Susan Bornstein, MPH brings over three decades of leadership in clinical data management, analytics, and innovation to her role as Principal at SMB Board Advisory and Consulting. She previously served as Executive Director of Clinical Data Sciences in Global Product Development at Pfizer and has held strategic roles in clinical informatics and analytics. Susan’s career spans driving digital transformation, shaping data strategy, and leading modernization initiatives across the pharmaceutical and biotech industries.

At Maxis AI, Susan serves as an Agentic AI Advisor, guiding the strategic evolution of the Agentic AI platform – including autonomous clinical data workflows, adaptive protocol optimization, and real-time insight generation. Her vision ensures that Maxis AI solutions are grounded in industry best practices, compliance-ready, and optimized for success in today’s complex clinical trial environment.

Indrani Kakade is a distinguished leader with over 29 years of experience in Global Pharma and Outsourcing Industry. She is an early adopter of Clinical Data Management Outsourcing to India with experience in Study set up, Data Management , Statistical programming, Drug Safety & Pharmacovigilance/Drug Safety Operations. She has held leadership roles at Pfizer Pharmaceuticals, Cognizant Technology Solutions, Sciformix Technologies, and Cliantha Research.

She is known for her entrepreneurial skills in establishing and managing global operations and teams, having successfully led numerous large-scale projects and clinical study transitions across multiple geographies. Currently works as an independent consultant for pharma, CROs and technology companies in the area of data management and analytics leveraging automation, AI and ML concepts.

Jerald Schindler has over 30 years of experience in senior executive leadership roles developing drugs, biologics and devices for regulatory approval. During this time, he has been the global leader of Biostatistics, Programming, Data Management, and Clinical IT. He has led the teams involved in over 40 successful FDA advisory committee meetings and many successful regulatory submissions in the US and across the world.

Dr. Schindler was one of the early advocates of adaptive clinical trials and is still involved in developing novel ways to collect and analyze high quality data quickly and efficiently. He has led the design and development of innovative IT platforms to acquire, manage, analyze and report data which has greatly accelerated the approval of new drugs. He currently consults with various pharmaceutical companies on FDA interactions, protocol design and analysis, advisory committee preparations and IT technology. Previously, he was the Global Head of Late Development Statistics at Merck Research Laboratories, The Chief Biostatistician and Global Head of Biostatistics and Clinical Technology at Wyeth Research, and the Global Head of Enterprise Biostatistics at Medtronic.

Kenneth Kaitin is Professor of Medicine at Tufts University School of Medicine and Senior Fellow and Former Director of the Tufts Center for the Study of Drug Development. He is also an Advisory Professor at Shanghai Medical College at Fudan University in China, and he serves on the faculties of the European Center for Pharmaceutical Medicine at the University of Basel, the American Course on Drug Development and Regulatory Science at the University of California, San Francisco, and the GMDP Academy-Kings College London Medical Affairs in Medicines Development Certification Program. Dr. Kaitin is recognized internationally for his contributions to the field of drug development policy and science. He consults, speaks, and writes on global trends in pharmaceutical development, and has provided public testimony before the U.S. Congress. A former President of the Drug Information Association, Dr. Kaitin served as Editor-in-Chief of Expert Review of Clinical Pharmacology, and as a consultant to the U.S. Department of Defense on bioterror countermeasures.

In 2011, he received the Dr. Louis M. Sherwood Award, granted by the Academy of Pharmaceutical Physicians and Investigators; he was named Global Fellow in Medicines Development by the International Federation of Pharmaceutical Physicians in 2020; and he received the Distinguished Achievement Award from the Sino-American Pharmaceutical Professionals Association (SAPA) in 2021. Dr. Kaitin is a director on the boards of Curis, Inc. (NASDAQ: CRIS), Bio-Tree Systems, Inc., and QCDx LLC. He earned his BS from Cornell University and MS and PhD in pharmacology from the University of Rochester.

Jayasree brings 15 years of experience of using business intelligence and analytical tools to provide analytical solutions. At MaxisIT, Jayasree focuses on understanding key analytical challenges in pharmaceutical environment and works closely with key stakeholders across clinical operations. Jayasree has a knack for turning data into insights, and discovering signals, patterns, and trends across different functions. One of her main objectives is to provide end users with data-driven holistic views through the MaxisIT platform.

Rajesh is a PMP- and CSM-certified professional who brings over 15 years of experience implementing eClinical systems within the life sciences industry. His expertise includes pre-sales engineering, product advocacy, solution implementation, computer system validation (CSV), and end-user training. He frequently collaborates with account executives to develop strategic account plans, conduct client discovery, and deliver impactful presentations that showcase the technological and business value of MaxisIT.

Ankur brings over 20 years of experience in clinical strategy, advisory, consulting, and solutioning in SaaS and functional services. His expertise spans clinical data management, statistical programming, biostatistics, data standardization, clinical operations, and digital transformation for thousands of clinical trials. A life sciences veteran, Ankur advises customers on all aspects of clinical software and services. He joined MaxisIT in 2004.

Nicole, a strategic leader with over 17 years of experience in the clinical research industry, has consistently driven transformative revenue growth across diverse markets. Her expertise lies in building strong partnerships and steering corporate strategies that align with evolving industry needs. At MaxisIT, Nicole is excited to bring her insights and passion for collaboration to expand the reach of MaxisIT’s Clinical Data Analytics Platform, helping clients streamline trials and achieve their objectives.

Nicole recently led business development and marketing at SDC, where she pioneered growth initiatives and contributed to shaping the future of clinical trial technology. An experienced speaker, Nicole has presented at numerous industry conferences on tech-driven innovation in clinical research. She holds a BA from the University of Texas San Antonio and an MBA from Baylor University. Based in Virginia, Nicole enjoys golfing, exploring new destinations, and karaoke in her free time.

Over more than 20 years, Kuldeep has developed a proven track record in the life sciences industry across service delivery, IT project management, PMO, vendor management, strategic planning, and process improvements. As COO, Kuldeep provides leadership and strategic vision to MaxisIT. He manages operational, managerial, and administrative procedures, reporting structures, and operation controls for the company. He delivers effective communication and fosters growth among the executive team and all employees. His vital leadership role drives results, spurs growth, and increases the overall efficiency of the corporation.

Moulik Shah has been at the forefront of leveraging technology to transform pharmaceutical and life sciences clinical trials for over 20 years. A passionate healthcare technology entrepreneur Moulik’s dedication to improving clinical outcomes has fueled his vision of an integrated healthcare ecosystem based on effective use of data and analytics platforms.

Moulik has been instrumental in driving innovation and progress in the industry. Under his leadership, MaxisIT has become a leading provider of clinical data and analytics, driving real-world impact in the pharmaceutical and life sciences clinical trials.