(~ 15-25 hrs/wk)• Advises and guides on CMC and program management towards technology translation into clinical testing, including detailed roadmapping.* Supported all aspects of business development activities* Established multiple CDMO relationships

Offered services in the areas of:1. CMC expertise for the early and late development of drug/device products and drug-eluting devices2. process improvement to accelerate fast prototyping towards early clinical validation for novel medical devices3. program management to facilitate multi-disciplinary teams towards meeting project goals, timelines, and budgets4. technology scouting, evaluation, and road-mapping of new technologies5. alliance management with external collaborations

* Executed a new directive to lead a dedicated New Tech Team (~$4-7M/yr) to develop soft contact lenses with new functionalities. • Assembled a team of technical experts (~20 FTEs) with adjacency skills to augment in-house team • Completed feasibility package on a clinical-ready anti-allergy slow-release lens prototype that met all CMC/device requirements. Satisfied Go/No Go criteria. • Completed feasibility package on an anti-microbial lens prototype. Screened Amic compounds and selected a lead peptide. Developed multiple slow and fast release lens prototypes. Met Go/No Go criteria, with one lens successfully meeting clinical endpoints and received CE Mark & FDA approval.* Appointed by Senior Mgmt to lead all front-end innovation activities and align R&D work with overarching commercial strategy (~$18-25M/yr) • Established business process jointly with Commercial Team to translate top ideation leads into both short/long-term pipeline products. Developed VOC criteria for new products. Developed business case and stage gate process to enable proper resource allocation. • Supervised/mentored Leads to oversee 3 major programs. Led cross-functional team to drive product concepts from prototypes to clinical POC comfort testing (50+ clinicals, 100+ disclosures). Constructed/executed a long-term program roadmap to advance a novel smart tunable-optical lens prototype towards clinical testing. Contributed to the development of a myopia control strategy. • Drove all aspects of business development activities with 3rd parties (academic and industry).* Selected for the CVI Inspirational Leadership Program - 1 of 17 company-wide executives recognized* Co-inventors on 8 patent applications / Co-authors on 7 presentations- V. Rogers, A. Luk, & S. Zalipsky “Ophthalmic Devices for Delivery of Beneficial Agents” (US9259350)- V. Rogers, A. Luk, and A. Back “Methods of Manufacturing Contact Lenses for Delivery of Beneficial Agents” (US9248928)

Independent consultant with 15+ years development expertise in pharmaceutical, medical devices and life sciences, with special focus on drug-device combination products. I have extensive experience in driving and leading rapid advancement of medical technologies from concept to clinical testing to tech transfer within a sound scientific and regulatory framework. Clients have obtained IDE and PMA approval for their drug-eluting devices.Presentations:-- A. Luk, C. Rhodes, G. Baklayan, et al., Invited Panel Discussion “Expanding Developments in Drug-Eluting Devices and Ocular Pharmaceuticals”, 3rd Annual Drug Delivery and Formulation Americas Summit, San Diego, April 2013--A. Luk, G. Junnakar “Critical challenges to the design of drug-eluting medical devices”, Therapeutic Delivery, April 2013, 4:471-477--A. Luk “Applying Drug Delivery Technologies to Existing Medical Devices”, 2nd Annual Drug Delivery & Formulation America Summit, San Diego CA, May 2012--A. Luk “Applying Drug Delivery Technologies to Existing Medical Devices”, 3rd Annual Drug Delivery & Formulation Summit, Berlin Germany, Jan 2012 (invited speaker)--A. Luk “Real Life Considerations for the Development of Combination Products”, MEDevice Forum San Diego, September 2011--A. Luk “Key Considerations to Successful and Rapid Development of Drug-Eluting Devices”, Surfaces in Biomaterials Foundation, March 2010 Newsletter

* Led a team of 12 R&D scientists and chemists to develop novel drug-eluting stent products (formulation, analytical and process development) with adherance to cGMP and Design Control Policy* Successfully developed the NEVO™ sirolimus-eluting stent into clinical testing in 13 months after project inception, with leading Core Team responsibilities to 1) oversee technical progress and troubleshoot joint mechanical/chemical issues 2) lead the preparation of CMC-related documents for regulatory submission/responses to ex-US clinical trial approval and US pre-IDE meeting; 3) initiate Tech Transfer with Operations Team, and 4) set analytical specifications and expiry date per ICH and FDA guidelines* Authored a portion of the Pharmaceutical Development section for the PMA submission of the CoStar® paclitaxel-eluting stent and acted as expert reviewer of the entire CMC PMA draft* Successfully developed a stable pimecrolimus stent and a stable first-in-class dual drug pimecrolimus/paclitaxel stent into First-in-Human trial in 15 months* Worked closely with Chief Technical Officer to develop and execute research strategy on novel vascular product concepts and on delivery platform enhancements* Named as co-inventors on 5 patent applications and co-authors on 7 presentations-- R. Falotico, A. Luk, T. Parker et al “Local Vascular Delivery of Adenosine A2A Receptor Agonists in Combination with Other Agents To Reduce Myocardial Injury” (US20120130481)-- S. Price, J. Stanley, A. Luk, et al. “Reservoir Eluting Stent” (12/652,996)-- A. Luk, T. Nguyen, T. Parker, et al. “Rapamycin Reservoir Eluting Stent” (US20110009953)-- R. Falotico, A. Luk, T. Parker et al “Local Vascular Delivery of mTOR Inhibitors in Combination with Peroxisome Proliferators-Activated Receptor Stimulators” (US20090074831)-- D. Dang, F. Litvack, A.S. Luk, et al. “Method and Apparatus For Reducing Injury From Acute Myocardial Infarction” (US2007068839; WO2007/134271)

* Led the strategic execution effort of a multidisciplinary Biopharmaceutical Delivery Team with focus in monoclonal antibodies and a subteam to develop a highly concentrated (>150 µg/ml) Mab formulation concept for potential subcutaneous or intramuscular administration* Acted as Technology and Project Leader to establish research strategy and oversee technical progress of an emerging delivery platform for proteins/peptides and small molecules (filed 10+ Invention Records), with leadership responsibilities to 1) identify new depot product concepts, 2) develop project work plan, manage allocated budget, assemble development strategy, analyze project scenarios, and conduct risk analysis with a multi-functional Core Team, 3) advance early development projects with internal J&J companies in the pharmaceutical and medical device sectors for both small molecules and proteins, 4) establish technology differentiation through a comprehensive competitor analysis, 5) advancing a protein delivery concept with an external partner from feasibility to IND preparation (+ qualification of an IND aseptic facility with IOPQ equipment) in 15 months * Supervised a team of 14 staff members to advance a controlled release implantable pump concept containing an anti-inflammatory cytokine to early clinical testing* Named as co-inventors on 7 patent applications and 5 scientific presentations-- “Osmotic Drug Delivery Devices Containing Suspension Formulations Comprising Particles ....” (US8211467)-- “Injectable Nonaqueous Suspension with High Concentration of Therapeutic Agent” (US20090022727; WO2008/092084)-- “Sustained Release Small Molecule Drug Formulation” (US20070077304; WO2007/041410)-- “Solvent/Polymer Solutions as Suspension Vehicles” (US8206745/8114437; WO2006/083761)-- “Injectable Non-Aqueous Suspension” (US20060142234/20060141040; WO2006/071696 & 071613) -- “Surfactant-based Gel as Injectable Sustained Drug Delivery Vehicle” (US20050118206; WO2005/048930)

* Supervised a group of 5 chemists and technicians and managed 7-10 active global formulation development projects (estimated sales of >$150M) from lab to process scale-ups to commercial manufacturing site* Advanced novel herbicide formulations (Callisto) from feasibility through late stage development to tech transfer* Received Zeneca award for troubleshooting 2 commercial products * Conducted product support and workshops for the sales force and customersPresentations:-- A.S. Luk “Interaction between Polymers and +ve-charged Colloidal Silica”, 219th WACS. SF, 2000-- A.S. Luk “Effect of Thickener on the Rheology of Suspension Concentrates”, 9th IUPAC Conf, 1998

* Conducted development activities on antiviral and glaucoma eyedrop formulations* Developed diffusion/pharmacokinetic models to validate the release profile of a hydrogel system* Designed novel sustained-release drug delivery vehicles for treatment of retinal diseases