Project Title Investigators 1 To see TIPS and FAQS for each slide, please look at this template in Notes view.

Slides:



Advertisements
Similar presentations
Overview of the Keys to Successful Commercialization Gerald J. Siuta, Ph.D. President Siuta Consulting, Inc. Tucson, Arizona October 18, 2001.
Advertisements

The Drug Discovery Process
Name of institute or company
Title Slide – Technology or Company Name
*This is an Example of Presentation Layout
Company Name/Logo Name of Founder/Owner MGT 487 May 2014.
The Statisticians Role in Pharmaceutical Development
Safety and Extrapolation Steven Hirschfeld, MD PhD Office of Cellular, Tissue and Gene Therapy Center for Biologics Evaluation and Research FDA.
Thursday, January 14 th 2010 Title of Project John Q. Public, Ph.D. Department of Biomedical Engineering Jane S. Day, M.D. General Hospital FYxx_Pzzz Please.
Chapter 9 Writing a Business Plan
Biomedical research methods. What are biomedical research methods? An integrated approach using chemical, mathematical and computer simulations, in vitro.
The NIH Roadmap for Medical Research
Bioinformatics Ayesha M. Khan Spring Phylogenetic software PHYLIP l 2.
2015 Startup Nomad Global Acceleration Application Team Name: Applicant Name:
Sample Format and Contents for 2015 High School Business Plan Competition Allotted presentation time –10 minutes 5 min. for Q/A Non proprietary information.
IGEM Project Technology Name Presenter’s Information and Title Title of Industry Contacts and University Contacts.
Chapter 13. The Impact of Genomics on Antimicrobial Drug Discovery and Toxicology CBBL - Young-sik Sohn-
Project/Product Title PI (and Co-PI) Affiliation August 10, 2012.
Adding Safety Pharm Endopoints To General Tox Studies - II Michael J Engwall, DVM, PhD Principal Scientist Safety and Exploratory Pharmacology Toxicology.
ENTREPRENEUR SLIDE PRESENTATION Company : Person in Charge : Designation :
Biomedical Research Objective 2 Biomedical Research Methods.
Biomedical Engineering Title of Project Name of PI and Co PI Oversight Committee Presentation.
Drug Discovery Process Massimiliano Beltramo, PhD.
AHRQ 2011 Annual Conference: Insights from the AHRQ Peer Review Process Training Grant Review Perspective Denise G. Tate Ph.D., Professor, Chair HCRT Study.
Biomedical Research. What is Biomedical Research Biomedical research is the area of science devoted to the study of the processes of life; prevention.
Center for cei Entrepreneurship & Innovation Technology Venture Sequence 9/6/05.
Medicine Differentiation Analytics Process Presentation to…. Date….
The Use of Scientific Advisory Boards An Invaluable Tool in Drug Development Dr Robert Miller Chief Medical Officer Fulcrum Pharma Developments 19 th Annual.
Developing medicines for the future and why it is challenging Angela Milne.
Intellectual Property Rights and Pharmaceutical Industry
Office of Technology Development Case No. ________ CONFIDENTIAL Intellectual Property Committee Presentation Inventor(s) Invention Title Presentation Guidelines:
Privacy Symposium / HIPAA Summit
Project Name Project Proposal Presentation to the Virginia Biosciences Health Research Corporation Project Management and Oversight Panel Presentation.
NHMRC Development Grants Overall Objectives The aim of a Development Grant is to progress research to a stage where it can attract investment from.
Examination Practice in Applications Presenting “Reach-Through Claims” George Elliott Practice Specialist Technology Center 1600
Medicine Differentiation Analytics Process Marketing Plan 3/30/3/30 March 21, 2011.
Bioassay Optimization and Robustness Using Design of Experiments Methodology 2015 NBC, San Francisco June 8, 2015 Kevin Guo.
Shows tendency for mergers. These big companies may be shrinking – much research is now outsourced to low cost countries like Latvia, India, China and.
Principal Investigator ESTCP Selection Meeting
Skolkovo PRESENTATION
[Project Title] [Presentation Date]
[Project Title] [Presentation Date]
Startup project presentation deck
PRODUCT NAME Team Leader: Faculty/ Research Alliance: Address:
Guidelines in Preparing the Business Plan
Principal Investigator ESTCP Selection Meeting
Pitch Deck template* cover slide
An Introduction to Medicinal Chemistry 3/e
From Bench to Clinical Applications: Money Talks
Project Title Investigators
[Project Title] [Presentation Date]
Application for UMP Accelerator Programme
Drug Design and Drug Discovery
Add title of your presentation for the technological track
Natural Gas Innovation Fund Investment Intake Template Project Title Submitted By *Note: This template is intended as a guide on content; you may.
Principal Investigator ESTCP Selection Meeting
Rational for the 5R Philosophy
Objective 2 Biomedical Research Methods
Project Title Investigators
Pillars of WARF Therapeutics: Invest - Develop - Partner
Principal Investigator ESTCP Selection Meeting
Proposal Presentation to the
Presentation Title [NAME] AFFILIATION [ ADDRESS] [WEBSITE]
Natural Gas Innovation Fund Investment Intake Template
X-Elevate.
Considerations for Successful Biopharmaceutical Product Development: Discovery to Proof of Concept -A Panel Discussion Stanley C. McDermott, PharmD, MS,
Technology Title One-line Description Name, PhD Title Department
Project title Company name.
Project Title Investigators
Contents of the Presentation
Presentation transcript:

Project Title Investigators 1 To see TIPS and FAQS for each slide, please look at this template in Notes view.

2 Two Year Goal Statement Your two year goal will frame the following assessment.

Brief background for team members and their roles on this project. Include relevant past experience, if any. Identify unfilled roles needed. 3 Project Team

Briefly, introduce background science. What is the problem worth solving? What is your solution? Why is it novel? 4 Scientific Background and Opportunity

Describe additional research data needed but which is outside the scope and capability of the investigator’s laboratory. 5 Research Plan

1.Describe your target and biological pathway 2.Does biochemical assay exist? 3.Does a cell-based readout exist? 4.What are assay readouts for all assays (e.g. luminescence, fluorescence intensity, image-based, others)? 5.What is your level of experience with the assays? 6.Are all critical reagents for the assays currently available? 6 Assay Feasibility Assessment

1.Target location(s): extracellular, intracellular, CNS, etc. and tissue type. 2.Can the protein be reliably expressed and purified? How? 3.Does crystal structure of target exist, resolution and RCSB code. If no, what are the closest homologs with crystal structure coordinates? 4.Predicted binding pocket affinity of target (YCMD determined); i.e., is the target druggable? 5.Are small molecule inhibitors known? 6.Synthetic accessibility (conducted after HTS analysis) 7 Med. Chem. Feasibility Assessment

1.Is the biology (i.e. pathway) well characterized? 2.Has modulation of the pathway been shown to correlate with changes in disease burden (e.g. phenotype of KO mice, relevant animal studies, GWAS) 3.Is there precedent for the MOA for similar disease targets? 4.Is there a reliable and predictive animal model that has a history in translating compounds to the clinic? 5.Does a clinically relevant biomarker exist? 6.Competition: Examine approved claims (efficacy and safety) of competitors. Examine the competitive environment for compounds currently in development. 8 Clinical Correlation Assessment

1-2 slides addressing Scope of unmet medical need Number people affected by disease (target population) Current standard of care and market size (commercial potential) Unique needs of the target population Phase II proof of mechanism and patient stratification strategy 9 Clinical Need/Potential Market

1 slide describing the desired characteristics of the proposed therapeutic for the intended indication What is the specific value of your drug/approach to patients? What advantages does it offer over existing or competing approaches? How your product meets the needs of your global market based upon performance features, costs, robustness, etc. 10 Targeted Product Attributes

1 slide addressing Office of Cooperative Research/Technology Commercialization Services disclosure and patentability status 11 Intellectual Property Position