MAKING GREAT DRUGS BETTER

The Team

Michael O'Rourke - portrait photography by Rob Harris Productions

Michael O’Rourke – Chief Executive Officer, Director

Michael O’Rourke, has been involved in “drug delivery” for over 30 years across Ophthalmology, Periodontal and Pulmonary markets including strategy development and global commercialization; previous companies include 3M Pharma, Pfizer, Alza, Chiron Vision, Bausch + Lomb and GrayBug. In 2009 Michael founded Scotia Vision Consultants advising ophthalmic companies on all aspects of commercialization and product development with a focus on anterior and posterior ocular drug delivery

Prior to establishing Scotia Vision Consultant in 2009, Michael was General Manager for the $200m Bausch + Lomb U.S. Pharmaceuticals division in Tampa FL with full P&L and operating responsibility, transforming the business to record levels of growth and managing 150 employees. Previously he pioneered new Bausch + Lomb global strategy divisions including Pharmaceutical, Drug Delivery and Surgical products in California and Rochester NY. Michael was CEO for the start up company GrayBug based in Johns Hopkins University (Baltimore, Maryland) where his accomplishments included the closure of an A2 round, securing 4 SBIR grants totalling $750K, developing an infra structure for business development deals and advancing pre clinical research programs in retina and glaucoma.

His ocular drug delivery experience includes launching the world’s first intra ocular drug delivery technology in Europe, Vitrasert®, and the world’s second, Retisert®, in the USA. Michael was the first European Marketing Director for Chiron Vision Europe. Additional experience includes Alza International (drug delivery) establishing their European division and launching the world’s first sustained release technology Actisite® treating periodontitis. At 3M Michael worked in both sales and marketing for new sustained release therapeutics and enhanced aerosol delivery technologies treating pulmonary disease.

Michael has managed 28 brands, led 13 product launches, structured/negotiated 12 strategic business deals and has been a team member in 18 device/drug approvals. Michael has both presented and published within ophthalmology at congresses and within respected journals. He is past Chairman of The Foundation Board for The Lions Eye Institute, guest speaker on strategic planning at the University of Tampa and was part time marketing lecturer at Trent University in Nottingham, UK.

He is a native of Scotland and has lived and worked in Europe, USA and Asia. In 2010 he became a member of the GlobalScot Business network; assisting Scottish based Life Science companies plan for USA market entry, and was appointed to the Hall of Fame in 2018. He is based in Tampa, FL.

Patrick H O’Ruane PhD - Chief Operating Officer, Re-Vana Therapeutics

Patrick H O’Ruane, Ph.D. – Chief Operating Officer

Patrick has dedicated over twenty years to the advancement of sustained release drug delivery systems, specializing in various medical disciplines such as Cardiovascular, Ophthalmology, Gastrointestinal, Ear Nose and Throat, Transdermal, and Surgical. His expertise lies in achieving controlled and prolonged release of Active Pharmaceutical Ingredients from biodegradable polymeric platforms integrated into drug-device combination products.

Patrick held key positions at prominent pharmaceutical companies, serving as CTO at Allay Therapeutics and Chrono Therapeutics, and as VP of R&D at CV Ingenuity, later acquired by Covidien. He is dedicated to improving patient care through novel sustained drug delivery systems, leveraging his multidisciplinary expertise to advance the field and enhance treatment options, ultimately improving patient outcomes.

Patrick, a highly skilled physical-organic photochemist, has made significant contributions to academic and patent literature through extensive publications. With undergraduate degrees from The Galway-Mayo Institute of Technology and Trinity College Dublin, he pursued a Ph.D. from University College Dublin. His expertise led him to research Reactive Intermediates and Reactive Oxygen Species (ROS) using Laser Flash Photolysis during a fellowship at The University of Toronto. At The Johns Hopkins University, he employed Time-resolved Infrared spectroscopy to investigate organic chemistry reactions and developed a controlled release caged system for nitric oxide delivery. His groundbreaking research at The Ohio State University resulted in the commercialization of a product for pathogen inactivation in human blood products. Patrick’s work bridges scientific research and practical applications, demonstrating his dedication and talent in advancing knowledge and addressing real-world challenges.

Overall, Patrick’s extensive training and research experience in physical-organic photochemistry have positioned him as a leading expert in the field. His contributions to academia, patent literature, and practical applications highlight his exceptional dedication and talent in advancing scientific knowledge and addressing real-world challenges.

Gregoire Schwach Head of Biologics at Re-Vana

Gregoire Schwach, Ph.D. – Head of Biologics

Gregoire brings 20 years’ leadership and technical experience in pharmaceutical drug product development with expertise in Biologics, Drug Delivery, Polymer Science and CMC. He transitioned from F.Hoffmann-La Roche in Basel, Switzerland, where he led the formulation, drug product and manufacturing process development from candidate selection to launch of the ocular pipeline of biologics. His team was involved in the successful development and approval of VabysmoTM, and under his leadership the SusvimoTM Port Delivery technology capabilities were successfully established in Basel, together with important vitreous ex vivo and in vitro models to investigate stability and release of therapeutic modalities into the eye.

Prior to Roche, Gregoire worked and lived in Denmark holding successive roles at Ferring Pharmaceuticals A/S, last as director of early stage formulation development, and prior to that, as CMC project leader of Firmagon® in late stage development and approval by FDA, EMA and Health Canada.

Gregoire has also a very strong expertise in drug delivery systems, biodegrable polymers and medical devices. He has worked for Phusis SA a former company of the Tornier group in France, as head of polymer development, supporting the development and approval by FDA and CE marking of Phusiline® bioerodible interference screws used in anterior cruciate ligament reconstruction.

He is educated as Chem. Eng. from INSA Rouen, France, with M.Phil, Ph.D. and postdoc fellowship from the Universities of Montpellier, France, and Geneva, Switzerland respectively.

Jenna Hewitt, Director of Programme Management

Jenna Hewitt – Director of Program Management

In July 2023, Jenna was appointed as the Director of Program Management. Jenna has 16 years of experience within the Biotech and Pharma industry, within this period she has made significant contributions in various scientific and leadership roles.

She started her career as a scientist, where she honed her expertise working diligently at industry leading organisations such as MedImmune/AstraZeneca, Norbrook, and AFBI, actively delivering drug development across multiple therapeutic areas. Her scientific background has equipped her with an in depth understanding of the intricacies of research and development, a valuable asset in her subsequent leadership roles. Jenna transitioned into program management and where she led delivery of complex biotech projects, ranging from discovery to commercial launch at Norbrook, Almac, Oxgene and Green Biologics.

Before assuming her current position, Jenna held the role of R&D Director at Fusion Antibodies, where she led and expanded the R&D Department. Under her guidance, the department delivered key R&D services and set a robust 3-5 year strategy.

Raj Thakur

Thakur Raghu Raj Singh, Ph.D. – Founder & Chief Technical Officer

Raj Thakur, Ph.D. has more than 18 years of R&D expertise in drug delivery. He holds a PhD in Drug Delivery, an MSc in Pharmaceutical Sciences, and a Bachelors in Pharmacy.

As the Founder and CTO of Re-Vana Therapeutics, Prof. Thakur is committed to developing innovative long-acting drug delivery systems. He also holds a prestigious Chair in Pharmaceutics position in the School of Pharmacy at Queen’s University Belfast, UK, where his research focus is on the design and development of novel long-acting drug delivery systems with particular interest in biologics. He has been the principal investigator for several multi-million-pound projects, which were funded by prestigious organizations such as Research Council UK, industry, and the EU. With one of the leading ocular drug delivery groups, he has successfully supervised numerous PhD projects in this area.

He has over 175 scientific publications and five textbooks authored, as well as five patents on long-acting drug delivery platforms for ocular drug delivery. He has also been recognized as an expert speaker, having been invited to present at numerous national and international conferences. In addition, he serves on the Editorial Board of Ophthalmic Drug Delivery and Frontiers in Drug Delivery, and acts as an assistant editor for Drug Delivery Translation Research.

Tom Biancardi

Tom Biancardi – Chief Financial Advisor

Tom Biancardi is a biopharma industry veteran with over 20 years of financial and operational leadership experience. As an advisor he has assisted numerous pre-commercial companies raise Series A capital and establish early operations including Carisma Therapeutics and Interius Biotherapeutics. He was one of the first employees of Ophthotech Corporation where he helped the company grow from a pre-clinical venture backed startup to a publicly traded biotech company with multiple clinical assets. He also worked with Eyetech Pharmaceuticals where he played a crucial role in the successful launch of the first ever pharmacologic treatment for macular degeneration.

Mr. Biancardi holds an M.B.A. from New York University, and Bachelor of Science degrees in both Mechanical Engineering and Economics from Rutgers University.

Scientific Team

David Waite

David Waite, Ph.D. – Lead Scientist, OcuLief Technology

David has a Ph.D. in Ocular Drug Delivery and an MPharm degree in Pharmacy from Queen’s University Belfast, UK. David has significant experience in the development and characterisation of formulations for sustained release of small molecules and proteins to the eye. As part of a 3-year Ph.D. project he has developed and characterised multiple injectable formulations that form implants in situ, prior to being photocrosslinked, to provide long-term, sustained protein delivery to the posterior segment of the eye. He also has significant expertise in formulation development and characterisation, development and validation of drug quantification methods, protein analytical methods, bioactivity determination and biocompatibility assays. He has authored a review paper on periocular drug delivery, with research papers in the pipeline (subject to patents) and presented posters at several conferences.

Gunjan Deshmukh

Gunjan Deshmukh, Ph.D. – Research Scientist

Gunjan has a B.Sc. in Chemistry, M.Sc. in Organic Chemistry from North Maharashtra University, India and a Ph.D. degree in Chemistry and Catalysis from Institute of Chemical Technology, Mumbai, India. He has over 14 years of industrial and academic research. His research work is amalgamation of synthesis of organic molecule and metal oxide-based nanomaterials. He has expertise in liquid and vapor phase reactions, fabrication of reaction setups along with associated characterization techniques such as NMR, LC-MS, GC-MS, column chromatography, flash chromatography etc. His Ph.D. research and postdoctoral studies focused on development of sustainable processes involving design and development of catalysts and their applications in fine chemicals. He has also experience in the field of polymers and their use in different therapeutic areas, drug molecules and intermediates. He has published over 20 peer reviewed research articles, reviews, and book chapters.

Lucy Finlay (née Geddes) PhD – Research Fellow

Lucy Finlay (née Geddes), Ph.D. – Research Scientist

Lucy has a MEng degree in Chemical Engineering and completed a multidisciplinary Ph.D. in Mechanical Engineering, Pharmacy and Chemical Engineering at Queen’s University Belfast. Her research focused on the evaluation of the in vitro inflammatory response of bioresorbable polymers at the late stages of degradation. She has significant experience in polymer analysis and characterisation techniques, including GPC, DSC, NMR and XRD; and experience in cell-based assays and analysis methods including cytotoxicity assays, ELISA, antibody microarrays and calcium mobilisation assays. She has published her work in the journals Polymer Testing and Acta Biomaterialia and presented at international conferences.

She has experience working in GMP environments, with recent roles in pharmaceutical product development as a Knowledge Transfer Partnership (KTP) associate with Terumo Blood and Cells Technologies and Queen’s University Belfast, and in quality compliance with Almac Clinical Services.

Sandip Gite PhD – Research Scientist

Sandip Gite, Ph.D. – Research Scientist

Sandip Gite is an accomplished professional with extensive experience in pharmaceutical research and development. He earned his Doctorate degree in Pharmaceutics from the Institute of Chemical Technology (ICT) in Mumbai, India. With over 12 years of experience in pharmaceutical R&D, Sandip has worked at renowned pharmaceutical companies such as Concept Pharma, Lupin Pharma, Ferring Pharma, Cipla Ltd, and Sichuan Credit Pharmaceutical Co. Ltd in India and China. He has a successful track record in developing innovative drugs and improving existing ones, with research expertise in oral proteins and peptide drug delivery, 505(b)(2), NDDS, QMS, and complex injectables. Sandip has published 18 research papers, review articles and book chapters in reputed journals and presented his work at national and international conferences. He is also a co-inventor of two granted patents in the USA and India.

Peter McKenna MPSNI, PhD – Research Scientist

Peter McKenna, MPSNI, Ph.D. – Research Scientist

Peter is a Research Scientist and Registered Pharmacist with over 10 years of experience working in the academic, industrial, and retail sectors of Pharmacy and Pharmaceutical Science. He obtained his MPharm degree and Ph.D. from Queen’s University Belfast.

To date, his research has focussed on the development of advanced polymeric drug delivery systems, namely microarray patches and subcutaneous implants, for the controlled release of a wide range of molecules with varying molecular weight, solubility, and potency. He has considerable expertise in formulation development using solubility enhancement strategies and nanotechnology; pharmaceutical analysis using chromatography and spectrophotometry; and formulation characterization using x-ray diffraction, microscopy, and thermal analysis. He has published over 10 peer-reviewed research articles, reviews, and book chapters and has delivered numerous poster and oral presentations at internationally recognized conferences.

Peter also has a successful track record of collaborating with industrial partners, including Janssen Pharmaceuticals, LTS Lohmann Therapie-Systeme AG, Ashland Global Inc., and PharmaTher Holdings Ltd., to accelerate the rate of translation of novel advanced drug delivery platforms.

Sangdi Wang, M.Sc., Ph.D.

Sangdi Wang, M.Sc., Ph.D. – Research Scientist

Sangdi has a Ph.D. in Pharmacy from Queen’s University Belfast, United Kingdom, an M.S. degree in Pharmaceutical Analysis, also from Queen’s University Belfast and a B.Sc. in Pharmaceutical Engineering from Chongqing University of Technology, China.

Sangdi has research experience in development of in situ forming implant formulations, specifically tailored for ocular delivery systems. These formulations are designed to enable the sustained release of biologics to the posterior segment of the eye, contributing to improved treatment outcomes in ophthalmology.

Sangdi also has extensive knowledge in protein analysis and characterisation techniques, including high-performance liquid chromatography (HPLC), spectrophotometry, thermal analysis, imaging techniques and biological assays.

Charles Haughey PhD - Laboratory Operations and Innovation Lead

Charles Haughey, Ph.D. – Laboratory Operations and Innovation Lead

Charles holds a B.Sc. in Biomedical Science and a Ph.D. in Oncology from Queens University Belfast, where his research focused on developing innovative models of prostate cancer and exploring radiation sensitivity. With over a decade of experience in molecular biology and immunology, gained through roles at Oxford University, QUB, pHion Therapeutics, and Fusion Antibodies, he has honed his skills in cancer research, antibody discovery, and therapeutic cancer vaccine development. Charles has contributed significantly to the development and implementation of research methodologies, models, and techniques, playing key roles in laboratory governance and maintenance. His expertise includes tissue culture, in vitro assays, library preparation, and RNA-Seq analysis, enabling him to identify novel treatment targets and validate them through cellular manipulation techniques. With a strong background in project management and laboratory operations, Charles has effectively translated research findings into practical applications for both industry and academia.

Prerna Fule - Junior Scientist

Prerna Fule – Junior Scientist

Prerna is a versatile pharmaceutical professional holding a bachelor’s degree in pharmacy and a master’s in industrial Pharmaceutics from Queen’s University Belfast. Her research expertise lies in “Characterization of Extracellular Matrices and Mucus in the lung using Total Internal Reflective Fluorescence Microscopy (TIRF) and Rheometer.” With a Chartered Management Institute Level 7 Certificate, Prerna possesses insights into effective management practices. She specializes in conducting in vitro release studies of implant-based formulations, focusing on long-acting formulations, and brings a robust background in ocular drug delivery, polymer synthesis, characterization, and sterile production to her work.

Hardik Shah - Junior Scientist

Hardik Shah – Junior Scientist

Hardik is a dedicated pharmaceutical professional driven by a passion for enhancing healthcare outcomes. With a master’s degree in industrial Pharmaceutics from Queen’s University Belfast, and valuable experience gained at Norbrook Laboratories, Hardik has honed his skills in analytical method development and quality control analysis. His proficiency spans various techniques, including HPLC, GC-MS, FTIR, UV, SOR, and Rheometer. His commitment to quality control and adherence to regulatory standards combined with his enthusiasm for innovation, makes him a valuable asset to any pharmaceutical endeavor. Now, as a Junior Scientist at Re-Vana Therapeutics, Hardik looks forward to contributing his expertise and learning from a dynamic team dedicated to advancing therapeutic solutions.