The CTSI is sponsoring a symposium on drug and device development on Monday, October 20, 2014. The event will run from 11:00 am to 5:00 pm at the Medical College of Wisconsin.
This symposium will provide insight into the changing landscape of pharmaceutical development and healthcare innovation. Presenters will describe available resources in Southeast Wisconsin to help researchers develop and commercialize drug leads two different ways, via licensing or the formation of a spinout company. Plenary and breakout sessions will bring together academic investigators and experts in the area of drug development and commercialization. The symposium’s topics will include intellectual property protection, the formation of biotechnology startups, funding strategies and financial models, and building strong partnerships.
Cynthia LaConte, CEO of Dohmen, will talk about the future of healthcare innovation in southeast Wisconsin.
Eric Olson, PhD, Chief Scientific Officer at Syros and former Director of the Cystic Fibrosis program at Vertex, will tell the scientific and business story behind the development of Kalydeco, a first-in-class drug, approved in 2012.
John Neis, Managing Director of Venture Investors, will speak about venture funding of drug and device development in Wisconsin and nationally.
- I’ve got a target, what next? William Clarke (Associate Professor of Anesthesiology, MCW; Director of Research Commercialization). As director of biology at GlaxoWelcome and global head of R&D at Amersham, Dr. Clarke oversaw the development of therapeutics and diagnostics for diverse biologic targets. This session will help investigators plot a drug development path, once they have identified a protein that is a drug target. It describes next steps, from the perspective of pharmacology, toxicology, and intellectual property.
- I’ve got a molecule, what next? Daniel Sem (CEO of Bridge to Cures, Inc.; Professor of Pharmaceutical Sciences, CUW). This session describes how you go from an initial small molecule lead molecule, to a drug suitable for IND-filing, with emphasis on the chemical optimization and patent considerations
- Intellectual property for startups. Lisa Mueller (Partner at Michael Best). During the last 13 years Lisa has spent multiple days each week on-site at Abbvie and Abbott assisting in-house counsel in procuring patents covering its pharmaceutical products and diagnostic assays. This session will describe IP issues that startups face, and provide an overview of what makes a drug, diagnostic assay, or device patentable.
- Design and Execution of a Phase I clinical cancer trial. James P. Thomas (Medical Director, Cancer Center’s Clinical Trials Office; MCW). Once a drug (or device) has completed pre-clinical studies, and an IND is filed, one must plan and execute the Phase 1 clinical trial. This session describes this process, and resources available at the Cancer Center’s Clinical Trials Office.
- Identifying drug development collaborations and resources in SE Wisconsin. John Imig (Professor of Pharmacology, MCW). This session is focused on helping investigators find collaborators and resources to assist them in drug discovery and development projects. The resources associated with two new organizations will be presented: (a) The Regional Drug Discovery and Repurposing Initiative, and (b) Bridge to Cures, Inc.
- SBIR/STTR funding strategies. Brian Curry (CEO, PhysioGenix), David Linz (Interim Director, Center for Technology Commercialization). This session describes the process of securing SBIR and STTR funds from NIH for drug and device development projects, and how to go about preparing a competitive proposal, and State resources and funding to assist with proposal preparation including the recently announced SBIR Advance Matching Grant program.
- So you want to start a biotech company. Doug Stafford (Director of the Milwaukee Institute for Drug Discovery). This session will describe the process of forming a company, as well as what investigators should be thinking about before making the leap to form a startup, versus pursuit of out-licensing. You will learn the steps one goes through in forming a company.
- Early stage financing of university spinouts. John Neis (Managing Director, Venture Investors), Lisa Johnson (Vice President Entrepreneurship and Innovation, WEDC), Todd Sobotka (Portfolio Manager, BrightStar Wisconsin Foundation, Inc.), and Craig Shimasaki (President & CEO, Moleculera Labs). In this panel-led discussion, investigators looking to finance startup companies will learn the process of securing state, angel, and venture capital financing, including what investors are looking for and what private funding sources are available in Wisconsin.
Symposium attendees can park in the MCW lot on north 87th street, across from the main entrance to MCW. Directions can be found here. To be admitted into the lot, pull up to the parking lot’s intercom and state that you are there for the Drug and Device Symposium.
CTSI Regional Drug Discovery and Repurposing Initiative