Regulatory affairs

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.

Pharma consultancy Boyds enhances clinical, medical affairs services

12-Sep-2019 By Melissa Fassbender

The pharmaceutical and biotech product development consultancy Boyds acquires Blue Duck Consulting to boost its clinical and medical affairs services offering.

FDA and CluePoints to further explore risk-based site inspection approaches

12-Sep-2019 By Melissa Fassbender

The FDA has extended its agreement with CluePoints to augment the agency’s oversight of clinical trials using data-driven approaches, with additional testing ideas focusing on moderators of treatment effect and real-world evidence, says CCO.

‘Everything to do with patient centricity’: Wearables to redefine research approaches

11-Sep-2019 By Melissa Fassbender

After ‘holding its breath’ for nearly half a decade, pharma and health care companies are ready to implement new technology in clinical trials – though data standardization will be key to fully realizing the benefits.

What’s next for M&A? Precision medicine, diagnostics, new customers to disrupt pharma services market

06-Sep-2019 By Melissa Fassbender

Increasingly complex clinical trials are putting pressure on CROs to expand their service offerings in what has been a historically monolithic space – with diagnostics also continuing to play a more important role in the market, says industry expert.

Advarra to acquire CTMS provider Forte, build research 'ecosystem' for streamlined operations

05-Sep-2019 By Melissa Fassbender

Advarra is set to acquire Forte in a bid to expand its offerings to include an integrated suite of standards-based trial management products and services – a platform for ‘an interconnected clinical research ecosystem,’ says CEO.

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

04-Sep-2019 By Melissa Fassbender

The last month of summer saw several hires, including a lead for Worldwide Clinical Trials’ Japan operations, CEO appointments at CordenPharma and LabConnect, and Altasciences’ new CSO, who joins the company from Syneos.