Pharma

Ines Perea, Strategic Advisor at QUIBIM

Quibim’s Strategic Advisor Inés Perea discusses the radical disruptions that quantitative imaging analysis can provide to cancer research

Quibim’s Strategic Advisor Inés Perea discusses the radical disruptions that quantitative imaging analysis can provide to cancer research amongst other areas

Inés Perea is a Doctor that graduated with honors in the Pharmacy and Executive Business Program by Instituto de Empresa of Madrid. Mrs. Perea has extensive and versatile experience spanning more than 20 years in the Pharmaceutical industry working within different roles within the Medical, Access and Commercial (Marketing, Sales, Strategic Planning) areas and international experience in Global and regional teams. Her main area of expertise is oncology and biologics where she has been involved in the strategic planning and commercialization of more than 10 drugs/indications, most of them linked to some form of biomarker diagnosis.

How did you come to know QUIBIM before becoming their strategic advisor?

I was in contact with founder and CEO, Angel Bayarri months prior to my start with Quibim. A mutual friend of ours, a director of a large genetics biomarker laboratory in Spain was working specifically on oncology genetic biomarker testing and I would get involved with his organization in the arenas of strategic value and development, as those are two of my core competencies. I was involved in the development and strategic value of genetic/biologic biomarkers in clinical trials in oncology. It was back in the 90’s when biomarkers were a thing of science fiction. Well, he introduced me to Angel and I really thought he had a fantastic idea when it came to implementation of 3-d imaging biomarkers and using algorithms to quantitatively analyze tumors. Once I learned about Quibim’s technology, I knew that the growth could be exponential if he partnered with strategic partners.

Your field of expertise is Oncology. The Quantitative Medical Imaging field has evolved significantly but we still use RECIST criteria for evaluation of treatment responses, what do you think is the main reason for this? Standardization?

This is the foundation for therapeutic trials. It is a standard when examining patients, however, it has some practical limitations. For example, with the latest breakthrough area in oncology research, immunotherapy, many immuno-oncology drugs are known to cause fluctuations in tumor size, which when analyzed simply with RECIST criteria, would appear as an increase to the tumor size, but it is now understood that tumor fluctuations occur regularly during immunotherapy treatments, often causing the tumor to grow prior to cell DE progression, which is in fact a good sign that would be captured with RECIST criteria well after the fact. In those cases, RECIST does not allow for factoring in the context of the holistic viewpoint that quantitative digital image analysis would facilitate.

What therapeutic indications are best served by incorporating quantitative imaging analysis into clinical research trials?

There is a very simple answer to this question: any therapeutic indication where standardized radiological assessments are a primary or secondary safety or efficacy endpoint of a study. This includes solid tumors, liver diseases, brain diseases, lung diseases, and many others.

Let’s discuss costs. Quantitative imaging analysis sounds expensive. However, automation and extraction of biomarkers as soon as a hospital acquires and uploads images related to a clinical trial can and do have a macroeconomic effect of lowering costs, therefore long-term costs decrease. What do you respond with when someone brings up this objection?

You are right, it is a tremendous cost saver from a macroeconomic point of view. What will continue to help this cause are national health systems, private funding, insurers, and other payers to see the long-term cost savings and efficiencies that quantitative imaging analysis facilitates. Essentially, we need to get quantitative image analysis included in the health system reimbursement system much like traditional biomarkers of a decade ago. As a matter of fact, it took health systems quite a bit of time to include standard biomarkers that we have all grown accustomed to, included on their reimbursement schedules. While it essentially all boils down to payers and health authorities, us researchers and technology pioneers need to continue to prove medium and long-term efficiencies and validate it with radiologists, clinicians and imaging researchers. Once we are able to do that effectively, the market will adjust accordingly, it always does.

The value seems to be in real-time results that can help in both safety and efficacy outcomes. Please expand further on this thought.

Real time results are everything if you really think about it. The main benefit is obviously how this technology facilitates the real time patient care capabilities of healthcare practitioners. Safety and efficacy instant results from treatments are critical when analyzing real time clinical research data. Imaging biomarkers can and will play a tremendous role in improving patient standard of care, and ultimately can make a real impact on disease outcomes.

by: Dan Sfera, also available at: https://medium.com/quibim/quibims-strategic-advisor-in%C3%A9s-perea-discusses-the-radical-disruptions-that-quantitative-imaging-54cef3a3e082

INTERVIEW | How Your Digital Twin Can Change Everything in Clinical Research

As technological advancements are rapidly increasing, the clinical research industry may not be too far away from doing in silico, or simulation trials which are truly virtual, and done of a healthy volunteer (or animal’s) digital model, otherwise known as a digital twin.  Imaging companies such as Quibim are best suited to pave the way forward for this next disruptive technology.  Not only will many animal and toxicity studies be able to be simulated, but can also theoretically be utilized as a pre-screening tool in order to proactively prevent SAE’s from occurring by running a simulation first and letting the patient and physician know what is likely to occur to patient if they enrolled into the study.  This may seem like science fiction, but so was the human genome project over a decade ago.

Outside of clinical research, just how patients are storing their own medical records for safekeeping and sharing with their healthcare providers, the same can in theory be possible when it comes to your digital twin that can be updated in real time, or perhaps every 5 years based on your MRI and other imaging results.

Ángel believes that phase 2-4 studies would still utilize real patients, but pre-clinical and toxicity studies can be completely simulated if the digital twin paradigm becomes commonplace in the research industry.  Not only will this mean faster clinical trials for animal and Phase 1 healthy volunteer studies, but it will allow for more sophisticated phase 2-3 pre-screening activities.

The in silico medicine movement will still require an opt-in from every patient that would want to: a.) have a digital twin and b.) share their digital twin with their healthcare providers.  Ángel believes that blockchain technology and the security and anonymity that is enables, will play a significant role in patients wanted to become involved with these types of technologies.  Our next episode will revolve around the topic of blockchain technology enabling technological innovations in clinical research and medicine in general.

INTERVIEW | Is Quantitative Imaging Analysis in Clinical Research Cost Effective?

Today we are interviewing Jose García, Project Manager of Quibim’s clinical trials, as well as Ángel Alberich-Bayarri, CEO and founder of Quibim.

We have discussed the benefits of quantitative imaging analysis in previous episodes, but in this interview we are analyzing the cost effectiveness of this solution.  Ángel explained that if we take a long term holistic approach, we would be able to have a real time monitoring of the statistical analysis of the study.  This alone saves Sponsors potentially millions of dollars, but even beyond that, patient selection for future or current clinical trials can be more efficiently targeted when utilizing imaging biomarkers.

Jose also explained that the utilization of Quibim’s technology is a natural advancement in the evolution of how we conduct and analyze clinical research studies.  Although we are at the forefront of this revolution, costs are going to continue to drop as the required technology for real time quantitative analysis advances.  Jose used the analogy of dispersed light versus the precision of a laser beam and how Quibim’s capabilities more accurately reflect the latter.

In regards to the macro-analysis of cost saving measures, centralizing the process of qualitative and quantitative image reading services as it becomes increasingly quantitative due to the parameters being extracted.  Artificial intelligence and algorithms will also play a large role in the quantitative analysis and will assist the qualitative readings of humans, such as radiologists.  The more we can automate the quantitative process, the greater the cost savings are made available to the study sponsors.

Towards the end of the interview, we discussed in silico studies, where, by utilizing a “digital twin” of an actual study subject, sponsors could in theory create a simulated clinical trial and determine outcomes while reducing potential risk to human participants, specifically in phase 1 trials primarily.  Quibim is at the forefront of this movement, and we will focus on this topic in our next episode!

INTERVIEW | The Inefficiencies of Qualitative Imaging Analysis in Clinical Research

In this episode of Quibim Blog, CEO and founder Ángel Alberich-Bayarri sits down with Dan Sfera and discusses the differences between quantitative and qualitative imaging analysis when it comes to clinical research.  Some of the more common therapeutic indications that involve image analysis include: oncology, central nervous system disorder, and respiratory illnesses.  Ángel made a great analogy in this interview of artificial intelligence, the algorithms that power Quibim’s quantitative imaging capabilities, being similar to GPS when it comes to assisting drivers in navigating during their commutes.  Algorithms in imaging analysis are similar in the sense that they are tools to assist the imaging analysis readers (radiologists) in making quantitative diagnosis’ rather that the current industry standard of qualitative assessments.  That seems to be the key benefit of Quibim’s value proposition: taking a subjective diagnosis and adding a quantitative component to it in order to allow the clinicians to make better informed decisions.

INTERVIEW | Biomarker Imaging Analysis and Real Time Clinical Trial Capabilities

In this episode, Quibim CEO, Ángel Alberich-Bayarri discusses some of Quibim’s technological capabilities which makes real time clinical trial safety monitoring and efficacy assessments practical and possible.  Angel discusses the importance of analyzing biomarkers in the form of images and how this method can provide several advantages over the traditional blood biomarker analysis.  Join our mailing list to be notified of future webinars from Quibim!

INTERVIEW | A Clinical Research Entrepreneur’s Story and The Loss Of CRO Dominance In Research

Quibim founder Ángel Alberich-Bayarri and Dan Sfera discuss Quibim’s origins, and the entrepreneurial spirit which is necessary to have a successful startup company in the Life Sciences industry. Dan and Ángel also discuss the emergence of artificial intelligence in the clinical research space as well as how algorithms can help identify therapeutic effect of a particular treatment on a medical condition. The interview segways into the Precision Medicine Congress Conference just held in San Fransisco in January of 2018, an event which Ángel and Quibim were well received at due to their innovative technology and strong leadership team. Finally, the interview discusses the emergence of sophisticated and technologically capable vendors, such as Quibim itself, and how their emergence is allowing Sponsors to bring more of their research initiatives in house. It will certainly be an interesting clinical research landscape to keep an eye on this year and Quibim Blog will continue producing these interviews for you!

INTERVIEW| JP Morgan 2019 Healthcare Conference Recap: AI and Blockchain

Dan Sfera had the opportunity to interview Quibim founder, Ángel Alberich-Bayarri live on location in San Francisco, CA for the 2018 JP Morgan Healthcare Conference.  Not only was Quibim proud to showcase some of it’s imaging and algorithmic capabilities and technologies, but we were also able to network and collaborate with other vendors from within the life sciences industry in order to bring better clinical research solutions to our customers and patients!  For anyone not able to attend the conference in person, we hope that by watching this video we could give you a glimpse into some of the trending topics that is of interest to the greater pharmaceutical and medical device industries.  The two most popular topics that kept popping up at this year’s conference: Artificial Intelligence and Blockchain Technology. We hope to provide another recap after Quibim showcases at yet another industry conference also in San Francisco later this month. Stay tuned!

INTERVIEW | The Differences Between Blood and Imaging Biomarkers in Clinical Research

We were able to site down with Quibim’s Chief of Research and Development, Fabio García.  Fabio is a software engineer by education who happened to have a passion for medicine, and has joined Quibim to help develop new products as they relate to identifying and analyzing imaging biomarkers.

In this interview we discussed the differences between blood and imaging biomarkers, the advantages and disadvantages of both, and the benefits of both working together simultaneously to provide optimal diagnosis in a clinical or research setting.

A biomarker is a way of identifying a biological process in the body that you can measure and quantify.  There are currently two ways of identifying and analyzing biomarkers: blood and imaging.

Fabio is excited in regards to what the future holds for imaging biomarkers in clinical trials, and as the technology becomes more cost effective, he believes the industry will continue further adoption of this novel diagnostic technique.

INTERVIEW | Quibim’s CTO Explains The Various Technological Capabilities For Biomarker Analysis

Quibim’s Chief Technology Officer, Rafael Hernández, sits down to explain how he got started with Quibim, the importance of biomarkers in clinical research, and some of the technology behind Quibim’s service offerings.

The key takeaway for me was the differentiation between the algorithms used to analyze the biomarker images, and the customizable software utilized to interface with the images.

Another point of interest is the storing capabilities of the images on a HIPAA compliant cloud server, or, on an equally secure local server at the location of the particular client, for example, a local hospital.

Finally, patient-centricity is at the root of these innovations. Quibim’s technology allows for encrypted and completely de-identified biomarker images that allow the Sponsors to analyze results without compromising the privacy of the individual patients. Furthermore, by pioneering breakthrough diagnostic services, Quibim is contributing directly to medical advances and breakthroughs that we can all benefit from in the near future!

INTERVIEW | Irene Mayorga Discusses Biomarkers and Clinical Research Image Analysis

Irene Mayorga, Clinical Trial Manager from Quibim discusses the emergence of biomarkers in clinical trials and how this will affect medical breakthroughs in the near future.

One of the more interesting things discussed with Quibim’s Clinical Trial Manager was the sophisticated process of analyzing images such as brain and lung scans with proprietary software that is then easily accessible by Sites and CRO’s alike through their web browsers.  Streamlining the receipt of the image scans from the various vendors across the globe, Quibim provides results and analysis as well as post processing of images and re-uploading the results to the Site/CRO portal.

Quibim is able to advance post process the images through quantifiable biomarkers, all in real time with simple access for the Sponsor/CRO/Trial Sites.  Biomarkers are important to analyze because they provide real time analytics to Sponsors who can analyze the process of the trial in real time.  Furthermore, the data being collected is added to the risk based monitoring components for any given trial that requires image results.  Study timelines can be reduced and save Sponsors millions of dollars per clinical trial due to these real time result and biomarker analysis.  Alternatively, clinical studies can be adapted in real time to enhance the safety profile of the subjects, or to manipulate the dosage of the investigational product when appropriate.

Quibim’s technology can apply to lung, bone, liver and other forms of cancer associated tumors due to the progression or regression of a particular tumor, again through biomarker analysis utilizing micro architecture analysis.  Allowing for virtual biopsies, as an example, liver tumors can be analyzed with greater precision and minimal invasiveness to study participants.  This has applications outside of clinical research as well, with the ability to save insurance companies a significant amount of associated costs.

Going forward, the clinical research industry will experience an explosion of diagnostics and device studies.  Quibim is well equipped to play a big role in the infrastructure of the safety and analysis of several critical endpoints when it comes to biomarkers and image analysis.