Overview Michelson Prize and Grants

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Presented by Aimee Gilbreath, Katy Palfry, and Dr. Shirley Johnston at the Alliance for Contraception in Cats & Dogs’ 4th International Symposium on Non-Surgical Contraceptive Methods of Pet Population Control, April 8-10, 2010, in Dallas, Texas, U.S.

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Michelson Prize & Grant Program Overview : 

May 17, 2010 Michelson Prize & Grant Program Overview

Agenda for this Session : 

Agenda for this Session Overview of Found Animals and Michelson Prize and Grant Program Aimee Gilbreath, Executive Director Overview of the Michelson Grant Application Process Katy Palfrey, Program Manager Overview of Animal Welfare Guidelines Dr. Shirley Johnston, Director of Scientific Research Overview of Projects and Concepts Dr. Shirley Johnston, Director of Scientific Research Q&A with the Full Panel 1

What is the Found Animals Foundation?www.foundanimals.org : 

2 What is the Found Animals Foundation?www.foundanimals.org A 501(c)(3) private operating foundation. . . . . .founded and funded by billionaire surgeon/ inventor and serial entrepreneur Dr. Gary Michelson. . . . . .and dedicated to developing innovative programs to minimize shelter euthanasia

Key Pet and Shelter Statistics : 

Key Pet and Shelter Statistics There are over 70 million dogs and 80 million cats in US households! 60% of US Households have pets Only 56% have children under 18 Tens of millions more cats live on the streets feral and free roaming 3 Between six and eight million pets enter US shelters each year 1/3 or more are once wanted pets being surrendered by owners ~25% of dogs in shelters are purebred Only 50% of them go home alive, 3-4 million are euthanized Some for behavioral or health concerns, but most for simple lack of a home An estimated 75% of the animals killed are cats U.S. Municipalities spend over $2B annually on animal care and control Approximately $7 per person per year Does not include amounts spent by private animal welfare groups

Two Major Levers for Reducing Shelter Euthanasia : 

4 Two Major Levers for Reducing Shelter Euthanasia Intake Hold Available Euthanize Return to Owner Foster Adopt to Rescue Adopt to Public Decrease intake Increase “Live Release” Stray/ Lost Surrender

Found Animals Programs Aligned Against Levers : 

5 Found Animals Programs Aligned Against Levers Decrease intake Increase “Live Release” Sterilization Owner Resources Adoption Education, Outreach, Policy Low cost spay/neuter Non-surgical research Pet tips and tricks Microchipping Pet friendly housing Shelter adoption events Adoption promotions Volunteer matchmakers Live webcast variety show from shelter locations, 24/7 “kitty cam” Social media promotions and contests Pet licensing as a funding mechanism for subsidized spay/neuter

What makes Found Animals stand out? : 

6 What makes Found Animals stand out? Embrace of business principles for a social mission Focus on development of sustainable business models Emphasis on innovation, creativity, and experimentation No need for “tin cup” fundraising Run by business and medical professionals

Media has started to notice Found Animals : 

7 Media has started to notice Found Animals

Current Status of Sterilization : 

Current Status of Sterilization Surgical spay/neuter is currently the standard for pet sterilization Surgery is very safe and effective Eliminates reproduction and secondary sexual behavior 8 Most US pet owners already sterilize their pets via S/N ~70% of dog owners ~ 80% of cat owners But, S/N remains out of reach for populations that drive shelter intake Low income pet owners cite cost and access as barriers 95+% of feral and free roaming cats are unsterilized And studies show that most litters are still “accidents” 68% of the households that reported a litter of kittens born said it was unplanned, 47% of these households reported having more than one litter that year 56% of households reporting a litter of puppies born, described them as unplanned with 21% having more than one litter

Non-Surgical Sterilization Will Remove Barriers : 

9 Non-Surgical Sterilization Will Remove Barriers

The Michelson Prize and GrantsAnnounced October 2008 : 

10 The Michelson Prize and GrantsAnnounced October 2008 The Michelson Grants in Reproductive Biology: Up to $50 million of grant funding available for research directed to achieving this goalFound Animals will provide up to $50 million in grant funding for promising research in pursuit of a safe, effective, and practical non-surgical sterilant for use in cats and dogs The Michelson Prize in Reproductive Biology: $25 million for innovation in non-surgical sterilization for cats and dogsFound Animals will offer a $25 million prize to the first entity to provide the Foundation with a safe, effective, and practical non-surgical sterilant for use in cats and dogs

Why a Prize and Grant approach? : 

11 Why a Prize and Grant approach?

Goal to Ensure an Effective Product Reaches the Market Priced for Maximum Impact : 

12 Goal to Ensure an Effective Product Reaches the Market Priced for Maximum Impact

Michelson Prize Details : 

13 Michelson Prize Details The winning entry for the Michelson Prize in Reproductive Biology will have, at minimum, the following characteristics:

Basic Prize Terms and Conditions : 

Basic Prize Terms and Conditions Applicants must demonstrate safety, efficacy, at a “proof of concept” level in target species No expectation that applicant will have submitted for or received regulatory approval, but should be clear pathway Must have clear understanding of manufacturing process and cost, but no need for facilities $25M Prize awarded in exchange for exclusive right to make and sell product worldwide May elect a royalty on eventual product sales instead of lump sum payment, if preferred Prize is open to any entity from any country (some details may vary based on entity and geography) 14

Michelson Grant Details : 

15 Michelson Grant Details

Basic Grant Terms and Conditions : 

Basic Grant Terms and Conditions Must submit quarterly progress reports and a final grant report Must comply with animal welfare guidelines and host annual scheduled site visits and intermittent (unannounced) animal welfare visits Must agree that Foundation will have first right of refusal to an exclusive license (with right to sublicense) to make, sell, and use product(s) in areas of interest to the Foundation rights to the background intellectual property required to exercise a license on product(s) resulting from funded research Foundation will compensate the licensor with a royalty or comparable compensation structure if a product is approved for sale 16

Our Website is a Great Resource : 

Our Website is a Great Resource 17

Join Michelson Prize & Grant Mailing List for Updates! : 

Join Michelson Prize & Grant Mailing List for Updates! 18

Agenda for this Session : 

Agenda for this Session Overview of Found Animals and Michelson Prize and Grant Program Aimee Gilbreath, Executive Director Overview of the Michelson Grant Application Process Katy Palfrey, Program Manager Overview of Animal Welfare Guidelines Dr. Shirley Johnston, Director of Scientific Research Overview of Projects and Concepts Dr. Shirley Johnston, Director of Scientific Research Q&A with the Full Panel 19

Got a Great Idea? : 

Got a Great Idea? 20

Grant Process Overview : 

Submit Letter of Intent (LOI) 21 Grant Process Overview Applicant Found Animals & Scientific Board 1 Submit full proposal Triage LOIs and invite full proposals Negotiate grant agreement and begin approved project Review proposals and make funding decisions 2 5 4 3

LOI is First Step in Grant Application Process : 

22 LOI is First Step in Grant Application Process Research team submits Letter of Intent to Found Animals which includes: Rationale for approach Summary of required research Explanation of how research will facilitate achievement of goal LOIs are limited to 2 pages and must be submitted through the website. Foundation reserves the right to decline LOIs which do not conform to guidelines. LOIs are accepted and reviewed on a rolling basis throughout the year. Found Animals aims to get back to applicants within 6-8 weeks from receipt of LOI.

Full Proposals Invited After LOI Approved : 

Full Proposals Invited After LOI Approved 23

Three Proposal Deadlines Per Year : 

Three Proposal Deadlines Per Year 24 Deadline Response

Major sections of the full proposal : 

25 Major sections of the full proposal

Full Grant Application Evaluation Process : 

26 Full Grant Application Evaluation Process Scientific Director Primary Reviewers Full Board Found Animals Writes 1-2 page non-evaluative summary Chooses two board members for primary review and one for animal welfare review Forwards application package and summary to reviewers Score application based on six criteria and a yes/no recommendation Combo of scores and yes/no determines consideration by full board Scientific Director breaks ties as needed One primary reviewer serves as presenter Board discusses strengths, weaknesses, and suggests modifications Board votes to approve/ disapprove funding Makes final funding decisions Notifies applicants of status Works with institution to implement

Found Animals relies on board expertise for Primary and Animal Welfare review : 

Found Animals relies on board expertise for Primary and Animal Welfare review 27

Scientific Advisory Board : 

Scientific Advisory Board Todd Alonzo, PhD, Biostatistician, USC Children’s Oncology Group David Brake, PhD, Founder, BioQuest Associates LLC David Brent, PhD, Founder, Brent Tech Scott Campbell, DVM, Founder, BanfieldTM the Pet Hospital Marcelo Couto, DVM, PhD, DACLAM, UCLA Gary Gamerman, MS, JD, Seraphim Life Sciences Thomas Graves, DVM, PhD, DACVIM, University of Illinois Carl Johnson, PhD, Hereditary Disease Foundation Safdar Khan, DVM, PhD, DABVT, University of Illinois & Poison Control Center Michelle Kutzler, DVM, PhD, DACT, Oregon State University Dennis Lawler, DVM, Ret, Nestle Purina Gary Patronek, VMD, PhD, Animal Rescue League of Boston Andrew Rowan, PhD, Humane Society of the United States Michael Skinner, PhD, Washington State University John D. Tegzes, DVM, DABVT, Western University of Health Sciences David Wildt, PhD, National Zoo, Washington DC Stephen Zawistowski, PhD, ASPCA, New York 28

Primary Reviewers Evaluate on Six Dimensions, and Give Overall Yes/No Recommendation : 

Primary Reviewers Evaluate on Six Dimensions, and Give Overall Yes/No Recommendation 29 Animal Welfare: proposal’s involvement of live animals & the safety of the experimental design and proposed product Budget & Period Support: justification of budget & the requested period of support Investigator(s) and Environment: the PI(s)’ relevant experience Scientific Merit: the overall strategy, methodology, & analyses of the proposal Innovation: the novelty of the approach Prize Criteria: the potential of the final product to fulfill all Michelson Prize criteria

Scientific Advisory Board meeting : 

Scientific Advisory Board meeting 30 One primary reviewer serves as presenter for the proposal Board discusses strengths, weaknesses, and suggests modifications Board votes to approve/ disapprove funding

Review Outcomes : 

Review Outcomes 31

Grant Contract Addresses Basic Terms and Conditions : 

Grant Contract Addresses Basic Terms and Conditions Must submit quarterly progress reports and a final grant report Must comply with animal welfare guidelines and host annual scheduled site visits and intermittent (unannounced) animal welfare visits Must agree that Foundation will have first right of refusal to an exclusive license (with right to sublicense) to make, sell, and use product(s) in areas of interest to the Foundation rights to the background intellectual property required to exercise a license on product(s) resulting from funded research Foundation will compensate the licensor with a royalty or comparable compensation structure if a product is approved for sale 32

Tips for applicants : 

Tips for applicants Carefully review Michelson Grant requirements Do not include overview of pet overpopulation issue Title should be descriptive of the work proposed Stick to the page limits Make sure your animal use numbers are consistent Know what has been tried before Research dog & cat anatomy Think outside the box Strictly adhere to animal welfare guidelines Consider review criteria 33

Agenda for this Session : 

Agenda for this Session Overview of Found Animals and Michelson Prize and Grant Program Aimee Gilbreath, Executive Director Overview of the Michelson Grant Application Process Katy Palfrey, Program Manager Overview of Animal Welfare Guidelines Dr. Shirley Johnston, Director of Scientific Research Overview of Projects and Concepts Dr. Shirley Johnston, Director of Scientific Research Q&A with the Full Panel 34

Otherwise Known As.. . . : 

Otherwise Known As.. . . How to keep a good “science” proposal from being disapproved because of a bad “animal use” justification 35

Slide 37: 

The Foundation seeks to set a high standard regarding use of animals in research 36

Animal Welfare Guidelines : 

Animal Welfare Guidelines General Concepts: http://www.foundanimals.org/index.php/About-Michelson/guidelines.html (15 guidelines) Guide for Care & Use of Laboratory Animals Draft IACUC proposal 37

Animal Welfare Guidelines : 

Animal Welfare Guidelines Use of animals shall be humane and consistent with IACUC regulations. Investigators and care staff will have animal care qualifications & experience. IACUC approval is required for disbursement of funding. IACUC approval for archived samples must be available. Informed owner consent is required for clinical trials. Unannounced site visits will be conducted to verify compliance. Statistical evidence must be provided to justify sample size. Living conditions for research animals must be appropriate for their species. Research animals must have compassionate care, comfort, and protection from unnecessary pain. Research animals must be appropriately socialized for their species and have appropriate environmental enrichment. When possible, animals will be made available for adoption at the end of the study. Terminal endpoints may be acceptable if essential information can be obtained in no other way. 38

Animal Welfare Guidelines : 

Animal Welfare Guidelines 13. Michelson Grants will not fund a study that induces or allows pain or distress unless controlled by appropriate anesthetic, analgesic or tranquilizing drugs. All invasive procedures shall require balanced anesthesia and preemptive, multimodal analgesia. 14. Michelson Grants reserves the right to terminate a study and/or withdraw grant funding if progress is deemed unsatisfactory or if there are concerns about animal well-being. 39

Animal Welfare Guidelines : 

Animal Welfare Guidelines “6. Found Animals will perform unannounced site visits for verification of compliance with animal welfare guidelines.” Found Animals Foundation staff will conduct announced site visits near the end of the third quarter of each year of funding to review progress toward goals, expenditures, and animal facilities. An ACLAM-accredited veterinarian will conduct intermittent unannounced site visits at funded institutions to review compliance with Animal Welfare guidelines. 40

Animal Welfare Guidelines : 

Animal Welfare Guidelines “7. Proposals must contain statistical evidence that the number of research animals proposed for use is not excessive, and yet is statistically adequate to achieve the proposed results.” a biostatistician on the Scientific Advisory Board reviews every proposal for sample size and appropriateness of statistical evaluation proposed. the number of research animals used must be consistent  in sections on Methods, Justification of Animal Involvement, and budgeted cost of animal acquisition. consider including an algorithm to communicate animal numbers, if use in some stages of the proposed research depends on outcomes from an earlier stage. 41

Animal Welfare Guidelines : 

Animal Welfare Guidelines “9. Research animals must have compassionate care, comfort, and protection from unnecessary pain. All invasive procedures shall require balanced anesthesia and preemptive, multimodal analgesia.” Provide detailed description of all animal protocols (analgesia, anesthesia, euthanasia) (drugs, routes of administration, etc). 42

Animal Welfare Guidelines : 

Animal Welfare Guidelines “10. Research animals must be appropriately socialized for their species, and have environmental enrichment appropriate for their species.” Indicate whether research animal housing will be in AAALAC-accredited facilities. Describe environmental enrichment that will be provided. 43

Animal Welfare Guidelines : 

Animal Welfare Guidelines “11. When possible, research animals will be made available for adoption at the study; research animals may not be reassigned to another research project at the end of the study.” Found Animals Foundation may assist investigators in finding adoptive homes. 44

Animal Welfare Guidelines : 

Animal Welfare Guidelines Other: Justify whether breeding studies offer an advantage over gonadal histology in demonstration of sterilization. Consider requesting funding for “pilot” or “proof of concept” studies before requesting major funding for a project dependent on an assumption that has not yet been demonstrated. Consider small pilots in target species (cat, dog) rather than exhaustive studies in non-target species. 45

Agenda for this Session : 

Agenda for this Session Overview of Found Animals and Michelson Prize and Grant Program Aimee Gilbreath, Executive Director Overview of the Michelson Grant Application Process Katy Palfrey, Program Manager Overview of Animal Welfare Guidelines Dr. Shirley Johnston, Director of Scientific Research Overview of Projects and Concepts Dr. Shirley Johnston, Director of Scientific Research Q&A with the Full Panel 46

Michelson Grants in Reproductive BiologyProjects & Concepts Funded to Date : 

Michelson Grants in Reproductive BiologyProjects & Concepts Funded to Date The Michelson Grants in Reproductive Biology was announced in 2008, with availability of $50 million in competitive funding for research leading to development of a single dose, nonsurgical sterilant that is safe and effective in male and female cats and dogs suitable for administration in a field setting, with a viable pathway to regulatory approval, and a reasonable manufacturing process and cost 47

Michelson Grants in Reproductive BiologyProjects & Concepts Funded to Date : 

Michelson Grants in Reproductive BiologyProjects & Concepts Funded to Date Letters of Intent received 102 [from North America, South America, Europe, Asia, Australia] Letters of Intent approved to progress to proposals 35 Proposals received 33 [from USA, Canada, UK, Australia; 7 in review process] Proposals approved for board review 22 [of 26; 7 in review process] Proposals recommended for full or partial funding 7 48

Michelson Grants in Reproductive BiologyProjects & Concepts Funded to Date : 

Michelson Grants in Reproductive BiologyProjects & Concepts Funded to Date Proposals have been received in categories of silencing of genes coding for proteins that are essential in the reproductive cascade, immunocontraception against GnRH, and targeted delivery of cytotoxins to pituitary or gonadal cells The Foundation seeks more proposals in these categories and others that may bear promise 49

Michelson Grants in Reproductive BiologyProjects & Concepts Funded to Date : 

Michelson Grants in Reproductive BiologyProjects & Concepts Funded to Date Proposals Recommended for Funding [$3.478 million] Davidson BL, Ojeda S, Dissen GA: Inducing stable [$160,000] infertility by RNA interference. Proof of principle studies. University of Iowa, Oregon Health Sciences Center Meyer RG, Meyer-Ficca M: Targeting Poly(ADP-Ribose) [$577,000] metabolism for development of a nonsurgical sterilant. University of Pennsylvania Marrack P, Munks M, Sosinowski T: Use of attenuated [$756,000] recombinant herpesviruses expressing fertility antigens, to induce infertility in cats and dogs. National Jewish Health, Denver 50

Michelson Grants in Reproductive BiologyProjects & Concepts Funded to Date : 

Michelson Grants in Reproductive BiologyProjects & Concepts Funded to Date Proposals Recommended for Funding [$3.478 million] TBA: Targeted delivery of cytotoxin [$206,000] TBA: Targeted delivery of cytotoxin [$133,000] TBA: Immuno-contraception, GnRH [$733,000] TBA: Targeted delivery of cytotoxin [$913,000] 51

Agenda for this Session : 

Agenda for this Session Overview of Found Animals and Michelson Prize and Grant Program Aimee Gilbreath, Executive Director Overview of the Michelson Grant Application Process Katy Palfrey, Program Manager Overview of Animal Welfare Guidelines Dr. Shirley Johnston, Director of Scientific Research Overview of Projects and Concepts Dr. Shirley Johnston, Director of Scientific Research Q&A with the Full Panel 52

Questions? : 

Questions? 53

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