Logged Time: 5-31-08: 2.5 hours 6-6-08: 2.5 hours 6-7-08: 0.5 hours 6-8-08: 2 hours 6-15-08: 1.5 hours 6-20-08: 0.5 hours Total: 31 hours 7-3-08: 2 hours 7-5-08: 1 hour 7-6-08: 1.5 hours 7-8-08: 1 hour 7-10-08: 1.5 hours 7-11-08: 1 hour 7-12-08: 1 hour 7-13-08: 1.5 hours 7-14-08: 1 hour 7-27-08: 3 hours 7-28-08: 1.5 hours 7-30-08: 0.5 hours 8-26-08: 1 hour 8-27-08: 1 hour 8-28-08: 1 hour Total:3 · “Initial Splash page” - Commercialization and Entrepreneurship 101, questions to direct towards either: o Welcome to the Epilepsy Therapy Project Entrepreneurship and Licensing Site! o Have an idea for a new epilepsy therapy that may help patients? Invented a technology or drug discovery platform that you want to patent or get funding to develop? Whether you’re starting from step 1 or have some knowledge of the commercialization process, this site will help guide you and provide advice on next steps to increase your chances of successfully bringing a new therapy to the market for the benefit of epilepsy patients. The site will answer questions such as § What do VCs look for? § What Funding Sources Are Available? (SBIR, NIH, Angels, VCs, Partnerships) § What do investors expect of me? § What do I look for in an Entrepreneur and what do they expect of me? § How do I keep from being taken advantage of in a business setting? o Content on this site is divided into licensing and entrepreneurship (links to definitions of each). The questions below should help guide you towards which section of the site is more appropriate. Feel free to browse both or skip directly to the Frequently Asked Questions section. To be clear, let me make one quick note on terminology – the term commercialization will often be used and simply means the entire process of developing a new therapy or technology and bringing it to the market. Licensing and entrepreneurship are simply two different modes of commercializing your invention. o
We welcome further input, additions, or comments
to the site! Please feel free to make
edits or to contact The Epilepsy Therapy Project or Chuck Eesley at eesley at
mit [dot] edu with questions or comments. · Licensing page and a Start-up page (product vs. company discussion) o A key question that it is worth spending some time thinking about early on in the process is whether to license your invention or to do a start-up. You may want to discuss the question with colleagues who have experience with one path or the other. Different people who you talk to may try to point you in one direction or the other depending on their interests, so it is important to think about the two options as they are quite distinct in what is required. Either way, the first step is to file an invention disclosure and have a conversation with your institution’s Technology Licensing Office (TLO). Depending on their resources, the TLO may help guide you in thinking through the following factors in whether a licensing or start-up arrangement is more appropriate. As a benchmark, for MIT, a very entrepreneurial university, about 20% of licenses are to start-up firms, so the vast majority of technologies developed appear to be more appropriate for a license to a large firm. o The decision comes down to four factors: § 1. Your Goals · If you choose to license your invention then you may wind up with a modest supplemental source of income and possibly some role in further scientific and technical development. · If you choose to participate in a start-up, then you can have a hand in shaping the entire process of choosing a first application, raising money, and commercializing the product. This can result in greater exposure to the experience of starting a business from scratch as well as equity in the company. § 2. The Resources Available (mostly - your time and energy) · The time and energy required of you to do a start-up is much higher than that required if you license the technology to an existing company or start-up. Depending on the size of the company that takes the license, on average licensing will require much less of your time and resources than doing your own start-up would. If your institution has a technology licensing (or technology transfer) office as most universities and medical schools do these days, then the personnel in that office will undertake much of the work in patenting and licensing your invention. However, it is important to recognize that these offices receive hundreds of invention disclosures each month. So yours may not receive the attention that you think it may merit or as rapidly as you like. § 3. Your tolerance for risk and expectations for Rewards · There is risk both in licensing and in starting a business, however, overall the risks (chances of failure) in a start-up are much higher. With those risks though, comes greater potential financial reward. Owning equity in a successful company can be much more lucrative than the royalty stream from licensing since most of the value generating activities come towards the end of the commercialization process. Nonetheless, there are risks inherent in licensing as well. If the license winds up being to a small company than many of the risks of a young, small company are present in this case as well. Even if the license winds up being to a large company, then there is often the risk that the large company will be slow to commercialize your therapy or may decide to bring an alternative technology to market and not to develop yours at all. Especially when technologies are very early stage or more radical or disruptive, large companies have historically been less likely to wind up bringing these products to market than small companies that have more to gain and less to lose. So there are risks on both sides, but overall the risks and the potential rewards of doing a start-up are higher. It is frequently the case that scientists and engineers will tend to think that all the hard work is in inventing and that commercialization and all the business side of marketing and selling the technology are relatively simple. This may be true, but it is important to recognize the high rate of failure for commercializing new technologies and there are many critical decisions and places where the risk of failure can pop up. It is my experience that most often the failure to bring an invention to the world results from people issues and not from a failure in the technology itself. Recognizing that the process from invention to successful commercialization is long and often difficult is important to properly set expectations. § 4. Is your invention a product or the basis for a business? · This is perhaps the most difficult of the four questions for an inventor to answer. It may require several conversations with your institution’s technology licensing office and local entrepreneurs and business people. In general, you should have a sense for which category your invention falls into. If the invention is a relatively minor improvement or single product with a small market, it is likely a better candidate for licensing. If the invention addresses a large market, is a substantial improvement, or could result in multiple products as a platform, then it could be more appropriate for forming a new start-up business around. This is a tricky question to know the answer to early on but it merits some thought. § Final thoughts · Whether through licensing or entrepreneurship, commercializing your new epilepsy therapy or diagnostic can be an exciting way to see results of your work in the real world. Many researchers, including MIT”s Institute Professor Robert Langer find commercialization to be a more effective means of bringing their work to the world than publishing. However, like publishing, in commercialization, you will find critical reviewers of your work that you must justify your contribution and advance over the state of the art in the field even when it seems obvious to you. Also like publishing, it is often a long process which does not always succeed on the first attempt. Nonetheless, if we are to make progress in the treatment of epilepsy, it is absolutely critical to have researchers who are willing to undertake the unique challenges of commercializing their innovations and bringing them to the bedside for physicians to use and patients to benefit from. · Licensing o Technology Transfer Offices § If you choose to license your technology then the first step is to talk with the Technology Licensing Office at your institution (sometimes these are called Technology Transfer Offices) and to file an invention disclosure form with them. The Association of University Technology Managers website has some resources discussing technology transfer. http://www.autm.net/aboutTT/index.cfm § The TLO officers will usually provide the following functions: evaluation of invention disclosures, management of literature searches, market assessment, decisions on patent filing, managing of outside attorneys on patent prosecution, marketing of the technology to potential licensees, negotiation of license agreements, and monitoring of licensee performance. o Should I conduct a patent search? No, it is typically best to leave this for the TLO. However, if you feel compelled to do a patent search to see if someone has already patented your invention, the following tools can be useful. § Patent search tool: www.priorsmart.com § Patent landscape tool powered by IPVision: www.see-the-forest.com
· Entrepreneurship o Even if you choose to do a start-up, the first step is still to go through your institution’s technology licensing office (TLO). The TLO will license the technology to the start-up firm that you and your cofounders create. · What to Look for in an Entrepreneur? · Business Plans – what to include and samples o http://mit100k.org/resource-business-plan-outline.php o Sample Executive Summaries § http://www.mit100k.org/docs/Summary_CheapTalk.pdf § http://www.mit100k.org/docs/Summary_CMS.pdf § http://www.mit100k.org/docs/Summary_SiliconTest.pdf § · Funding o What Funding Sources Are Available? (SBIR, NIH, Angels, VCs, Partnerships) o What do investors expect of me? o What do VCs Look For? § http://www.mit100k.org/entrant/vcpitch.php § How to Approach a VC - http://www.mit100k.org/docs/kivel_041702.pdf · What Do Entrepreneurs Expect of Me? - Timeline Expections, On-going involvement Expectations · Medical Devices vs. Pharmaceuticals o Medtech/Medical devices specific videos: http://biodesign.stanford.edu/bdn/resources/video.jsp o · Diagnostics vs. therapeutics · Common Start-up Mistakes · Common Licensing Mistakes · Characteristics of Successful Start-ups - Market size, competition, IP, regulatory path, reimbursement, adoption, major risks · General Strategies for Success and Dealing with Business People and Entrepreneurs · Much of this content should be duplicated in a FAQ page Links: A good basic outline for a Company Prospectus or First Draft Executive Summary for Investors and Entrepreneurs: http://otl.stanford.edu/industry/resources/ncprospectus.html General Resources MIT - http://www.mit100k.org/resources.php Stanford - http://otl.stanford.edu/inventors/resources.html#early Stanford bmesource – Biomedical technology specific - http://171.65.102.151/~bmesource/Entrepreneurship http://171.65.102.151/~bmesource How do Investors/Entrepreneurs Evaluate Business Plans? http://mit100k.org/resource-how-judges-evaluate.php Research tools – company and industry analysis http://entrepreneurship.mit.edu/research_tools.php Other portals of entrepreneurship resources: http://entrepreneurship.mit.edu/services_resources.php#portals Services for entrepreneurs: http://entrepreneurship.mit.edu/services_resources.php#services High-quality assessments for CNS-related clinical trials - MedAvante http://www.medavante.net/index.asp PharmaSTART™ is a consortium of research organizations led by SRI International that offers translational drug development services to help California-based universities, research institutes, and small biotech companies bridge the gap between identifying exciting new drug discoveries and bringing them successfully through clinical development. The goal of PharmaSTART is to facilitate the translation and funding of discovery research from California based Universities and their small cap companies, by offering drug development consulting, networking, and drug development services including lead development, GLP toxicology, analytical and regulatory services and cGMP manufacturing. Funding resources for entrepreneurs: http://entrepreneurship.mit.edu/services_resources.php#funding Legal and Government Resources: http://entrepreneurship.mit.edu/services_resources.php#legal Networking Tips and Tools: http://entrepreneurship.mit.edu/networking_tools.php General advice and tips from MIT alumni entrepreneurs: http://entrepreneurship.mit.edu/advice_tips.php#Wisdom Recommended Reading: Booklist http://entrepreneurship.mit.edu/booklist.php
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