About Translational Drug Development (TD2)
Translational Drug Development (TD2) is a world-class drug development organization specializing in getting the newest and best oncology treatments to cancer patients as quickly as possible.
To focus cutting-edge science into translational solutions. Driven by science and motivated by patients, TD2 strives to make a significant impact on cancer.+
World class preclinical, regulatory and clinical science aligned with unique patient identification and recruitment solutions and the ability to execute with urgency.+
“Development of new medicines requires both the best possible preclinical and clinical science. It also demands working with a great sense of urgency. The TD2 team provides innovative solutions that give new medicines the best chance to work for patients with cancer. With expert capabilities that support early discovery, pharmacokinetics, regulatory affairs and clinical development through Phase II, TD2 represents a comprehensive solution for oncology-focused companies.”
Daniel D. Von Hoff, MD, FACP, Chief Development Officer - TD2
“TD2 has a rich scientific heritage and has successfully identified, translated and applied -omics driven outcomes to speed the development of new oncology medicines, and to identify those cancer patients most likely to have clinical benefit from these new drugs.”
Jeffrey Trent, PhD, FACMG, President and Research Director - Translational Genomics Research Institute (TGen)
IND Categories There are two categories for INDs: commercial and research. The main difference is who submits the application to FDA and the intended purpose of their clinical research. The FDA publishes guidelines to help ensure you submit a...
Types of IND Applications A potential new drugs needs IND approval to enter the clinical investigation part of development. IND approval must be completed before the new drug application can be submitted for approval to market to doctors and...
Phases of IND Investigations As part of an IND application, clinical protocols are submitted for review. A clinical trial protocol should be written for each phase of the clinical investigation according to FDA specifications. IND investigations are divided into...
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