Cato Research has merged with SMS-oncology forming CATO SMS, a fully integrated global company, delivering innovative strategies and robust solutions based on over 30 years of background in regulatory insight, therapeutic experience, and operational expertise. 

Pharmaceutical

Cato Research

Sandy Ferber is a senior executive and entrepreneur with more than 20 years of clinical trial research experience in the biopharmaceutical industry. As president of the CATO SMS Biometrics team, Ferber has responsibility for data management, biostatistics, and statistical programming activities globally.

Her experience includes clinical development with pharmaceuticals, biologics, and medical devices, having served as the lead statistician on Phase I-IV clinical trials, patient registries, and multiple drug submissions leading to successful drug approvals.

Ferber serves as a key member of the client’s strategic drug development teams, providing solutions for complex study designs in standard and innovative regulatory paths. Prior to her current role, Ferber served as the founder and CEO of Array Biostatistics. In that role, she built and led a full-service biostatistical and statistical programming CRO committed to providing expert, adaptable, and dedicated services with a team of highly experienced biostatisticians and statistical programmers. Prior to founding Array Biostatistics, she worked at a global, full-service CRO, providing statistical expertise in clinical research.

Ferber obtained a Master of Science in Epidemiology and Biostatistics from [Case Western Reserve University](/org/case-western-reserve-university) after earning a Bachelor of Science in Cellular and Molecular Biology from the University of Michigan.

Sandy Ferber

Dr. Heschi Rotmensch serves as chief medical officer of CATO SMS. In this capacity, Rotmensch is responsible for the global medical affairs and pharmacovigilance departments.

Prior to his current role, Rotmensch served as senior vice president, drug development. In this capacity, he was responsible for ex-North America clinical trial operations at CATO Research Ltd. and oversaw the expansion of operations outside North America by applying his extensive clinical research experience in cardiovascular, neurology, and rare disease drug development. Prior to that he served as vice president, clinical research division Germany at Parexel International. Prior to joining the CRO industry, Rotmensch served as associate director of the division of clinical pharmacology at Merck Sharp & Dohme Research Laboratories and at the Jefferson Medical College in Philadelphia. Subsequently, Rotmensch was appointed chief of medicine at the Edith Wolfson Medical Center in Holon, Israel.

Rotmensch holds an M.D. degree from the Sackler Faculty of Medicine at the Tel-Aviv University and an MBA from the Kellogg-Recanati Faculty of Management. Rotmensch is board certified in internal medicine and clinical pharmacology and has published more than 90 research papers, including nine book chapters.

Heschi H. Rotmensch

David Godwin is a sales and marketing executive who currently serves as chief revenue officer at CATO SMS. In this capacity, Godwin is responsible for all business development and marketing activities.

Godwin has over 35 years of experience in healthcare and, more specifically, the clinical development industry. Prior to his current role, Godwin was at [Parexel](/org/parexel) International where he most recently served as the senior vice president of global business development and as a member of the executive committee. During his over-20-year tenure in business development at [Parexel](/org/parexel), Godwin built and led high performing global teams that consistently drove business growth and market expansion, including the successful launch of an informatics business, establishment of industry-leading sponsor partnerships, development of business across Asia, and the creation in 2010 of a business focused exclusively on small and emerging sponsor companies. Prior to [Parexel](/org/parexel), Godwin worked in several teaching hospitals where he held management positions, including department director in information management.

Godwin earned a B.S. in health information management from [Ithaca College](/org/ithaca-college) and an MBA from [Boston College](/org/boston-college).

David J. Godwin

Richard Shimota is a senior finance professional with more than 30 years of experience leading financial teams in professional services organizations spanning multiple industries. Shimota joined the organization in June 2019 as chief financial officer. In his current role, Shimota is responsible for leading the finance organization as well business technology.

Prior to joining the organization, Shimota served as the chief financial officer for inVentiv Health Clinical Solutions where he oversaw the integration of the organization and partnered with operations to build out the operating infrastructure and improve operational performance and consistency at scale, enabling the business to deliver above market growth and financial returns. inVentiv Health merged with INC Research in 2017 and became [Syneos Health](/org/syneos-health). Shimota served in a similar capacity for the next 16 months until he left the organization in December 2018.

Prior to joining inVentiv Health, Shimota served as a senior financial executive in numerous professional services companies, primarily focused on engineering and construction. Shimota began his career with Raytheon and spent time in appliance manufacturing and corporate audit.

Shimota holds a Bachelor of Business Administration as well as a Master of Business Administration, both from the [University of Wisconsin](/org/university-of-wisconsin-madison). Shimota is a certified public accountant.

Richard Shimota

Raymond Hoffmans is a senior executive with over 10 years of experience in clinical research. In his current capacity, he serves as head integration management officer of CATO SMS and is responsible for the integration of the legacy companies.

Prior to his current position, Hoffmans served as chief business development officer at SMS-oncology. As a member of the management team of one of the only CROs solely dedicated to oncology, he was instrumental in the continuous success and growth of SMS-oncology since 2014. In July 2019, Hoffmans also became the managing director of the German subsidiary company SMS-oncology GmbH, paving the way for international expansion and managing local clinical operations. Hoffmans started at SMS-oncology as a consultant of oncology drug development in January 2010 and led the consultancy group from October 2012 to February 2015 as director of consultancy. In these positions, he supported many clients by giving proficient advice and translating science into realistic and pragmatic clinical study designs.

Hoffmans was a postdoctoral research fellow at the Dana Farber Cancer Institute (Harvard Medical School) in Boston (2006–2009), as well as at the Hubrecht Institute in Utrecht, Netherlands (2009). Hoffmans holds a Ph.D. in natural science from the Molecular Biology Institute at the [University of Zurich](/org/university-of-zurich). He has authored multiple papers in renowned international peer-reviewed journals.

Raymond Hoffmans

Philine van den Tol is a senior executive and entrepreneur with over 20 years of experience in the life science industry. Van den Tol is president, clinical trial operations of CATO SMS. In her position, she is responsible for global clinical trial operations, including executive oversight, strategic planning and leadership, and day-to-day operations within new and ongoing clinical projects. In addition, van den Tol is managing director of CATO SMS’ Amsterdam office.

Preceding her current role, van den Tol served as chief executive officer of SMS-oncology, where she built and led one of the world’s leading boutique clinical research organizations solely dedicated to oncology. With her strong entrepreneurial sense and determination for excellence and client satisfaction, van den Tol was an essential lead in the rapid expansion of SMS-oncology, which resulted in the successful merger in the fall of 2019. Van den Tol built and led the company, focusing on growth, reputation, sales, and development of improved business processes and systems. Van den Tol previously served as chief operating officer, driving strong growth and high performance in the company’s largest business segment. Prior to SMS-oncology, van den Tol guided international breast cancer research at the Dutch Breast Cancer Research Group (BOOG) as clinical study manager. Van den Tol began her career in clinical research and oncology as central data manager at the Dutch Comprehensive Cancer Center West (CCC).

Van den Tol studied innovative business management at the University of Applied Sciences in Leiden, Netherlands. She also completed her training in safety, health and environment management education and served as staff physiotherapist at the Leiden University Medical Center.

Philine Van Den Tol

Kim Washburn has over 25 years of experience in the life sciences, clinical research, and regulatory compliance in academic, private, and government sectors. As VP quality for CATO SMS, Washburn is responsible for overseeing the company’s global quality strategy and policy/procedure development, as well as implementing and communicating the quality strategy throughout the organization.

Her background and experience in quality have been in the regulated science and clinical research arena. Previously, for 22 years, Washburn was a member of the Quintiles/IQVIA quality team as a senior quality leader focused on the design and implementation of quality assurance and compliance programs on a global level. She further developed capabilities within the organization to support overarching regulatory governance (e.g., GxPs, 21 CFR Part 11, Data Privacy) through leading of the vendor management assessment program, quality acquisitions and integrations, quality risk management, and systems compliance quality office. Washburn was formerly a research biologist with the National Institute of Environmental Health Sciences, a part of U.S. NIH, working in the areas of reproductive and developmental toxicology which included studies in steroid and peptide hormone action, endocrine disrupters, and environmental estrogens.

Washburn has a Bachelor of Arts degree in biology and environmental sciences from Hiram College in Hiram, Ohio. She also holds a paralegal certification and IAPP certification requirements for Certified Privacy Professional. She has authored/co-authored many scientific research publications.

Kim Washburn

Chris Brennan is a seasoned general counsel and business executive who has managed all facets of complex legal, compliance, human resources, regulatory, and government affairs matters, while serving as a valued member of executive management teams for the past 20 years.

After serving as an active duty officer in the United States Air Force for over five years during the Gulf War and then earning his law degree, Brennan practiced corporate law for five years at the two prominent and internationally recognized law firms of Cravath, Swaine & Moore LLP and [Dechert LLP](/org/dechert-llp). Brennan left private practice to launch a venture-capital-backed specialty pharmaceutical company as the second employee. Over the next five years, he served in many administrative and operational capacities, tending to all legal, compliance, human resources, quality, and manufacturing matters as the startup company grew to nearly 100 employees worldwide with a portfolio of over a dozen pharmaceutical products. Brennan went on to serve as a senior member of management as executive vice president, general counsel, and chief compliance officer within the CRO industry at PharmaNet, Bioclinica, and at the world’s largest vitamin, mineral, herbal, and supplement company, Nature’s Bounty. During this time, Brennan worked closely with various well-respected private equity firms, including [The Carlyle Group](/org/the-carlyle-group), [H.I.G. Capital](/org/h-i-g-capital-llc), [JLL Partners](/org/jll-partners), and [Water Street Healthcare Partners](/org/water-street-healthcare-partners).

After earning a Bachelor of Arts from [Fordham University](/org/fordham-university), Brennan went on to earn a Master of Science from [Syracuse University](/org/syracuse-university) and his Juris Doctorate from [Fordham University](/org/fordham-university) School of Law, where he held the top student position of Editor-in-Chief of the Fordham Law Review.

Christopher S. Brennan

Dr. Mark A. Goldberg is a senior life science executive and innovator. In his current role, he serves as executive chairman of CATO SMS. In this capacity, Goldberg is responsible for overall strategy and day-to-day operations of the business. He also serves as chairman of the board. Goldberg is an executive advisor to [Water Street Healthcare Partners](/org/water-street-healthcare-partners) in Chicago and one of the private equity owners of the company.

Prior to his current role, Goldberg served as president and chief operating officer at [Parexel](/org/parexel) International, where he led one of the world’s largest biopharmaceutical services companies. Goldberg was a key player on [Parexel](/org/parexel)’s executive management team for more than 20 years. He was instrumental in driving business results through the application of his combined medical, technical, and clinical research expertise. Goldberg previously served as president of Clinical Research Services, driving strong growth and performance in the company’s largest business segment. Previously, he served as president of Perceptive Informatics (now [Parexel](/org/parexel) Informatics), helping to build [Parexel](/org/parexel)’s leadership position in providing eClinical solutions that accelerate drug development. He also oversaw the geographic expansion of [Parexel](/org/parexel)’s clinical development capabilities, including the extension of capabilities in the Asia-Pacific region. Prior to [Parexel](/org/parexel), Goldberg served as president and director of WorldCare, Inc. (which he helped found), a telehealth spin-off from Massachusetts General Hospital (MGH).

Goldberg holds a degree in computer science and engineering from the Massachusetts Institute of Technology and an M.D. from the University of Massachusetts Medical School. He completed residency training in diagnostic radiology at MGH, where he served as chief resident, as well as staff radiologist. Gold

Mark A. Goldberg

Lynda Sutton is the chief regulatory officer for CATO SMS, currently serving as the FDA agent for multiple sponsors for IND and post-marketing products, including two with Breakthrough Therapy Designation. She oversees the preparation of regulatory submissions and ensures that regulatory requirements for the approval and launch of new products are satisfied.

Sutton has over 40 years of experience in the drug development industry. She has led teams from pre-IND to marketing approval for a variety of products including biologics, drugs, and drug/device combination products. Since cofounding CATO Research in 1988, 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. Sutton has provided interpretation, guidance, and advice on regulatory issues; facilitated regulatory interactions on behalf of sponsors; and assisted with the development of regulatory strategies. She has served as the primary regulatory contact for more than 100 sponsors over the last 32 years. As the regulatory agent, she is responsible for developing and coordinating meeting strategies, attending regulatory agency meetings, and serving as the moderator at these meetings. In addition, Sutton has cofounded nine other companies and participates as a member of the board of directors for several of these companies. She has special expertise in the development of biological products, including stem cell therapy, gene therapy, blood products, and vaccines, and in the development of oncology, infectious disease, and neuropharmacology agents.

Sutton’s education included achieving salutatorian of her high school and obtaining a leadership scholarship to Troy State University where she obtained a double major in biology and chemistry.

Lynda Sutton

Leslie DeVos has more than 35 years in the biopharmaceutical/healthcare industry, along with strong expertise in biotech product development.

Prior to joining CATO SMS, DeVos served as the global head of Parexel’s Regulatory and Compliance team for over 13 years, where she played a key role in establishing and leading a team of global health authority experts responsible for the successful development and launch of many new therapies. DeVos’ experience includes biotech, regulatory, and clinical operations, project management/LEAN Six Sigma in the areas of oncology and sepsis, and several orphan indications.

She holds a Bachelor of Science degree in Nursing from The Catholic University of America and a Master of Science in Nursing from the [University of Maryland](/org/university-of-maryland). Prior to her biopharmaceutical career, she served as an oncology clinical specialist and critical care nurse.

Leslie Devos

Cato Research's leadership team has experience in a variety of industries, including healthcare, consulting, and project management. They have also received education from a variety of institutions, including The Catholic University of America.

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