OBE, Falconer, Xena , Nidan, Dado and all of these who have noticed the not to gentle shift in drug development, my hat is off to you. With the passage of the 21st CCA and arrival Scott Gottlieb the old way of doing things in the FDA has been Over Come By Events. No longer is the FDA standing passively by waiting for companies to come with their proposals for trials. Now it is a much more collaborative effort with CDER working in conjunction with the drug companies to get the most promising and impactful drug technologies to market. As Dr. Gottlieb said in july ..."We need to make sure that our regulatory principles are efficient and informed by the most up to date science. We don't want to present regulatory barriers to beneficial new medical innovations.."
So while the new drug development guidance is waiting formal unveiling next month, you can be sure that any drug currently before CDER is being crafted IAW 2istCCA architecture.This is just what Dr Missling has alluded to in the 10Q. Also, see Dr Woodcock's second point below. As to Falconer and other's point of trials development for drugs of similar MOA's that could be combined in "Master Protocols" see point three. Janet Woodcock had postulated this approach in an abstract in the past.....let's open up our eyes to the 21 Century approaches and not pine for releasing data that is already being folded into trials development....after all the FDA needs it more than we shareholders. Our reward will be three trials moving forward
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" The FDA is waiting with baited breath for an effective Alzheimer's drug. As I indicated form listening to Scott Gottlieb's confirmation hearing before Congress, one of his immediate goals was to make the CNS and Cardiovascular Divisions of the FDA as successful in innovation as the Cancer Division has been. He and his staff at CDER, run by Janet Wookcock, are definitely looking to facilitate the progess of the most promising candidates. You can be assured that CDER is working with Anavex (and Ariana) to design an adaptive "in silico" P2/3 trial for 2-73 using the body of data from P2. Along with that data, CDER, which approves and facilitates trial design, monitors execution and evaluates the results for drug approval, will also have the the P1 results for RS and PK at this time. You can bet the Tayo Fadiran will be "greasing the skids" for all of this. He worked directly with Mrs Woodcock when was employed at CDER during his over two decades of employment with the FDA.
Go back and read Dr. Gottlieb's 7 July 2017 speech on FDA's Future Plans (Post 110705)
Here are DrJanet Woodcock's key points to Congress on how the the 2!stCCA will Modernize Clinical Trials. I've added emphasis on a coupe of the points.
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From 21st Century Cures - Modernizing Clinical Trials and Incorporating the Patient Protection, Janet WookcockMD, FDA Center for Drug Evaluation and Research. before the House Subcommittee on Health
"What is needed to reduce the cost and length of drug development? Although no simple set of initiatives will quickly produce a flood of new treatments, much can be done to improve drug development, both in the short and long term. Today I want to talk about FDA’s efforts to increase the speed and efficiency in several areas in the clinical trial phase of drug development. These include:
Accepting flexible clinical development designs; such flexible programs may use surrogate endpoints, or have fewer than the two traditional randomized, controlled trials of efficacy, or have other non-traditional elements.
Meeting frequently and working closely with industry sponsors throughout the development process to plan efficient clinical trial programs and agree on needed data, a process that has been shown to shorten drug development by up to several years.
Helping create clinical trial networks and “master protocols,” where appropriate, to greatly reduce the cost of conducting clinical trials and reduce the time needed to carry them out.
Using surrogate endpoints, both in accelerated approvals (approvals based on an unvalidated surrogate endpoint that is reasonably likely to predict clinical benefit) and traditional approvals (i.e., approvals not requiring confirmatory evidence of efficacy post-market). Surrogate endpoints have been the basis for 60 percent of rare-disease approvals.
Listening carefully to patients and organizations that represent them to learn more about how they perceive benefits, risks, and unmet needs.
When appropriate, encouraging the use of “adaptive” trial designs that allow design modifications as information about drug response accumulates, leading to more efficient studies.
When appropriate, encouraging “enrichment” strategies to enroll patients more likely to respond to drugs under study, thereby reducing trial size and helping to direct drugs to patients who will benefit from them.
Allowing the use of a wide range of study designs, including single-arm studies, when patient populations are extremely small, as in some orphan diseases, and the natural history of the disease is well-characterized and the drug’s beneficial effects are large.
Collaborating with scientists in industry and academia on biomarker development; and
Identifying opportunities for streamlining regulatory processes.
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