Roundtable: What are the key learnings from 2022 in pharma?

EPM asked several pharma industry experts what key learnings and takeaways they are taking from 2022 within pharma manufacturing.

Recipharm:

"We have seen a significant increase in demand for pre-filled syringe (PFS) sterile filling this year, which is set to continue for the foreseeable future. This is part of a broader 12% increase in demand for sterile fill & finish of complex dosage forms over the last 12 months - double that of overall aseptic filling. This is driven by a larger proportion of biologics coming through the development pipeline, which require parenteral delivery and, as a result, need aseptic processing.

As they arrive with the patient or healthcare professional (HCP) already filled with the required dose, PFSs are easier to administer - and self-administer - than traditional injectable forms. This makes them highly desirable for pharmaceutical companies going forward as they look to support over-stretched HCPs across the globe dealing with treatment backlogs following the COVID-19 pandemic.

However, one learning to consider from this year is how to meet this high PFS filling demand with the required sterile fill and finish capability. We need to provide the specialist infrastructure that offers both the capacity to meet the expected high demand over the coming years, as well as the flexibility to be easily changed over to other filling tasks during lulls in PFS projects.

Another key development in 2022 is the rise in the number of biopharmaceutical drug development projects that are prioritising ease of administration during formulation development. These drugs traditionally must be administered parenterally due to the sensitivity of their actives and their poor bioavailability.

This year, thanks to innovations in both inhalation and oral solid dose (OSD) technology, more pharmaceutical companies began to explore other delivery routes. For example, innovation in soft mist inhaler (SMI) technology means we are seeing oral inhalation being considered to deliver sensitive large molecules, while advances in OSD technology mean that it is possible for some biologics, such as insulin, to be developed for oral delivery, allowing the biopharma space to take advantage of the patient convenience benefits of OSD.

Nevertheless, biopharma developers face challenges when trying to formulate to harness alternative delivery routes, from regulatory compliance to formulation issues, to device customisation requirements. A key takeaway from this year has to be the importance of engaging specialist formulation and device development expertise in the earliest stages of the project to maximise the chances of successful commercialisation."

Christian Dowdeswell, vice president, head of Commercial Development, Small Molecules, Lonza:

"As we emerge from the pandemic, there have been signs of an investment slowdown after record VC funding levels driven by Covid treatment and prevention, although investment by VC remains at historically high levels. However, while the 20% drop in non-Covid treatments entering clinical trials in 2020 was more than compensated for by Covid trials, it has not yet recovered.

The biggest impact has been in Phase 1, meaning there will be fewer candidates to progress into later phases in future. Trial recruitment has become more challenging, not helped by the war in Ukraine. And the FDA has approved fewer NMEs. Yet in the CDMO sector we continue to see high demand and capacity utilisation, potentially having a delaying effect on new trial starts.

In the past, the CDMO sector has been relatively immune to inflationary pressures – although costs go up, and inflation has always affected materials, energy and salaries, we would normally expect this to be partially compensated by efficiency gains. But in the past year, there have been sustained inflationary pressures that are already bringing a fundamental shift to the way our industry responds to inflation."

Sara Lesina, MBA, general manager Business Unit Europe, Sirio Europe:

"Consumers are now taking nutraceuticals to help treat or manage a broad range of conditions. Industry analysts agree that pandemic clearly accelerated consumer demand for nutraceutical products that contribute to better physical and mental health outcomes. Nutraceuticals' role in healthcare is rising in prominence and the sector’s response has seen significant investment in innovation across the sector. The momentum of the market post-pandemic is undeniable with industry analysts projecting the global nutraceuticals market to grow from the approximately $350 billion it is today to approximately $650 billion by 2030.

This represents tremendous commercial opportunity for the world’s nutraceutical developers. It also represents a growing responsibility for the industry to deliver ever-higher volumes of safe effective high-quality nutraceuticals to people, just like its more regulated counterparts in large and small-molecule pharma. It’s also increasingly evident that the industry will be turning to contract development and manufacturing organisations (CDMOs) for the formulation, manufacturing know-how and capacity it needs to reach markets and consumers faster and more successfully."

Tony Page, SVP Insight Analytics, Within3:

“In 2022 we saw the initial phase of the health crisis subside, and life science companies accelerated tech adoption to manage everything from supply chains to clinical trial processes. In 2022, organisations embraced decentralised clinical trials, digital technology and tools across the product development process, and earned heightened levels of patient trust."

Cathy O’Brien, vice president for International Sales, UPS Healthcare:

“Putting resilience into action. The pandemic and its continued effects have led to an industry-wide rethink of how we construct and maintain supply chains.

For the previous decade or so, we had worked through a period of relative stability. The pharmaceutical industry was focused on lowering costs and moving most of its API production bases to Asia. At the same time, more biologics came into the market, requiring specialised storage and transport conditions – all with virtually no margin for error. The result was longer, more complex supply chains.

With the need to distribute billions of doses of Covid-19 vaccines we saw new and augmented supply chains built and tested in record time – proving to the industry how important a resilient, multi modal and flexible network is to ensure the efficacy of product delivery to patients, particularly in this ever increasing need for temperature controlled distribution.  

From a distribution point of view, we are not only looking at a shortened supply chain but potentially a greater number of production sites so that product can be nearer to its consumer market to reduce risk of no supply of important materials. To add to that, we’re now operating in perhaps a more uncertain period of economic and geopolitical uncertainty which complicates the picture.”