Clinical Trial Materials

COVID-19: Shoring Up the Drug Delivery Infrastructure

July 02, 2020

BioPharm International

Manufacturers and the US government are investing heavily in traditional and non-traditional forms and materials to ensure supplies of containers and delivery devices for COVID-19 treatments and vaccines.

Finding New Efficiencies in Clinical Trial Logistics

June 01, 2020

BioPharm International

The COVID-19 pandemic has led to increased demand for direct-to-patient shipments, challenging cold-chain specialists to become more agile and to strengthen their global distribution networks.

2019 Investments Centered around Cell and Gene Therapies

June 01, 2020

BioPharm International

Previous investments set a foundation for later efficiency improvements.

Are We All In This Together?

June 01, 2020

BioPharm International

Achieving herd immunity will require testing, data, a vaccine, and public support.

Plasma-Based Antibody Therapies Battle Against COVID-19

June 01, 2020

BioPharm International

Therapies for early and late treatment and passive immunization of COVID-19 are needed and can be developed using antibodies from recovered patients.

HCATS, apceth Biopharma Form Strategic Manufacturing Agreements with bluebird bio

May 13, 2020

Hitachi Chemical Advanced Therapeutics Solutions and apceth Biopharma entered into long-term development and manufacturing services agreements for the clinical and commercial supply of multiple bluebird bio therapies.

Catalent, Arcturus Therapeutics Sign Vaccine Deal

May 05, 2020

Catalent will manufacture a mRNA-based COVID-19 vaccine for clinical trials and potential commercialization.

Initial US Patients Dosed in mRNA Vaccine Trial

May 05, 2020

Trial begins in the US for the Pfizer-BioNTech mRNA COVID-19 vaccine; manufacturing plans announced.

Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug

May 05, 2020

The companies have entered into a manufacturing agreement to supply leronlimab, an investigational new drug currently being used in clinical trial protocols for COVID-19.

FDA Updates Clinical Research Policy to Reflect COVID-19 Disruptions

March 20, 2020

FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.