FDA guidance recommends diversity in clinical trials for medical devices, but can’t require it

The FDA often stresses the importance of enrolling diverse patient populations in clinical trials conducted to support product applications — both in industry guidance documents and during interactions with product sponsors. In Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies, guidance released in September 2017, the FDA makes multiple […]

For the tradition-bound biopharma industry, resisting change is no longer an option

“For nearly half a century the pharmaceutical industry has lagged other industries in terms of productivity, efficiency and, some might argue, innovation,” wrote Bikash Chatterjee. “The excuse was that, as a regulated industry, any flexibility to implement improvements is limited, and compliance is of paramount importance.” Chatterjee, president and CSO of Pharmatech Associates, made these […]

R&D spend up, capital down makes for shorter runways for midmarket biotech companies

Spending on R&D by midmarket biotech companies increased 18 percent from 2015 to 2016, from an average of $65.9 million to an average of $80.6 million, according to the 2017 BDO Biotech Briefing, a report from BDO USA LLP analyzing the 10-K SEC filings from companies in the Nasdaq Biotechnology Index (NBI) with revenue of less than $300 million.

DCAT Week ’17 session looks at emerging pharma market trends

The health of emerging pharmaceutical companies can be assessed, in part, by financing and partnership activity with larger companies, Richard Harrison, Chief Scientific Officer at Clarivate Analytics, told a DCAT Week ’17 audience in a session titled “Emerging Pharma: Market Overview, Project Management and CMC Readiness.”