIE P. DWYER, MD
NEPHROLOGY
Associate Dean for Clinical Research, Professor of Medicine at the Data Coordinating Center and Clinical and Translational Research Institute at the University of Utah, Chair of the Board, President, and Principal Investigator of the Collaborative Study Group
About Dr. Dwyer →
JAMIE P. DWYER, MD
NEPHROLOGY
Associate Dean for Clinical Research, Professor of Medicine at the Data Coordinating Center and Clinical and Translational Research Institute at the University of Utah, Chair of the Board, President, and Principal Investigator of the Collaborative Study Group
Dr. Dwyer is Associate Dean for Clinical Research and Professor of Medicine in the Division of Nephrology/Hypertension, and is the Director of the Data Coordinating Center at the University of Utah. 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.
Ole Isacson, MD, PhD
NEUROLOGY
Founding Director of the Neuroregeneration Research Institute at McLean Hospital, Professor of Neurology (Neuroscience) at Harvard Medical School, Professor of Neurology at Massachusetts General Hospital
About Dr. Isacson →
Ole Isacson, MD, PhD
NEUROLOGY
Founding Director of the Neuroregeneration Research Institute at McLean Hospital, Professor of Neurology (Neuroscience) at Harvard Medical School, Professor of Neurology at Massachusetts General Hospital
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.
Robert S. Negrin, MD,
HEMATOLOGY
Professor of Medicine and former Chief of the Division of Blood and Marrow Transplantation, Stanford University
About Dr. Negrin →
Robert S. Negrin, MD,
HEMATOLOGY
Professor of Medicine and former Chief of the Division of Blood and Marrow Transplantation, Stanford University
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.