First-In-Human

Evotec signs novel antibiotics research deal with Nosopharm

04-Jul-2019 By Melissa Fassbender

Evotec is collaborating with Nosopharm, which expects to launch first-in-human studies in 2021, to accelerate the development of novel antibiotics.

Lonza serves small biotech with services to accelerate movement to the clinic

06-May-2019 By Maggie Lynch

Lonza announces service offering to accelerate the movement of poorly-soluble small molecules into first-in-human clinical trials.

Accelerating the path to first-in-human clinical trials

23-Apr-2019 By Melissa Fassbender

On the path to first-in-human clinical trials one of the main challenges is “velocity, ensuring rapid delivery of delivered drug product into the clinical program,” says CDMO.

Revised FIH guidelines: AstraZeneca reflects a year later

20-Nov-2018 By Maggie Lynch

Sponsors have had to take steps to follow the new EMA guidelines for first-in-human clinical trials, which can pose risk and operational challenges.

HIV-drug ‘kills’ infected cells in FIH clinical trial: Zion Medical

05-Nov-2018 By Maggie Lynch

The first-in-human clinical trial of Zion Medical’s HIV drug showed virus-eliminating results after four weeks of treatment, the company said.

CROs respond: FDA guidance on expansion cohort use in FIH trials a ‘welcome step’

20-Aug-2018 By Melissa Fassbender

Industry executives are welcoming the FDA’s draft guidance on expansion cohort use in first-in-human clinical trials – the increasing use of which is evidence of a changing drug development paradigm, says CRO.

Certara outlines the role of quantitative systems pharmacology in FIH trial design, EMA responds

09-Aug-2018 By Melissa Fassbender

Modeling and simulation can provide “meaningful prediction” of a drug’s pharmacodynamic range and maximum dose – the use of which might have prevented the tragic outcome of the BIAL 10-2474 trial in 2016, says Certara VP.