FDA Law Blog

FEBRUARY 2, 2023

The law defines this term to mean “a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug.” Tobolowsky & Charles G. FDORA § 3209(a)(1). FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

Clinical Trials 64

Clinical Trials Clinical Trials In-Vivo In-Vitro 64

Pharmaceutical Technology

JUNE 21, 2023

Coya Therapeutics has expanded its patent estate for COYA 301 by entering a licensing agreement with UNeMed, the University of Nebraska Medical Center’s technology transfer office. Coya secured exclusive patent rights and intellectual property rights related to COYA 301 and combinations to treat Parkinson’s disease (PD).

In-Vivo 130

In-Vivo Immune Response Clinical Trials Clinical Trials 130

Drug Discovery World

NOVEMBER 9, 2023

Peter O’Callaghan, PhD, Head of Expression System Sciences, Biologics and Licensing, Lonza, on: ‘Solve bispecific heavy-light chain mispairing with bYlok technology’. Gail Calvert, Field Application Scientist, Sartorius UK, on: ‘Leveraging integrated and advanced technologies for successful cell line development’.

Engineer 52

Engineer Antibody Protein In-Vivo 52

Drug Discovery World

APRIL 25, 2024

For drug discovery and development, cell lines allow researchers to test the efficacy of therapeutics before moving into in vivo studies. It is a crucial for the development of biopharmaceuticals since they use a living host to produce the therapeutic in question.

Development 59

Development Protein In-Vivo Life Science 59

Drug Discovery World

OCTOBER 2, 2023

DDW’s Megan Thomas heard from attendees about their key takeaways from the event. Dr Mindy Miller, Lead Research Scientist, Terumo Blood And Cell Technologies Conversations and data shared at the CAR-TCR 8 th Annual Summit highlighted the importance of optimising the science behind the therapies to broaden patient access.

In-Vivo 105

In-Vivo Manufacturing Production Gene Therapy 105

The Pharma Data

OCTOBER 15, 2020

F4 Pharma — In order to help F4 Pharma advance its COVID-19 asset FX06 and to provide strategic guidance, F4 Pharma has appointed a scientific advisory board consisting of clinicians and scientists. The Advance awards recognize the work of remarkable global Australians making an extraordinary impact worldwide.

In-Vivo 52

In-Vivo Business Development Manufacturing Development 52

Drug Discovery World

AUGUST 4, 2022

Therefore, scientists unfortunately need to use many analytical technologies at the same time. Susan A Darling, Senior Director, CE and Biopharma, SCIEX and Todd Stawicki, Senior Global Marketing Manager, Biopharma, SCIEX examine advanced analytical technologies can help ensure that biopharma candidates are commercialisable.

Development 52

Development Protein Manufacturing Drugs 52