Come with us on a journey into commercialization as we deliver a set of focal points to help you navigate your product’s pathway to market.
In this new era, we understand that launching new medicines is more challenging than ever. The complex landscape, rapidly changing global supply chains, and evolving regulatory dynamic requires collaboration with experts and the harnessing of best practices.
Together in this impactful seminar, we’ll share experiences, watchouts, and key learnings, revealing the key considerations that will make planning for your product’s launch seamless, swift, and safe.
Thursday 15th June 2023 – Crowne Plaza Hotel, Dublin Airport
Agenda
Steve Tooker, Vice President, Commercial Packaging – EU & Justin Schroeder, Global Vice President, Technical Sales
The biopharma industry has been steadily evolving, with growth in compelling new areas such as novel biologics, breakthrough advancements in oncology, successes in rare diseases and lifechanging treatments for patients who had not previously had any available course of therapy. Furthermore, technological advancements are providing exciting new possibilities in advanced drug delivery forms, targeted and personalized medicines, connected health and broadening healthcare access through rapidly advancing technological connectivity. This optimistic and exciting backdrop is contrasted with unprecedented and interrelated challenges over the past few years in the forms of global pandemic, socioeconomic disruption and unpleasant supply chain realities. The industry now looks to chart a course forward in a very different landscape as compared to just a few years prior. We will explore facets of this new landscape and what that means for drug development in this new age.
David Lorenzo Gonzalez
Successfully navigating the new biotech landscape and bringing lifechanging medicines to patients around the world requires careful planning, both in the immediate as well as the longer term. David will highlight the real-world application of the biotech journey and a vision for the future from the lens of drug development and manufacture, coupled with the interconnectivity with downstream packaging platforms and the ultimate supplies to the increasingly global market.
Paul Smallman, Senior Director, Global Technical Sales & Severine Duband, Global Category Manager Nemera
PCI’s Paul Smallman and Nemera’s Severine Duband will spotlight best practices in developmental approaches based on recent collaborations for bringing new therapies to successful commercialization and global market expansion. Reflecting on the interconnected roles of the sponsor, the CDMO, the injectable device developer, and assembly machine manufacturers, the team will explore collaborative pathways for success in a systems based approach, including watchouts and lessons learned for future applications, as well as a focus on specific decision points and the focus on holistic collaboration ensured a seamless pathway to a successful outcome.
Justin Schroeder, Global Vice President, Technical Sales
With an ever-expanding world of drug delivery forms and rapidly advancing new science to bring therapies to patients in need, PCI’s Justin Schroeder will explore thoughts and considerations for today’s evolving biopharma world and its prospects for the future, in an ever changing and challenging global landscape. The evolving characteristics and dynamics of today’s market demand innovative approaches to thoughtful strategy for lifecycle management, starting with optimal approach to each phase of clinical development, a seamless pathway to regulatory approval and market introduction, global expansion, and ongoing market success. This is navigated against a backdrop of challenging market conditions as sponsors look to execute a purposeful and efficient integrated global supply network.
