There is no shortage of ideas for improving the efficiency and/or efficacy of drug discovery and development, but I’ve been struck by the unusually large number of recent reports, announcements, studies, and presentations that have spotlighted various new procedures for accomplishing either or both of those objectives. I don’t have the background, experience, or space to conduct a comprehensive evaluation of every idea put forth in those documents, so I hope my readers will help me ascertain whether they really have the potential to change the dynamics of drug discovery and development.

The mid-April Partnerships in Clinical Trials conference featured a few dozen workshops and presentations describing the joint efforts of sponsors and providers to improve the conduct of clinical trials. In an interesting break from the past, the organizers made most of the presentations available online to registered attendees a few weeks before the conference. I hope that outreach effort enabled the attendees to gain a deeper appreciation for the practicalities suggested in those presentations, and to interact more closely with the presenters following the conclusion of the conference.

In early April, the Tufts Center for the Study of Drug Development released the results of one of its periodic Executive Forum Roundtables. The attendees focused on three ideas to help bring more new products to the market:

• reduce the traditional distinctions between clinical trial phases, and start human trials earlier,
• engage in more collaborative relationships such as the newly formed Asian Cancer Research Group, and
• make greater use of exploratory INDs to evaluate various products or formulations simultaneously in order to identify a lead compound.

The April CenterWatch Monthly profiled a movement toward patient-centered trials. It related many companies’ attempts to engage patients more actively in the clinical trials process and to connect those trials to real-life experiences.

The April 5 edition of eCliniqua.com commented on the prospects for using information from Electronic Health Records (EHR) to improve the matching of patients who have various conditions or diseases with appropriate clinical trials. It noted the Mayo Clinic’s recent engagement of Centerphase Solutions Inc. to accomplish that goal within its database of more than seven million patients.

The March 15 edition of Genetic Engineering & Biotechnology News included several comments from participants in a conference on Predictive Human Toxicity and ADME/Tox Studies. They noted the effectiveness of many new tools and strategies aimed at decreasing attrition in the preclinical research phase. In particular, they noted the success of data sharing consortia such as the EU’s eTOX program.

In February, the FDA issued its Draft Guidance on Adaptive Clinical Trials for Drug and Biologics. The agency seems to be encouraging sponsors to streamline trials by adjusting them to take advantage of accumulating study data and to analyze that data according to a prospectively written plan.

In January, MIT’s Center for Biomedical Innovation (CBI) summarized Phase I of the work on its NEWDIGS project. This 25-page report reviewed the May-December 2009 deliberations of participants from more than a dozen healthcare companies and institutions. It identified numerous market, operational, product, and policy strategies intended to close the gap between the current state of the pharmaceutical industry and the blueprint of a desired future state. Phase II will focus more specifically on the design of new drug development paradigms, and use test-bed demonstration projects to evaluate the viability of those ideas.

Conferences, reports, and announcements come and go. Here’s hoping those I’ve noted, as well as many others, really do prove to be meaningful steps along the path towards improving the efficiency and efficacy of drug discovery and development.

Michael A. Martorelli is a Director at the investment banking firm Fairmount Partners. For additional commentary on the topics covered in this column, please contact him at [email protected], or at Tel: (610) 260-6232; Fax (610) 260-6285.