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The Insiders: Pricing strategies

BIO has definitely become an extraordinary convention event. For many years I've been walking the hallways of ASCO, and I feel that BIO has no reason to envy the top scientific meetings that take place every year in the US. The vibrant entrepreneurial spirit, the eagerness to partner and establish genuine dialog, plus the willingness to explore outside-the-box strategies and organizational alliances makes this international conference very unique.

During the CEO Forum I had the opportunity to hear Mark McClellan and Alan Garber speak about value-based pricing and the future of biotechnology companies. It was an insightful roundtable with a very outspoken audience. One of the topics discussed by the panelists was the issue of moving to value-based pricing strategies. That is, strategies that measure and pay for the net impact of a drug on the population rather than a model based on a pill-by-pill payment. In other words, only those who benefit from a drug are the ones expected to pay.

A company representative asked: How do you measure the cost of failure so frequent in clinical development?

A biotechnology CEO added: Time is the most expensive aspect of our business, even more so than direct costs. Any delay in rewarding the research and development output may have serious consequences on innovation. How can you manage that?

Whether value-based pricing provides a better health economic framework or a greater risk for innovation will continue to be a challenging debate. In the meantime, seeing policymakers participating actively in the discussion makes me feel that the contribution of biotechnology to the present and future health of the world is significant and undeniable. Congratulations to all the researchers and leaders that are making possible the miracle of innovation.

-- Edmundo Muniz, president and CEO, Tigris Pharmaceuticals

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The Insiders: Outsourcing

While at BIO, Michael Griffith had these thoughts...

It is clear that investors and entrepreneurs have become savvier about corporate evolution and the role of outsourcing to leverage and protect core competencies. They recognize that, as their nascent companies staffed with a handful of very bright discovery scientists approach milestones requiring increased production of drug and delivery of clinical results, the mere act of investing in internal development skills sets can be daunting and very disruptive to an organization whose mission is still primarily directed toward the discovery of new drugs. Outsourcing development to consulting groups and service organizations has become a logical move for emerging companies to rapidly respond to their pipeline needs and to mitigate risk, while preserving their core mission by remaining focused on discovery.

If you find yourself in that blessed situation of having a product nearing clinical trials, my advice: seek help! If you don’t yet have a pharmaceutical partner, external consultants and outsourcing partners with hands-on experience in manufacturing and development can play a central role in moving the product forward. Evolving from an “idea” company to a “product” company is probably the trickiest transition in the business. The best way to make that transition is to work with people who have already been to “the other side,” who can weave together the various functions (formulation, scale-up, logistics, etc.) and recognize the synergies between them.

-- Michael A. Griffith, CEO and founder, Aptuit Inc.

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The Insiders: Building relationships

From the perspective of the CEO of Tacere Therapeutics, an old/new RNAi company, I’m at BIO to lay the foundation for partnering our lead clinical candidate for HCV -- an RNAi “cocktail in one drug.” We started this program four years ago in a small private CA biotech, had an excitingly public diversion overseas for a couple years then returned to our roots in the Bay Area.

So out of a desire to hear other perspectives, I attended a session this morning that was insightfully chaired by Steven Holtzman, CEO of Infinity Pharmaceuticals, on how to structure strategic relationships. His opening presentation was an unabashed comparison of a strategic alliance to a successful marriage, necessarily containing all the same components -- respect, trust, shared values, shared goals, willingness to allow the other to change, desire to see ones’ self and the other succeed. He had then paired four couples representing partnerships from early discovery stage (Novartis/Alnylam) to marketing (Millennium/J&J). And sure enough, there was no doubt that the most successful and inspired partnerships were led by two people that shared a vision and the willingness to achieve it together. There was the couple in an uncomfortable post-honeymoon, still convinced they’d done the right thing, but not really looking one another in the eye anymore. There was the couple that had sort of inherited a relationship to find, much to their pleasure, that it was a thoroughly sound one. The couple that had been on eHarmony for 18 months identifying every characteristic of the perfect partner and when they found them, hightailed it to Las Vegas and were still grinning. And then the comfortable couple that, having renewed their vows in ever more complicated ceremonies, have found that they still rather like one another. All in all a thoroughly enjoyable session with some good insights and atypically candid remarks about how to make an alliance work.

One comment made was that ego is one of the main derailers of a good strategic alliance -- that the collaboration must be able to weather changes in personnel, with a formal and informal structure in place that is focused on the product, on the patient. And that works as a company gets larger and closer to market, as the influence of the CEO on the solvency of the company decreases. But for small biotechs, where your investors have bet the jockey and it's only your perseverance that will yield an ROI, ego is a critical component. What an ask it is of pharma to suspend ego, and yet Steven Holtzman was absolutely right in that these are relationships between people and ego is always disruptive.

And speaking of partnering -- we were wondering why there was no map of the convention center in the BIO program directory. After the fourth partnering session entailing the third trek across the bridge over the exhibition halls in two minutes or less, we concluded it was because they hadn’t actually seen a map of the convention center. Well, at least everyone will leave BIO fitter!

-- Sara Hall, founder, director, president and CEO, Tacere Therapeutics

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The Insiders: Fully charged

Hectic Sunday to start the week. Redeye out of LAX made sleep impossible despite an Ambien and two gins and tonics. Arrived Boston barely in time to shower, shave, dress and make my 8:30 breakfast with a venture fund. But now I'm charged and ready to slay the day.

-- Scott Salka, CEO, Ambit Biosciences