Biotechnology’s Path To Web3

While the financial industry is experiencing ruthless backlash from the loss of value in cryptocurrencies, especially the heralded stable coins, the Biotechnology industry is positioning itself for success in entering in the next phase of the internet; web3 also referred to as web3.0.

The global biotechnology market was valued at US$ 793.87 billion in 2021 and is expected to surpass around US$ 1.683 trillion by 2030. This increase is due to changing market dynamics in opportunities for new entrants; typically small biotech firms as well as those in developing countries. Many developing countries are developing a Life Sciences industry as a means of driving growth given the breakneck levels of investment pouring into new innovations.

Multinational pharmaceutical companies have been increasingly sourcing new IP from a variety of small biotech firms that specialize in drug discovery (the very early stages of R&D). Small biotech firms are responsible for nearly 70 percent of new drug approvals in the US and are much better at seeing results from it (1).

Alongside changing market conditions, lingering global challenges such as the Covid-19 pandemic and cross-border data privacy and security regulations continue to persist, casting a shadow for many players in the biotech industry, although, opening new opportunities for technology to alleviate many of these issues.

At the 2022 Biotechnology Innovation Organization (BIO) International Convention, representatives on a panel covering the US, EU and China discuss the extraordinary data privacy and security headwinds facing global clinical development in biotechnology. Drug developers, hospitals, and CROs conducting multi-country trials are subject to stringent national and international health data regulations that apply to the collection, use, retention, protection, and cross-border transfer of clinical data.

Failure to comply can result in enforcement actions as well as reputational damages. But the lack of harmonized standards and the increasingly onerous requirements not only are costly to operate, but they also can impose significant delays in drug development and adversely impact competitive positions according to BIO .

The panel which featured Amgen’s
AMGN
Paul Neureiter, Executive Director for International Government Affairs and Trade Policy at Amgen, outlined challenges that were faced by Amgen, where they could not proceed with an international pediatric clinical trial due to concern of legal liability in an EU country. “This creates friction at a time when rewards and incentives are at an all time high.”

Favorably, the US and EU are already working to resolve these nuances. According to Hannah Bracken- Policy Analyst at the US Department of Commerce/International Trade Administration data exchanged between the US and EU is worth upwards of $7.1Trillion USD. Both territories recently entered into the Trans-Atlantic Data Privacy Framework. Key principles in this agreement aim to note:

  • Data will be able to flow freely and safely between the EU and participating American companies.
  • Specific monitoring and review mechanisms will be put in place; Data Protection Review court with positions held by US judges.

Other countries such as China take a more conservative stance and deem access to their data as a national security concern. Two new Chinese laws dealing with data security and privacy came into force in the fall of 2021 that are likely to have an impact on many multinational companies operating in China or whose operations touch China. These two laws — the Data Security Law and the Personal Information Protection Law — provide more specificity about the data localization, data export and data protection requirements that first appeared in the Chinese Cybersecurity Law in 2017 ( 2).

For example, Critical Information Infrastructure Operators (“CIIOs”) that handle data dealing with informational networks, infrastructure and natural resources must ensure that data that was generated in China is stored in China and that a security self-assessment is conducted before China-originated data is sent abroad.

Both CIIOs and non-CIIOs are prohibited from providing any data stored in China, regardless of the data’s sensitivity level and whether or not the data was initially collected in China, to any foreign judicial or law enforcement agency without the prior approval of the relevant PRC authorities.

Companies found in violation of regulations concerning “core data” face penalties of up to RMB 10 million (~US$1.56 million), the forced shutdown of their businesses and potential criminal liabilities. Companies found in violation of regulations concerning “important data” face penalties of up to RMB 5 million (~US$780,000).

Positively, the use of historical data in clinical research is important to the continuation of the industry’s development. International collaboratives such as the Together trial between Canada and Brazil for potential COVID-19 therapies is an example.

“This was the first trial to demonstrate that a low-cost repurposed medicine (fluvoxamine) could prevent hospitalizations for COVID-19. It evaluated nine different interventions and managed to eliminate six of them as ineffective at a very early stage, thereby saving both time and money…only [proving] possible because researchers were able to access existing clinical data. A data strategy should be at the heart of any digital transformation strategy if we are to continue to drive economic growth in this important industry sector” (Leslie Galloway, 3).

Fortunately, decentralized trials and the path to digitization are here to stay. In 2019, 38% of pharmaceutical sponsors and CROs stated that virtual trials would be an important part of their portfolios, and 48% stated that they would run trials with aspects conducted in the participants’ homes, according to the McKinsey report. By 2020, those numbers had shifted to 100% and 89%, respectively.

Wednesday morning’s keynote address from Paul Hastings CEO of Nkarta Therapeutics alluded to China playing a big role in the covid-19 vaccine creation on Jan. 11, 2020, after researchers in China uploaded the COVID-19 genome to a public website, kickstarting efforts to tackle the virus from big name pharmaceutical companies including Pfizer
PFE
and Moderna.

Cryptocurrencies achieved the ability to transact financial payments across borders with ease, with governments like EL Salvador adopting bitcoin as a national currency. The question now remains on how governments will embrace web3 technologies to assist in the sharing of their most prized digital assets; clinical data ?

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