Management Team

An influential biostatistical thought leader, Cyrus Mehta has concentrated his research on developing innovative methods and software for flexible clinical trial designs and non-parametric exact statistics.

Dr. Mehta has been a chief contributor to Cytel's development of permutational algorithms which can be applied to categorical data analysis, nonparametric tests, power and sample size calculations, the analysis of contingency tables and, more generally, to inference concerning the parameters of regression models for categorical data. The same algorithms have made it computationally feasible to obtain accurate p-values, confidence intervals and sample-size designs for small or unbalanced data sets and for sparse contingency tables. These innovations have revolutionized general statistics practices.

His more recent research centers on adaptive and group sequential clinical trial methods, and advanced trial design tools. Dr. Mehta is chiefly responsible for developing Cytel's East® system, the most widely used software for designing and simulating clinical trials. He regularly provides trial design training at major biopharmaceutical companies, universities and government agencies, including the FDA.

Dr. Mehta has published over 75 papers in journals including JASA, Biometrics, Biometrika, Circulation, Good Clinical Practice and Statistics in Medicine. He and co-authors, Dr. Nitin Patel and Dr. Karim Hirji received the 1987 George W. Snedecor Award from the American Statistical Association.

Dr. Mehta is an elected a Fellow of the American Statistical Association and was named the Mosteller Statistician of the Year by the Massachusetts Chapter of the American Statistical Association. Dr. Mehta has been a member of the faculty in the Department of Biostatistics, Harvard School of Public Health since 1979. Previously he taught at the University of Pittsburgh. Dr. Mehta holds degrees from the Indian Institute of Technology, The Massachusetts Institute of Technology, and the Harvard School of Public Health.

Nitin Patel is a recognized expert on the development of fast and accurate computer algorithms to implement computationally intensive statistical methods. At Cytel, Dr. Patel has played a leading role in the development of StatXact® and LogXact® widely used pioneering software for exact nonparametric inference, as well as XLMiner® data mining software for Excel.

Dr. Patel is more recently engaged in developing the statistical and computational methods innovations behind the new clinical trial simulations tools now in use at major pharmaceutical companies. These advances have resulted in improved planning of clinical studies, especially through accurate medicine supply prediction and the dynamic patient randomization technologies required for complex, adaptive trials.

He has published over sixty-five refereed papers in the areas of statistics, operations research and computing and co-authored a book on data mining for end-users. Along with co-authors Dr. Cyrus Mehta and Dr. Karim Hirji, he received the 1987 George W. Snedecor Award from the American Statistical Association. Dr. Patel is a Fellow of the American Statistical Association

Dr. Patel has been a visiting professor at MIT since 1995. Previously, he was CMC chair professor at the Indian Institute of Management, Ahmedabad, and held visiting positions at Harvard, the University of Michigan, the University of Montreal and the University of Pittsburgh. He won India's Vikram Sarabhai Medal for systems analysis research in 1985. He has served as President of the Operations Research Society of India, and as Vice President of the International Federation of Operational Research Societies. He was a co-founder of Tata Consultancy Services, a leading Indian software company and is a Fellow of the Computer Society of India. Dr. Patel co-founded Cytel Software with Dr. Cyrus Mehta in 1987. He holds a Ph.D. degree in Operations Research from MIT.

Ranganath Nayak is the Chief Executive Officer of Cytel. Earlier, he was Vice President of The Boston Consulting Group, where he did extensive work in India, as well as working with US clients such as Gillette and Ford Motor Company. For two decades before that, he worked at Arthur D. Little, Inc., the technology and management consulting firm, where his consulting had a particular focus on innovation, new product development, and organizational learning. He also oversaw the Arthur D. Little School of Management.

Nayak is the co-author of Product Juggernauts: How Companies Mobilize to Generate a Stream of Market Winners, a Harvard Business School book on managing product development, and principal author of Breakthroughs!, a best selling study of hugely successful commercial innovations such as Tagamet, the microwave oven, Federal Express, the videocassette recorder, the Compact Disc, Post It notes, the CAT scanner, and the Toyota production system.

He received a PhD from the Massachusetts Institute of Technology.

John Hallinan’s fiscal experience in the life sciences and software industries reflect positions of increasing responsibility across a broad range of strategic and operational disciplines. Hallinan’s background encompasses venture financings, corporate development, technology licensing, and mergers and acquisitions.

Before joining Cytel, Hallinan most recently served as Chief Financial Officer at Signet Laboratories, a leading supplier of diagnostic assays to the pharmaceutical and biotech industries. Prior to Signet, Hallinan was interim CFO at Cambium Learning, a private equity-backed publishing company that completed two acquisitions during Hallinan’s tenure.

Hallinan was the Chief Financial Officer of AnVil, Inc. a venture-funded silico drug discovery company, where he also led the company’s business development efforts in the healthcare market. At CambridgeSoft Corporation, Hallinan rose to CFO of that leading pharma/bio applications and enterprise solutions supplier. As Animation Technologies’ CFO, Hallinan guided the company’s first and second rounds of venture funding.

He is active within the Massachusetts Biotechnology Council, currently serving on the Economic Development Advisory Group, and as co-chair of the Finance Committee and Entrepreneurs University.

Mr. Hallinan holds a BBA from St. Bonaventure University, is a certified public accountant, and a member of the MIT Venture Mentoring Service.

Steve Herbert has helped build some of the most successful companies yet to emerge from the life science and information technology sectors, in areas as important as molecular modeling, combinatorial chemistry, bioinformatics and statistics. These include Pharmacopeia, Accelrys and OmniViz.

Herbert was the president and CEO of OmniViz, a bioinformatics company, selling product to the pharmaceutical and healthcare markets. He raised funding and guided OmniViz to $5m in sales.

Prior to that, under his sales and marketing leadership, Accelrys became the industry's fastest growing and most prominent supplier of molecular modeling software. At combinatorial chemistry company Pharmacopeia, he led their sales with uninterrupted growth through several acquisitions.

Steve Herbert is a graduate of York University and Harvard University's Extension School.

Clinical research and business development executive Irving Dark heads Cytel’s cutting-edge clinical trial design and global implementation services. Mr. Dark brings to Cytel 18-years of management experience guiding drug, biologic and medical device products successfully through the development process, along with a record for growing commercial clinical research organizations.

Just prior to joining Cytel, Irving Dark was Vice President, Business Development and Operations for Veristat, Inc. There he established and oversaw the company’s Data Management, Project Management, and Business Development departments. He was also integral to Veristat’s Corporate Compliance activities ensuring adherence to regulatory and GCP guidelines key to Veristat’s oncology, influenza, and smallpox vaccine program successes.

Before Veristat, Mr. Dark held key positions at full-service trial leader PAREXEL managing phase 1 - 3 clinical trials in the US, South America, Europe and Asia. Irving began his career at Women & Infants’ hospital in Providence, RI, being responsible for pediatric research data management and statistical programming including: Gestational Diabetes, Neonatal Intensive Care, Audiology Clinic, and with Brown University’s Sleep Research Lab.

Mr. Dark is experienced in statistical programming, electronic data capture, international project management, accumulating an in-depth clinical development knowledge. He is the co-author of numerous published clinical studies and a recent DIA invited speaker. Mr. Dark received an Economics, BA in 1991 from the University of Rhode Island.

As Vice President of Research & Development, Dr. Pralay Senchaudhuri has shared responsibility for managing the software development of Cytel Inc., in both the USA and India offices. Dr. Senchaudhuri also manages Cytel’s research projects funded by the National Institute of Health. The NIH SBIR grants are a source of much of the company's leading-edge applications development.

Dr. Senchaudhuri is an expert in the field of computational statistics and is especially adept at converting new algorithmic concepts into computer code. He leads Cytel’s continuing statistical computation research and has co-authored publications in the field.

Pralay manages the statistical methodology and implementation development of Cytel software products, beginning with the popular StatXact® and LogXact® lines. More recent responsibilities include guiding the statistical development of SiZ® and the underlying Architecture™ computation and interface environment.

Before joining Cytel, Dr. Senchaudhuri worked at the Indian Institute of Management, Ahmedabad, and the Indian Space Research Organization. Dr. Senchaudhuri earned his Ph.D. in Biostatistics from Harvard University and holds an MS from the University of Calcutta.

Judith Quinlan began her career as a statistician in agriculture in Australia, before joining the UK-based pharmaceutical industry leader GlaxoSmithKline. While at GSK, Judith was director of Statistics for Neurology and GI in the UK, later moving to the US as Director of Statistics for Biopharmaceuticals. Throughout her GSK tenure, Judith actively promoted the use of adaptive designs, and other new statistical approaches, to improve clinical development. Following 10 years with GSK, Judith joined Cytel as Vice President, Adaptive Clinical Trials.

Judith heads Cytel's adaptive study consultancy business, responding to the rapidly increasing demand for better clinical approaches from pharmaceutical, biotechnology and medical device companies.

An active member of the PhRMA Adaptive Design Working Group (ADWG), Judith chairs the Adaptive Trial Case Study work stream. Judith is an often-invited speaker, well regarded for her innovative trial planning and implementation insights by statisticians, biopharmaceutical management and regulatory officials alike.

Judith attended Flinders University (South Australia) and Murdoch University (Western Australia) and has a MSc (UK equivalent).

Ajay Sathe is Chief Executive Officer of Cytel's subsidiary in Pune, India, and is responsible for Cytel software development and analytics services delivered out of Pune. His management experience includes applications development, product management and the supervision of outsourced analytic services.

Prior to joining Cytel Inc., Sathe was Founder and Technical Director at Spectrum Business Support Ltd., where he led teams building both WordMiner, an information retrieval library, and Jurix, a law information service.

Ajay Sathe studied Electronics Engineering at Banaras Hindu University, India, and received an MBA from The Indian Institute of Management, Ahmedabad.