Clinical Life Science

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Coming out of the global COVID-19 pandemic, the future holds both opportunity and increased complexity for the clinical life sciences industry.

Precision Medicine is Making Waves

The development of genetic-based precision formulas will impact the clinical life sciences industry and could begin a major shift. In the last twenty-five years, adverse reactions have resulted in the withdrawal of more than 450 medicines worldwide. Precision medicine could be a game-changer.

A Place For AI

Artificial intelligence isn’t a matter of choosing technology over people – the truth is that AI augments what humans can do. Acceptance of AI tools in the clinical life sciences industry is growing, mainly in R&D. More pharma companies are hiring for AI roles internally, with a few global leaders considered dominant players in the space. Next year, life science teams will better understand what AI means in a life science context and how it can support – not replace – skilled people doing important work.

Patent Cliff

Big Pharma will soon be on a hunt to replenish some $200 billion of revenue from drugs that are coming off patents in the next five years. The downside is when Big Pharma buys the biotechs and companies with no commercial products, they will absorb the R&D into their infrastructure – leaving tons of labs, flex spaces and warehouses empty. In areas where the ecosystem and the research are grounded. The impact may be a little less because smaller and newer pharmas and biotechs will backfill the space – if they are funded.

R&D’s Next Frontier — A Digital World

Pharmas, contract research organizations and health care services companies today are using technology in a far more advanced manner than they did even two years ago. A Deloitte report on the global outlook for the clinical  life sciences industry notes that digitalization is one of the key factors that may lead to the cost of producing a drug dipping lower in the coming years.

CRO’s

As a service industry, the clinical life sciences industry is experiencing pressure on earnings due to inflation and limited skilled labor. While many contract research organizations have intended to pass cost increases on to sponsors as new business is awarded, a funding slowdown for middle market biotechs means that CROs may experience increased pushback from sponsors as companies plan to maximize their limited liquid assets.

Clinical Trials

More clinical studies were started by the end of 2021 than ever before.  This was an increase of almost 18% from 2020 to 2021, including more non-Covid trials. Oncology saw the biggest increase at almost 1,300 trial initiations in 2021, a 23% increase. There are over 16,000 active, industry-funded and interventional clinical trial studies, with no signs of this count dropping significantly in the near term. According to IQVIA’s Global Trends in R&D 2022, oncology continues to be the leading therapy area, comprising at least 33% of all study starts.

Next-generation treatments also continue to gain momentum, while still making up a relatively small portion of the overall study population. Over 800 next-generation biotherapeutics were in development in 2021—encompassing CAR T-cell therapy to fight cancer, cell therapy, gene therapy and RNA therapeutics. The next-generation pipeline has seen a CAGR of 27% since 2016.

Enrollment challenges – 1.4 million: This is the number of participants needed to meet enrollment requirements across phase 3 studies that are still actively enrolling. Only 46% of phase 3 studies started over the past five years reported having met enrollment requirements. CVS and, most recently, Walgreens represent two pharmacies entering the clinical trial business and hoping to leverage their networks of thousands of locations to improve study recruitment and diversity. In addition, decentralized clinical trials continue to gain traction and provide flexibility in study locations, which widens the available participant population.

Conclusion

Despite the challenges that pharmaceutical companies have had and the high standards required by this industry and the large-scale demands generated by the pandemic, they have managed to implement new technologies that have allowed the industry to advance worldwide.

Digitization in all areas has become an essential tool to maintain leadership, guarantee accurate results and improve processes within pharmaceutical companies. This digitization process to improve efficiency has resulted in the evolution towards the pharmaceutical company 4.0.

In the end, innovation, capital markets and federal policy will play the lead role in recharging the life sciences and pharma sectors.

Interested in discussion your career or your hiring needs in the clinical life sciences industry?  Contact Smith Hanley Associates Biostatistics and Clinical Trials Executive Recruiter Nihar Parikh at nparikh@smithhanley.com.


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