Life Science Leader Magazine

NOV 2014

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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45 LIFESCIENCELEADER.COM NOVEMBER 2014 datatrak.com +1.440.443.0082 marketing@datatrak.com DATATRAK ONE ® Unifi ed Experience™ eClinical solutions and services remove complexities in clinical research, delivering time and cost savings. See how D ATATRAK can safely accelerate your trial, from Concept to Cure ® . End the Frustration and Wasted Time of Data Integration C o m b o c r i t e r i a ? Biologic rationale based on the mecha- nisms of action will be used to prioritize testing of combinations. Preclinical mod- els may provide additional insights, but ultimately, combinations will need to be tested empirically in the clinic. N a r r o w o r w i d e a p p l i c a t i o n s ? Initial approvals will be in advanced patients with relatively narrow indica- tions based on single arm trials in some cases. Subsequent confirmatory tri- als earlier in the treatment paradigm will be randomized and address larger patient populations. If dramatic anti- tumor effects with clear clinical bene- fit are observed in individual patients, then we can anticipate that cohorts of patients in smaller indications could be sufficient for label expansion or at least reimbursement. P e r s o n a l o r b r o a d ? Initially, combinations will be tested on groups of patients rather than on indi- viduals. By appropriately investing in biomarkers that can help predict which patients are benefiting, we will have the opportunity to tailor the agent or com- bination to a particular patient. Some of the pathways or immune mechanisms are common across various disease types, and it is possible to imagine moving towards a paradigm where we screen patients for a biomarker and treat them based on the biomarker, as opposed to whether they have a particular cancer type. C o m m e r c i a l i z a t i o n c h a l l e n g e s ? Historically, companies have been hesi- tant to let their drugs be tested in com- binations prior to obtaining regulatory approval. That appears to be changing, and we are seeing several companies part- ner on combination studies early in the drug development process. Regulators also are more receptive to new approach- es to bringing combinations to market. Cost of goods will need to be controlled with novel biologic therapies, but the increased clinical benefit that can poten- tially be provided by these approaches should still translate to value for patients and payers. We have run as many company responses as space allows this month and will follow with the remainder next month and beyond if needed to follow this rich vein of lessons in translational R&D;, business development, scale-up, and commercialization of breakthrough medicines. We are still open to hearing from other companies that either missed our first invitation or believe they belong in the conversation. Meanwhile, please join the discussion on Twitter at #CCIRLSL. L

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