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Open Innovation in Small Molecule Lead Discovery 
“Center for Open Innovation in Drug Discovery” 
From Molecules to Business –25 September 2014 
JacWijkmans
Take Home Messages 
Great need to organize pharma R&D in a different way 
Academia hold the key to bridge the innovation gap between exploratory research & early clinical development 
Merge the strengths of academic & industrial drug research 
Initiated a feasibility study to create “Center of Open Innovation in Drug Discovery” to place RU/Radboudumcat forefront of translational medicine 
Similar successful initiatives exist abroad that have proven to provide a sustainable academic drug discovery enterprise
The Pharma Landscape 
Society 
‒Increasing incidence of chronic diseases. 
‒Escalating health care costs 
‒Increased patient awareness 
‒Personalized health care 
Industry 
‒Declining productivity 
‒Risk aversion 
‒R&D externalization 
‒Late stage focus 
‒Innovationpull 
‒Driver: Shareholder value 
Academia 
‒Austerity measures 
‒Clinical trial experts 
‒Increasingly entrepreneurial 
‒Early stage focus 
‒Valorizationpush 
‒Driver: Publications & health
Evolving R&D Process 
<2005: The ‘good old days’ 
2005 -present:Shift fromR&D toS&D (Search & Development) 
Industry 
Academia 
Pre-clinical candidate
Need to Organize Early R&D Differently 
Spin-off 
CRO #1 
CRO #2 
CRO #3 
? 
A: 
B: 
‒Too early to out-license 
‒Shortagein funds 
‒Missing skills 
‒No open innovation(recycling of knowledge, molecules, IP) 
Issues
Academia Hold the Key, however, … 
… while targets, assays, compound synthesis & patients are present, medicinal chemistry capabilities are critically missing 
Frye et al. Nature Rev. Drug Discov. 10, 2011, 409
Medicinal Chemistry 
Optimizing Molecular properties to get into Business 
Not acceptable Ideal 
1. Affinity 
2. Selectivity 
3. Efficacy 
4. Solubility 
5. Metabolic Stability 
6. Protein binding 
7. Toxicity
Medicinal Chemistry 
Optimizing Molecularpropertiestoget intoBusiness 
Ideal 
Not acceptable 
1. Affinity 
2. Selectivity 
3. Efficacy 
4. Solubility 
5. Metabolic Stability 
6. Protein binding 
7. Toxicity 
Multidimensional 
optimization 
paradigm
Empower Academic Drug Research 
Academic biomedical research 
Medicinal chemistry capabilities 
“Blend academic biomedical research with industry- standard drug discovery capabilities to valorize innovation” 
“Establish a leading force in academic drug discovery” 
Center for Open Innovation in Drug Discovery 
COIDD
Creating Value Chains
A Sustainable Pharma R&D Ecosystem 
IP 
(pre-)clinical candidates 
Platform technologies 
Spin-offs 
Publications 
Synergies/cross- overs 
Education & training 
$$$ 
$$$ 
Potential projects identified 
European Lead Factory 
HTS
Center forOpen Innovationin Drug Discovery (COIDD) 
Incorporate the highest level of drug discovery into academic research and advance the most exciting scientific breakthroughs towards the development of drug candidates suited for clinical studies 
Vision 
Establish an unique & sustainable pharmaceutical R&D ecosystem to create new small molecule therapeutics to improve public health and place RU/Radboudumcat forefront of translational medicine 
Mission
COIDD CoreExpertise 
MedicinalChemistry 
Chemical Biology 
Drug discovery 
Tool compounds 
Project Management & Development 
Leads & (pre)clinicalcandidates 
New projects 
industry-trained professionals 
Dedicated facilities
Open Innovation in Practice 
New molecular target or differentiating assay 
Clinical 
Need? 
amenable 
for HTS? 
HTS & compound optimization 
Pre-clinical candidate 
out- 
licensing/ 
partnership 
For example: 
Revolving funds
A Validated & Sustainable Model! 
“De-risking investments in new treatments for brain disorders by blending academic based research with state-of- the-art drug discovery resources” 
“Bringing dedicated medicinal chemistry expertise to bear on biological targets being investigated by UNC faculty”
A Validated & Sustainable Model! 
Vanderbilt Center for Neuroscience Drug Discovery 
Founded in 2003, Track Record: 
2009:Drug discovery pact with J&J 
2010:Research collaboration with Seaside Therapeutics 
2011:Partnership Michael J. Fox Foundation 
2011:License deal KarunaPharma 
2012:BMS Parkinson R&D collaboration 
2013:Licensing & research deal with AstraZeneca 
“De-risking investments in new treatments for brain disorders by blending academic based research with state-of- the-art drug discovery resources”
A Validated & Sustainable Model! 
“Exploiting and transforming innovative research into pharmaceutical applications in close cooperation with academic partners” 
Lead Discovery Centre Dortmund 
Founded in 2007, Track Record: 
2011:First LDC lead licensed to Bayer 
2013:2nd LDC lead licensed to Qurient 
Drug discovery alliance AstraZeneca 
Strategic partnership Merck Serono 
2014:Drug discovery alliance Daiichi Sankyo
Embedding in Health Valley Region 
Radboud NanomedicineAlliance 
“HealthyBrain” 
Technology centers
Feasibility Study –Next Steps 
1.Get buy in and commitment from major stakeholders 
2.Determine focus, identify key partners, select projects 
3.Learn from “best practices” 
4.Further develop business plan (revenue model, financial requirements, organization, team) 
5.Apply for grants, raise capital investments 
6.Build team 
3Q4Q1Q2Q3Q 
2015 
2014 
preparation phase 
financing phase 
Go/NoGo 
Accelerate 
Project X 
Project Y 
Start
Conclusions 
Great need to organize pharma R&D in a different way 
Academia hold the key to bridge the innovation gap between exploratory research & early clinical development 
Merge the strengths of academic & industrial drug research 
The COIDD will place RU/Radboudumcat forefront of translational medicine 
Successful & sustainable precedents of COIDD exist but The Netherlands are falling behind … and we are determined to change this!
Initiators 
Prof. Floris Rutjes 
Dr. Thea van Kemenade 
Prof. Alain van Gool 
Dr. Pedro Hermkens 
Dr. JacWijkmans

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Open Innovation Small Molecule Lead Discovery

  • 1. Open Innovation in Small Molecule Lead Discovery “Center for Open Innovation in Drug Discovery” From Molecules to Business –25 September 2014 JacWijkmans
  • 2. Take Home Messages Great need to organize pharma R&D in a different way Academia hold the key to bridge the innovation gap between exploratory research & early clinical development Merge the strengths of academic & industrial drug research Initiated a feasibility study to create “Center of Open Innovation in Drug Discovery” to place RU/Radboudumcat forefront of translational medicine Similar successful initiatives exist abroad that have proven to provide a sustainable academic drug discovery enterprise
  • 3. The Pharma Landscape Society ‒Increasing incidence of chronic diseases. ‒Escalating health care costs ‒Increased patient awareness ‒Personalized health care Industry ‒Declining productivity ‒Risk aversion ‒R&D externalization ‒Late stage focus ‒Innovationpull ‒Driver: Shareholder value Academia ‒Austerity measures ‒Clinical trial experts ‒Increasingly entrepreneurial ‒Early stage focus ‒Valorizationpush ‒Driver: Publications & health
  • 4. Evolving R&D Process <2005: The ‘good old days’ 2005 -present:Shift fromR&D toS&D (Search & Development) Industry Academia Pre-clinical candidate
  • 5. Need to Organize Early R&D Differently Spin-off CRO #1 CRO #2 CRO #3 ? A: B: ‒Too early to out-license ‒Shortagein funds ‒Missing skills ‒No open innovation(recycling of knowledge, molecules, IP) Issues
  • 6. Academia Hold the Key, however, … … while targets, assays, compound synthesis & patients are present, medicinal chemistry capabilities are critically missing Frye et al. Nature Rev. Drug Discov. 10, 2011, 409
  • 7. Medicinal Chemistry Optimizing Molecular properties to get into Business Not acceptable Ideal 1. Affinity 2. Selectivity 3. Efficacy 4. Solubility 5. Metabolic Stability 6. Protein binding 7. Toxicity
  • 8. Medicinal Chemistry Optimizing Molecularpropertiestoget intoBusiness Ideal Not acceptable 1. Affinity 2. Selectivity 3. Efficacy 4. Solubility 5. Metabolic Stability 6. Protein binding 7. Toxicity Multidimensional optimization paradigm
  • 9. Empower Academic Drug Research Academic biomedical research Medicinal chemistry capabilities “Blend academic biomedical research with industry- standard drug discovery capabilities to valorize innovation” “Establish a leading force in academic drug discovery” Center for Open Innovation in Drug Discovery COIDD
  • 11. A Sustainable Pharma R&D Ecosystem IP (pre-)clinical candidates Platform technologies Spin-offs Publications Synergies/cross- overs Education & training $$$ $$$ Potential projects identified European Lead Factory HTS
  • 12. Center forOpen Innovationin Drug Discovery (COIDD) Incorporate the highest level of drug discovery into academic research and advance the most exciting scientific breakthroughs towards the development of drug candidates suited for clinical studies Vision Establish an unique & sustainable pharmaceutical R&D ecosystem to create new small molecule therapeutics to improve public health and place RU/Radboudumcat forefront of translational medicine Mission
  • 13. COIDD CoreExpertise MedicinalChemistry Chemical Biology Drug discovery Tool compounds Project Management & Development Leads & (pre)clinicalcandidates New projects industry-trained professionals Dedicated facilities
  • 14. Open Innovation in Practice New molecular target or differentiating assay Clinical Need? amenable for HTS? HTS & compound optimization Pre-clinical candidate out- licensing/ partnership For example: Revolving funds
  • 15. A Validated & Sustainable Model! “De-risking investments in new treatments for brain disorders by blending academic based research with state-of- the-art drug discovery resources” “Bringing dedicated medicinal chemistry expertise to bear on biological targets being investigated by UNC faculty”
  • 16. A Validated & Sustainable Model! Vanderbilt Center for Neuroscience Drug Discovery Founded in 2003, Track Record: 2009:Drug discovery pact with J&J 2010:Research collaboration with Seaside Therapeutics 2011:Partnership Michael J. Fox Foundation 2011:License deal KarunaPharma 2012:BMS Parkinson R&D collaboration 2013:Licensing & research deal with AstraZeneca “De-risking investments in new treatments for brain disorders by blending academic based research with state-of- the-art drug discovery resources”
  • 17. A Validated & Sustainable Model! “Exploiting and transforming innovative research into pharmaceutical applications in close cooperation with academic partners” Lead Discovery Centre Dortmund Founded in 2007, Track Record: 2011:First LDC lead licensed to Bayer 2013:2nd LDC lead licensed to Qurient Drug discovery alliance AstraZeneca Strategic partnership Merck Serono 2014:Drug discovery alliance Daiichi Sankyo
  • 18. Embedding in Health Valley Region Radboud NanomedicineAlliance “HealthyBrain” Technology centers
  • 19. Feasibility Study –Next Steps 1.Get buy in and commitment from major stakeholders 2.Determine focus, identify key partners, select projects 3.Learn from “best practices” 4.Further develop business plan (revenue model, financial requirements, organization, team) 5.Apply for grants, raise capital investments 6.Build team 3Q4Q1Q2Q3Q 2015 2014 preparation phase financing phase Go/NoGo Accelerate Project X Project Y Start
  • 20. Conclusions Great need to organize pharma R&D in a different way Academia hold the key to bridge the innovation gap between exploratory research & early clinical development Merge the strengths of academic & industrial drug research The COIDD will place RU/Radboudumcat forefront of translational medicine Successful & sustainable precedents of COIDD exist but The Netherlands are falling behind … and we are determined to change this!
  • 21. Initiators Prof. Floris Rutjes Dr. Thea van Kemenade Prof. Alain van Gool Dr. Pedro Hermkens Dr. JacWijkmans