The drug industry is usually out front in assisting disaster relief, and many manufacturers have already come forth with major donations of money and supplies to Haiti in the aftermath of this week's earthquake.

Abbott will donate $1 million and says it has donated drugs that are already "on the ground" in Haiti. 

Eli Lilly has mapped out its "innovation strategy" going forward . . . The summary from Lilly is here, with the segment on emerging markets pasted below.

Eli Lilly announced that it will be moving 1,000 key employees from its (leased) Faris facilities in Indy to its (owned) downtown corporate center, where it is renovating Building 88 and establishing its Development Center of Excellence, aimed at getting drugs to market faster.

Pfizer has decided to drop two late-stage drug candidates because, according to this AP story, it sees no real market potential for them. That is, it sees no blockbuster potential. And, as the article implies, this is in direct response to the Wyeth purchase and the fact that the company is flush with new compounds to consider and prioritize.

I don’t know about you, but the relentless drum beat of negative news has been getting to me lately.  Every day seems to bring news of some drastic four-figure layoff...er, restructuring, whether in pharma or other industries.

The past few months have seen renewed vigor from FDA's DDMAC (Division of Drug Marketing, Advertising, and Communications) in scrutinizing manufacturers' claims of safety and efficacy. In particular, DDMAC has cracked down on makers and marketers of ADHD medications for their alleged false and misleading claims.

The rumors can be put to rest, as it is revealed that Eli Lilly has agreed to purchase the company for $6.5 billion.

--PWT

Yesterday's announcement that Eli Lilly had sold off its Greenfield, Indiana, R&D facility to Covance is perhaps not just a big deal, but really a bellwether move that may signal a trend of Big Pharma companies not just outsourcing aspects of their R&D operations but selling them off altogether. As the above-linked article suggests, the time for companies like Lilly to assume the role of financiers who aggregate data may be closer to reality.

Your thoughts on the significance of the deal? We'll be keeping a close eye on this one, and include expert input in posts to come.

--PWT

Eli Lilly will determine within the next year whether or not it will close its plant in Lafayette, Indiana. Prospects for the site are not good, writes the Indy Star.

--PWT

Clinical trials may have uncovered a possible link between inhaled insulin and lung cancer. In testing its blockbuster manque Exubera, Pfizer said six of the 4,740 Exubera-treated patients versus one of the 4,292 patients not treated with Exubera developed lung cancer. One lung cancer case was also found after Exubera reached the market.  However, all those affected were smokers, so connections are still somewhat unclear, although Pfizer is adding to warning labeling for whatever product might still be out there.  More from a news brief issued this morning.

What might be clear, though, is the role that a true Quality by Design approach could have played in developing this product.  Pfizer's "Right First Time" appears to have failed, utterly, in this case.  This is not playing Monday morning quarterback but pointing to a case where pharma lost billions by failing to connect more closely with customers and with its own work force.  There's another case playing out right now, which shall remain nameless, with huge implications for industry professionals , particularly those based in New Jersey.  

The Exubera product concept was brilliant, from the stabilization process that allowed its active ingredient to be manufactured to the delivery device itself.  But nobody wanted a large device with complicated dosing instructions, so Exubera violated Toyota's "customer focus" rule.  (Not to mention the fact that Pfizer transferred some manufacturing folks from its Brooklyn location to a fairly remote site to make the product.  In the end the company only wound up laying them off...so it wound up violating Toyota's "respect for the worker" rule, too.)

Both Lilly and Novo Nordisk have reportedly stopped inhalable insulin development, and Nektar has suspended discussions with other potential partners.  A shame because, if the kinks were worked out, inhalable insulin could solve a great many problems and be much easier for patients to take, particularly in parts of the world where needle availability and safety might be in question (assuming its costs went down, of course). 

 So perhaps it's time to go back to the drawing board.  But, this time, maybe with the right tools (and many more physician and patient customer focus groups) in place? (And an eye to "right sizing" staffing requirements for the next blockbuster, up front)