Event Archive

11.15.2017 - 11.17.2017

EBF Open Symposium

EBF was founded in 2006 at the initiative of 12 pharmaceutical companies, all of them having bioanalytical lab activities in Europe. The goal of bringing these companies together was to implement a platform for discussions of science, day-to-day procedures, business tools, technologies and last but not least regulatory issues. Until 2010, EBF membership was limited to companies involved in bioanalytical activities in a pharmaceutical research and development environment in Europe. From 2011 onwards, the EBF welcomed CROs involved in bioanalytical activities in a pharmaceutical research and development environment in Europe. Currently, the EBF counts 51 members (October 2015). Since 2010, the EBF became a non-profit organisation (vzw) established pursuant to the Belgian Act of 27 June 1921 on non-profit associations, international non-profit associations and foundations.
See Event Info
Convention AAPS Annual Meeting 2017
11.12.2017 - 11.15.2017

AAPS Annual Meeting 2017

The 2017 AAPS Annual Meeting and Exposition programming will focus on five themes:

Advanced Formulation Characterization Approaches
Patient-Centered Innovations in Healthcare Technology
Products for Pediatrics: It’s Not Child’s Play
Improving Inter-organization Collaboration
Cancer Moonshot: Emerging Modalities for Oncology

Each theme will spotlight a keynote speaker expected to outline the broad goals of the thematic programming and identify key scientific areas that will be addressed during the meeting.
See Event Info
Convention GPhA Fall Technical 2017
11.6.2017 - 11.8.2017

GPhA Fall Technical 2017

The Association for Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association (GPhA), is the nation’s leading trade association for manufacturers and distributors of generic prescription drugs, manufacturers of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic industry.
See Event Info
Webinar WEBINAR: Pre-existing antibodies within clinical samples: How does this affect immunogenicity outcomes?
10.19.2017

WEBINAR: Pre-existing antibodies within clinical samples: How does this affect immunogenicity outcomes?

Pre-existing antibodies in treatment-naïve subjects have been often detected during clinical ADA assessments. However, limited information on prevalence, physiological effect, and impact on post-treatment ADA induction is available. This presentation will address pre-existing antibody characterization and implications for immunogenicity management and strategies during clinical studies.

See Event Info
Convention World ADC 2017
9.20.2017 - 9.22.2017

World ADC 2017

The 8th World ADC San Diego is the industry’s longest standing and most comprehensive antibody-drug conjugate conference.

The value that this leading ADC event provides you is the power of insight and the connections to develop more clinically impactful ADCs.
See Event Info
Convention Applied Pharmaceutical Analysis
9.18.2017 - 9.20.2017

Applied Pharmaceutical Analysis

Our organizers have gathered another excellent group of speakers for the annual APA & APS conferences. The program is arranged to incorporate extensive audience participation and discussion. We encourage attendees to take full advantage of the opportunity to engage in discussion in order to receive the maximum benefit from the APA & APS experience.
See Event Info
Convention Contract Pharma
9.14.2017 - 9.15.2017

Contract Pharma

The 16th Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 14-15, 2017 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 14th provides the perfect venue for easy, informal discussions for manufacturing, packaging, laboratory services and more! The tabletop exhibition will be held one day only on Thursday, September 14th with an additional half day of sessions held on Friday, September 15th.
See Event Info
Webinar WEBINAR: Outsourcing Analytical Testing for Biologics from a CRO point of view!
8.31.2017

WEBINAR: Outsourcing Analytical Testing for Biologics from a CRO point of view!

Biologics are large molecules with inherently complex structural heterogeneity. Thus, the analytical tests to support CMC (Chemical, Manufacturing and Controls) activities of biologics need to be highly sophisticated to reveal the multifaceted quality attributes. As biopharmaceutical companies are increasingly outsourcing analytical testing to CROs (contract research organizations), the paradigm has shifted for CROs from merely being a pair of extra testing hands to problem-solvers. The new trend is driving CROs to hire top-tier scientists to provide expert solutions for clients with in-depth characterization of the quality attributes. This analysis is performed using cutting edge technologies for structural elucidation, post-translation modification, and degradation pathways, etc. In the meantime, the modalities of biologics are becoming more and more complex, such as antibody drug conjugates, PEGylated proteins, conjugate vaccines, fusion proteins, and gene and cell based therapies. In light of this complexity, biopharmaceutical and biotech companies are demanding innovative and creative solutions from CROs.

The advent of revolutionary technologies offers new instruments to advance analytical science. Many analytical methods are rapidly evolving. For example, high-resolution mass spectrometry enables top-down, or middle-down approaches to characterize structure and modification of the macromolecules, in addition to traditional bottom-up peptide mapping; the workflow for N-linked glycan analysis is integrated with highly active PNGase F and a novel probe for both fluorescence and mass detection, while new endoglycosidase for O-linked glycan is becoming commercially available; capillary electrophoresis is replacing traditional slab gel for SDS-PAGE, IEF and Western blotting. Advances in instrumentation for surface plasmon resonance (SPR) and bio-layer interferometry (BLI) techniques make it feasible for routine testing of receptor binding kinetics. In addition, the Solo VPE technologyenables direct and neat determination of protein concentration without the need for sample dilution and thus received rapid acceptance in the biopharmaceutical industry when it was introduced.

At the center of the field, regulatory agencies have provided specific guidelines for large molecule analytical testing. In the "Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use" document, the US Food and Drug Administration (FDA) requires that "a precise and thorough characterization of antibody structural integrity, specificity, and potency should be conducted and described in the IND." While the guidance pertained specifically to monoclonal antibody products for human use, it can be applied to all other biologics in general. In July 2017, FDA issued the guidance for "Analytical Procedures and Methods Validation for Drugs and Biologics", which complements the International Conference on Harmonisation (ICH) guidance Q2(R1), "Validation of Analytical Procedures: Text and Methodology Q2(R1)" for developing and validating analytical methods. The guidance provided general requirements for analytical procedure development and validation using statistical tools, for example, analysis of variance (ANOVA) to assess regression analysis.

In response to the demand from biopharmaceutical and biotech companies, as well as the regulatory agencies, CROs also need to modernize the analytical capabilities to support clients and solve the most challenging problems for large molecules, as well as provide service for release and stability testing. This webinar will provide the audience with a general explanation of how CROs can support biologics testing, ranging from product release and stability to in-depth structural elucidation and degradation pathway studies.

Click here for More Information: http://xtalks.com/Outsourcing-Analytical-Testing-Biologics-CRO.html
Click here to REGISTER: https://register.gotowebinar.com/register/1041119148838122243
See Event Info
Convention American Chemical Society National Meeting & Exposition
8.20.2017 - 8.24.2017

American Chemical Society National Meeting & Exposition

ACS National Meetings are where chemistry professionals meet to share ideas and advance scientific and technical knowledge. By attracting thousands of chemical professionals, the meeting provides excellent opportunities for sharing your passion for chemistry, connecting with the world’s largest scientific society, and advancing your career in this ever-changing global economy.
See Event Info
Convention 2017 BIO International Convention
6.19.2017 - 6.22.2017

2017 BIO International Convention

There’s no better place to connect with biotech’s top people and most innovative technologies than at BIO 2017. The ideas shared here go beyond professional development. Experience powerful business partnering, benefit from invaluable education sessions and network with 16,000+ of the industry’s brightest.
See Event Info