Safety Biomarkers in Drug Development

Event Overview

The issue of drug safety has never been higher on the agenda of the Food and Drug Administration (FDA), EMEA and other global regulatory agencies. As a result of the Vioxx case and several high-profile product recalls in recent years, fears about serious adverse events are increasing. One of the major reasons for the decline in new regulatory approvals is clearly due to hesitancy surrounding the lack of sufficient clinical evidence of safety. Biomarkers are increasingly being seen by regulators as helping to provide the clarity, predictability, and certainty that they require and increase their confidence in decision making. New discoveries in traditional areas of biomarker research based on physiology and pathology are being made almost daily. Furthermore, genomics and proteomics-based biomarkers are making great progress in being able to predict possible adverse-events before they occur, rather than purely diagnosing negative reactions only after they have happened.

Drug development companies are investing heavily and spending more time on biomarker research and development than ever before. The ability to accurately predict adverse events related to areas like cardiology, nephrology, neurology, haematology and hepatology is extremely exciting. Validated safety biomarkers provide the opportunity for smarter and earlier decision making in R&D, meaning project „kill“ decisions are made quicker, later-stage projects become less risky and hundreds of millions of dollars can be saved.

Although, although great strides have been made in predictive biomarkers in recent years, the industry is still far away from developing a complete and accurate range of safety tests. This conference will summarise what are the most innovative recent scientific developments and the most promising regulatory initiatives, as well as providing a platform for partnering amongst the pharma, biotech, diagnostics and academic sectors. Furthermore, the networking opportunities will be strong as attendees will be a unique mix of senior drug safety and regulatory executives, as well as scientific-focused clinical, biomarker and academic experts. This event will be a great chance to pool knowledge and expertise and take safety biomarker research to the next level.

Why Attend?

• Understand the regulatory requirements to demonstrate safety through biomarkers.
• Make partnerships and alliances with biomarker R&D experts.
• Gain access to the latest successful biomarker development case studies.
• Review multi-stakeholders perspectives: pharma, regulators, research institutes, academia & solution providers.
• Learn how to integrate biomarker knowledge in monitoring safety in drug development to reduce risk.
• Identify and understand better, advanced cardiac, renal, hepatological and neurological risk markers.
• Discover cutting-edge approaches for identification and development of new markers.

Who will benefit:

Pharmaceutical, Biotech, Diagnostic & Academic research organisations:
CEOs / Vice-Presidents / Heads / CSOs / Managers / Professors and Scientists involved in: R&D, drug safety & pharmacovigilance, biomarker discovery/validation, molecular diagnostics, pharmacogenomics/genetics/proteomics, translational medicine, clinical science and development, molecular imaging, pre-clinical development, modeling and simulation, pharmacology, pharmacokinetics/pharmacodynamics

Solution providers & consultants:
CCEOs, Business Development, Senior Consultants, Regional Heads

Your Prestigious Speaker Panel

A more detailed list of speakers’ names is available on the downloadable agenda. Please "request event agenda" below. 

Contact Details:

Tel: +421 232 662 621
Fax: +421 232 662 622
Email: clinical@nextlevelpharma.com