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NEWS & EVENTS

DEC 1, 2016 – A CLINICAL TRIAL ROADMAP: WHO, WHAT, WHEN, & HOW – PRACTICES, PERSPECTIVES AND PERSONAL INSIGHTS

While many of us conceptually understand the clinical trial process, a deeper dive will provide essential information regarding the parties involved, the risks, structuring and optimizing clinical archicture, design, efficiency, visibility, and more. What are the recommended practices? What is Just-inTime Monitoring? How should you manage your supply chain? How do you select the best CRO? The key is to understand the elements and thus ensure smooth navigation throughout the complex clinical trial landscape and journey. There are a myriad of drugs in clinical trials, each with a story to tell.

Valley Fever Solutions’ (VFS) first-in-class compound, Nikkomycin Z (NikZ) is being developed as a dramatically superior potential cure for Valley Fever (VF), a painful and debilitating orphan disease. Collectively, the market for anitfungals across a spectrum of similar disease organisms approaches $1B. Broadly and worldwide, the market reaches $6B. With Orphan Product designation, NikZ’s Phase I trial results have been very promising, and VFS has a “fast track” plan to proof of concept in 10 months.They anticipate showing human efficacty working with an existing trial at the NIH. VFS expects to be a good candidate for an additional $1.5M FDA orphan drug product trial grant in 2017. Join us and learn from a true expert’s professional and personal journey.

About the Speaker:

davidlarwood_pcDavid Larwood has been a chemist for decades, most recently leading Valley Fever Solutions since 2007 as its CEO. His PhD research at UC San Francisco included the world’s first PEGylated liposomes, later leading to Doxil. He was the first to make suitable PEGylated lipids. Earlier, at UC San Diego, he was the first ever to make Iotrolan, a contrast agent still in commercial use 37 years later.

Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis). Since securing grant support to continue with Phase II trials, Mr. Larwood has been leading improving the API manufacturing process, working on drug product, planning for clinical trials, and organizing the trials.

Mr. Larwood moved away from being a bench scientist when he took a law degree. He advised well known companies on patent matters until he moved to a position at Apple Computer for four years. He took an executive role at a startup, again in an IP role. He then moved to another startup taking Verisity Design public as General Counsel, continuing in that role through a successful acquisition in 2005. David also received an MBA in entrepreneurship from UC Berkeley and Columbia University.

Mr. Larwood is the third of his family to be involved in Valley Fever. His father is a clinician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a hot spot for Valley Fever. His mother started a foundation in about 1998 and raised some $20M for research into vaccines for Valley Fever. Her chief scientist was the program manager at Shaman running the Nikkomycin Z drug development project. Timing was perfect for Mr. Larwood to join Valley Fever Solutions in 2007 to drive that project forward.

Title images are licensed under Creative Commons License.

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