Regulatory affairs

Zosano readies contract manufacturers for pre-approval inspections

25-Nov-2019 By Nick Taylor

Zosano Pharma prepares contract manufacturers to host pre-approval inspections to support filing for approval of migraine drug.

Sosei Heptares pulls dementia trial to minimize CRO expenditure

18-Nov-2019 By Nick Taylor

Sosei Heptares withdraws Phase II dementia with Lewy bodies trial to reduce spending on contract research while clinical activity is suspended.

The next act: ACRO, R&D Caucus moving forward with second Cures bill

07-Nov-2019 By Melissa Fassbender

ACRO is collaborating with the Congressional Research and Development Caucus and others to bring forth a new Cures bill focused, in part, on patient engagement, data, and digital health – with draft legislation anticipated early next year.

People on the Move: Outsourcing-Pharma roundup October ‘19

01-Nov-2019 By Melissa Fassbender

This month’s people on the move includes a new therapeutic lead at Advanced Clinical, with plans to create a network of investigation sites, as well as CEOs at AIT Bioscience and Pharm-Olam, who discuss plans for moving forward.

Sponsors need to understand and prepare for CCPA: Greenphire

30-Oct-2019 By Melissa Fassbender

California’s data privacy law will provide clinical trial participants with confidence that their information will not be misused – though additional clarity is needed as the pharmaceutical industry faces mounting pressure to increase transparency.

Letter to the Editor

Counterpoint: 3 reasons Right to Try is less flexible than expanded access

29-Oct-2019 By Richard Klein, director of expanded access programs and policy, GE2P2 Global Foundation

In a letter to the editor, Richard Klein, director of expanded access programs and policy for the GE2P2 Global Foundation, outlines three reasons why Right to Try is less flexible than expanded access.

FDA guidance ‘a step in the right direction’

11-Oct-2019 By Melissa Fassbender

The FDA has published the second in a series of guidance documents that aim to accelerate research and the use of patient input to inform clinical development programs, says Iqvia head.

Right to Try programs to ‘significantly accelerate' drug development: Beacon of Hope CRO

09-Oct-2019 By Melissa Fassbender

Beacon of Hope CRO is working with sponsors and other service providers to design Right to Try treatment programs, which the company’s founder says have ‘unmatched’ flexibility, an ability to treat screen fails and create ‘interim clinical milestones,’...

Elligo advancing RWD project under FDA grant

03-Oct-2019 By Melissa Fassbender

The FDA has awarded a grant to Elligo Health Research to continue work exploring the ability to extract clinical evidence from real-world data.

Rho: 'The hurdles are high when you have a drug that the world doesn’t need'

01-Oct-2019 By Melissa Fassbender

Rho experts speak to the challenges facing drug development, meeting unmet needs, quality by design, and advances in technology, among other topics, during a sit-down at the CRO’s headquarters.

Pilot project to answer where and how RWE can be used

27-Sep-2019 By Melissa Fassbender

The Friends of Cancer Research, in collaboration with Iqvia and other health care research organizations, are working to determine where and when real-world data can be trusted.

Elsevier developing risk calculator for DDIs ‘aligned with pharma’s needs and challenges’

24-Sep-2019 By Melissa Fassbender

To improve patient safety and reduce risk, Elsevier is developing an improved drug-drug interaction risk calculator in collaboration with several pharma partners, including Boehringer Ingelheim, Eli Lilly, and Servier.

AI in drug development: ACRO, DIA, and Owkin to talk use cases and what comes next

18-Sep-2019 By Melissa Fassbender

There has been a lot of discussion surrounding the use of artificial intelligence in drug development – with several deals, alliances, and partnerships made so far this year. Here, Outsourcing-Pharma takes a look back at some of these announcements, as...

Gottlieb on board to advance Aetion’s RWE work, guide platform development

17-Sep-2019 By Melissa Fassbender

Aetion today announced that former FDA Commissioner Scott Gottlieb has joined its board of directors to help to advance the use of RWE in drug development and commercialization.

South Korea's 5-year plan to advance clinical trials a boon for US biotech

13-Sep-2019 By Melissa Fassbender

South Korea looks to accelerate review timelines and study start-up with a new five-year plan that will benefit biotechs looking for locations outside the US to ‘ramp up’ clinical development programs, says CRO.