Smb 30012014 martijn wilmer incedo bioscience

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Incedo Bioscience is spinning off to transport your drugs safely into clinical development

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Transcript of Smb 30012014 martijn wilmer incedo bioscience

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Incedo Bioscience is spinning off to

transport your drugs safely into clinical

development

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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

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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)

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Conditionally Immortalized Proximal Tubule Epithelial Cell line

2002: collection of urine from healthy volunteers

The history of ciPTEC

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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)

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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

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(…) 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 (…)

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(…) I want to put all my energy and focus on my PhD thesis

(…) I will not start a spin off company at this moment

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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

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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…

The history of ciPTEC

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The history of ciPTEC

2008: I’d like to forget it.

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)

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Conditionally Immortalized Proximal Tubule Epithelial Cell line

2009

March 9th manuscript submitted (Cell Tissue Research, IF 2.8)

The history of ciPTEC

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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

The history of ciPTEC

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Conditionally Immortalized Proximal Tubule Epithelial Cell line

2009

March 9th manuscript submitted (Cell Tissue Research, IF 2.8)

July 28th 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

The history of ciPTEC

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Conditionally Immortalized Proximal Tubule Epithelial Cell line

Current status:

EPO -> intention to patent

US -> office action

The history of ciPTEC

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We have a patented cell line. Who cares?

Scientists:

However: spreading the cells means competition!!

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.

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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

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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 3721-3722. Best regards,

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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 feed-back 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? (…)

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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!

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Let’s spin off!

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Start off a good model will boost the benefits

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Unique selling points of ciPTEC

human origin

stable renal cell line

expression of relevant proteins

answer recent FDA/EMA recommendations

IP protected

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• renal elimination studies

• drug-drug interactions

• renal toxicity

ciPTEC applications:

Why is renal transport important?

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Incedo transports your drugs into clinical development by:

• more efficient drug development

• reduce animal experiments

• decrease development costs

Why do FDA and EMA care?

pharmacokinetics

• decrease adverse effects

drug drug interactions

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Focused segmentation in developing market

$ 0,9 billion (2013) -> $ 2.2 billion (2018)

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Hybrid R&D Strategy: from service to product

Big

Pharma

SME/CRO

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Intelligent marketing & sales strategy

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Impressive product pipeline

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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)

Management Team

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• Superior predictive model: ciPTEC

• Successfull market introduction

• Targeted product-market combinations

• Revenues invested in R&D

• 5M revenues in 5 years with 500k investment

INCEDO bioscience

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7 out of Top 12 Pharmaceutical

companies

showed serious interest in ciPTEC

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WE TRANSPORT YOUR DRUGS INTO CLINICAL DEVELOPMENT