Medelis Expands Worldwide CRO Services with New European Division Led by Deirdre Tessman, Ph.D.
Medelis Europe offers complete oncology drug development services from preclinical through phase III
Phoenix AZ — October 7, 2008 — Medelis, Inc., a contract research organization providing complete oncology clinical trial design, management and execution, today announced the formation of Medelis Europe and the appointment of Deirdre Tessman, Ph.D. as its Managing Director.
Formerly of Tessman Technology Ltd. and ILEX Pharmaceuticals, Dr. Tessman brings more than 30 years of worldwide drug development and regulatory experience to the Medelis organization. She has directed all phases of pharmaceutical development from research through drug approval and marketing with additional expertise in the startup and turnaround of pharmaceutical companies.
"We are excited to make this significant step in expanding our geographical coverage and our service offerings to our worldwide clients who wish to bring their drugs to the European community for approval and sale," said Medelis CEO Bob Bosserman.
"Dr. Tessman has a long-term relationship with Medelis, and we're delighted to make it official," he continued. "Deirdre has an excellent track record and established reputation for founding and holding senior positions within both CROs and pharmaceutical companies. She is the clear choice to lead our firm's European office and will be a substantial asset for our U.S. and European clients as well as for Medelis' continuing evolution as a worldwide leader in oncology drug development."
Her appointment at Medelis reunites her with longstanding former colleagues Dr. Daniel Von Hoff, Dr. Skip Burris, and Dr. Mace Rothenberg, all members of Medelis' Medical Advisory Board.
CRO services in Europe
Medelis Europe delivers complete oncology drug development services from preclinical through phase III. European, U.S., and Asian sponsors looking to bring drugs to the U.S. & European markets can now take advantage of Medelis’ full service offering, which now includes EDC for phase I studies; internet-based patient recruitment; and integrated preclinical studies aligning the preclinical, regulatory and clinical teams.
The other components offered by Medelis Europe include:
- Oncology clinical trial management and design, including strategic plans for regulatory approval from Phase I through FDA and European marketing approvals
- Preclinical program design, management and execution
- Preclinical review and "gap analysis"
- Protocol development
- Site identification, qualification, management, contracting and payment
- Investigator identification and recruitment
- Project management and monitoring of clinical studies
- Medical monitoring and management
- Oncology patient recruitment and accrual
- Data management
- Biostatistics analysis and reporting
- Document preparation and production
- Quality assurance and regulatory compliance
- Medical writing
About Dr. Deirdre Tessman
As Managing Director, Dr. Tessman will bring her 10 years of experience managing European studies, an extensive understanding of European regulatory requirements and a deep familiarity with all phases of clinical development to Medelis clients who wish to complete the regulatory requirements of the European Community for their therapies and devices.
Dr. Deirdre Tessman has 30 years of experience leading technology and product development programs in the pharmaceutical, biopharmaceutical and CRO fields, and has spent the last ten years running European CROs. In 1997, she helped establish San Antonio-based ILEX Oncology, a developer of cancer drug treatments, and served as the company's Senior Vice President before moving on to run their European CRO, ILEX Services Limited. In 2001, she acquired the CRO business from ILEX and transformed it into Tessman Technology Ltd., a successful privately-held oncology CRO and clinical investigator network offering clinical monitoring services in both the U.S. and European communities.
Dr. Tessman also held the positions of Director, Worldwide Pharmaceutical Projects for Schering AG, where she led the company's first global project management team in obtaining EMEA approval of an oncology drug. She also held senior executive positions at Triton Biosciences and spent 20 years with Warner-Lambert/Parke-Davis.
Dr. Tessman has been named to the Top 100 Business Women in Scotland and received a Leukemia Society of America award for her contributions to the leukemia therapy field. She received a Doctor of Philosophy in Business Administration from California Coast University, an M.B.A. from the University of Michigan, and a Bachelor of Science from Margrove College.
To learn more about Medelis' services and our global capabilities, please visit our services page.
About Medelis, Inc.
Medelis, Inc. is an oncology contract research organization providing a total solution for biotechnology and pharmaceutical companies seeking rapid drug development and approval. Medelis' medical founders, team physicians and clinical trial management physicians, including Dan Von Hoff, James Gourzis and Michael Gordon, are internationally-recognized oncology thought and opinion leaders who understand the future of personalized medicine and threshold of credibility trials. Offerings include strategic plans for regulatory approval from phase I through final approval and complete oncology clinical trial design, management and execution.
Medelis is privately-held and located in Phoenix, Arizona with other U.S. locations in Nashville, Boston and Reno. Medelis Europe will initially be headquartered in Port Vendres, France.