Multiinvestigator Consortiums For Business and Research Activities

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Multi-investigator Consortiums For Business and
Research Activities
Richard Larson, MD, PhD Senior Associate Dean for
Research Professor, Pathology University of New
Mexico School of Medicine
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Challenges For Pathology Departments

• Declining Clinical Reimbursement
• Declining Funds for Sponsored Research
• Educational reimbursement

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Challenge Research Funding is harder to obtain
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Challenges Clinical reimbursement is declining
Changes in professional billing payment over
two year period among pathologists
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Innovative Approach Multiple investigator
consortiums

• Definition Collaboration and consortiums among
  multiple investigators, clinicians, or
  scientists, but with eye toward commercial/profit
  making component that may be used to support or
  further fund research/scholarly effort.

• Types
• Multiple-entity Clinical Enterprises
• Government-sponsored University/Commercial
• affiliations
• National Lab Affiliations

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Multi-investigator consortiums

• Advantages
• Plays to the strength of academic departments-
  specialized testing, academic endeavors, teaching
• Doesnt require cultural shift- allows
  academicians to approach collaboration in a
  comfortable manner
• Opportunity to address financial pressures while
  building academic or scholarly pursuits
• Can be pursued by Departments of all sizes
• Provides alternatives to NIH funding

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Multiple-Entity Clinical Enterprises

• TriCore Reference Laboratories

• A clinical enterprise that has supported
• our research and development activities
• and an outlet for scholarly pursuits
• A New Mexico not-for-profit corporation
• Established July 1, 1998, Started 1999
• Result of a regional laboratory
• consolidation
• Sponsors of TriCore
• University of NM Health Sciences Center
• Presbyterian Healthcare Services

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University of New Mexico Health Science Center

• 133 M in sponsored grants and contracts
• University Hospital is incorporated into UNM HSC
  (1954) 450 M in clinical care 127 M
  uncompensated
• Only Level I Trauma Center, Childrens Hospital,
  NCI-designated Cancer Center
• Only medical school in the state 75 students

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UNM Department of Pathology

• Faculty- 54 FTE
• Clinical
• 21.3 FTE
• 6-7 M in clinical billing (60 special
  arrangements such TriCore)
• Sponsored Research- 6.6 M direct costs
• Education- Significant role in Medical and
• Graduate School includes MLS program

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Presbyterian Healthcare Services

• States largest not-for profit healthcare
• organization
• Provides New Mexicans
• 1. acute hospital care (Cardiology)
• 2. primary and specialty ambulatory care
• 3. rehabilitation services
• 4. home nursing care
• 5. healthcare insurance plans
• In operation since 1908

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Reasons for Consolidation

• To hold and expand market share!
• Economies of scale to achieve a lower cost per
  test for sponsors hospitals
• To support a more expanded consultation service
  for the UNM Department of Pathology
• To expose UNM residents and medical technology
  students more real life pathology experience
• To support research effort (particularly
  traditional clinicopathologic studies, new
  testing methodologies, etc.)

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Guiding Business Principles

• Quality diagnostics
• Retain regional control of laboratory testing
• Employee equity/challenging work
• Maintain historical pathology group
  relationships
• with hospital
• Research and Education mission retained and
• supported
• Accreditation

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TriCore Business

• Contracts at competitive rates
• Provides lab services in NM, eastern Arizona
  and
• southern Colorado (sponsor hospitals and
  clinics,
• physicians, non sponsor hospitals, employers,
• other healthcare providers)
• Specialized services throughout the United
  States
• (hematopathology, molecular diagnostics)
• Maintains services levels and TATs teaching
• mission research and development component

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Organizational and Financial Relationships

• UNM and Presbyterian Pathologist contract for
  medical directorships
• Professional fees for consultation are received
  by Department TriCore receives technical fee
• Sponsors (University Hospital/UNM and
  Presbyterian Hospital) obtain reduced cost of
  testing from economies of scale, tax benefits,
  and surplus distribution
• 8 member board (4 UNM, 4 Presbyterian)
• Very little capitalization to start

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UNM Pathologists serve as Medical Directors

• Consultative Pathology Services Oversight
• Core Lab Activity Informatics, Clinical
  Chemistry and Toxicology, Microbiology, Virology
• Genetics and Cytometry Laboratory (GCL)
  Cytogenetics, Flow Cytometry, Histocompatibility,
  Molecular Oncology
• University Hospital Laboratory
• Histology and Cytopathology Laboratories
• Cytopathology Services

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TriCore Financial Picture

• Operates a 24 hr/day, 7 days-a-week hospital and
  reference lab operation
• In 2000, TriCore generated 25.5 million in net
  revenues In 2006 78 million
• TriCores gross revenue sources are approximately
  60 from the sponsors and 40 from other
  commercial sources
• Commercial revenues are generated by 12 client
  billing, 9 patient, 17 government, 25
  insurance, and 38 capitation

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What Worked Well from the Beginning

• Specialty labs increased their business and their
  developmental research work (PCR, molecular
  testing, FISH)
• Expansion of Consultative Services
• Reimbursement per FTE for medical direction
  (PART A) has been higher than prior to TriCore.
• The virology/microbiology laboratory expanded
  both its space and volumes, including
  developmental work
• A spirit of partnering with the community has
  always dominated the enterprise.
• Increased volumes of cases and enhanced support
  of our residency program

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TriCore as Research Resource

• Research and development
• May be performed by faculty and may be used for
  their scholarly development
• May be processed through Clinical Trials Center
  (IDC return)
• May simply support clinical trial

• Annually (not including salary costs)
• 1. 1.2 M in device/instrument trials
• 300K in new test development (not including
  salaries or
• bringing in established testing)
• 3. 100-200K in performance of clinical tests for
  clinical trials

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Additional Lessons

• Research and Developmental Activities for
  spectrum of faculty can be supported within a
  Multiple Entity Clinical Enterprise
• Could work better
• Leadership
• Informatics investments and CIO are critical to
  organization- continual need for modification,
  internet and intranet services, and billing
  issues.
• Need for alignment of incentives for Sponsors and
  Pathology groups

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Government-sponsored University/Commercial
Affiliations

• Establishing Collaborations between a Department
  of
• Pathology and Commercial Entities that allow
  for
• enhance scholarly output, research activity and
  NIH
• funding.
• Commercial component makes the grant proposal
• more competitive!
• New Mexico Multiple Library Screening Center
• Network (NM MLSCN)

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Small Molecule Discovery and Uses
Target Choice
Lead Generation
Pre-Clinical Studies
Synthetic Optimization
Imaging Agent
Functional Assay
If Promising
Biologic- Ligand Based Sensor
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NM MLSCN

• Consortium committed to small molecule discovery
  that can be used for drug development, cellular
  imaging, and non-invasive imaging
• Principally focused on using flow cytometry and
  computational techniques for small molecule
  discovery
• Consortium, lead by UNM investigators from the
  Department of Pathology, that includes gt 10
  commercial entities, several academic
  institutions, and several departments within UNM

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NM MLSCN Goals and Expectation

• IMPACT AT UNM BY ENHANCING
• Biomedical Research through molecular target
  development
• High Throughput Technology
• BioInformatics
• Medicinal Chemistry
• Academic and Commercial Collaborations
• High Profile (18 press releases where we are
  named)
• OUTPUT
• Small Molecular Probes
• Imaging Agents
• Leads for Drug Discovery
• Position UNM investigators for R01 funding
• Position UNM for competitive MLSCN renewal
  22.5M
• Serve as bellweather for Biotechnology in
  Albuquerque

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Challenges of NM MLSCN

• Challenges
• Create success in an arena dominated by endowed
  institutions (Scripps, Emory, Penn, Columbia)
• Much smaller institutional investment possible
• Considerably smaller or fewer existing resources
  at UNM

Approach Form partnerships that could provide
resources and expertise not available at UNM
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Partners in Process
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Organization of NM MLSCN

• Commercial Relationships
• 1. Flow cytometry and reagents BD,
  Beckman-Coulter, Dako AMnis, Luminex, Dharmicon,
  Luminex partners
• 2. Automation- Beckman-Coulter and Aurora
  Discovery technology that tests 200,000
  samples/day
• 3. Pharma/Biotech- approached by or have
  relationship with Novartis, Liily, Berlex,
  Schering, Wyeth, Biogenidec, Cue, QTL, MDS Pharma
  Services

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NM MLSCN took advantage of the NIH Roadmap

• NIH Roadmap
• Accelerating Biomedical Research generating new
  tools for discovery 1 Budget
• New Pathways to Discovery
• Building Blocks, Biological Pathways, and
  Networks
• Molecular Libraries and Imaging (Biggest Part)
• Structural Biology
• Bioinformatics and Computational Biology
• Nanomedicine
• Research Teams of the Future
• High-Risk Research and NIH Director's Pioneer
  Award
• Interdisciplinary Research
• Public-Private Partnerships
• Re-engineering the Clinical Research Enterprise

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NIH Roadmap Molecular Libraries Initiative

• Goal to have Centers that will screen large
  library of compounds in assays provided by
  investigators throughout the U.S.
• 10 Centers were funded (89.9M for 9 external to
  NIH)
• NCGC
• Scripps
• Burnham
• SRI
• UNM (8.965M/3 years)
• Pitt
• Penn
• Emory
• Columbia
• Vanderbilt

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NM MLSCN Serves as Biotech Model

• Developed model of collaboration that provides
  resources for all steps of small molecule
  discovery
• Commercial (Relationship with gt10 Companies -
  Pharma, Biotech, Instruments, Reagents,
  Chemistry, Data Systems, Pharma Services)
• Multidisciplinary Engineering, Chemistry,
  Biocomputing, Cell and Molecular Biology,
  Biophysics
• Cross Campus Includes School of Medicine, COP,
  Arts and Sciences, SOE
• Regional NMSU, NMT, UAz (in process)
• Collaborative , Cell Biology, Pathology,
  Internal Medicine
• Infrastructure Resonance between research,
  resources, and innovation (generalizable to
  shared resources)

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Keys to Success

• Faculty Leadership and Coordination
• Institutional Flexibility with Commercial
  Agreements (IP, MTA)
• Low investment is possible with this model

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Roadmap Opportunities

• Discovery/Screening
• Nanotechnology Nanoforces and distances
• Protein-Protein Interactions Assemblies and
  Mechanism
• Cellular Pathways Cell by cell high content
  phosphoprotein and image analysis

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National Laboratory Affiliations
Sandia National Laboratories

• Partnerships to take advantage of shifting
  research and development priorities to national
  defense

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National Laboratories (DOE)

• Sandia National Laboratory and Los Alamos
  National Laboratories are located in NM
• DOE system has 21 National Laboratories that
  covers most areas of technologic development
  recently been encouraged to collaborate more with
  universities and commercial entities

Plantex, Texas
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Examples of Successes at UNM in 2005-2006

• SNL/UNM/3M collaboration in development of
  biologic ligand-based sensors for biodefense
  (8.5 M/5 years)
• Tularemia vaccine program (25 M/5
• years)
• Pulmonary response to biothreats (14
• M/5 years)

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Multi-disciplinary teams

• Strength of grant proposals was in the
• Breadth and difficulty of the project
• Expertise and resources that could be brought to
  bear on the problem

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Commonalities among successful efforts

• Multi-disciplinary team
• Faculty leader experience in multi-disciplinary
  team building
• Facilitation and Mentorship of faculty not
  experienced in multi-disciplinary team building
• Need for Communication/Educational Process to
  understand work culture

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Process

• Identify potential RFA or killer ap
• Bring together large group- cant be done by
  email
• Brief presentations and lunch!
• Pilot funding is sometimes, not always necessary
• Larger, multiple team need more formalized
  management (timelines, budgets, meeting
  schedules)

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Biosensor Development

• Goal Portable, real time detection of select
  agents in water-based sample

Needs 1. Biologists- select agent production
and ligand production 2. Chemist-
Surface chemistry and conjugation chemistry
3. Electrical Engineer- electronics and
packaging 4. Fabrication Unit-
produce acoustic wave devices 5.
Commercial Entity- mass production
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Role of Academia (UNM)

• Ligand and bioagent production
• Expertise in components of surface chemistry
• Unbiased analysis of the technologies
• Biologic expertise
• Dual use applications

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Role of Sandia National Laboratories

• Expertise in acoustic wave sensor development
• Expertise in components of surface chemistry
• Fabrication expertise

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Role of 3M

• Fabrication of devices
• Financing
• IP arrangement agreed upon upfront

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Biosensor Project

• No pilot funds (cost of lunch)
• 3 years of collaboration (4 programmatic grants,
  multiple publications)
• Positioned group for response to new NIH
  priorities (NIEHS, NIBIB)
• Opened up new possibilities (electrolyte sensing
  team, nanotube sampling team)

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Keys to Success

• Multi-disciplinary teams National labs have
  capabilities not found in most academic
  institutions, Academia has expertise not found at
  National Labs
• Faculty Leadership- needs to be able to handle
  organizational complexity
• Not all National Labs are the same!
  Infrastructure needed to work with academia
  (subcontracting, IP MOUs)
• Universities must have infrastructure to work
  with national labs (export control, security,
  budgeting differences in DOE vs. NIH)
• Need face-to-face meeting and learn each others
  language

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Summary

• Current environment is challenging to maintain
  research, education and clinical missions in
  Departments of Pathology
• Innovative approaches involving multiple entities
  can be area of opportunity

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What Worked Poorly Initially, But Now Is Much
Improved

• Logistics with histology laboratory and turn
  around times
• Computer system was slow and not equipped to deal
  with new volumes
• Billing was not fully Y2K compliant Billing
  office has had continual challenges
• Morale among technical staff and faculty has
  ebbed and flowed with each major change
  (Informatics, billing, specimen tracking)