With constant changes to global regulations, ever-evolving technologies, growing environmental and safety concerns, and other forces impacting the pharmaceutical business, it’s a fascinating time for highly potent active pharmaceutical ingredients (HPAPIs). With that in mind, the presenters of the HPAPI Summit have put together an online program of focused sessions dedicated to helping industry professionals keep up with the latest developments.
Jennifer Small, senior program director with show organizer Hanson Wade, spoke with Outsourcing-Pharma about the features of the event, who should attend, and key sessions to check out.
OSP: Could you describe the HPAPI Summit in a nutshell? Also, this is your 10th anniversary; how has the industry changed over that time?
JS: It has indeed been quite a journey for our HPAPI Summit. Since we launched in 2011, we have become the world’s largest and longest-standing meeting dedicated to highly potent API manufacturers and drug developers, welcoming over 200 attendees in 2020.
A lot has happened over the past decade, but our mission and commitment to the community remain the same – manufacturing a novel, safe and cost-effective drug for patients while ensuring EHS and quality for their operating staff.
With the number of antibody drug conjugates (ADCs) and oncology drugs approved, we have seen huge growth in the highly potent API industry, with a spurt in flexible containment. A little-known fact is that the HPAPI Summit first spun out of Hanson Wade’s World ADC Summit, although of course we now cover many more modalities than just ADCs.
With just 50 attendees at the first-ever meeting in 2012, we hosted over 280 at the 2020 meeting, and now have two parallel streams of content.
What we notice over the last few years is the number of new entrants, mid-sized biotechs joining us. It’s not just the traditional manufacturing in attendance; there are also processing engineers, toxicology, EHS – chemistry, industrial hygiene, quality assurance, and regulatory teams.
We have seen a real emphasis from pharma, biotechs, and contract manufacturing organizations (CMOs) on the safety, sustainability, and flexibility approach towards manufacturing these highly potent and cytotoxic drug substance and drug products, both small molecules and biologics at every stage of pharmaceutical development.
Recognizing HPAPI is not just limited to industrial hygiene and toxicology, we expanded the meeting into a two-stream format in 2020 to include the handling of potentially cytotoxic material in R&D, process development, and scale-up challenges, as well as the essential environmental considerations.
We are equally excited with some innovative technologies and solutions presented by our long-standing partners and presenters, such as flexible containment, continuous processing, environmental monitoring, freeze-drying of drugs containing HPAPIs, and human factors engineering.
OSP: You’ve been running this meeting for 10 years; what’s new in 2021?
JS: Occupational exposure limits (OELs) and regulation mean operators have certainly become more aware of risks associated with highly potent or toxic material handling within the scale-up and commercial manufacturing context. However, the increase in potent pipelines often means, even at R&D scale, many APIs can pose significant risks.
In the 2021 meeting, we will continue to raise awareness of hazardous molecules at R&D labs, highlighting the importance of EHS measures across all stages.
Coupled with that, sustainability and environmental impacts continue to dominate top priority amongst pharma leaders. We can all help implement green chemistry, despite pharmaceutical manufacturing tends to be ‘single-use’; continuous manufacturing, advanced cleaning prior to waste disposal are all steps we can embrace, with a direct financial incentive through energy saving from lower temperature reactions.
Finally, a silver lining of the pandemic is that we’ve seen huge investment in pharma, which is being translated into new HPAPI facilities. With the rise of Industry 4.0, it is important that these facilities are equipped for the digital revolution and provide flexibility for future pipelines – the extended case study from Merck is a really exciting example of how far this technology can go.
OSP: This year’s event has some add-ons, such as interactive workshops and seminar days. Can you tell us more about these?
JS: Beyond the very practical case studies, we believe a lot of learnings stem from interactive, small group discussions – where our colleagues can challenge, share and debate their own experiences in a closed-door environment.
Digging into topics such as ‘Integration of EHS in Product Development’, led by Jay Brown, Director of EHS at Mayne Pharma, the workshops sessions are designed to ensure you can get insight from industry experts and expand your skillset in each selected area. These workshops are structured to give you a full introduction to a new area or sink your teeth into a topic to further your expertise.
To recreate the in-person interactive element, we also have virtual break out discussion groups, polling, live Q&A, group exercises, and much more, to allow you to go beyond the traditional PowerPoint for an immerse experience that will solidify the content in your knowledge base, for you to take back to your company. I very much look forward to hearing the industry’s experience in:
- Integration of EHS in Product Development
- Mathematical Modelling for Estimating Exposure and Exposure Control
- Outsourcing, Technology Transfer, & CMO-Client Relationships
- Facility Design & Risk Management in HPAPI Manufacturing
OSP: Could you please tell us about the keynote addresses?
JS: We’re excited to have the FDA and World Health Organization joining us for a panel discussion on Future Pipelines in the HPAPI Landscape & Changing Regulations alongside senior representatives from Ipsen and Takeda. With recent updates to EU Annex 1 and a focus on uniting regulatory standards globally, we’re looking forward to defining the HPAPI regulatory landscape of 2021 and beyond.
OSP: Do you have anything else to add?
JS: Without being physically ‘out of office’ we know how hard it can be to switch off. We have worked hard to ensure all content will be available post-event, to revisit at your own time and convenience, so you’ll never miss a key takeaway.
Finally, we’d like to thank the 32 expert industry presenters sharing their experiences with our audience at the meeting – our largest ever speaking faculty, and our event partners who will be hosting virtual exhibition booths with bonus videos and content download. We look forward to welcoming you to the 10th Annual HPAPI Summit, to ensure a safe, quality, and cost-effective HPAPI at every stage of pharmaceutical development.
The 2021 HPAPI Summit is scheduled June 22-24, in an online-only format. Visit www.hpapi-summit.com for additional details.