preparing industry proposals and budgets scott davis, cra associate director office of research...
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Preparing Industry Proposals and Budgets
Scott Davis, CRAAssociate Director
Office of Research AdministrationUniversity of Oklahoma Health Sciences Center
• Research Type– Industry funded research
• Pfizer, GlaxoSmithKline, etc.
– Private funded research• American Heart, Komen, etc.
– No direct Federal Funding
• Workflow– PI identifies funding– PI prepares the proposal/SOW– RESEARCH OFFICE REVIEWS PROPOSAL– Award – Award reporting and close-out
• Will not be discussing– Contract Language– Clinical Trials
• Differences with Federal Grants– Approve terms in advance– Allowable Costs– Allowable IDC
• Problematic Areas– Cost share– Reduced or no F&A– Non-negotiable terms– One application per Institution– CDA
• Instructions– Guidelines– Budget– IDC– Same Information / Different Forms
• Different from NIH
• Read and Follow All Application Instructions!
• Review Process– What’s Needed
• Required Institutional Paperwork• Copy of Guidelines• Statement of Work (SOW)• Budget• Research Agreement
– Review guidelines
• Required Institutional Paperwork– Routing form– Cost Share Approval– COI forms– IDC Exceptions– IACUC/IRB
• Guidelines– Review
• Requirements to apply– Restrictions
» 501 c3» No tobacco funding
• IDC• IP
• Statement of Work (SOW)– Formal document that defines:
• Work Activities• Deliverables• Timeline must execute in performance of specified
work for a client.
– Includes:• Requirements• Pricing• Regulatory and governance terms and conditions
http://en.wikipedia.org/wiki/Statement_of_work
• SOW Components– Description of work being performed– Location– Period of performance– Publication– Scientific input– Invention– Budget
• SOW Bad Example– I will be reviewing square pieces of glass
containing some goo. I will report to the guy in charge of the results.
• SOW Good Example– EGG NOG expert pathology reviewers are assigned to
active EGG NOG study protocols for confirming institutional diagnoses, to assess relevant enrollment criteria, for assigning subtypes of tumors to the appropriate protocol arms, and for validating the suitability of tumor tissues for biology-based studies. Reviewers will assess materials provided to them and return their reviews in a timely fashion to the EGG NOG Biopathology Center.
• Budget– Industry or Private Funding– Simple or Detailed– Fixed Price or Cost Reimbursable
• Fixed Price vs. Cost Reimbursable– Fixed Price operate under an established price
that cannot be revised. – Cost-Reimbursable sponsored projects allow costs
to be expended up to a set amount.
• Cost Reimbursable Advantages– No incentive to cut corners– Quality vs. time– Less risk
• Cost Reimbursable Disadvantages– Sponsor requires more financial reporting– Refund unused funds– Less incentive to be efficient
• http://govwin.com/knowledge/cost-reimbursement
• Fixed Price Advantages– Know total price upfront– Best interest to Control Cost
• Leftover money to PI/Department
• Fixed Price Disadvantages– No Price Adjustments– Maximum risk
BABOON STUDY
Unit cost Number Total
Adult Baboons $ 7,000.00 2 baboons $ 14,000
Per Diem Charges $ 15/day 2 baboons 15 days/each $ 450
IACUC Preparation by Veterinarian $ 125/hr. 2hrs $ 250
Surgical Room Use Fee $ 250/ day day 1 & day 14 $ 500
Anesthetics, Drugs, Disposables $ 800/baboon 2 baboons $ 1,600
Anesthesia Charges for Veterinarian (ACLAM)
for Physical exam & Ophthalmology Exam -1or - 2 day $125 1 hour/ baboon 2 baboons $ 250
Test day Anesthesia procedure $125 2 hrs /baboon 2 baboons $ 500
Anesthesia on test day for Toxicokinetics serum collection $125 9 hours $ 1,125
Anesthesia for Toxicokinetics serum collection day 4,7,& 14 $125 1 hr./collection 2 collections 2 baboons $ 1,500
Euthanasia by Veterinarian $125 1/2 hr. / baboon 2 baboons $ 125
Baboon Carcass Disposal $ 45/each 2 baboons $ 90
Surgical & Anesthetic Tech Support Technician time
days -1, day 1,days 2,day 3, 4, 7, 14 , & necroposy $ 45 hr. 16 hrs $ 720
Necroposy by Veterinary Pathologist(ACVP) $ 1,000
Histopathology/cut in slides and H@E staining $40 20 slides $ 800
Comparative Medicine administrative costs, shipping,contracts,etc. $ 3,253
Indirect Costs (30%) $ 7,849
Total Estimated Costs for University $ 34,012
Total Payment $100,000 Payment Schedule:
1. Upon signing of the Agreement by the University, Big Pharma shall pay $50,000
2. Upon receipt of Results from studies, $50,000
Big Pharma shall pay
• Contract or No contract
• Receive Award without Prior Review• Game plan
– Start process as if new
• Reasons for No Prior Review– Small amount we don’t need a contract– No IDC/F&A lead to larger studies– Competing against other Universities
• Do I need Contract/Budget? Why?– A contract is a legally enforceable agreement – Creates binding obligations, rights and duties for
each party• Payment of money
– Institution has a legal obligation to protect its personnel, assets and resources
– Institution must ensure that it limits its liability– Comply with the terms in the contract
– Comply with state and federal laws and regulations
– Contracts submitted for Institutional Approval• Office of Research Administration• Legal Office• Office of Technology Development• IACUC• IRB• Department
• Questions?
Thank You for Your Participation
Scott DavisAssociate Director
Office of Research Administration The University of Oklahoma Health Sciences Center