Michael J. O'Rourke Email & Phone Number

Belfast, Northern Ireland, Gb

Re-Vana Therapeutics is a venture-backed company at the forefront of therapeutic and drug delivery innovation, specializing in sustained-release technologies for the treatment of eye diseases that represent multi-billion dollar markets. Our proprietary, crosslinked platforms are designed to deliver biologics, large molecules, and small molecules over an extended period (3–12 months) through non-surgical administration in a clinical setting. This approach promises to drive significant advancements in treating global retinal diseases.Re-Vana follows a hybrid strategy, focusing internally on the development of a 6-month sustained-release anti-VEGF asset, while also forging strategic partnerships with major pharmaceutical companies to expand our impact in ophthalmic care.

Tampa, Fl, Us

Ophthalmic consulting business specializing in Drug, Drug Delivery and Medical Devices for both Established and Start Up companies in the USA and Europe.Business Development/Licensing - Strategy - Marketing - Product Development - USA/European Integration Scotia Vision, formed in 2009, has worked with 30 companies including some of the industries most innovative products, including multiple drug delivery technologies, topical drugs, small and large molecules, the world’s first “bionic eye” surgical prosthesis, femtosecond cataract, breakthrough pediatric visual diagnostics, neutraceuticals, a unique ocular research center, and many more, both in the USA and Europe. In 2015 we formed a partnership with medeuronet (London UK, Strasbourg France) to support USA based medical device companies plan for European market entry with a broad range of services including Strategy and Marketing - CE marking - Regulatory - Reimbursement - Clinical - PR www.scotiavisionllc.com

GrayBug is a pharmaceutical and drug delivery company, developing therapeutic products for major ocular disease indications including wet AMD and Glaucoma through a continuum of proprietary micro - and nanoparticle controlled release technologies. Major leadership accomplishments:Raising >$2.5m including the closure of an A2 roundSecured 4 SBIR grants totalling > $750KAdvanced pre clinical research programs including GB 102 in wet AMD Strengthened the scientific teamCreated global GrayBug awareness and established major interest from potential partnersEnhanced the corporate infrastructure including the transition from LLC to C Corp and conducting an external valuation

Bridgewater, Nj, Us

Promoted to General Manager with full P&L responsibility. Charged with turning around one of the 3 B&L operating North American divisions totaling $1.3B. Successfully established it as a $170M net sales business unit and the fastest growing division for 2 successive years in Bausch & Lomb worldwide with record levels of retention, motivation, and sales growth. Reported to North American President. Focused on raising caliber of 150-person team with top-class hires, achieving greater market focus, providing proactive cost management, executing profitable investments, developing innovative people strategies, and transforming business culture to one of “passion” and “desire for success.” Hired and provided leadership to 80 new sales professionals and 30 new managed care/marketing employees. * Drove 314% growth over 4 years to $170M net sales and increased operating margin 7 points. * Led global cross-functional team in developing and launching the world’s 2nd ocular drug delivery product Retisert® to treat inflammatory blindness. Added critical mass and sales coverage by negotiating/signing co-promotional deal with Novartis.* Grew the Loteprednol portfolio (Lotemax®, Alrex®, Zylet®) to $100M+ by repositioning brands and targeting Lotemax for dry eye inflammation. Established Lotemax® as the #1 prescribed topical branded steroid in the USA.* Provided new sales/marketing opportunities by developing and receiving approval from CEO/ Board to implement plan for broadening the pharma P&L to $310M via integration with $140M OTC portfolio, including nutritionals and dry eye.* Instrumental in retaining 100% of the employee base during challenging period involving a major product withdrawal from the market in another Bausch & Lomb division (contact lenses). Alleviated employee concerns by phoning or meeting individually with all 150 employees to assist them during this difficult period.

Bridgewater, Nj, Us

Selected by the CEO as Global VP of Strategy (2001-2004) to pioneer new and first-ever global strategic pharmaceutical division covering prescription, generic, and OTC nutritional products. Created global strategy team and planning process, identified and hired key opinion leader advisory team, identified investment opportunities, and set global pricing. Concurrently, managed existing surgical business initiatives over 12-month period as company searched for replacement. Hired and managed team of 12. Previously as Global Director of Strategy (1998-2001) spearheaded the company’s first ever-global surgical strategy division for cataract and retina, an initiative that included leading the development of breakthrough drug delivery devices.* Grew pharmaceutical division business 30% – resulting in continued multimillion-dollar investments – upon developing/executing strategic plan approved by the CEO/Board. * Created unique, aggressive disease state sales strategies combining medical devices and drugs delivering special portfolio growth – an effort that contributed to the 30% business growth.* Identified and negotiated new business targets to secure new product technologies encompassing drugs, drug delivery, and early phase devices – including plasminogen, genestein and the first 25 gauge vitrectomy device.* Grew Medical Device/Pharmaceutical business 20% to $309M over 3 years (1998-2001). Attributed compelling business performance to the development and implementation of the first ever global strategic plan through teamwork and cross-functional collaboration.

Hired to form and merge a new European business team and lead the marketing function for a new ophthalmic medical device and drug delivery company that was created via integration of 4 European companies (Domilens France, Adatomed Germany, Technolas Germany, and Iolab UK) and merged with US company Chiron Vision. In 1997, the company was acquired by Bausch & Lomb, which also acquired competitive ophthalmic company (Storz). Subsequently involved in leadership capacity with integration of Chiron/Storz into Bausch & Lomb. Gained extensive merger and integration experience working across the cultural and competitor divide.* Grew business from $50M to $70M in 2 years through effectively managing, merging, and integrating teams from the 4 European companies.* Successfully transformed 3 medical devices business units into one cohesive and functioning team as the European Leader for the Chiron/Storz/Bausch & Lomb global integration strategy.* Led European cross-functional team in the development and launch of the world’s 1st ocular drug delivery product Vitrasert® to treat blindness in HIV patients. Achieved first year target of $15M.

Seattle, Washington, Us

Started European operation for a $400M world leader in drug delivery technology as the company’s first ever ex-USA employee; company was later acquired by Johnson & Johnson. * Established European base and infrastructure from the ground up and brought in Actisite®, a new drug product from the USA and the world’s first drug delivery technology treating periodontitis. Gained regulatory approval and negotiated/signed distribution deals in 8 European markets.

Hired by $2.5B world leader in orthopedic implants to re-launch the Gamma Nail® in Europe, Asia and Japan, and to lead commercial, R&D, and advisory team in developing and launching the world’s first ever customized trauma product designed specifically for the “Asian” femur – this technology is still regarded today as first line treatment for fractured femurs. Managed 3-person global product management team, and developed/executed against global strategic plan. * Drove sales to $70M – exceeding sales target within 24 months.* Developed worldwide recognition for the Gamma and Gamma AP brands.

St Paul, Mn, Us

3M PHARMACEUTICALS, England UKMarket Development Manager, Senior Product ManagerProduct ManagerMedical Liaison Specialist, Sales TrainerSenior Medical Representative, (No. 1 UK/Ireland rep)

Executive Development (2002 With Advanced Course 2006, Business Strategy

Post Graduate In Marketing, Business

Post Grad, Teaching & Education

B.Sc (Hons), Chemistry