The Evolving Food and Drug Industry: Key Takeaways from the FDLI Conference
If there was one word we could use to describe the Food and Drug Law Institute (FDLI) conference, it would be “evolving.” Oxford team members attended the annual FDLI conference in Washington, D.C. in May to keep pace with the upcoming trends and changes in the industry. Exciting developments are occurring, and having insight into the near future of medicine and therapeutic technology, as well as food and drug laws, was certainly informative.
Some of the most notable points we took away were from the keynote speakers.
Global Harmonization
FDA Commissioner Dr. Scott Gottlieb spoke at his keynote about the importance of global harmonization of industry regulations and standards around the world. Currently, every country has a regulatory body like the United States FDA. With each administration enforcing different regulations, food and drug companies become limited in their ability to expand outside of their respective countries. By developing globally harmonized standards and regulations, countries can work together to improve their product and product development processes.
Data-Driven Inspection Protocol
Another fascinating keynote came from Dr. Donald Ashley. He spoke about the FDA’s transition to a more data-driven inspection protocol. For years every food and drug company had the same inspection protocol, where they would be visited by the FDA to review the firm’s compliance with their regulations to ensure such things as patient safety, product efficacy, product uniformity, and protection against contamination. The newly envisioned inspection process will be more reliant on data to decide which firms get inspected and when. This will create more efficiency and enhance patient safety in that the process will utilize post-market data such as recalls and complaints. This would determine the amount and frequency of inspections a company would receive. Firms with high levels of negative post-market data would be the focus of inspectional activity.
Advances in AI
Another enthralling aspect of the conference was the focus on the future of the medical industry. It almost seemed like something out of science fiction! When speakers at FDLI spoke about artificial intelligence (AI) and “deep learning” programs, it felt like “the future is here.” Soon robots/machines will be capable of making their own decisions for patient care, treatment, and therapy. A robot/machine would take a patient’s vitals, make an assessment, and then create a personalized treatment plan based on the data they received. This could cut down on wait times at hospitals, giving doctors and physicians more time to focus on the patient, while the robot/machine handles testing, administration of treatment, and patient monitoring.
New Treatment Options
In the same futuristic vein, Dr. Anne Marie Polack spoke about the ability to use CRISPR to grow new organs for those in need, and to reconstruct genes in people with health problems. The FDA has approved a gene altering treatment for children with leukemia, called Novartis Kymriah. FDA Commissioner Scott Gottlieb has approved the study of 550 gene therapies that could possibly make way for new cancer therapies, end hereditary diseases, and even eradicate immune disease goliaths such as AIDS.
Summing up the experience, Gary Bergman, Oxford’s Life Sciences Practice Director, said, “The FDLI conference provided a valuable forum for professionals, the legal community, and the FDA to present and discuss recent advances and topics in the Life Sciences industry. It is always rewarding to interact and connect with colleagues to stay current with industry topics and trends.”