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TIDES: Oligonucleotide and Peptide Therapeutics from Research through Commercialization

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Access the hottest fields in therapeutics by attending TIDES - the only event with full coverage of discovery, development and manufacturing

May 03-06, 2015
Town and Country Resort Hotel
San Diego, CA

Speaking Opportunities

Speaking Opportunities

If you are working in any of the following scientific areas, we encourage you to submit a speaker proposal by Friday, October 31, 2014 for a podium presentation. We are looking for case study data and practical applications of manufacturing/CMC technologies, analytical methods and regulatory strategies OR clinical results and discovery/preclinical strategies in the 4 tracks below. Coverage of discontinued projects with lessons learned would also be very beneficial to this audience.

To submit a presentation for consideration, please click the corresponding link below and provide a description of the proposed presentation's content by Friday, October 31, 2014.

If your talk is accepted, you will receive a formal invitation to speak at the conference. This invitation will reflect a deadline for you to send a final presentation title and 60-word abstract. Your abstract and presentation must describe scientific results and must not contain marketing or business development content.

For questions about submitting a speaker proposal, please contact:

Michael Keenan
Project Manager and Producer
IBC Life Sciences
mkeenan@ibcusa.com

Scott Wallask
Conference Producer
IBC Life Sciences
swallask@ibcusa.com

Oligonucleotide Manufacturing Technology, Analysis, CMC & Regulatory

  • Practical manufacturing examples, novel synthetic technologies and scale-up: validation approaches (synthesis, purification, Qbd), chiral vs. achiral
  • Novel delivery approaches & challenges, oligo conjugation, nanoparticles, applying the delivery toolbox, peptides to deliver oligos, lipid-based delivery, PEGylation
  • Analytical characterization and formulation strategies for more complex molecules: conjugates, aggregation, higher order structure, stability, degradents, impurities, etc.
  • Raw materials and impurities: method validation, harmonization of amidite control, how to control raw materials for conjugates, vendor qualification
  • CMC and quality: case studies from development through successful commercialization
  • Regulatory/tox perspectives on CMC challenges, impurities, biosimilar peptides, Qbd
  • Drug product and formulation: case studies and challenges
  • Anatomy of an IND: from discovery to CMC in the context of regulatory requirements
  • Process optimization and process validation strategies

» Submit a presentation proposal

Peptide Manufacturing Technology, Analysis, CMC & Regulatory

  • Practical manufacturing examples: novel synthetic technologies ,scale-up, validation (of synthesis, purification, Qbd); chemical vs. recombinant, generic, long or biocidic peptides
  • CMC case studies from development through successful commercialization
  • Alternative peptide delivery/formulation: conjugation, pulmonary, transdermal/microneedle, nasal, particle delivery, PEGylation and immunogenicity, long-release methods
  • Oral peptide delivery and new dosage forms -how to develop more "conventional" formulations
  • Analytical, characterization and stability and aggregation of complex peptides
  • Supply chain control, raw material validation, building blocks, methods and QC, vendor qualification
  • Regulatory perspectives: impurities, biosimilar peptides, Qbd approaches
  • Conjugation: peptide linkers, peptide-oligo conjugates, ADCs w/peptide toxins & bioconjugates
  • Anatomy of an IND: from discovery to CMC in the context of regulatory requirements
  • Process optimization and process validation strategies

» Submit a presentation proposal

Oligonucleotide Discovery & Clinical Development

  • Clinical updates and translational strategies: connecting clinical results to regulatory realities
  • Novel discovery/preclinical platforms and emerging modalities: PNAs, aptamers, morpholinos, spherical nucleic acids, oligo-peptide conjugations, exon skipping
  • CRISPR and genome editing: therapeutic applications and discovery strategies
  • Oligonucleotides for underserved indications and difficult targets: cancer, CNS, non-coding RNAs
  • Oligonucleotide distribution and mechanisms of action/delivery
  • Understanding RNAi mechanisms and siRNA developments (orphan designations)
  • Novel chemical modification strategies for oligonucleotides
  • Bioanalytical strategies, DMPK and safety of oligonucleotide therapeutics
  • Oligonucleotide targeting beyond the liver: tissue, tumor and cell-specific targeting
  • Novel oligonucleotide applications : molecular diagnostics, agriculture, ebola virus, DNA storage, nanostructures

» Submit a presentation proposal

Peptide Discovery & Clinical Development

  • Clinical peptide updates and novel peptide NCEs : lessons learned
  • New therapeutic indications for peptides: IBS, endocrinology, ophthalmology, immunotherapy, oncology, infectious diseases, neurological disorders, obesity
  • Peptide biomarkers for therapeutic and diagnostic applications
  • Discovery/preclinical and hit finding for drug-like peptides: complex peptides, glycopeptides, conjugates, peptide modifications
  • Peptide therapeutics for intracellular delivery, "undruggable" and difficult targets, BBB
  • Emerging peptide scaffolds and evolving physicochemical properties: non-natural cyclic, macrocyclic peptides, cell permeation, substituted amino acids, stapling/bridging
  • Bioanalytical methods and DMPK of peptide therapeutics
  • Approaches to improve oral bioavailability
  • Peptide vaccines and vaccines cocktails: hurdles to overcome and lessons learned
  • New frontiers in peptide development: biomaterials, surfactants, cosmetic applications, anti-fouling agent

» Submit a presentation proposal