Robert Ashley Email & Phone Number

San Diego, Ca, Us

Provisio Medical is a medical device company based in San Diego, California seeking to establish a new standard in vessel sizing, a critical step in millions of endovascular procedures performed every year. Provisio’s SLT IVUS™ technology, which is incorporated into the type of catheters that physicians are already using, is designed to revolutionize interventional therapies by giving physicians the exact information that they need, when they need it, while enhancing procedural workflow.The Provisio SLT IVUS System consists of the SLT IVUS™ P1 System and the SLT IVUS™ Support Crossing Catheter. The SLT IVUS Support Crossing Catheter is an over-the-wire intravascular ultrasound catheter with an ultrasound transducer array at the distal end that also functions as a support crossing catheter. The information from the ultrasound signal is used similarly to sonar technology to measure vessel dimensions in real-time and measure the peripheral vessel’s flow lumen.Provisio Medical obtained FDA 510(k) clearance of the Provisio™ SLT IVUS™ System in April 2024.

Consulting firm providing services to the biopharmaceutical industry; specializing in management of global operations / clinical development / regulatory affairs / R & D, strategic planning, business development and technology assessment.

Following the reverse merger of Vital Therapies with Immunic, joined a small start up team at Epirium Bio as Head of Regulatory (initially 6 persons between founders in San Francisco and San Diego based management team) including prior VTL CEO to take forward nascent small molecule technology in the field of mitochondrial biogenesis, structure and function for initial application in rare diseases. Epirium Bio Inc is a clinical stage biopharmaceutical company developing therapeutics that optimize both tissue bioenergetics and structure through a novel mechanism of action discovered by the company and others. The Company completed a Series A financing led by Longitude Capital and joined by additional investors ARCH Venture Partners, Bluebird Ventures, Adams Street Partners, Vertex Ventures HC, and The Longevity Fund. Epirium intends to continue advancing its clinical candidates in diseases of the neuromuscular system in 2022.• Member of 7-person Company executive committee• Provided extensive input into company operations including budget, hiring plan, facilities, research program, clinical development plan, manufacturing strategy, quality operations and fund raising strategies.• Supported $85MM Series A fund raise.• Established and implemented company regulatory strategy• Took on responsibility for toxicology program and bioanalytical program.• Devised novel route to gain ownership of an active research IND enabling new clinical studies to start within 6 months• Obtained orphan drug designation for lead product in US and Europe• Completed commercial IND filing for lead candidate

San Diego, California, Us

CSO for Vital Therapies, a publicly-traded (NASAQ: VTL) company engaged in late stage clinical development programs in the US, EU and China to develop ELAD, the first human cell-based bio-artificial liver. • Part of 3 man team that successfully took the company public ($60MM) in April 2014, then raised additional capital ($32MM) in follow on offering in October 2014 resulting in an “impregnable” ($100MM) capital position going into 2015. Maximum company valuation ~$800MM.• Provided leadership of worldwide manufacturing, clinical and regulatory operations during period of mid and late stage clinical development.• Developed and implemented novel clinical and regulatory development strategy worldwide.• Recruited and built senior management team (from 9 to 100 employees) over 2 year time period to implement clinical and regulatory strategy.• Developed R & D capability from scratch resulting in unique understanding of complex cellular therapy MOA.• Repositioned development program for new indication in pivotal trials.• Successfully engaged US FDA and EU EMA in meaningful discussions and reached agreement with written guidance on common pivotal trial design over a period of only 6 months.• Engaged Chinese FDA in dialog to facilitate first approval of ELAD in China.• Directed program to obtain local and international development and marketing partners for ELAD.

Biopharmaceutical company based on novel nasal mucosal drug delivery technology sourced from Sweden.Raised $400,000 seed capital; successfully carried out proof of principle studies in animals using virtual development model. Negotiated license agreement with inventor and managed evolution of product claims through interface with external patent counsel. Recruited local CEO and transitioned company to independence.

Us

A start-up pharmaceutical company developing therapeutics for the treatment of cancer based on technology licensed from the University of Arizona and Research Corporation Technology.Raised >$25MM in Series A and B preferred stock funding from angel, venture (Valley Ventures, Solstice Capital) and other sources. Voted Arizona Bioscience Company of the Year (2006) and one of 50 Arizona Companies to watch.Negotiated terms and in-licensed second significant clinical stage oncology product from University of Arizona to complement internally developed product opportunities.Reworked and gained buy-in from senior clinical and regulatory personnel, as well as shareholders and Board for revised development plans due to lack of activity of primary product in first indication.Managed clinical development program through initiation of Phase II clinical trials.Developed European and South East Asian business development opportunities.Maintained strict financial control.Carefully built company payroll from 5 to 20 over three year period.

A venture start-up in dental pharmaceuticals (one of the first ever virtual pharmaceutical companies based on University-licensed technology) that successfully transitioned to a dermatology-based NASDAQ-quoted public company. Eventually sold to Galderma for $450MM. Dramatically increased shareholder value. Company raised two rounds of venture financing (~$15MM) then conducted a successful IPO in June 1996. Valuation grew from $10MM to a peak of > $500MM. Filed NDA on time and in budget for lead product (Periostat). Resolved potentially fatal issue with FDA. Gained approval within 2 years. Gained UK approval March 2000. Launched product in US (October 1998) and UK (October 2000). Repositioned company by acquiring dermatology company and in-licensed dermatology products. Concluded European and Japanese licensing relationships and completed technology licensing deals with leading multinational companies, including Medtronic, Boehringer Mannheim and Smith and Nephew.Implemented CRADA with NCI leading to an IND filing for lead candidate and Phase II clinical trials.Established European subsidiary in UK and held role of Managing Director to manage regulatory and licensing activities in Europe. Gained approval for and launched Periostat in UK, 8 other European countries, Israel and Canada.Extended range and scope of proprietary technology through numerous new worldwide patent filings, including sustained release technology resulting in Oracea, the current standard of care for the treatment of rosacea (worldwide sales >$300MM).Developed strategy and in-licensed multiple products for co-promotion by dental sales force; included rights to sell VIOXX to dentists, doubling market cap overnight and lauded as a unique partnership between big and specialty pharma.Reached settlement with generic companies avoiding threat of generic introduction and developed successful strategy to preclude FDA approval of generic competitor.

Lawrence Township, Nj, Us

Increasing levels of responsibility for commercial development, product management, market management, business development and strategic planning in the in vivo diagnostics division of BMS. Led multidisciplinary team to launch ProHance, the first non-ionic MRI contrast agent. Developed strategy to expand into new diagnostic imaging markets and acquired and led development of early stage ultrasound imaging drugs. Positioned the division for growth culminating in the successful sale of the division in 1994 to Bracco Diagnostics, a private Italian pharmaceutical company.

Various roles in a rapidly evolving UK government spin off developing and marketing in vivo diagnostic imaging pharmaceuticals. Successfully transitioned manufacturing processes from manual to computer control, developed novel market leading products, undertook product planning for complex just in time supply worldwide, product managed the critical product line combined with highly successful restructuring of national sales force leading to recapture of market leading position in first year.

Masters, Biochemistry

A Level, S Level, Math, Physics, Biology, Chemistry, General Studies