by Dr. Hsien-Hsien Lei
Posted May 1, 2007 in Personalities with DNA
Internet start-ups still suck up a lot of bandwidth, especially over at TechCrunch, but chattering right alongside them are biotech start-ups with new ideas for advancing the genome revolution. Dr. Keith Batchelder leads one such company – Genomic Healthcare Strategies . GHS focuses on personalized medicine, the intersection of personal genetic information with healthcare. Dr. Batchelder recently took some time to tell me more about GHS.
Hsien Lei: Genomic Healthcare Strategies sounds like a cutting-edge agency devoted to helping companies incorporate genomic technology in their business strategies. Can you give us an example of a project that GHS has worked on? Can you describe what GHS does in a couple of sentences? (I found the How We Work page somewhat overwhelming!)
Dr. Keith Batchelder: Hsien,
Thanks for allowing me a chance to speak with you and your blog readers. The Internet and blogs like GenticsandHealth [editor's note: my former genetics blog] are some of the new forces advancing what we at Genomic Healthcare Strategies (GHS) call “personalized medicine. As patients and consumers take more active roles in managing and buying their own health and wellness products and services, they will look more and more to sources like the Internet for useful information. I think the power of credible, thoughtful bloggers in the healthcare area will only increase.
GHS is in business of helping change the landscape of health care, particularly in the health and wellness area. GHS does this by assisting traditional health-related companies such as diagnostic, biotech, pharma and a surprisingly wide variety of others interested in this space to devise and implement the strategies needed to enter these emerging markets.
GHS has worked with a small medical diagnostic company with technology that predicted rates of recurrence for an individual with cancer, which provides useful information in deciding how aggressive a course of therapy to choose. We helped them create a business plan and strategy that allowed them to get funding to develop this test, take it through the regulatory process and move it rapidly into the market.
GHS is working with a Fortune 100 company to devise and implement an initiative that uses a genetic test to lower the number of significant adverse medical events and save money. Optimal dosing of the commonly prescribed anti-coagulant, warfarin (21 million prescriptions in 2003) is difficult, with hospitalizations due to bleeding and clotting frequent. Using this “personalized medicine” diagnostic test allows categorization of patients into fast, slow and regular warfarin metabolisers, and with this additional guidance to help with appropriate dosing can limit the number of bad outcomes, improving care and lowering costs.
HL: What kinds of people work at GHS? What skills do you look for when hiring people for GHS?
KB: Personalized Medicine is at the intersection of many areas of healthcare and is having a broad impact. Issues that highlight patient privacy and confidentiality are combined with business issues such as how to obtain reimbursement, cost effectively conduct clinical trials and protect intellectual property on drugs coupled with companion diagnostics.
At GHS, we believe that the changes which are happening will be disruptive and that significant creativity and strategy expertise, coupled with a wide knowledge of whatâ€™s happening, plus the traditional health care disciplines, are needed to understand and manage these new markets. GHS draws on expertise in its team, from physicians, ethicists, and business strategists who understand mergers and acquisitions to people with broad operating experience and consumer marketing know-how. GHS sees personalized medicine, enabled by molecular insights as a transformation in healthcare. In times of transition, an entrepreneurial perspective is very helpful. We look for people who can plan for the future in ways that are both visionary and realistic and have a track record of successful implementation.
HL: What do you think of direct-to-consumer DNA tests, in particular nutrigenomic vs disease gene testing?
KB: This is a very interesting question as it highlights the tension between the traditional physician/hospital/insurance/acute-care disease focus and the informed consumer/patient/self-pay wellness and prevention perspective. As consumers, exemplified by affluent baby boomers, seek help in living healthy and well, they will turn to sources of information beyond their physician – like direct-to-consumer nutrigenomic testing.
The ultimate value of any diagnostic test will be determined by its science, validation and utility. The science must be good, the results corroborated in a reputable way with a statistically significant number of test subjects, and the information useful in beneficially guiding what a consumer/patient might do. Unfortunately, doing the science, getting validation and showing the utility are usually time-consuming and expensive. I expect there will be instances where new health products and services are brought to market where shortcuts were taken along the way; hucksters will exist.
I think it is important to remember that a cancer diagnosis is usually of more immediate and severe clinical impact than providing information used to modify dietary intake. Therefore, Iâ€™m less concerned about somewhat exaggerated claims for a DNA-based test which encourages a consumer to take more anti-oxidants than I would be about wrong results or bad information about a BRCA1 or BRCA2 test. And itâ€™s unclear that, with limited regulatory resources available, that the rules for less-important tests should be the same as for clinically important tests. This is an area where GHS hopes consumer groups will take the lead.
HL: Personalized medicine has already begun. You mentioned that personalized medicine is about more than “genomically informed therapeutic decisions.” Can you tell us more about that?
KB: At Genomic Healthcare Strategies, we believe that personalized medicine (which goes beyond just making genomically informed therapeutic decisions) will radically alter the health care landscape, bringing in new players, changing the power relationships of participants, altering old economic models and creating new ones, and making informed consumers a major force. A lot of Personalized Medicine activity will take place outside of hospitals and doctorâ€™s offices.
With the continuing advances in molecular medicine and biomarkers, pre-symptomatic therapy is a reasonable and viable healthcare concept. The attentiveness of baby boomers to new information about scientific advances and their enthusiasm for learning about their state of health will fuel this market. There are some regulatory barriers; for example, for example, at present not all states allow individuals to buy their own diagnostic tests directly. However, we believe that regulation will not be the driving force for what happens in personalized medicine. What the market wants, within reason, will drive regulation and there are 76 million worried baby boomers, who are internet informed, have disposable income, and vote!
HL: What are your predictions for the genome revolution?
KB: We see new players in the personalized medicine area coming from companies and directions that are not traditionally associated with direct patient care, for example:
o Functional Foods
* Drug Store
* Mass Merchandisers
o Quick Medical Clinic
Healthcare Technology Vendors
o Visualizing therapy response
* Information Systems
o Genomic data incorporated with medical records
o Point of Care, Direct-to-Consumer diagnostics
* Personal Confidential Health Records
o Patient controlled medical records
Entities that help the consumer manage their health and wellness will be rewarded in the marketplace. We look forward to companies in the Direct-to-Consumer personal product space becoming very active and successful in this area, very soon. Genomic Healthcare Strategies believes that we have some insights and practical strategies that can help companies, with the vision to enter this space, enjoy rapid profits and maintain high margins.
Ultimately healthcare costs will be lowered as ineffective treatments are avoided and prevention accepted as the norm by payors (traditional and out-of-pocket). There will be early adopters, those late to accept these disruptive ideas, and bumps along the road to scientific validation. Over time, however, these new healthcare benefits will accrue to patients and their employers.
Thank you very much, Keith, for taking the time to tell us what GHS is all about. Patients are waiting for the day when they can receive effective medical care that’s personalized just for them and their families’ unique conditions. GHS sounds well-positioned to help speed the genome revolution along.
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