Algorithme Pharma | May newsletter
JULY 2013
NewsNEWS

Webinar - Last Chance to Register
11:00 AM EST - July 11, 2013
A Multiplexed Approach for Immunogenicity Assessment Using the New SQiDliteTM System: Case Study Analysis

In this webinar, we will be presenting a case study on Heparin-induced thrombocytopenia (HIT) antibodies developed in response to heparin, and its low molecular weight analogues using the SQI Diagnostics platform. This case study will illustrate the capabilities of the new SQiDliteTM system in assessing the immunogenicity of a wide variety of biologic therapeutics, which is required in safety and efficacy studies.

Click here to register for this webinar >>

The 505(b)(2) Approval Pathway

The 505(b)(2) pathway provides an accelerated timeline to approval for a wide range of new drug applications involving already approved drug molecules.

Algorithme Pharma has recently conducted more than 50 clinical trials for multiple 505(b)(2) targeted filings, where several have received Food and Drug Administration (FDA) approvals. Our most recent audit, in March 2013, successfully met all requirements in the FDA inspection of our clinical, bioanalytical and phamacokinetics units. With high quality 505(b)(2) trial conduct and individualized clinical program guidance, Algorithme Pharma continues to support sponsors in successfully navigating this development pathway.

Learn more >>

 
 
   Meet UsPOSTER PODCAST

First-in-Human (FIH) Clinical Program Design for New Entities: A Comparison Between the Traditional Linear Approach and the Integrated Multiple Parts Approach

Presented at the 2013 CSPS & CRS Annual Symposium

Severe impact of hemolysis on stability of phenolic compounds

Eugénie-Raphaëlle Bérubé, Marie-Christine Lacasse, Milton Furtado and Fabio Garofolo

Bioanalysis, 2013, 5 (12), Pages 1491-1499.

 
 
 
 
   Meet UsMEET US

4th JBF Symposium
August 2, 2013
Tokyo, Japan

Join Dr. Fabio Garofolo, VP Bioanalytical Services, who will be giving the following presentation: Challenges and Solutions in Large Molecule Quantification using LC-MS/MS,
August 5-6, Osaka, Japan August 7-8, Tokyo, Japan

ACCP
September 22-24, 2013
Bethesda, MD

SILS
September 26-27, 2013
Sherbrooke, QC

 
 
 

Contact us at 1 (450) 973-6077, 1 (888) 267-7449, or contact@algopharm.com
www.algopharm.com