Part I Highlights of BIO Asia-Taiwan 2020 (Day 1): The Effect of COVID-19 on Global Biotech Industry
By Rajaneesh K. Gopinath, Ruchi Jhonsa, & T. Chakraborty, Ph.D.
TAIPEI, TAIWAN – The first day of BIO Asia-Taiwan 2020 featured several talks on global biotech trends. Distinguished speakers from the biopharma industry presented critical insights, including the impact of the COVID-19 on their business domain. We compiled some key highlights from the day. Link to Part 2
Global Industry Trends: Financing, Pipelines, COVID and Policy Implications
Joseph Damond, Executive Vice President, International Affairs, BIO, shared his overview of the emergence of new biopharma, the impact of the pandemic, and Taiwan’s role in strengthening the biotech ecosystem in Asia. He noted that there are about 3,300 emerging biopharma (EBP) companies in the world that accounts for approximately 65% of the global clinical trials. In fact, among the new drugs marketed in 2018, 42% were developed by EBP. He also observed that global financing for gene and cell therapies has doubled from the previous year, and clinical trials in this area have increased by 27%. He reckons that this industry will attain a market value of $35 billion in 2026.
He acknowledged the unprecedented increase of more than 625 unique drug programs since the onset of the COVID-19 pandemic. Over 50% of COVID-19 drugs are discovered in the USA, and small companies currently develop over 70% of COVID-related therapies (antivirals, treatments, and vaccines). Dr. Damond observes that the pandemic has forced the global supply chain to shift towards domestic manufacturing, a worrisome trend that could affect global access to medications. He also discussed that the pandemic could raise the issue of intellectual property rights and delay authorizations of non-COVID products. He conceded that the global healthcare system would be under immense pressure in the post-pandemic era both financially and also with regard to upholding high ethical standards in evaluating sophisticated technologies such as gene editing.
“Singapore and Taiwan (are) head and shoulders above the competition,” he said referring to the pro-innovation policy reforms in both countries that result in superior real-world outcomes, including clinical research. Currently, the number of studies in these two countries accounts for 60% of clinical trials conducted in Asia. He observed that Taiwan holds an advantageous position in the current scenario. It has the potential to move up the biotech value chain with continued emphasis on biotech, and life science research, policies, and innovation.
Picturing Today’s Global Fundraising
Dr. David Flores, Co-Founder, President, and CEO at BioCentury Publications, painted a picture of global investments in the biotech companies in the past year. Since the market hit its low in 2008, global fundraising for biotech has multiplied six-fold. There has been a rising interest in biotech, which is evident from the funding in the first half of this year, amounting to nearly $50 billion.
IPOs and Series A funding has contributed to a rapid rise in biotech formation and sustainability. In the past year (July 2019-July 2020), around 182 companies received Series A funding, and 81 filed for IPO worldwide. Among them, 41 companies were from Asia. From his analysis of 54 companies that raised $30 million in Series A funding, he observed that neurodegenerative diseases, rare disorders, and tumor biology were hot topics. He also analyzed 24 companies that received more than $200 million in IPO and found that they either worked on small molecule targeted therapies, next-gen antibodies, gene editing/cell therapy, genomics, or immuno-oncology. The list, however, missed rare diseases, manufacturing companies, and pharma asset spin-outs.
However, he cautioned that the above-mentioned trends were perhaps pre-COVID decisions, and it may not reflect the impact of the pandemic. He admitted that funding would get difficult due to the challenges in churning out clinical data required to generate corporate value. A more significant challenge in the post-COVID era would be the inability of companies to build new investor networks and, conversely, the ability of investors to find new assets. “COVID has derailed the accepted ways of becoming globally visible,” Dr. Flores noted.
Lessons from the Pandemic: Opportunities in Policy and Regulation
Steven Galson, Senior Vice President, Global Regulatory Affairs and Safety, shared how Amgen has been adapting to innovative solutions to facilitate drug discovery and clinical trials. Amgen decided that their research and development must not be halted because of the pandemic. Therefore, they adopted the following measures:
- The use of telemedicine to monitor patients,
- Remote source data review,
- Relaxation of “wet signature” requirements,
- Direct delivery of investigational products (IP) to patients,
- Alternative methods of patient consent, and
- Use of local labs and imaging centers
Besides, it has set aside three visions to override the virus.
- The first vision provides insight into remote patient enrollment, dosing, and engagement. A patient who has been enrolled in a cardiovascular trial but lives remotely can request an initial screening by telemedicine to save time.
- The second vision considers remote monitoring of clinical trial sites. Amgen suggests using statistical models to identify sites with higher risks. In the future, it aims to invest in tools for remote data collection and continue to develop remote trial capabilities guided by risk assessments even as conditions improve.
- The third vision looks into the possibility of using electronic submission and inspection of documents that enables global access. Conducting reviews over a secure teleconference would reduce costs and encourages disciplined and focussed communication between sponsors and investigators.