Jim Greenwood, President & CEO, Biotechnology Innovation Organization- BIO
Emerging therapeutic companies are driving innovation. As of May 2019, out of the total 6,984 clinical-stage industry pipeline programs, 73% of these came from emerging companies versus large companies. The top 3 disease areas from the drug programs are oncology, immunology and metabolic.
For FDA approvals (novel drugs only), 2019 has a slow start in comparison with 2018, which is by far a record-breaking year.
There will be 40 gene therapy solutions to be approved by the FDA by year 2022.
Some of the hot topics for what is next in biotech innovation: (1) New methods in evaluating efficacy, (2) Antigen specific intolerance, (3) Microbiome-inspired therapy, (4) Nearly 7K in pipeline with heavy emphasis on metabolic.
Discussion on opioids and pain epidemic (Changing the paradigm of treating pain and addiction). The rise of opioid deaths appears to have occurred in three waves: first prescription opioids, followed by heroin, and most recently, synthetic opioids.
The Future Is Bright for Somatic Cell Genome Editing.
Over the past 5 years, growth in the vaccine sector has slowed markedly to below 5 per cent annually, but changes to investment strategies and a shift in focus to more technical and complex vaccines could renew the innovation engine.
Capitalising on big data analysis, digital health will continue to impact bio space and healthcare overall, improving R&D, cutting costs and positive healthcare outcomes.
A "patient-centered" approach as shared by Christi Shaw (SVP, Lilly and Co., President, Lilly Bio-Medicines) — (1) Understanding the patient's journey, (2) Ensuring access to novel treatments, (3) Looking at patients holistically, (4) Addressing both the opioid epidemic and pain crisis, (5) Focusing on patient out-of-pocket costs, (6) Delivering transparency across the drug cost ecosystem.