Injectable Drug Delivery

The Essential Annual Conference for Pharmaceutical and Medical Device Professionals in the Parenteral Drug Delivery Industry (London, United Kingdom - March 22-23, 2018) - Seite 3

US regulatory considerations for injectable delivery systems

• Implementing 21 CFR 4: Integrated development and product maintenance
• Integrating essential performance into control strategy
• Approaches for bridging changes made during development
• Regulatory submission strategies for initial registration, post-approval changes, platform technologies and master files

Suzette Roan, Senior Director, Global Regulatory Affairs, Sanofi, USA

Advances in Needle Free Drug Delivery

• Portal Instruments is developing a next generation needle-free drug injection platform to transform the drug delivery experience for patients suffering from chronic diseases such as ulcerative colitis, multiple sclerosis, rheumatoid arthritis, and psoriasis
• Our approach, which is issued from MIT research, uses a computer-controlled linear actuator that pressurizes the medication and injects it in a very fine jet
• It can administer up to 1 mL of medication, is relatively quiet, fast, and automatically adapts to both the viscosity and temperature of the medication
• Clinical studies we've conducted have shown that patients perceive less pain and prefer the Portal Needle-free injector versus needle and syringe injections

Andrew Coats, Director of Engineering, Portal Instruments, USA

Enhance existing devices or move to brand new integrated solutions? Two approaches for smart pen injectors

• Moving towards connected devices in the field of injection seems inevitable: two approaches are possible to achieve this goal
• Some benefits of connectivity: automatic collection of treatment information (dose, time and date), reminders, alerts, treatment calendar on the smartphone, advice, engagement
• The advantages of Add-On approach: seamless for the patients (do not change patient's habits, same device, same use), painless for the pharma (regulatory and industrial processes remain unchanged)
• The advantages of integrated solutions: enhance accuracy, comfort, and security
• Elements to consider in order to make a choice: time to market, regulatory environment, specific needs (dosage, comfort), maturity of the market

Arnaud Guillet, Business Development Associate, Bicorp, France