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AMPLEXOR Webinar: Transformation in Life Sciences - Regulatory Affairs as a Valued Partner for Innovation

The digital health market size is set to exceed USD 379 billion by 2024, according to a new research report by Global Market Insights. 

Digital technologies, such as smartphones and other mobile platforms, enable pharmaceutical and medical device companies and their info tech partners to speed up clinical trial recruitment, identify gaps in a therapeutic category, more quickly respond to requests for information and collect real world patient data throughout product development and commercialization.

The impact of digital in life sciences is explored in the newly launched book, Managing Biotechnology: From Science to Market in the Digital Age (Wiley, 2017), written by my colleague Dr. Francoise Simon.   Dr. Simon describes why the collection of real world evidence is pivotal to putting patients at the center of care, and requires establishing close relationships with patient groups.  The industry has always understood the value and importance of collaboration and on-going dialogue with physician key opinion leaders during product development, especially at the outset.  Now, the industry’s current commitment to patient-centricity entails considering patient groups as thought leaders, too.

For example, Biogen partnered with the advocacy group PatientsLikeMe and Fitbit to better understand the utility of wearables in tracking activity of multiple sclerosis patients, and to explore patient adherence to monitoring after a clinical study. 

Regulatory acceptance of technologies that capture behavioural data will accelerate digital transformation.  However, regulatory science and digital development are not always aligned and questions will arise.  For example, can behavior be used as a surrogate endpoint, either for clinical efficacy or for quality of life?  It will be important for drug and device companies to collaborate with regulators and interact with them early and often to address these issues.

Collaboration at all levels is the force behind efficient digital innovation which must be networked (co-created) to develop products that are truly patient-centric, Dr. Simon underscores.

Collaboration internally among diverse professionals such as commercial, regulatory, legal, medical, and compliance functions make digital innovation more efficient. Companies accelerate speed to innovation when human assets are effectively utilized.  That’s why Return on Collaboration (ROC) must become a new metric for digital success.  ROC is the benefit companies realize from giving employees the tools they need to collaborate efficiently and effectively.

I’ll be presenting even more examples of digital innovation and how Regulatory Affairs professionals can position themselves as high value partners to the business during this time of digital transformation. Register now.

This article was created in collaboration with the sponsoring company and our sales and marketing team. The editorial team does not contribute.