David Wiseman Email & Phone Number

Formulation and process development for ocular sustained drug delivery device, for active pharmaceutical ingredients and indications beyond glaucomaSimilar responsibilities as previous employment with Mati Therapeutics (Canada) Inc.

Burnaby, B.C.

• Develop vapour-phase hydrogen peroxide decontamination cycles (and research potential alternative decontamination cycles) for barrier isolator systems• Analytical testing including particle distribution mapping for isolator air and determining residual oxygen content of sealed vials (for vacuum stoppering chamber cycle development)• Statistically analyze process data• Technical writing (includes: company blog article and other industry articles; sample media fill protocols, batch records and validation protocols; and development protocols, data summaries and reports)

Burnaby, Bc

• Attend weekly update teleconferences• Where required, review documents, set up and test equipment (and test manufacturing process) in new lab, and demonstrate process to personnel from third-party companies

Richmond, Bc, Canada

• Continued development of ocular sustained drug delivery device technology purchased from QLT Inc.• Streamlined mixing process for 1500-unit scale, performed troubleshooting related to process variation and wrote report summarizing early development at Mati• Conceived of mixing process for >25,000-unit scale, and aided in its preliminary testing • Technology transfer of manufacturing process to contract manufacturer, including providing process instructions, reviewing manufacturer draft batch records, training/instruction• Developed and performed analytical methods – coulometric Karl Fischer water content determination and Brookfield viscometry • Performed statistical analyses using Excel • Developed protocol and determined required resources for final studies to minimize intra/inter-batch variability

Vancouver, Canada Area

• Performed statistical design of experiments (DOE) to study/optimize multi-factorial processes and formulations, and performed statistical process capability studies, using JMP4.0 software• Liaised with engineers for design/fabrication of specialized process equipment• Formulation development, lab-scale (and some pilot-scale) process development, technology transfer and troubleshooting activities involving, for example, sustained ocular delivery devices (silicone and plastics based), in situ gelling eyedrops and other liquid formulations for both hydrophilic/phobic active pharmaceutical ingredients (APIs), container/closure (syringe/stopper combination) for stability of 2 lyophilized formulations during ethylene oxide sterilization• For pilot-scale manufacturing facility, developed vaporized hydrogen peroxide decontamination cycles for barrier isolators, method for pre-qualifying biological indicators, depyrogenation cycles for vial loads, solid-load autoclave cycles, high ramp rate/short dwell autoclave cycle (in advisory role), lyophilizer steam-in-place cycle • Yeast culture bioprocessing – performed shake-flask experiments testing base media, carbon sources, and orders of addition to maximize yield; helped to guide scale-up via statistical design/analysis• For preformulation, performed solubility studies for 2 APIs in organic solvents, co-solvents and aqueous solutions• Manufacturing experience – involved in dozens of clinical batches including liquid fills, oil-based oral dose in vials/capsules, thin-film intermediates, sustained ocular delivery devices• Technical writing: wrote SOPs for GMP manufacturing equipment decontamination and operation, and formulation/process development reports and protocols (totaling >2000 pages), plus many other documents

Vancouver, Canada Area

• Developed slow-release liposomal antibiotic hydrophilic paste formulation for testing against in vivo bacterial infection models• Greatly improved lab-scale process for producing drug-containing liposomes incorporating viral membrane• Co-developed pH-sensitive liposomal antibiotic formulations against intracellular bacterial infections, liaised with collaborators performing in vitro cell culture and in vivo model testing of antibiotic liposomal formulations, and compiled data and performed statistics (resulted in co-authorship of 4 research publications and co-inventorship on 1 patent)• Business identity systems – won contest for creating potential trade name for proprietary lipid• Authored 8 technical reports