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Cambridge Healthtech Institute’s Fourth Annual
Protein-Device Combinations
Integrating Protein Formulations with Parenteral and Alternative Administration Devices
January 15-16, 2014

Cambridge Healthtech Institute’s Fourth Annual Protein-Device Combinations conference will cover the latest trends and challenges in integrating protein formulations with parenteral and alternative administration devices. In addition to focusing on parenterals, non-invasive and alternative routes for delivery will also be discussed. Specific considerations for formulating protein delivery systems so they maintain their stability and remain within their efficacious and safe target doses will be discussed. The meeting will feature in-depth case studies and discussions on the design and development of protein-device combinations that are safe and effective, compliant and commercially successful.

Join colleagues from around the world in this discussion of the key challenges and solutions in protein-device combinations development, and see how experts like you are integrating protein formulations with parenteral and alternative administration devices.



Day 1 | Day 2 | Download Development Brochure | Speaker Biographies 

TUESDAY, JANUARY 14

1:30-2:00 pm Conference Registration


Buzz Sessions Green 2

2:00 BuzZ Session A (More Details >>)

3:00 Refreshment Break in the Exhibit Hall with Poster Awards

3:45 BuzZ Session B (More Details >>)


4:30-5:00 Short Course Registration

5:00-8:00 Dinner Short Courses (SC8-SC14) More Details >> 

WEDNESDAY, JANUARY 15

7:30 am Conference Registration

8:00 Morning Coffee


Regulatory Guidance And COMMERCIAL Considerations 

8:15 Chairperson’s Opening Remarks

David Cipolla, Ph.D., Senior Director, Pharmaceutical Sciences, Aradigm Corp.

Co-Chair:Robin Bogner, Ph.D., Associate Professor, School of Pharmacy, University of Connecticut


Keynote Presentation

8:20 Stabilization of Proteins by Freeze Drying: New Guidelines, or “Formulation and Process Heresy”

Michael PikalMichael Pikal, Ph.D., Pfizer Distinguished Endowed Chair in Pharmaceutical Technology & Professor of Pharmaceutics, University of Connecticut

Commonly, “rules” for formulation and process design include the “command” to freeze dry below the Tg’ to insure product quality. Moreover, formulations should have very high Tg’s to insure good storage stability. These “rules” mean that more than trace levels of amorphous low Tg solutes or electrolytes should be avoided. However, recent data indicate that these rules can often be relaxed greatly without damage to critical quality attributes.

9:00 FDA Regulatory Requirements and Guidance for the Development and Marketing of Prefilled Syringes and Advanced Drug Delivery Devices

Michael GrossMichael Gross, Ph.D., Owner and Principal Consultant, Chimera Consulting North America

This presentation will consider recently issued FDA regulations and guidance for the development and marketing of drug delivery devices which are either indicated for, or co- packaged or prefilled with drugs and biological products. It will include good manufacturing practices, scientific and engineering information to be included in marketing applications and the reporting of manufacturing and design changes to approved applications.

Featured Presentation

9:30 Commercial Considerations that Drive Protein Device Combinations Strategies

Sesha NeervannanSesha Neervannan, Ph.D., Vice President, Pharmaceutical Development, Allergan, Inc.

This presentation will discuss the marketing and commercial considerations that are driving research and development of protein device combinations strategies.


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

NEEDLE-FREE INJECTIONS 

10:45 Rethinking Systemic Delivery Approaches for the CNS

Pankaj KarandePankaj Karande, Ph.D., Assistant Professor, Department of Chemical & Biological Engineering, Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute

The blood brain barrier (BBB) poses a formidable challenge for delivery of biologics to the central nervous system. Current clinical approaches for brain disorders bypass the systemic delivery route in favor of brute-force approaches such as intra-cerebral catheters and drug releasing implants. I will discuss our work on targeting the paracellular route of the brain microvascular capillary vessels that facilitates the delivery of systemically introduced biologics through the BBB.

11:15 Needle-Free Injection of Viscous Biologic Formulations

Brooks BoydBrooks Boyd, Ph.D., Senior Director, Pharmaceutical Development, Zogenix, Inc.





Amy HeintzCo-Presenter: Amy M. Heintz, Ph.D., Senior Research Scientist, Battelle

Advances in formulation technology have allowed biologics to be formulated at ever higher concentrations, where viscosity becomes limiting, often necessitating large bore needles or longer injection times. Needle-free injection can resolve those issues by delivering viscous formulations in a fraction of a second, while providing market advantages via product differentiation. The impact of needle-free injection on protein activity and integrity following administration is evaluated at both aqueous and elevated viscosities.

11:45 A New Technology for High Volume/High Viscosity Biologics

Michael D. Hooven, President and CEO, Enable Injections, LLC

A new wearable Bolus Injector technology for subcutaneous delivery of high-volume/high-viscosity biologics has been developed that utilizes standard vial container closure. The system uses simple mechanical means to deliver 20+cc of high viscosity fluid with automated mixing of two vials and point-of-delivery dose adjustment. The unique power supply allows for very high pressures to be achieved, allowing rapid delivery though a 29-33g needle.

 

West Pharma12:15 pm The Importance of Considering All Aspects of an Integrated Delivery System to Help Optimize Patient Outcomes

Reynolds_GrahamGraham Reynolds, Vice President, Marketing and Innovation, West Pharmaceutical Services

Optimal outcomes can only be achieved when all aspects of drug delivery are considered as an integrated system. The four key elements are the drug molecule, the primary container, the delivery device and the patient. For any treatment to be effective these elements have to work in harmony. This presentation will highlight the importance of this approach, with examples of systems designed to optimize the patient experience.

12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own


Next-Gen And Alternative Delivery Technologies For Biologics 

2:00 Chairperson’s Remarks

Pankaj Karande, Ph.D., Assistant Professor, Department of Chemical & Biological Engineering, Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute

2:05 Improving Patient Compliance through Alternative Formulation and Pulmonary Delivery Technologies

David CipollaDavid Cipolla, Ph.D., Senior Director, Pharmaceutical Sciences, Aradigm Corp.

This talk describes the use of the inhalation route for delivery of proteins and peptides. Patient preference for inhalers over injections may lead to greater compliance and thus improved outcomes translating into a pharmacoeconomic benefit. The pitfalls and opportunities to develop an inhaled protein product will be summarized. Molecular optimization, formulation development, and device selection are essential factors when developing an inhaled product. Case studies, including in vitro and in vivo data, will be shared.

2:35 Oral Inhalation as a Delivery Option for Protein and Peptide Drugs

Kieran Curley Ph.D., Senior Principal Scientist, Formulations Development, Mannkind Corp.

Almost all protein and peptide drugs are delivered by injection. Unfortunately, this invasive route of administration is a barrier to initiation of therapy and a hindrance to compliance once therapy has started. As an alternative, the oral inhalation route, integrating protein/peptide formulations with simple inhalers, provides a viable delivery option. The development of these non-invasive, patient-friendly combination products will be discussed.

3:05 Implantable Miniaturized Biosensors for Metabolic Monitoring

Diane BurgessDiane J. Burgess, Ph.D., Board of Trustees Distinguished Professor of Pharmaceutics, Department of Pharmaceutical Sciences, University of Connecticut

A totally implantable miniaturuzed biosensor is being developed by our group for metabolic monitoring. This device utilizes immobilized enzymes for monitoring glucose and other metabolites. To prevent the foreign body response to the implanted sensor, we have developed a biocompatible coating that releases drug, (dexamethasone) and other tissue response modifiers (such as VEGF (vascular endothelial growth factor) and PDGF (platelet-derived growth factor). This presentation will focus on the biocompatible coating as well as the biosensor composition and functionality.

3:35 Selected Oral Poster Presentation: Lyophilization in Plastic versus Glass Syringes and Cartridges

Timothy Dutill, Associate Scientist, Lyophilization Technology, Inc.

Lyophilization in pre-filled devices is a growing interest in the field of parenteral lyophilized products. The behavior during processing is influenced by the unique geometry and construction of the containers. In these studies, the sublimation rate and finished product attributes of model systems where evaluated in plastic syringes and glass cartridges. The studies show a direct comparison of the effects of the heat transfer characteristics of plastic versus glass syringes /cartridges. The processing data and finished product attributes will be presented.

3:50 Refreshment Break

4:15 Achieving Long-Term Antibody Release from Polymer-Based Drug Delivery Systems

Karthik RajgopalKarthik Rajagopal, Ph.D., Scientist, Drug Delivery, Genentech, Inc.

This presentation will discuss our work on slow release formulations of proteins for ocular delivery. Formulations are prepared by first spray-drying followed by hot melt extrusion to produce a slow release formulation for proteins.

4:45 Extended Q&A Session

 5:15-6:30 Reception in the Exhibit Hall with Poster Viewing



Day 1 | Day 2 | Download Development Brochure | Speaker Biographies