1 / 31

ACADEMIA,VENTURE AND ADVENTURE: from Academia to an SME

ACADEMIA,VENTURE AND ADVENTURE: from Academia to an SME. Patenting in Life Sciences – Challenges and Questions Eurotel Victoria, Les Diablerets, June 27 and 28, 2011 Christophe Bonny, PhD UGM-CHUV. From the lab to the start-up: how much is your I P worth ?.

herve
Download Presentation

ACADEMIA,VENTURE AND ADVENTURE: from Academia to an SME

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. ACADEMIA,VENTURE AND ADVENTURE:from Academia to an SME Patenting in Life Sciences – Challenges and Questions Eurotel Victoria, Les Diablerets, June 27 and 28, 2011 Christophe Bonny, PhD UGM-CHUV

  2. From the lab to the start-up: how muchisyourIP worth?

  3. 1. IP takes time.. Exemple: Xigen • 1997-2000: Technology developed at CHUV • 2000:First IP protecting lead compound (Composition of Matter) • 2002: Creation of Xigen as a “Development” company (stroke) • 2004: Initial financing round (5 MIO) • 2004: Out-licensing of first product (hearing loss) • 2006: Second financing round (20 MIO). Acceptance of IP in EU • 2008-2009: Completion of two Clinical Phases I trials; third financing (20 MIO) • 2009: New TA; repositioning of Xigen as a “Discovery” company • 2009: (Novel) Indications IP, first IP strikes, new data to be generated • 2010-2011: back to Xigen “Development”; launch of two Clinical Phases II trials • 2011: Acceptance of IP in US

  4. ..and means • A good part of your time and meanswill go to IP • Genarate new data • These times and meanswill not beused for publications or «funding»

  5. ..and if whatyou do is REALLY interesting… • So it’s REALLY going to take a lot of your time • Especiallyseveralyears AFTER filing

  6. 2. Your IP isyour value • How muchisyour IP worth? • Onlythreeparameters: • The size of the marketprotected by your IP • It iscalculated as the sum of the sales for a given indication • Thsstage of development (pre-/clinical) • Patents do not reallyinterest Pharmas before a Phase 1 (safety) and a first 2a (first indication of efficacy) • How much time isstillcovered by your IP

  7. ..somenumbers • Total costs for 2009, BIO: • Asthma: 6 • IBD: 5 • Cancer (breast): 11 • mAb: 32 • Source:

  8. …however! • Pre- and clinicalinvestmentis HUGE: • 50-300 MIO for «usual» pathologies • The RISK associatedwiththeseinvestmentswill MARKEDLY decrease the today’s value of your IP

  9. …and.. • The investments are sohugethat has a consequence, a product has not only to give a solution to a therapeuticneed, but before all and of the upmost importance: • Capacity to partnerwith a bigplayer BE SAFE

  10. 3. When to sellyour IP? You have to «de-risk», the consequencebeing: • Fact: It’salmost impossible to sell/partnerbeforecompletion of the clinical phases 1 and 2a: «safety & efficacy» • Bigadvantage of oncolgydrugs,-specificregulationfavorising straight jump into 1b/2a

  11. Investissements scales Required for a product to progress in the clinic • Pre-clinical: 0.5-1MIO • Phase 1: 1 MIO (15’000.-/patient-60) • Phase 2a: 1-2 MIO • Phase 2b: 2-5 MIO (20’000.-/patient-200) • Phase 3-4: 30-200 MIO (30’000.-/patient-3000) source: ClinicalTrialBenchmarking

  12. Evolution Of the risk-adjusted net present value (rNPV) of a compound throughdevelopment Ex: • 1.3 MIA/y sales • 5% marketshare: 65 MIO/y • x10 year IP-delayedPYS: ~0.6 BIO total revenues • 90% risk inPC: 60 MIO

  13. Realistically, sadlyenough… These values keep for a long time below the total amount of investmentsstill to bedonebeforemarket For IBD as an example, total investment up to marketis ~100 MIO: Valoafter PC: 60-100= - 40 MIO ValoafterPhase 1: 100-100= - 00 MIOValoafterPhase 2: 350-100= +250 MIO

  14. Inconclusion, youmightexpect.. • Somehundred of thousandsbeforePC • Verylowinterestfrom pharmas • 0.5-2 MIO afterPC • Lowintereststill • 1-3 MIO afterphase 1 • The intereststartsraising • 3-10 MIO afterPhase 2a • The interestbecomes real • A lot afterPhase 2b • And in all cases, milestonesand royalties (3-5% of sales)

  15. ..but do not forget • Pharmas spend30% of theirR&D budget in «clinical trials» • The solde of investmentisthere to identifynovelentities and bringthem in pre-clinical • That’swhatyoubring: yourresearch, ie70% of theirexpenses for a new product

  16. 4. How to calculate a rNPV(risk-adjusted Net Present Value)? • Simplystated: • Take total number for sales in yourgiven indication • Take5% of these total sales for yourproduct • Multiply by the number of years of sales covered by the IP • Correct by a «risk-factor» • Formule:

  17. 5. Whatis the investment? • IP filing: 5-10’000.- • National Phases:30-80’000.- • Keeping: 10’000.- • Total for 10 years: 200’000.- • Note that the buyerwill have to start by reimbursingthesecosts

  18. 6. How to value? • Start-up: • Finance clinicaldevelopment up to Phase 2a-2b (ideally), with the goal of maximalise return on IP andconvince a buyer • Dilution of your stocks willdecreaseyour return • Partner: • Immediatelyafteryour IP has been filed; «milestones payements»; lowerreturns • The biggestrisk: nobodygetsinterested

  19. 7. Conclusions • IP filingisonly the first step • IP valorizationisalwaystough • In most cases you have to generateclinical data beforeinteresting a buyer/partner • Role of start-ups • Valorization has to go throughindustrialpartnership • Start-up: stocks-options and royalties back to academia • Pharma: royalties throughacademia(5%) • The real work to protectyour IP oftenstarts 5 to 10 yearsafterfiling • This workwill not lead to publication

  20. the transferfrom the academic world..

  21. 1. The ideal world for a scientist.. • Being at the bench and/or running a lab with enough financial support to perform the desired experiments • Publish his results in the best journals • Get the credit for the work • No administration • Few teaching (possibly none) • Being paid decently for it BUT…as you know….

  22. The real world for a scientist.. • Difficult to get financial support for his research • Difficult to publish in the best journals (we even pay to publish, charges for pages or figures….) • The working week is more than 42.5h • Difficult to get tenured

  23. Getting a permanent position in CH.. • Be the right person at the right time in the right place without any enemy • Demonstrate that you are useful for the Institution or you will bring something new or important for the Department (research topic, IF, $$ grants, teaching experience, integration) • Be prepared for the interview (get advises if possible from insiders)

  24. If finally, you get tenured… The real world is: • Still difficult to get financial support for his research • Still difficult to publish in the best journals • Difficult not to be embedded in administrative tasks (teaching, members of commissions, running a department,…) • You will be asked to be a great scientist, a great fund raiser, a great speaker, a great administrator, a great teacher… • but at least you have a “more or less” secure position (reviewing), you can choose your research topic, organize your work, your week: freedom of research!!!

  25. 2. So..Should I really do it? • YES! • If you have any spark of an entrepreneur mindset… • If one day, you want to go concrete • If you have time to spend for it • Academia changed a lot in the last 10 years. By some aspects, it is also an enterprise (setting up projects, collaborations, organization…You will learn something which will be useful or interesting for you

  26. But still…Should I really do it? • YES! • If confidentiality was respected: any disclosure (you and your collaborators !!) • If I have well documented notebooks with dates and signatures • If it is an invention, it is new and has industrial potential • No similar invention/ product published, patented, or in the market • GO to the Tech transfer officer of your Institution

  27. If YES, be Careful to: • Be careful to the authors on the patent! Include only the persons who brought an idea or a development (not a technician who simply did what she was asked to do; it is not a publication) • Ask your collaborators to wage their rights to the tech transfer office or to let you in charge of it • Disclose everything you know (competitors) (Disclosure statement) • Once filed, follow up on the deadlines (patent law office should give you enough time) • To get it granted, go to the patent office and discuss with the patent officer

  28. 3. Can youmake a business out of it? • Identify the market (Marketsurvey) • Who are mycustomers? • How much are theywilling to pay? • Are theycompetitiveproducts? • Who are mycompetitors? • Whatismyadvantage(s)? • Time to reach the market? • How to getknown? • How much cash do I have? Whatismy business model: stand alone, develop and sell, sell licences and getmilestonepayment and royalties?

  29. Yourcompany: • Developyourcompany • How to fill up my pipeline? A single productcompany? • Survey the market, discusswithyourcustomers (who are they?), withsalesmen? • How to acquire the technology? the know-how? • Differentways to acquire the technology? The know-how? • Partnership

  30. Being employed in a start-up is not being employed in a SME.. • SME make money..start-ups don’t for many years • Your position in the company: • CEO: NOT a good idea, almost always • CSO: that’s a good idea, and it’s a good position • Project leader • Scientist • My future? • Adviser?

  31. 5. Conclusion: Certainly an exciting place to be.. • Good salary • Feeling of “concrete” • Feeling of “responsibility” • Feeling of contributing to some good • BUT:…FOR HOW LONG….?

More Related