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Smb 30012014 martijn wilmer incedo bioscience

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Smb 30012014 martijn wilmer incedo bioscience

  1. 1. Incedo Bioscience is spinning off to transport your drugs safely into clinical development
  2. 2. Curriculum Vitae Nov 2001 – March 2006 Technician Laboratory Pediatrics and Neurology Radboudumc April 2006 – Dec 2009 PhD student Laboratory Pediatrics and Neurology Radboudumc Jan 2010 – June 2010 Post Doctoral Fellow Pediatrics Katholic University Leuven July 2010 – present Post Doctoral Researcher Pharmacology and Toxicology Radboudumc
  3. 3. Main focus during 10 years of research Human renal epithelial cells And especially: The development and characterization of a human conditionally immortalized Proximal Tubular Epithelial Cell line (ciPTEC)
  4. 4. The history of ciPTEC Conditionally Immortalized Proximal Tubule Epithelial Cell line 2002: collection of urine from healthy volunteers
  5. 5. The history of ciPTEC Conditionally Immortalized Proximal Tubule Epithelial Cell line 2002: collection of urine from healthy volunteers 2005: immortalization using SV40t antigen and hTERT 2005-present: characterisation ciPTEC 2006: discovery of several drug transporters in ciPTEC Pgp (ABCB1) OCT2 (SLC22A2)
  6. 6. The history of ciPTEC Conditionally Immortalized Proximal Tubule Epithelial Cell line 2002: collection of urine from healthy volunteers 2005: immortalization using SV40t antigen and hTERT 2005-present: characterisation ciPTEC 2006: discovery of several drug transporters in ciPTEC 2007: first brainstorm towards commercial activities and patenting of ciPTEC
  7. 7. (…) new model system to study renal excretion of pharmaceutical compounds (…) protect this by a patent and find commercial partners (…) One of the co-inventors, Martijn Wilmer, would like to start a spin-off company in the future (…)
  8. 8. (…) I want to put all my energy and focus on my PhD thesis (…) I will not start a spin off company at this moment
  9. 9. The history of ciPTEC Conditionally Immortalized Proximal Tubule Epithelial Cell line 2002: collection of urine from healthy volunteers 2005: immortalization using SV40t antigen and hTERT 2007: first brainstorm towards commercial activities and patenting of ciPTEC 2008: first collaboration agreement with pharmaceutical industry “Preliminary evaluation of immortalised renal proximal tubular cell lines for an in vitro bi-directional transport assay” (…)we can conclude that this model is promising in terms of trans-epithelial transport experiments (…) …due to re-organisation: no fincancial support for an extension of the collaboration
  10. 10. The history of ciPTEC Conditionally Immortalized Proximal Tubule Epithelial Cell line 2002: collection of urine from healthy volunteers 2005: immortalization using SV40t antigen and hTERT 2007: first brainstorm towards commercial activities and patenting of ciPTEC 2008: first collaboration agreement with pharmaceutical industry 2008: I want to publish… discuss with valorisation about the do’s and dont’s of publishing material intended for IP -> don’t publish…
  11. 11. The history of ciPTEC Conditionally Immortalized Proximal Tubule Epithelial Cell line 2002: collection of urine from healthy volunteers 2005: immortalization using SV40t antigen and hTERT 2007: first brainstorm towards commercial activities and patenting of ciPTEC 2008: first collaboration agreement with pharmaceutical industry 2008: I want to publish… 2008: Rejection of patent application (characterization so far is not unique) 2008: I’d like to forget it.
  12. 12. The history of ciPTEC Conditionally Immortalized Proximal Tubule Epithelial Cell line 2009 March 9th manuscript submitted (Cell Tissue Research, IF 2.8)
  13. 13. The history of ciPTEC Conditionally Immortalized Proximal Tubule Epithelial Cell line 2009 March 9th manuscript submitted (Cell Tissue Research, IF 2.8) July 28th Surprise!! Other patent agency reports cell line itself can be IP protected Strict conditions: - not published yet - unique properties (that other cell lines don’t have) - deposit ciPTEC in cell bank
  14. 14. The history of ciPTEC Conditionally Immortalized Proximal Tubule Epithelial Cell line 2009 March 9th July 28th manuscript submitted (Cell Tissue Research, IF 2.8) Surprise!! Cell line itself can be IP protected!! September 9th manuscript accepted –under embargo because of IP issues October 26th deposit cell line at DSMZ November 4th filing patent; November 9th publication on-line 2010 Positive examination report 2011 May 4th International publication by WIPO (18 months after filing) 2012 May 4th PCT phase – protect ciPTEC in Europe and US
  15. 15. The history of ciPTEC Conditionally Immortalized Proximal Tubule Epithelial Cell line Current status: EPO -> intention to patent US -> office action
  16. 16. We have a patented cell line. Who cares? Scientists: I have read with great interest your paper describing the generation of an immortalized human proximal tubule cell line (Cell Tissue Res 2009). (…) I would like to ask you if it is possible to receive an early passage of your cell line and to use it in our lab. However: spreading the cells means competition!!
  17. 17. Dear Dr. …., (…) Therefore, I regret to inform you that because of IP issues we are not allowed to provide you with this cell model. Kind regards, Martijn Wilmer
  18. 18. Dear Dr. Wilmer, I am very delused from your answer. I believe that a correct scientific behaviour implies the free exchange of published materials. On this point there is a consent in the scientific community (…) Uniform Principle for Sharing Integral Data and Materials Expeditiously PNAS 2004 vol. 101 no. 11 37213722. Best regards,
  19. 19. Who else cares? Pharmaceutical Industry (…) From our side we are open to any type of deal including a license agreement with you. We are waiting for the feedback from your contact person from the technology Transfer Office. (…) For information are you planning to be close to Basle in the next future? If yes would you agree to visit us? (…)
  20. 20. But, do I care? Finally getting recognition for your scientific work from the outside world Apparantly there is a need Financing your scientific work with money from the industry Grants hard to obtain as junior PhD Obtain new (business) skills More future perspectives (compared to a ‘pure’ scientist) NGI Venture Challenge NIABA Biobusiness Masterclass Life Sciences meetings (drink&talk) A new goal after the ‘post-PhD-thesis-depression’: start a company!
  21. 21. Let’s spin off!
  22. 22. Start off a good model will boost the benefits
  23. 23. Unique selling points of ciPTEC human origin stable renal cell line expression of relevant proteins answer recent FDA/EMA recommendations IP protected
  24. 24. Why is renal transport important? ciPTEC applications: • renal elimination studies • drug-drug interactions • renal toxicity
  25. 25. Why do FDA and EMA care? pharmacokinetics • decrease adverse effects drug drug interactions Incedo transports your drugs into clinical development by: • more efficient drug development • reduce animal experiments • decrease development costs
  26. 26. Focused segmentation in developing market $ 0,9 billion (2013) -> $ 2.2 billion (2018)
  27. 27. Hybrid R&D Strategy: from service to product SME/CRO Big Pharma
  28. 28. Intelligent marketing & sales strategy
  29. 29. Impressive product pipeline
  30. 30. Management Team  Martijn Wilmer ◦ General management, technical and scientific development  John Speksnijder ◦ Business development, sales and marketing strategy  Advisory Board ◦ Roos Masereeuw (expert in pharmacology) ◦ Bert van den Heuvel (expert in renal cell biology) ◦ Laura Suter-Dick (FHNW, >20 years experience at Roche)
  31. 31. INCEDO bioscience • Superior predictive model: ciPTEC • Successfull market introduction • Targeted product-market combinations • Revenues invested in R&D • 5M revenues in 5 years with 500k investment
  32. 32. 7 out of Top 12 Pharmaceutical companies showed serious interest in ciPTEC
  33. 33. WE TRANSPORT YOUR DRUGS INTO CLINICAL DEVELOPMENT

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