About

About

About Cato Research

Cato Research (CATO) is an international regulatory and clinical contract research organization (CRO) that has been delivering successful outcomes for its clients since 1988. Through highly qualified and experienced personnel located in offices across North America, Europe, Israel, and South Africa, supported by strategic alliances with selected regional CROs, CATO offers tried-and-trusted international coverage.

CATO has the advantage of integrated regulatory, clinical, and scientific expertise. We provide integrated services to pharmaceutical, biotechnology, and medical device companies. We specialize in complex development programs requiring innovative regulatory and clinical strategies, and we have experience implementing and conducting successful clinical trials and development programs.

Our highly talented and experienced international team offers services from preclinical through IND (or equivalent), clinical development, and marketing approval to Phase 4 postmarketing research. Our track record includes successes across many different health products, including drugs, biologics, vaccines, cell therapies (including stem cells), nutriceuticals, medical foods, devices, and diagnostics. In terms of diseases and indications, in more than 30 years of operation, CATO has been involved in a wide variety of projects with a dominant focus in oncology, neurology/CNS, and rare and orphan drug indications. This experience includes leadership of, and involvement in some of the most challenging and innovative products.

As a midsize CRO, Cato Research offers a complete range of services with personalized attention and flexibility. The relationships we create with our sponsors produce positive, tangible results.

 

Cato History

Allen-Cato-Lynda-Sutton
In 1988 Dr. Allen Cato and Lynda Sutton, cofounded Cato Research.

Dr. Allen Cato and Lynda Sutton founded Cato Research in 1988 as a contract research and development organization to help pharmaceutical and biotechnology companies design and execute successful development strategies. Cato Research provides sponsors with a cost-effective alternative to building an internal structure for research and development while contributing the highest quality scientific, medical, and regulatory expertise. From the beginning, Cato Research has been recognized for our knowledge of science and technology, as well as our ability to guide creative new products through the regulatory process. Cato Research has taken a controlled-growth approach, expanding its operations selectively across North America and in other selected international countries.

In 2018, Cato Research formed a strategic partnership with healthcare investors, JLL Partners and Water Street Healthcare Partners, to continue its successful growth and expansion.

With a unique footprint that encompasses regulatory, clinical, scientific and preclinical services, Cato is large enough to undertake substantial programs, but small enough for each client project to matter.

Mission and Quality Statements

Cato Research Mission Statement

The mission of Cato Research is to be the premier, scientifically and medically based, international, healthcare research and development service company, and to build value for our clients, partners, and their stakeholders.

Cato Research Quality Policy Statement

Cato Research is committed to providing quality services and products that consistently meet or exceed sponsor and regulatory requirements and expectations.

Cato Research Leadership

Allen Cato, M.D., Ph.D.
Cofounder

Biography

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 35 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
Cofounder and President

Biography

Ms. Sutton has more than 30 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

Biography

Dr. Cato has more than nineteen years of experience in the development of new drugs in the pharmaceutical industry, with particular expertise in the areas of drug metabolism and pharmacokinetics. Prior to joining Cato Research early in 2000, Dr. Cato was employed as a clinical pharmacokineticist for more than two years at Ligand Pharmaceuticals, and for four years at Abbott Laboratories. While in pharmacy school, Dr. Cato spent a year at Burroughs Wellcome where he worked as a member of the data management team on the development of Zidovudine. Dr. Cato has been involved in the conduct and analysis of both nonclinical and clinical drug disposition studies, and has been responsible for coordination of the development and validation of several bioanalytical methods. He has experience with both small molecules and large oligonucleotides, and has contributed to the Human Pharmacokinetics Sections of seven NDAs.

Dan Cato, M.S., M.B.A.
Managing Director, Cato Research Washington, Vice President, Project Operations

Biography

Mr. Daniel Cato joined Cato Research in 1990 and has extensive experience in project budgeting, project planning, corporate strategy, operations, facilities management, and administration.

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.

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

Biography

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.

Michael Cato, M.S., R.A.C.
Vice President, Quality Assurance

Biography

Mr. Cato serves as a Vice President of Quality Assurance at Cato Research. He helps guide the integration of the corporate strategies of Cato Research. He has nearly 20 years’ experience in research and management in the area of material sciences, 8 of which was at Michelin, where he was part of the senior management focusing on quality assurance. Mr. Cato obtained his M.S. from North Carolina State University in the Department of Textile Engineering, Chemistry, and Science and is regulatory affairs certified by the Regulatory Affairs Professionals Society.

Myron (Skip) B. Peterson, M.D., Ph.D., F.A.A.P.
Vice President, Medical Affairs

Biography

Dr. Peterson is currently senior clinical research physician and Vice President of Medical Affairs at Cato Research. He also manages our Boston office.

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.

Rainer Gerhard Schuckelt, Ph.D.
Managing Director, Central and Eastern Europe

Biography

Dr. Schuckelt has more than 20 years' experience in project design, clinical research, project coordination, and project management of multinational, multicenter Phase 2 through Phase 4 clinical trials. He has received extensive training regarding Good Clinical Practice guidelines and has been responsible for clinical trial monitoring of cardiovascular, pulmonary, central nervous system, psychiatric, and ophthalmological diseases. Dr. Schuckelt also has been actively involved in revising and reviewing standard operating procedures, has performed quality assurance functions, and has been responsible for training clinical research associates. In addition, he successfully completed a lead auditor course. Dr. Schuckelt has wide theoretical and practical knowledge in the pharmacology field and has worked as an adviser for drug development for pharmaceutical companies. Recently, Dr. Schuckelt has been responsible for clinical trial monitoring operations, including supervision and training of clinical research associates, project coordination, clinical research management, and the supervision of all company European activities.

Randal R. Lane, MBA, RAC
Vice President, Pharmaceutical Development, Managing Director of Cato Research San Diego

Biography

Mr. Lane serves as Vice President of the pharmaceutical development function at Cato Research and serves as managing director for Cato Research's San Diego office. Mr. Lane has more than 35 years' experience in the pharmaceutical, medical device and diagnostics areas. Before joining the Cato team, Mr. Lane served for 8 years as senior director of Manufacturing and Pharmaceutical Development for Maxim Pharmaceuticals, and before that he worked for Accumetrics, Pacific Pharmaceuticals, and for Lilly subsidiaries Pacific Biotech and Hybritech. Mr. Lane has certifications in Production and Inventory Control, Materials Management, and Regulatory Affairs. He has had responsibility for directing the pharmaceutical development and CMC activities for numerous products, including recombinant and natural proteins, peptides, DNA, stem cells, small molecules, oligonucleotides, radiopharmaceuticals, and devices in parenteral, oral, and topical dosage forms; CMC sections for global regulatory filings; defining and designing development plans for sponsors; helping sponsors complete all necessary activities to file successful regulatory documents and helping sponsors manufacture clinical trial material. Other areas of experience include planning and attending a variety of FDA meetings; conducting GMP and GLP audits; and overseeing the complete development programs of various products.

Thomas Soeder, M.A.S.
Chief Statistical Officer

Biography

Mr. Soeder is a biostatistician with more than 25 years’ experience in the pharmaceutical and biotechnology industries working for both large pharmaceutical companies and contract research organizations. He has experience with statistical aspects of clinical trials in a very broad range of therapeutic areas, and he has experience with marketing applications, including the primary responsibility for all statistical aspects of marketing applications. Mr. Soeder also has extensive experience with direct client interactions and participation in Food and Drug Administration meetings. He received SAS Certified Professional certification and has extensive experience using SAS for statistical analysis and for production of reports and graphics. In addition, Mr. Soeder has management experience including resource management, personnel supervision, and development and maintenance of operating procedures. He is a member of the steering committee for the local Research Triangle Park CDISC (Clinical Data Interchange Standards Consortium) User’s Group.

William T. Lee, Ph.D., R.A.C.
Vice President of Regulatory Affairs

Biography

Dr. Lee has more than 25 years’ research and industrial experience in gene therapy, cellular immunology, and therapeutic vaccines, including 11 years in regulatory affairs. He has experience in the writing of patents and in the design and execution of preclinical studies, and he currently participates in the preparation and submission of various INDs, NDAs, and FDA meeting packages. Dr. Lee has experience in pharmacogenetics and the therapeutic areas of infectious diseases and oncology. Dr. Lee is regulatory affairs certified by the Regulatory Affairs Professionals Society.

Accolades

With timely advice for over a decade, sponsor personally acknowledges
Cato Research for their significant involvement in their success.

“…Cato was instrumental

"…Cato was instrumental in helping us with site identification, site qualification, supporting our regulatory submissions and identification of quality vendors in support of trial logistics.




They supported us regarding the IVRS system, monitoring central labs and build of lab kits. The collaboration between Cato and [OUR COMPANY] was excellent."

- Global Healthcare Company

2017-11-22T15:49:15-05:00

- Global Healthcare Company

"…Cato was instrumental in helping us with site identification, site qualification, supporting our regulatory submissions and identification of quality vendors in support of trial logistics. They supported us regarding the IVRS system, monitoring central labs and build of lab kits. The collaboration between Cato and [OUR COMPANY] was excellent."

No Hesitation in Recommending CATO as a CRO that can Add Value to Any Project!

"We would like to thank CATO for the work achieved on the Phase 111 international study they managed on our behalf in the United States, Canada and Israel.

Their expertise and their valuable input in regulatory affairs allowed us to meet the timelines in these three countries.

As for monitoring, CATO's team did a great job in following up closely with the sites to get answers to multiple requests but also in being responsive to our demands.

We want to stress that the partnership spirit and the high degree of professionalism they demonstrated during this project was highly appreciated.

This is the reason why we are looking forward to continuing our collaboration for future studies.

Consequently we have no hesitation in recommending CATO as a CRO that can add value to any project."

- European International CRO

2019-08-20T14:05:41-04:00

- European International CRO

"We would like to thank CATO for the work achieved on the Phase 111 international study they managed on our behalf in the United States, Canada and Israel. Their expertise and their valuable input in regulatory affairs allowed us to meet the timelines in these three countries. As for monitoring, CATO's team did a great job in following up closely with the sites to get answers to multiple requests but also in being responsive to our demands. We want to stress that the partnership spirit and the high degree of professionalism they demonstrated during this project was highly appreciated. This is the reason why we are looking forward to continuing our collaboration for future studies. Consequently we have no hesitation in recommending CATO as a CRO that can add value to any project."

“…And a special thank you

"…And a special thank you to you and everyone at CATO.  You have been a very very valuable partner in this journey and we could not have gotten to where we are without you.  I deeply appreciate everything that you and your team at CATO have done for us and I look forward to continuing to have a strong relationship with CATO in the future as well.


Thank you again for all of your help.  We couldn't have done it without you!"

- Pharmaceutical Company Headquartered in Los Angeles, CA

2017-11-21T21:12:43-05:00

- Pharmaceutical Company Headquartered in Los Angeles, CA

"…And a special thank you to you and everyone at CATO.  You have been a very very valuable partner in this journey and we could not have gotten to where we are without you.  I deeply appreciate everything that you and your team at CATO have done for us and I look forward to continuing to have a strong relationship with CATO in the future as well. Thank you again for all of your help.  We couldn't have done it without you!"

Our CATO team has been really delivering for us.

Our CATO team has been really delivering for us. We have had a lot of Information Requests throughout the NDA review and have provided a number of submissions to CATO, very late in the day often at inopportune times, despite intensive planning from the moment of receipt. We do not wish to make a habit out of this and continue to strive to ensure there is fair and adequate time for everyone to do their job under reasonable circumstances. Our team has consistently delivered, and gone above and beyond over and over.

 

- North America Biopharmaceutical

2019-05-28T13:12:27-04:00

- North America Biopharmaceutical

Our CATO team has been really delivering for us. We have had a lot of Information Requests throughout the NDA review and have provided a number of submissions to CATO, very late in the day often at inopportune times, despite intensive planning from the moment of receipt. We do not wish to make a habit out of this and continue to strive to ensure there is fair and adequate time for everyone to do their job under reasonable circumstances. Our team has consistently delivered, and gone above and beyond over and over.  

“…We have no reservations

"...We have no reservations recommending CATO to other companies requiring assistance with the monitoring of all phases of clinical trials..."

- Global Pharma Co.

2017-11-22T15:48:10-05:00

- Global Pharma Co.

"...We have no reservations recommending CATO to other companies requiring assistance with the monitoring of all phases of clinical trials..."

“…Thanks to all of you!

"...Thanks to all of you!  You guys are terrific!  It's a real pleasure to work with you.  Thanks to all the efforts and professional work.  Looking forward for the next phase on this project!
Please find attached the APPROVAL letter for Product.  Please share in our excitement as you have been partners in this adventure!"

Global U.S. Biotechnology Company

2017-11-21T21:08:17-05:00

Global U.S. Biotechnology Company

"...Thanks to all of you!  You guys are terrific!  It's a real pleasure to work with you.  Thanks to all the efforts and professional work.  Looking forward for the next phase on this project! Please find attached the APPROVAL letter for Product.  Please share in our excitement as you have been partners in this adventure!"

“Dear Cato team,

Thank you so much for all your hard work which has resulted in our NDA being submitted one day earlier than our already extremely tight timeline.


All our partners were very surprised when we set such an ambitious timeline in April when we changed from a paper CR to an eCTD, and many have said they did not think we would make it.  But with your team spirit and hard work the impossible has been made possible."

-Specialty Pharmaceutical Company

2017-11-21T21:16:33-05:00

-Specialty Pharmaceutical Company

Thank you so much for all your hard work which has resulted in our NDA being submitted one day earlier than our already extremely tight timeline. All our partners were very surprised when we set such an ambitious timeline in April when we changed from a paper CR to an eCTD, and many have said they did not think we would make it.  But with your team spirit and hard work the impossible has been made possible."

“Thank you for your continued support and valuable contribution…

"We would like to share some good news with the Cato Team. Yesterday, we received FDA Breakthrough Therapy designation for our [ABC Drug].

On behalf of our company, we would like to thank you for your continued support and valuable contribution to the success of our regulatory submissions."

- Biotechnology Company Headquartered in Rockville, MD, USA

2017-11-22T15:53:33-05:00

- Biotechnology Company Headquartered in Rockville, MD, USA

"We would like to share some good news with the Cato Team. Yesterday, we received FDA Breakthrough Therapy designation for our [ABC Drug]. On behalf of our company, we would like to thank you for your continued support and valuable contribution to the success of our regulatory submissions."

“…Your firm consistently supported our company

"…Your firm consistently supported [OUR COMPANY] in its clinical research efforts that resulted in [OUR COMPANY] being the first and only Canadian company to ever obtain a FDA PMA approval for a therapeutic medical device.


We have no reservations in considering CATO as an important partner for our future clinical endeavors and recommending CATO to other companies."

- Canadian Medical Technology Co.

2017-11-22T15:46:09-05:00

- Canadian Medical Technology Co.

"…Your firm consistently supported [OUR COMPANY] in its clinical research efforts that resulted in [OUR COMPANY] being the first and only Canadian company to ever obtain a FDA PMA approval for a therapeutic medical device. We have no reservations in considering CATO as an important partner for our future clinical endeavors and recommending CATO to other companies."

Congratulations Team! Another Approval!

I would like to thank the Cato Research team for their contributions to this successful application including the advice, guidance and participation in the Type A meeting we had with the FDA last year after the CRL was issued.

I have shared the approval letter with the Executives.

- A Canadian Innovative Drug Company

2019-07-26T11:07:21-04:00

- A Canadian Innovative Drug Company

I would like to thank the Cato Research team for their contributions to this successful application including the advice, guidance and participation in the Type A meeting we had with the FDA last year after the CRL was issued. I have shared the approval letter with the Executives.