Bringing novel – and cost-effective – new drugs and devices to the market is the lifeblood of the life sciences industry, but it can’t do it without a symbiotic relationship with patients and regulators.
PricewaterhouseCoopers just put out a new report that highlights the relationship between the Food and Drug Administration, the life sciences industry and consumers. Here’s what it found:
– Life sciences execs say the hulking, bureaucratic beast that is the FDA has actually become more communicative and open. Forums like Medical Device Innovation Consortium are helping regulators and execs parlay.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
– The same execs say that certain clemencies have to be made to balance innovation and risk – particularly when increasing patient access to new (potentially risky) therapies. For instance, most of ’em said these fast-tracked FDA therapeutics should be balanced by receiving stricter post-market surveillance.
– Smaller companies rely more on FDA’s guidance materials than formal meetings with the agency, PWC says:
– Both the clinical outcomes and the cost of drugs are now considerations when figuring out a drug’s value; just a few years ago, that definitely wasn’t the case. To make it to market, drugmakers will have to show that their wares are an improvement over existing therapies.
– The FDA’s standard review speed’s improved, particularly devices. Check out this infographic that shows the change in review times for drugs and devices, as measured in months over five years:
BioLabs Pegasus Park Cultivates Life Science Ecosystem
Gabby Everett, the site director for BioLabs Pegasus Park, offered a tour of the space and shared some examples of why early-stage life science companies should choose North Texas.
– Consumers are getting more vocal. Patients want their input considered when the FDA reviews a drug; many manufacturers are also looking to their audience for clues on how to better develop their drugs.
