BioCommercialization Blog :: Enhancing the Potential for Successful Biotechnology Commercialization

St. Louis Science, Math and Engineering Education/Youth Exploring Science Networking Extravaganza

Kevin Buckley — Tue, 22 Jul 2008 10:19:21 GMT

This week marks the first networking event for the Youth Exploring Science program housed in the Taylor Community Science Resource Center at the St. Louis Science Center. YES is a structured work-based program launching fourteen-year-olds on a four-year journey of self-discovery providing them opportunities to explore scientific concepts through inquiry-based experiences and then to teach others. In their teaching initiative YES teens take museum science education out into the community and facilitate science and mathematics activities. YES teens begin as volunteers and then become employees of the Saint Louis Science Center earning minimum wages. The invitation for the event is below.

Other educational programs in the St. Louis area for young Science, Math and Engineering students include a program started by my friend Dr. Ken Mares at the University of Missouri, St. Louis. Students and Teachers As Research Scientists (STARS) is an incredible program that takes the best and brightest high school students (often with perfect SAT scores!) who are interested in pursuing careers in science, math and engineering research and launches them into a supportive and dynamic basic research environment. Some of the collaborating institutions include Saint Louis University, Washington University, University of Missouri, St. Louis, and the Donald Danforth Plant Science Center. Solutia is a longstanding sponsor of the program. Ken and I worked for four years to pass state legislation to fund the program -- unfortunately we were unsuccessful -- but I keep a positive outlook for passing the legislation in the near future because it has become so important for the future of Missouri's standing in the global economy.

Another resource for students and educators is provided by the Missouri Biotechnology Association. I worked with Monsanto in 2001 to add this platform to MoBio's mission, and it is slowly-but-surely impacting many conversations regarding the future of Missouri's life sciences community.

The Saint Louis Science Center Requests Your Participation at the

Inaugural Youth Exploring Science Networking Extravaganza

July 25, 2008

The Saint Louis Science Center cordially invites you to attend a complimentary breakfast and/or luncheon as part of a special networking opportunity for teens in our Youth Exploring Science (YES) Program. They are bringing together professionals from the Saint Louis area in hopes of building communication skills and bridging experiences to their aspiring careers. As role models and mentors to our YES teenagers, this event will give you a very unique opportunity to have direct impact on our teens by allowing them to practice professional skills in a realistic and safe environment.

The YES Program works with 250 teenagers facing multiple risk factors throughout the course of their high school career, providing them with a work-based, inquiry-learning environment that focuses on science, mathematics, and technology. Participants of YES gain professional, academic, and real world skills that assist in building self-confidence and personal success.

Please consider joining them for this special event, which will include a formal breakfast and luncheon and the opportunity to mingle with other community leaders and teenagers from the YES Program. They understand that you are busy, so please feel free to pick either the breakfast or lunch session if you cannot attend the whole day.

Friday, July 25, 2008

9:00-11:30 a.m. or 12:00-2:30 p.m.

Please RSVP by Friday, July 18 by contacting Priscilla Thomas at (314) 289-1487 or via e-mail at pthomas@slsc.org. Hope to see you on July 25, 2008!

Global Healthcare Investing Conference

Kevin Buckley — Fri, 02 May 2008 13:13:07 GMT

I spoke on the "Opportunities in Emerging Geographies" panel at the Global Healthcare Investing Conference where I discussed the 2005 Patent Act of India, new Indian drug pricing policies, and evolving pharmaceuticals case law and current litigation in India. The Global Healthcare Investing Conference is sponsored by BioEnterprise and International Business Forum Conferences and this is the second year I've spoken. Many special thanks to Baiju Shah who continues to lead the growth and development of Midwest healthcare companies and commercializing their technologies.

My talking points focused on what I've learned about evaluating investment opportunities in India. As a patent attorney, my analysis begins with intellectual property issues and how downstream information and events impact an innovator's IP. Things I analyze downstream IP include the ability and freedom to operate for an innovator to license its technology, whether the technology is over- or under-funded in the angel, corporate and venture capital market, whether an innovation comprises certain aspects that may require heightened regulatory scrutiny, whether delivery of the technology can be reimbursed by the government, and so on. Looking specifically at India, I highlighted a few quickly evolving laws, policies and administrative issues that are making a proper evaluation of investment opportunities more difficult.

First, I focused on the evolving interpretations of the text of the India Patent Act of 2005. Because many of the amendments to the previous Act have not been scrutinized in court, it is understandable that there is uncertainty as to the precise meaning of the amendments. For example, Section 107A of the Act may provide a loophole for generic drug manufacturers to import drugs currently protected by Indian patents from what the World Trade Organisation defines as least developed countries until 2016. Before the 2005 amendments to the Act, section 107A provided that it was not an infringement to import a patented product "duly authorised by the patentee to sell or distribute the product." Howerver, amendments to the Act now only require the exporter of such patented product (for example, a drug manufacturer in Bangladesh) to be "duly authorised under the law to produce and sell or distribute the product." Hence, an authorization from the drug controlling authority in Bangladesh may be able to authorize a drug manufacturer or its partner under Bangladeshi law to export the drug into India without infringing the Indian patent. In other words, one interpretation of section 107A is that an Indian company can import a drug from a WTO-defined "least developed country" where the drug is not patented without infringing the Indian patent. Reconciling this interpretation of Section 107A in light of inconsistent provisions in the India Patent Act of 2005 (e.g., Section 48 right to importation), not to mention the TRIPS agreement, will provide guidance on what an Indian patent actually protects in India. Until then, I believe an investor in Indian technology must take the evolving interpretation of the India Patent Act into account and what patents might exist in "least developed countries" when analyzing the value of an Indian technology.

Next, I focused on new Indian policies and litigation/case law that may effect the analysis of an investment opportunity. New drug pricing policies were recently proposed to make sure drugs are affordable to Indian consumers. What is not clear is how these policies will be enforced -- can a drug manufacturer's patent be cancelled if the manufacturer fails to comply with the new policy? This is an enforcement mechanism currently in place in other countries. In addition, recent jurisprudence in CIPLA v. Roche make it harder for an investor to evaluate the validity of an Indian patent. In that case, the Indian court focused on three things that I find surprising -- the U.S. Supreme Court case KSR v. Teleflex for guidance on what is "obvious," the cost of the generic drug currently being manufactured while Roche's patent was in force, and the availability of the drug to Indian consumers as Roche's manufacturing facilities are outside India. While some interpret CIPLA v. Roche as a fair balance between high prices and market exclusivity versus lower prices and generic availability, I am not sure this case helps make the process of Indian courts "busting" patents transparent enough for potential investors in Indian technology to make a fair assessment of what can be protected in India.

As yet another example of what is currently making it hard to evaluate investment opportunities in India, I put forward a difficulty that many IP attorneys and consultants face everyday in conducting IP due diligence in an Indian investment transaction -- the Indian Patent Office does not provide electronic versions of its patent file wrappers to enable those outside India to readily conduct IP due diligence in anticipation of the investment transaction.

Related to these laws and policies, I discussed how investment opportunities in Indian pharmaceutical technologies and biotechnologies are changing as generic pharmaceutical manufacturers add innovative pharmaceutical products to their pipelines. It appears that all the evolving laws and policies in addition to increasing outside investment and an influx of highly-educated scientists and entrepreneurs are providing India a greater "home field advantage" for the development of innovative new drugs and related technologies. Certainly, the spin-outs of R&D facilities by Ranbaxy and Dr. Reddy's, large generic drug manufacturers in India, for the purpose of developing branded drugs highlights this change. I am also aware of new formulatory, vaccine, stem cell and antibody technologies being spun-out or independently developed that present interesting new investment opportunities. In short, while we wait and see whether Indian innovative products receive the same scrutiny as technologies developed outside India, the same problems outlined above are providing Indian companies an incentive to develop new technologies and new companies that present greater opportunities for investors.

Within that framework, I concluded with legal and business strategies that can be employed in conjunction with contract researcher organizations ("CROs") and investors to commercialize those new Indian technologies, but my summary will have to wait for another post. Some of the highlights of the remainder of the conference included a keynote address by Carol Kovac who provided an insightful perspective on the future of medicine and healthcare investing worldwide. If Carol can guide her portfolio companies in the same manner she did while building IBM's life sciences platform, we are sure to see an exciting new array of "disruptive biotechnologies" (that's a good thing!) commercialized in the near future. John McCain was also a surprise visitor speaking about his new national healthcare plan.

New Life Sciences legal practice - Spencer Fane Britt & Browne LLP

Kevin Buckley — Fri, 02 May 2008 11:26:09 GMT

I recently joined a new law firm as a partner and established its Life Sciences Practice. Spencer Fane provides a much bigger platform for my clients including a full range of legal services including venture finance, strategic business planning, and patent litigation services. The firm also has the financial resources to work with new companies that are frequently undercapitalized. Spencer Fane is committed to supporting the commercialization model I began developing in the year 2000 and fully implemented in 2006 and we will continue to serve clients in this entrepreneurial capacity. It's a great opportunity that I'm very excited about, even though it brings Biotactica to an end.

Valerie Tomlinson, with whom I have worked for six years, joined me and will continue to handle international patent matters as our IP paralegal. The Life Sciences Practice's first hire is Dr. Gale Starkey, a medicinal chemist who has a decade of experience as a university professor, inventor and organic chemist in industry. Gale and I go back several years when he was with a St. Louis start-up, Apath LLC, and we worked together drafting patent applications for his anti-viral compounds. We've been embraced by a tight-knit team including Kyle Elliott, chair of the firm's Intellectual Property & Technology practice, Glenn Robbins, Scott Kimsey, and Mike Thorne, among many other members of this incredible law firm.

Now that I am settled, I plan to focus more more attention on the BioCommercialization Blog. Until then, cheers!

New University-Industry Collaborations

Kevin Buckley — Sat, 02 Feb 2008 13:24:03 GMT

As my first post to the BioCommercialization Blog, I want to focus on what leaves many university inventions to wilt on the vine and never mature into needed medicines: bridging the funding gap between bench top and the first stages of commercial development that some have called the "valley of death."

Several new university-industry collaborations for funding basic research have been announced recently. The latest deal between Washington University in St. Louis and Pfizer marks a year where billions of dollars have passed from private industry to both public and private basic research institutions while at the same time federal funding for those same institutions has declined. The Wash. U./Pfizer deal has been noted both as a “new paradigm for other academic-industry collaborations” and also as a continuation of an agreement between Wash. U. and Monsanto that dates back to 1982. The $25 million, five-year renewal targets immuno-inflammatory diseases such as arthritis and asthma.

A few other university-industry agreements entered in the last year include:

2007 The Scripps Research Institute and Pfizer ($200M from 2007 to 2012)
2008 University of California at Berkeley, Lawrence Berkeley National Laboratory and University of Illinois and BP (British Petroleum) ($500M from 2007 to 2017 – targeting biofuels research)
2008 The Salk Institute for Biological Studies and Ipsen ($10M/year from 2008 to 2013 – targeting acromegaly, inflammation and other research)

If the past is a good measure of the future, there is a good chance many new technology targets for commercialization will arise from the laboratory benches that can be developed by the industrial collaborators.

I was struck by the very early date of the original 1982 Wash. U./Monsanto agreement. I am only aware of one other major agreement dating back so early: that between The Scripps Research Institute and Johnson & Johnson ($10M/year from mid-1982 to the end of 1996). At least one small molecule was discovered and commercialized under the Scripps/J&J agreement. Leustatin™ (2-chloro-5’-deoxyadenosine) was discovered by Dr. Dennis Carson while he was at Scripps in the 1980’s and developed by J&J subsidiary, Ortho Biotech, as a treatment for hairy cell leukemia. Sales of that drug is predicted to be about $13M/year (2004 numbers) and is currently in clinical trials as a potential treatment for Multiple Sclerosis. Thus, it appears that the Scripps/J&J deal was good for both parties.

Other older, noteworthy agreements include:

1992 The Scripps Research Institute and Sandoz AG ($200M from mid-1997 to mid-2007)
1994 Massachusetts Institute of Technology and Amgen ($3M/year from 1994 to 2004)
1999 University of California at Berkeley and Novartis AG ($25M from 1999 to 2004 – targeted to plant biotechnology research)

Casually observing the numbers above, it appears that the trend toward increased industry funding of university research has been steadily increasing. However, the numbers available from the National Science Foundation show otherwise:

The Y-axis above shows the percent of university research funded by industry and represents all technologies, not just biotechnologies, but it is likely a good proxy for biotechnologies.

I am surprised that industry investment peaked in 1996 at 7.5% and is currently at a level not seen since 1983. I would have suspected that industry would have funded a higher percentage during the peak of the dot-com boom from 2000 to 2001. I also would have suspected that industry funding would increase after 1996 to supplement industry internal R&D efforts -- how many times recently has the declining drug pipeline, and declining stock prices, been invoked in investor conference calls?

Perhaps the reduced percentage of industry funded academic research indicates that industry is funding technologies at a later stage of the commercialization process rather than at the university innovation stage. If this is the case, then fewer university innovations will be developed with the assistance of the biotechnology industry. In addition, many of the above funding arrangements are targeted which leaves research areas outside the targeted area unfunded. These possibilities raise the need for university researchers to find alternative ways to fund commercial development of their inventions.

While each university-industry research funding agreement provides a source of funding for research and development of university innovations, a large gap still exists between the bench and the first stages of commercial development. In later posts to the Blog, I hope to provide a few alternatives to these traditional industry and government funding models that may enhance the number of university innovations ultimately reaching market.

Welcome to BioCommercialization Blog!

Kevin Buckley — Thu, 17 Jan 2008 00:54:07 GMT

I created this blog to provide a forum for discussing what I am deeply committed to in my business life -- speeding biotechnology, life sciences and pharmaceutical innovations to market while enhancing the potential for increased license revenue, venture capital funding, regulatory approval, and reaching the market more efficiently.

That's a handful!

I plan to highlight relevant, useful and interesting information regarding biotechnology commercialization so that like-minded people have a friendly place to discuss the practical application of our ideas to commercializing biotechnology, life sciences and pharmaceutical innovations.

Thank you for visiting and as I get started on my journey.