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European Pharmaceutical Contractor

Digesting Data

EPC: What was it that first attracted you to the biopharmaceutical industry, specifically R&D?

Munther Baara:
The end goal of biopharma stakeholders is to help bring medicines to patients – this is really the driver behind why I do what I do. It was my dad who influenced me to enter this field. He was diagnosed with diabetes at the young age of 38; this has impacted his quality of life significantly. Eventually, as a result of his condition, he lost his sight and had to have one leg amputated, which made his life extremely difficult. He spent 15 years of his life in bed. I wanted to help prevent this from happening to other people; it is what compelled me to be a part of this industry and to want to make a difference.

Another reason why the biopharma R&D industry piqued my interest is that the foundation is based on science – and I love to ask questions, observe and experiment. I like that in this sector we contribute to the cutting-edge of science and innovation. We are able to solve and address business problems and pain points through data observations. Right now, I feel that there is no better industry to work in, especially because of recent advancements in technology: enabling the creation of transformative business models within biopharma R&D.

Describe your business philosophy.


I believe in a culture of accountability, a focus on problem solving and an emphasis on thinking outside the box. Implementing this decision-making process within the biopharma R&D industry empowers enhanced discovery.

Can you speak about which TransCelerate initiative you are presently working on and its goal?

I am currently working on two initiatives that are very much connected. I lead the Investigator Registry and am also the workstream lead for a couple of sub-teams within the Shared Investigator Platform Initiative – specifically, the thinking behind and creation of the user and facility profiles. The Shared Investigator Platform creates a vehicle for clinical trial sites and sponsors to interact in an effortless way.

Today, the main pain point that clinical trial sites note is the arduous administrative tasks that sponsor companies bombard them with. From a ‘study starter’ perspective, all of the information on a site’s facility is repeatedly asked for when it could have been collected and stored at the first stage. The Shared Investigator Platform and the Investigator Registry enable us to streamline operations.

What advice would you give biopharma companies to improve their engagement with investigators and study sites?

We need to improve our relationships with the investigator first. Reducing the administrative burden on trial investigators will result in more time spent with the patient and an improvement in the patient experience, which is very important to the investigator and the sponsor company. The Shared Investigator Platform acts as a centralising location for investigators and site staff to create a seamless interaction and collaboration between us and the investigator sites. In addition, I would encourage a better use of data to help find the ‘right’ investigator, where ‘right’ means more than just past performance but also our ability to use other data about capabilities and patient populations (to name just a couple of considerations), and recognise both human eyes and predictive analytics to find the right matches of principal investigators and protocols.

Which emerging business technologies are currently having the most impact?


Thanks to the internet, you can connect with anyone across the globe. The new online ecosystem that connects devices, processes and data with people has led to a massive network of interaction and a large opportunity for engagement. It has created a major shift in our industry and an emphasis on efficiency. As a result, the biopharma industry is being challenged to think differently, stay ahead of technological trends and think about how to interweave these emerging technologies into business models.

For example, if patients were to wear devices and sensors as part of a clinical study, we would need to figure out how to best use the potentially huge amount of data to improve clinical trial protocols and results.

What trends in R&D will we see emerging over the next few years?

One of the most important trends I expect to observe in biopharma R&D is an increase in patient engagement with clinical trials. We are likely to see more proactivity from regulatory authorities, patient advocacy groups, academia, researchers and trial sponsor companies to identify ways to not only inform and educate patients prior to and during a clinical trial, but to also get their input on trial design and experiences after it has taken place.

Another major area is the use of wearable devices and sensors for patients in clinical trials. This presents a great opportunity to collect data on a real-time basis, which can give investigators insights into patient experiences in-between visits. Getting data in real-time means we can truly track a patient’s health, progress and quality of life as they receive an investigational medicine, standard of care or placebo, all while partaking in their daily activities. As a result, when the patient comes to see their doctor, they can have a constructive conversation based on the data that was collected. In 5-10 years, we will hopefully see the patient playing the role of data hub or central network, with the ability to share his or her data in real-time to investigators and other site personnel.

Disclaimer

The views and opinions expressed in this article are those of the interviewee and do not necessarily reflect the official policy or position of Pfizer.


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Munther Baara has over 20 years of experience in the pharmaceutical industry. He is currently Senior Director of Development Business Technology at Pfizer. In charge of Clinical Paradigm within the WRD-BT Development at Pfizer, Munther is spearheading initiatives driving innovation in development operations to align with the paradigm shift in the clinical trials execution model and emerging technologies. In addition, he has extensive experience in application and system strategies, best practices, and standards that work for clinical and enterprise architecture, information management, workflow/process automation and integration of both home-grown and commercial applications across mixed platforms. Munther is also a leader of the Investigator Registry Initiative at TransCelerate BioPharma Inc.
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