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Originally Published IVD Technology June 2005
INDUSTRY NEWS
FDA shares initial
thoughts on drug-IVD development
Richard Park
 |
FDA has issued a preliminary concept paper on drug-diagnostic codevelopment. In addition to the recent release of its final guidance on pharmacogenomic data submissions, FDA appears to be continuing to demonstrate its support for advances in personalized medicine.
“This is widely viewed as another step in FDA setting the groundwork for anticipated developments in personalized medicine,” says Richard S. Schifreen, PhD, vice president of research products at Mirus Bio Corp. (Madison, WI). “I believe the concept paper is the agency’s way of showing its support and providing some practical guidance for both drug and IVD companies. FDA’s intention to encourage development of companion IVDs seems very clear.”
This concept paper reflects FDA’s preliminary thoughts on how to prospectively codevelop drugs and tests in a scientifically robust and efficient manner. The report’s recommendations have been put forward for discussion purposes only. After soliciting public comments on the paper, the agency will follow up by developing a draft guidance.
“I believe the point in introducing this only as a concept paper is to put some educational information and guidance out into the community, while leaving the area flexible until there is more experience and the final best practices emerge before writing a guidance document,” says Emily S. Winn-Deen, PhD, vice president of strategic planning and business development at Cepheid (Sunnyvale, CA).
The concept paper states that drug/IVD combinations can provide many clinical benefits to patients. Such benefits include the following: differential diagnosis of a disorder or identification of patient subsets, identification of potential responders to specific drugs, a way to target therapies, an approach to identifying individuals at risk for adverse events, an adjunct tool for monitoring responses to drugs, and a way to individualize therapies.
The paper also addresses issues related to developing IVDs for mandatory use in clinical decision making about drug selection for patients. Both the IVD and the drug would be used in the clinical management of the patient.
“The diagnostic tests being considered in this context may be used to identify patients most likely to respond to a drug, patients most likely to fail to respond to a drug, and patients most likely to exhibit adverse events that might contraindicate drug administration,” states the paper. “The tests may also be valuable as optional tests during the drug development process to assist in understanding mechanisms of a disease, or in determining how to enrich or select patient populations to conducting more rapid and predictable clinical trials for new therapies.”
The concept paper acknowledges that since 1972 the use of IVDs to help select drug therapies has been a well-established technique. However, despite this recognition, FDA has approved only a small number of tests of this type.
“FDA has had experience with two real companion IVD products to date, Her-2/neu testing for Herceptin and epidermal growth factor receptor testing for Erbitux,” says Winn-Deen. “This has given FDA an experience base to begin to draw from: what went smoothly and what did not.”
Industry analysts believe the concept paper’s recommendations on best practices are well founded and helpful, particularly for educating pharmaceutical companies on how best to integrate a companion IVD into their clinical trials and data submissions.
“FDA is certainly getting prepared for more of these types of submissions and is being active in setting the stage,” says Winn-Deen. “This will not take the place of detailed discussions between FDA and the pharmaceutical and IVD companies contemplating this route to product introduction. However, it does allow them to be prepared when they come to FDA with an outline for their study designs that are likely to meet FDA’s needs.”
Other analysts believe the recent advances in the area of drug-diagnostic codevelopment should lead to further alliances between drug and IVD companies.
“My impression is that the drug companies are quietly beginning to look at companion IVDs,” says Schifreen. “This work is mostly behind the scenes right now. At the same time, IVD companies appear to be more open about expressing their interest in developing partnerships. The most visible area right now is for therapeutic monoclonals or other binding reagents specifically targeted toward proteins expressed by tumor cells. I think this will expand to other models, but it’s hard to predict how quickly.”
The paper may be accessed via the FDA Web site at www.fda.gov/cder/genomics/pharmacoconceptfn.pdf. Comments on the paper can be submitted to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with docket #2004N-0279.
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