Centre Mont Royal, Montreal, QC – June 10-13, 2014
Algorithme Pharma is a clinical contract research organization (CRO) with over 20 years of experience. We provide services for the pharmaceutical, biotechnology and generic drug industries.Click here to request a meeting.
Tuesday, June 10th – BUILDING OPPORTUNITY DAY, 1:30PM
Key Considerations for Efficient Development of New Molecular Entities (NME): Biotech and Clinical CRO Perspectives
With the recent changes in drug discovery and clinical models, collaborations between key stakeholders are critical for generating efficient development programs. This session will present several considerations from an early stage clinical CRO & Biotechnology perspectives which are used for developing new drugs and efficient trials. Design factors include sponsor objectives, regulations, type of compounds and timelines. However, additional factors such as study population, medical expertise, safety events and communication can have a significant impact on study conduct. A case study analysis will be used to discuss the development of efficient programs while accounting for key stakeholder collaborations and design considerations.
Marc Lefebvre, Vice-President, Scientific & Regulatory Affairs, Algorithme Pharma
Patrick Colin, Chief Development Officer, GI Care
Thursday, June 12th - Morning Session, 10:15AM
SESSION 7: New Trends in Mass Spectrometry for Drug Discovery & Development
Current Advancements in Large Molecule Bioanalysis by High Resolution Mass Spectrometry (HRMS)
Ligand binding assays (LBA) are a common approach to large molecule bioanalysis including the PK determinations of biologics and the measurement of biomarker concentrations in biological samples. However, during the last few years LC-MS has evolved as a reliable technique for the accurate quantitation of therapeutic proteins and large peptides in biological fluids by offering a valid alternate to LBA. Indeed, large molecule quantification using LC-MS is becoming a leading technique in the pharmaceutical and biotechnology industries. LC-MS instead of LBA in quantification of biologics has many advantages such as no need for high affinity reagent; uniform approach; large linear range; higher selectivity and well accepted by Regulatory Agencies. It is commonly performed by using tryptic digestion, then purifying and detecting one or more small signature peptides by triple quadrupole instruments. However, sometimes, triple quadrupoles are not specific enough for the signature peptides quantification coming from large molecules due to high background noise, unspecific fragmentation, unacceptable variability, lack of selectivity to eliminate isobaric interferences, need for long cleanup and chromatography. In the past, High Resolution Mass Spectrometry (HRMS) had limitations in terms of sensitivity, linear dynamic range and speed, to fulfill the need for reliable quantification in bioanalysis. However, the new generation of HRMS is able to overcome these limitations and it could become “the ultimate tool for large molecule bioanalysis.” With increasing demand in biotherapeutics/biologics programs in pharmaceutical industry, HRMS opens new opportunities for quantification of peptides and proteins in biological samples during pharmacokinetic studies. The wide scan range on HRMS instruments is advantageous for intact peptide or protein quantification and these instruments are able to increase the selectivity while maintaining sensitivity. This presentation will focus on describing the main challenges and provide practical solutions on protein and peptide quantification in a regulated environment with and without tryptic digestion by HRMS. Multiple concrete case studies of increasing complexity will be presented and advantages of HRMS versus triple quadrupoles demonstrated for Large Molecules bioanalysis.
Fabio Garofolo, Vice-President Bioanalytical Services, Algorithme Pharma