Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory

In a recent Blog by at LifeScienceVC, Bruce Booth comments on the poor R&D productivity at big pharma. He makes a point that the problem lies with the culture in these companies. He cites the “Tyranny of the Committee”, “Stagnation through risk avoidance” and the negative impact of the organization’s entropy.  More...

According to a recent Life Science Venture Blog posting by Bruce Booth, average exits for venture backed biotech firms has been around $150-$175M. Less than 10% of the exits are over $400M and only a handful have been above $1B. The takeaway is that biotechs are more likely to have a small exit than large which puts constraints on the amount of capital they can raise. By the time of a $150M exit, most biotechs will have raised about $50M to get them to a Proof of Concept trial in humans. This is not a lot of money in the development world so biotech development has to be as capital efficient as possible. More...

After spending a week at the JP Morgan Healthcare Conference in San Francisco last week, I reflected on the themes that emerged this year.  The two primary themes are 1) early stage biotech assets and companies are getting more attention, and 2) funding of early stage programs is increasing. More...

Enobia Pharma Corp of Montréal, Canada was purchased by Alexion Pharmaceuticals Inc., of Cheshire, Conn., at the end of 2011 for $610 million up front and $470 million in sales and regulatory milestones. Was this the result of good strategic planning?  More...

Valeant recently made several attempts to get into confidential discussions and due diligence with ISTA. Valeant has a history of acquiring companies that have niche products on the market  and the ISTA acquisition would be in line with their business strategy to minimize their development investment and focus on marketing and sales.  ISTA has several products on the market already and is in a good position to launch several more in the next few years so they probably looked like a worthwhile take over target.  After getting rebuffed by ISTA, Valeant tried an unusual tactic of trying to get the shareholders of ISTA to pay attention by publishing an open letter that proposed doubling their share price with a $6.50/share buyout offer. More...

The news that Momenta is acquiring Virdante’s Sialic Switch assets leaves me wondering about the timing.  Virdante received $47.8M in Series A funding back in 2009 which should have been enough to let them get through Phase 1 and 2a clinical trials.  Instead Virdante is opting to sell their primary program at the preclinical stage for $4.5M upfront.  It seems to me that they are missing out on a potentially big inflection point in the value creation chain – proof of concept in humans.  Have they run out of money or did they have too much sunk cost to attract new financing?  Those are the only reasons I can come up with to explain why the investors would be willing to cash out now. More...

Pfizer Inc., a pharmaceutical major based in New York, agreed to acquire Excaliard Pharmaceuticals Inc., a spin off from Isis Pharmaceuticals. This is a good example of the virtual biotech model in action. More...

Clovis Oncology went public yesterday and raised a whopping $130M in new money.  They originally priced their offering at $13-15 per share.  Most analysts expected the price to get discounted as has happened to so many other biotech IPOs in the last two years.  Clovis was able to close its IPO at $13/share at the low end of their original offering.  Is this a case of the market opening up as the economic indicators are improving or do you have to go for over $100M to get close to your original offering or is it due to the faith the public is placing in a management team that has a record of success.  What do you think? More...

Biopharmaceutics is defined as the study of the physical and chemical properties of drugs and their proper dosage as related to the onset, duration and intensity of drug action. The science of biopharmaceutics is essentially comparing the dissolution of a drug to its in-vivo performance and its effectiveness. Passing this evaluation based on specific criteria has been one of the keys to getting approval from the US Food and Drug Administration.  But, there is much more value to this science then initially meets the eye.  Read the rest at our Resource Center White Papers.
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Every company has creative initiative and some core competencies; activities that require these attributes should remain inside.  All else is fair game for outsourcing as long as outsourcing is done effectively.  Although there are many guides for finding contract research organizations (CRO) and contract manufacturing organizations (CMO), there are few for understanding how to work with them effectively.  Outsourcing is a skill that has to be taught and practiced to make it work for each pharmaceutical company.  This is especially important for small startup companies that need the CRO resources, but are not far enough along in their funding efforts to afford mistakes. More...