Tuesday, July 28, 2015

Teams Pitch Once More at Culmination of CIMIT/B-BIC Boot Camp, Sure to Not Be Their Last

The program ended as it had begun: with a pitch. Just as the teams had done on day one, except this time armed with loads more insight on the value of their innovative business concepts garnered from a combined 500 customer interviews, they assumed their place in front of a room full of strangers turned peers and mentors to present how, with their idea, patient care would be forever changed. 

Over the course of the seven-week intensive program that was the CIMIT/B-BIC i-Corps Healthcare Commercialization Boot Camp - a life sciences version of the "Lean Launchpad" course developed by Steve Blank at Stanford, now widely adopted by the NSF and NIH - ideas and the individuals behind them were put to the test. Through an iterative process and interactive course design, the teams refined their business concepts, in some cases making a complete 180 (or “pivot” as the entrepreneurs like to say) from where they started, as they received guidance from expert coaches from CIMIT and B-BIC and invaluable feedback from their fellow participants – entrepreneurs, technicians and clinicians in their own rights. Though without a doubt, the most valued perspectives were that of the potential customers (“buyers”) and consumers (“users”) of the product or service.

The process teams underwent during the course of the i-Corps program falls entirely under "Search" in the above diagram. The threshold created by the dashed line, marks an organization's transition from the "Search" to a phase of "Execution", i.e. from a start-up / early-stage to a more developed company. 

In the complex world of healthcare, the nature of buyers and users can change dramatically depending on the product. This meant that teams had to be intentional in targeting their interviews for specific players who could help address key questions related to their product and its potential application. While one group is interested in polling clinicians, another is focused on hospital administration, and still another is isolating the government and NGO funding community. In reality, most cast a net that covered some mixture of the above, with one prevailing commonality being the shared interest in bringing the benefit to patients.

In ritualistic fashion, Mike Dempsey, Accelerator Program Lead at CIMIT and Entrepreneur-in-Residence at B-BIC, succinctly summarized the experience by reminding the group of what drove them to be here: “patient impact” as their “metric for success”. Traditionally, the ideas themselves, the fodder of innovation, are what receive the lion’s share of attention in the forms of financial backing (e.g. NIH funding) and mainstream media coverage. But, as Mr. Dempsey asserted, “patient impact requires a two-part equation”, with the idea itself occupying one space, and the “path to patients, in some cases through commercialization” filling the other. In the latter area, money has tended to be more difficult to come by, especially for early-stage companies or technologies (pre-company formation) - labels appropriately suited for nearly all in attendance - coming out of academia.

What the Boot Camp sought to do was flip the traditional dichotomy on its head – turning attention away from the particularities of the technology, to instead focus almost exclusively on the path to patients. This required getting outside of comfort zones, and in a literal sense, getting outside, period, as participants were pushed to talk to increasing numbers of people and seek an excess of information over a dearth of it. The resulting difference seen in the second-go at their team pitches was obvious, as all who spoke that day exhibited greater confidence in their ideas and validation for their unique approaches to improving the patient experience.

At the culmination of the program, the usual undertone, all too familiar on the hallowed grounds of the surrounding institutions of higher education, was made clear; that this is not an end, rather it’s a beginning. With the knowledge and experience gained from their rigorous training, the next time these participants take the stage they could be vying for the potential to bring their innovation to an even greater scale, in an effort to meet patient need.

* Those interested in learning more about the "Lean Launchpad" approach to building Start-Ups should visit the online course site at Udacity for a detailed curriculum outline and the opportunity to take the course online for free!

Monday, July 20, 2015

Meeting & Mixing of the Minds at BU OTD’s Tech, Drugs, and Rock n’ Roll

It was an evening full of collisions of all kinds at the Boston University Office of Technology Development’s 6th Annual Tech, Drugs, and Rock n’ Roll (TDRR) held in the George Sherman Union on BU’s campus set along Boston’s Commonwealth Ave. Entrepreneurs, academic scientists, industry folks and funders from venture capital and government / non-profit entities alike mixed and mingled over the course of an eventful evening. Much of the action centered around “Funder Alley” – a row of booths and monitor displays that featured many of the area’s funders of upstart biotechnology, including your own B-BIC. Kingsley Flood provided the ambiance, laying down tracks of clashed brass, percussion and string over vocals that spread out atop the clamor of casual conversations springing up from across the convention hall floor.

Starting from humble roots in 2010, TDRR has quickly developed into the premiere biotech networking event of the summer, drawing larger and larger crowds year-to-year, while continuing to turn out up-and-comers from the local Boston music scene - this year’s Kingsley Flood having been recognized several times over by local outlets for their Americana style hits. New this year was the aforementioned Funder Alley as well as the MAPP - Mobile App Development Contest, which awarded cash prizes to the top three mobile app ideas. The contest’s inaugural first-prize went to J. Gregory McDaniel, PhD, Associate Professor of Mechanical Engineering at BU, and Chiraag Devani, an engineering undergrad at BU, for their “Study BUddy” mobile app idea. Keeping with the vibes of a summer college cookout, there was grilled food and cold drink aplenty, and even a couple of cameo appearances by none other than Rhett the Boston Terrier mascot, who was seen rocking out beside the band and lofting t-shirts from the catwalk above to the frenzied party goers below.

With all of these ingredients mixed together, you have the makings of a concoction that affords the opportunity for both fun and meaningful connections to be made between the diverse crowd of attendees from Boston’s many universities and industries. It may feel like it’s always been the case that innovation has just tended to well up from university settings, particularly from those formidable Boston-area research institutions like BU, Harvard, MIT and Northeastern. But, it’s nights like tonight that remind me that it can’t hurt to attempt to help usher innovation along, by providing opportunities for more casual collisions to occur at an event like BU’s TDRR or by providing financial and educational resources for investigators and their nascent projects to grow forth. The key is, whether serendipitous or belabored, innovation isn’t likely to happen without a few collisions.

A sampling of photos from the evening - (from L to R, bottom to top) the B-BIC booth was a hotbed of activity, Kingsley Flood and Rhett supplying the R&R, the mouth of Funder Alley, sign on Commonwealth Ave. beckons!

Tuesday, July 7, 2015

A Nuanced View of the World of Drug Development & its Value to Society

It’s not every day that you have the opportunity to play audience to a preeminent biotech company’s chief executive (in Boston it’s more like every other day), so I couldn’t pass it up when I learned Genzyme CEO David Meeker, MD, would be sitting down with Boston Globe Life Sciences Reporter Robert Weisman for a “fireside chat” (hold the fire) hosted by the MIT Enterprise Forum at the Broad Institute of MIT & Harvard in Cambridge’s Kendall Square. Equally compelling was the thought provoking topic of conversation; “The Value of Drug Development: Can Society Afford Today’s New Wonder Drugs?” Given Dr. Meeker’s previous clinical and academic accomplishments as former Director of the Pulmonary Critical Care Fellowship at the Cleveland Clinic and Assistant Professor at Ohio State University, plus a variety of high-level managerial undertakings with Genzyme prior to becoming CEO, he seemed uniquely positioned to offer a nuanced take on the world of drug development and its value to society.

The drug industry, well represented in this part of town centered on Kendall Square, over its history has played the part of the regular scapegoat for all that is wrong with big business in America. A lifesaving drug might fill a void by addressing a formerly untreatable disease, but with price tags that are known to reach into the five-six digits for an annual regimen, it’s hard to say simply if this is an overall net positive for society. One can’t help but think it might be exchanging one problem for another – now your disease is under control, but your finances aren’t. And how does this look on a societal level with all the different players involved – payers, providers, regulators, patients, etc.? Very quickly we begin to find ourselves in a tangled mess.

Luckily, on this occasion, Dr. Meeker was there to help us sort this out. In particular, he provided insights on a critical piece of the equation: How do drug companies come to price their drugs? Far from an expert on the matter, what I will share is in many ways a shorthand for the intricate process that takes place, as I offer a summary of the discussion from that night:

The drug pricing picture takes initial form with a few key considerations: the cost of development for bringing the drug to market, the prevalence of the condition it’s designed to treat, and the comparative clinical value that the drug provides. In the rare disease world that Genzyme occupies, treatments can sometimes have a target population of less than 10,000 (an example being Gaucher’s disease, for which Genzyme offers several treatment options priced at $300k/yr.) In these cases, for a company to recoup its investments from their sales of the drug and continue to produce innovative treatments, can it only work out if the drug carries a six-figure price tag? Lacking many of the elements of a market system (namely no competitor drugs and “customers” having no choice as to whether or not they have a given condition), how does one arrive at a “fair price” – where all sides win? The payers, e.g. CMS and private insurers, play a key part here, as they take on the role of determining coverage and negotiating what’s reasonable in terms of price (though the exact mechanisms through which these processes take place can differ from country to country). The payers also shield patients from much of the financial burden of affording a given treatment – though in the US, it’s still not too uncommon for patients to face a sizeable enough bill to make me take pause.

As we look to the numbers we see that drugs account for roughly 10% of total health expenditures. So it might be fair to say they’re given a disproportionate amount of the attention when it comes to what drives overall costs to the system. Dr. Meeker also noted that payers typically turn over larger chunks of the cost of drugs to patients compared with hospital care, as average coinsurance coverage amounts to 19% and 5%, respectively. One is left to wonder what sort of effect these types of cost sharing breakdowns have on the system. Is this the best means for extracting the most value from our treatments?

As I find myself mapping out the connections between many of the different players involved, I realize that painting the picture of modern healthcare quickly becomes an overly complex task. For one, a static representation won’t suffice given the lightning pace at which innovation proceeds and the system adapts. 

Looking forward, Dr. Meeker offered his thoughts on some of the major developments that he felt could have broad implications for how we develop and eventually pay for our treatments. Firstly, he acknowledged that the market for biosimilars (generic versions of biologics) is on the horizon with the EU and US having recently laid the regulatory framework for new approvals in this area. This could dramatically impact price as the number of different treatment options for a given condition could multiply rapidly, and lend itself to a price war between new arrivals and off-patent originators. Of similar importance is the healthcare system’s present shift to value-based payment models focused on clinical outcomes. With changing incentives underway, it will be interesting to see how cost structures evolve in the coming years. Similarly, the advancement of more precise means for categorizing conditions and calibrating treatments, what many call “precision medicine”, could also further segment drug markets, as treatments cater to indications comprising smaller and smaller patient cohorts, and affect overall costs.

Coming away from the talk, I was almost dizzy from the number of different thoughts I had swimming around in my head – the primary challenge was to keep it all straight. A task that I think many working in healthcare can relate to. An ever-changing, increasingly complex healthcare system lends itself to many a challenge in organization and coordination, but it’s undeniable the amazing outcomes it can produce – the “wonder drugs” of today being the closest thing our society has to modern miracles. With all the attention paid to big pharma and biotech, due or undue, it’s worth bringing light to the importance that the other players in the system play in creating the types of medical innovations that save lives. Without a piece of it, the whole system might falter. So while the question of whether our drugs are too expensive is fair, one should not expect the answer to fall neatly between binary lines (good or bad). More appropriately, a nuanced view is called for – what should be a far from surprising result in the worlds of health and healthcare.