This meeting covers 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 are discussed. The meeting features in-depth case studies and discussions on the design and development of protein-device combinations that achieve effective and safe delivery, regulatory compliance and commercial success.
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TUESDAY, JANUARY 10
1:30 pm Conference Registration
2:00 BuzZ Session A
2:45 Refreshment Break in the Exhibit Hall with Poster Awards
3:30 - 4:15 BuzZ Session B
4:30 – 7:30 Concurrent Dinner Short Courses (SC5-SC9)
Details on Page 3. Separate Registration Required.
WEDNESDAY, JANUARY 11
7:00 am Conference Registration
7:30 Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:15 Chairperson's Opening Remarks
Von Nakayama, Industry Advisor, Retired FDA Reviewer
KEYNOTE PRESENTATION
8:20 Industry Trends in Combination Products: Case Studies in Key Markets
Donna French, Ph.D., Senior Director, Device Development, Genentech
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9:00 Engineered Drug Delivery for Protein Injection Devices
Amy Heintz, Ph.D., Principal Research Scientist, Advanced Materials Applications, Battelle
Transitioning protein formulations to injection devices requires addressing challenges associated with delivering high concentrations of high molecular weight molecules in a manner that is easy, reliable, and painless for the patient. Battelle has taken a systems approach to addressing these challenges. The design of specific devices for patients suffering from autoimmune disease versus cancer incorporates human-centric design features that provide feedback on the limitations and requirements of devices for these different diseases.
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9:30 Understanding Packaging Systems for Parenteral Administration of Biopharmaceuticals and Biological Products
Vinod D. Vilivalam, Ph.D., Director, Strategic Market and Technical Development, Daikyo Crystal Zenith, West Pharmaceutical Services, Inc.
Newer biologics including mAbs are characterized by high doses and higher viscosities, which increases the chances of aggregation due to packaging systems. In addition, recent regulatory scrutiny of glass particles and delamination has added to the challenges to drug device combinations. These market factors have resulted in considerations of plastic delivery systems. The discussion will focus on a Daikyo Crystal Zenith plastic prefillable syringe systems, and cartridge based microinfusion system for large volume delivery. Attributes such as break resistance and the absence of silicone and tungsten, as it relates to drug storage systems for biopharmaceuticals will be discussed with appropriate case studies. The discussion will also include sterile CZ vials and bulk container systems that are proven to be effective for cold temperature storage for biopharmaceutical and cell therapy products.
10:00 Networking Coffee Break in the Exhibit Hall, Poster Viewing
10:45 Developing Dosage Form Based on Expressed and Latent User Needs
Charlie Hitscherich, Ph.D., Associate Director, Protein Pharmaceutical Development, Biogen Idec
This presentation will focus on how utilizing market research combined with innovation a pharmaceutical company can develop a delivery system that meets the end users' needs. Discussion will focus on the formulation, primary container closure as well as delivery system. The discussion will focus on technical challenges as well as how one can acquire the user needs data to drive development and innovation.
11:15 Starting At The End: Patient Centric Innovations in Drug Delivery
Reade Harpham, Manager, Human Centric Design, Health and Life Sciences, Battelle
Without integration of end user needs at the initial stages of development, true drug delivery innovation falls short, and new products fail to live up to their potential. As part of Battelle’s Engineered Drug Delivery Initiative, a patient centric approach to technology innovation has been used to uncover unmet needs, inspire development teams, and guide strategic investments in next-generation technologies.
11:45 Lipid-Based Depots for Protein Drugs
Gerhard Winter, Ph.D., Professor, Chair of Pharmaceutical Technology and Biopharmaceutics, LMU Munchen
Parenteral depots for protein drugs had been developed on the basis of PLGA polymers before, but with limited success. Implants based on triglycerides can now be produced by cheap, low temperature extrusion processes and provide steady release kinetics for therapeutic proteins up to several months. Detailed mechanistic studies have elucidated the unique release mechanisms.
12:15 pm Close of Morning Session
12:30 Luncheon Presentations (Sponsorship Opportunity Available) or Lunch on Your Own
2:00 Chairperson's Remarks
Charlie Hitscherich, Ph.D., Associate Director, Protein Pharmaceutical Development, Biogen Idec
2:05 Peptide Delivery by Inhalation: Simplified
Andrea Leone-Bay, Ph.D., Vice President, Pharmaceutical Research & Development, MannKind Corporation
A major challenge facing peptide drug administration is the need for injection. A suite of innovative techniques including dry powder formulations, patient-friendly disposable devices, and advanced development methodologies have been built to meet these challenges and allow peptide drug administration by inhalation. A translational medicine bench to bedside, patient-centric approach to inhaled peptide drug development using these techniques will be discussed as case studies.
2:35 Case Study: An Innovative Formulation and Device Combination Approach for Treating CNS Diseases
Hanne Bentz, Ph.D., Senior Research Fellow, Jansson Pharmaceutical, R&D
Poor delivery of biologics to the CNS has been a long standing barrier to new therapeutic opportunities and high systemic exposures via peripheral dosing methods may pose a safety risk. Novel approaches to target the brain and increase central drug exposure of biologics are under investigation. This talk shares progress made and points out the impact and challenges for formulation and device design in the nasal-to-brain approach, a non-systemic delivery modality.
3:05 Needle-Free Delivery of Viscous Biomolecule Formulation
Brooks Boyd, Ph.D., Senior Director, Product Development, Zogenix, Inc.
Formulation viscosity is a limiting factor in injection of concentrated protein formulations. DosePro needle-free injection system enables subcutaneous delivery of pharmaceutical formulations at viscosities not achievable using a needle and syringe or pen injector. This talk will present an in vitro case study for delivery of viscous formulations (up to 2000 cP) by DosePro, supported by in vivo PK data with protein formulations of lower viscosities.
3:35 Sponsorship Presentation (Opportunity Available)
3:50 Networking Refreshment Break
4:30 Overcoming Regulatory Hurdles in Drug/Device Development: Current State of Regulation Development for Quality Systems for Combination Products
Michael Gross, Ph.D., RAC, Senior Consultant, Biologics Consulting Group
This presentation will consider the state of FDA combination product quality systems requirements with emphasis on prefilled drug and biologic delivery systems. Following the 2004 draft guidance, in 2009 FDA published a proposed rule on good manufacturing practice for combination products. FDA received comments from industry on both the draft guidance and the proposed rule and stated publicly that the final rule will be issued by the end of 2011. If the final rule is published before the meeting the presentation will consider the final rule and its implications for drug and biologic manufacturers. If the final rule is not published, the discussion will be based on the proposed rule and industry comments.
5:00 Approaches to Product, Process and Submission Quality: How Does the FDA Actually Evaluate You and Your Product?
Von Nakayama, Industry Advisor, Retired FDA Reviewer
Quality means different things to different people. This presentation will identify the unique FDA approach to quality and discuss the regulatory implications of this approach.
5:30 - 6:30 Reception in the Exhibit Hall with Poster Viewing
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Links to Companion Meetings
Optimizing Biologics Formulation Development
Lyophilization and Emerging Drying Technologies
Protein Aggregation and Emerging Analytical Tools