In this interview, Michael Riordan, founder of Gilead Sciences, outlines the company’s strategy to develop novel nucleotide‑based antivirals for diseases that have been historically untreatable, emphasizing a pipeline that includes first‑in‑human molecules targeting AIDS. He explains how these candidates act as potent inhibitors of viral replication enzymes, showing greater potency than existing drugs like AZT in animal models, and are now entering clinical trials. Riordan discusses the FDA’s high‑priority review and a new inter‑agency panel (FDA, NIH, HHS) aimed at accelerating AIDS therapeutic approvals, which he expects will benefit patients. He then addresses Gilead’s financing plans, noting rising expenses due to multiple indications and geographic expansion, and outlines a strategy of forming alliances and potentially raising equity, contingent on market conditions. Finally, he highlights Gilead’s commitment to industry advocacy, stressing the importance of engaging legislators and policymakers to ensure healthcare reform supports biotech innovation.
Chapters
Gilead is developing an array of products for viral diseases that previously had been untreatable or only modestly treated by existing therapeutics. Viruses have been largely unconquered by modern medicine, and we think that over time, the approach of using nucleotides and other advances in biotechnology, we can overcome this historical impediment to developing effective antiviral medicines. And I think that that That recognition will grow over time as we report on the progress of our clinical trials.
How would you compare other biotech companies or pharmaceutical companies that are doing work in AIDS specifically? What sets you apart?
The molecules that we're testing for AIDS, and we have one molecule in clinical testing now and another one that will start shortly, these are the molecules, these molecules are the first of their kind to be tested against the AIDS virus in humans. And these molecules are very potent inhibitors of the enzymes that the AIDS virus uses to replicate its own genetic material. And in animal studies of retroviral infections— and the AIDS virus is a retrovirus— these molecules have been shown to be very potent, more potent than drugs like AZT. We are now testing to see if that is borne out in human clinical trials.
On the one hand, you're concerned the administration may put a cap on drug prices. On the other hand, I think the Food and Drug Administration, which is part of the administration, has been better— and I want your opinion on this— in terms of pushing through speedier approvals for things like AIDS therapeutics. How do you react to that?
Clearly the FDA has placed as high priority the review of therapeutic candidates in the area of AIDS and in other very severe and life-threatening diseases. And I think that has been reflected now in the turnaround time of review of products in development in, particularly, the AIDS category. Recently, the Department of Health and Human Services has announced a new panel that will include input from the FDA, from the National Institutes of Health, and other sectors to try to further accelerate the development and review of AIDS therapeutic candidates. And I think in the best case, that kind of close scrutiny by a very high-level panel will result in further acceleration that will benefit patients.
What will be your financing plans for the next year or so in terms of how you will finance, what will be your needs for financing, and what you suspect your burn rate will be?
As I mentioned, given the number of product candidates we have in development, our expenses will go up, and that's based upon the need to develop these for multiple indications in different geographic areas. We hope to offset that by entering into alliances with other companies that can help fund development and share in the marketing responsibilities. And it's quite possible that we'll raise additional equity. That all depends upon market conditions and our cash projections.
Given the importance of healthcare reform and various industry associations, I would assume Gilead wants to take a leadership role. Are there any things you're doing in particular to try and kind of rally the flag, if you will, to get investors more interested and also to take a leadership role in making sure that healthcare reform benefits the biotech industry?
At Gilead, we think it's important to be good citizens and to make sure that our representatives, senators and congresspeople, know the issues that are important in terms of fostering the further development of the biotechnology industry, which I think most people recognize now as a major asset of the United States.
