3 Data Access Enhancements That Expedite Drug Development and Approvals


2021-bl-unlocking-your-data-potential_715x320The recent brouhaha over AstraZeneca’s claims about the efficacy of its COVID-19 vaccine has reaffirmed how seriously regulatory bodies and government agencies take data accuracy. After the biopharma company issued a press release claiming its vaccine reduced symptomatic disease by 79%, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) shot back, saying that figure was based on outdated information that “may have provided an incomplete view of the efficacy data.” (1) Although the actual efficacy of AstraZeneca’s vaccine is believed to be only slightly lower (the NIAID still endorsed it as “very likely a very good vaccine”), the mistake of releasing outdated and inaccurate data will likely cause the general public to have reservations about the company’s product. (2)

AstraZeneca’s data debacle isn’t an uncommon event. Throughout the frenetic sprint to research, develop, and distribute COVID-19 vaccines, tests, and therapies, every organization across the pharmaceutical industry has been forced to reckon with one undeniable fact: there is nothing more important than up-to-date, accurate data. And although the velocity of drug development may have garnered most of the public’s attention throughout the pandemic, regulatory agencies have never wavered in stressing that reliable data is the force that tempers the rampant acceleration of unproven products.

Even as his tenure as U.S. Food and Drug Administration (FDA) Commissioner came to a close, Dr. Stephen Hahn continued to reiterate the centrality of high-quality data in regulatory efforts.

“I strongly believe that we need to do everything we can to attain more and better data for the work we’re doing, to be more proactive in gathering data, and to be more creative and thorough in our analysis of it,” Hahn said. “By harnessing this power, we can improve our regulatory decision-making and more effectively connect today’s groundbreaking scientific discoveries with the rapid development and approval of new products.” (3)

Aligning With Regulators’ Emphasis on Data Quality

Regulators are stressing their focus on actionable data of the highest quality, and the companies whose products they regulate must follow their lead. The results of Gartner’s latest surveys of pharma executives indicate the industry is finally beginning to recognize the urgency of improving data usage. The research firm reports that data analytics has recently become the No. 1 investment increase priority of pharma CIOs. (4)

The trend of pharma companies’ improving their access better data — and to adopt new methods of generating, collecting, and applying it — is central to supporting innovation and developing more effective products that meet the gold standard for safety and effectiveness, according to FDA statements. (5) As companies follow the lead of the FDA and other data-focused regulators, Deloitte predicts that the increasing emphasis on data connectivity will enable faster approvals and enhance the dissemination of information about the value and risk of products. (6)

“Pharmaceutical businesses are under pressure to improve the financial returns on their drug development, particularly in a world of increasingly personalized medicine,” Deloitte’s researchers noted. “Equally importantly, they should prepare for a more data-led healthcare system that challenges them on drug performance.” (7)

The snowball effect of regulators and pharma organizations magnifying their focus on data quality will exponentially boost the value of all data. That means it’s never been more important for companies to find ways to effectively connect the data they already have at their disposal and to operationalize it in meaningful ways.

3 Tactics for Unlocking Your Data’s Hidden Potential

There are three actions a pharma company can take to start deriving new insights from data that is already available, however disconnected or unstructured it may be.

#1. Incorporate Strategies From Pandemic Successes

The organizations that have thrived during the pandemic are those that found innovative ways to link and activate data. Seek out companies similar to yours and look at their success stories. You will likely find companies that demonstrated flexibility and foresight while facing trying circumstances, and there are undoubtedly parallel approaches you can incorporate into your own drug development cycles. Successfully doing so can turn theoretical concepts into practical outcomes and should result in a better balance between process acceleration and the production of high-quality products.

#2. Invest in a Platform Cornerstone

Uniting data, applications, and processes within a common architecture brings countless benefits. You can achieve far greater data and process governance by running multiple applications within a single integrated operating system rather than piecing together disparate applications. In addition to offering the reassurance of native connectivity, a holistic digital framework also lays the groundwork for integration with the emerging technologies you’ll need to stay competitive in the future.

#3. Unite Data Layers by Creating Integration Points Between Core Systems

When you connect information that has historically been maintained in disparate, siloed systems it establishes a single source of truth for all your organization’s current data. A platform with robust integration capabilities can enable seamless data exchange and consistency across all your core systems and business processes.

Benefits of a Platform Approach to Data Connectivity

Bringing data and processes together within a common platform doesn’t just prepare an organization for the next crisis. It creates efficiencies that help companies work smarter, decrease costs, and get products to market sooner. According to BCG researchers, companies that adopt a platform approach that prioritizes data speed and agility (as opposed to digitizing core systems individually in a multiyear effort) receive a wide range of advantages that include:

  • Two times faster time-to-value.
  • Two times more value created.
  • 50% lower costs.
  • The formation of a data layer that liberates information from core systems scattered across the enterprise.
  • Simpler interfaces.
  • Greater agility of and collaboration between teams.
  • Data that moves faster and has greater likelihood to create competitive advantages. (8)

To learn more about the many ways platform integration can help your organization better connect and operationalize data, visit MasterControl’s product life cycle management platform page.


References:

  1. AstraZeneca Will Release More Vaccine Data As Health Officials Detail Worries,” Kaiser Health News Morning Briefing, Mar. 24, 2021.
  2. Astra Zeneca commits to more vaccine data after concerns from NIH,” Axios, Mar. 23, 2021.
  3. FDA’s new chief stresses data, consumer empowerment and innovation,” Medical Design & Outsourcing, Jan. 31, 2020.
  4. 2020 CIO Agenda: Life Science, Medical Equipment and Other Science-Based Manufacturers’ Perspective,” Michael Shanler, Gartner, Dec. 19, 2019.
  5. Remarks by Dr. Hahn to the Public Meeting on Rare Diseases,” FDA website, Feb. 24, 2020.
  6. A bold future for life sciences regulation: Predictions 2025,” Deloitte Centre for Health Solutions, Nov. 2018.
  7. The future of pharma services: The growing impact of data in outsourced pharma services,” Deloitte, 2020.
  8. Digital Accelerations is Just a Dream Without a New Approach to Tech,” Karalee Close, Antoine Gourevitch, et al., BCG, July 2020.

2019-bl-author-james-jardine

James Jardine is a marketing content writer at MasterControl, Inc., a leading provider of cloud-based quality and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.


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