January 13 - 17, 2014
Renaissance Hotel and Palm Springs Convention Center Palm Springs, California

A Community Dedicated to the
Evolving Field and Future of Biotherapeutics
Archived Content

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Third Annual
Protein-Device Combinations
Integrating Protein Formulations with Parenteral and Alternative Administration Devices
January 21-22, 2013 
 

 

Day 1 | Day 2Download Pipeline 5 Brochure | Download Formulation and Packaging Flyer 

This annual conference covers 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. 

SUNDAY, JANUARY 20


4:00-5:00 pm Registration for Short Courses

5:00 – 8:00 Recommended Dinner Short Courses (SC1-SC4)*


*Separate Registration Required


4:00-8:00 pm Conference Registration


MONDAY, JANUARY 21

7:30 am Conference Registration and Morning Coffee

 

Characterization and Formulation Principles for Combination Products 

8:55 Chairperson’s Opening Remarks

Andrea Leone-Bay, Ph.D., Vice President, Pharmaceutical R&D, MannKind Corporation


» KEYNOTE PRESENTATION: 

9:10 Overcoming Challenges in Protein-Device Combination Development: Efficient Screening of Device Parameters and Drug-Device Interface for Robust Product Development

Anand SubramonyAnand Subramony, Ph.D., Principal Fellow & Head, Novel Delivery Technologies & Therapeutics (NDT), Novartis Institutes for BioMedical Research, Inc.

Delivery of biologics requires unique devices that can deliver high viscosity formulations, ability to handle larger volumes, and achieve programmability in delivery. Early screening of devices with features and parameters appropriate for the delivery of payload is critical for product development. The choice and features of the device has to meet the delivery criteria and target product profile for the molecule. Emerging devices in the area of subcutaneous delivery for biologics and devices for respiratory therapy as well as back of the eye will be discussed.

9:50 Devices for Delivery of Viscous Protein Formulations and Their Impact on Protein Structure

Amy Heintz, Ph.D., Senior Research Scientist, Advanced Materials, Battelle

Battelle is utilizing a systems approach to develop devices for delivery of viscous therapies, by incorporating design for manufacturing, formulation, and usability considerations. We are exploring adaptations to traditional autoinjectors, as well as new delivery devices, that enable delivery of fluids greater than 70 cP. An additional challenge is to understand the stability of formulation to the injection event becomes a concern. We are examining the impact of shear rate on the stability of proteins as a function of concentration. The results indicate that both the shear rate and the exposure time to the shear forces are important. Proteins such as monoclonal antibodies can be delivered without impact to their activity, secondary structure, or stability. We will highlight the impact emerging devices, such as DosePro, can have on the drug delivery market.

10:20 Coffee Break

10:45 Issues to Consider When Developing an Inhaled Protein Formulation and Product

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

Inhalation of proteins may be a patient-preferred alternative to injections. This talk will summarize the pitfalls and opportunities to develop an inhaled protein product. Molecular optimization, formulation development, and device selection are essential factors to ensure success when developing an inhaled product. A primer on the requirements for success will be discussed. Successful and failed case studies will be shared including both in vitro and in vivo data.

 

Injections and Syringes 

11:15 Trends and Innovations in Pre-Filled Delivery Systems

Graham Reynolds, Vice President, Marketing & Innovation, West Pharmaceutical Services

11:45 Technical Challenges to Consider for Biologic Products and Injection Devices

William Lambert, Ph.D., Fellow, Drug Delivery and Device Development, MedImmune, Inc.

A number of therapeutic areas are experiencing significant competition, particularly as second generation biologics and biosimilars begin to enter the market. Device technologies can play a key role in providing competitive advantage for your product. However, to be successful, product development must consider the various technical challenges that generally exist for biologic formulations and devices. This presentation will review the use of device technologies for marketed products and provide insight for development approaches.

12:15 pm Close of Session

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

 

Non-Invasive and Alternative Delivery 

2:00 Chairperson’s Remarks

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

2:05 Practical Considerations for Alternate Delivery of Proteins: Case Studies

Christopher A. Rhodes, Ph.D., President, Christopher A Rhodes & Associates LLC.

The discussion will focus on practical issues of formulation and device development for a number of alternate delivery approaches. Examples will be included for nasal, pulmonary, and transdermal systems.

2:35 Development of Orally Inhaled Peptide/Device Combination Products

Andrea Leone-Bay, Ph.D., Vice President, Pharmaceutical R&D, MannKind Corporation

Developing peptide/device combination products requires early integration of formulation and device technologies. For inhalation products, dry powder formulations and inhalation devices are intrinsically linked and product development challenges can be simplified when these efforts are combined at an early stage. This presentation will address these challenges with case studies of inhaled peptide/device combinations products.

3:05 Formulation Challenges in Long Acting Delivery of Proteins for Ocular Disease

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

Anti-VEGF therapies have proven effective for treatment of wet age-related macular degeneration (AMD) but require monthly intravitreal injection. Less frequent dosing would be more convenient for patients. Strategies including molecule modification, and polymer-based depot and solid implant formulations for slow release, are being explored for long-acting delivery of anti-VEGF antibodies. Preparation of slow release formulations involves exposure of the antibody to “harsh” conditions. Considerations for molecule selection and excipient choice for stabilization to facilitate this approach will be discussed.

3:35 Sponsored Presentation (Opportunity Available)

3:50 Refreshment Break

4:15 Advancements in Drug and Vaccine Delivery Technologies

Darin Zehrung, MBA, Technical Officer, Portfolio Leader, Vaccine Delivery Technologies, PATH

PATH develops innovative solutions to complex problems in drug and vaccine delivery, ensuring that the technologies we support are affordable, acceptable, and culturally appropriate for global public health. Alternative routes of administration may help increase safety, immunogenicity, mitigate supply constraints, and improve cost effectiveness. However, designing value-added drug and vaccine delivery technologies for the communities we serve involves unique challenges that require innovative solutions. PATH involves users at all stages of the process, from assessing the need and generating the product design to planning for technology introduction and use. Mr. Zehrung will discuss issues related to the design and development of novel technologies for vaccine and drug delivery in low-resource settings, using practical examples from work underway at PATH in collaboration with public- and private-sector partners.

4:45 Immunopotentiator Delivery Strategies

Kevin Harper, Director, Formulation, Filling & Packaging, Sanofi Pasteur

Sensitive biologicals must be targeted to specific tissues to ensure proper and efficient immune system processing. This talk illustrates this need using both early stage research work, and a series of case studies. For example, vaccines and monoclonal antibodies must be delivered very differently, yet we can learn quite a lot from the rationale and results of these opposite approaches. A focus on new vaccines will help add understanding in this rapidly growing area. The audience will gain a better understanding of design of protein delivery strategies from both the perspective of the protein construction and the delivery system selected.

5:15 Needle-Free Delivery of Macromolecules through Skin

Samir Mitragotri, Ph.D., Professor, Chemical Engineering, Founding Director, Center for Bioengineering, University of California, Santa Barbara (UCSB)

Skin offers an excellent route of administering drugs for the treatment of local conditions and systemic diseases. I will discuss the challenges in delivering macromolecules through the skin and provide an overview of technologies for overcoming these challenges.

5:45 – 7:00 Welcome Reception in the Exhibit Hall with Poster Viewing

7:00 Close of Day

Day 1 | Day 2Download Pipeline 5 Brochure | Download Formulation and Packaging Flyer 

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      Premier Sponsors: 

EMD Millipore 

 Novozymes (white) 

PerkinElmer NEW 2009 

 Protein Simple  

  

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Training Seminars 

Mon-Tues, January 13-14 

Biologics Formulation and Delivery  

 


Buzz Sessions
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