- August 22, 2024
CHARLOTTE, N.C.; Aug. 22, 2024 (Business Wire) – Catawba Research , dedicated to becoming the world’s most trusted Contract Research Organization, announced the expansion of its Scientific Advisory Board (SAB) today with the appointments of Mary Spellman , M.D., and Cornelis (Cees) Wortel , Ph.D . Spellman, a board-certified dermatologist, has worked closely with the FDA to develop clinical endpoints for novel indications and serves on the editorial board of the Journal of the American Academy of Dermatology . Wortel, a seasoned executive and founder of Clinquest, served as clinical team leader for the development of Remicade and brings extensive expertise in immunology and autoimmune diseases.
These new appointments add further value to Catawba Research’s unparalleled customer-centric support model and expertise in dermatology and immunology — pivotal fields in the development of many cutting-edge therapies today. This enhanced expertise enables customers to better navigate the complexities of clinical trials with greater confidence, ultimately accelerating the path to market.
“The addition of Spellman and Wortel to our SAB is a testament to our dedication to scientific excellence and innovation and will be invaluable in supporting the development of groundbreaking therapies. As we celebrate our company’s 10 th anniversary, we continue to strengthen our position as the top choice for companies seeking a CRO with deep, specialized knowledge in these rapidly expanding areas of clinical development,” said Jack McLane , Ph.D. , Chief Scientific Officer and chair of the SAB at Catawba Research.
Spellman and Wortel are the most recent additions to Catawba Research’s team of scientific and regulatory advisors who support sponsors across a multitude of therapeutic areas and provide clinical development and regulatory strategy across North America, Europe and Asia.
With these new thought leaders on board, Catawba Research has further set itself apart as the CRO that understands the complexities of drug development and possesses the specialized knowledge to drive success in the most challenging indications. Our commitment to excellence, coupled with the unique insights of our expanded advisory board, makes Catawba Research the definitive choice for companies seeking to achieve extraordinary outcomes in their clinical trials.
Meet our new SAB members
Mary Spellman, M.D., is a board-certified dermatologist with over 30 years of experience in biopharmaceutical development. Her focus has been on inflammatory and infectious diseases, acne vulgaris, rare genetic skin conditions and cutaneous carcinomas. Her clinical oversight includes NDAs for topical corticosteroids, antifungals, antibiotics, retinoids, the PDE4 inhibitor crisaborole and systemic agents for dermatologic and oncologic indications. She has also collaborated with the FDA to develop and validate clinical endpoints for novel indications.
Mary has held senior leadership roles at Castle Creek Biosciences, Menlo Therapeutics, Revance Therapeutics, Biogen Idec, Connetics Corporation and Novartis, providing clinical leadership for numerous global regulatory submissions. She has served on the Board of Directors and as President of Dermatologists in Industry, on the Board of Directors for Women’s Dermatology Society and as associate editor for the Journal of the American Academy of Dermatology. Mary earned her M.D. from the Medical College of Wisconsin and is a diplomate of the American Board of Dermatology and a fellow of the American Academy of Dermatology.
Cees Wortel , Ph .D., is a senior executive with over 25 years of experience and has a proven track record in the design and impleme ntation of clinical development plans and regulatory strategy. His expertise spans a wide range of indications with a focus on autoimmune and immun o -oncology indications . After earning his M.D. and Ph.D. in immunology re search at the University of Amsterdam, he joined Centocor as a clinical team leader for the development of Remicade . He m ost recently served as Chief Medical Officer at Bingli and has held senior consulting leadership roles at Critical Therapeutics, Aegerion Pharmaceuticals, Galapagos and Molecular Partners AG.
Cees is a venture partner at Vesalius Biocapital III , has chaired and presented at regulatory agency meetings in both the U nited S tates and E urope and has extensive experience in digital health, data science, real-world data and AI/ML .
About Catawba Research Catawba Research is a full-service contract research organization (CRO) providing clinical management expertise and services. Our executive leadership team has over 160 years of experience and is comprised of industry professionals from large global pharmaceutical, small- and medium-sized biotechnology, global full-service CRO, and eClinical technology backgrounds. Our cross functional team of clinical trial professionals have successfully supported 800 + clinical trials across their careers and s ince 2014, our work has delivered 33 regulatory agency approvals. As an international service provider, we have headquarters in North Carolina, USA and Mumbai, India. Our service offering also includes a Site Management Organization (SMO) based in Texas, USA. For more information, please visit www.catawbaresearch.com .