CPhI: expect surge in IND applications, FDA approvals by 2025

By Jenni Spinner contact

- Last updated on GMT

(ipopba/iStock via Getty Images Plus)
(ipopba/iStock via Getty Images Plus)

Related tags: Fda, IND applications, New drug application, Contract manufacturing, CDMO, CPhI Worldwide

A new report from the organization forecasts a wave of pharma innovation over the next four years could lead to 75 FDA drug approvals annually by 2025.

A report from CPhI that examines the post-pandemic pharmaceutical landscape predicts that the industry will experience a surge in innovation, with oncology and rare diseases standing to be the biggest beneficiaries. The study predicts a number of trends, including accelerated development timelines, an increase in remote trials, new technologies emerging in genetic and target screening, and more.

The report foresees breakthroughs in multi-modal disease therapies by the 2025 mark, with mRNA platforms poised to transform many new non-infectious disease treatment options. Additionally, the report anticipates significant huge growth in contract services due to the recent surge in investigational new drug (IND) applications, with an estimated 75 annual FDA approvals expected by 2025.

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,​” said Nicola Souden, brand manager at Informa Markets. “Despite the challenges of the pandemic era, industry-wide partnering and collaboration are flourishing, and it is a dynamic time with potential record levels of growth and innovation expected in the medium term​."

This analysis combines insights from a range of industry professionals, covering perspectives from biologics and CMC analysts to CROs and innovators. One major positive to emerge for CPhI event 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.

According to the analysis, In fact, the FDA received 3806 IND applications in April-June 2020, more than in the previous eight years combined (3576 in 2012-2019). Valdas Jurkauskas, vice president of technical operations at Black Diamond Therapeutics (who compiled the FDA figures) expects to see an increase in contract demand from Phase I to Phase II.

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​,” Jurkauskas said. “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 I to Phase II​.”

This surge of new targets entering the market is complemented by more rapid approvals, faster trials, and improved target identification using AI. In fact, the report’s CRO commenter identified decentralized trials, remote patient monitoring, and data collection as the keys to running more trials at once, and also at a potentially lower cost.

Increased competition for experienced CROs in the rare disease sphere, according to the report, will see mid- and small-size sponsors competing to partner with CROs, rather than simply outsourcing services. Access to quality sites with a higher degree of expertise likely will give sponsors an edge, the report surmises.

The CPhI report also highlights the wider potential significance of mRNA vaccines. While the initial breakthrough was secured for COVID-19, CPhI experts expect this to be a watershed moment as the technologies validated use opens many new doors.

Bikash Chatterjee, CEO for Pharmatech Associates, predicted that in the next four to five years, the industry will witness drug therapies emerge 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 predicted the application of artificial intelligence (AI), of AI, “whether it's on the early precursor chemical synthesis processes, in the formulation development processes, or in the treatment algorithms​” as a catalyst to explore new options—the ‘what ifs’ of discovery and development—very efficiently.

Automation also was mentioned in the report, with smart factories improving efficiencies and enabling real-time remote monitoring. Parrish Galliher, managing director of BioProcess Technology Group (a division of BDO USA), suggested the convergence of these factors likely 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​,” Galliher commented. “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 contract development and manufacturing organization (CDMO) capacity becomes constrained, inevitably biotechs advancing targets may need to look at alternative manufacturing strategies and perhaps use the improved venture capital markets to build their own facilities.

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,​” he added. “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 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. These professionals 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.

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