When is $100,000 a year more expensive than $500,000 a year? The answer: when developing drugs to treat common diseases (e.g., cancer) rather than rare diseases. According to a new article in Forbes magazine, governments and insurers are willing to pay upwards of $200,000 and as much as $500,000 for new orphan drug treatments that attack rare diseases (usually caused by a single gene). Since people suffering from these diseases have a known genetic profile, these targeted treatments are far more effective than most cancer drugs, for which insurers will usually cover up to $100,000 per patient per year.
National Institutes of Health (NIH) Director Francis Collins is urging companies to find more treatments for rare diseases. Of the 7,000 diseases that affect humans worldwide, 6,000 are rare. Traditional drug discovery and development methods for mass populations won’t be effective against these diseases. But more targeted approaches, with specific biologics and companion diagnostics, could be.
What do you think? Are companies like Agios a flash in the pan? Does $500,000 a year per patient sound like a viable pricing strategy? Are orphan diseases and drugs to treat them the future of medicine? Share your thoughts with us.
Tags: cancer drugs, companion diagnostics, genetic profiles, orphan drugs, targeted treatments, treating rare diseases
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An Interview with AdvaMed Conference Producer Ray Briscuso
In preparation for AdvaMed 2011: The MedTech Conference, we had a unique opportunity to interview Ray Briscuso, President and CEO at Life Sciences Conference Group, LLC. Each year, Briscuso works with the Advanced Medical Technology Association (AdvaMed) to produce one of the most important meetings focused on medical devices and diagnostics, and which brings together more than 1,500 key MedTech executives from companies in every sector of the industry. It is the premier conference, exhibition and partnering event for medical device, diagnostic and health information companies. In the past, internationally respected voices, such as former Presidents George Bush (Sr.) and Bill Clinton, have been featured as plenary speakers.
I am eagerly anticipating September 26-28 when AdvaMed 2011 will be held in Washington, DC. Following are some insights and highlights from our discussion with Ray about how to get the most out of this year’s event:
Q: AdvaMed 2011 promises to be an action-packed three days. What discussions, events, or talks are you most looking forward to this year? What will be 2011’s most pressing issue?
A: I’ll answer that in three parts:
- First, I’m always interested in the CEO Spotlights at the conference. We get some of the top names in the industry that literally sit on a barstool and have conversations with our attendees. This year, look for discussions from industry leaders such as Steve MacMillan, President & CEO, Stryker Corporation; Joe Almeida, President & CEO, Covidien; and Jeff Binder, President & CEO, Biomet, Inc., to name a few.
- Second, I value opportunities to hear from former presidents of the United States. This year we’ve got former President George W. Bush. In the past, Presidents Clinton and Bush (Sr.) have spoken – you could have heard a pin drop during their talks.
- Third, because the global financial situation is contributing to continued turbulence in financial markets, I’m interested in sessions that focus on investment in our industry – everything from venture capital to private banking dollars. I want to learn: What’s happening to the money? Who is getting investments? This is also the answer to what I believe is the most pressing issue to be discussed at the conference overall this year. I expect discussions on economic development incentives to continue to foster the industry within the United States. There is an opportunity to help support, create, and nurture an industry that pays high wages and employs highly skilled people.
Q: As you mentioned, plenary speakers at the AdvaMed Conference are very important and influential people, and this year is no different. What issues will the speakers, including former President George W. Bush and Maryland Governor Martin O’Malley, address? How did they get involved in this year’s event?
A: With respect to Governor O’Malley, we invited him because there is such a large medical technology industry in Maryland; it’s a key part of the O’Malley Administration strategy to get to know the industry and to foster its growth. We saw that and invited him – and we are pleased he is willing to make the trip to Washington. While a lot of Marylanders think about the bioscience medical industry in the state, Maryland is also home to many device and diagnostic companies such as BD and Qiagen.
As for President Bush, his family has a long history of personal experience with medical devices, which helps provide a personal connection for him as a speaker.
The U.S. Secretary of Health and Human Services, Kathleen Sebelius; the FDA Director of the Center for Devices and Radiological Health, Dr. Jeffrey Shuren; and Counselor to the FDA Commissioner John Taylor will also be part of the meeting this year.
Q: In Vitro Diagnostics is a new Program Track at this year’s conference. What should we expect to hear about in this discussion? Why was it added?
A: AdvaMed has been around for more than 35 years. Last year, the association started “AdvaMedDx” to focus solely on the regulatory, payment, and legislative needs of its in vitro diagnostics (IVD) members. AdvaMed is very proud that all 10 major diagnostic manufacturers are members of AdvaMedDx. The members asked us to make sure AdvaMed 2011 was the de facto meeting for AdvaMedDx – and it is. We added a dedicated track and a great deal of other programming specific to the diagnostics industry.
Q: I’m particularly interested in new tools being developed to address inefficiencies in the healthcare system and believe this is a general strategy that will be quite profitable to those companies that execute well. What are your thoughts on this front?
A: In the current budget environment, all parts of the health care industry are being asked to do more with less. Medical technology delivers tremendous patient value so AdvaMed member companies are uniquely situated to help improve value across the continuum of care.
We’ll be educating attendees about proposed government changes. We’ll feature 60 company presentations, many from early-stage companies seeking to address healthcare system inefficiencies. Our members know the importance of medical and economic value in the care setting. This theme will permeate the conference.
Q: AdvaMed conferences bring together people of varied backgrounds with a stake in the MedTech industry. How does this impact the value of the conference?
A: Our conference features investors, seasoned business leaders, and niche service providers with the right experience – we have it all. For attendees, this isn’t about finding a needle in a haystack but rather it’s an efficient way to connect with others who can help them. Like Delta Airlines uses Atlanta as a hub, everyone flies in for our conference and our MedTech Partnering software system allows companies to match needs with skills. It is unique to have such a huge cross-section of the industry, and its senior leadership, represented in one place. We provide efficiencies to small companies who accomplish a lot by attending the MedTech conference.
Q: What advice would you offer first-time attendees for how to make the most out of the conference?
A: The key is to prepare in advance of the conference. Opt-in to the partneringONE® MedTech Partnering system we have as part of the conference. This will open you up to a searchable database to look at anyone else who opted in. You can post a profile, describe your company, and explain your reasons for attending the conference (e.g., to meet with potential strategic partners, to secure funding, to gather regulatory advice). You can search for those who fit your profile and find the right people with which to meet. Look at the schedule in advance and lock down much of your days. During open times, go to a session and introduce yourself to a speaker.
If you don’t plan in advance, you’ll still get your money’s worth, but you are leaving more to chance. Our telephone number is 202-434-7213 and our web address is www.advamed2011.com. Attendees are welcome to call us for more planning tips to ensure you get every ounce of benefit from coming to the conference.
Are you attending this year’s conference? Will your company be participating in MedTech Partnering? I’d be happy to meet up with anyone interested. Please feel free to share your contact information, comments, or your own questions for Ray Briscuso below.
Tags: AdvaMed, AdvaMed 2011, Advanced Medical Technology Association, diagnostics, medical devices, Popper and Co, Ray Briscuso
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Last month, my colleague Shane Climie wrote a post inspired by an article in the New York Times (“How Bright Promise in Cancer Testing Fell Apart”), which exposed disturbing and cautionary insights into the application of genetic testing technology. Today, I’m responding to a recent New York Times article in which reporter Andrew Pollack wrote of challenges facing Myriad Genetics in spite of the company having received a victory when a federal appeals court upheld the company’s patents on two human genes – and the validity of gene patents.
It’s worth checking out Andy’s article for more context, but here are my two cents on some of the issues covered:
- My hunch is that eventually courts will rule (and in so doing give clear guidance) that while products of nature cannot be patented, companies likely will be able to continue to patent the knowledge that a gene or other physiological marker (all of which are “products of nature”) correlates to a particular condition, disease, and/or drug response. This is a key point of clarity that is needed in order for the field of “personalized medicine” to reach its full potential.
- As is clear from some of the expert and company representative quotes in the article, what we’re looking at here is a chicken-egg situation. In most cases, clinical validation that a gene correlates with a particular condition (or another type of correlation) is made possible by the investment of capital in a private company’s research, and the investors depend on the research entity having patent protection to help generate a return on their investment. On the other hand, society as a whole (i.e., public health) may be worse-off if use of the knowledge of the correlation is not allowed or made widely available.
- And, as we’ve written about in previous blog posts, whole genome sequencing will soon be done at a relatively low cost but how the resulting data is interpreted and used will continue to present challenges and be subject to the competing forces described above.
As life science consults with deep experience in medical devices and in genomics research, this issue is fascinating to the Popper and Company team. How does it strike you? Do you agree that this boils down to a chicken-egg situation or do you see it differently? Do you have any specific insights on the Myriad situation or similar business examples? We welcome your thoughts on this important topic.
Tags: gene patents, genomics research, life sciences consulting, myriad genetics, patenting genes, validity of gene patents
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Even great athletes – like Rafael Nadal at this year’s Wimbledon Championships – suffer setbacks and losses at times. Thus, we shouldn’t be too hard on Google for the recent downfall of Google Health, although we may analyze it and look for lessons learned just as Rafael surely does after a losing match.
The Google Health downfall carries with it a long chain of assumptions: everything ranging from design clumsiness to the search engine giant’s inability to bring the medical community into its fold. MIT’s own Technology Review chalked up the failure to the nation’s broken medical system and a recent article in Mobihealthnews (“10 Reasons Why Google Failed”) outlined it so clearly that you could use it for study in a Business 101 class.
Putting all other missteps aside, I believe many companies veer off track in the earliest phases of product planning. Large corporations, by virtue of pure muscle, sometimes are further burdened when they think they can create a need where one simply doesn’t exist. In this case, Google miscalculated whose problem it was they were actually trying to address.
Consumer-based electronic medical records have been a Holy Grail quest in the medical community for at least a half dozen years. Online medical records offer central efficiency for medical and drug providers, cost savings in online storage for hospitals and small offices, and a virtual file cabinet for patients that want to have their medical histories (at least the part of it to which they have been granted access) at their fingertips.
But the central question remains, “What does the consumer really want?”
Plain and simple: She wants easy-access to information, a bit of fun, and social connection. If it’s practical, it has to be practical with the additional benefit of providing even more connection and enjoyment, more readily, or must yield huge savings in time and/or money. An application that can do all of these things would be a “killer app.” An example outside of the medical realm is Twitter—a product providing many people with a customized news stream, making the process of staying informed easier and more efficient while also allowing for easy dialogue with ones peers.
So the demise of Google Health offers tremendous insights for the life science industry, especially as we strive to develop and place new products in an increasingly complex consumer/patient marketplace. We also have to wonder about what Google has learned from this endeavor. Do you think the company will begin to probe a bit more into what consumers actually want the next time? What companies could serve as role models for Google if it decides to remain in the consumer health space?
We’d love to hear your ideas here.
Tags: consumer empowerment, consumer health, google health, life sciences
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In business life as in the movies, change can come unexpectedly and throw us for a loop. An individual career – as well as entire industries – can move in unpredictable ways. Some days are ordinary, and on other days we arrive home, as does Mr. Popper in the new movie Mr. Popper’s Penguins, to find a giant box of birds!
As it is for driven businessman Mr. Popper, so it can also be for life science companies. And so, as a life sciences consulting firm named Popper and Company, we just couldn’t resist a light-hearted post relating what we do to the movie (we know, it’s a stretch).
Mr. Popper is a business guy who doesn’t know anything about penguins when a box of these birds unexpectedly enters his life. Now, if the movie’s Mr. Popper had a Mrs. Popper like our own, he wouldn’t have had a problem at all. To demonstrate the point: When I mentioned the movie as a potential topic for our blog, the first thing Caroline did was google “penguin genomes.” Of course she did.
Take a look at the Wired Science article Caroline found (“Penguins Evolving Faster Than Thought”). The article states that “penguins are evolving on a molecular scale two to six times faster than standard calculations indicated.” Think of it, at some point, penguins are going to demand quality healthcare like the rest of us. Who’s going to insure all of these penguins? Are medical schools equipped to train the next generation of physicians who will need to cross specialize in human and penguin care? And the treadmill stress test may have to be completely rethought – both in terms of administration and reimbursement.
Fortunately, Caroline and the rest of us here at Popper and Company think ahead. We constantly monitor the changes and trends – the evolution – of the life science industry. Take, for example, our 10-year interest in personalized health care – a field we were tracking long before the topic became a buzz word. Then there’s the emergence of eHealth into mHealth and the current impact of an increasingly empowered consumer in healthcare who can hold medical decision making in the palm of his (or her) hand via a smartphone. We’ve been watching all of this closely and the life science trends haven’t taken us by surprise.
Okay, you say, so what would happen if a box of birds did happen to land on Popper and Company’s doorstep…or in other words, what if something totally unexpected happened? We quickly dive into emerging health related topics to help prepare for the next “big thing,” even if it turns out to be the health needs of penguins. As a creative, flexible and adaptable life science consultancy, we’re ready to be at the forefront of where the life science industry’s changes are occurring.
Welcome to summer everyone! We hope you had fun with this post and that you have some time to get away, maybe even to see this movie in a cool air-conditioned theatre. And, we hope you’ll let us know your thoughts about bird evolution, if you’re so inclined! Stay cool!
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With the abundance of information available online today, sometimes it’s hard to sort through the SPAM to find quality sources of news and opinions, particularly if you want to stay current on trends and policies in healthcare and medical technology. I’m here to help with some of my favorite sites for great info on these topics. Add your picks to the comments, and together we can create a resource to sort through the junk.
The Healthcare Blog: WebMd dubs this blog “a free-wheeling discussion of the latest healthcare developments.” I enjoyed last week’s post on “The Incredible and Wasteful Complexity of the U.S. Healthcare System,” which provided a brief and twistedly entertaining look at the mishmash of laws, regulations, and other pieces that combine to create complexity and inefficiency in the U.S. healthcare system.
MedGadget.com: The “internet journal of emerging medical technologies” has something for anyone interested in gadgets and medicine. A recent article spoke of new medical scrubs featuring fabric patterns based on micrographs of pathogens. What an opportune way for every nurse, medical student and hospital staffer to stand out from the crowd.
The Medical Technology Caucus: From the U.S. House of Representatives, the Medical Technology Caucus is a bi-partisan organization comprised of 48 representatives whose purpose is to raise awareness among House members of critical issues relating to medical technology. For the citizen reader, it’s a good source of medical technology news in the political sphere.
Mobi Health News: This is the go-to source for information about the practical convergence of healthcare and mobile technology. One recent article (“Albert: iPad has already won healthcare tablet war”) covers the electrocardiogram (ECG) app and the developer’s thoughts about tablet and iPad use for medical purposes.
Aza Raskin’s Blog: This blog is full of unique insights from the cofounder for Massive Health, who formerly served as creative lead for Firefox and before that was the head of user experience for Mozilla Labs. In The Story of Paul MacCready, Aza writes about Gossamer Condor as an example of creative problem solving.
Share your favorite links to stories, apps, great blogs and more with us here. We’d love to learn what inspires you.
Tags: biotech, healthcare information, healthcare resources, lifesci, medtech information, medtech resources, online information, technology resources, what we read
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If you’ve ever missed a connection because of a delayed flight, or been stuck in traffic for hours, you understand one of my biggest pet peeves: inefficient use of time.
Because we – and our clients – are spread around the world, we use a variety of tools to keep us productive and efficient from virtually any location. These tools allow us to work remotely and sometimes they even eliminate the need for commuting or travel.
Some tools that we use include:
- Skype: Great for making international calls from a cell phone (as long as you have an internet connection – look for free WIFI when traveling) and for videoconferencing from a Mac or PC. Macs also have videoconferencing capability (iChat) built into the operating system.
- Web-based conferencing solutions: Including WebEx, GoToMeeting, Fuze and Onconference, to name a few. Of these only WebEx has video capability. Warning: Just because these tools help make meetings virtual, doesn’t mean they can’t still be derailed by a lack of group focus.
- Web-based project management tools (We use Basecamp): Basecamp serves as a virtual project hub to keep track of documents that require input from multiple team members. It’s a great resource for version control.
- Online contact management tools (our favorite is Highrise): Online contact management is useful if more than one person on a team is interacting with a contact. These tools provide a way to capture notes and dates from phone calls and meetings so that others on the team stay current.
- Dropbox: A free cloud storage service (though heavy users may need to upgrade to a paid license), Dropbox is an easy way to access a file from multiple devices (laptop, smartphone, iPad). It is also a great way to share very large documents that cannot be emailed. Simply copy a file to your Dropbox folder, send a link to that file, and the recipient clicks the link to download the file.
- Penultimate and Note Taker HD: The need for paper has been greatly reduced thanks to email but note taking in meetings is often still a paper-based task, unless you have an iPad – in which case you have options. These two apps allow you to write on your iPad using a stylus or finger and then email the notes. Note Taker is the more feature rich of the two, but requires a little effort to learn whereas the simpler Penultimate sports a more intuitive interface.
- Quickbooks Connect: For invoicing clients from the road there are a number of web-based solutions that also offer a mobile app. We use the Quickbooks Connect iPhone app to access our Quickbooks data, but there are many others that offer varying degrees of both accounting tasks and connectivity options. The choice of small business accounting software can be a daunting task and one that you may want to ask your accountant or financial advisor about.
What is your experience with streamlining your workplace environment with technology? Has an agile, cloud-based technology ever come in to save or increase your productivity in a pinch? Share your tech solutions with us here.
Tags: cloud computing, efficiency, Ken Walz, productivity, technology, tools, working remotely
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As one of the nearly 8,500 attendees at this year’s J.P. Morgan Healthcare Conference, I’m not alone in recording my observations. However, while the crowds and the climate are still fresh in my mind, I didn’t want to miss the opportunity to share some of my key takeaways. If you were there, please feel free to add your thoughts to the comments section. If you weren’t, let me know if you have any questions about a point I’ve made or curiosity you had about the conference that I haven’t covered.
Also, whether you attended or not, you may want to check out the ruminations of TheStreet.com’s Adam Feuerstein who blogged “live” from the conference as well as In Vivo’s Blog on the subject and the prose of the IR Report’s Dominic Jones.
My observations:
- Fire codes be damned: Attendance was up significantly from last year with the number of registrants approaching 8,500 compared to closer to 7,200 last year. It is difficult to imagine that the Westin could accommodate any more people, yet apparently there is unyielding resistance to a change of venue. I think this is a case where tradition trumps fire code.
- Optimism prevailed: Or, more to the point, everyone we talked to expressed their opinions that “there seems to be a greater sense of optimism.” To the extent that economics is, in large, a measure of a function of human behavior, this “sense of optimism” may be good enough to get things moving in the right direction again.
- Realism in Health IT: Among the health IT companies, I noted a sense of realism. Some executives in this space acknowledged that the federal stimulus funding directed to their industry – rather than the must-have nature of their products – may be a primary reason for the growing interest in that space.
- mHealth wasn’t in the house: One thing that we did not see or hear much about was mobile health, probably reflecting the public company nature of this event. Most of the activity in the mHealth space is dominated by privates or large publics for whom mHealth is a tiny piece of their life science business.
- Moving systems closer to point of care: Part of the mHealth story is increasing efficiency, often at the patient or consumer level. Efficiency was a feature mentioned by several instrument companies looking for ways to move systems closer to point of care.
- Social networks playing a role in wellness: Finally, though the conference was largely dominated by pharmaceuticals, devices, and research tools, there seemed to be an uptick in the number of mentions of wellness and the role of healthy behaviors and decisions in preventing disease and illness. The power of social networks to effect behavioral change is clearly a part of this mix.
Tags: 2011, conferences, Health Care, J.P. Morgan Healthcare Conference, Ken Walz, life sciences, mHealth, Pharmaceuticals
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When it comes to the life science industry, many have made 2011 predictions, including renowned biotech specialist, venture capitalist, and frequent public speaker Steve Burrill. It’s not all that surprising that he envisions much of what will happen in the year ahead will be based upon an environment that favors risk-mitigated companies, emerging biotechnology markets (e.g., Brazil and China), and challenges due to U.S. healthcare reform.
While I encourage you to take a look at his full list of predictions, I’m most interested in those that tie to some of the topics we’ve been discussing since we launched this blog in November, especially with regard to converging technologies.
Read the rest of this entry »
Tags: biotech, converging technologies, Health care predictions 2011, iPhone, Ken Walz, life sciences, mHealth, Steve Burrill
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The World Circulating Tumor Cell Summit occurred in Boston, Massachusetts from November 30 to December 1, 2010. My colleague Shane Climie and I attended, and here we share the top 10 ideas we took away from this important meeting, which focused on exploring the near-term commercial potential of many of the exciting new CTC technologies. Presenters and attendees at the meeting also discussed how CTCs might be utilized both in clinical trials and in clinical practice.
While the research community is still seeking to determine exactly what a CTC is, efforts to detect, isolate and characterize CTCs continue to increase.
Our Top 10 Takeaways:
- Pharmaceutical companies, diagnostics companies and venture capital firms are showing accelerating interest in CTCs.
- Several interesting new platforms are close to market as this is definitely a “hot” space with commercial potential. Some companies will launch their platforms imminently by providing services in their own (CLIA) labs.
- New assays in this space will have analytical performance challenges (e.g., the coefficients of variation (CV) are high).
- Many preanalytical issues remain to be resolved, such as how samples should be collected, prepared, and shipped as well as how long they can be stored.
- There is a general lack of consensus among researchers and industry regarding how to best use CTC information in clinical decision-making. We believe that this will be reduced over time as experience with the new tools accumulates.
- Currently, there appears to be growing interest in the characterization of CTCs. Many current applications of CTCs (mostly prognosis) relied entirely on enumeration. However, characterization of CTCs may enable several other applications, including prediction and monitoring of drug response and patient selection.
- Researchers are showing particular interest in Her2 status of CTCs in breast cancer and EMT in lung and other cancers. In order to compare platforms, a standardized definition of what a CTC is must be established.
- Although a standardized definition of CTC is needed, any such definition is likely to change over time as the technology evolves to enable the isolation of other CTC-like rare cells that are found in the circulation of cancer patients.
- The CTC population is definitely very heterogeneous: We do not yet know what component is most important in cancer metastasis. We therefore envisage a “differential count” or segmentation of the CTC population, analogous to a differential count of the circulating white blood cell population.
- We believe that the measurement of some flavor of CTCs will be routine in cancer monitoring in two to five years.
There is no doubt that the cancer diagnostic landscape is changing rapidly, and we are fascinated with the role that CTCs may play in this space. Is this a trend that you are monitoring? How may it impact your business? Do you have other observations about CTCs that you would add to the list above? Please share your comments here.
Tags: Caroline Popper, Circulating Tumor Cell, CTC summit, Shane Climie, World Circulating Tumor Cell Summit
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