Focusing on interoperability and technology accelerators
The Regulatory, Quality and Compliance space remains dynamic and evolving in 2023. With new guidance and regulations being put into place, increasing price pressures with the looming recession, and a global pandemic that remains among us, companies have had to evolve and find new ways of managing their regulatory, quality and compliance mandates to remain relevant and competitive.
Technology adoption with a focus on interoperable compliant platforms to serve as the basis for regulated workloads (e.g., GxP, HIPAA, PHI) serve as a vital path to accelerate development timelines yet industry continues to host duplicative infrastructure for separate business and product development use and struggles to meet the ICH compliance rigor required.
Precision medicine products (e.g., CAR-T, TCR), require regulatory compliant process and technology maturity significantly earlier in the product lifecycle in comparison with traditional drugs and devices. This constraint, coupled with the infrastructure challenges of start-up companies who must stand-up environments on aggressive schedules has resulted in a need to swiftly move to FDA’s CSA guidance here. The migration from legacy computer validation to the CSA model will be a focus in 2023 and beyond.
With the venture capital market focus solidly on cell and gene therapy (where $68B was invested in 2021 equating to roughly one-third of all private LS investments1), the pressure to increase automation and develop technology accelerators that achieve global regulatory requirements is key to gaining a competitive advantage and achieving best patient outcomes.
In Digital Health, regulatory, quality and compliance remain the focus to achieving high medical value for clinicians and the patients they serve. The potential new sources of revenue streams await those organizations who can creatively gain regulatory approval for Software-as-a-Medical Device (SaMD) and similar clinical decision support (CDS) products. Artificial intelligence (AI), machine learning (ML), natural language processing (NLP), and robotic process automation (RPA) are at the core of the endless pipeline of health aids and tools in the digital health ecosystem and organizations who can successfully meld their software development capabilities with a quality-by-design (QbD) and Quality 4.0 approach will succeed in the market and drive real patient impact.
Big Tech is responding to global privacy regulations (e.g. GDPR) in a big way; Google announced plans to deprecate third-party cookies by the middle of 2023, and Apple already rolled out app tracking transparency (ATT) requiring apps to request user permission to track the user or the device. Most users (~96%) are opting out.
As cookies disappear and third-party data sources become riskier or more costly, pharma marketers are making unprecedented moves to safeguard consumer data and invest in solutions to target consumers in a privacy-compliant manner. Many are investigating Data Clean Room technology.
Alvin Lee, Rio Longacre, Peter Rossi
What's next in digital health product development?