View on the growing technology need in drug development in 2021 and beyond.
We are out of the 2020, and into 2021, reminiscing of the first lockdowns and re-analysing the biotech sector rise. On our minds, probably daily – is the vaccine challenge, especially as both Pfizer and AstraZeneca are warning about the vaccine shortages. While our governments are recognizing that rolling out the covid vaccine will be a huge technologically intense task.
Will 2021 be the year of huge IT challenges or the year of the Right Solutions coming in the right time?
2020 became the most active year in the history of the innovative life sciences companies with 78 life sciences IPOs (totalling $14.5l) and M&A transactions of $86 bl. Today, biotech sector is no longer considered to be a specialty sector. Suddenly this is the belle de jour for deployment of capital.
Perhaps, this is the time to re-allocate investments from Zoom (NASDAQ: ZM) and Peloton (NASDAQ: PTON) into the technologies that will enable the world to prevail over the covid disruptions and allow us to move the drug development further, beyond pre-2020 standards.
As investors and drug developers are recognizing the lucrative potential of advancing clinical trials and the introduction of new technologies, 2021 will no doubt see more technology-centred drug development initiatives becoming a new norm.
2021 will no doubt see more technology-centred drug development initiatives becoming a new norm.
The 2021 may show as the year of high-tech innovation rewarding those who are breaking the mould and pushing adaptation of innovation across the therapeutic areas.
1. Data Privacy and Data Exchange
General Data Protection Regulation (GDPR) in Europe and Health Insurance Portability and Accountability Act (HIPPA) in the USA require consumer’s permission and provider’s compliance to certain regulations in order to exchange the data or communicate with the consumer. This includes patient information, which of course is even further protected due to its proprietary nature. If 2021 will see more national and even international systems for reliable and seamless data anonymization, blockchain powered de-identification and cloud-enabled sharing, we will be able to create repositories and use patient information to build predictive models and keep them informed.
2. Vaccine Passports
The data infrastructure for those who received their vaccine will need to be designed and supported internationally. The ‘passport’ will need to be recognized beyond one country’s borders and accepted in many languages, barcodes, and formats.
Thinking about how the medical results theft can be prevented is almost as important is to think about reducing the feel of being discriminated if you did not get a vaccine, for whatever reason.
The next few months will identify the leaders (public health, healthcare providers, healthcare systems providers and even the retailers) who can agree to the new standards of normal and help implementing the data infrastructure that can support much needed efficiencies, protect patient privacy and maximize the transparency.
3. Drug Development for Diseases other the Covid
While covid is on everyone’s mind, we are becoming more and more aware how much of a back-seat the development in cancer, neuro-degenerative, rheumatic, and other diseases took place in the last 12 months. We must accelerate and for that, we need to share information and finding solutions faster.
What technologies and techniques can enable us to do so?
From IAG, Image Analysis Group’s expertise, the fast drug development stands on 3 pillars:
- use of the modern technology infrastructure,
- use of the best available methodologies for faster go / no go decisions and
- brining all available data, including real-world evidence to maximize the power of the decisions.
In 2021, the pressure to unblock clinical trials operational bottlenecks such as optimize strategies for patient selection, use AI to accelerate efficacy results and increase the number of participating sites so that the flow and diversity of the patient population can be increased.
Many believe that the studies will embrace the decentralized approach, which places less importance on the use of a particular site but rather emphases the increase in recruitment. Of course, from every angle, quality control will become paramount.
IAG’s 15 years of working in imaging clinical research tells that human eye is less effective when it comes to assessment of the quality of the image (MRI, CT) which is sent from the site. We bring the right tools and the right tech to ensure that incorrectly acquired image is not going to muddle the statistical significance of the results.
4. AI: from Computer-Aided Assessments to Radiomics
Precision imaging analytics, everything from a simple computer aid for a radiology reviewer to a sophisticated approach such as radiomics will see increased adoption in 2021 and will be incorporated into drug development strategies and clinical trials management.
We believe that the concept of precision dosing will start gaining momentum. The most important decisions are often made early in the trials, so the measurement of response at the phase Ib/IIa will be critical for the future successes.
As the treatment impact is becoming more complex, we cannot just rely on a single set of known methods to identify manifestations of the impact such as pseudo-progression, not just in oncology but in immune and rheumatic conditions.
For those working in oncology, we understand that we can no-longer see tumours in 2 dimensions, it is indeed a complex 3D structure which has to be understood and treated with this understanding.
AI-powered analytics will enable biotech and pharma players to gain deeper insights from medical images, thus driving accelerated development of emerging therapies and greater personalization of treatments.
5. From Telehealth to Objective Metrics of Drug Performance.
With Telehealth allowing for efficient management of patients, but less of a ‘hands-on approach’, we need to rely on the objective tools to assess the outcomes. Medical imaging and biomarkers may finally become recognized on a par with patient reported outcomes or pain questionnaires. This maybe the year of the biggest wins, in markets such as osteoarthritis and Alzheimer’s where subject measures of disease progression hinder our drug development progress and their regulatory acceptance.
We truly believe that the world’s priorities, alongside the priorities of the drug makers and technology leaders will continue to evolve, showing how growing understanding of modern power of technology solutions and precision medicine can enable faster development, dissemination, and impact.
If you are planning a new trial in oncology, rheumatic, auto-immune diseases, this is where we can help to think through the trial design, optimal use of imaging biomarkers, use of cloud platform for imaging data central review and use of AI – to assess complex manifestations of the new treatments. Email to: firstname.lastname@example.org
About IAG, Image Analysis Group
IAG, Image Analysis Group is a strategic partner to bio-pharmaceutical companies developing new treatments to improve patients’ lives. Our dynamic Strategy, Trial Solutions and Bio-Partnering divisions work closely to meet critical needs of biotechnology companies: funding, clinical development, and monetization of their assets. We fuse decades of therapeutic insights, risk-sharing business model and agile culture to accelerate novel drug development. IAG broadly leverages its core imaging expertise, proprietary technology platform DYNAMIKA and capabilities to support an objective early go no/ go decision and drive excellence for tomorrow’s innovative therapeutic agents with speed.