June 19, 2008

BIO Break

by Peter Pitts

There’s so much going on at the BIO convention. It’s a healthcare policy feast.

One panel I attended was on the future of personalized medicine via diagnostics. A few of the points made were:

* At present, “trial and error medicine” is the standard of care. Not good for providers, patients, nor payers. That’s true.

* What we today call “personalized medicine” will be referred to in the near future as “medicine.” That’s hopeful.

* Diagnostics will deliver personalized care via drug selection, dosing, efficacy, disease status, recurrence risk, and predisposition. That’s exciting.

* Diagnostics lead the league in the price/value proposition – and that’s what will initially drive uptake. That’s reality.

* To that point, there was also discussion of a diagnostics acceptance continuum beginning with “fear” and then moving to “value” and finally “acceptance.”

* And the constituencies moving along that path include pharmaceutical companies, physicians, patients, payers – and regulators.

* Specifically, to more expeditiously sashay down the Critical Path, the diagnostics industry needs industry-wide guidelines for clinical research.

Take-away is that "personalized" medicine is 21st century medicine. And that's a "win" for physicians, payers ... and even patients. As BIO Chairman (and Vertex CEO) Dr. Joshua Boger commented at the opening day's keynote, we must all be "a confederation of optimists."

Posted by peterpitts at 11:01 AM
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February 14, 2007

Pharma moves for open access to genetic research

by Kelly McKenna

In a move illustrating increased collaboration, or more likely a realization of the time involved in translating the Human Genome into medicines, several drug companies are providing free access to their genetic research. Theoretically, more researchers analyzing the data translates into more targeted therapeutics reaching the market and patients quicker.

Open access takes the ownership of genes away from medical companies, raising questions for researchers and smaller biotech companies needing to secure private funding and make a profit. In the patent debate, both sides argue the stifling of innovation – granting patents on genes creates a monopoly and halts the development of medicines, yet privatization enables biotech companies to survive and thus, research and develop new therapies. Regardless, the number of gene patents is decreasing, and just last week, the Genomic Research and Accessibility Act was sponsored, which would ban "the practice of patenting genes found in nature".

Open access to genetic information will definitely spur innovation and discovery, and ideally, increase industry collaboration. In the end, the benefit to big pharma is the creation of a better, quicker drug pipeline. If it’s not their own, they can just buy it!

Read more about Novartis' move to provide free access to the company’s diabetes genetic research: http://www.forbes.com/home/2007/02/12/novartis-genes-diabetes-research-biz-cz_mh_0212novartis.html

Posted by kelly_mckenna at 12:56 PM
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January 16, 2007

JPMorgan conference reinforces consolidation

by Kelly McKenna

The recent JPMorgan Healthcare Conference held in San Francisco reinforced the continued growth and valuation of the biotech industry and big pharma's increasing efforts to capitalize on biotech’s innovative science and targeted therapeutic approaches.

Bloomberg data illustrates this growth. With the most annual acquisitions yet, 2006 showed a 32 percent increase in biotech deals, including acquisitions and product alliances, over 2005. The average premium rose 10 percent (from 23 to 33 percent). Biotech companies raise $20 billion in partnerships (over $17 billion in 2005), according to Burrill & Co. Analysts and investors agreed that deals and buyouts would continue, and bidding wars would ensue.

Pharma companies are not only focusing on biotech to build a sustainable pipeline (for example, Pfizer entered six research partnerships within the past three months), they're finally seeing the value in targeting niche patient populations and the underlying causes of disease vs. treating the symptoms alone. The risks involved with potential failure of a blockbuster drug are too great for big pharma (continuing the Pfizer example).

Pharma companies are now working to build reputations as good partners for smaller biotechs. Beyond the ability to successfully commercialize drugs, these companies need the right messaging - communicated early and often - and tangible support (e.g., a history of mutually beneficial partnerships, partner testimonials, presence at biotech forums/conferences) to be successful. Biotechs can now pick and choose their partners, so differentiation and commitment are key.

Posted by kelly_mckenna at 11:18 AM
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November 13, 2006

VC funding lags in diagnostics

by Kelly McKenna

It's clear that diagnostics offer huge potential: reducing costs, predict an individual's risk of acquiring diseases and responding to specific therapies…the list goes on. Yet, venture capital funding has been minimal compared to investment in other healthcare areas – pharma, biotech and even devices. Key reasons may include a lack of understanding of this new business model, no blockbuster (big pharma) product prospects, slow-moving reimbursement and a general skepticism due to the misperception that few to no companies have shown a tangible cost savings.

Smaller, early stage diagnostics companies rely on funding for R&D. And, unfortunately, there are few successes, even though these companies can bring products to market and generate revenue quicker because their products typically don’t undergo the lengthy FDA review and approval process. Companies like Genomic Health and XDx have generated significant funding, commercialized products with several in the pipeline (essential to these companies long-term success) and paved the way for start ups. The diagnostics business model does work, but it requires investment and commitment. Diagnostics companies are and will enable the reality of personalized medicine.

Posted by kelly_mckenna at 06:29 PM
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November 06, 2006

A targeted approach to PR for small biotechs

by Kelly McKenna

Bioetchs can't compete with the marketing muscle and budgets of big pharma. Traditional consumer marketing campaigns, including the use of celebrities and sports figures, are just not possible for the early to mid-stage biotechs. Additionally, many of these companies focus on niche diseases, developing drugs, devices and technologies for small patient populations, to secure market share and establish leadership. These factors make generating media attention and coverage very difficult. For these niche disease categories, quality of life doesn't resonate as much with reporters either because such small populations are affected. It’s all about the data.

PR teams needs to be targeted and cost efficient, focusing heavily on numbers – data differentiating the product and demonstrating cost savings over treatments/technologies currently on the market. Often it’s overcoming the enormous hurdle of creating a new standard of care and changing physician behavior. As such, communications efforts need to be targeted to niche healthcare professionals, patients and their caretakers.

The best approach – in terms of cost effectiveness and credibility, the biggest bang for your buck – is through specific professional third-party organizations and patient advocacy groups. We’re constantly identifying new channels such as newsletters, member emails, Web site activities and ongoing programs to reach these groups and their constituents on behalf of our clients. One hit to the right outlet, and your message goes a long way.

Posted by kelly_mckenna at 01:34 PM
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October 25, 2006

PricewaterhouseCoopers, biotech loves you too

by Kelly McKenna

For the first time, biotech and medical device companies received more VC funding last quarter than software companies, according to a report from PricewaterhouseCoopers and the National Venture Capital Association. In the state of California - the birthplace of biotech - the industry is now the second-largest driver of the high tech economy and has contributed more jobs than the motion picture and computer industries, according to a report by the California Healthcare Institute and PricewaterhouseCoopers.

Thanks to PricewaterhouseCoopers, biotech is being recognized as a true competitive and contributing industry.

Posted by kelly_mckenna at 03:48 PM
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October 16, 2006

Patent proposal may hinder biotech innovation

by Kelly McKenna

With a backlog of more than 700,000 cases, the U.S. Patent and Trademark Office is seeking ways to remedy their patent application system. However, they’re current ideas could hurt biotech companies and hinder innovation.

Proposals under consideration would limit continuations and the number of application claims that can be filed. The rules, which could be implemented before the end of the year, would ultimately discourage or punish innovation. The nature of biotech requires complex, lengthy and add-on applications, and their survival, particularly small companies, depends on patent protection. Long-term patents enable them to gain an industry foothold and niche leadership and to recover the costs of development, often decades invested and millions spent.

To read commentary on the potential negative effects and how companies see the rules discouraging investment and incentive, go to http://www.uspto.gov/web/offices/pac/dapp/opla/comments/fpp_continuation/continuation_comments.html

Posted by kelly_mckenna at 02:18 PM
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September 19, 2006

The new business model...positioning for a sell

by Kelly McKenna

Biotech and biopharma companies are increasingly looking to sell. While, in the past, these early to mid-stage companies wanted to do it themselves - commercializing and marketing their product, going public, building their pipeline and maturing into a Genentech or Amgen. With Wall Street less inviting, they're now exploring more lucrative alternatives to IPOs. Reflecting this trend, there were more IPOs in European biotech last year than U.S. biotech. Granted this was also a factor of globalization of the field and a conservative U.S. investment market.

As PR professionals, we need to: 1) help our clients position themselves favorably to potential buyers, an audience now just as important as investors, and 2) prepare and protect ourselves from erosion through ongoing mergers and acquisitions. This is particularly an issue in California, where hundreds of biotech start-ups pop up every year.

Posted by kelly_mckenna at 11:37 AM
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September 11, 2006

Epigenetics: an area to watch

by Kelly McKenna

Following the mapping of the Human Genome and new insights regarding DNA, epigenetics has increasingly gained attention and funding – mainly because many scientists see it as the next step in translating information about the human genome into therapies.

Epigenetics refers to how modifications or “marks” to genes - other than changes in the DNA sequence itself - affect gene expression. Essentially, they’re an instructional code that overlays DNA. For industry, it will likely provide unique insights on the genetics of a disease that translate directly into therapies. Additionally, according to a May 10th Nature article, "epigenetic codes are much more subject to environmental influences than the DNA sequence", which “could explain how lifestyle and toxic chemicals affect susceptibility to diseases”.

While the role of epigenetics is still under investigation in a variety of diseases, positive data has been published regarding epigenetics in cancer therapies, specifically for liquid tumors. Evidence has shown that the epigenetic silencing of key genes – such as tumor suppressor genes – may be reversible, giving experts hope that epigenetic approaches to cancer therapy could not only treat cancer, but also help to prevent it. Instead of using molecules that kill tumor cells (and, often, healthy cells in the process), epigenetic therapies “reactivate” silenced genes to restore the natural mechanisms that control abnormal cell growth.

Several leading oncology organizations and research institutes are now focusing more heavily on the field. For example, within the next few weeks, charter members of the International Human Epigenome Project (IHEP), an international effort proposed by the American Association for Cancer Research (AACR), plan to publish results from their first meeting, held in July. Keep your eye out for these results as well as more attention to the field during the upcoming America Society of Hematology (ASH) meeting in December.

Posted by kelly_mckenna at 07:51 PM
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