Service and experties aiming for a win-win for pharmaceutical development companies, investors, patients, health care providers and payers

Early stage advice and feasibility

• Which drugs and features will qualify for inhaled drug delivery? (1) (2)(3)
• Evaluating the patent landscape and assessing the potential for freedom to operate. (1) (2)(3)
• What must be considered for inhaled drug delivery concepts and systems?
  (1) – (6)
• Which delivery system (MDI, DPI, nebulizers) will be suitable for a distinct project? (2)(3)
• How to conduct feasibility tests to develop and/or select the most feasible drug device combination? (2)(3)(5)
• Suitable in-vitro and in-vivo tests for drug device differentiation and selection. (2)(3)(5)(6)
• Planning of tailored product development steps considering realistic timelines and budgets (2)-(6)
• What can be achieved in a realistic timely and cost-effective manner? (1)-(6)
• What is important to approve a drug-device combination for inhalation? (1) – (6)
• What must be considered for a new product in a competitive therapeutic field and market? (1) – (6)

Regulatory aspects and guidelines for orally inhaled products (OIPs)

• Regulatory pathways, (NCEs, hybrids, generics, orphan drug status). (4)
• Demands differing between Europe and the USA for NCEs, generics and orphan drugs (1)(4)
• Medical device characterization and registration in the EU and USA, (1) (3) (4)
• Advice on chemistry, manufacturing, and controls (CMC), (2)(3)(4)
• In-vitro and in-vivo tests needed to complete the development pharmaceutics section, (2)(3)(4)(5)
• Regulatory expectations on safety- and efficacy aspects (phases I-IV), (4)
• Demands on clinical and pharmacokinetic studies for demonstration of bioequivalence and/or therapeutic efficacy compared to standard therapy. (4)
• Support on medical advice with regulatory bodies.(4)(6)

Input on device and formulation for optimized drug delivery and targeting

• Disease and patient specific requirements and hurdles, (1) – (6)
• Identification and selection of devices including risk assessment, (2)(3)
• Definition of development objectives and preliminary product specifications, (2)-(5)
• Manufacturing and scale-up of formulation and device, (2)-(5)
• Cost of goods (CoGs) analysis (1)(2)(3)(5)(6)
• Patient needs, skills, preferences on drug device configurations, (2)(3)(6)
• Handling and simulated use tests (SUT), (2)(3)(5)
• Hygiene aspects and cleaning,  (1)-(4)
• Pricing and reimbursement. (1)(2)(3)(5)(6)

Preparation of expert opinion reports on:

• Device and drug formulations for nasal and pulmonary inhalation (1) (2)(3)(4)
• Regulatory expectations, potential hurdles and pitfalls (2)(3)(4)(5)
• Strategic consideration and concepts to become successful in a competitive market (1)(3)(4)(5)(6)
• Risk assessment and gap analyses (1)-(6)