The game is changing: Developing your patient-centric therapy for commercial success
The biopharmaceutical market is rapidly evolving with exciting new modalities and therapies addressing difficult disease states, giving hope to underserved patient populations around the world.
This new era is met with accelerated change and an evolving drug development landscape, as the circumstances of the past few years have necessitated aggressively pushing the boundaries of traditional norms and standards for both development practices, logistical approaches as well as breakthroughs in game changing technologies, both in processing and manufacturing as well as transformative pathways for drug delivery.
These catalysts for breakthrough drug development technologies come with expectations for an increasing patient centric approach and ever-expanding global patient access, but with real challenges in increasing industry standards for quality and regulatory, headwinds in global material supplies, and ever-present cost pressures.
Join us for an insightful conversation about where the industry is, and where the industry is going, with PCI’s leading industry experts discussing key considerations and critical success factors in developing a holistic approach to accelerating your molecule to global success.
Dates & Locations:
Wednesday 17th January 2024 | Bridgewater, NJ
Thursday 18th January 2024 | Cambridge, MA
Wednesday 24th January 2024 | San Francisco, CA
Thursday 25th January 2024 | San Diego, CA
Let’s talk future.
Justin Schroeder Global VP – Technical Sales, PCI Pharma Services / Trinity Life Sciences
The global environment for development and commercialization has considerably changed in the past 5 years, and the rapid evolution is clearly accelerating. Drug developing companies face a complex road through the clinical lifecycle to commercialization, requiring a relentless focus on innovation, strategic planning and business excellence to succeed in navigating these difficult industry challenges. In this session our presenter(s) will share insights into:
The latest evolving industry trends
What challenges and opportunities they present
The importance of strategic partnerships and building robust supply chains
Tom McGrath VP Global Quality Development & Manufacturing Services, PCI Pharma Services
With conflicting objectives of bringing biologic drug products to clinic in a rapid timeframe typically in vial presentations, and needing to developing patient centric delivery forms for late phase trials and commercialization, this presentation will uncover best practices in parallel development to not only save time for clinical progression but also create a more valuable drug product asset. Key learning outcomes:
Getting ahead of the curve by taking a ration process development approach
Leveraging early development and stability data for a jumpstart to your product
Planning for commercialization at an early stage without breaking the bank
Bill Welch and Design Science Executive Director Services, PCI Pharma Services and Design Science
In a world of rapidly advancing drug delivery forms, including complex drug-device combinations, the mode of administration and the supporting packaging work together to ensure a truly patient centric approach.
With the advent of drug-device combination products, the complexities of development and regulatory filing demand a well-orchestrated approach to be successful. Equally, packaging design is a critical area of importance and seamless development bridging clinical and commercial is vital. Considering package design earlier in the drug development process can lead to both cost and time efficiencies, and more importantly ensure successful administration by the patient in realizing optimal therapeutic outcomes. During this presentation our experts will share their expertise and industry experience and provide guidance on:
Key considerations for drug-device combination product design
Design processes focused on human-factors engineering and technical functionality
The importance of early pack design for your injectable drug product and laying out key interconnected
milestones for drug delivery and packaging development
Considerations and requirements for manufacturability and operational delivery for successful scale-up
With time and cost considerations and often internal resource constraints, sponsor companies too frequently focus on the task in hand and the next tangible milestone without thinking ahead and planning their roadmap for commercial success. In this presentation our expert speaker will guide you through the future considerations at each clinical phase and you will learn:
The steps you need to prepare for in advance of progressing to the next clinical phase to accelerate timelines
Phase appropriate processing and analytical validation
Strategies for delivering positive patient health outcomes
The key elements of a commercial readiness checklist
