Allen Cato, M.D., Ph.D.
Chief Executive Officer
As a cofounder of the company, Dr. Cato created and maintains the corporate vision. In addition, he directs sponsor interactions, and seeks business opportunities and strategic alliances with other companies and organizations. Dr. Cato serves as an advisor on project teams and develops complex strategic development plans and study designs. He maintains hands-on experience with all phases of the development process, and is especially skillful in devising regulatory and clinical strategies and representing sponsors at regulatory meetings.
Dr. Cato has more than 30 years of experience in clinical research and new drug development. He has directed or participated in the development of more than 100 INDs and NDAs. Dr. Cato's areas of expertise include the following: clinical pharmacokinetics, biostatistics, drug surveillance, pharmacoepidemiology, adverse drug reactions, clinical study design, regulatory interactions, pulmonary and pediatric medicine, and clinical research and development. Dr. Cato has published hundreds of papers, principally in the fields of clinical pharmaceutical research, cystic fibrosis, gene therapy and global drug development. He serves as a member of the board of directors for several pharmaceutical and biotechnology companies.
Lynda Sutton, B.S.
President and Chief Regulatory Officer
Ms. Sutton has more than 20 years of experience in the drug development industry, specializing in the development of regulatory strategies for drugs and biologics. She has coordinated activities in various disciplines (e.g., toxicology, pharmacology, pharmacokinetics, analytical and pharmaceutical development, and clinical research). Ms. Sutton has been involved in the development of new clinical entities; has overseen the preparation of FDA pre-meeting submissions; and has ensured that regulatory requirements necessary for the approval and launch of new products have been satisfied.
Since cofounding Cato Research in 1988, Ms. Sutton has served as project leader or project advisor on numerous project teams. In this capacity, she has been responsible for the strategic planning of full development programs for both drugs and biologics in a variety of therapeutic areas. In her current position, Ms. Sutton provides interpretation, guidance, and advice on regulatory issues; oversees the preparation of regulatory submissions; reviews documents that will be submitted to regulatory agencies; initiates and facilitates FDA interactions on behalf of sponsors; and assists with the development of regulatory strategies. She has served as the primary regulatory contact for more than 100 sponsors over the last 10 years. As the primary regulatory contact at Cato Research, she develops and coordinates strategies for regulatory agency meetings, and serves as the moderator at these meetings.
In addition, Ms. Sutton has cofounded several small biotechnology companies and serves as a member of the board of directors for several companies. She has expertise in the development of biological products, with emphasis on gene therapy and blood products, and in the development of oncological, anti-infective, and neuropharmacological products.
Allen (Jo) Cato, Ph.D.
Chief Operating Officer and Managing Director, Cato Research San Diego, San Francisco, Canada, and South Africa
Daniel Pharand, C.P.A., C.A.
Chief Financial Officer
Mr. Pharand is a Chartered accountant with over 25 years of experience in the pharmaceutical, biotech and life sciences industries where he has a proven track record as a portfolio manager. Mr Pharand was the Chief Financial Officer of Pharmacia Canada and of Pharmacia KK (Japan). He subsequently became an entrepreneur with a successful Canadian distribution company of innovative pedicular screws systems in orthopaedic therapies. Mr Pharand later was involved in the Biotech Venture with Innovatech Grand Montreal over his 5 years as Portfolio Manager. Mr Pharand is presently Chief Financial Officer at Cato Research.
Mr. Pharand has also acted as a director and has served on various board committees for more than 30 publicly traded or life sciences corporations including Corautus Genetics Inc. (NASDAQ : VEGF), Bio 1 Inc. (now TSX-V : ARU) and LAB International Inc. (TSX : LAB). Mr. Pharand is also a director of Mistral Pharma Inc. (TSX-V: MPI).
Linda Markus Daniels, J.D.
Vice President Corporate Development and Chief Legal Officer
Ms. Daniels has been working with technology-based companies for over 25 years, having co-founded of the first resident law firm in Research Triangle Park, North Carolina. During her years in private practice she concentrated her practice in the representation of entrepreneurial, technology-based and international businesses, and their investors. In this practice she is called upon to work on such matters as mergers and acquisitions, venture capital and securities transactions, the licensing, distribution and protection of intellectual property, tax problems and various international issues. Ms. Daniels received her undergraduate degree in public policy, with honors, from Duke University and then received a M.A. with distinction in International Economics from the Johns Hopkins School of Advanced International Studies.
After working as an international and regulatory economic analyst for three years, she returned to Duke University School of Law where she earned a J.D. and served as an editor of the Duke Law Journal. She has served as an officer and director of the North Carolina Technology Association, a director of the Council for Entrepreneurial Development, and Chairman of the 2008 and 2006 Venture Conferences, the 2004 and 2002 InfoTech Conferences, and the 2000 and 1994 Conferences on Entrepreneurship. Ms. Daniels has received the North Carolina Technology Association Top IT Support Service Provider award, Triangle Business Journal’s top “Women in Business” award, and Business Leader’s “Woman Extraordinaire” award, “Financial Impact Leader” award and “Legal Elite” award. She was selected to represent the lawyers of North Carolina on the bar exchange missions to Taiwan and Argentina. She is also a member of the Section Council for the International Section of the North Carolina Bar Association and a founding member of the first North Carolina chapter of the national Women President’s Organization.
Heschi H. Rotmensch, M.D., F.A.C.C., F.A.C.P.
Chief of Project Operations
Senior Vice President, Drug Development and Managing Director, Cato Research Europe and Israel
Dr. Rotmensch manages the operations of Cato Research Israel and promotes the numerous advantages of conducting clinical trials in Israel and Europe. He provides medical and scientific guidance for project-related tasks, including development of study protocols and final study reports, as well as medical monitoring.
Dr. Rotmensch is board certified in Internal Medicine and Clinical Pharmacology and served as Chief of Medicine at Edith Wolfson Medical Center in Holon, Israel. Academic appointments include Assistant Professor of Medicine and Pharmacology at the Jefferson Medical College in Philadelphia and Senior Lecturer in Internal Medicine at Sackler Faculty of Medicine, Tel Aviv University. He has more than 90 scientific publications including nine book chapters.
Dr. Rotmensch is a Fellow of the American College of Cardiology, a Fellow of the American College of Physicians, and a graduate of the E.M.B.A. Program at the Kellogg-Recanati Faculty of Management. He has more than 18 years of experience in all aspects of pharmaceutical development, including 10 years of research experience in Israeli institutions.
As Associate Director of the Clinical Pharmacology Unit at the Thomas Jefferson University Hospital in Philadelphia, he has designed and directed clinical research for Merck Sharp & Dohme Research Laboratories and numerous other sponsors.
Prior to joining Cato Research, Dr. Rotmensch served as Vice President of Clinical Research Germany for Parexel International.
Julie (Jules) Szabo Schotzinger, M.S.
Vice President, Global Clinical Trial Operations
As the Vice President of Global Clinical Trial Operations, Jules Szabo Schotzinger manages the division of Cato Research responsible for planning and executing global and domestic clinical trials. Ms. Schotzinger has worked in the CRO and biotechnology sectors of the pharmaceutical industry for 30+ years and specializes in project management, clinical trial operations, trial management best practices, clinical monitoring, and clinical operations department leadership. As a former Director of Clinical Operations for two emerging biotechnology companies, Ms Schotzinger served as the Study Director for various international clinical trials in which her teams selected and oversaw the performance of numerous CROs. Ms. Schotzinger’s sponsor experience is complemented by her employment for nearly 20 years in the CRO industry where she has held numerous positions of increasing responsibility. With a Master of Science in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy, Ms. Schotzinger provides both technical and practical operational leadership to CRAs, Clinical Study Managers, Project Managers, and other trial operations specialists. She is a guest faculty member in drug development and clinical research graduate courses at both Campbell University and UNC-Chapel Hill.
James F. Cahill, M.S., Ph.D.
Vice President, Biopharmaceutical Sciences
Dan Cato, M.S., M.B.A.
Managing Director, Cato Research Washington, Vice President, Project Operations
He received his MBA from Duke's Fuqua school of business with a concentration in health sector management. Mr. Cato also serves on the Board of Directors for Cato Holding Company, Cato Research Ltd., and RTP Federal Credit Union. At RTP Federal Credit Union Mr. Cato is Secretary/Treasurer and a member of the Asset Liability and Charge-off committee.
Myron (Skip) B. Peterson, M.D., Ph.D., F.A.A.P.
Managing Director, Cato Research Boston, Vice President, Medical
Dr. Peterson is currently senior clinical research physician and Director of Medical Affairs at Cato Research.
He joined Cato Research in 1998. He received his medical degree at the University of Colorado, magna cum laude, and served as an intern and resident at Children's Hospital Boston. Fellowship training was completed at Children's Hospital Boston in Pulmonary Medicine, at Massachusetts General Hospital in Anesthesia, and at Peter Bent Brigham Hospital in Cardiovascular Medicine. He has been a National Institutes of Health Special Research Fellow (Heart), a Fellow of the Johnson and Johnson Institute, and an Established Investigator of the American Heart Association.
Dr. Peterson served on the faculties at Harvard Medical School, Duke University, and Tufts University School of Medicine. He was Division Chief of the Pediatric Critical Care Services at Tufts University School of Medicine for 12 years. His peers elected him to the American Pediatric Society in 1992 and Best Doctors in America in 1997.
He has extensive research experience, in both basic and clinical sciences, and has conducted seminal research in mechanisms of congestive heart failure (myosin active site alterations, protein synthesis and structure, and metabolism), mechanisms of pulmonary hypertension (prostaglandins/leukotrienes, acute lung injury, ARDS, congenital heart disease) and mechanisms of injury during cardiopulmonary bypass.
Dr. Peterson has conducted pre-clinical and clinical trials in acute lung injury, cardiac and liver transplantation, septic shock, trauma, and re-perfusion injury. Also, the evaluation of different types of monitoring devices and ventilators used in critical care, including artificial membrane oxygenators. He has extensive experience in critical care transport (aeromedical and ground), and integrated emergency medical systems. He is board certified by the American Board of Pediatrics in pediatrics and pediatric critical care medicine.
He has served in numerous consulting positions with pharmaceutical companies, and health care organizations such as Blue Cross of Massachusetts, Prudential Insurance, and Centers for Disease Control. He has been Vice President of DeltaBiotech Inc. since 1982.
Dr. Peterson is experienced in management ranging from strategic planning to organizational development, budgeting, facilities planning and construction, staffing, marketing, contracts to licensing, and regulatory compliance, with considerable business/computer systems development and implementation background.
Julie Bédard, M.Sc., C.C.R.A.
Director, Clinical Research Management
Ms. Bédard is a trained nutritionist with more than 10 years' clinical research-related experience. Since joining Cato Research, she has gained experience in all levels (Phases 1 through 4) of clinical project activities, and she has monitored American and Canadian drug and medical device studies to ensure they were conducted according to Good Clinical Practices and applicable regulations. Ms. Bédard is a certified clinical research associate by the Association of Clinical Research Professionals. As a program director, she is currently responsible for investigational device programs comprising several U.S. and Canadian multicenter clinical trials in cardiology and vascular disease, cartilage repair, dermatology, and neurology.
In her global position with Cato Research, Ms. Bédard is responsible for overseeing the activities of the Clinical Trial Operations group in Canada, which includes all aspects of personnel management, budget preparation, and long-range planning, and she ensures the continuity and quality of services and deliverables provided by the group across all Cato Research locations.
Ms. Bédard has experience in clinical studies in nutrition, pulmonary and respiratory disorders (asthma, bronchitis/pneumonia), dermatology (diabetes foot ulcers, mycosis fungoides), cardiology and vascular disease (hypertension, arrhythmia, angina, peripheral vascular disease, coronary vascular disease, lipid disorders), neurology (migraine, aneurysm, chronic pain, gait disorder), articular cartilage damage (cartilage repair and pain), and infectious disease (HIV, hepatitis C). She also has experience with studies using electronic data capture.
As managing director of the Canadian office of Cato Research, Ms. Bédard is responsible for ensuring that the Canadian office operates in compliance with all applicable laws, regulations, and internal policies, and she oversees all facility management and administrative operational areas.
Trisha L. Whelan, S.P.H.R., B.A.
Senior Director, Human Resources
Ms. Whelan is a certified Senior Professional in Human Resources with 20 years of comprehensive experience in the biotechnology industry. She serves as a strategic partner with global managers to recruit a high-quality staff and maximize each employee's abilities across all locations. Ms. Whelan is skilled in the development of a corporate culture that maximizes the potential of all employees, both professionally and personally. She oversees and conducts leadership training sessions of managers, and she has facilitated programs of mentoring within the organization.
Ms. Whelan continually investigates opportunities to enhance the company's work environment and expand the corporate benefits package by using her knowledge and experience, as well as her own creative ideas. Ms. Whelan represents the management of the organization as an advisor to the company's many voluntary committees. These committees design innovative ways to provide employees of Cato Research the ability to balance work/life issues.
Ms. Whelan has also been serving on the Board of the Duke School of Nursing, since September 2007. Ms. Whelan's experience in the Human Resources field brings value both to employees and to the company.