Getting people vaccinated can be a public health challenge. Getting them to come back for a second dose at the right time can be even more difficult. This week we highlight why people may be skipping their second COVID-19 dose and how challenging getting that second dose can be even for people motivated to receive it. We also look at a Food and Drug Administration advisory panel reviewing accelerated drug approvals, diversity and inclusion in the life sciences industry, the promise and challenges of artificial intelligence in patient diagnosis and the evolution of the regulatory environment for biopharma companies.
Each week, we highlight five things you need to know in the life sciences industry. Here’s the latest.
At the time of this writing, 29% of the U.S. population have been fully vaccinated using the Pfizer-BioNTech, Moderna or Johnson & Johnson vaccines. For those getting the Pfizer or Moderna vaccine, approximately 8% of patients have missed their second dose. This trend is both worrying and expected. For example, with a two-dose shingles vaccine, nearly 25% of patients miss their second dose. This New York Times article explores further.
The FDA offers a variety of pathways to expedite the review process of new drugs. Twenty-three percent of new drugs were approved under the accelerated approval process in 2020 and approximately two-thirds of new drugs used some form of accelerated approval. This week, an FDA advisory panel is reviewing the long-term performance of three blockbuster oncology drugs that received accelerated approvals for additional indications. This will provide a window into the FDA’s thinking on how officials may balance future approvals.
Informaconnect conducted a survey of life sciences company employees and found that women and minorities were under-represented in these companies. Among respondents, 34% stated that minority representation in leadership was the largest issue facing the industry related to diversity and inclusion. More worrying, 41% of respondents said they had faced bias based on their gender, ethnicity or sexual orientation.
4. AI uncovers heart condition in one patient, but can results always be trusted and lead to appropriate care?
Stat shares a remarkable story of a patient whose EKG was analyzed by an artificial intelligence algorithm which spotted a very subtle indication that he was likely suffering from atrial fibrillation. After the patient wore a heart monitor for several days, doctors observed the condition and adjusted their course of treatment. This article raises an important question: does this intervention actually improve patient treatments and prognosis, or does this simply increase the amount of care received?
Clinical Leader recently interviewed Scott Cleave, vice president of regulatory compliance at bluebird bio. He provides an overview of the evolution of the regulatory environment over the course of his career and the move from paper-based filings to gathering real world evidence of patient outcomes. We don’t often think of the regulatory environment as rapidly changing, but he offers a variety of examples of how both the FDA and clinical trials are adapting to new technologies and a massive increase in available data.