This area will bring together our internal whitepapers as well as any that we deem “foundational” to our own work and thus appropriate for adding to any required reading list.

As noted elsewhere, two pieces by Schein and Schein/Scheffler are definitely foundational to the work of Accelerate Progress.

They are:

The Case for a New National Program for the Development of Cancer Therapeutics by Dr. Schein is a great starting point

and

Barriers to Efficient Development of Cancer Therapeutics by Dr. Schein and Barbara Scheffler is an excellent follow-on reading, thought it stands on its own merits as well.

Additionally, for focused insights on our approach to the use and development of advanced trial designs and statistical analysis methods within regulatory development, this recent piece by Dr. Scott Gottlieb, former Deputy Commissioner at the FDA, and also a member of our Scientific Advisory Board, as presented at the Food and Drug Law Institute Colloquium on Access to Unapproved Drugs.

Improving Access to Life-Saving Medicines through Modernization of the Regulatory Review Process

As Dr. Gottlieb notes, it’s all about “Accelerating Access Through Better Science”.  We have the tools and our understanding of the science has advanced significantly enough to allow us to design better trials, to use better statistical analysis tools, and to learn more in shorter periods of time, but we need to focus on using those tools and science to full advantage.  Accelerate Progress will be leading the way in this area by forming appropriate academic, industry, and governmental collaborations and funding direct research efforts to improve our knowledge and use of advanced trial designs and analytical tools.