Alta Sciences

AUGUST 28, 2023

We wish the team at Ischemix continued success on the next Phase of clinical research.” That is incredibly rewarding,” stated Dr. Morelli, MD, Chief Medical Officer and Principal Investigator for Altasciences. “We Altasciences helps sponsors get better drugs to the people who need them, faster.

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The Premier Consulting Blog

JUNE 18, 2023

A Modern Twist for the Gold Standard of Clinical Research The gold standard for clinical research intended for regulatory approval is the randomized controlled trial that compares an investigational drug candidate to either a placebo, active control, or standard of care (SoC).

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Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Alta Sciences

JULY 31, 2024

Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinical research.

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Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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The Anticancer Fund

JUNE 7, 2022

Gauthier Bouche & Pan Pantziarka Gauthier Bouche (MD) is Director of Clinical Research at the Anticancer Fund. His efforts are dedicated to collaboration with clinicians, researchers and patients groups to initiate clinical trials. You can easily subscribe to this newsletter by clicking here.

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Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

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Agency IQ

MARCH 1, 2024

Date Group Event Notable FDA Speakers February 28 TransCelerate Rapid RWD Analyses to Support Safety Signal Assessments February 28 White House Rare Disease Forum Julie Tierney March 1 Foundation Fighting Blindness PFDD Meeting on Dry Age-Related Macular Degeneration (Dry AMD) March 4 America’s Blood Centers 2024 Annual Meeting Peter Marks March (..)

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Drug Target Review

MARCH 25, 2025

With extensive experience in developing novel therapeutics, spanning discovery to clinical trials, he oversees both preclinical and clinical pharmacology of assets from Phase I to III.

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Drug Target Review

JANUARY 20, 2025

Basket Trials and the Evolution of Clinical Trial Design in an Era of Genomic Medicine. Journal of Clinical Oncology, 33 (9), 975977. Adaptive Clinical Trial Design in Oncology: An Overview. Clinical Pharmacology & Therapeutics, 86 (1), 97100. Barker, A. Food and Drug Administration. FDA.gov biotx.ai

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