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Drug development interrupted; how to apply technology to biotechnology

Although the headlines indicate recent growth, the R&D productivity of the biotechnology and pharmaceutical industries has been Steady decline. So why for most of 20 years, an industry built on bold and visionary beliefs?day The century—think about the rise of insulin, antibiotics, Salk polio vaccine, biotechnology, and monoclonal antibodies—is trying to restore the innovation and entrepreneurial spirit from which it originated?

The rising cost of development assets and the extension of development time are part of the reason. However, this also reflects a more secretive culprit-increasingly conservative R&D management practices that focus on the predictability of drug development, but have led the industry to enter a decade of incremental innovation (except for some Notable exceptions, such as antiviral drugs/hepatitis C, immuno-oncology).

Accept risk in drug development
Drug development is riddled with failures, so it is a risky business. Only 5% of the compounds entering clinical development become commercial products, and many products cannot recover their development costs after they are on the market. Most of the R&D budget is spent on these failures, and industry insiders have not ignored this fact. This explains why many companies invest mainly in approved drugs. In order to stabilize the production of new drugs, minimize financial risks, and introduce more predictability in the process, the entire industry is trending toward portfolio management techniques, where detailed forecasts and risk forecast numbers provide confidence in the progress of the entire process Wrong impression. pipeline.

Ironically, this attempt to reduce the perceived risk of the development process has prompted pharmaceutical companies to pursue a narrower development strategy, which refers to the fact that drugs enter the development stage with a predetermined purpose, thereby reducing the scope of their development. Although these strategies (validated goals, validated mechanisms of action, and more targeted patient groups) on the one hand seem to be less “risky”, they are due to high clinical data standards, pricing and adoption barriers, from a commercial point of view , Innovation is still gradual, for example as market access, pricing restrictions and prescription guidelines. These narrow development strategies increase the risks associated with premature specialization or selection of development paths too quickly.

Pharmaceutical companies continue to ignore the role of tilt, the ability to adjust during the development process when new data emerges, or the coincidence of seeing opportunities that actually occur in drug development. Ignoring the effect of tilt and contingency is to ignore famous examples, such as Avastin, which “failed” many times before entering the development stage, Herceptin, which was rotated 180 degrees when seeing its phase II data, and the entire statin I have seen a lot of “fake failures” before becoming one of the biggest blockbusters in the industry. In most cases, the ability to “know” in advance is inconsistent with the desire to explore.

Although there is no low-risk strategy in drug development, it can be said that there are good risks and bad risks-the companies that will succeed in the future will be those, not companies that seek to reduce absolute risks and aim to better limit risks and balance them. Good risks and bad risks, known risks and unknown risks. What is important is that behaviors that include oblique and contingency in the development process can reduce actual risks more than the currently emphasized understanding or predicted risks.

Learn from the technology industry
One way to increase the balance between “good” risks or seeking opportunities is to introduce optionality (“scope”) early in the drug development process. Why only test a single indication of a molecule in the first case-such as rheumatoid arthritis, knowing that the biological pathway is superfluous, and the literature may suggest that anti-inflammatory drugs have a broader role in other autoimmune indications , Which may be more compelling-are both clinical (in terms of unmet needs) and commercial (ie regulatory environment/pricing/competition)? Similarly, embracing and integrating emerging technologies (clinical trial modeling, artificial intelligence/machine learning methods to discover/target recognition, panomics characteristics of patient populations, digital therapy) should allow early prototype design of new therapeutic digital combinations. The combination may have a past that is unthinkable.

However, the strict operational infrastructure within the pharmaceutical industry does not accept optionality in this way-here we can learn from the principles of the technology industry used in the skunk factory.

According to the definition of Wikipedia, the skunkworks project is “a project developed by a relatively small and loosely structured group of people who research and develop projects mainly for radical innovation.” Lockheed Martin first introduced this concept during World War II. The concept has been widely adopted by the technology industry (Google’s X Innovation Lab) to encourage and support the development of fundamentally innovative and disruptive products to solve difficult problems. technical problem. Clarence Kelly Johnson, chief engineer of the original Lockheed Martin Skunk Factory, said,

“We are not defined by the technologies we create, but by the process by which we create them.”

By giving a small group of outsiders access to a full range of views and technologies, pharmaceutical companies can seek to replicate this potentially destructive skunk factory approach. Using perspectives other than traditional company R&D, asking questions about new drug candidates, designing a learning plan, and generating evidence early in the development process (perhaps at relatively low preclinical costs) can increase the chances of success in later clinical development and approval Rear.

Covid-19 – Cultivating the seeds of optimism
A kind Marginal rise The return on R&D investment in 2020 (from 1.6% in 2019 to 2.5% in 2020)—according to Deloitte’s analysis, this is the first time in six years—shows reasons for optimism. However, it remains to be seen whether covid-19 will become a catalyst for a lasting reversal of this trend. The pre-competitive cross-departmental data sharing and collaboration, supporting and participating regulatory agencies, and unified unmet needs are key factors in the success story of the covid-19 vaccine. One of the main lessons of 2020 is that alternative decision-making methods are the key to success. By learning and seeking to reinvent these elements, pharmaceutical companies can translate the lessons of this life-changing pandemic into opportunities for continued positive change throughout the industry and in the years to come.

Photo: Metamorworks, Getty Images

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