Alta Sciences

JANUARY 23, 2024

“James’ proven leadership skills, and deep knowledge of all phases of clinical research, will be invaluable in delivering expert guidance for our clients along their early-phase clinical journey,” said Ingrid Holmes, Vice President, Clinical Operations, Altasciences.

Clinical Pharmacology 40

Clinical Pharmacology Clinical Trials Clinical Research Pharmaceuticals 40

Drug Target Review

MAY 7, 2024

Small patient populations often result in difficulty in determining a significant effect of a therapy, given the low confidence power associated with the statistics. In 2020, 78 percent of orphan drugs and biologics approved were targeted therapies.

Disease 59

Disease Clinical Trials Clinical Pharmacology Trials 59

The Pharma Data

OCTOBER 1, 2021

Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. People with psoriasis report an impression on their emotional well-being, straining both personal and professional relationships and causing a reduced quality of life.

Disease 52

Disease Laboratories Clinical Pharmacology Treatment 52

Agency IQ

FEBRUARY 2, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes January 31 Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement Meeting February 12 Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment Notice February 12 Advanced Manufacturing (..)

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

MARCH 1, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes Request for Information February 29 (Extended) Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments Draft Guidance March 11 Advanced Manufacturing Technologies Designation Program Draft Guidance March (..)

FDA 40

FDA Science Clinical Trials Regulations 40

Alta Sciences

AUGUST 28, 2023

There are no TBI-specific therapies approved for the treatment of patients suffering brain injury, yet it is estimated that in the U.S. We wish the team at Ischemix continued success on the next Phase of clinical research.” We are proud to support Ischemix in advancing this vital new therapy.”

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. As a direct consequence, in silico methods in human clinical trials are emerging as an important new paradigm in the development of medical therapies – particularly useful for rare diseases.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52