Download: Presentation ‘Exploratory ‘First in Man’ Studies: Planning to Fail, or to WIN?’

Lewis B. Kinter, Ph.D., Senior Director: Regulatory Toxicology, and Head Toxicological Operations, Safety Assessment (US), AstraZeneca Pharmaceuticals, spoke at last year's Exploratory Clinical Development World. I thought you might be interested in downloading his presentation on ‘Exploratory ‘First in Man' Studies: Planning to Fail, or to WIN?' for free. Download the presentation here. The presentation includes: – Reasons for development …

Download: Presentation “Exploring valuable tools to accelerate CNS product Development”

Massimo Bani, Global Head Clinical Pharmacology, UCB Pharma SA, spoke at last year's Exploratory Clinical Development World Congress. I thought you might be interested in downloading his presentation on ‘Exploring valuable tools to accelerate CNS product Development: steps towards a mechanistic prediction' for free. Download the presentation here. The presentation includes:–  Novel approaches in psychiatry, developing suitable    paradigms to …

Another example of how #biomarkers can rescue the pharma pipeline and support drug value– The story of Amgen’s MAb and Roche’s Avastin

Amgen had put aside the monoclonal antibody, rilotumumab, which was being developed for the treatment of gastric cancer and is an Ab for the hepatocyte growth factor (HGF). The experimental biologic was acquired in the Immunex purchase for $16 billion in cash and stork in 2001, but because of concerns in improvements in survival the project was put aside. The …

A look at early #cancertreatments in the news this month

Phase II clinical data on Agenus' HSPPC-96 vaccine (also known as vitespen) was just announced at the 80th American Association of Neurological Surgeons Annual Scientific Meeting. The study focused on more than 40 patients suffering from Glioblastoma multiforme (GBM) the most common and most aggressive of the brain cancer known as gliomas. The cancer is difficult to treat and most …

Abbott’s oral Hep C drugs ABT-450 and ABT-333 bring some exciting news in Phase II.

  In a presentation released at the European Association for the Study of the Liver (EASL) meeting, a combination regimen including the oral drugs ABT-450 and ABT-333 resulted in cure rates of over 90% in 50 patients which had previously been untreated. Quite remarkable results indeed and larger mid-stage trials using various combinations of the experimental drugs are now underway. …

Promising HIV treatments in early development – Part 2

  With our Exploratory Clinical Development World Europe conference fast approaching (22-24 May), I thought I would continue to touch on some of the interesting HIV treatments which have passed through Phase IIa and now entering later stage studies: Entry Inhibitors BMS-663068 – This early experimental drug demonstrated good antiviral activity in phase 2a, with the results announced at the …

What does disappointing results of Gilead’s oral Hep C drug mean for early development in direct-acting antivirals?

GS-7977 was the major asset behind Gilead's $10.8billion acquisition of Pharmasset last year and was at the forefront of big pharma's bet in this field. The megablockbuster prospect of a next-gen oral therapy to quell the hep C virus without the use of interferons (which have well-described side-effects – fatigue, influzena-like symptoms, hematologic abnormalities and neuropsychiatric symptoms) is something that …