A post-pandemic pharma report from CPhI predicts the next few years will deliver strong growth in pharma innovation, with oncology and rare diseases potentially the biggest beneficiaries of positive covid legacies – including accelerated development timelines, remote trials and new technologies in genetic and target screening.
The report anticipates breakthroughs in multi-modal disease therapies within five years, mRNA platforms to transform many new non-infectious disease treatment options, and huge growth in contract services due to the recent surge in IND applications – with 75 annual FDA approvals expected by 2025.
This new analysis combines detailed insights from world leading experts covering perspectives from biologics and CMC analysts to CROs and innovators. One major positive to emerge for CPhI attendees was the growth in contract services – both CRO and CDMO – with providers predicted to see an imminent knock-on effect from the recent surge in IND applications.
“These findings are hugely exciting for CPhI audiences – both exhibitors and visitors – and we are hosting the online event CPhI Discover in May with the specific goal of helping our communities meet, source, partner and discover. This will be crucial in sustaining industry growth and bringing increasing numbers of therapies to patients. These findings show pharma companies now need to use platforms like CPhI much earlier to make sure they have the right suppliers and development partners to meet future demand and bring on additional contingencies. Despite the challenges of the pandemic era, industry-wide partnering and collaboration is flourishing, and it is a dynamic time with potential record levels of growth and innovation expected in the medium term,” commented Nicola Souden, Brand Manager at Informa Markets.
In fact, the FDA received 3806 Investigational New Drug Applications (INDs) in April-June 2020, more than in the previous eight years combined (3576 in 2012-2019). Dr. Valdas Jurkauskas, VP, Technical Operations at Black Diamond Therapeutic, who compiled the FDA figures, expects to see an increase of contract demand from phase 1 to phase 2. “First, if we look at the numbers of studies, they are significantly higher than what we’ve seen before. Secondly, in 2020, accelerated development became the new norm for pharma. So, we now see large volumes of studies and the majority of them are on accelerated regulatory pathways. How fast can the CDMOs and CROs expand? How do you grow those resources? With accelerated pathways, you get a massive jump in scale because there is this aspiration to file an application in phase 2. Therefore, the increase of services demand is very rapid from phase 1 to phase 2.”
This surge of new targets entering the market is complemented by speedier approvals, faster trials, and improved target identification using AI. In fact, the report’s CRO insider identified decentralised trials, remote patient monitoring, and data collection as the key to not only running more trials at once, but potentially also at a lower cost. Expanding competition for experienced CROs in rare disease will see mid- and small-size sponsors competing to partner with CROs, rather than simply outsourcing services. And access to the best sites and expertise will be a key component in which sponsors advance fastest.
Interestingly, the CPhI report also highlights the wider potential significance of mRNA vaccines. While the initial breakthrough was secured for COVID-19, the CPhI experts expect this to be a watershed moment as the technologies validated use opens many new doors.
Bikash Chatterjee, Chief Executive Officer for Pharmatech Associates, explained: “perhaps the biggest prediction I can make is that in the next four to five years we’re going to see drug therapies come out for one of the multi-modal disease states that have been incredibly difficult to gain traction on, such as multiple sclerosis or ALS.” He also cites the application of AI, “whether it’s on the early precursor chemical synthesis processes, in the formulation development processes, or in the treatment algorithms” as a huge catalyst to explore new options—the ‘what ifs’ of discovery and development—very efficiently.
Automation was a more immediate effect highlighted and its use is growing rapidly in manufacturing, with smart factories improving efficiencies and enabling real-time remote monitoring. Parrish Galliher, Managing Director, BioProcess Technology Group, a division of BDO USA, suggested the coming together of all these factors will lead to the industry achieving record levels of development: “With the many new drugs coming in, there is a big push to increase the efficiency of manufacturing through automation and, for instance, applying AI to reactor operations. The advances in titre [Galliher foresees titres of 100 g/L in the next few years] and single-use are working together to help reduce the scale needed, which reduces site size, and ultimately, lowers the capital cost of those facilities. So, process efficiency, process productivity and yield through the application of genetics and automation and novel unit operations together could bring step changes in the cost and numbers of candidates advancing.”
However, Galliher also forewarned that as CDMO capacity becomes constrained inevitably biotechs advancing targets may now need to look at alternative manufacturing strategies and perhaps use the improved venture capital markets to build their own facilities. He added “what we now hear is a lot of activity around building your own capacity versus outsourcing, with biotech exploring building first early stage and then later stage manufacturing facilities. Understandably, that has resulted in a re-examination of the economics of plants and what types of facilities are best. Obviously single-use becomes very attractive as a less expensive initial option.”
The report’s authors concluded that the consequences are especially noteworthy to the CPhI global pharma community – with events not returning until the second half of 2021 – anticipating increased pressure to find partners over the next six to 18 months, with potentially a surge of partnering once events return. Unusually, they foresee a situation, at least over the next 12 months, whereby demand for early-stage contract projects could quickly exceed supply and innovators will need to start conversations with outsourcing partners much earlier, with a view to further accelerating conversations quickly in Q3 and Q4 of 2021. Their advice is that all pharma companies now need to be selecting partners very early so they don’t get caught out by a lack of demand when they need it. And, for those who can afford to, a range of strategic partner agreements should be sought ahead of any future manufacturing or development needs.
Commenting on the report’s far-reaching conclusions, Chatterjee added: “one of the positives to come out of the back of 2020 and moving forward into 2021 is that intellectual property is able to flow more globally, more quickly, and with less boundaries. As a result of the pandemic, R&D data were shared in a way that we have not seen before, and I believe it’s something pharma will look to expand upon in the future, both in strategic collaborations and informally in groups.”
An in-depth breakdown of the industry’s major trends expected post-pandemic from Chatterjee, Jurkauskas and Galliher is available as a podcast. Alternatively, a copy of the full CPhI Report: Post-Pandemic Legacy Trends can be found here.