For stem cell case plaintiff, faith and science go hand-in-hand

Yesterday, we shared a Q&A with the lead plaintiffs in the controversial federal lawsuit challenging federal funding for embryonic stem cell (eSC) research, Dr. James L. Sherley, a biological engineer at Boston Biomedical Research Institute, and Dr. Theresa Deisher, research and development director at AVM Biotechnology LLC in Seattle.

Both researchers agreed to field questions about their beliefs regarding eSC research. Deisher, who has been especially vocal about her Catholic faith and how it informs her research, also agreed to take a few questions about the connection she sees between her beliefs and science.

According to Deisher’s bio, she has 17 years of experience in scientific and corporate leadership positions involving research, discovery, production and commercialization of human therapeutics. She obtained her Ph.D. in molecular and cellular physiology from Stanford University. Prior to founding AVM Biotechnology in 2007, Deisher held positions at Repligen Corp. in Cambridge, Mass., ZymoGenetics Inc., Immunex and Amgen in Seattle and CellCyte Genetics Corp. in Bellevue, Wash. She has had 23 patents issued and has published numerous scientific manuscripts.

ddn: Do you find any conflict between your faith and the scientific research you engage in?

Deisher: I do not find any conflict between my faith, which is Catholic, and my research. My faith enhances my work. My Christian faith calls me to focus on drugs and treatments that are affordable so that the greatest number of people will benefit. My faith calls me to use reason and the order of natural law to determine, for instance, the stem cell most optimal for clinical use. My faith calls me to focus only on those treatments that will be effective. My faith also calls me to respect the intrinsic dignity of human life in my work.

ddn: How does your faith impact your research approach?

Deisher: My faith is completely complementary to my research, which focuses currently on stem cells for regenerative medicine and alternative vaccines.

Adult “self” stem cells, meaning a patient’s own stem cells, are affordable, compared to all other stem cell therapies. For the most part, therapies using adult stem cells will cost about $25,000 compared to Geron’s projected $500,000 for embryonic stem cell-based therapies. Adult “self” stem cells are found naturally in every organ, in each of us, and they are “preprogrammed’” to perform the functional regeneration that patients require. They also lack the issues of immune rejection or tumor formation that plague pluripotent stem cells such as embryonic stem cells. Adult “self” stem cells are far advanced in clinical trials, and in comparison to “patented” stem cell lines, they show more effectiveness in patients. Whether one believes in God or Darwin, one can arrive at an optimal stem cell for patients using objective measures, common sense and business criteria to generate the greatest good for the most people.

I would apply these same criteria to any type of treatment that I would work on, including biologics and small molecules: Will the therapy be affordable, or will only the very few benefit? Will the therapy be effective or merely enhance my stock price or financing temporarily? Will the therapy be undermined by adverse side effects? These criteria are sound business objectives and compatible with my faith.

Up next: Academia’s role in cancer research

If you’re a regular reader of ddn, you’ve probably read the first couple installments of our current series, Trends in Cancer Research, and now the October issue will bring you a focus on the growing importance and role of companion diagnostics in oncology drug pipelines and revenues.

In November, we will be examining academia’s growing role in cancer research as the effort to find new drug candidates to fight this insidious disease continues. We will examine which academic research centers are at the forefront of cancer research; some of the more significant advances in cancer research that came from the academic world; and their main focus in the expansive universe of oncology reseach, be it tumors, delivery, genomics or some other area.

As I cover these areas, another subject I hope to learn more about is whether studying at one of these centers can unlock more career opportunities for its students.

Lastly, we will be asking people how academic research centers select commercial partners—an important issue, of course, with ddn’s business focus.

I welcome input from ddn readers on this vast topic, as many of you are experts in this very area, work in academia in key leadership positions, or know people who have the insights we need for the articles. We have our sources, but we can’t know everyone, and if you can help expand our network, please do. To participate as a source for our upcoming installment or to suggest a source you think I should contact, e-mail me at hutton@drugdiscoverynews.com.

Eye of the beholder

There are good drugs, there are bad drugs and there are questionable drugs.

But except in cases where a drug is clearly harming people (like, say, making them drop dead of heart attacks in droves), the value of a drug is a matter of perspective. Some argue that we overmedicate people, particularly in the Western nations, and others say we need to have more pills for everything. One person’s passion for developing a drug for an orphan disease is another person’s idea of a waste of money.

In any case, on this fall Friday, let the following image remind you that sometimes, it’s all a matter of perspective:

Have a good weekend, everyone.

Market may be shrinking, but there are opportunities not to be sneezed at

According to global business information and analysis firm Datamonitor, generic erosion is set to shrink the allergic rhinitis market, and the firm predicts a 20% decline in sales value over the next 10 years despite a marginal increase in sales volume.

Datamonitor estimates that there are approximately 181 million people living with allergic rhinitis in the seven major markets, driving disease-specific drug sales of approximately $5 billion in 2009. This is set to drop to $4 billion in 2019 as a result of the entrance of generics following patent expiries, most notably in the United States.

However, despite the forecast drop in sales in the allergic rhinitis market, Datamonitor has identified potential growth areas, most notably in the immunotherapy segment of the market. Furthermore, life cycle management strategies have been identified that may help to lessen the impact of patent expiry of symptomatic treatments.

“Immunotherapy is the only treatment option for allergic rhinitis with a disease modifying potential, but concerns over cost and safety, particularly for subcutaneous formulations, have kept symptomatic treatments as the more popular choice,” notes Jacoba van der Gaag, healthcare analyst at Datamonitor. “However, in recent years we’ve been witnessing large-scale development programs in immunotherapy for the first time, driven largely by new guidelines and changing regulations. This will always be a niche market, though this innovation is now promising growth.”

For example, Datamonitor forecasts that two new sublingual tablets targeting grass allergies, Grazax (ALK-Abelló) and Oralair (Stallergènes), will have combined sales of $264 million in the United States and European Union by 2019. The potential for growth in this market is reflected by the pipeline for allergic rhinitis, which is dominated by immunotherapies targeting multiple types of allergen.

Another opportunity exists within the antihistamine class, where life cycle management strategies are used to lessen the impact of generic erosion. An established strategy amongst key brands is the reformulation of molecules and/or combinations with decongestants. This strategy helps to reduce the loss to franchise sales and strengthen brand recognition following patent expiry of the primary molecule.

Jacoba concludes: “The success of this strategy relies heavily on timing of new launches relative to generic entry. Merck’s Clarinex (desloratadine) suffered as a result of launching after its predecessor Claritin’s (loratadine) patent expired, which was demonstrated by it reaching only a quarter of Claritin’s peak sales in 2009. Meda Pharma, on the other hand, has seen successful patient switching from once to twice-daily azelastine having launched prior to patent expiry, and is developing an azelastine/fluticasone combination that is expected to further strengthen its franchise.”