Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory

It seems that interest is growing for starting Phase 1 trials in Australia due in part to the comparative ease of regulatory submission, the scientific confidence in the results and the lower costs. There is quite a bit of regulatory history in Australia that might contribute to a combination of adherence to good clinical practices and favorable regulatory procedures. More...

Alan Frazier of Frazier Healthcare has quite a few opinions about the state of venture funding in today’s financial climate.    He has new ways of thinking on how biotechs can be funded and how VCs can recoup their investment. More...

One of PharmaDirections' formulation development experts was named as a co-inventor on a recent patent entitled "Layered Pharmaceutical Formulations".  See the recent press release. 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...

Are you trying to figure out how to take advantage of Computer PK Models in drug development? Pharmacokinetics is not rocket science; it’s far more complex. So how well can they do at actually predicting drug delivery and disposition? 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...