The new branch of the CRO (contract research organisation), Medelis Europe aims to deliver a complete preclinical and clinical oncology drug development service offering that will help European, US and Asian sponsors bring anticancer drugs to both the US and European markets.
The firm’s preclinical offering will include programme design, management and execution, as well as electronic data capture (EDC), preclinical reviews and gap analysis to ensure alignment of the preclinical, regulatory and clinical teams.
For those compounds that pass through preclinical testing successfully, the company will offer a complete oncology clinical trial management and design service package, which includes strategic planning for regulatory approval from Phase I through to NDA (new drug applications).
The company pride’s itself on bringing its pharmaceutical customers clinical answers more quickly by finding the right patients for targeted therapeutic candidates and speed successful drugs to market.
"We are excited to take 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 Bob Bosserman, CEO of Medelis.
The company has focussed on oncology trials as they are usually longer and more complex than those targeting other diseases, giving Medelis a greater opportunity to differentiate itself form its competitors.
Additionally, even though cancer is the second leading cause of death recruitment and enrolment can be a challenge with less than 3 per cent of cancer patients enrolling in trials.
This has led the company to turn to internet-based patient recruitment to assist investigators find and enrol patients using a unique blend of electronic public relations and marketing programmes.
The new division will be led by Dr Deirdre Tessman, formerly of Tessman Technology and Ilex Pharmaceuticals and her appointment will reunite her with former colleagues on Medelis' Medical Advisory Board Dr Daniel Von Hoff, Dr Skip Burris, and Dr. Mace Rothenberg.
"Dr Tessman has a long-term relationship with Medelis, and… has an excellent track record and established reputation for founding and holding senior positions within both CROs and pharmaceutical companies,” said Bosserman.
“She is the clear choice to lead our firm's European office and will be a substantial asset for our US and European clients as well as for Medelis' continuing evolution as a worldwide leader in oncology drug development."