Wednesday, July 23, 2014  
 
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Theradex
Theradex
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Management
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Management

Our Contact Information

Mailing ::
Theradex®
CN 5257
Princeton, NJ 08543

Courier ::
Theradex®
4365 Route 1 South
Princeton, NJ 08540

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Phone 609.799.7580
Fax 609.799.4148
Email: info@theradex.com

Our Management Team
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Robert Royds, M.B., B.S., M.R.C.P.

Medical Director and Chairman of the Board


Dr. Royds directs the scientific affairs of the company, drawing over 30 years of domestic and international experience both as an investigator and administrator in clinical research and development. A member of the Royal College of Physicians, he earned his medical degree in 1967 at the University of London. He trained in clinical pharmacology at St. Bartholomew’s Hospital where he then served as Chief Assistant to the Professor of Medicine and Senior Registrar of the Medical Professorial Unit. After entering industry, Dr. Royds expanded his expertise in clinical study design, management, monitoring, regulatory affairs, and product development as an executive with Merck, Sharp & Dohme Research Laboratories and Hoffman-LaRoche, Inc. Since 1979, Dr. Royds has served as a consultant in clinical research and development to both government and industry. Since 1982, he has been Principal Investigator for the Clinical Trials Monitoring Service (CTMS) for the National Cancer Institute.


Meg Valnoski, B.S.

President


Ms. Valnoski has served as President of Theradex® since 1994. As president, she is responsible for the management of operations at Theradex®. Ms. Valnoski oversees all business operations of the company and is responsible for the management of all existing contracts and projects in order to ensure the quality and continuity of services provided to clients. She also actively participates in the acquisition of new business. Ms. Valnoski has extensive experience in the regulatory development aspects of oncology drug products and bringing new agents into the clinical trial development phase, in addition to over twenty years of pharmaceutical industry experience in operations managements, project management, regulatory affairs, medical writing, and development of pre-clinical strategies for new drug products. She is also highly experienced in the development of new chemical and biologic products according to CMC requirements. As a result of her extensive experience in product development, Ms. Valnoski has worked closely with Dr. Royds and Dr. Ungerleider to successfully coordinate FDA negotiations for new drug products at pre-IND, end of Phase II, and pre-NDA meetings. She uses her expertise to provide global development services to our clients in conjunction with the regulatory staff of Theradex® Europe Ltd. She has been a member of the Theradex® team since 1988.


Richard S. Ungerleider, M.D.

Senior Vice President, Clinical Affairs


Dr. Ungerleider provides expert advice in the design and conduct of large-scale pivotal oncology studies as well as participating in developing the research plans for pilot and laboratory-translational trials. He provides scientific leadership and administrative direction to the senior project managers at Theradex®. Prior to joining Theradex® in 2001, Dr. Ungerleider had been Chief of the Clinical Investigations Branch at the NCI for over a decade in which role he was responsible for the Cooperative Group large-scale clinical trials. His career in the U.S. Public Health Service spans twenty-seven years, the last twenty-five of which were spent at the NCI. Dr. Ungerleider’s involvement in policy development to improve the conduct of clinical oncology trials provided him with extensive exposure to the scientific, regulatory, and industrial communities and familiarized him with the different interests of each.


Dr. Barry Anderson, M.D., Ph.D.

Vice President, Clinical Research Affairs


Prior to joining Theradex in 2007, Dr. Anderson was a Senior Investigator at the Clinical Investigations Branch of the NCI Cancer Therapy Evaluation Program for eight years. He worked closely with extramural NCI-supported investigators in the design, conduct and oversight of Phase I, II and III cancer clinical trials conducted by the NCI Cooperative Groups. He served on numerous Data Safety Monitoring Boards for national cancer trials and was a leader in the development of the NCI-supported Pediatric Central IRB. Dr. Anderson was also an assistant professor and clinical attending in the Division of Pediatric Hematology, Oncology and Stem Cell Transplant at the Lombardi Cancer Center of Georgetown University for five years prior to joining the NCI. His experience with clinical patient care and the design and implementation of large, multi-institutional cancer treatment studies has provided Dr. Anderson with significant exposure to the scientific, regulatory and clinical aspects of contemporary cancer clinical trial conduct.


Marie Moores, M.Sc., R.G.N.

Director, Clinical Operations , Europe


As Director, Clinical and Regulatory Operations, Ms. Moores oversees the Regulatory and Clinical Operations of Theradex® (Europe), drawing on her experience in the industry for over 13 years. She serves as a key liaison for multi-continental projects on behalf of Theradex® (Europe) and oversees general operations of Theradex® (Europe) in order to ensure that quality services are provided to clients. She is also actively involved in the acquisition of new business. Ms. Moores acts as Qualified Person for EudraVigilance in respect of safety reporting to the European Medicines Agency on behalf of clients.


12
Senior Management
Team Experience

The senior management team has an unmatched depth of experience with less than 5% turnover per year world-wide.

Over 100 man-years of experience in: Early Stage, Pre-Clinical, Registrational and Post-marketing Oncology Drug Development, Adult and Pediatric Care, Clinical Trial Design, Regulatory Submissions, FDA & Health Authority Defense.



Long-Standing
Regulatory Relationships

Theradex has formed long-standing relationships with FDA and other international Health Authority reviewers and personnel. Frequent contact with the health authorities allows Theradex to obtain quick and accurate answers to clients' regulatory questions.