How TechBio is speeding up clinical trials and cutting through red tape

The traditional route from innovative ideation to hitting the market is littered with bottlenecks and bureaucracy. However, Hanadi Jabado, managing partner at innovation investment fund Sana Capital, is extolling the virtues of TechBio’s cost-and-time-cutting benefits.

Here, she talks about how independent thinking and positive change is making medical advancement faster and more effective.
 

How does TechBio expedite the process of clinical trials?
Let’s start by explaining what clinical trials are and why they are so important… Clinical trials are medical research studies involving people; they are key to ensuring the safety and efficiency of a drug, a treatment or a medical device before it is made available to the wider public.

Clinical trials need to be thorough and are highly regulated - for instance, it can take anywhere between ten to 15 years to get a drug through all three phases. They are very expensive as they are time and resource intensive. There are very strong barriers to entry (and commercialisation of a product or a drug) due to high regulatory hurdles, high scrutiny, often high capital requirements and low accepted margins of error as we are dealing with human health compared to most other sectors.

In my opinion, two of the major hurdles of clinical trials are around patient recruitment and data (data collection, data analysis, data interpretation and lack of heterogeneity of the datasets).

TechBio, also known as technology-enabled biotechnology, can play a unique role in expediting the clinical trial process by improving the efficiency of patient recruitment, as well as reducing the time and resources required for data collection, analysis and interpretation.

Wearable devices and mobile apps can collect data from clinical trial participants in real-time, away from the hospital or the clinical setting, oftentimes, in the comfort of the participants’ own homes or work environments. This can reduce the need for on-site visits and streamline the data collection process. This is a move towards DCTs (Decentralised Clinical Trials).

London-based TechBio startup ExSeed Health focuses on male infertility. ExSeed has partnered with a large pharma company in a clinical trial where the large pharma is using ExSeed's male fertility point-of-care diagnostics platform in order to collect RWE (Real World Evidence). This is game-changing as it enables more frequent collection of real-world evidence from the comfort of home.

Clinical trials generate very large datasets which can be time-consuming and require significant expertise. TechBio tools can automate the analysis of these large datasets, they can speed up the process and oftentimes can identify patterns which may be missed by the human eye.

Cambridge-based data startup Qureight has successfully partnered with healthcare providers to analyse large datasets on IPF (Idiopathic Pulmonary Fibrosis). IPF is a complex lung disease that usually affects people around 70-75 years of age and results in scarring of the lungs and increasingly difficult breathing. IPF is typically diagnosed and then tracked through lung scans, which require patients to attend a hospital or clinic on a regular basis. These scans are then read manually by experts (such as radiographers), who will compare the images to track progression and highlight the afflicted areas of the lungs. This is a highly specialised and time-intensive task and can be more of an art than a science, as it is incredibly difficult to quantitatively track the disease on such a minute scale using only eyesight.

Qureight’s intelligent algorithm is trained by experts to read these lung scans, solving the issue of tracking the disease in a more definite and quantifiable way at a much faster pace. The process is sped up, more reliable, and reduces strain on clinicians and radiographers. Through their partnership and by leveraging their AI-powered tools, Qureight were able to significantly speed up the clinical trial process of an IPF treatment.

Historically, clinical trials have had very homogeneous populations, normally limited to easily accessible participants. However, to ensure generalisability across patient groups, it is critical that we have good representation amongst the clinical trial participants. TechBio tools support decentralised clinical trials, enabling patient groups that have been historically difficult to reach (e.g. older adults, patients from different ethnicities etc.) to be included.

TechBio tools can identify potential study participants based on their medical history, genetic profile, and other criteria. This can help researchers recruit participants more quickly and efficiently.

Qureight partnered with Galapagos, a European pharmaceutical company, to structure scans from a Phase II study. Qureight’s AI-driven technology found more efficient ways to determine the efficacy of a drug than a traditional study. Not only does this have the potential to reduce the time and number of patients needed for a clinical trial, but it could also produce higher-quality results; effectively producing more reliable results at a cheaper cost.

Furthermore, as we discussed earlier, the process of certifying medical devices has been very cumbersome, mainly due to the difficulty in recruiting participants and the evaluation of how a new solution impacts their health. TechBio tools, such as AI or machine learning-based solutions, can sometimes be used to evaluate entirely retrospectively on existing databases, completely or partially removing the need to recruit participants for a trial.

“TechBio can use predictive analytics to identify potential safety issues before they occur.”

Red tape is traditionally a bottleneck for medical innovation, can TechBio help to cut through bureaucracy?
This is such an important point! Red tape is definitely a bottleneck for medical innovation and TechBio is absolutely disrupting the regulatory burden!

Let’s zoom in on one particularly onerous bit of red tape: the requirement to submit large sets of supporting data to document the FDA approval process for new drugs or new diagnostics. With electronic data submission, TechBio can automate the submission of data to regulatory agencies, reducing the time and resources required for manual data entry and review.

TechBio tools, such as wearable devices and mobile apps, can monitor patients in real time, which can provide a more comprehensive and accurate picture of treatment outcomes. This not only streamlines the reporting process, it also reduces the need for follow-up visits. And the disruption goes further. In effect, TechBio can use predictive analytics to identify potential safety issues before they occur, enabling earlier intervention and reducing the likelihood of regulatory delays. The almost real-time data provided to the regulatory authorities help get medicines and technologies approved faster.

TechBio startups not only have the potential to reduce the regulatory burden on medical innovation by streamlining the regulatory process, but they can also improve data quality and accuracy, and they definitely enable more efficient communication and collaboration between all stakeholders, cutting through the red tape.

In TechBio, we have seen a real shift in mentalities, with TechBio startups acting as a convening power between healthcare providers and big pharma companies, two breeds of very established large and complex organisations who historically have struggled to collaborate efficiently, ultimately benefiting us all.

Has Covid-19 positively changed how things get done in the world of modern medicine?
In all industries, timing is key. Technologies can be latent unless there is a major external event that triggers a mentality shift. Pre-2008, Uber and Airbnb would not have taken off. Would you have rented your spare bedroom to a total stranger? Would you have gotten into a stranger’s car? Post-2008, the economic crisis drove the mentality shift in the way Covid-19 accelerated behavioural changes needed to modernise our approach to medicine.

When people think about the impact of Covid-19 in the world of modern medicine, they quote the accelerated development of vaccines. I would firmly disagree. The reason why we were able to develop multiple vaccines in a record time is twofold.

As we have discussed earlier, one of the major hurdles of clinical trials is patient recruitment. During a pandemic, this is so much less cumbersome! TechBio has provided a digital platform for various stakeholders to communicate in a more transparent way and removed a lot of the red tape.

While the Covid-19 vaccines have set a precedent for faster regulatory processes in the future, I am not sure that the same speed will be accessible to other vaccines or diseases.

What will outlive the pandemic, however, is the importance of data sharing and collaboration in medical research, leading to increased efforts to share data and collaborate across institutions and borders.

Telemedicine has been available for more than a decade pre-Covid-19. It had more success delivering access to healthcare for patients in remote or underserved areas but struggled to be democratised in urban and developed areas. Patients were keen on wanting to meet doctors face to face, needing that trip into the surgery, and did not trust online consultations. With the pandemic, patients were terrified of walking into their doctors’ surgery (the very thing they desired pre-Covid-19) as they feared infections; this accelerated the adoption of telemedicine as the only route for patients to access the care they needed.

This behavioural change is across generations and across social classes. It is here to change and there is no going back to universal face-to-face consultations, enabling the democratisation of healthcare. Indeed, patient expectations have shifted with most patients expecting healthcare to be accessible at home.

Covid-19 accelerated the mega-trends of patient empowerment and near-patient activities. An example of this was the adoption of at-home diagnostics, which was also seen in the area of fertility where ExSeed teamed up with fertility clinics like the Agora Clinic to help them manage their patient flow and allow people without access to attend physical meetings to progress on their treatment pathway.

Post-Covid-19, we note a proliferation of large-scale procurement for virtual solutions; in the UK, virtual wards have a dedicated budget of £450m which reflects a very deliberate shift of healthcare away from conventional hospital based delivery.

London-based company Feebris is working with NHS partners across the UK on such projects, enabling clinical teams to bring healthcare to patient homes and reducing the pressure on hospital infrastructure. Using proprietary AI tools, Feebris ensures that data generated in the community is clinically reliable and that deterioration is detected early to inform more proactive management of health needs. To guarantee accessibility anywhere, Feebris is the only AI-powered virtual care platform that can operate entirely offline, powering healthcare in some of the most remote areas in the UK and globally. 

“Focused TechBio startups are often more agile and innovative than large established companies or institutions.”

TechBio is very much being led by independent thinkers and focused startups. Why is this?
TechBio companies need to be “Natives” in both tech and biotech. TechBio requires a very multidisciplinary approach to build creative and quite complex solutions. Large companies suffer from fragmentation, operating large but mostly siloed teams. A TechBio solution will require expertise in AI (Artificial Intelligence), ML (Machine Learning), software, clinical, biomedical engineering, regulatory, and business.

Focused TechBio startups are often more agile and innovative than large established companies or institutions. They are able to quickly identify and respond to emerging trends and opportunities and are not burdened by the bureaucracy and legacy systems that can slow down larger organisations.

Oftentimes, TechBio companies are started by people who have encountered the issue firsthand. TechBio founders are often driven by a passion for using technology to improve healthcare outcomes, rather than just for profit. They often have a deep understanding of the needs of patients and healthcare providers and are able to design and develop solutions that are both effective and user-friendly. Qureight was started by two consultants from Papworth who were frustrated by the delays and the lack of resources available to access, interpret and analyse scans.

Breastfeeding app Anya was started by an isolated mother wanting to breastfeed but struggling to access appropriate information and support.

As per Uber and Airbnb, you cannot just innovate the tech, you need to innovate the business model too. And that is very difficult for incumbents.

What’s required of TechBio investors to succeed and make a difference?
Traditionally, investors in the TechBio sphere have either come from the Life Sciences investors pool or from the Tech investors pool. They both have their own strengths and weaknesses when it comes to investing in TechBio companies. LifeSciences investors will understand the longer timelines needed as well as the whole regulatory pathway, they will struggle however with innovative business models involving tech and non-traditional licensing deals. Tech investors will be very comfortable with the agility around the business models and with the Tech-specific scaling issues, they will struggle however with the timelines and different milestones from what they are used to in a pure Tech environment.

To succeed and make a difference in TechBio, investors need to be, just like the TechBio founders, “natives” in both Tech and biotech. TechBio investors will have a business-model innovation mindset, they will be ready to imagine the future of healthcare. They will take a long-term perspective, understanding that the healthcare industry is complex and highly regulated and that it may take several more years for a TechBio company to achieve profitability and the £1m ARR compared to a traditional Tech company. Like the TechBio founders, the TechBio investors must be driven by a patient-centric mission with a desire to improve patient outcomes and access to healthcare alongside delivering return on their investments.