2020 Tailwinds Usher in a Post-Pandemic Biotech Revolution

The COVID-19 pandemic accelerated innovation in vaccines and telemedicine by two, three or even five years. But greater cooperation and increased speed to market will lead to other changes that will have a profound effect on drug developers of all sizes, leading to bottlenecks among contract organizations and another look at single-use bioprocessing, according to a just-released report by CPhI Pharma.

“One of the positives to come out of the back of 2020, and moving forwards into 2021, is that intellectual property is able to flow more globally, more quickly, and with less boundaries. R&D data was shared in a way, as a result of pandemic, that we have not seen before. I believe it’s something pharma will look to expand upon in the future both in strategic collaborations and informally in groups,” CPhI panelist Bikash Chatterjee, CEO, Pharmatech Associates, said in the report.

Cooperation and collaboration accelerated drug development timelines during the pandemic, and those gains are expected to continue into the coming years. Innovation is increasing too, as new tools are developed. In all, the industry is buoyed by “strong tailwinds,” that include:

• A reputation that is at an all-time high
• Underused venture capital from 2020
• Less expensive, more accessible technology

Therapeutically, CPhI expects oncology and rare diseases to benefit the most, leveraging accelerated development timelines, remote clinical trials, and new technologies for genetics and target screening to bring therapeutic to the market faster than ever before. Multimodal diseases, such as multiple sclerosis or ALS, will see new therapies emerge in the next five years, Chatterjee said.

The validation gained by mRNA vaccines will carry through to other therapeutics, CPhI’s experts predicted. “Our experts expect that these technology platforms will now be used in other indications,” where they will speed manufacturing, just as they have for vaccines.

Clinical trials will be more widely distributed and less expensive in a post-COVID world. Digital technologies (such as remote monitoring) are the reason, enabling patients who couldn’t or were unwilling to travel to major medical centers to participate in clinical trials.

AI – artificial intelligence – is bringing a step-change to the industry in terms of diagnosing patients earlier and more accurately, which has the potential to lower overall healthcare costs. Consequently, “Patients over the next five years are predicted to be diagnosed far earlier and have specialized diagnostic tools to identify the best therapies for the disease pathway’s unique biology,” the report noted.

For the biopharma industry, “It means chemistry services and early discovery will be less reliant on Ph.D.s … (so) even small companies can explore advancing more potential targets simultaneously,” Chatterjee said.

A booming investment scene is likely, too.

“A lot of pent-up liquid capital (is) available,” CPhI’s experts agreed, predicting particular interest in personalized medicine “as therapies move to scale-up process rather than scale out.”

Preclinical companies are going for IPOs earlier and for larger valuations than before the pandemic. For example, in 2020, 71 companies filed for an IPO. Of those, 66% were in the early stages of development. Specifically, 21 were at the pre-clinical stage and 26 were in Phase I development. 

Panelist Valdas Jurkauskas, Ph.D., VP, technical operations at Black Diamond Therapeutics, noted a significant acceleration of investigational new drug applications (INDs) last summer that will reverberate for years to come. For perspective, “The FDA received 3,806 INDs in April - June 2020, which is more than in the previous eight years combined (3,576 in 2021-2019.)”

As 2020 progressed, applications continued to accelerate. INDs for respiratory infections increased 484%. Applications for Alzheimer’s disease increased 100%, diabetes 73%, COPD 70% for the period of July through December 2020 compared to the same period the previous year.

With such large numbers of studies, most of which are on accelerated pathways, CPhI questioned how contract research organizations (CROs) and contract development and manufacturing organizations (CMOs) can expand. Even with the usual drug attrition rates, existing facilities will be stretched to accommodate the influx of studies. Competition already is starting for specialists’ expertise in oncology and rare diseases.

Single-use bioprocessing is helping fill the CDMO capacity bottleneck. “We hear… a lot of activity around building your own capacity versus outsourcing, with biotech exploring building, first, early stage, and then later stage manufacturing facilities,” panelist Parrish Galliher, managing director, bioprocess technology group, a division of BDO USA, observed.

Single-use systems are affordable options to building traditional facilities and allow companies a hands-on manufacturing option, especially for early quantities and some personalized therapeutics. Even CDMOs see the advantages and many are building single-use facilities in the 500-2000 L range. Throughout the industry, concern exists about a pending shortage of single-use systems.

Overall, however, the biopharma industry is expected to boom, realizing the renaissance that was predicted years ago.

The convergence of innovation, accelerated development and approvals – all these factors -- will see the industry achieving record levels of development, Galliher said. “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.” When that happens, molecule selection will improve and attrition rates will fall.

Within the next five years, if these improvements continue, the CPhI panelists predicted that FDA approval number could reach 100 per year.