Welcome to TIDES Tube
Redefining the Therapeutic Peptide Business in the 21st Century
Presenter: Rodney Lax, Ph.D., Business Consultant at PolyPeptide Group
The last 30 years has seen significant changes in our expectations for peptide therapeutics. While the peptide manufacturing industry has consolidated during that period, the complexity of the products themselves, the scale of manufacture, and number of potential delivery platforms have continually increased. Costs, quality and regulatory controls and the handling of IP are ongoing challenges. What is the status of the peptide therapeutic manufacturing industry today, what are the current threats and opportunities? How can we use the experience of the past to predict and prepare for the future?
Quark's Long History of Oligonucleotide Development
Presenter: Danny Zurr, Ph.D., Chairman and CEO at Quark Pharmaceuticals Inc.
This presentation provides an overview of Quark's pipeline, based on its long history in oligonucleotide development and its research activities into genes, novel concepts and technologies. Multiple programs were originated at Quark and progressed to advanced clinical studies including two Phase III projects, one Phase IIb project and two Phase II projects. A wealth of clinical experience has been gained from the dosing of 1,500+ patients at 150+ hospitals and Quark was the first to receive approvals in multiple geographies for these programs: USA FDA- siRNA systemic injection in humans, India - clinical studies, China- greenpath.
Mixed-Incretin Receptor Biochemical Signaling at Multiple Receptors
Presenter: Richard D. DiMarchi, Ph.D., Standiford H. Cox Professor of Chemistry at Indiana University
Glucagon, Glucagon-like Peptide-1 (GLP-1), and Glucose-Dependent Insulinotropic Polypeptide (GIP) are regulatory hormones responsible for maintaining control of metabolism. Each hormone possesses unique pharmacology. We have developed a series of novel peptides which exhibit high potency and balanced agonism across these three receptors that demonstrate superior, sustained efficacy in lowering body weight and glucose in animal models. These results have established the basis for several ongoing clinical studies with mixed-agonists.
Peptide Vaccines for Cancer: Recent Progress
Presenter: Bijan Nejadnik, M.D., Executive Vice President & Chief Medical Officer at Galena Biopharma
Peptide vaccines for cancer induce T cells reactive to well characterized tumor antigens and also enabling assessment of vaccination, by monitoring antigen-specific T cell responses. Cancer cells express peptide antigens recognized by CD8+ (CTL), which are typically 8-10 amino acids long and lead to significant immune response rates.
Treatment Opportunities for Cystic Fibrosis Using Aerosolized Antisense Oligonucleotides
Presenter: Shuling Guo, Ph.D., Director of Antisense Drug Discovery at Ionis Pharmaceuticals, Inc.
Cystic fibrosis (CF) is one of the most common life-threatening genetic diseases affecting ~30,000 people within US and ~70,000 worldwide. Lung disease is the major cause of morbidity and mortality in CF. Antisense oligonucleotides (ASOs) administered by aerosol delivery distribute broadly into many cell types in the lung with a long tissue half-life and negligible systemic exposure. In this presentation, I will discuss our recent progress in developing novel antisense therapies for the treatment of CF.
Personalized Medicine Patent Law Update
Presenter: Laura A. Labeots, Ph.D., J.D., Partner at Husch Blackwell
Brief summary of Subject Matter Eligibility of patents based on natural products (35 USC 101) will be presented, along with discussion of practical implications of developing case law surrounding personalized medicine and nucleic acid diagnostics and therapeutics. USPTO Interim Guidelines for nature-based products will be reviewed. Strategies for patent protection of nucleic acids will be provided. I will also include a brief discussion of the patent landscape for peptides.