Virtual Pharma Company, Large Pharma - IMP Supply Project and fast track clinical trial supply case studies.

Client: Virtual Pharma Company

Challenge:

• Problematic formulation and analytical method
• Blinding issues with market leading comparator

Penn solution/ongoing support:

• Developed a suitable manufacturing process and re-built the analytical method
• Over-encapsulated market leading comparator and developed the analytical method to general appropriate stability data
• Support for three simultaneous phase III trials
• Average of 1,800 patients per trial
• Multi national trial – EU, US and ROW
• 64,000 monthly kits over two years
• Bespoke child resistant – senior friendly (CRSF) packaging solution
• Liaise with two CROs
• Liaise with two IVRS providers
• Penn arranged multiple global distribution depots

Client: Large Pharma – IMP Supply Project

Challenge:

• Each patient pack contained four products – 16 vials
• Multinational trial – US, EU and ROW
• Supplies despatched at 2°C-8°C to countries with varying external ambient temperatures

Penn solution/ongoing support:

• Bespoke packaging configuration
• Multiple global distribution depots
• Use of specialist courier
• Use of PDF data logger with programmable alarm

Fast track CTS case studies

Phase I dose escalation

• Dose escalation study required extra cohort of 16 patients urgently to complete study
• Monday: Teleconference with client
• Tuesday: Prepare and approve documents for label text
• Wednesday: Product labels, receive product from manufacturer
• Thursday: Pack, release and distribute product

Phase I toxic compound

• Required 20 patient kits packed and shipped at -20°C – highly toxic compound
• Product could only remain out of freezer for maximum of five minutes
• IMP packed by team in walk-in freezer
• Classified as dangerous goods i.e. special pack and shipping conditions
• Shipped successfully to site in Estonia on time

Blinded complex study

• Nine drug materials, seven table strengths + active and placebo auto-injectors
• Innovative approach to labelling to ensure injector remained blinded after firing
• Tables shipped refrigerated due to stability issues
• Short timescales
• Project completed successfully and on time