drug development Archives - HEALTH & LIFE SCIENCES NEWS

After the Curve Podcast: Focus on Life Sciences

In this time of crisis, the life science industry has demonstrated remarkable speed, innovation and resilience. In this episode of the After the Curve podcast, our life sciences partners join us to discuss the most promising areas of drug discovery and device development that are emerging from the pandemic and the outlook for the industry in a post-COVID-19 world. McDermott’s Chief Marketing Officer, Leslie Tullio, is joined by Stephen Bernstein and Kristian Werling to discuss key topics impacting the life sciences industry today, including:

The reasons behind the immunity of life sciences to slowed investments
Why more investors are focusing their equity in healthcare and life sciences
Promising areas of drug discovery and device development emerging from the pandemic
Critical considerations for life science companies regarding rapid regulatory changes
Tactics for moving developments forward at an increased speed
The importance of Collaborative Transformation to the life sciences industry

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Modernizing FDA’s New Drugs Regulatory Program – Reviewing the Guidance Ecosystem and Implications for Life Sciences Companies

In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while reducing regulatory burden, as well as to increase efforts for critical research and increase the involvement of patients and their perspectives in research and the product development process. The Cures Act specifically provided the US Food and Drug Administration (FDA) authority to modernize product development and review, and create greater efficiencies and predictability in product development and review. In June 2018, in response to this congressional mandate and corresponding new authorities, as well as reauthorizations of FDA’s user fee agreements, FDA made a series of announcements for a proposal to modernize new drug development.

Highlights of FDA’s initial proposal included:

Focusing on recruiting talent across disciplines;
Building multidisciplinary teams for more efficient collaboration;
Prioritizing operational excellence through a single and consistent review process;
Improving knowledge management through enhancements to information technology and honed expertise within review divisions;
Emphasizing safety and risk-benefit analysis before and after approval; and
Incorporating the patient voice into product development.

As articulated by former FDA Commissioner Scott Gottlieb, “[a] principal aim of these proposed changes is to elevate the role of . . . scientists and medical officers to take on even more thought leadership in their fields.” The agency contemplates implementing organizational and structural changes that make drug review divisions more therapeutically-focused [...]

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