Download Date of submission Day: Month: Year: Short Title of the Invention

SANOFI TURKEY R&D CALL
PRE-PROPOSALS SUBMISSION FORM
Date of submission
Day:
Month:
Year:
Short Title of the
Invention
1. Contact Information
Full Name of Project Coordinator:
Institution:
E-mail:
Job / Title:
Phone number:
Cellular phone:
Address:
While answering the questions, please take into account the following instructions:
1. Provide clear and concise scientific package of non-confidential data;
2. Provide sufficient information (actual data), so that it can enable determining if your
offer is within the strategy and scope of our enterprise1;
3. Provide information that can be understood by a competent scientist, not necessarily
an expert in the field;
4. Anticipate the obvious questions and answer them in advance;
5. Include links to published material relating to your technology (articles and patents)
After completing the form, please send it to Sanofi R&D Call Committee, at
following e-mail address: [email protected]
An “Asset / Molecule / Technology Evaluation Check List” is provided in Appendix. To submit the
Project, it is not requested that you have all the information listed; however, the more information you
provide, the higher will be the ability of the Coordinating Committee to appraise your Project. Also, do not
limit yourself only to the space provided by the form fields.
1
2. Application
Title of the Invention:
Area:
[ ] Oncology
[ ] Diabetes
[ ] Cardiovascular
[ ] Rare Diseases
[ ] Multiple Sclerosis
[ ] Immune- Mediated Diseases
[ ] Degenerative Diseases of the Elderly
[ ] Ophthalmology
[ ] Infectious Diseases
[ ] Other*
* Includes programs in tissue protection and repair,
pain, sensory disorders and neglected infectious
diseases
The unmet need:
In this section, explain in detail what is the problem / unmet need that you intend to solve
with your project. Explain why this problem is relevant and why it has not been solved
yet.
Proposed solution:
Describe your offerings and the proposed innovation in a clear and objective manner.
Does this project have any type of
restricted information or material used
from third parties?
[ ] YES
[ ] NO
Does this project have any type of
agreement for distribution or information
or material transfer with third parties?
[ ] YES
[ ] NO
Competitive advantages:
Why would this innovation be well received by the market and what is the competitive
advantage? How does your invention address the above problem/ unmet need better than
current technologies? What are the other innovations that compete with your invention?
Why do you think that no one has discovered it (or developed it) before?
Stage of development:
Describe the stage of development of your project. It is important to provide nonconfidential information regarding all the tests that have been carried out, as well as
results obtained so far.
Publications of your authorship related to the proposal
Intellectual property status:
Is it already protected under patent(s)? [ ] YES
[ ] NO
If Yes, please provide patent(s) deposit number(s) and status
3. Research Staff
Main team:
Describe the capabilities of the team involved in the Project, highlighting your and their
background, experience, profile and differentials.
The partners:
Are there commercial or development partners? What are the relationship history and
the level of involvement?
4. Related research projects approved or being analyzed for approval
5. Other relevant information
APPENDIX
“ASSET / MOLECULE / TECHNOLOGY EVALUATION CHECK LIST”
(This list will not be filled-in; just for information purpose)
Asset/ Molecule/ Technology Evaluation Check List
Category
Details
Description
1. Company/organization
2. Molecule
1.
2.
3.
4.
Name/ mol wt, mol formula, Log D, H bond donors, H bond acceptors, ligand efficiency –
Nature of mol – appearance, solubility in water, pH, compatibility
Indications
3. IP status/ Reg data
1. Patent filed
2. Publication date 3. PCT date –
4. Market Potential
1. Value –
2. Unmet need –
5. Target evaluation
» Target
» Indication(s) –
» Off target effects –
» Liabilities –
» Novelty of target
» Failures reported
6. Competitive landscape
» No. of players –
» Discovery –
» Ph I – III –
» Launched » Alternative therapies –
7. CMC
»
»
»
»
»
»
Complexity assessment No of steps/ cost Salt selection Chiral centers – purity of enantiomers Physical and Chem properties – solubility, stability( solution, photo,
thermal, hygroscopicity, crystallinity Packaging and storage –
»
»
»
Potency
Selectivity –
Other effects (eg phospholipidosis, cytotoxicity)
8. In vitro
9. In vivo
»
»
»
»
»
»
»
Models –
Efficacy –
Selectivity
PK/ PD
Comparison with benchmarks –
Synergies/ additive/ antagonism effects –
Safety and tolerability
10. In vitro ADME
» Solubility (method) –
» Stability – microsomes/ hepatocytes/ plasma/ buffer (pH 2 and 8)
across species –
» CYP – profiling, Induction, inhibition –
» Pgp substrate, inhibitor/enhancer (tissue specificity) –
» Protein binding (method) –
» Permeability – CACO 2… 11. In vivo ADME
» DDI –
» PK across species » tissue distribution/ concentration/ brain penetration
» Elimination routes and rates –
» Bioavailability, half-life –
» Volume distribution –
» Clearance
» Metabolism –
12. Toxicology
»
»
»
»
»
»
»
»
»
»
»
hERG –
Dog CVS/RS/ GI/Renal/CNS
Acute tox – rodent;
Repeated dose GLP tox – 14, 28, 90 day – rodent, non-rodent (dog/
monkey) –
TK – GLP – 2 species –
MTD (nude mice if applicable) –
Genotox – AMES, micronuclei, chromosomal aberration…
Age related tox –
Safety margin – NOAEL, NOEL –
Expected human dose and frequency –
Broad panel screen (eg CEREP) –
13. Formulation and Stability
» Formulation work done –
» Dosage form and route of administration » Stability » Clinical packaging –
14. Clinical studies
» Regulatory approvals –
» FHD – problems and issues
» SAD
» MAD –
»
»
»
»
»
»
»
Dose proportionality
Duration of studies –
Ease of recruiting
Outcome of trials Future clinical plan
Ph II a/ b/ III
Co-administration with other drugs related to diseases and comorbidities–
» Biomarker strategy – tissue sampling/ analysis
» PK/ PD –
» Country issues –
» Size of disease population –