Strategic GPS: Where could we go if we changed the model of university tech transfer and licensing?

Lately, I’ve been sharing some views on “A Faster Path from Lab to Market” (from the title of a Harvard Business Review article).



Some thought-leaders have made a case that current restrictions imposed by U.S. research universities on the ways their faculty can commercialize federally funded discoveries are slowing the diffusion of new technologies.



As readers of this blog will know, most universities channel commercialization through centralized technology licensing offices established in the wake of the passage of the Bayh-Dole Act. Over time, according to some, too many of these offices have become monopolies that slow the process of commercialization due to the constraints of the current system.



“We know that there are many vital innovations and discoveries languishing in university labs because of a suboptimal licensing system at many universities,” said Robert Litan, vice president for research and policy at the Kauffman Foundation. “One simple amendment to the Bayh-Dole Act would allow faculty members to choose their own licensing agents/experts and bring these discoveries to market quickly. Unleashing this kind of innovation will lead to the creation of new companies and new jobs.”



This approach, argue that if faculty members can choose their own licensing agents, the increased competition would speed up the commercialization of new technologies while still allowing universities to collect the same royalties as under the current system. The free agency solution is one of the 10 ideas that HBR says “will make the world better.”



In sum, continued federal support for research in academia and the federal labs is important for innovation, and has important economic benefits for the national economy and local economies. But at the same time, we will not maximize the benefits of this spending for society unless we do all we can to maximize the incentives for commercializing the innovations that this spending generates.



Our current innovation eco-system has clear limitations. These can and should be addressed as part of any national “innovation agenda.”



I've found in my work with Bioscience Bridge that we support many of the ideas here for doing so.



Bioscience Bridge is a technology transfer agency represents leading universities and their tech transfer offices. We connect partners to in-license life science discoveries and medical inventions for development into new products, applications, or services.

Strategic GPS: Where is the regional impact of licensing of university innovation

In other recent posts, I’ve been sharing some views on “A Faster Path from Lab to Market” (from the title of a Harvard Business Review article).



As universities and federal labs step up the commercialization of their innovations through tech transfer, the discoveries by faculty members often create “star scientists.”



Beyond the impact of star scientists on specific universities or firms, there are many regional benefits.



Kauffman Foundation researchers Robert Litan and Dane Stangler write that the mere existence of star scientists in a given region has a propensity to increase the number of technology startups in the area.”



In part, this positive impact flows from scientists working directly with businesses. In addition, the “star power” these scientists bring to their enterprises help develop an ecosystem—other scientists and professionals, as well as skilled workers—around the firms they help create. This ecosystem makes it easier for other entrepreneurs with their own ideas to launch new ventures, creating a virtuous circle of development.



It is in this way that regions can develop into hubs of new technology, ventures and ideas. Examples given by the Kauffman Foundation include: Silicon Valley with Stanford and Berkeley, Austin (University of Texas), Boulder (University of Colorado), San Diego (UC San Diego), Raleigh-Durham-Chapel Hill (Duke, North Carolina, North Carolina State), and Seattle (where the local university, Washington, has been important, but not the critical ingredient to that area’s entrepreneurial success).



When I work with early-stage technologies through Bioscience Bridge, we use a proven process designed to configure the technologies’ “road map” called Strategic GPS® Navigation Process. This process:

• Identifies the key targets

Articulates the current situation (Where we are)

Defines the desired objective (Where we want to be) 

Conveys the over-arching strategy

Delineates the milestones

Outlines the key tactics

Strategic GPS: The numbers show where we’re headed with university innovation

If you took academic innovators out of the commercialization process, it could significantly reduce the likelihood that the discoveries from the lab will be turned quickly to productive uses by society outside the university.



That’s the view from Bioscience Bridge, because they believe creative academic thinking alone cannot promote medical advancement unless it is applied to real-world scientific problems and challenges.



In this blog, let’s look at some numbers on how the spreading of ideas is regularly best accomplished when an innovation is commercialized. This gives the innovation the infusion of human and financial capital that enables innovations to scale up.



Here are some numbers that show where we’re headed:



Block and Keller published “Where Do Innovations Come From? Transformations in the U.S. National Innovation System” in which they showed universities and federal laboratories have become much more important sources of the top 100 innovations over the last 35 years. They analyzed the top 100 “most technologically significant new products” listed each year in R&D magazine. In 1975, for example, they note that private firms accounted for over 70% of the R&D 100, while the academic institution share was just 15%. By 2006, just three decades later, these two shares were reversed: academia contributed over 70% of the top 100 innovations, while private firms accounted for about 25%.



University-generated innovations, if anything, should be even more important to the U.S. economy and society in the years ahead.



Moreover, I’ve always believed that creativity is thinking about new ideas, while innovation is putting ideas into practice.



That’s why in my work with Bioscience Bridge, we work with early-stage technologies using a proven process designed to configure a “road map” called Strategic GPS® Navigation Process. This process identifies the key targets, articulates the current situation (where we are) and defines the desired objective (where we want to be). Most important, it conveys the over-arching strategy and delineates the milestones to bridges the science and the business.

Strategic GPS: Where we’re heading toward an open, competitive licensing system for university innovators

Over the last few years, experts in our field have been debating ways to create “A Faster Path from Lab to Market” (from the title of Litan and Mitchell’s article in Harvard Business Review).



Increasingly, universities and federal labs are accelerating the dissemination of their innovation through commercialization activities—particularly the licensing of discoveries by faculty members either to existing firms or to companies they form. Some have argued whether commercialization should be a university function at all, since they believe that universities exist to further the creation of new basic knowledge – not to engage in commercialization.



Based on this view, they worry that commercial activities distract faculty from more fundamental research and their instructional activities. Moreover, it is occasionally claimed that commercialization can warp the values and culture of the university, its faculty and its leaders.



In my work with Bioscience Bridge, I believe creative thinking alone cannot promote medical advancement unless it is applied to real-world scientific problems and challenges.



And this spreading of ideas is regularly best accomplished when an innovation is commercialized. This gives the innovation the infusion of human and financial capital that enables innovations to scale up.



Bioscience Bridge is a technology transfer agency represents leading universities and their tech transfer offices. We connect partners to in-license life science discoveries and medical inventions for development into new products, applications, or services.

21% of new drugs approved from 1990-2007 involved PSRIs

It’s been about a year now since the New England Journal of Medicine published an article by AUTM President Ashley Stevens finding public-sector research had a more immediate effect on improving public health than was previously realized. (Stevens AJ, et al. N Engl J Med 2011;364:535-41)

Just about the same time, I was advising Bioscience Bridge on connections for university research from Boise State, Tulane, and Purdue.

This research article underscores the important role the universities play in improving healthcare.  And why Bioscience Bridge continues to create attention to commercialization of intellectual property.

In the introduction to the article, Stevens states that historically, “public-sector researchers have performed the upstream, basic research that elucidated the underlying mechanisms of disease and identified promising points of intervention.”

This is contrasted with corporate researchers who performed the downstream, applied research resulting in the discovery of drugs for the treatment of diseases – and who carried out development activities to bring them to market.

Today, however, the boundaries between the roles of the public and private sectors have shifted substantially since the dawn of the biotechnology era, and the public sector now has a much more direct role in the applied-research phase of drug discovery.

The authors (organized by Stevens, and including researchers from Boston University Schools of Medicine, Law and Management, the Radium Hospital, Oslo, along with collaborators from the National Institutes of Health led by Mark Rohrbaugh, Ph.D., J.D.) found that during the past 30 years, 153 new FDA-approved drugs, vaccines, or new indications for existing drugs were discovered through research carried out in public sector research institutions (PSRIs). These drugs included 93 small-molecule drugs, 36 biologics, 15 vaccines, 8 in-vivo diagnostic materials, and one over-the-counter drug.

Their conclusion:

“We believe that our study supports the concept that the emergence of biotechnology in the mid-1970s, combined with policy changes implemented in the early 1980s regarding the ownership and management of the intellectual property of PSRIs, allowed these institutions to play an important role in the downstream, applied phase of drug discovery.”

Specifically, the data show that PSRIs have contributed to the discovery of 9.3 to 21.2% of all drugs involved in new-drug applications approved during the period from 1990 through 2007. It also suggests that PSRIs tend to discover drugs that are expected to have a disproportionately important clinical effect.

9 best practices in technology licensing -- and the effects of patents in drug repositioning

This is the last of five posts this weekend on drug positioning -- trying to get a new drug genie out of the bottle.

And remember why it's of such interest:

Drug development is a long, complex, costly, and high-risk business. According to the Tufts Center for the Study of Drug Development, drug development from discovery to U.S. approval takes about 15 years on average and costs over $1 billion, and only 3 in 10 drugs on average make enough revenue to sustain R&D.

In order to get a return on investment, companies need to ensure that their repositioned drug will have at least some patent protection. 

Drug repositioning candidates that are still in development may have composition of matter patents, depending on how far into development they are and how long they have been on hold. Companies developing off patent drugs or drugs with patents close to expiry have to rely on data protection, method of use patents, or patents related to formulation technologies. 

Manufacturers launching drugs have some protection against generic competition through data exclusivity, which provides 3 to 11 years of data protection after launch, depending on the market.

Read more in “Getting The Drug Repositioning Genie Out Of The Bottle” at www.lifescienceleader.com

I’m working now with a small nanotechnology company in this area of Technology Licensing.

We work at ensuring best practices for success are being followed by both parties in the licensing process. This may include identifying target application areas, drafting communication documents, promoting technologies on-line and through direct personal contacts, and providing assistance in deal facilitation and in the negotiation process.

1. Non-disclosure agreements
2. Needs and objectives
3. Key elements of the term sheet
4. Positions on relevant issues
5. Negotiating schedule and deadlines
6. Progress reports
7. Documentation
8. Draft agreements
9. Legal counsel

The challenges in drug repositioning -- and application of B.E.A.M.S

In my weekend series of posts on drug repositioning, let's look at a number of challenges for companies repositioning drugs.  Some are unique to this process and others common to any form of drug development. 

In the development of a drug for a completely new indication, drug repositioning cannot avoid the potential risk that the drug will not be effective in late-stage clinical trials -- especially if it has not previously moved further forward than preclinical development.

Drug repositioning can be based on marketed drugs that are off patent. This means that the active ingredients are easily available. However, if the dose required is similar to the dose used for an existing indication, physicians may simply choose to use the generic form, which is likely to be cheaper than the newly available, and possibly higher cost, branded repositioned drug.

“Because of this, it is important for a repositioned drug to have a difference in presentation. This may be a difference in delivery system or formulation, or a significant difference in dose — for example, Merck & Co launched the 5-alpha reductase inhibitor finasteride as Proscar for benign prostatic hyperplasia and then relaunched it as Propecia, at a significantly reduced dose and under a new patent, for male pattern baldness,” says one major company executive.

Access to data can have an impact on drug repositioning timelines. Companies that are developing a compound that they have not originated will need access to a competitor’s data or will have to rely on public domain data. This dependence on publicly available data can have its pitfalls. “If the company relies wholly on using public databases for their in silico screening, then there is a risk that their discovery may be found simultaneously by others,” adds another industry expert.

It may be harder for drug repositioning companies to get funding, as some investors have been burned by project failures, and others may be more familiar with traditional drug development and so are unsure how to value repositioning projects, especially as existing financial models don’t work.

Read more in “Getting The Drug Repositioning Genie Out Of The Bottle” at www.lifescienceleader.com

When I have consulted with Bioscience Bridge, LLC, we worked with clients to classify and prioritize existing technology assets through the use of our proven process in the evaluation of a university’s bioscience IP portfolio.

The B.E.A.M.S. Evaluation Tool measures a technology’s:

• Breakthrough potential
• Ease of development
• Advantages over competitive technologies
• Marketability
• Sampling or prototyping for evaluation

2 experts answer "What are the opportunities for drug repositioning?"

Drug repositioning is a growing field, with many companies looking to exploit its potential.  

In today’s blog, we hear from two industry executives:

1. Ken Phelps, president and CEO, Camargo Pharmaceutical Services. Phelps founded Camargo in 2003 as a strategic partner in drug development, including drug repositioning.
   
   
2. Steven Flostrand, MBA, business development director, Marco Polo Pharmaceuticals. “From a commercial perspective, with the era of ‘easy’ discoveries seemingly over, it makes sense to revisit existing drugs to ensure that we are making the best possible use of them.” Marco Polo Pharmaceuticals, founded in 2008, specializes in geographic repositioning — developing existing drugs for new markets.

Phelps says, “Generic companies are aware that as pharma pipelines decline, there will be a fall in the number of molecules coming off patent, so they are using drug repositioning to create new markets. Pharmaceutical companies are using drug repositioning to extend the life cycles of marketed products, creating new patents and defending themselves against generic competition, and to salvage the investment in failed or failing drug candidates. Finally, entrepreneurs are creating new drug repositioning companies to provide a service.”

Flostrand comments, “Many older drugs and drug candidates in development have never been fully explored. These can be looked on as resources, as they already have stores of valuable preclinical and clinical data on toxicity, safety, and dosing.”

Read more in “Getting The Drug Repositioning Genie Out Of The Bottle” at www.lifescienceleader.com

4 kinds of candidates for drug repositioning

Because of the decline in drug launches, drug development companies are under increasing pressure to reduce costs and shorten development timelines through a range of different approaches.

These approaches include improving processes and protocols, moving more toward collaboration, and licensing and drug repositioning.

This weekend, I'll be posting a series of blogs on "drug repositioning.”  Also known as drug repurposing, drug reprofiling, or therapeutic switching, is the process of developing existing molecules for new indications.

Candidates for repositioning fall into four key groups, explains David Cavalla, Ph.D., founder of Numedicus:

1. marketed drugs that are still under patent or patents that have expired,
2. drugs that have moved through development and fallen at clinical or regulatory hurdles, and
3. stereoisomers or metabolites of existing compounds.
4. small change in the molecular structure — this provides stronger patent protection but still reduces the risk of failure.

Cavalla founded Numedicus in 2008 to provide collaborative services to companies seeking novel uses for existing drugs.

Read more in “Getting The Drug Repositioning Genie Out Of The Bottle” at www.lifescienceleader.com