What Biotechnology's Paradigm Shift Means for Businesses Technology is transforming biotechnology and biopharmaceuticals, both in research and development and manufacturing.
By Jessica Wong Edited by Micah Zimmerman
Opinions expressed by Entrepreneur contributors are their own.
The past three years have changed nearly every industry. Where business used to be conducted in person, in offices and laboratories, the coronavirus pandemic forced a change. When remote work became mandatory, even traditional industries like the biopharmaceutical sector had to embrace new technologies.
Today, the world may no longer be required to isolate and keep a distance, but the influence of advanced technologies is only growing. Their potential is apparent in shortening the time it takes to bring medications to market, dealing with supply chain issues and personalizing medicine.
The paradigm shift of biopharma
The biopharmaceutical industry has a reputation for being rather traditional. Despite its dependence on research, development and innovation, the industry has relied on tried and tested ways of conducting research. Conducting clinical trials and bringing new medications to the market tended to follow a specific format. This traditional business model has helped biopharma in the U.S. become a global leader for decades.
Although emerging countries have been mounting a challenge, the United States continues to dominate the global pharmaceutical market. Five of the top ten pharmaceutical companies worldwide are based in this country. Their sales account for nearly 50% of all sales of medication around the world.
2020 turned the industry on its head. As governments decided to impose lockdowns on their citizens, countless clinical trials came to an abrupt halt. Other companies rechanneled their energies into developing Covid-19 vaccines; for one of those companies, Pfizer, the vaccine resulted in the business becoming number one in the U.S.
Others again started to look at advanced technologies to transform their operations. This is how artificial intelligence (AI) and machine learning (ML) entered this field. Initial results of AI and ML developments are exciting and have ensured that these technologies are here to stay for the foreseeable future.
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Making medications available faster
The biopharmaceutical industry has long faced questions about the time it takes to develop, test and deliver a new drug to the market. During the pandemic, the rapid development of mRNA vaccines showed that technology could accelerate the process safely. In addition, the Pfizer / BioNTech and Moderna vaccines also proved the viability of mRNA technology.
Jan van de Winkel, President and CEO of Danish biotechnology company Genmab, believes that next-generation technologies will be the key to accelerating drug development. In this context, biopharmaceutical companies are starting to take advantage of the likes of AI and ML. AI can process and analyze larger data volumes than humans can. This enables scientists to recognize patterns and their implications faster than ever before.
ML-based algorithms are being used successfully in clinical trials. One recent example of this is Anavex Life Sciences. The company's drug candidate Anavex2-73 looks set to provide treatment for dementia patients. The drug is undergoing a phase 2a clinical trial with only 32 patients. Anavex has been using decentralized trials since before the pandemic, minimizing the need to travel and making trials more accessible for patients. The company is supplementing them with whole genome analysis to enhance trial results.
Utilizing technology like this can help speed up the development of new drugs without compromising patient safety.
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Improving supply chains
One of the pandemic's most noticeable consequences was supply chain disruption. Like others, the biopharmaceutical industry scrambled to continue supplying life-changing medications. As manufacturing and shipping all but halted in countries with strict restrictions, biopharma manufacturers needed to look for alternatives.
Establishing closer relationships with external contractors proved to be one of the solutions. Those contract manufacturing organizations (CMOs) have always been a part of the industry. But their role was often confined to early clinical development or filling in the odd production lot. Since 2020, CMOs have both cemented and extended their role in the biopharma industry. Currently, CRB survey results suggest that more than half of biopharma manufacturers plan to use these contractors as an integral part of their pipeline.
Genmab found that working with CMOs added value to their manufacturing of modified antibody candidates and related products. External organizations were able to offer highly specialized services that supported in-house manufacturing.
Personalizing medicine
Precision medicine, or personalized medicine, holds the promise of customizing treatments for the individual. Backed by data, this approach would allow doctors to make recommendations based on the patient's genetics and lifestyle. Precision medicine has huge potential in cancer treatment, for example.
Experts also believe that precision medicine may hold the key to the continued growth of the entire sector. According to analysts from Boston Consulting Group, medicines driven by biomarkers derived from genomic data will be at the heart of this development. At the same time, the analysts highlight the challenges this type of medication brings. Personalizing treatments and drugs increases manufacturing complexity in ways that the industry is only just starting to explore.
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Cooperating for patient benefit
The biopharmaceutical industry is competitive. However, during the pandemic, cooperation between businesses became one of the drivers behind progress. Accelerating the time it took to develop, test, and distribute vaccines worldwide required manufacturers to streamline their processes. They also needed to work closely with regulators to ensure vaccines were both safe and effective before entering mainstream production.
Some industry insiders refer to the pandemic years as a period of creativity. Key players in the industry were forced to change their approach to manufacturing and distribution. The entire sector came together to solve a global problem at an unprecedented scale. Larger manufacturers provided the capacity and infrastructure that small, innovative biotechnology outfits needed to bring their products to the public. The cooperation between Pfizer and BioNTech is perhaps the best-known example of this synergy.
Biotechnology and the biopharmaceutical industry are starting to embrace technology to transform their research and development departments and manufacturing processes. Continuing this digital transformation will give patients faster access to life-saving treatments and, eventually, personalized pharmaceuticals.
