Some sceptics claim that electronics and therapeutics are incompatible because the life cycle management of apps and tech hardware is measured in months, not in years or decades as it is for drugs and biologics. We will therefore need to get smart about updating tech for approved drugs without seeking new approvals from FDA every 6-12 months as the technology associated with the drugs is upgraded.
For that to work, we need to have the FDA in this total game-changing paradigm as a partner, and FDA Commissioner Dr. Scott Gottlieb recently affirmed his belief that FDA must encourage the development of new digital tools. It seems that Flatiron’s success in oncology was at least partly the result of such a partnership.
Together, we must maintain sharp focus on the needs and hopes of the ultimate stakeholders: the many different “me”s who are both the patients and the source of all the precious data. Finding the answers and making the solutions accessible to patients is our collective responsibility and an unprecedented opportunity.
It seems therefore fitting to close with a quote from the CEO and Chairman of PatientsLikeMe, Jamie Heywood: “We started with the assumption that patients had knowledge we needed, rather than we had knowledge they needed. We didn’t have the answers, but patients had the insights that could help us collectively find them.”
Igor Gonda is the Founder of Respidex, a San Francisco-based consulting company helping pharmaceutical companies in all aspects of development, financing, approval and commercialization of products for prevention, diagnosis and treatment of diseases. Dr. Gonda had a variety of executive positions in US and Australian private and public pharmaceutical and biotech companies, most recently as President and CEO of Aradigm Corporation.
His research focus was primarily in the area of drugs and biologics administered to the lung and nose conducted in industry and, prior to that, in universities in England, Australia and USA. Dr. Gonda’s current interests additionally include the role of patient advocacy groups in the pharmaceutical R&D and approval decision making process, and in opportunities for acceleration of development of accessible individualized precision medicines. Contact: igonda@respidex.com
