CHI's Formulation Strategies for Improved Delivery of Biologics Conference - Overview - Biologics Formulation Delivery Summit - Day 2


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2014 Formulation Strategies for Improved Delivery of Biologics 


Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Biographies 

TUESDAY, MAY 6

8:00 am Morning Coffee

DEVICES FOR HIGH DOSE / HIGH VOLUME DELIVERY 

8:25 Chairperson’s Remarks

Russell G. Burge, Ph.D., Application Scientist, Freeslate, Inc.

8:30 Needle-Free Drug Delivery to Specified Tissue Depths Using a High Performance Lorentz-Force Jet Injector

Ian HunterIan W. Hunter, Ph.D., Hatsopoulos Professor, Department of Mechanical Engineering, Mechanical Engineering, MIT

We will overview the development of a high performance Lorentz-force actuated jet injector (JI). The custom actuator is under closed-loop position (volume) and pressure control via a non-linear control system implemented in an embedded microcontroller. The JI is used in delivery in to the middle ear, vitreous humor, joints, skin, and muscle. We overview the JI’s use to deliver drugs having a wide range of viscosities into various tissue types in a variety of animals.

9:00 Considerations for Subcutaneous Delivery of Large Volumes

Podcast 

Bill LambertWilliam J. Lambert, Ph.D., Fellow, Drug Delivery and Device Development, MedImmune, Inc.

How can one deliver large doses of a biologic product to a patient in a convenient manner? This is a significant challenge for many biotech scientists and engineers, particularly for self-administration by patients. This presentation will address patient considerations (e.g., injection site pressure and pain) and formulation- and device-based approaches, with particular attention to so-called patch pumps.

PROTEIN DELIVERY To THE BACK OF THE EYE 

9:30 Challenges and Advances in Macromolecular Delivery to the Back of the Eye

Cindy Wu, Ph.D., Principal Scientist, Pharmaceutical Sciences, Allergan, Inc.

Peptides and proteins are showing promise in clinical and preclinical stages of development for treating a wide variety of ophthalmic conditions. Direct intravitreal administration of macromolecules addresses the issues of poor bioavailability, however short half-lives relative to duration of therapy results in a requirement for frequent high dose administrations. In this presentation, the challenges and advances in the delivery of these therapeutic agents will be discussed.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing

10:45 Novel Pentablock Copolymer-Based Compositions for Long Term Delivery of Protein Therapeutics

Ashim MitraAshim K. Mitra, Ph.D., University of Missouri Curators’ Professor of Pharmacy, Division of Pharmaceutical Sciences, School of Pharmacy, University of Missouri-Kansas City

Current treatments for posterior segment ocular diseases require frequent intravitreous injections which have undesirable side effects. We have developed novel pentablock copolymers (PBC) which are biodegradable and biocompatible. PBC have been used to develop nanoparticles and thermosensitive gels which can sustain the delivery for a long period of time. This delivery system can be utilized for subcutaneous injection, and hence, represents a versatile platform technology for long-term delivery of biologics.

11:15 Delivery of Biologic Drugs to the Back of the Eye Using Novel Hydrogels

Rami ElHayekRami ElHayek, Ph.D., Research Manager, Research and Development, Ocular Therapeutix, Inc.

Ocular Therapeutix is encapsulating anti-VEGF drugs within its proprietary hydrogels to create sustained release therapies for retinal diseases. The biodegradable hydrogel provides localization and controlled release of the biologic agent over durations up to six months, while its biocompatible nature allows their use in the demanding intravitreal compartment. Such therapies are one of the biggest unmet needs in ophthalmology, with over 2.5 million intravitreal injections in the U.S. each year.

11:45 Long Acting Delivery of Antibody Therapeutics to the Back of the Eye

Bob KelleyRobert Kelley, Ph.D., Senior Scientist, Drug Delivery, Genentech, Inc.

Anti-VEGF therapies have proven effective for treatment of wet age-related macular degeneration (AMD). Due to a relatively short half-life of antibody therapeutics in the eye, maximal clinical benefit involves frequent intravitreal injection. Pharmacokinetic studies suggest that diffusion and molecular charge contribute to the vitreal clearance of antibodies. Sustained release formulations and implanted devices are being explored for long-acting delivery of antibodies to the eye. Considerations for molecule selection and formulation to facilitate these strategies will be discussed.

12:15 pm End of Formulation Strategies for Improved Delivery of Biologics

 

Welcome Reception in the Exhibit Hall with Poster Viewing

Monday, May 5 | 5:45 - 6:45 pm

PFM Co sponsored 1  PFM Co sponsored 2 

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