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Forensic Science

  • Approval and access: Overcoming the final hurdle of drug development Approval and access: Overcoming the final hurdle of drug development Professor Luca Pani, University of Miami, Angelika Joos,MSD (Europe) Inc. Ana Palma, Sobi, Belgium Mar 10 2017 11:00 am UTC 75 mins
    2017 is once again a year of significant change for pharma market access in Europe, with affordability on the agenda for almost every country in the region. There is a move toward greater collaboration in health technology assessment and more transparency between countries for pricing, therapeutic protocols and and details of negotiations with drug manufacturers. We also see member states working to understand the process of enabling cost-effective patient access to personalised and high-cost treatments, such as new oncology combination therapies, antibiotics and stem cell therapies, which offer the promise of efficacy in key disease areas.

    With market access being referred to as the “fourth hurdle” in drug development (beyond efficacy, safety and quality), it is vital that the requirements for both approval and access are addressed early in the process. Parallel scientific advice from HTA bodies and regulators is increasing to deliver tangible and successful strategies, but is the process smooth enough to overcome the challenges from both sides?

    pharmaphorum in partnership with DIA will be hosting an expert panel debating the best way forward for life sciences companies, payers and providers in this emerging European market access paradigm.

    Join our webinar to hear from experts in industry and healthcare discussing the challenges and solutions of access in the changing European market.
    Topics up for discussion include:
    •Integrating HTA and regulatory strategy – the best way forward
    •Regional variation and implication – how to efficiently and effectively navigate EU market access
    •Proving value – how to leverage real world evidence to meet increasing demands for observational data
    •Future proofing market access – how to improve upon evidence generation and use technology effectively and competitively
  • New CE marked Testosterone Serum Calibrator Kit for In-Vitro Diagnostic Testing New CE marked Testosterone Serum Calibrator Kit for In-Vitro Diagnostic Testing Derrell Johnson, Innovation Manager Reference Materials - Life Science Business of Merck KGAa Darmstadt, Germany Mar 15 2017 3:00 pm UTC 45 mins
    The use of calibrators in an analytical method is important to ensure measurement accuracy and traceability and instrument reliability. The major challenges with testosterone testing by LC-MS/MS typically involve achieving consistency in performance and accuracy of results at low levels found in women and children across different laboratories. This lecture presents the new CE marked testosterone serum calibrator kit for in-vitro diagnostic (IVD) from Merck KGAa Darmstadt, Germany . It is for use in LC-MS/MS testosterone testing methods. Mr. Johnson will highlight the unique features and benefits of this regulatory cleared Certified Reference Material as a calibrant for standardization of laboratory LC-MS/MS testosterone methods.
  • Precise Cell Volume Analysis Precise Cell Volume Analysis Elena Lazarova, M.D. Mar 15 2017 6:00 pm UTC 60 mins
    In this webinar, Elena Lazarova, M.D., esteemed clinical biology specialist, researcher and speaker, will discuss the value of precise cell volume measurement in differentiating for blood disorders and its importance in effective patient care. Gaining information about cell volume at different stages in the maturation process provides important insight into a patient’s underlying pathology and may have added value in the diagnosis of blood disorders. Beckman Coulter offers precise cell volume measurement* through the advanced technology and sophisticated algorithms of its uniquely designed DxH 800 hematology systems.

    After the webinar, you will be able to:

    • Cite the challenges laboratories face in differentiating for rare types of anemia
    • Outline the benefits of flow cytometric reticulocyte analysis, available on the DxH 800 platform
    • Understand the value of precise cellular volume measurement* to aid in the differential diagnosis of anemia

    *For research use only and not cleared by the FDA for clinical diagnosis
    **P.A.C.E. credit is available for your participation.

    Presenter:
    Dr. Elena Lazarova earned her M.D. degree from the Medical University of Varna, Bulgaria, in 2002. With over 10 years of experience in clinical and laboratory hematology, immunohematology and transfusion medicine, Dr. Lazarova is a highly sought-after teacher and lecturer. She has authored/co-authored seven medical journal articles and has served as primary author on 17 poster and oral presentations at congresses throughout the world. Dr. Lazarova continues her work in laboratory medicine, focusing on hemoglobinopathies and red blood cell pathologies (hereditary spherocytosis and autoimmune hemolytic anemia) in laboratories at Hôpital Erasme in Brussels.
  • Sanger Arrayed CRISPR Screening in partnership with Evotec Sanger Arrayed CRISPR Screening in partnership with Evotec Dr. Hauke Cornils-Res Scientist, Evotec & Shawn Shafer-Dir. Advance Genomics Life Science Business of Merck KGaA, Darmstadt, Mar 16 2017 3:00 pm UTC 75 mins
    CRISPR Cas9 nucleases have revolutionized the field of gene editing and high-throughput lentiviral screens continue to hold ever-increasing promise for both basic research and development of future therapies to benefit human health. Even with such powerful technologies at hand, researchers new to the field may find the screening of multiple targets to be challenging and time-consuming. This webinar discusses the Evotec partnership with Life Science Business of Merck KGaA, Darmstadt, Germany and the screening services for drug discovery.
  • CE marked Testosterone Serum Calibrator Kit for In-Vitro Diagnostic Testing(DE) CE marked Testosterone Serum Calibrator Kit for In-Vitro Diagnostic Testing(DE) Dr. Norman Hardt, Product manager Reference Materials - Life Science Business of Merck KGAa Darmstadt, Germany Mar 29 2017 2:00 pm UTC 60 mins
    **This webinar will be presented in German**

    The use of calibrators in an analytical method is important to ensure measurement accuracy and traceability and instrument reliability. The major challenges with testosterone testing by LC-MS/MS typically involve achieving consistency in performance and accuracy of results at low levels found in women and children across different laboratories. This lecture presents the new CE marked testosterone serum calibrator kit for in-vitro diagnostic (IVD) from Merck KGAa Darmstadt, Germany . It is for use in LC-MS/MS testosterone testing methods. Dr. Hardt will highlight the unique features and benefits of this regulatory cleared Certified Reference Material as a calibrant for standardization of laboratory LC-MS/MS testosterone methods.