Panelists at the 14th Annual BIO CEO & Investor Conference session – Drugs Need Friends, Too – Companion Diagnostics and Drug Development – addressed how these new technologies fit into the biotech business model and how companies can best leverage companion diagnostics to enrich products and expand therapeutic opportunities.
Companion diagnostics are changing the face of drug discovery and development and clinicians and investors alike are coming together for partnerships focused on the development of therapies for specific patient populations. The panelists outlined four areas that represent the future of diagnostics: clinical benefit and success, optimizing patient selection, optimizing target expression and combining multiple mechanisms.
As biomarkers are discovered, using a companion test to predict if a specific drug or therapy will work in individual patients, and determining the appropriate dosage, can improve health care safety and drug efficacy.
“The patient simply must come first in clinical trials,” Joanna C. Horobin, MD, President & CEO, Syndax Pharmaceuticals, Inc.
Patrick J. Mahaffy, President and Chief Executive Officer of Clovis Oncology added, “We must direct patients who do not respond to other options, we have that responsibility.”
Thomas Davis, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics, Inc asserted that capturing statistics on the odds or likelihood of a response in patients is one area that holds great promise for the future.
Panelists were optimistic regarding the regulatory process for companion diagnostics.
“The question is whether or not the Food & Drug Administration (FDA) understands and appreciates the uniqueness of comparative diagnostics, and we’ve seen evidence of real progress with two approvals last year,” said Dr. Horobin.
Potential challenges may exist with reviewing gene signatures, but it may be too early to tell as no company has submitted yet.
Panelists agreed that partnerships hold the key to success in comparative diagnostics.
Mark J. Pykett, VMD, PhD, President and Chief Executive Officer of Navidea Biopharmaceuticals, Inc., asserted that success is easier to achieve through academic and clinical collaborations. Dr. Davis added that partnerships with academia can provide better access to tissue samples. Dr. Mahaffy agreed, saying “The tissue is the issue.”
Dr. Pykett highlighted that there are significant opportunities in off label uses, and despite the small market potential; the therapeutic areas that diagnostics could be applied to are sizable.
Partrick M. Burke, PhD, Vice President of Strategic Collaborations at Myriad Genetics Laboratories, Inc. asserted that there are opportunities for products already on the market.
The Personalized Medicine Coalition, a nonprofit advocacy group, reports that there were 72 prominent examples of personalized medicine drugs, treatments, and diagnostics products available last year.
Last year, there were two significant drug approvals in companion diagnostics:
Pfizer’s Xalkori: Approved to treat patients with late-stage lung cancer who have an abnormal ALK gene in August. Comes with a companion diagnostic test to screen potential patients for the ALK mutation.
Daiichi Sankyo (Acquired when the company bought U.S. based biotech Plexxikon last year ) and Roche’s Zelboraf: Approved in August for BRAF V600E-mutation positive melanoma. Also comes with a companion diagnostic test to screen patients for the mutation.
The panel session was moderated by Steve Brozak, President, WBB Securities LLC.
The BIO CEO & Investor Conference wrapped up on Tuesday, February 14th in New York City at the Waldorf=Astoria.