Alta Sciences

MARCH 4, 2025

The CCALC is a grassroots organization that was founded by several pharmaceutical industry members seeking clarity around the conduct of abuse and dependence potential assessments for novel drugs in development. I have spent the better part of my career working to make drugs safer.

Clinical Trials 52

Clinical Trials FDA Drug Development Trials 52

Drug Target Review

MAY 23, 2023

Algae – an overlooked resource for new therapies It is only in recent years that algae research has expanded beyond their potential for producing biodiesel, to also consider them as a bio-resource, not only for novel prebiotics but also for compounds with unique structures and pharmaceutically relevant bioactivities. 7 (Suppl 2), S4 (2005).

Drugs 75

Drugs Small Molecule Production Disease 75

Alta Sciences

OCTOBER 9, 2024

Dr. Setnik made the list of 100 honorees for her hands-on leadership and nearly 20 years of experience in clinical drug development, with a focus on abuse potential studies. Each winner represents the transformative impact of the pharmaceutical industry in their own unique way.

Clinical Pharmacology 40

Clinical Pharmacology Drug Development Science Clinical Trials 40

The Pharma Data

DECEMBER 15, 2020

TOMI-T1D is an international partnership between academia, the pharmaceutical industry and nonprofit organizations. The project also seeks to engage the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory endorsement of such drug development tools.

Drug Development 40

Drug Development Clinical Trials Trials Vaccine 40

Drug Target Review

APRIL 9, 2024

In 2005, he joined CNIO to lead the Genomic Instability Group where he has been ever since. Initial works from the lab concentrated on exploring the role of replicative stress in cancer and ageing, for which the group combined cell biology, mouse models and drug development projects.

RNA 64

RNA Cell Biology Clinical Development Disease 64

FDA Law Blog: Drug Discovery

JUNE 11, 2023

Clissold — In May 2023, CDER and CBER published a draft guidance titled “Pediatric Drug Development: Regulatory Considerations – Complying with the Pediatric Research Equity Act [“PREA”] and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act [“BPCA”]” (the “Draft Guidance”).

FDA 40

FDA Drug Development Production Drugs 40

Codon

APRIL 9, 2024

It was only in 2005, after the emergence of widespread resistance of P. falciparum to monotherapy with conventional drugs like chloroquine and sulfadoxine-pyrimethamine, that the WHO recommended treating malaria with drugs in combination with artemisinin. Meanwhile, on the other side of the Pacific, the U.S.

Drugs 139

Drugs Science Research Doctors 139