CHI's Formulation Strategies for Improved Delivery of Biologics Conference - Overview - Biologics Formulation Delivery Summit - Day 1

2014 Formulation Strategies for Improved Delivery of Biologics 

The safety and efficacy of protein and peptide therapeutics are limited by in vitro and in vivo instability, immunogenicity and short circulating half-lives. CHI's Inaugural Formulation Strategies for Improved Delivery of Biologics conference will discuss new formulation approaches designed to overcome biologics delivery issues through as chemical modifications, new formulations and delivery technologies and advanced analytical tools to characterize protein interactions with excipients. These strategies have the potential to facilitate the development of next generation peptide and protein therapeutics which are safe, efficacious and promote patient compliance. 

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9:00 am – 4:00 pm Pre-Conference Registration

10:00 am – 1:00 pm Short Course 1: Challenges and Opportunities in Protein and Peptide Drug Delivery*

2:00 – 5:00 pm Short Course 2: Converting Emerging Delivery Technologies into Successful Patient-Friendly Therapies*

*Separate registration required. 


7:00 am Registration and Morning Coffee

8:30 Chairperson’s Opening Remarks

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


8:40 KEYNOTE PRESENTATION: The Growing Role of BioTherapeutics Delivery: Opportunities and Challenges

Julia Rashba-StepJulia Rashba-Step, Ph.D., Senior Director, Novel Delivery Technologies, Pfizer, Inc.

There is a rapidly changing environment with the constantly growing role of Biotherapeutics. The presentation will cover thoughts on the future trends on BioTherapeutics and importance of drug delivery in commercial, clinical differentiation and also the need for enabling technologies. Also it will also cover strategic plans for current and future delivery reflective of needs of Pfizer’s BioTherapeutics portfolio.

9:10 Strategies and Consideration for Developing Parenteral Protein Device Combination Products

Sujit BasuSujit K. Basu, Ph.D., Senior Director, Global Technical Operations, Shire

This talk will discuss various considerations and strategies for developing innovative injectable delivery technologies. Examples will be drawn from our intrathecal delivery programs to discuss role of new approaches such as protein device combinations in successfully delivering injectable biotherapeutics.

9:40 Formulation Considerations for Various Routes of Drug Administration

Carsten Olbrich, Ph.D., Senior Scientist, Formulation Development, Bayer Pharma AG

Different application routes (iv, sc. ocular) require different drug properties, which can be influenced, at least in part), by an appropriate formulation. Important aspects will be presented accompanied by some practical experiences and case studies.

10:10 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing 

11:10 A Novel Drug Complex/in situ Gelling Delivery Technology for Oral Biologics

Dai WeiguoWeiguo Dai, Ph.D., Scientific Director, Fellow, Drug Product Development, Johnson & Johnson

Oral delivery of biologics has been a great challenge for years due to limited absorption and poor stability in the gastrointestinal tract. An approach to incorporate drug complex into an in situ gelling formulation will be presented. This novel drug delivery technology can enhance oral bioavailability significantly and provide a new approach to oral delivery of biologics.

11:40 Microfluidics-Assisted Engineering of Protein Formulations

Sabiruddin Mirza, Ph.D., Sr. Research Associate, School of Engineering and Applied Sciences, Harvard University

Protein-based therapies hold an enormous potential for treating many terminal diseases. Nevertheless, the lack of universal technological approaches that enable development of protein formulations with the targeted attributes significantly impedes clinical translation of these advanced therapies. This presentation will overview the use of droplet based microfluidic technology for developing protein formulations with pre-programmed functional characteristics, including size and internal morphology, encapsulation efficiency, and protein release profile.

12:10 pm Late Breaking Presentation

12:25 Luncheon Presentation (Opportunity Available) or Enjoy Lunch on Your Own

12:55 Session Break


2:00 Chairperson’s Remarks

Weiguo Dai, Ph.D., Scientific Director, Fellow, Drug Product Development, Johnson & Johnson

2:05 Lyophilized siRNA Nanosome Formulation

Tarun MandalTarun Mandal, Ph.D., McCaffrey/Norwood Endowed Professor of Pharmacy & Director, Center for Nanomedicine & Drug Delivery, College of Pharmacy, Xavier University of Louisiana

Sequence specific gene silencing based on RNA interference (RNAi) holds great promise for molecular-targeted treatment of various diseases. However, delivery of siRNA presents a special challenge due to its rapid in vivo degradation, large molecular weight, and polyanionic charge. In this study, cationic lipid (DOTAP)-based non-toxic formulations were developed for the treatment of HCV.

2:35 Highly-Automated Procedures for the Assessment of Protein Formulations 

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

A highly automated process was devised to prepare and analyze samples for the formulation development of proteins. Automation increased efficiency of the activities compared to current methods and procedures. Forty eight protein formulations were generated together with placebos. Automated procedures were employed for appearance (color, turbidity, and particles),viscosity, and pH testing. Spectrophotometry, chromatography and light scattering were performed using semi automated procedures. Performance of the formulations was evaluated after subjecting the vials to stress conditions.

3:05 Protected Peptide Nanoparticles: Experiments and Brownian Dynamics Simulations of the Energetics of Assembly

Robert Prud'hommeRobert K. Prud’homme, Ph.D., Professor and Director Program in Engineering Biology, Department of Chemical & Biological Engineering, Princeton University

Soluble peptides, susceptible to degradation and clearance in therapeutic applications, have been formulated into protected nanoparticles for the first time through the process of kinetically-controlled, block-copolymer-directed rapid precipitation using Flash NanoPrecipitation. Complimentary Brownian dynamics simulations qualitatively model the nanoparticle formation process. Additionally, the influence of the polymer-peptide interaction energy on the efficiency of nanoparticle protection by polymer surface coverage is elucidated in both experiments and simulations. Approaches to encapsulate, and protect more soluble polypeptide constructs using conjugation strategies will be presented.

3:35 Prefilled Syringe Technologies for Improving Drug Stability and Reliable Plunger Performance for Auto-Injectors Applications 

Kevin ConstableKevin Constable, Director, Technology Development, Global Pharmaceutical Solutions, Terumo Medical Corporation

4:05 Refreshment Break in the Exhibit Hall with Poster Viewing

4:45 Problem Solving Breakout Discussions 

This interactive session provides conference delegates and speakers an opportunity to choose a specific roundtable discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to network, meet potential collaborators share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. 

Topic 1: Screening and Optimization of Biological Formulations 

Moderator: Russell Burge, Ph.D., Application Scientist, Freeslate, Inc. 

• What are the most effective and efficient studies and methods for formulation screening?
• How representative are screening results from 96-well formats of those in the final container-closure, such as PFS or vials?
• How and when should a container closure be selected for formulation studies of a drug product?

Topic 2: Challenges in Topical and Transdermal Drug Delivery 

Moderator: Ajay K. Banga, Ph.D., Professor and Department Chair, Pharmaceutical Sciences, Endowed Chair in Transdermal Delivery Systems, College of Pharmacy, Mercer University 

• Human skin as an in vitro surrogate model for bioequivalence comparison of topicals
• Challenges in passive patch development: Residual drug, crystallization, and cold flow
• Challenges in getting proteins and vaccines across the skin – limitations of iontophoresis and microneedles

Topic 3: Commercial Biological Products without Cold Chain Management? 

Moderator: Weiguo Dai, Ph.D., Scientific Director, Fellow, Drug Product Development, Johnson & Johnson 

• What is the biggest benefit for “room temperature controlled” biologics? Saving money in cold chain management vs. patient convenience?
• Challenges and current approaches in developing “room temperature controlled” biologics

Topic 4: Understanding Toxicity of Polymer-Based Nanocarriers for Drug Delivery 

Moderator: Pirouz Daftarian, Ph.D., Assistant Research Professor, Department of Biochemistry and Molecular Biology, University of Miami Miller School of Medicine 

• What are the proper pre-clinical toxicity tests / biomarkers / analytes that ensure a proactive approach for dissecting the toxicity of polymer-based nanocarriers?
• What is the acute and chronic spectrum that guarantees undesired reactions?

Topic 5: Challenges in Treatment of Brain Diseases 

Moderator: Reinhard Gabathuler, Ph.D., Chief Scientist, biOasis Technologies, Inc. 

• How do we overcome blood brain barrier and what technologies are available for drug delivery to brain?
• Intrathecal injection versus i.v injection: Which one is better and when?
• Delivery across blood brain barrier- Challenges posed by small molecules and biologics 
• Is intracellular delivery of a drug addressed in its design and therapeutical efficacy?

Topic 6: Prefilled Syringe Technologies: Improving Drug Stability and Auto-Injector Performance 

Moderator: Kevin Constable, Director, Technology Development, Global Pharmaceutical Solutions, Terumo Medical Corporation 

• Minimizing degradation
• Control of dissolved oxygen
• Functional performance in Auto-Injector



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

6:45 End of Day

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