SAN DIEGO—PepTalk: The Protein Science Week, conducted by Cambridge Healthtech Institute (CHI), is one of the largest gatherings of protein science researchers in the United States. Held its first 11 years in San Diego before CHI moved the show a bit northeast in California for Palm Springs, PepTalk has come “home” for the upcoming 2015 conference that runs from Jan. 19 to Jan. 23.

 

The conference offers an array of education, innovation and networking programs. More than 300 high-caliber speakers share case studies, unpublished data, breakthroughs and solutions that can support and enhance attendees’ research. Ample networking opportunities allow everyone to connect with colleagues from around the world and gain new perspectives on the evolution of biologics.

 

Altogether, there are 20 conferences, 13 short courses, 3 training seminars and more than 80 BuzZ Session discussion roundtables from which to choose, with dedicated exhibit hall and poster viewing hours that allow attendees to create a custom agenda that fits their research agenda and schedule.

 

PepTalk is, of course, devoted to the large-scale study of protein structure and function, which govern, to a large extent, the metabolic pathways of cells. The proteome has been determined to be extremely complex and to vary with time and distinct requirements, or stresses, that a cell or organism undergoes. Proteomics is still an emerging exploration of protein systems and behaviors from the overall level of intracellular protein composition to structure to the proteome’s own unique activity patterns. In its complexity, the proteome is an important component of functional genomics, CHI notes.

 

“The year’s conference is devoted to biotherapeutics, upstream to discovery and downstream to production,” states Nicole Proulx, CHI’s director of product marketing. Underscoring the very significant breadth of the exploration of its theme, Proulx points out that this year’s plenary keynote speaker Prof. John Yates’ presentation is titled “From Yeast to the Brain.”

 

One of the features on tap to help attendees focus on specifics are the PepTalk preconference short courses, which are intense learning opportunities and an effective way to highlight the areas of emphasis in the effort to develop a better understanding of the proteome, its complexity and its myriad functions. For more information on those courses, see the sidebar article “A short guide to the PepTalk short courses” in this show preview section.

 

 

In addition to the short courses, Proulx notes that there are six “pipelines” within PepTalk 2015, with three meetings per pipeline, each one covering a highly relevant topic of current research interest. In addition to the 20 conferences, there will be three training seminars held concurrently with the conferences.

 

“In designing PepTalk, the team led by Mary Ann Brown, who is executive director of CHI conferences, scheduled each presentation to start and end at the same time so everyone can easily customize their own agenda,” Proulx says.

 

Pipeline One features meetings on recombinant protein therapeutics, enhancing antibody binding and specificity and improving the clinical efficacy of antibody therapeutics. Pipeline Two covers cancer targets for antibody therapeutics, antibody-drug conjugates and bispecific antibody therapeutics. Pipeline Three will address the issue of optimizing biologics formulation development and lyophilization and emerging drying technologies, as well as protein aggregation and emerging analytical tools.

The first of Pipeline Four’s meetings is on engineering genes, vectors, constructs and clones, with the other two being on recombinant protein expression and production and transient protein production. Pipeline Five covers characterization of ADCs, bispecifics and new biotherapeutics, detection and characterization of particulates and impurities and also extractables and leachables. Finally, Pipeline Six addresses single-use technologies and continuous processing, protein purification and recovery and higher-throughput protein purification.

 

In addition to pipelines, there are 80 breakout discussions where participants can join any table they want to attend, network and share knowledge. In addition to the 325 speakers from companies as varied as large pharmas and startup biotechs, the conference will feature 120 exhibitors, many with posters on view.

“We typically see a number of product launches,” Proulx observes, and she notes that PepTalk’s January timing is probably a favorable factor for more of that.

 

Another interesting feature is PepTalk’s BuzZ sessions. Each of the 20 to 30 tables has a designated host with 200 to 300 researchers in the room, “all talking at the same time,” Proulx states—hence the ‘buzz’ part of the name. “We’re trying to get scientists to step out of their comfort zone, discuss and collaborate,” she concludes.

 

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NEWS BRIEFS

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SAN DIEGO—The plenary keynote address at the PepTalk meeting is titled “From Yeast to the Brain: Advances in Proteomics” and will be held Wednesday, Jan. 21, at 4:25 p.m. The speaker is Dr. John R. Yates, Ernest W. Hahn Professor, Chemical Physiology and Molecular and Cellular Neurobiology, The Scripps Research Institute. As the PepTalk organizers note of the presentation, proteomic methods are advancing rapidly to allow studies of complex biological systems approaching the scale and speed of genomic methods. Nearly complete proteomes are possible to acquire, allowing far more sophisticated biological studies. In addition to advances in technology, quantitative proteomic studies using advanced proteomic methods to understand depression will be discussed during the keynote address.

 

Yates’ research interests include development of integrated methods for tandem mass spectrometry analysis of protein mixtures, bioinformatics using mass spectrometry data and biological studies involving proteomics. He is the lead inventor of the SEQUEST software for correlating tandem mass spectrometry data to sequences in the database and developer of the shotgun proteomics technique for the analysis of protein mixtures. His laboratory has developed the use of proteomic techniques to analyze protein complexes, post-translational modifications, organelles and quantitative analysis of protein expression for the discovery of new biology.

 

Many proteomic approaches developed by Yates have become resources to numerous investigators in the scientific community, both nationally and internationally. He has received the American Society for Mass Spectrometry research award, the Pehr Edman Award in Protein Chemistry, the American Society for Mass Spectrometry Biemann Medal, the HUPO Distinguished Achievement Award in Proteomics, the Herbert Sober Award from the ASBMB and the Christian Anfinsen Award from The Protein Society. He has published 751 scientific articles with approximately 57,000 citations.

 

 

SAN DIEGO—Selected students will qualify to present their posters to more than 1,200 protein science researchers while attending PepTalk, for as little as $295. Full-time graduate students and Ph.D. candidates were encouraged to apply for the PepTalk 2015 Student Fellowship, the application deadline for which was Oct. 24. Fellowship award winners will receive a poster presentation slot and a savings of over $900 on their registration fee.

 

Interested students were required to complete the 2015 Student Fellowship Application and to present a scientific poster. All applications were reviewed by the scientific review committee and accepted students notified in November.

This fellowship is limited to 20 students and is for the Premium Conference Package only. Accepted 2015 Student Fellows will be asked to help promote the conference at their college and throughout their social media networks.

 

CHI notes that the discounted rate cannot be combined with any other discounts for the event, and discounted registration does not grant access to any of the short courses or preconference events. It also does not include hotel, travel or meals.

 

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The PepTalk short courses are described as “intense learning opportunities” and as an effective way to highlight the areas of emphasis in the effort to develop a better understanding of the proteome, its complexity and its myriad functions. Held on Sunday, Jan. 18, from 5 p.m. to 8 p.m., the 13 areas of exploration cover the following:

 

SC1: Production Challenges for Complex Biologics: ADCs, Bispecifics and Fusion Proteins—This course addresses the typical production issues encountered with complex biologics, namely fusion proteins, antibody-drug conjugates and bispecific antibodies.

 

SC2: The S-Score System: A Tool for Identifying New Cancer Targets for Antibody-Drug Therapy—The course discusses a new method that aids identification and prioritization of predicted cancer genes for future analysis. It generates a gene-specific “S-score” by incorporating data from different analysis types.

 

SC3: A Rational Approach to Formulation Development of Biologic Therapeutics—As its title implies, this course offers a forum discussing how to develop formulation for biologic drugs.

 

SC4: Genome Editing Using CRISPR—Mammalian cells are the workhorses for biopharmaceutical production. Thus, genome engineering/editing of these hosts to improve product quality and yields are of great interest. CRISPR, the newest gene-editing tool, is gaining popularity among protein engineers and cell line developers.

 

SC5: Accelerated Stability Testing of Biologics—This short course guides the researcher in designing studies for accelerated stability testing of biologics, beginning with basic underlying concepts governing protein drug product stability, and focuses on design principles for measuring stress and accelerated stability testing.

 

SC6: Establishing the Business Case for Single-Use and Continuous Processing—This short course introduces attendees to the paradigm shift and a new way of economic and manufacturing considerations for implementing single-use systems and continuous processing.

 

SC7: Targeting of GPCRs with Monoclonal Antibodies—While GPCRs (G protein-coupled receptors) are important therapeutic targets, it has been challenging to discover therapeutically relevant antibodies against them. This course examines different steps along the anti-GPCR antibody discovery pathway and highlights various approaches to accomplishing each step.

 

SC8: Affecting Effector Function: Engineering the Fc Region—There are a growing number of antibodies and Fc fusion proteins in development that contain a modified Fc region, either via changes in amino acid sequence or in glycoforms. Engineering antibodies and Fc fusion proteins has become more sophisticated at generating molecules that are better suited to the pharmacological activity required.

 

SC9: Protein Aggregation: Mechanism, Characterization and Consequences—Protein aggregation is recognized by regulatory agencies and the biopharmaceutical industry as a key quality attribute of biotherapeutic products. Various aggregates hold the potential for adversely impacting production and patients in a variety of ways. This in-depth workshop reviews the origins and consequences of aggregation in biotherapeutics.

 

SC10: Transient Protein Production in Mammalian Cells—This short course introduces both the fundamental concepts and technologies needed to establish transient protein production in mammalian cells. This allows for the rapid generation, purification and characterization of milligram-to-gram quantities of secreted or intracellular recombinant proteins for therapeutic, functional and structural studies.

 

SC11: Materials in Contact with Biologics: Understanding Risk to Quality and Safety—Materials that contact biologics during manufacturing, storage and final packaging can pose risks to biopharmaceutical quality. This in-depth course reviews the regulatory requirements, types of materials used and material chemistry, and then examines the strategies for prediction and risk assessment of potential threats to quality and safety of biologics drug products.

 

SC12: Protein Purification Strategies: Dealing with Proteins that Are Prone to Aggregate—This course provides a comprehensive and detailed outline of hands-on issues for purifying proteins.

 

SC13: Continuous Processing of Therapeutic Proteins in Single-Use: Technology and Production Concept—The course demonstrates how each unit operation in a typical mAb process can be run continuously and also shows how these unit operations are integrated into a truly continuous process.

 

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PepTalk 2015 will feature three in-depth, two-day training seminars. One will explore bioprocessing, another covers formulation and delivery and the third addresses analytical method development and validation.

 

Jan. 19, 8:30 a.m.-5:30 p.m.

Jan. 20, 8:30 a.m.-12:30 p.m.

CHI’s Introduction to Bioprocessing training seminar offers a comprehensive survey of the steps needed to produce today’s complex biopharmaceuticals from early development through commercial offering. The seminar begins with a brief introduction to biologic drugs and the aspects of protein science that drive the intricate progression of analytical and process steps that follows. The presenters will then go through the stages of bioprocessing, beginning with the development of cell lines and ending at the packaging of a finished drug product. The seminar also will explore emerging process technologies, facility design considerations and the regulatory and quality standards that govern the industry throughout development. The important roles played by the analytical and formulation steps in developing and gaining approval for a biopharmaceutical are also examined. This one-and-a-half-day class is directed to attendees working in any aspect of industry, including scientific, technical, business, marketing or support functions, who would benefit from receiving a detailed overview of this field.

Dr. Susan Dana Jones is a seasoned biotechnology entrepreneur with experience in product development, outsourcing and strategic planning. Jones is a subject matter expert in cell line development and characterization for biosimilar, new biopharmaceutical and vaccine development programs. She has broad knowledge of regulatory requirements for manufacturing products for human use and has prepared CMC sections of multiple regulatory submissions. She currently serves on the board of directors of Gene Solutions, the scientific advisory board of Symphogen and is a member of the editorial advisory board of BioProcess International. She received her Ph.D. in genetics from the University of California, San Francisco.

Dr. Sheila Magil has more than 20 years of experience in quality and analytical method development for biologics, peptides and small molecules. Her expertise includes quality assurance, protein and peptide biochemistry and analytical development. She was formerly senior manager of analytical development and quality control at Biomeasure Inc., and previously held positions at WaratahPharma, Alkermes, Bion and HHMI at Massachusetts General Hospital. Magil has implemented quality systems and has managed external analytical and quality-control activities for multiple biopharmaceutical products and  holds a Ph.D. in biochemistry from the University of Minnesota.

 

Jan. 21, 8:30 a.m.-4:25 p.m.

Jan. 22, 8:30 a.m. -12:30 p.m.

This course focuses on strategies to plan and execute reformulation and formulation development studies for biologics, which require co-optimization of multiple physical, chemical and conformational stability attributes while operating under accelerated timelines to deliver the drug to the clinic. The course begins with an overview of biophysical and biochemical properties of proteins. A typical development workflow (including statistical analysis and DOE elements) will be outlined to demonstrate the core elements employed during protein formulation. The course concludes with real-world examples from formulation development projects for liquid and lyophilized products.

Dr. Tim Kelly has more than 20 years of experience in protein and nucleic acid characterization. In his role at KBI Biopharma, Kelly is responsible for analytical development, formulation development and quality control. Prior to joining KBI Biopharma, he held the position of director of quality control for Diosynth Biotechnology, where he was responsible for method validation, in-process control, release and stability of clinical and commercial biopharmaceutical products. Kelly’s experience also includes the analytical development, formulation development, characterization and/or production of more than 200 clinical and commercial protein therapeutics, including monoclonal antibodies, enzymes, cytokines, fusion proteins, PEGylated proteins, protein vaccines and peptides. He has led the successful formulation development of over 95 clinical and commercial biopharmaceutical products, including liquid and lyophilized dosage forms for intravenous and subcutaneous administration, at protein concentrations ranging from 10μg/mL to 200mg/mL. Kelly earned his Ph.D. in molecular genetics and biochemistry from Georgia State University.

 

Jan. 21, 8:30 a.m.-4:25 p.m.

Jan. 22, 8:30 a.m.-12:30 p.m.

This course is a panoramic review of analytical method development and validation for therapeutic proteins, including antibodies and enzymes. It is intended for scientists working on therapeutic proteins in analytical development, quality control, product development or related functional areas. It starts with basic knowledge of work on therapeutic proteins: manufacturing of proteins drugs, regulatory affair knowledge and protein chemistry. It then discusses fundamentals and practical aspects of commonly used analytical methods for proteins, including methods for structure elucidation, glycan characterization, biophysical characterization, potency measurement, purity and impurity analysis. The course concludes with the strategy and common practice in method validation and method transfer, including regulatory compliance at different stages of product development, application of DOE and QbD. The course emphasizes practical applications, real-world examples and useful tips.

Benefits of participating include gaining a complete picture of the analytical method development and validation process, as well as a basic understanding of commonly used analytical methods for proteins. According to CHI, those who should attend would primarily be analytical development scientists, process development scientists, quality control analysts, regulatory affair managers, project managers and quality assurance managers.

Dr. Jichao Kang holds a Ph.D. in pharmaceutics and has been working on characterization, method development and validation and formulation for protein therapeutics since 1995. He is an accomplished researcher, with over 15 peer-reviewed journal articles and book chapters, several patents and numerous conference presentations. The proteins he has worked on extensively include cytokines, antibodies, enzymes and protein conjugates. He is a key contributor in dozens of IND/IMPD and BLA/MAA filings. He is currently the director of analytical and formulation development at Gallus BioPharmaceuticals NJ LLC, one of the leading contract manufacturing organizations for biologics, and held the same position at Laureate BioPharma before it was acquired by Gallus. Prior to Laureate, he was the department head of Analytical Development at Auxilium Pharmaceuticals Inc., and was a key contributor in Auxilium’s successful marketing application of Xiaflex in both the United States and European Union. He also worked in MedImmune, PDL and Neose Technologies.

 

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In addition to all the “standard” PepTalk activities, there will also be two Accompanying Conferences. The first, running Jan. 21 to 22, will discuss membrane proteins as “ the gateways to the cell” and, thus, valuable drug targets. To design better-targeted drugs, researchers must know their structure and functional characteristics. But determining them is difficult because of the large amounts of membrane protein needed. Sources are scarce due to the practical problems of working with membrane proteins in expression, purification and crystallization. The membrane proteins conference addresses strategies and solutions for their extraction, expression and purification, along with case studies showcasing their value as an antibody drug target.

The second Accompanying Conference, also occurring on Jan. 21 to 22, will focus on CHO cells. To meet the huge demand for recombinant proteins, advances in CHO cell culture technology continue to significantly improve production. This achievement is due to progress in both engineering stable and transient cell lines as well as optimizing the cell culture process. When both are accomplished, higher-production titers and better product quality result. The CHO cells conference gathers cell culture specialists and cell line engineers to explore the latest data, tools and strategies for improving biotherapeutic protein production, expression and product quality.

 

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Needham, Mass.-based Cambridge Healthtech Institute (CHI) considers itself to be the preeminent life-sciences network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHI’s portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Cambridge Marketing Consultants, Barnett Educational Services, Cambridge Meeting Planners and CHI’s Media Group, which includes news websites and e-newsletters such as Bio-IT World and Clinical Informatics News.

 

Founded in 1992, Cambridge Healthtech Institute strives to develop quality information sources that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments. Basic research related to commercial implications is covered, with heavy emphasis placed on end-user insights into new products and technology as well as coverage on the strategy behind the business.

 

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As the largest privately owned resort and convention center in San Diego, the Town and Country Resort Hotel & Convention Center, this year's location for PepTalk, has hosted successful conventions and meetings for more than five decades.

 

The experienced staff provides conference organizers with assistance from the initial planning stages to the implementation of a very successful meeting and exposition. The resort features more than 1,000 guest rooms and 200,000 square feet of flexible meeting space and elegant banquet halls, including the new state-of-the-art 41,000-square-foot Grand Hall and Plaza Pavilion.

 

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“It was a great program and as mostly with CHI, I received a lot of inspiration for my current work. In addition, there were ample opportunities to network with old friends and new contacts. I have to congratulate you and [your] colleagues to again set high standards for THE protein conference.”

 

“PepTalk provides access to the cutting-edge research in protein expression and analysis, and brings together a very large group of both academic and industrial scientists, who have a very broad prospective on all the key subjects in the field. It provides excellent opportunity for generating new ideas and networking with the leaders in the field.”