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WEDNESDAY, MAY 7
8:00 am Registration and Morning Coffee
8:30 Chairperson’s Remarks
Andrea Leone-Bay, Ph.D., Vice President, Pharmaceutical R&D, MannKind Corp.
8:35 FEATURED PRESENTATION: Translational Nano-Medicine: Targeted Therapeutic Delivery for Cancer and Inflammatory Diseases
Mansoor M. Amiji, Ph.D., Distinguished Professor and Chairman, Department of Pharmaceutical Sciences, School of Pharmacy, Northeastern University
This presentation will focus on the development of multifunctional nanoparticle systems for targeted therapies in the treatment of cancer and inflammatory diseases. Specific examples will address the development of combinatorial-designed nano-systems for tumor drug resistance, anti-inflammatory gene therapy strategy for the treatment of rheumatoid arthritis, and oral RNAi approach for the treatment of inflammatory bowel disease. In each project, there is strong emphasis on use of safe materials and scalable fabrication methods to facilitate clinical translation.
9:10 Evolution of Targeted Delivery Technologies: Past, Present and Future
Ramin Darvari, Ph.D., Principal Research Scientist II, Novel Delivery Technologies, Pfizer, Inc.
The desire for improved safety and efficacy of pharmaceuticals has inspired the targeted delivery approaches. In this presentation, the advancement and new frontiers in targeted delivery technologies will be discussed.
9:40 Bioengineered Nanomaterials in Immunotherapy
Marian Gindy, Ph.D., Director, Pharmaceutical Sciences, Merck Research Laboratories
A wide range of bioengineered nanomaterials have been developed for use in diagnostic and therapeutic applications. By virtue of their size, nanomaterials possess unique properties that facilitate more productive drug delivery to disease cells. In cancer immunotherapy, bioengineered nanomaterials are being combined with tumor antigens to improve antigen stability, tumor penetration, and targeting properties. They are also explored for their antigenic properties as immune stimulating agents. Here, nanomaterial-based opportunities in cancer immunotherapy are discussed.
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
10:45 A Simple Approach to Biologics Delivery: Oral Inhalation Isn’t Just for Pulmonary Disease
Kelly Kraft, Ph.D., Director, Pharmaceutical R&D, MannKind Corp.
Dry powder formulations based on advanced particle engineering and patient-friendly, breath-powered inhalation devices have been integrated to simplify drug delivery by oral inhalation. This approach expands this route of delivery beyond pulmonary disease. These technologies will be exemplified for new biologics product development and life-cycle management in the therapeutic areas of diabetes, pain, and obesity.
11:15 Getting Proteins across the Skin – What Works
Ajay K. Banga, Ph.D., Professor and Department Chair, Pharmaceutical Sciences, Endowed Chair in Transdermal Delivery Systems, College of Pharmacy, Mercer University
Hydrophilic macromolecules like proteins do not normally pass through the skin unless enabling technologies are used. Some of the enabling physical enhancement technologies include iontophoresis, phonophoresis, or the various skin microporation approaches. Recent innovations in these technologies, especially for iontophoresis and microneedles, will be presented. Application, limitations, challenges, and commercialization of these technologies will be discussed.
11:45 Safe and Stable Peptide Nanomedicines Targeted to Treat Rheumatoid Arthritis, Acute Lung Injury and Diabetes
Hayat Onyuksel, Ph.D., Professor of Pharmaceutics and Bioengineering, Department of Biopharmaceutical Sciences, College of Pharmacy, University of Illinois
Delivery of peptide drugs is challenging due to their side effects and short half-life. This presentation will demonstrate how these problems can be overcome using sterically stabilized phospholipid micelles (SSM) as nanocarriers for peptide drugs. Peptides (VIP, GLP-1, PP) efficacies obtained on appropriate animal models of rheumatoid arthritis, acute lung injury and diabetes, when used as nanomedicines, will be shown. These targeted peptide nanomedicines are easy to prepare and scale up, can be freeze-dried without the use of cryo-or lyo-protectants for required half-life, and most importantly safe and stable for i.v. use, with a high potential for translational research.
12:15 pm Novel Technologies for Delivery of Vaccines
Maya Salnikova, Ph.D., Senior Scientist, Lead for Process and Product Development, Novartis Vaccines & Diagnostics, Inc.
Currently most vaccines are delivered subcutaneously or intramuscularly. There has been a growing interest to develop novel delivery technologies utilizing cutaneous respiratory and oral routes of administration that can influence type of immune responses. Such delivery options could improve effectiveness, safety, provide dose-sparing/specific and cost-effective approaches. In this talks will focus on development, challenges, current status, success and future directions in novel vaccine delivery and device technology.
12:45 Selected Poster Presentation: Uptake and Retention of DVD-Ig™ in Mouse Brain by Intravenous or Intraperitoneal Injection
Farid Gizatullin, Scientist II, Biologics Discovery, AbbVie Bioresearch Center
Blood–brain barrier (BBB), which is naturally protective, provides a challenge for drug delivery into the CNS. Here, we will describe the generation and expression of DVD-Igs™ which are capable of binding specific targets in the brain. The levels and localization of DVD-Igs™, which were injected systemically, were assessed by two orthogonal methods. Results showing the brain uptake and retention of DVD-Igs™ up to 96 hours will be demonstrated.
1:00 Luncheon Presentation (Opportunity Available) or Enjoy Lunch on Your Own
1:30 Session Break
2:00 Chairperson’s Remarks
Reinhard Gabathuler, Ph.D., Chief Scientist, biOasis Technologies, Inc.
2:05 Preclinical Safety and Efficacy of an Oral, APC Targeted/Adjuvanted Nanocarrier for Biologics Delivery
Pirouz Daftarian, Ph.D., Assistant Research Professor, Department of Biochemistry and Molecular Biology, Miller School of Medicine, University of Miami
We have created a nanocarrier by i) surface functionalization with “a ligand moiety” that targets antigen presenting cells, universally, ii) surface modification to assure biocompatibility, and iii) enteric coating that degrades in pH > 7. In preclinical setting, the [platform/ova-DNA] oral therapyrejectedB16/ova melanoma in mouse model. Moreover, in an infectious mouse model, the platform also reduced murine salmonella infection significantly when mice were fed with [platform/Poly IC]. Finally, blood chemistry showed no toxicity in either model.
2:35 Development of a Directed Evolution Strategy to Identify Cell Penetrating Peptides (CPPs) for Brain Delivery
Scott Banta, Ph.D., Associate Professor, Department of Chemical Engineering, Columbia University
Cell Penetrating Peptides (CPPs) have received significant attention since they have the ability to deliver various functional cargos to cells and tissues including the brain. In order to identify new CPP sequences we have developed a selection strategy using plasmid display to identify novel CPPs from randomized peptide libraries. This method can be further developed to identify novel sequences with both targeting and delivery capabilities.
3:05 Development of a New Peptide Vector For Biologics Brain Delivery: Transcend
Reinhard Gabathuler, Ph.D., Chief Scientist, biOasis Technologies Inc.
Different approaches in development for brain delivery will be summarized and discussed. A new vector delivery system developed by biOasis Technologies Inc. based on the melanotransferrin protein (Transcend) will be presented. Different applications of this proprietary vector on delivery of biologics across the Blood-Brain Barrier will be summarized.
3:20 Refreshment Break in the Exhibit Hall with Poster Viewing
4:00 Engineering Transport Vectors within Biologics for Delivery to the CNS
Pankaj Karande, Ph.D., Assistant Professor, Department of Chemical & Biological Engineering, Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute
Drug delivery to the brain has been a long-standing challenge in the treatment of neurological and neurodegenerative disorders due to the formidable blood-brain barrier (BBB). I will specifically discuss the design of peptide vectors that can facilitate the delivery of biologics by hijacking a critical physiological pathway for transport of systemic proteins in to the brain. Peptide-mediated delivery is an efficient and significantly less invasive alternative to current methods of CNS delivery.
4:30 Brain Shuttle Module Delivers Antibodies Efficiently to the Brain
Per-Ola Freskgard, Ph.D., Senior Leader and Vice Director, Neuroscience, Roche
Although biotherapeutics have vast potential for treating brain disorders, their use has been limited due to low exposure across the blood-brain barrier (BBB). This talk will describe a Brain Shuttle module, which can be engineered into a standard therapeutic antibody for successful BBB transcytosis based on a monovalent binding mode. These findings will have major implications for the development of biologics-based treatment of brain disorders.
5:00 pm End of Conference
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