The Path to Product Excellence: Avoiding Common Pitfalls and Enhancing Commun...
Smb 30012014 martijn wilmer incedo bioscience
1. Incedo Bioscience is spinning off to
transport your drugs safely into clinical
development
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. 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. The history of ciPTEC
Conditionally Immortalized Proximal Tubule Epithelial Cell line
2002: collection of urine from healthy volunteers
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. 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. (…) 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. (…) 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. 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. 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. 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. The history of ciPTEC
Conditionally Immortalized Proximal Tubule Epithelial Cell line
2009
March 9th
manuscript submitted (Cell Tissue Research, IF 2.8)
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. 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. The history of ciPTEC
Conditionally Immortalized Proximal Tubule Epithelial Cell line
Current status:
EPO -> intention to patent
US
-> office action
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. 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. 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. 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. 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!
22. Start off a good model will boost the benefits
23. Unique selling points of ciPTEC
human origin
stable renal cell line
expression of relevant proteins
answer recent FDA/EMA recommendations
IP protected
24. Why is renal transport important?
ciPTEC applications:
• renal elimination studies
• drug-drug interactions
• renal toxicity
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
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. 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. 7 out of Top 12 Pharmaceutical
companies
showed serious interest in ciPTEC