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  • Zack Schmidt

My Mission: Helping Biopharma Firms Get New Treatments to Patients Faster and Cheaper

In 2012 I visited a major pharmaceutical company in the San Francisco Bay Area. They were involved in cancer treatment research which promised to significantly slow cancer tumor growth. However, one area of their clinical research never stopped growing: The mountains of office file boxes overflowing with paper based FDA and EU regulatory documents and clinical trial data. The clinical trial operations staff was drowning in the reams of paper, and most of their work seemed to involve manual document printing, scanning, filing, retrieval and tracking. After speaking with the clinical trial research and operations team members about the prevalence of paper based processes, it was clear that they really needed systems, teams and strategies to help them automate and ease their massive manual paperwork burdens.

With my background in technology I knew that there had to be a faster and more effective process for clinical trial document management.

With my background in enterprise software and systems automation at companies like Oracle and Adobe, I had spent 10 years helping companies design, automate and deploy systems to automate manual business processes, saving firms significant time and money along the way. I knew that their was a faster and more effective way for them to get their clinical trial paperwork done. After seeing the paperwork mountain and challenges faced by the clinical research industry, in 2012 I decided to focus exclusively on helping clinical research firms in the health sciences industry by developing new software technology so firms could go digital with paperless systems. My mission and goal shifted from helping businesses save time and money, to helping health science firms save lives with paperless smart systems.

Soon after my move into the health sciences market, my mission to help save lives with smart systems became even more relevant. Global health maladies such as the worldwide outbreak of COVID-19 had widespread worldwide impact, with a devastating effect on people, businesses and entire industries.

While these impacts have been and continue to be primarily negative, there is one positive impact: The life science ecosystem of BioPharma firms, government agencies, R&D centers and stakeholders are scrutinizing the processes, systems and regulations that impact the timelines for new therapies and treatments. The overall objective of this ecosystem is simple: we all strive to deliver new vaccines and treatments to patients faster, with measurable quality.

However, the solutions to reducing treatment development timelines are not so simple. Recent research by Gartner in 2020 has identified multiple qualitative trends and factors that impede the R&D process: Manual paper based processes, standalone siloed systems and data, and regulation. From a technology perspective, the R&D drug development process today is similar to the banking industry of 100 years ago - paper-based manual processes are the rule, not the exception. When technology is deployed, it's often deployed as a disconnected, siloed system, with no connectivity to existing systems or stakeholders in the R&D ecosystem. Finally, regulatory agencies have added hundreds of new rules and regulations that are never adjusted for new technologies. Often these regulations - although created by lawmakers with the best intentions - hinder, not help, new treatment delivery timelines.

Cloud based technology, smart applications and automated processes can and are fundamentally changing the way that new medical treatments are researched, developed and delivered. As an example of the positive impact that technology products on treatment development timelines, in 2020 my firm SureClinical surveyed customers to learn how they were using our products for clinical trial regulatory document management, and if they could share quantitative data on their product development timelines before and after implementing SureClinical. One of the customers surveyed was a clinical research organization. Before implementing SureClinical, they used paper based processes and email to enroll clinical investigators in new clinical trials, a process which took them about 12 months to complete. After implementing SureClinical’s automated paperless solution, they were able to enroll clinical investigators in five months with automated data capture, reducing the timeline for enrollment by over 50%. Manual scanning was eliminated, they were able to build a digital investigator database for reporting, analysis and trending.

Why should anyone care about my new mission to automate paper based systems to help get new treatments to patients faster? If we can trim the timeline of a clinical trial by five months, then the following would be possible: Patients can get life saving treatments five months earlier, BioPharma companies gain revenues five months earlier with reduced R&D costs, and drug and treatment costs could be reduced proportionally. Saving lives, speeding new treatments to market for patients, and saving patients money on drugs is a mission that everyone should get behind - sponsors, patients, clinical research organizations, government regulators and the entire clinical trial ecosystem.

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