Letter of Intent Instructions

Letter of Intent Instructions

To have your Rediscovery Research Grant considered for the Patient Impact Initiative (PII), please complete this Letter of Intent form and e-mail it to Partnership for Cures along with a Principal Investigator (PI) Biosketch. We will review the Letter of Intent and contact you to complete a grant application if your project fits our Rediscovery Research™ model.

ELIGIBILITY

The Patient Impact Initiative is open to all researchers and clinicians at or on staff at academic medical centers and other research institutions that have agreed to become Partner Institutions in the Patient Impact Initiative. It is also open to invited researchers at other institutions.

PLEASE REVIEW THE DESCRIPTION BELOW OF THE RESEARCH WE ARE REQUESTING. The closer the research is to making a direct patient impact, the more likely it is to be highly ranked. Pilot or other clinical trials are ideal. Cost effectiveness is a key ranking criterion.

AREAS OF FOCUS: We accept proposals in any disease and for any Rediscovery Research therapy. We do have some committed funds for clinical trials in CLL ($30K/year for 2 years, to prolong remission), myelodysplastic syndrome (RARS variant, up to $100K/year for 2 years) and lung cancer ($30K/year for 2 years.) We also have funders interested, but not committed to, pediatric cancer and rare disease projects.

There is no fee to apply to the Patient Impact Initiative.

CHECKLIST

Please include:

·  Completed Letter of Intent Form below, including the grant title/description (400 word max) of you proposed research project

·  PI Biosketch or CV so your eligibility can be confirmed

PLEASE NOTE

·  Letters of Intent must be submitted electronically to

·  Letters of Intent are due not later than March 2, 2012 at 9:00 pm Central Time

·  Required documents listed above must be submitted as a single Microsoft Word Document file (any version.) Submit only the Letter of Intent Form and PI Biosketch. Do not include the rest of the information in this document.

·  The file should be named in the following format:

PII LOI Year-Month Institution First Name Last Name Project Title.doc

(Example - PII LOI 2012-1 UIC Bruce Bloom Repurposing Maddonic Acid for Rockitis.doc)

Patient Impact Initiative Letter of Intent Form

Please complete the following Principal Investigator and Project information:

First Name
Last Name
Degree(s)
Dept/Division
Academic Title
Institution
Street Address
City
State
Country
Postal Code
Office Phone
Mobile Phone
E-Mail Address
Project type (Please check all that apply) / Lab Only Lab/Animal Trial Animal Trial
Lab/Human Samples Human Clinical Trial
Estimated project length in months
Estimated project cost

Research Project Title:

Research Description (Please type here - Not more than 400 words describing the proposed research project. The 400 words do not have to fit on this page only-they can continue onto a separate page.)

If you have any questions, please contact:

Dr. Bruce E. Bloom, Ashoka Fellow 2010-2012
President and Chief Science Officer, Partnership for Cures
585-542-8737 or

Rediscovery Research™ Description

The Patient Impact Initiative inspires scientists and clinicians (and interested parties outside of medicine) to create and complete pilot clinical trials and other Rediscovery Research to directly impact patients. This “Rediscovery Research” can impact patients by reusing, reconfiguring and combining already existing drugs and devices, modifying treatment protocols and testing clinical observations. These 1-3 year Rediscovery Research Projects can focus on any disease, use any therapy and impact any group of patients, as long as they meet the parameters of the Patient Impact Initiative, which are to create better near term treatment options, improve early diagnosis and lengthen disease remission reusing science and medicine that has already been discovered once.

What qualifies as Rediscovery Research?

The following are some examples of Rediscovery Research. It is likely that once the Patient Impact Initiative creates the incentive for Rediscovery Research, bright minds will find new ways to use reuse, combine and newly apply already available science and medicine to help patients.

1.  repurposing an FDA approved drug or drug combinations to treat "off label" diseases

2.  combining an older drug or a combination of older drugs with a newer drug to increase the newer drug effectiveness

3.  combining a drug with a non-drug treatment option, such as radiation, to make the non-drug treatment work better

4.  combining a non-drug treatment option with an available drug to make the drug work better

5.  testing combinations of available drugs that are not currently prescribed together but are already used in one specific disease to see if the combination works better in that disease

6.  scientifically testing combinations of vitamins, supplements and botanicals, that would be available to physicians and their patients, if efficacy can be proven

7.  in limited circumstances, human clinical testing of new compounds, in rare diseases for which there is no current treatment, and there is strong likelihood of efficacy and accelerated approval

8.  repurposing FDA approved devices to treat "off label" diseases

9.  modifying current treatment protocols to make them work better and help more patients for longer periods of time, such as modifying the time of day of drug administration, reducing drug doses while increasing the frequency of drug administration to reduce side effects, testing radically lower doses of effective medicines that patients refuse because of side effects

10.  scientifically testing clinical observations or sound clinical ideas, including those from integrative medicine or from other parts of the world

Examples of Rediscovery Research

·  Repurposing of thalidomide for multiple myeloma, then other blood cancers, other cancers, and non-oncologic diseases, and the development of Revlimid (Repurposing Example 1 from above)

·  Testing the addition of NK cells to autologous stem cell transplants to improve the remission rate in non-Hodgkin’s lymphoma (Repurposing Example 9 from above)

·  Combining an old malaria drug with a new kinase inhibitor to help the kinase inhibitor work for more lung cancer patients for a longer period of time (Repurposing Example 2 from above)

·  Creating life saving treatments for children with familial dysautonomia by screening and then proving that specific vitamins and botanical compounds increased the overall production of a critical protein (Repurposing Example 6 from above)

·  Repurposing a device originally developed to help the blind “see” to significantly improve functional performance in multiple sclerosis and traumatic brain injury patients (Repurposing Example 8 from above)

·  Repurposing a laser ablation device originally used to treat breast cancer to treat prostate cancer patients with a much low incidence of side effects such as incontinence and impotence (Repurposing Example 8 from above)

·  Repurposing the pain medication buprenorphine for the interruption and maintenance of heroin and other opioid addictions (Repurposing Example 1 from above)

·  Repositioning the anti-Parkinsonian drug Requip for the treatment of both Restless Legs Syndrome and SSRI-induced sexual dysfunction (Repurposing Example 1 from above)

·  Repositioning anti-epileptics gabapentin and pregabalin for treating anxiety disorders and neuropathic pain. (Repurposing Example 1 from above)

·  Proving that Hatha Yoga breathing and relaxation can be as effective a treatment for Generalized Anxiety Disorder as drugs or counseling (Repurposing Example 10 from above)

Why Rediscovery Research?

There are thousands of potential treatments waiting to be rediscovered in the medicine and science that already exists. Of the top 50 selling pharmaceuticals in 2004, 84% have had additional indications approved since their initial US licensure (http://www.msi.co.uk/drug-repurposing). This type of Rediscovery Research provides

·  low research costs and fast delivery of “new” effective treatments to patients by leveraging knowledge, resources and regulatory approvals already paid for through past research and clinical experience

·  treatments that typically use low cost drugs and devices with known safety profiles, following slightly modified treatment protocols with which clinicians are already familiar

·  significantly reduced healthcare costs created in a fraction of the time and expense

The Patient Impact Initiative Rediscovery Research will take place at academic research Partner Institutions, biotechs, pharmaceutical companies and large clinical practices. Administration will be centrally provided by the staff of the Partnership for Cures. Project reviews will be conducted by independent volunteer clinicians, scientists and lay reviewers using an electronic interface. Rediscovery Research Projects must be designed to make a direct impact on patients in 1-3 years and can cost $10,000-$100,000 per year, with an emphasis on funding frugal, cost-effective grants that impact patients.

What is the Patient Impact Initiative Grant Process?

The Patient Impact Initiative has a two-step Grant Process. Step one is the completion and submission of a very short Letter of Intent (LOI) form. This enables our scientific and lay reviewers to determine if the project is likely to meet our Patient Impact Initiative parameters.

You will be informed within 2 weeks of your LOI submission whether or not to submit a full Grant Proposal. If you are invited to submit a full proposal, we will send you a form to complete that will include:

·  A description of the proposed research (1600 word max)

·  A budget and timeline

·  A description of how/when your Rediscovery Research idea will impact patients

·  The NIH Biosketch of the PI and full PI contact information

·  Names of three scientists and/or clinicians you feel are qualified to review your project who have no conflict of interest

Grants will be reviewed and ranked by scientific and lay reviewers. The closer the research is to making a direct patient impact, the more likely it is to be highly ranked. Pilot or other clinical trials are ideal. Cost effectiveness is also a key ranking criterion.

All LOIs and Grant Proposals should be sent as Microsoft Word documents via e-mail. Instructions are included on the LOI and Grant Proposal forms.

Mission: The mission of the Patient Impact Initiative is to secure funds to improvehealthcare outcomes and reduce patient healthcare costs worldwide by financing, facilitating, and publicizing Rediscovery Research solutions that repurpose drugs, test clinical observations, and modify treatment protocols.

Vision: To create and manage a global collaboration of philanthropists, disease specific non-profits, research institutions, researchers, clinicians, industry, media and the lay publicthat raises and deploys funds to drive the development Rediscovery Research solutions to patients that quickly improve quality and length of life.

APPLICATION
GRANTEE INFORMATION
Sponsoring Institution Name / Peotone State University
Grantee's First Name / Bruce
Grantee's Last Name / Bloom
Link to Grantee’s research/profile website / http://www.4cures.org/home/meet_the_staff
Grantee's Institutional Address, line 1 / 70 West Madison Street
Address, line 2 / Suite 1500
Address, line 3
City / Chicago
State / IL
Zip code / 60602
Grantee’s Email address /
Home phone / 847-948-7004
Office phone / 312-696-1366
Cell phone / 847-529-6888
Fax number / 312-263-0939
Current academic title and degrees / Assistant Professor, MD, JD
Current academic department(s) / Clinical Research
RESEARCH PROPOSAL
Title of research proposal / Pilot human clinical trial to determine the effectiveness of a three different olfactory trained service dogs in the early detection of lung cancer
Estimated total budget / $28,000
Estimated length of research (in months) / 18 months (2 months for IRB approval and dog training and validation, 12 months for enrollment of subjects and collection of data, 1 month for data processing and statistical analysis, 3 months for preparation, submission and acceptance of manuscript)
Indicate whether this is lab research, animal study, human clinical trial, other (if other, describe) / Human clinical trial
Number of human subjects (If applicable) / 300
Age range of human subjects (if applicable) / 21-49
Primary disease(s) research could impact / Lung cancer
Secondary disease(s) research could impact / Other cancers that have metastasized to the lung; TB, other inflammatory lung diseases
Key words (as many as possible) (Examples: stem cell, gene therapy, sRNA, diagnostic, prevention, treatment, consortium, anti-viral, botanical, translational, multiple sclerosis, cancer, pediatric, geriatric, etc.) / Service dog, expired breath, lung cancer, spiral CT, early detection, smokers, smoking, x-ray, screening
INSTITUTIONAL OFFICER CONTACT INFORMATION
Institutional Officer Contact Name / Jerry Paris
Contact Title / Department Chair
Address, line 1 / 70 West Madison Street
Address, line 2 / Suite 1500
Address, line 3
City / Chicago
State / IL
Zip code / 60602
Email address /
Office phone / 312-696-1368
Fax number / 312-263-0939
PUBLICATION AND DISCLOSURE
Publication-has there been any public disclosure of this idea, either by you or some other party (Yes/No/I don’t know?) If Yes, when and by who? / Yes, see http://www.pinestreetfoundation.org/articles/ICT.pdf
Disclosure- Have you disclosed this concept to your institution, and, if not, is there a plan for disclosing / Yes
CONTACT INFORMATION FOR SCIENTISTS QUALIFIED TO REVIEW YOUR GRANT (AFTER THEY SIGN A NON-DISCLOSURE AGREEMENT.) THEY MUST BE FROM OUTSIDE OF YOUR INSTITUTION AND NOT INVOLVED IN ANY OF YOUR RESEARCH.
Potential Reviewer #1
Name / Steve Brown
Institution / University of Chicago
Email address /
Office phone / 312-555-1212
Potential Reviewer #2
Name / Doug George
Institution / University of Southern California
Email address /
Office phone / 773-555-1212
Potential Reviewer #3
Name / Jeff Smith
Institution / Rush University Medical Center
Email address /
Office phone / 708-555-1212
Now Please Complete Grant Proposal Information Below

Please type in 11 point Arial font-Thank you!
Principal Investigator and co-investigators, including affiliations / PI-Bruce Bloom, DDS, JD, Chief of Pulmonary Oncology, Peotone State University, Peotone ,IL
Coordinator-Kathy Knorr, MS, BSN, Peotone State University, Peotone ,IL
Dog Safety-John Smith, DVM, PhD, Head of Animal Sciences, Floosmor Veterinary College
Dog-Trainer-Ron Pace, Owner, Dog Training International, Chicago, IL
Dog Handlers-Graduate students John Jones, Tom Brown, Laura White from Floosmor Veterinary College