Transcript see slides from dr. alving`s presentation

National Center for
Research Resources
NATIONAL INSTITUTES OF HEALTH
T ranslatIng
research from basic discovery to improved patIent care
Enhancing Translational Research Through
Public-Private Partnerships
Third Annual Meeting of the Indiana CTSI
April 25, 2011
Barbara Alving, M.D., MACP
Director,
National Center for Research Resources
National Institutes of Health
Goals of the CTSA Program
Led by the National Center for Research Resources
the CTSA program supports a national consortium
of medical research institutions that work together
and share a common vision to:
 Improve the way biomedical research is
conducted across the country
 Reduce the time it takes for laboratory
discoveries to become treatments for patients
 Engage communities in clinical research efforts
 Train a new generation of clinical and
translational researchers
www.ncrr.nih.gov/ctsa
NCRR
CTSA Consortium Goals: Promoting Efficient
Translation from Laboratory to Community
Basic Research
Enhancing T1 and PublicPrivate Partnerships
Clinical Research
Improving Clinical
Research Management
Clinical and Community Practice
Enhancing Health of Communities/
Comparative Effectiveness Research
Promoting Collaborations, Providing Tools, Addressing Informatics Needs
Training
NCRR
CTSA Consortium – Building Connections at
University of California, Davis
Center for Entrepreneurship seminars to explore links between
research and inventions. Topics include:
 Dynamics of the commercialization process of new inventions
 Moving along the path of research to market
 Purpose of intellectual property in the commercialization
process
 When is an idea worth protecting and why
 Options for faculty, students, and staff in commercializing
their research
 Resources available to navigate the journey from research to
commercialization
NCRR
Columbia CTSA and Merck Collaboration
 Establishment of a seminar series developed to introduce
Columbia investigators to drug development by scientists
from Merck Pharmaceutical
NCRR
Gender Differences in Patenting in the Academic
Life Sciences
Reasons for Lower Likelihood for Patenting
Among Women Faculty:
 Lack of exposure to industry contacts
 Concern that pursuing commercialization will hinder academic career
opportunities
 Failure to include patenting into research strategy, especially among
senior researchers
Ding WW, Murray F, and Stuart TE. Gender differences in patenting in the academic
life sciences. Science 2006; 313: 665-667
NCRR
Interdisciplinary Team Science at Columbia CTSA
Gravity Neutral Orthotic (GNO) Device: a novel
rehabilitation device for people with severe physical
disability
 Columbia CTSA pilot funding enabled
neurologist Petra Kaufmann, M.D., M.Sc.* to
develop an apparatus for children with spinal
muscular atrophy (SMA)
 Partnered with Elisa Konofagou, Ph.D.,
Assistant Professor of Biomedical Engineering
and Radiology
 Outcome: Patent IR 2380: Limb motion capture
and rehabilitative assist device
* = Currently Associate Director for Clinical Research at the
National Institute of Neurological Disorders and Stroke, NIH
NCRR
CTSA-Related Translational Efforts at the
University of Pennsylvania
Commercialization and Entrepreneurship Program (CAEP)
 Exploring business practices and best
management models in developing
collaborations in the pre-competitive
space
 Developing workgroups to address
barriers to collaboration
 Engaging both the private and nonprofit sector to identify gaps and
opportunities for partnership and
collaboration with CTSA institutions.
http://www.itmat.upenn.edu/ctsa/caet/index.shtml
NCRR
2010 CTSA Industry Forum Highlights:
Models of Collaboration Between CTSAs and Industry
Northwestern University: Medical Device Innovation Course
 Students from various disciplines form teams
• Spend a few weeks in the hospital observing in
order to develop lists of clinical needs
• Develop a need statement based on a market
analysis, current products and competition, and
customer specifications
• Brainstorm a technology to solve a problem, screen
solutions, develop a prototype,
• Present it to the companies that sponsor the course
NUCATS
Clinical and Translational Sciences Institute
NCRR
Models of Collaboration Between CTSAs and Industry
Stanford University
Stanford Biodesign Program - mission is to develop leaders in
biomedical technical innovation
 Yearlong fellowship program for doctors in their residency and
graduate engineers
 Fellows work in teams and spend two months in clinical immersion to
develop a ranked list of 200 unmet needs
 Teams then brainstorms solutions and develops implementation
strategies that address areas such as IP, regulatory strategy, and
clinical trial design
Graduate Course in Biodesign
 Outside experts (venture capitalists) teach and advise the teams
 Teams work on highly-ranked needs that are identified but not
pursued by the biodesign fellows
 Fifteen companies have already formed based around fellow and
student innovation
NCRR
Models of Collaboration Between CTSAs and Industry
Stanford University
Stanford
 Also has two programs to fund more than $1 million
annually in proof-of-concept research:
 the CTSA program
 Grant from the Wallace H. Coulter Foundation
 A request for proposals for the CTSA program received
more than 80 proposals, of which 8 were funded
NCRR
Models of Collaboration Between CTSAs and Industry
University of California, San Francisco – T1 Catalyst Program
 Brings together academic-industrial teams
 Winning proposals work with consultants to make a
development plan
 Make presentations to potential partners
 Activities have resulted in seven funded projects
UCSF is testing whether the program could
be a model for the entire university
NCRR
Models of Collaboration Between CTSAs and Industry
University of California, San Francisco
Pfizer Collaboration
 $9.5 million, three-year collaboration with Pfizer
 Research activities are evenly divided between UCSF and
Pfizer
 UCSF maintains intellectual property rights to inventions
made on its campus, with Pfizer receiving the right to first
negotiation
 100 proposals have been reviewed and 7 funded
 Too early to judge success and the intellectual property
negotiations have not yet begun
NCRR
CTSA Translational Projects
The Scripps Translational Science Institute
Wireless Health Care Research
Scripps Translational Science Institute has partnered
with wireless telecommunications company
Qualcomm to use wireless technology to potentially
decrease health care cost
Pictured: Dr. Eric Topol (left), director of the
Scripps CTSA and Gary West, a philanthropist


CTSA program served as the catalyst that connected Scripps to
Qualcomm and other technology firms
Scripps and other CTSAs are conducting a 1,200-patient
randomized clinical trial to evaluate a wireless monitor (size of
large adhesive bandage) that monitors heart and breathing rates,
fluid status, posture, and activity data in patients with chronic
heart failure
NCRR
Providing New Ways to Speed Translation
Harvard Catalyst & InnoCentive Prize for Innovation
Using American Recovery and Reinvestment funding Harvard and
InnoCentive launched a series of contests aimed at investigating
whether new approaches might be useful in sparking novel research
directions and collaborations
February 1, 2010
 Harvard launched a search for new solutions for type
1diabetes by posting a challenge on their internal websites
 Cash prizes awarded for winning hypotheses or concepts
 Harvard investigators will then take these solutions to the next
level by conducting experiments to see if they work
NCRR
CTSA Pharmaceutical Assets Portal
UC Davis CTSA
 Provides investigators with access to
“shelved” compounds that can
be repurposed for other indications
 Has generated strong interest among
both researchers and pharma community
• Pfizer initiated agreement with UC Davis to further
develop Portal site
• UC Davis is also in talks with other industry groups
who also wish to list their available compounds
http://ctsapharmaportal.org/index.html
NCRR
CTSA Public-Private Partnerships
Intellectual Property Portal



Aggregates and markets
technologies from CTSA
institutions and NIH
Enhances research
activity and private
partnerships across the
CTSA consortium
Currently there are 15
CTSAs contributing
information on their
technologies to the site
http://www.rochesterctsa.org/ip/
NCRR
NCRR Recovery Act Funds to Enhance Scientist and
Resource Networking
Two Web-based initiatives bring power of Internet-based tools,
exemplified by social networking to biomedical research
Harvard Medical School
eagle-i: Networking Research Resources Across America
 Will create a federated national informatics network
 9 institutions participating
 Goal is to enable any investigator across America to discover research
resources that are presently invisible
University of Florida
VIVO: Enabling National Networking of Scientists
 Will create a social network to enable connections among the scientific
community and create pathways that lead to others they know
 6 institutions participating
www.ncrr.nih.gov/u24
NCRR
Collaborative Development of New Technology:
NCRR-DOE-Agilent
Next Generation Proteomics Platform: Prototype liquid chromatography-ion mobility
spectrometry- mass spectrometry (LC-IMS-MS)
Proteomics Research Resource Center for Integrative Biology
Pacific Northwest National Laboratory (PNNL)
•
Integration of NCRR and DOEsupported technology into a single
platform
•
Collaboration with mass
spectrometry instrument company
(Agilent)
•
Collaboration with OHSU CTSA :
First population scale proteomics
experiment
•
Instrumental methods
•
Sample handling
•
Data management and analysis
NCRR
NCRR- fundedTranslational Technology Development:
National Resource for Biomedical Accelerator Mass Spectrometry (AMS)
Lawrence Livermore National Laboratory (LLNL)
PI: Ken Turteltaub
 AMS is a highly sensitive technology for metabolic
studies
 Allows safe microdosing with toxic or
experimental molecules in humans
 An integrated HPLC-AMS system will make quantitative analysis of
metabolism and metabolic networks routine, analysis times will
decrease from 36 hours to 30 minutes
 Licensed patents to 3 commercial entities
 Workshop with Pharma held Nov 19, 2009
• Explored uses and barriers to the use of AMS in pharmaceutical research
• Planning second workshop focused on Academia and CTSAs
 Establishing international user’s group
 Working with Pharma
• NIAID contract ($27M/5 yrs) for taking broad-spectrum antibiotics to phase
1 with Trius Therapeutics
• Access through on fee-for-service ; provides education and training
NCRR
Thomas Edison: A Design Thinker
Design Thinking
 Methodology imbues the full spectrum of innovation
activities with an understanding of what people want
and need
Edison’s Approach
 Team-based
 Multidisciplinary
 Good business sense
 Nimble budget
 Full product launch — light bulb, electric power
system, etc.
Source: Brown T. Design thinking. Harvard Business Review.
June 2008.
NCRR
Taking a Global View of Design Thinking:
Aravind Eye Care System in India
Largest and Most Productive Eye Care Center in the World
More than an eye hospital, Aravind is:
 A social organization committed to the goal of elimination of
needless blindness through comprehensive eye care services
 An international center for research and implementation of
sustainable eye care programs as well as manufacturer of world
class ophthalmic products available at affordable costs
NCRR
Proposal for FY 2012: Creation of the
National Center for Advancing Translational Sciences
(NCATS)
To advance the discipline of translational
science and catalyze the development and
testing of novel diagnostics and therapeutics
across a wide range of human diseases and
conditions
NCRR
NCATS: Challenges & Opportunities
 Deluge of new discoveries of potential targets
 Unmet therapeutic needs for many conditions,
especially rare and neglected diseases
 Need to view drug development pipeline as a
scientific problem – ripe for experimentation and
process engineering
NCRR
NCATS: Functions
To improve processes in the therapeutics development pipeline
by:
 Experimenting with innovative approaches along the pipeline
utilizing an open-access model
 Choosing therapeutic projects to test innovative approaches
 Promoting interactions to advance regulatory science
To catalyze development of novel diagnostics and therapeutics
by:
 Encouraging collaborations, partnerships across all sectors
 Providing resources to enable therapeutic development
 Enhancing training in relevant disciplines
NCRR
NCATS will:
 Facilitate – not duplicate – other translational
research activities supported by NIH
 Complement – not compete with – the private
sector
 Reinforce – not reduce – NIH’s commitment to
basic research
NCRR