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CTSA PHARMACEUTICAL ASSETS PORTAL www.ctsapharmaportal.org Kate Marusina, Ph.D., MBA  December 2009
Goals ,[object Object],[object Object],[object Object]
Achievements to Date ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What is CTSA? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CTSA Pharmaceutical Assets “Database” ,[object Object],[object Object],JANUARY 10, 2007 Penn Researchers Demonstrate Ability of New Therapy to Treat Patients With Severely Elevated Cholesterol Levels  New England Journal of Medicine Publishes Report of New Therapeutic Approach That Has Implications for People With High Cholesterol   (PHILADELPHIA) - Researchers at the  University of Pennsylvania School of Medicine  have demonstrated the potential of a new type of therapy for patients who suffer from high  cholesterol   levels. In this study, patients with homozygous  familial hypercholesterolemia  (FH), a high-risk condition refractory to conventional therapy, had a remarkable 51% reduction in  low-density lipoprotein (LDL)  or “bad cholesterol” levels.
Challenges of the “database” approach ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Recent Number of NMEs  Approved by FDA is Disappointing PhRMA R&D Productivity (Avg Annual R&D Spend Increase = 10.3%; ’90-’07) Source: Pharmaceutical Research and Manufacturers of America, PhRMA Annual Membership Survey, 2008; CDER PhRMA R&D Spend (Billions of Dollars) Number of NME Approvals by FDA NMEs  Approved
Research & Development Productivity Needs Attention  The Challenge – 1 of 10 is Aspirational!
…… ..but Opportunities to Improve Abound Preclinical Phase 1 Phase 2/ PoC Phase 3 Approval 65  55  25  65  85  Cumulative = 5% “ In times of profound change, the learners inherit the earth, while the learned find themselves beautifully equipped to deal with a world that no longer exists.”   “ It still holds true that man is most uniquely human when he turns obstacles into opportunities.” - Eric Hoffer Stage % Survival versus
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Pfizer Indications Discovery Products Process Evolution
Indications Discovery Business Plan –  An Ever-Evolving Model DISEASE RELEVANT SCREENING HYPOTHESIS GENERATION Reg Tox through Phase 2 Pre-Clinical VALIDATION Endorsement to Initiate Clinical PoC Study Internal, Partner, Out-license MINE EXISTING KNOWLEDGE ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Phase 3/Marketed CANs LDs Active Clinical Candidates Failed compounds – “RIPs” Those losing CoM patents Internal, Partner In vivo models Clinical Proof of Concept Internal, Partner, Out-license In vitro   assays
Pfizer Indications Discovery – Learnings  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Pfizer Indications Discovery – Key Focus Area: MoA-Disease Association  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Collaboration
An Invitation to Collaboration ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Two ways to create a match  between Academia and Pharma
From Academia to Pharma ,[object Object],[object Object],[object Object],[object Object]
How to join the Portal (www.ctsapharmaportal.org)
Members of the Portal (as of June 09)
The Portal at a glance ,[object Object],[object Object]
The Portal at a glance ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Specific target/disease interests (~150)
Two ways to create a match  between Academia and Pharma
From Pharma to CTSA via FoX target Disease A Disease A Disease C Disease B Disease D Disease B
FoX Pilot for 5 universities ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Data cloud for a target X
Examples of Filters ,[object Object],[object Object],[object Object],[object Object],[object Object]
Example of a Filter
Pharma Concerns re: research with their compounds ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Next steps – Contractual Issues ,[object Object],[object Object],[object Object],[object Object],[object Object]
Call for Action to the Foundations ,[object Object],[object Object],[object Object],[object Object],[object Object]
Summary - Future Plans ,[object Object],[object Object],[object Object]
Team : ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object]

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Pharma Assets Portal

  • 1.
  • 2. CTSA PHARMACEUTICAL ASSETS PORTAL www.ctsapharmaportal.org Kate Marusina, Ph.D., MBA December 2009
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8. Recent Number of NMEs Approved by FDA is Disappointing PhRMA R&D Productivity (Avg Annual R&D Spend Increase = 10.3%; ’90-’07) Source: Pharmaceutical Research and Manufacturers of America, PhRMA Annual Membership Survey, 2008; CDER PhRMA R&D Spend (Billions of Dollars) Number of NME Approvals by FDA NMEs Approved
  • 9. Research & Development Productivity Needs Attention The Challenge – 1 of 10 is Aspirational!
  • 10. …… ..but Opportunities to Improve Abound Preclinical Phase 1 Phase 2/ PoC Phase 3 Approval 65 55 25 65 85 Cumulative = 5% “ In times of profound change, the learners inherit the earth, while the learned find themselves beautifully equipped to deal with a world that no longer exists.” “ It still holds true that man is most uniquely human when he turns obstacles into opportunities.” - Eric Hoffer Stage % Survival versus
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16. Two ways to create a match between Academia and Pharma
  • 17.
  • 18. How to join the Portal (www.ctsapharmaportal.org)
  • 19. Members of the Portal (as of June 09)
  • 20.
  • 21.
  • 23. Two ways to create a match between Academia and Pharma
  • 24. From Pharma to CTSA via FoX target Disease A Disease A Disease C Disease B Disease D Disease B
  • 25.
  • 26. Data cloud for a target X
  • 27.
  • 28. Example of a Filter
  • 29.
  • 30.
  • 31.
  • 32.
  • 33.
  • 34.

Notas del editor

  1. 05/13/10
  2. Killing projects early is a theme to return to later in the talk.
  3. 05/13/10
  4. 05/13/10