Author Archives: Dennis McCarthy

Patient Centricity, Only a Buzzword?

TalkIntoStethI read and hear more about “patient centric care” now.

When I see or hear the phrase, I imagine a “Dilbert Cartoon” poking fun at corporate management for trotting out the latest management buzzword.

This topic, however, is likely more than a simple buzzword.

By necessity, given demographics and the cost of healthcare in the US, we’ll inevitably focus more on results than processes.

Also, the internet is providing patients with access to information about their healthcare which is changing the relationship dynamic.

This is not likely to be an overnight change but as Steve Hobbs suggests in his Pharma IQ article (Click here), it’s a change that the healthcare industry should see coming and prepare for.

Family Office Funding

threadingneedleFamily offices have substantial capital to invest and have become a popular buzzword among company executives and investment bankers. I’ve found, however, that there are many misperceptions among these executives and bankers about family office investing.  Here’re my observations.

1. This is not “dumb money”.  Any dumb money was wiped out in the great recession.

2. Preservation of capital is key.  Many times, social goals are important.  Earning a financial return is in the top five goals.

3. Investment focus is often “nichey” or very narrowly focused and tied to special knowledge of the investment team or its advisers.

4. Because of #3, family offices prefer to keep a low profile to avoid being deluged with proposals outside the investment focus.

5. Because of the above points, raising capital from family offices is a challenging task.

These have been my observations. The article linked to this post efficiently highlights five key points about family office investing.  I highly recommend that you read ” Five Reasons Why Family Offices Invest in Life Science Companies by  Lucy Parkinson, Senior Research Manager of Life Science Nation.  From my experience, Lucy is “spot on”.

FDA Guidelines for Medical Product Information Online

SisyphisImageSearching for medical product information online is generally a frustrating experience with the occasional gem of discovery.

The Internet is the newest “wild west” with seemingly little to no regulation of content.

Because online information can and should be a valuable source of medical product information, the FDA has issued a set of guidelines for (i) medical product information in limited space formats (think Twitter) and (ii) fixing incorrect medical product information online.

With so many independent sponsored sites of medical product information online, the task to “clean up” the internet is immense and well beyond the scope of these first guidelines.

Is it a good first step or an impossible task?

Click here for an article by the law firm, Searcey Denney, on JD Supra, the online magazine.

Keys to Product Development Alliances

BrownRudnickLogoProduct development alliances have become more common.  My colleagues and I regularly encourage our clients to consider some form of alliance among the capital market options pursued.

Forces driving large life science companies to partner include:

  • Need to enhance product development pipelines;
  • Availability and low cost of investment cash for product development; and
  • Reduced evidence of “not invented here” mentality.

The primary force driving smaller companies to seek out partners is the scarcity of development-stage investment capital from venture capital, angels, etc..

Given the different goals and cultures of the large and small firms in these alliances, care should be taken to structure and manage the relationship.

Rob Funsten, co-chair of Brown Rudnick’s global life science group, provides us with a useful summary of preparations and practices to a successful alliance.

Click here for the article in “Corporate Counsel” magazine (free registration required).

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Should Doctors Consider the Cost of Care?

weighingcostsWhether doctors should consider the cost of treatment in recommending care is a growing issue facing the medical profession. It’s an issue which is likely to grow more common given the practical need to moderate health costs in the face of the demographic wave.

Excerpt from the New York Times – (Click here to read the full story)

“Saying they can no longer ignore the rising prices of health care, some of the most influential medical groups in the nation are recommending that doctors weigh the costs, not just the effectiveness of treatments, as they make decisions about patient care.

The shift, little noticed outside the medical establishment but already controversial inside it, suggests that doctors are starting to redefine their roles, from being concerned exclusively about individual patients to exerting influence on how health care dollars are spent.”

The US Congress is already staking a role in this issue as described in the related post – Congressional Hearing Pressuring Stock Price?

Public Good vs Patent Rights

SumoWrestlingIn a battle of titans, Edwards Life Science and Medtronic have squared off in a patent infringement case in which Edwards claims Medtronic is willfully infringing on its patents in offering Medtronic’s CoreValve product.

Excerpt of article on “The Recorder”.

Thursday’s filings are the latest development in a case that vividly sets a private company’s patent rights against public access to potentially lifesaving technology. At issue is the fast-growing market for artificial valves that can be inserted via the transfemoral vein and inflated into place inside the aorta, without open-heart surgery. Though the devices were first approved by the Food and Drug Administration only three years ago, the market is already estimated to be worth $500 million in the United States.

U.S. District Judge Gregory Sleet of Delaware on April 11 enjoined Medtronic from selling its valves, which a jury found—and the Federal Circuit has agreed—willfully infringed a version marketed by Edwards. Sleet acknowledged that Medtronic’s CoreValve product can be used on a wider variety of patients, and that it’s “safer” and leads to “better outcomes with a lower risk of death.”

“At the same time,” Sleet said, “the court cannot downplay the strong public interest favoring enforcement of patent rights.”

Cost of Cancer Drugs

TidalWaveOngoing pressure to reduce treatment costs in the face of the looming demographic wave of healthcare costs prompted this article on the cost of cancer drugs in the “New England Journal of Medicine”.

Excerpt

“The high cost of cancer drugs has been criticized by leading academics and lamented in the popular press.  The average price of 1 year of treatment with a new cancer drug now exceeds $100,000, and the benefits of many of these therapies — often improvement in median survival on the order of weeks to months — do not appear commensurate with their prices.

Expensive cancer drugs cost society in two ways. First, high prices are borne by payers each time these drugs are prescribed. And second, high prices preclude independent comparative effectiveness trials that would seek to establish equally effective but cheaper alternatives — thereby protecting the market share of expensive drugs.

Click here to read the article in the “New England Journal of Medicine”.

Congressional Inquiry Pressuring Stock Price?

USHsEnrgyCommCommOn March 20, 2014, Democratic members of the US House Energy and Commerce Committee sent to Gilead Science’s CEO a request for a briefing on pricing of the company’s new Hepatitis C drug, Sovaldi.

The letter states, ” Our concern is that a treatment will not cure patients if they cannot afford it.  Reports indicate that Gilead intends to sell Sovaldi at $84,000 per treatment.  In cases where Sovaldi is prescribed with other treatments the costs could be even higher.  According to a recent Reuters report, “many doctors are requesting a $150,000 combination of Sovaldi … and Olysio.” (Click here for full letter.)

The stock prices of Gilead and Arrowhead, another Hepatitis drug company, lost value in the days after the release of the letter.

This may be another example of the battle between necessary cost control and drug companies’ need for profit to fund expensive pipeline products

Gilead

Arrowhead

Marketing Unapproved Uses

ReprintCartoonA life science company’s marketing of unapproved or “off-label” use of drugs and devices has been regulated largely by the FDA’s 2009 Guidance.

On March 3, 2014, the FDA issued new 2014 Draft Guidance which clarifies certain rules and requires life science companies to provide additional detailed information.  The comment period on this 2014 Draft Guidance runs to May 2, 2014.

Latham & Watkins, the law firm, has prepared a helpful article on the regulatory history of “off-label” marketing as well as the important elements of the 2014 Draft Guidance.  Please click on the button below to download the Latham & Watkins “Commentary”.

Download the PDF