The Life Sciences in New York State

links for 2005-12-01

• Spray insulin war heats up
  Development and commercialization in India! Interesting...
  (tags: DrugDelivery insulin India)
• Chinese trade reps visit WNY - 2005-11-30
  (tags: Buffalo NY)

Spray insulin war heats up

Bentley Pharmaceuticals, based in New Hampshire, has signed a development and commercialization deal with Biocon, based in India. The agreement is focused on Bentley's intranasal insulin spray. Interesting? You bet.

1. Bentley is developing an interesting alternative to inhaled insulin, which, while approved recently, has some folks concerned over potential lung side effects. It's entirely possible that the intranasal formulation Bentley has will cause some irritation, but I'd take that over the potential decrease in lung function any day. Although I still think achieving consistent bioavailability (the amount of insulin which reaches the circulation) is going to be problematic. Their formulation does have much higher bioavailability than inhaled, which will manifest itself as a smaller device (a good marketing angle) and less insulin per dose (lower COGS).

2. Bentley's approach of pursuing ex-US development and commercialization opportunities is interesting. This agreement with India's Biocon follows a similar agreement with South Korean Dong Sung Pharma. I find it interesting that companies like Bentley (and Generex as well) are focused on commercialization on a global scale. It used to be that a small company had to license their technology to a big pharma company in order to tap into the huge US market and the infrastructure a partner would provide. Now, anyone can tap into global markets from the beginning. I think this has an important implication for start ups, namely, the need to think globally from day one.

3. One key reason why Bentley signed the deal is because Biocon has significant capabilities to produce insulin. While Biocon is an example of a potential "biogeneric" in insulin, it also shows how the capability can be married to drug delivery to create additional opportunities. I would not be surprised if we started to see more relationships between biogeneric companies ex-US (India, China, Eastern Europe) and drug delivery companies looking for low-cost protein drugs for their delivery systems.

Very interesting...I'll have to think and blog some more on this point.

Link: Spray insulin war heats up.

links for 2005-11-30

• R.I. venture capital: talent vs. funding
  RI has problems similar to other states which lack venture capital, but have the technology around which companies cna be formed.
  (tags: venturecapital)

A Look Back: Trends in Venture Capital Funding in the 1990s

Those were the days:

From 1981 to 1985, the average amount of venture capital funds needed for a company's first five start-up years was $7 million. From 1988 to 1992, the average amount needed was $19.1 million, a 173 percent increase.² Today a company needs an average of $16 million in venture capital during the first five start-up years, a 129 percent increase from 1985.

Link: Archive - Buzz of the Week - News - VC Experts.

The Business Plan - Who is it for?

The debate over the length and format of a business plan is not a new one. Recently, Brad Feld started a series on the business plan. He makes a critical point, which I think gets lost in the debate (emphasis is mine):

I believe the business plan is a critical document for an entrepreneur to organize his thoughts around his new business.  In today’s world of excessive PowerPoint presentations, the art of sitting thoughtfully and writing out the plan has – in many cases – been lost.

Brad is absolutely correct. Many entrepreneurs forget (or don't realize) that a business plan is a PLAN. While the basic content is fairly standard, the plan is a uniquely crafted document which captures the thinking of the initial management team. The most important aspect of the plan is to document how the entrepreneur intends to capture the unique economic opportunity she/he has identified. It is easy to say in a plan that a market is huge and growing (China, India, baby boomers, diabetes, cardiovascular disease, Google, Web 2.0, etc.). It is an entirely different matter to explain to a prospective investor or to yourself how this opportunity will be captured.

It is critical that the "How?" question be kept in the forefront during the planning process. How will you market this product or service? How will you retain and service customers post-sale? How will you approach potential licensing partners? The answers will be action-oriented, and that is what any prospective investor will want to know. Yes, the opportunity is huge, but HOW will you execute?

I had a professor in graduate school who once said that ideas are cheap. It's the design and execution of the experiments that's tough. Same in a business plan.

As a business plan creator, you may very well identify prospective investors who feel perfectly comfortable with a 10 slide presentation or an executive summary. However, the notion that a 2 page summary is sufficient is a grave mistake. The notion that you are writing the plan so that the investor can file it away and forget it is also a grave mistake. The business plan is first and foremost a document for YOU and your team. It is an expression of how you are going to uniquely capture the economic opportunity you have identified. Some investors will take the plan and file it away, but only if those 10 slides or those 2 pages are well thought out and logical. Each sentence and each slide must contain the essence of a great deal of thinking and planning. It is the thinking and planning which should be written down in the format of a business plan.

Aha, you say! I can answer all of the how questions in a well-thought out manner, and do it in 10 slides or three pages. Well, be my guest. But once the hard operational and tactical questions start coming at you from the VCs, don't be surprised if many of them are turned off by the lack of ready documentation. No market size or management team pedigree is going to help you.

See some of my earlier posts on this point here and here.

Fibrates turn off a process inside cells that causes serious complications of diabetes

Interesting and frustrating discovery. Given that so many diabetics also have elevated lipids, the thought that they can not take fibrates is troubling.

Link: Fibrates turn off a process inside cells that causes serious complications of diabetes.

links for 2005-11-29

• GREATBATCH MOVING R&D JOBS TO NY
  Maryland's loss is New York's gain
  (tags: Buffalo NY jobs)
• Merck Cutting 7,000 Jobs
  More bad news for Merck
  (tags: pharmaceuticals Merck economics)
• Tech-Confidential: VC money flows again
  (tags: venturecapital)

What does my del.icio.us tell you?

Brad Feld makes an excellent point regarding del.icio.us:

It dawned on me that my del.icio.us tag is akin to the first derivative of what I’m thinking about.  For a while, I struggled with tagging stuff as I didn’t get the benefit.  Now, I tag everything I read on line that I find interesting and am finding myself referencing my del.icio.us tags regularly to find stuff that I’d tagged a few days earlier (rather than going to Google and doing a new search – hmmm.) 

My del.icio.us feed is here.

Business Plans from India

I've posted on India and China in the past. Over the past few months, I've received a number of business plans from companies in India looking for capital and/or strategic partnerships in the US. If anyone has any ideas or contacts who can help, please do let me know.

Random Thoughts...and Thanksgiving

Light day today, as I'll be spending the rest of today preparing for a family gathering here tomorrow. Cooking, chopping firewood, and setting up the cocktails are my primary responsibilities so far...

A few notes:

Tuesday's Wall Street Journal (page D1) has an article discussing how physicians are backing off the use of patch-based contraceptives. The reason? More hormones are being absorbed transdermally than orally. Up to 60% more estrogen is being absorbed transdermally versus orally. This may increase the risk of blood clots and other side effects. It goes to show you just how a change in delivery route can make significant differences not only in efficacy and compliance, but safety as well. It will be interesting to see if Rx volume for the patches begins to plummet.

Derek Lowe has a good summary of Serono, their history, and their attempts to seek "strategic alternatives," which is CEO talk for "Find me somebody who will buy my company."

Garr Reynolds continues to hammer Microsoft for perpetuating poor slide design and communications. I agree with Garr. Cereal boxes should not be the model used to design slides. Some of these slides are excrement.

Thanks to all of the great comments I received on my "Top Five Mistakes" series. I've made a few additional edits to it, and would be happy to share with anyone who is interested.

Have a great Thanksgiving, everyone!