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Program

 Preliminary Program—Now Available!

Program Themes

The 2017 National Biotechnology Conference will feature sessions in five themes that examine science from multiple perspectives:

Bioanalysis and Biomarkers

The generation of bioanalytical information is an integral part in the development of biotherapeutics. Bioanalytical methods offers qualitative and quantitative identification, as well as determination of biomarkers. Bioanalysis and the characterization of biomarkers can be extremely challenging from an analytical, logistical, and compliance standpoint. This theme will cover different bioanalytical methodologies, as well as the interpretation of bioanalytical information. Scientific, regulatory, logistical, and strategic aspects of PK, ADA, and use of biomarkers within translational research will be discussed. This theme will also discuss soluble target engagement, receptor occupancy, biomarkers used as surrogates of drug-drug interactions and biomarker assay development.

Biosimilars

The scientific and regulatory path of Biosimilar drug approval is rapidly evolving. With several biosimilar submissions and approvals in recent years, the successes and challenges of biosimilar development are becoming apparent. This theme is designed for individuals who are developing biosimilars, and are willing to share their experiences (both successes and challenges) in developing a biosimilar. Some areas of interest for this theme are; the analytical characterization, safety assessments both non-clinically and clinically, bioanalytical assay formats, and clinical plans/strategies towards the totality of evidence

Emerging Topics

The tremendous progress in technology, biology, and pharmaceutical sciences provides a great potential in pharmaceutical research and development, and is a driving force in developing new drugs as well as improving patient outcomes and increasing patient access to medicine. From a career standpoint, staying abreast of new innovations in pharma can be extremely beneficial, therefore the Emerging Topics theme is designed to help you adapt to change, seize new opportunities, and focus on developing the skills you need the future. The Emerging Topics theme will explore how biology, technology, and pharmaceutical science become ever more closely intertwined. We will develop programs on topics like, precision medicine, targeted therapies tailored to the genetic makeup of individual patients, role of immune system to treat cancer, drug metabolizing genes, and a role of microbiome and metagenome function in health and disease. This theme will also focus on topics with a significant impact on pharmaceutical industry and health care including recent trends in clinical trials and translational medicine.

Formulation Development, Drug Delivery, and Manufacturing

The Formulation Development and Drug Delivery theme will focus on CMC issues, delivery aspects, and challenges related to the development of current and emerging biologics

Novel Therapeutic Constructs and Modalities including Immunotherapies

Beyond the “traditional” monoclonal antibodies, growth factors, and cytokines, this theme includes all topics related to the development of novel therapeutics such as multi-armed mAb-based constructs, probodies, millamolecules, oligonucleotides, T-cell receptor bispecifics, viral gene delivery vectors, autologous T-cell constructs (CAR-T), and alternative scaffolds based on endogenous molecules (DARPins, Adnectins, etc).

Workshops

Short Courses

  • Short Course 1: LC-MS Based Biomarker Assays in Precision Medicine–Discovery to Validation
  • Short Course 2: Understanding and Predicting Immunogenicity by a System Biology Approach