Even aside from the development of COVID-19 vaccines and treatments, the last few years have seen the biopharmaceutical industry going from strength to strength, with 55 FDA drug approvals in both 2020 and 2021 – in addition to the Emergency Use Authorizations associated with COVID-19. Although controversial, the FDA’s accelerated approval of Aduhelm is another high-profile example of momentum gained, irrespective of the pandemic.
At the same time, for those in the industry, it has been challenging adapting to working in remote conditions – from working from home to virtual regulatory inspections. The global supply chain disruptions have simultaneously added even more difficulties to overcome.
In these conditions, coming together at industry events, like the 2022 ISPE Biotechnology Conference, is crucial to regroup and be inspired by the future direction of the industry. From 28-30 June, we can be sure this will be happening in Boston (and virtually), as we hear about exciting developments and future potential in digitalization, R&D, commercial manufacturing, process intensification and much more.
The breadth of novel ATMPs/CG&Ts progressing from clinical to commercial scale is increasing. mRNA technology is promising a new suite of applications. New process technologies are being developed and scaled up, revolutionising current best practices. This has all led to new ways of working that capitalize on collaborative communication channels. In parallel, the entire industry is undergoing a digital transformation, as Pharma 4.0™ principles are embraced. Consequently, now is an incredibly exciting time to join the ranks of the biopharmaceutical industry; nevertheless, for those just starting out, there is an increasingly challenging barrier of entry. An understanding of the technical processes, GMP principles and regulatory requirements is a “must” and being familiar with these before starting in a new role reduces the learning curve significantly.
It is therefore crucial to develop initiatives to engage and encourage the involvement of the industry’s Emerging Leaders – students and young professionals. Experience is vital, and there is no better way to learn than by making personal connections to build upon predecessors’ work –undeniably much easier said than done. Industry networking events specifically catering for Emerging Leaders is one of the best ways for both young professionals to engage with more experienced colleagues, and senior industry leaders to meet the talent coming up through the ranks.
That is why, on the afternoon of 28 June, the ISPE Think Tank panel discussion “Expanding Your Footprint: Opportunities in Biotech,” sponsored by Women in Pharma®, will engage all conference attendees in a thought-provoking conversation about the future opportunities for the industry. Designed for everyone, regardless of their level of experience, this session will guide all participants to think of the future from a personal, professional and industry level. From regulators and industry leaders to young professionals and students, collaboration and engagement between academia, research and development, and industry will be encouraged. All participants will have the opportunity share new innovative ideas and gain insights to broaden their footprint as they either embark on, or continue, their pathway in the industry.
In starting this post, one of the defining moments of this century, the COVID-19 pandemic, was referenced. Innovation aside, the key “takeaway message” for the biopharmaceutical industry would have to be the importance of future preparedness for whatever disruption might be around the next corner. Consequently, the conference will culminate on Thursday, 30 June, with an executive panel discussing “Risk Management for Future Disruptions”. Conference participants will have the opportunity to hear from an esteemed and diverse panel, comprising: Oliver Hennig, PhD (Senior Vice President Operations, BioNTech SE), Marco Cacciuttolo, PhD (Senior Vice President, Novavax), Nilanjan Banerjee, PhD (Professor of Computer Science and Electrical Engineering, University of Maryland, Baltimore County), Seneca D. Toms, MS, RAC (National Expert, Drugs, U.S. Food and Drug Administration (FDA)) and Norman A. Goldschmidt (President, Genesis AEC). Topics of discussion will include: supply chain management, cybersecurity, energy management, and regulatory opportunities, with panellists providing insight on how to prepare for, and adjust to, these risks.
The 2022 ISPE Biotechnology conference will be an exciting opportunity for all attendees to be motivated by the biopharmaceutical industry’s future prospects. The organising committee looks forward to meeting participants at all stages of their career and engaging in fruitful discussions during the range of networking opportunities. Register today so as to not miss out!
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