As new product formats such as antibody-drug conjugates, multispecific antibodies and fusion proteins progress through development and into the regulatory process, the role of analytical characterization is taking on new meaning. Regulatory agencies are themselves learning about these new formats, and to support filings, industry companies are being asked to provide ever more complex data across a wide range of analytical methods. The use of platformed analytical programs, developed as a cost and time saver by the industry, is now diminishing as novel molecules and product formats demand more individualized characterization steps. And instrumentation suppliers are striving to support this new era with unique product features, software and feature combinations. In 2014, PEGS will explore these changes in the progression of analytical development, and offer a case study forum for those working in the field to share ideas, experiences and solutions that support the development of exciting new biotherapeutics.
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Recommended Pre-Conference Short Courses*
Novel and Emerging Conjugation Methods for ADCs - View Detailed Agenda
Translational Strategies for Development of Monoclonal Antibodies from Discovery to Clinic, Part 1: Focus on Early Discovery - View Detailed Agenda
& Part 2: Focus on Nonclinical Development to Clinic - View Detailed Agenda
*Separate registration required.
MONDAY, MAY 5
7:00 am Registration and Morning Coffee
Plenary Keynote Session
8:30 Chairperson’s Opening Plenary Remarks
Kristi Sarno, Chair, Greater Boston Chapter, Women in Bio; Director, Business Development, Pfenex, Inc.
8:40 Harnessing the Patient’s Immune System to Combat Cancer
Peter CR Emtage, Ph.D., Vice President, Immune Mediated Therapies, MedImmune
With recent FDA approvals, modulation of the immune system is now a clinically validated approach in the treatment of some cancers. At MedImmune, the Oncology Department is developing assets and expertise in Immune Mediated Therapy of Cancer (IMT-C). The challenges from a drug development perspective are multi-fold. The talk will focus on the relevance of preclinical models and translational science to address key issues, including dose selection and rationale combinations.
9:25 Building Regeneron’s Pipeline: From Trap Technology to the VelocImmune Platform to Veloci-Next
George D. Yancopoulos, M.D., Ph.D., President, Regeneron Laboratories; CSO, Regeneron Pharmaceuticals, Inc.
George D. Yancopoulos, M.D., Ph.D. will discuss how he and his colleagues exploited a commitment to science and technology to start the company, withstand years of challenges and failures, and emerge with a pipeline of promising technologies and novel/biologics that are beginning to bring hope to countless patients and their families.
10:10 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing
11:05 Chairperson's Remarks
Hubert Kettenberger, Ph.D., Principal Scientist, Large Molecule Research, Roche Diagnostics GmbH, Germany
11:10 Keynote Presentation:
Regulatory Challenges for Protein Therapeutics
John Alvino, Senior Manager, Global Regulatory CMC, MedImmune
Common regulatory challenges exist among protein therapeutics but there are unique concerns for novel molecules. This talk will present specific and general concerns for innovative non-mAb therapeutics which are becoming increasingly more important and are now in preclinical pipelines. Finally, the presentation will conclude with a case study highlighting a fusion protein which utilizes a nonstandard manufacturing process, illustrating the challenges with determining specifications, comparability and process validation for a novel molecule.
11:40 Novel ADC Chemistry for Improved Stability and Pharmacokinetics
Robert Lyon, Ph.D., Associate Director, Protein Chemistry, Seattle Genetics
Drug-linker stability is a key attribute of an ADC. We have developed a new conjugation chemistry that allows for the generation of stable ADCs using native IgG1 antibodies. ADCs prepared with this method exhibit increased ADC exposure resulting in potent activity coupled with diminished toxicity.
12:10 pm Advances in Antibody Characterization and Collaborative Workflows
Ken Butenhof, Ph. D., Senior Application Field Scientist, Accelrys, Inc.
Antibody discovery is driven by complex time consuming experimental processes involving numerous teams. Evolving technologies enable researchers to make more informed decisions early in the process. Here we suggest collaborative and comprehensive capabilities in antibody characterization and development: capabilities to analyze, annotate, predict 3-dimensional structures, mutation energies for stability and binding affinity, electrostatics properties, aggregation propensity, developability and more. Collaborative environments for registration, workflow and sharing will be discussed.
12:40 Luncheon Presentation I: Deconvoluting Receptors Targeted by Antibodies and Protein Ligands Using the Retrogenix Cell Microarray Platform
Jim Freeth, Ph.D., Managing Director, Retrogenix Ltd
Selecting antibodies by phenotype, rather than against a pre-determined target, leads to novel, disease-relevant antibody targets. Retrogenix’s Cell Microarray technology overcomes the target deconvolution hurdle, with high success rates. The technology also provides a powerful approach to identify potential off-target activities to guide lead selection, and to identify previously unknown receptors of protein ligands.
1:10 Luncheon Presentation II: High Throughput Analysis and Characterization Methods for Improved Process Development Workflows
Alissa Thompson, NA Biotherapeutics Product Specialist, PerkinElmer The development of Biotherapeutics is a complex and lengthy process and there is a need for techniques which can increase profitability, productivity and improve the speed of development. Process development can involve multiple complex steps and PerkinElmer offers solutions to simplify and improve the workflow. The LabChip® GXII microfluidic technology enables the rapid analysis (<68sec/sample) of multiple protein characterizations including, molecular weight, titer, purity assessment, N-glycans profiling, and charge heterogeneity.
1:40 Session Break
2:00 Chairperson's Remarks
2:05 Making and Characterizing Antibody-Maytansinoid Conjugates for Preclinical Research and Development
Nicholas Yoder, Ph.D., Scientist, Biochemistry, ImmunoGen, Inc.
Antibody-maytansinoid conjugates (AMCs) show promise for the treatment of many cancer indications, as exemplified by the FDA approval of Kadcyla for Her2-positive breast cancer. Robust protein chemistry is required to provide material for early stage AMC research and lead selection. Sophisticated analytical techniques are employed to understand crucial molecular and biological properties of AMCs. Both these topics will be discussed in the context of candidate therapeutic development.
2:35 Role of Analytics in the Development of Antibody-Drug Conjugates
Samadhi Vitharana, Ph.D., Senior Scientist, Core Sciences & Technologies, Takeda California
Monoclonal antibodies linked to cytotoxic payloads known as antibody-drug conjugates represent an emerging technology in clinical oncology. ADCs utilize the specificity of a mAb to deliver a cytotoxic drug to targeted tumor cells. Chemistry of the linker, cytotoxic drug and sites of attachment often result in complex and heterogeneous drug product preparations. Analytics to evaluate different architectures of ADCs will be discussed.
3:05 Analytical Characterization of Fleximer-Based ADC
Alex Yurkovetskiy, Ph.D., Senior Director, Chemistry, Mersana Therapeutics
ADC design utilizing biodegradable polymer scaffolds for drug payload immobilization provides remarkable flexibility in the selection of targeting ligand format, active agent type/density and bioconjugation strategy. This ADC subclass requires development of new approaches to characterize ADC composition, stability, and pharmacokinetics. The analytical methods developed for characterization of polyacetal-based ADCs is presented.
3:35 Investigation into Temperature-Induced Aggregation of an Antibody-Drug Conjugate
Heather Flores, Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.
We explored the effect of thermal stress on the physical stability of an ADC and the effects of conjugation on the ADC secondary and tertiary structures. Analysis showed that for species with high drug loading, conjugation does not measurably alter the secondary structure, but it does render the CH2 domain less stable to thermal stress. The variable domain of the antibody may also contribute to the extent of aggregation.
4:05 Refreshment Break in the Exhibit Hall with Poster Viewing
4:45 Problem Solving Breakout Discussions
These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.
Mass Spectrometric Techniques for Protein Therapeutic Analysis
Moderator: Jennifer Nemeth, Ph.D., Principal Research Scientist and Head, Biologics Mass Spectrometry & Allied Technologies, Janssen R&D LLC
- What MS platforms are being used in biopharma today?
- What is the required resolving power needed to address most intact mass questions?
- When can you use intact mass profiling vs. employing a peptide map?
- What are the critical assays for biotherapeutic development?
Interchangeability of Biosimilars: Impact on Drug Product Formulations and Presentations
Moderator: Kelly Neelon, Ph.D., Associate Director, Drug Product Formulation, Momenta Pharmaceuticals
- How does formulation change effect interchangeability or biosimilarity status?
- What are the studies/data need to support a formulation change and still achieve interchangeability or biosimilarity status?
- Is interchangeability or biosimilarity achievable with a formulation change?
- How does primary container effect interchangeability or biosimilarity status?
- When is incorporating current delivery technology into the drug product beneficial and justifiable?
- What are the risks of incorporating these technologies into biosimilars?
Early Lead Selection for Antibody-Drug Conjugates
Moderator: Nicholas Yoder, Ph.D., Scientist, Biochemistry, ImmunoGen, Inc.
- Antibody or targeting protein optimization
- Linker/payload selection
- CMC screening approaches
- Activity screening approaches
Novel Approaches for Improving Throughput and Workflow in Biologics Process Development
Moderator: Roger Bosse, Senior Global Product Leader, Reagents, PerkinElmer Life Science & Technologies
- Current technical limitations and challenges in biologics process development
- New tools & techniques to improve protein process development
5:45 Welcome Reception in the Exhibit Hall with Poster Viewing
6:45 End of Day
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