The Life Sciences in New York State

FDA Critical Path initiative

For several years, the FDA has been working on a Critical Path initiative. The aim of this initiative is to reduce drug development times, and to ease the introduction of innovative diagnostics and therapeutic approaches.

The Critical Path team has assembled a very interesting list of opportunities, available here (PDF). These opportunities are divided into 6 major groups:

Better Evaluation Tools - Of these, I think imaging, better predictive toxicity models, and the standardization of microarray-based data are critical.

Streamlining Clinical Trials - I think the introduction of microdosing will be a big help here.

Bioinformatics - Clinical trial simulation sounds great in theory, but these are tremendously difficult models to construct. Better biomarkers for safety/toxicology are definitely needed.

Improved Manufacturing - What I don't see here is the issue of biogenerics. The branded companies claim (with good reason) that a biogeneric is impossible because differences in the final product emerge depending on the manufacturing method. This issue simply has to be resolved.

Urgent Public Health Needs - While many focus on infectious diseases from a bioterrorism perspective, I think the focus should instead be on emerging resistance to common antibiotics.

Special Populations - Pediatrics - Curiously, pediatrics is mentioned, but not geriatrics.

Overall, I think this is a very good, detailed list. I've noted a few items of interest, but there are many more noted in this document.

Mylan acquires India-based Matrix

Good move by Mylan. Not only does it provide Mylan with access to the Indian market, but also to emerging markets in China and Africa.

Mylan to acquire stake in Indian drug maker

Seeking oil and natural gas contacts

For reasons which are beyond the scope of this blog, I am seeking contacts in the oil and natural gas industry.

Specifically, contacts within companies (large or small) who may be interested in divesting their productive oil/natural gas assets (fields, not refineries, not reserves).

By assets I don't mean an individual oil well, but a productive field with multiple wells. Domestic fields in decline are of special interest.

Thanks.........

Reasons not to choose a career in consulting

Good comments from an experienced consultant. This is good advice to keep in mind.

Steve Shu's Blog: Some Reasons Not To Go Into Consulting

Big Changes on 42nd Street

Interesting commentary coming from a company that has redefined pharmaceutical marketing.

Pfizer’s New Leader Realigns Top Positions

No scientists reported directly to Hank McKinnell, Pfizer’s previous chief executive. The elevation of Dr. LaMattina and Dr. Feczko reflects the fact “that science is at the heart of what we do,” Mr. Kindler wrote in an open letter to Pfizer employees yesterday.

$2 billion and rising

Borderline unreadable summary from a keynote presentation on drug discovery and development costs. Of interest:

1. High Phase II attrition rates implies that Preclinical models of human efficacy are still poor predictors of what should happen in Phase II and III. Technologies, whether in silico, in vivo, or in vitro, that can improve these attrition rates will become increasingly valued.
2. He says that finding targets is easy, but finding leads to hit those targets is difficult. True, but it depends on the aproach. Being excessively focused on hitting the target can lead you away from broader pharmacologic effects. The key in my mind is to bring animal models earlier into development. The challenge, however, is that this increases time and cost. It's a risk some companies may not be willing to take. Conversely, this is a great opportunity for early stage companies focused on discovering new candidates. Now if only the VC industry would take note.
   
3. In the article, he notes that 80 successful drugs will lose patent protection in the next five years. He suggests increasing exclusivity times for drugs, akin to what happens with copyrights. I've generally been against this idea due to the concern that it will increase overall costs. But with so many generics and therapeutics out there, I'm not so sure this is the case. It will dive up drug costs in some therapeutic areas, but not all. And, drug costs will continue to rise anyway. So why not extend exclusivity to, say, 10 years after patent expiry.
   

Drug Costs Nearing $2 Billion

Two of the major points Lilly is focusing on are the rate of attrition in Phase II trials (only one in five drugs passes along to Phase III) and reducing the cost of new medical entities from $1.2 billion to $800 million. “We have targets up the wazoo,” said Paul. “Finding leads, small molecules … that’s another order of magnitude [harder].” Biomarkers will be “useful all across the value chain,” aided by the Biomarker Consortium.

Where have you been?

Busy!! Very very busy. Unfortunately, the blog has taken a backseat to many other activities. But, now that August is upon us, I will try to catch up on all the news in pharma, biotech, and venture capital.

Cheers!