BRIAN DAVID BARNEY Managing Director, Peritus Consulting Limited 7 Thornden, Cowfold, West Sussex, RH13 8AG bbarney@peritusconsultingltd.com ═══════════════════════════════════════════════════════════════ CAREER SUMMARY 40+ years of experience in medical device development, industrialisation, strategy, and leadership across inhalation and injectable drug delivery systems. 32 career patents. ═══════════════════════════════════════════════════════════════ EXPERIENCE PERITUS CONSULTING LIMITED July 2010 – Present Managing Director & Owner Senior consulting services to the Medical Device and Pharmaceutical industry. Services include project management, development, due diligence, market analysis, strategic analysis, engineering expertise, product evaluation, and development road mapping. Business leadership for novel systems including business plans, investor financial plans, and board presentations. Key engagements: • Program Manager — Electro-Mechanical Injection system (concept to industrialisation) • Program Manager — Auto-Injection system for Belgian Biotech company • Acting VP of R&D — medical device company, 3 new device developments • CEO — VaryDose dry powder filling technology • CEO — Start-up dry powder inhaler company, Cambridge (licensed to Italian company) • Strategic advisor — UK Government COVID-19 vaccine delivery systems • European Director — US-based marketing strategy company • Training — DFM/DFA methodology for leading German Stent manufacturer • Commercial Director — Cambridge Consultants Ltd (Drug Delivery) NOVARTIS PHARMACEUTICALS UK LTD Jan 2008 – July 2010 Global Head of Device Strategy Bridged the gap between Device Development and senior management. Delivered a 7-year plan against the Respiratory Pipeline covering Device Roadmap, Skills, Knowledge, Costs, Timelines, and Regulatory information. Reported to the Board on Budgets, Strategies, and Commercial Opportunities. Global Head of Inhalation and Device Development Led technical due diligence for the evaluation and acquisition of Nektar. Integrated Nektar USA device group with Basel, Horsham UK and East Hanover USA into a focused Global Inhalation Group across 4 sites. Head of Inhalation and Device Development UK Recruited and led a 29-person Centre of Excellence for Inhalation Device and Early Formulation. Grew group to 70 people by 2010. Procured and validated a purpose-built facility in Horsham (opened March 2009). CAMBRIDGE CONSULTANTS LIMITED Oct 2004 – Jan 2008 Commercial Director / Head of Drug Delivery Led commercial aspects, client relationships, and drug delivery strategy. Championed the "Conix" inhalation technology — wrote business case approved by CCL Board, successfully licensed to multiple companies and outright to 3M in 2007. IVAX PHARMACEUTICALS UK LTD May 1997 – March 2004 Head of Device Technology Jan 2000 – March 2004 Led global development and commercialisation of inhalation delivery systems. Capital budget >$25m. Project Owner for Easi-Breathe scale-up in Singapore (£12m project). Responsible for MDPI Airmax development, Easi-Breathe continuous improvement, tooling strategy, and global supplier management. Device Engineering Manager May 1997 – Jan 2000 Led development of MDPI "Airmax". Managed tooling, automation, and device design. Implemented CAD system (IDEAS). Technology licensed to Novartis for Formoterol delivery. INNOVATIO LIMITED March 2004 – Sep 2004 Consultancy — concept to production medical device expertise. PA CONSULTING GROUP 1987 – 1997 Consultant, Medical Device Group (1995–1997) Projects for Leiras, GSK, AstraZeneca, Pharmacia, NMT, Novartis, Aventis, Norton Healthcare. Led Easi-Breathe device development from initial concept through production, technology transfer to Nypro USA. Engineering Consultant (1987–1995) Multi-sector engineering consultancy across pharmaceutical, food, packaging, and FMCG. BESPAK AEROSOLS LTD 1979 – 1987 Design Engineer — novel valve and delivery system design for pharmaceutical delivery and fire protection systems. ═══════════════════════════════════════════════════════════════ PRODUCT PORTFOLIO (Selected) Inhalation: Easi-Breathe · Airmax · Conix · Breezehaler · Turbuhaler Mk3 & Mk4 · Accuhaler · ProHaler · MicroDose · DeyHaler · Miathaler · Novolizer · VaryDose DPI filling technology · Connix single-use inhaler (vaccine) · Generic Respimat · Soft Mist Inhaler · Novel DPI (capsule & blister filling) Injectable: Auto-Injector x4 · Electro-Mechanical Injection system · Cimzia Autoclicks · AVA Electronic smart connected Injection system · Safety Syringe system Other: Fox Nebuliser · Lifestent · Sylc Dental · Counter systems (mechanical & electronic) GSK MDI compliance · Dischaler compliance · AERx Essence · AERx IDMS ═══════════════════════════════════════════════════════════════ KEY SKILLS Leadership & Strategy Project Management Industrialisation Business Development Due Diligence DFM / DFA Regulatory Strategy Inhalation Device Development Injectable Device Development Technology Transfer Competitive Intelligence Investor Relations Validation (IQ–PV) Supply Chain Management Training & Mentoring ═══════════════════════════════════════════════════════════════ PATENTS 32 career patents in drug delivery and medical device systems. ═══════════════════════════════════════════════════════════════ EDUCATION & PROFESSIONAL DEVELOPMENT Engineering foundation and professional development through PA Consulting Group, Bespak Aerosols Ltd, and ongoing CPD across regulatory, strategy, and device development. ═══════════════════════════════════════════════════════════════ Brian D. Barney — Peritus Consulting Limited bbarney@peritusconsultingltd.com