Presentation on theme: "Preparing a SBIR Fast-track Application: The Start-Up Perspective Chris Rogers, PhD."— Presentation transcript:
Preparing a SBIR Fast-track Application: The Start-Up Perspective Chris Rogers, PhD
Mission/Vision Mission oExemplar Genetics is committed to enabling an improved understanding of life threatening diseases and facilitating the discovery of life changing therapies in an effort to reduce human suffering. Vision oExemplar Genetics intends to accomplish this mission through the creation and delivery of animal models that represent human disease and to provide the support necessary to study said animals.
The Problem Insufficient Models oAnimal models that faithfully represent human disease are not currently available. This represents an enormous barrier to: Understanding human disease mechanisms. Developing novel diagnostics, procedures, devices, prevention strategies and therapeutics. Predicting the efficacy in humans of new procedures, devices and therapeutics.
The Solution A Better Model oPigs represent a much improved animal model of human disease because: Pigs and humans share many anatomical, histological, biochemical and physiologic properties. Pigs and humans are more genetically similar than are mice and humans. Pigs and humans have similar immune systems and inflammatory responses. Pigs are excellent models for cardiovascular disease, obesity, diabetes, alcoholism, hypertension, toxicology, intestinal function, nutrition, and injury and repair.
Initial Models Cystic Fibrosis CFTR-null CFTR-ΔF508 Received a SBIR Fast-track grant from NIH/NHLBI: “Development of a Humanized Porcine Model of Cystic Fibrosis”
The Start-Up Perspective Background The company didn’t exist at time of submission Two main individuals were involved The science guy (Me) – then, a post-doc Academic background, research plan experience The business guy – had another job at the time Academic and business background, business plan experience
Tip #1: Start Early! Basic things Business name, address, phone, email, etc. – Choose wisely! (See Tip #4) Registrations galore EIN, DUNS, CCR, eRA Commons, etc. I was a one-man Office of Sponsored Research/Grants Management That took a lot of time…
Tip #2: Provide lots of letters Letters of support Collaborators & Consultants Letters of interest Potential customers Academic Industry Disease Foundations Potential investors Investment groups Companies
Tip #3: Supplemental Data We submitted new, breakthrough results just before review. We communicated the importance of the data to our SRO. It was clear from the reviewers’ comments that this had been vital. These were the most important two pages of our submission.
Tip #4: You’re not done yet We changed our name between the time we submitted the grant and the time we received the award letter. Big mistake! Multi-agency nightmare ensued NIH, OLAW, IRS Funds finally available 7 months after award letter! (17 months after submission!) It’s a good thing we weren’t depending on funding.
Summary Start early, there is a lot more to it than the research plan. Provide as many letters as possible. Send in supplemental data. Be patient, a lot can happen before you access your funding.