Oncology Consultants to the Pharmaceutical Industry
Thistle Oncology is committed to the rapid development of new agents for solid tumors and hematologic malignancies. Formed from the team recognized for its successful approvals for alemtuzumab and clofarabine, Thistle consultants have participated in all phases of the development of more than one hundred small molecules and targeted agents entrusted to them by leading pharmaceutical companies around the globe. They understand the imperative for acceleration of the approval process while aware of the complexities of cancer drug development. Thistle consultants are available to provide guidance around the pitfalls inherit in protocol design, study conduct, government regulations, and post-marketing surveillance.
Thistle consultants have a broad range of experience with product in-licensing, intellectual property and business development of chemical, pharmaceutical and biotech compounds for large and small corporate entities. This includes the positions of Chief Patent Counsel in the biotech/pharma sphere.
Thistle consultants have numerous US-issued patents. Clofarabine was in-licensed under guidance by now Thistle consultants.
They have helped to marshal 5 NDAs, 3 BLAs, 3 ANDAs, 4 orphan drug designations, 20 INDs and a medical device through the FDA. They have participated in FDA Drug Advisory Committee meetings for the approval of new drug entities and have written numerous regulatory dossiers including INDs, NDAs, orphan drug designations, clinical protocols, Investigator Brochures, and serious adverse event reports.