Posts Tagged ‘life sciences’
One of the most enjoyable aspects of my role at Popper and Company involves constantly surveying the global digital health ecosystem. Recently, I attended Dr. Leslie Saxon’s 6th annual USC Body Computing Conference (BCC).
While the conference offered a comprehensive overview of what’s trending in digital health (BCC never fails in this regard!), I was fascinated to see the evolution of biometric and other types of sensor-based monitoring in motor vehicles. While BMW Group (a new partner at the Center for Body Computing), was represented at the conference, Ford Motor Company is also aggressively pursuing ways to improve the driving experience and health of drivers and occupants alike. Here’s a brief rundown on the efforts of both automakers:
- BMW Group seeks to enhance the driving experience by measuring a driver’s heart rate, which could provide feedback to the driver to calm things a bit (even adjusting music), or comparing the driver’s heart rate to, say, a professional race car driver’s.
- Ford is collaborating with Medtronic and WellDoc to develop its In-Car Health and Wellness Solutions program. The collaborators are developing applications and services that monitor the driver’s chronic illnesses and medical disorders while they are behind the wheel. Systems that monitor blood glucose, manage diabetes, or report on environmental pollutants and allergens could provide data and warnings to drivers, and could even safely disable the vehicle in the event of a heart attack, for example.
The approaches on display by both automakers are quite different. While BMW—the company with the advertising tagline “The Ultimate Driving Machine”—is looking for ways to appeal to the “driving enthusiast” in its customers, Ford is leaning more toward the car as an extension of a holistic approach to wellness. As consumers, it’s natural for us to gravitate to things we perceive as fun rather than things that connote a doctor’s visit or surveillance. However, since monitoring and intervention need not be obtrusive, differentiation in this segment of digital health will most likely boil down to marketing, something which automakers do quite well. It will be interesting to see how these solutions are commercialized and presented to the public, as well as to see whether they can drive the success of certain brands or particular models.
Is the entertainment quotient of digital health as integrated into the driving experience more consumer friendly than medical and safety applications? Do you think the automobile could—or should—be part of a healthcare monitoring and/or delivery system? What might these developments mean for the life sciences industry or medical device developers?
Tags: biometric monitoring, digital health, healthcare monitoring, life science industry, life sciences, medical device development, motor vehicle technology
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This week, the FDA issued draft guidance for in vitro companion diagnostics. After a day or so of reflecting about it, here’s what I think it may mean for you:
Overall, while the guidance itself may not be BIG news, it does seem to make good sense for business and to offer life science companies some flexibility. Whether you are a therapeutics company or a diagnostics company, you should see new opportunities as a result.
Following are the key points I took away from my review of the guidance:
- The FDA acknowledges that not all co-development of diagnostic tests and therapeutic drugs can occur simultaneously. Thus, there is room for you to secure approval of a drug before the test is available and also to seek to modify the drug’s label as new diagnostics information emerges. There is also room for you to potentially market an as yet uncleared or unapproved test, if the marketing of the test is critical in the context of a drug.
- Every test that provides guidance about a treatment is NOT a “companion” diagnostic. For example, tests that predict a patient’s risk for adverse reactions to Warfarin are not companion tests. Instead, they are adjunct tests in clinical decision-making. This is an important distinction.
- Put another way: Labeling really matters! A companion diagnostic would be labeled to indicate it is the determining factor in the safe and effective use of a drug. Keep this in mind as you plan your regulatory strategy.
- Furthermore, drug labeling is likely to refer to a category of tests rather than to a specific branded test. Test labeling may reference a specific drug or drug class. Here again, this has implications for how you intend to market your companion diagnostic or targeted therapy.
- FDA will allow submission of a test’s clinical validity data from the drug trial as the agency is keen to make the approval process efficient rather than requiring a separate study. This would obviously play into your clinical strategy in conjunction with your regulatory strategy.
So I see this approach as good news for my friends, colleagues and clients in the diagnostics and therapeutics industries. Clearly, the guidance shows a strong acknowledgement by the FDA of the growing role of diagnostic tests in targeted therapy. The agency appears to recognize that its facilitation of a smooth approval process is in the public’s best interest.
What are your thoughts about the guidance? Do you plan to submit comments? Are you willing to give us a sneak preview of your thoughts? We’d love to see them included below.
Tags: companion diagnostics, diagnostics, drug testing guidelines, fda drug testing, life sciences
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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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Having a pulse on global trends in the biopharmaceutical industry requires a wide range of insights from experience in pharmacological research and technology development through to the core operations of large-scale and startup life science businesses. With this in mind, I’m pleased to welcome Dr. Andreas Muehler as our second strategic advisor. Dr. Muehler’s experience with preclinical and clinical development, major product launches, licensing, business development, and marketing provide him with a unique combination of technical and business perspectives.
In the United States, Dr. Muehler developed and managed multiple startup medical device and medical technology companies. Among them were 3TP LLC d/b/a CAD Sciences (White Plains, NY), a medical software company that was sold to iCAD Medical in 2008. Dr. Muehler was also President & CEO of MicroMRI Inc (Langhorne, PA), a medical device company that received FDA clearance for both hardware and software components during his tenure. Dr. Muehler has also been managing director of a German healthcare private equity fund, Palladius Healthcare GmbH in Munich, which acquired distressed medical device companies. Read the rest of Dr. Muehler’s impressive bio here.
Dr. Muehler’s role as a strategic advisor to Popper and Company, along with Dr. Mills who we wrote about earlier this month, provides a wonderful opportunity for us to convey a truly global view of the industry on behalf of our clients. We’re especially excited about Dr. Muehler’s in-depth knowledge of the medical device marketplace, and look forward to featuring his insights via our blog. I was able to spend a few moments with Dr. Muehler recently and following are some of the highlights of our discussion about his background and experience:
CP: You were trained as a physician. How did you first enter the industry side of things? Was it a deliberate move from medicine to industry? Would you have done anything differently?
AM: When I went to medical school, what interested me and was exciting to me was the technology involved in health care. When I started in radiology – CAT scans were new, MRI was brand new – and the technology was of interest to me. After doing clinical work during the day, the most exciting time for me was after 5 p.m. when I could do new things with technology. So, I went to UCSF for a post doctorate fellowship to see what it was like to focus on technology all day. From there, I stayed with what I really like to do.
CP: You’ve engaged in many roles within the industry. Which was your favorite and why?
AM: I very much enjoyed serving as CEO of a medical device company dealing with diagnosis of and therapy control for osteoporosis. When I came in, the company was building large, expensive-to-develop devices. It was a difficult time. I was able to work with the people holding the technical expertise while at the same time I tried to understand the market, leveraging good people and positioning the company as a provider of software and algorithms, which was less expensive. Implementing change was at first a tough decision for the founder, but then he was supportive and we were successful. A year later, results of the new strategy were evident with an FDA approval of the software package. The employees were on board and the company was going in the right direction.
CP: Are there examples of business leaders others should emulate?
AM: There are lots of excellent leaders out there. Learn from them and take the best from each. As a leader, you have to have versatility and flexibility. You have to be able to listen and convince others—win their hearts and minds. You have to make tough decisions quickly and you have to adapt to situations with your own leadership style in a thoughtful way. And you must be careful to avoid generalizing. Examples from other business leaders work well in some situations but not others. You have to learn, but adapt as you go. And be aware of your own myopia sometimes as one often duplicates where you had success in the past. Don’t rely on assumptions of how it should be done.
CP: What’s your key business philosophy?
AM: I’ve mainly been involved in startups and early growth settings. I’ve met a lot of people who want to be involved in startups or form their own companies. I always tell them, it can be very rewarding. They usually say “I know” because they’ve seen examples of amassed wealth. But, I always warn people not to get involved in startups only because they believe it will lead to wealth. You’ll see that only one in five turn out to be successful and even then, it’s a rare example when one gets lost in wealth. Basically, you should get involved early so you can experience the excitement of a startup. Look back every two months or so and you’ll be amazed and how much you’ve contributed versus working in a larger company. It has to be more than the money. Enjoy what you do and where you are doing it. The financial rewards will come eventually.
We’re fortunate to have Dr. Muehler working along with us, lending his wealth of knowledge and international experience. We’ll provide more on his take on the differences in the device markets between the U.S. and EU soon. Until then, please feel free to let us know what you think about the European and U.S. markets for new medical technologies. Processes and legislation are constantly changing so it’s an ever-changing course. What agencies, trends, topics are you watching? Share your thoughts here.
Tags: business, Dr. Andreas Muehler, leadership, life sciences, Popper and Co, startups, Strategic Advisors
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“Translating the knowledge we are gaining from gene discoveries into practical clinical and public health applications will be critical for realizing the potential of personalized health care and improving the health of the nation.”
Muin J. Khoury, M.D., Ph.D., Director, Office of Public Health Genomics, Centers for Disease Control & Prevention
There are several interesting and exciting developments in personalized health that extend well beyond clinical medicine and into areas of science, ethics, government policy and regulation, patient advocacy, and business. In January of this year, the Ewing Marion Kauffman Foundation published The Personalized Health Project—Identifying the gaps between discovery and application in the life sciences, and proposed solutions. This report provides insights from key thought leaders as to how far we have come, where there are gaps and barriers, and how far away we are from reaching the goal of implementing personalized health care solutions.
It is incredible to think that we are already 20 years into the Human Genome Project and so much has been gained in terms of huge data repositories of genomic knowledge. More and more we see genetic tests being utilized to prevent, predict, diagnose and treat. Some of these tests used in clinical medicine are becoming incorporated into clinical guidelines and standard of care. Additionally the cost of genome sequencing has decreased tremendously in the past 10 years, eclipsing Moore’s Law, which is typically an accurate way to conduct long-term planning for technological innovation.
(www.genome.gov/sequencingcosts)
While progress has occurred, there still exists a need to understand, refine, translate and validate the knowledge gained in the last 20 years and to apply it to personalized health. For example, understanding the complexity of the information generated from a genetic test is a key component to consider integrating into personal health. How realistic is it to assume a physician will be able to interpret genetic tests? For physicians and patients, and in the case of direct-to-consumer tests, it will be imperative to communicate clear results to the end-user. (See Point/Counterpoint: On FDA Regulation of DTC Genetic Tests.)
With the daily deluge of information written on the topic of personalized health, one source of information that I find to be particularly useful is on the CDC Genomics and Health Impact Update whereby the CDC provides weekly updates on genomics and public health along with important and useful links.
Industry conferences are another source of current information. Popper and Co. will attend the 3rd Annual Personalized Medicine Partnerships Conference from April 11-12 in Washington, DC. It will be interesting to hear firsthand how different businesses have developed successful models for bringing to fruition their strategic approaches to personalized health.
Where do you see gaps in the translation of genomic data into useful personalized health strategies? Are there “go-to” sources for information on personalized health topics and trends that you’d like to share? Please respond below. We look forward to learning more.
Tags: genomics, human genome project, life sciences, moore's law, personal genomics, personalized health, personalized health care, personalized health project
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Sometimes, between the hotel room, the lectures, the networking, the power lunches and the data consumption at a conference, you’re on the plane home before you have time to reflect upon why you attended in the first place. I’m excited to be heading to the 18th International Molecular Medicine Tri-Conference in San Francisco this week—and I’m setting out my reasons for going this year beforehand.
I always look forward to this conference because of its balanced range of life science topics, including those with technical, scientific, business, strategy, regulatory and reimbursement slants. Within this balanced range of topics, the Tri-Con uses a channel structure to help attendees “tune in” where they can get the biggest bang for their buck. I’m excited to learn more about the following specifics within each channel:
- Diagnostics—Rapid changes are taking place on the diagnostics stage this year. Personally, I’m interested in molecular diagnostics, personalized diagnostics, cancer markers and circulating tumor cells (CTCs). I’ll be tuning in to discussions on the adoption and integration of the next generation of sequencing, companion diagnostics and the use of/characterization of CTCs.
- Drug discovery & development–Here, sessions promise updates on translational science, including the use of biomarker technology to support drug development.
- Biologics–This is a vast topic, but I’m especially interested in discussions on the study and use of stem cells. I’ll be looking to learn more about the applications of stem cells to support drug testing and for use as therapeutics.
- Cancer–For this channel, I’ll be focusing on sessions related to companion diagnostics, stratification of patient populations (including predictive and prognostic markers), and recent developments in pathway-driven or targeted drugs (a.k.a., personalized medicine).
- Informatics–Within this area of focus, I’ll watch for updates on methods to analyze integrated data types, workflow management and more.
The integration of each of these channels (which include more than 250 presentations), the focus throughout on industry-changing and trendsetting technologies, and the quality of keynote presenters is what distinguishes Tri-Con from other industry events. It also doesn’t hurt that more than 70 scientific posters will be displayed and that the exhibit hall is packed with vendors that present their latest products and technology (often in a manner that enables you to dig in and understand the role of the product/technology in the R&D process).
In addition to all of the educational aspects of the conference, I’m also looking forward to meeting thought leaders in many of the disciplines, and to connecting with Popper and Company clients and colleagues who will be attending.
If you’ll be there, please comment below or drop me a note, and let’s plan to connect. If you’re not attending, but are interested in any of the channels above, I hope you’ll tune back into our blog for my follow up piece post conference. As for now, I’m leaving on a jet plane…
Tags: 18th international molecular tri-conference, biologics, cancer markers, ctcs, diagnostics, drug discovery, Health Care, informatics, life sciences, medical devices, personalized diagnostics, tri-con
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Danaher Corporation (NYSE:DHR) announced today (see San Francisco Chronicle story here) that it has entered into an agreement with Beckman Coulter, Inc. (NYSE: BEC) to acquire Beckman for approximately $6.8 billion. When the acquisition is complete, Beckman will become part of Danaher’s Life Sciences and Diagnostics business segment.
This is yet another example of the diagnostics landscape’s rapid upheaval in which different players will clearly be dominating and leading the industry.
The diagnostics industry shake up is in full swing: As we wrote recently, sequencing technology (one critical part of the Dx space) is changing at an earth-shattering speed and today’s announcement is evidence of what is happening on the market level. Need more evidence? Check out this post by Xconomy’s Luke Timmerman on “diagnostics warming up.”
There’s little doubt that established diagnostics players will have interesting strategic responses to all of this change as they move to shore up their product positions and to maintain their channel franchises.
In all, it’s a great time to be in diagnostics and a broader variety of partnering and exit opportunities are emerging for small, innovative diagnostic companies. We’ll be writing about other diagnostics and device industry trends and changes in our blog (including a post later this week on the FDA’s recently announced 510(k) action plan). We’d love to hear what you think (so please leave a comment below) and we hope you’ll continue to read our views here.
Tags: beckman coulter, biotech, Caroline Popper, danaher corporation, devices, FDA, life sciences, sequencing
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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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A recent issue of The New Yorker included an interesting article by Jonah Lehrer entitled, The Truth Wears Off—Is there something wrong with the scientific method? The article focuses on the “decline effect,” which has been observed and debated in various studies in disciplines ranging from psychology to pharmacology to biomedical research. One of the observations is: As more trials were conducted with a given agent, the less efficacious that agent appeared. In many cases, the agent was no better than its predecessor, even though the initial study results were significant.
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Tags: biotech, FDA, jonah lehrer, JP Morgan Healthcare Conference, life sciences, medical technology, patti doherty, product development
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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.
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Tags: biotech, converging technologies, Health care predictions 2011, iPhone, Ken Walz, life sciences, mHealth, Steve Burrill
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