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THE Industry Meeting Place to Exchange Real-World Solutions to Improve Speed, Cost and Quality

Conference: October 26-29, 2015 · Exhibition: October 17-19, 2015 · John B Hynes Veterans Memorial Convention Center · Boston, MA

Preliminary Agenda of Confirmed Speakers

Preliminary Agenda of Confirmed Speakers

Keynote Speakers

David J. Pollard, Ph.D.

Innovating Antibody Production to Support the Immunotherapy Revolution
David J. Pollard, Ph.D.
Executive Director, BioProcess Development
Merck & Co. Inc

Spencer Fisk

Innovative Process Development Strategies to Drive the Rapid Clinical Introduction of Emerging Biologics
Spencer Fisk
Global Head, Biologics Process Research and Development
Novartis, Switzerland

Pre-Conference Workshops
Monday, October 26, 2015

Workshop #1:
Antibody-drug Conjugate (ADC) Development and Production

Workshop #2:
Bispecific Antibody Development and Production

Workshop #3:
Cell Therapy Bioprocessing

Workshop #4:
Innovation through Integrated Process Development

Two-Day Training Courses
Monday-Tuesday, October 26-27, 2015

CMC Analytical, Comparability and Stability Studies
Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC

Introduction to Biopharmaceutical Manufacturing
Sheila G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants
Susan Dana Jones, Ph.D., Senior Consultant, BioProcess Technology Consultant

Main Conference
Tuesday-Thursday, October 27-29, 2015

Manufacturing Strategy Track

A Successful Lean Manufacturing System in a Biologics Manufacturing Plant
Richard Reineke, Director, Upstream Manufacturing, Amgen, Inc.

Therapeutic Protein Production On-Demand
Govind Rao, Ph.D., Professor and Director, Center for Advanced Sensor Technology, University of Maryland, Baltimore County

Manufacturability Considerations during the Development of a Phase III Cell Culture Process for the Production of an IgG4 Antibody
Marcella Yu, Ph.D., Staff Scientist II, Commercial Cell Culture & Development, Genzyme, a Sanofi Company

Design of a Clinical Manufacturing Facility Strategically Aligning Single-use and Fixed Equipment
Sourav Kundu, Ph.D., Director, Biopharmaceutical Development, Teva Biopharmaceutical USA

Single Use Standardization - Town Hall Forum
James Vogel, Founder and Director, The BioProcess Institute

Condensed Playbook for Continued Process Verification (CPV)
Marcus Boyer, Associate Director of Process Life-cycle Management, Bristol-Myers Squibb

Implementing Continued Process Verification (CPV) for Legacy Products
Bert Frohlich, Director, Technology Development, Shire

Continued Process Verification (CPV) Informatics Systems and Validation
Carly Cox, Senior Process Engineer, Pfizer

Closed Processing and Sanitizing Temporary Openings
Kavita Ramalingam Iyer, Senior Process Scientist, Merck, Inc.

Importing Best Practice into Raw Material Change Notification
Shamini Nathen, Senior Quality Engineer, Bristol Myers Squibb

Analytical, Formulation and Quality Track

Implementing Multi-Attribute LC/MS Methods for More Informed Process Development
Matthew Traylor, Analytical Scientist, Process Development, Shire

Big Data Concepts in Biologics: Applied Statistics and Advanced Analytics
Greg Stromberg, Senior Manager, Process Analytics, Global Manufacturing Sciences, Biogen Idec

Rapid Microbiological Methods for Real-Time Release of Autologous Cell Therapy Products
John Duguid, Principal Scientist, Vericel Corporation

High Throughput Analytics to Support Process Development of Non-mAb Glycoproteins
Bernice Yeung, Ph.D., Analytical Development, Rare Disease Unit, Shire Pharmaceuticals

Connecting Analytical Technologies to Critical Quality Attributes: Experiences that Facilitated Approval of a Live-virus Vaccine
Michael Washabaugh, Ph.D., Senior Director, MedImmune

Critical Quality Attribute (CQA) Assessment - From Theory to Practice!
Marco Thomann, Ph.D., Group Leader, Development Analytics, Roche Diagnostics GmbH, Germany

High-throughput Product Quality Attribute Testing for Rapid Process Development
Veera Padmanabhan, Ph.D., Director, R&D, MedImmune

Quality by Design in Biosimilar Development: Enhanced Process Knowledge for Targeting Product Quality
Dénes Zalai, Ph.D., Candidate, Vienna University of Technology, Austria

Connecting Developability and Formulation Development
Valentyn Antochshuk, Ph.D., Principal Scientist, Group Leader, Formulation Design and Process Compatibility, Merck & Co.

Opportunities and Challenges of High Concentration Biologics: Case Studies
Mark Moody, Ph.D., Chief Scientific Advisor, ReForm Biologics

Phase Appropriate Formulation Development Strategies
Moumita Bhattacharya, Ph.D., Senior Scientist, Merck

CHO Host Cell Proteins and Impacts on Product Formulation
Kelvin H. Lee, Ph.D., Gore Professor of Chemical & Biomolecular Engineering and Director, Delaware Biotechnology Institute, University of Delaware

Analytical Session Chairman
Johnson Varghese, Ph.D., Senior Director/Head, Analytical Development, Shire

Drug Product Manufacturing & Fill-Finish Processing Track

Case Study on Drug Product Manufacturing and Fill-Finish Processing for Biologics
Kevin Maloney, Principal Scientist, Protein Pharmaceutical Development, Biogen Idec

Collaboration to Reduce Particulate Ingress via Stoppers
Presenter TBA, Biophorum Operations Group (BPOG) Stopper Team

Impact of Hydrogen Peroxide on a Lyophilized Product during Fill Finish Process
Weiqiang Cheng, Ph.D., Processs/Analytical Scientist, Genzyme, a Sanofi Company

Streamlining Biological Drug Development to Ensure Manufacturing Continuum from Drug Substance to Drug Product: Phase-Specific Strategies to Improve Success
Suketu Desai, Ph.D., Vice President, Biologics Development, Drug Substance and Drug Product R&D, Allergan, Inc.

Single Use: Adding Flexibility to Fill Finish
Christopher Smalley, Ph.D., Director, Engineering, Global Technical Operations, Merck & Co.

Early Stage Biologics and Early Stage Companies Track

Biophysical Properties of Antibody Drugs: Predicting and Engineering Developability
K. Dane Wittrup, Ph.D., C.P. Dubbs Professor, Chemical Engineering & Biological Engineering; Associate Director, Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology

Phase Appropriate Specifications for Biologics - Strategies for Early Stage Biologics and Early Stage Companies
Melissa Morandi, Vice President Quality, Acceleron Pharma, Inc.

Biological Drug Development from Clone to Clinical to Commercial: Phase-Specific Strategies to Improve Success
Suketu Desai, Ph.D., Vice President, Biologics Development, Drug Substance and Drug Product R&D, Allergan, Inc.

Rapidly Accelerating Biologics Development through Use of CMOs
Susan Dexter, Principal Consultant, Latham Biopharm Group

Recovery & Purification Track

The Use of a Scalable High-Throughput Method to Characterize and Optimize the PEGylation of a Recombinant E.coli Derived Enzyme
Christopher Miller, Senior Process Development Scientist, Downstream Process Development, KBI Biopharma

Data Based Comparison of Capture and Polishing Steps in a Mab Process
John Schreffler, Ph.D., Group Leader, Purification Process Development, Eisai

Preparative Scale Monoclonal Antibody Purification Using Displacement Chromatography
Prashant Kardekar, Senior Scientist, Team Lead, Biologics, Dr. Reddys Laboratories Ltd., India

Use of Mechanistic Modeling to Improve Process Understanding and Control of Polishing Chromatography Steps for Fc-Fusion Proteins
Xuankuo Xu, Ph.D., Senior Scientist, Biologics Process Development, Bristol-Myers Squibb

At-line Process Analytical Technology (PAT) for Feed-forward Control and More Efficient Scale Up of Biopharmaceutical Microfiltration Unit Operations
Douglas Watson, Ph.D., Senior Process Engineer, Merck Manufacturing Division, Merck & Co., Inc.

A Risk Based Strategy for Implementing Disposables in a Commercial Manufacturing Process
Chad Atwell, Associate Director, Manufacturing Science and Technology, Genzyme

Hydrophobic Interaction Chromatography (HIC) Step Process Improvement in a Legacy Recombinant Human Enzyme Manufacturing Process
Rohit Ingale, Ph.D., Process Engineer III, Manufacturing Sciences and Technology (MSAT), Genzyme Corporation, a Sanofi Company

A Universal Non-Affinity Purification Platform for Toxicity and Phase I Trials
Pete Gagnon, M.S., Group Manager, Downstream Processing, Bioprocessing Technology Institute, Singapore

Antibody Unfolding/Aggregation on Macroporous and Polymer Grafted Cation Exchange Resins
Giorgio Carta, Ph.D., Lawrence R. Quarles Professor, Department of Chemical Engineering, University of Virginia

Perfusion and XD Process Characterization, Building Robustness to Control Product Quality
Shaun Eckerle, Principal Scientist, Cell Culture Development, Patheon Biologics

Cell Culture & Upstream Processing Track

Transcriptomics of CHO Pipeline Clones with Respect to Inherent Bioprocess Properties
Wolfgang Budach, Ph.D., Lead Late Phase Process Development, BPRD, Novartis Pharma AG

Glycosylation of Non-mAbs
Christopher Barton, Ph.D., Senior Scientist, MedImmune

Mammalian Cell Culture Process Improvement Using Chemically Defined Media Via High Throughput Screening and Scale Up Production of a Monoclonal Antibody
Jianlin (Jim) Xu, Ph.D., Senior Scientist II, Biologics Process Development, Bristol-Myers Squibb

Application of Quality by Design (QbD) Principles to the Development, Characterization and Scale-up of a Late Stage Perfusion Cell Culture Process
Tom Hayes, Process Engineer III, Commercial Cell Culture Development, Genzyme, A Sanofi Company

Application of Novel Reactor Control Strategies for Upstream Bioprocess Development
Jessica Whelan, Ph.D., Director, Tech Operations, Process Development, APC Ltd

Modeling of Glycosylation
Michael Butler, Ph.D., Professor of Microbiology, University of Manitoba, Canada

Mitigating Scale up and Process Challenges for a High Cell Density CHO Perfusion Process in Single Use Bioreactors
Hang Yuan, Ph.D., Associate Director, BioProcess Development, Shire

Accelerating Bioprocessing of Virus-Based Products Using Real-Time Direct Affinity Quantification
Michael Olszowy, Ph.D., Chief Technology Officer, ViroCyt

From Upstream to Downstream: Large-Scale, High Titer Transient Transfection Platform for Biomanufacturing
Weili Wang, Ph.D., Principal Scientist, Protein, R&D, MaxCyte

Performance Consistency of Platform Fed-Batch Cultures Across Multiple Systems Used in Industrial Process Development
Matthieu Stettler, Ph.D., Manager, Biotech Process Sciences, Merck Serono SA

High Cell Density Fermentation of Microorganims for Production of Chemicals Using New Disposable High Throughput Ambr250™ Technology
Alison Arnold, Ph.D., Head of Fermentation and Microbiology, Ingenza Ltd, United Kingdom

Impact of an Accurate, Reliable, High Throughput Nutrient and Metabolite Analyzer Used in Cell Culture, Media Development, and Fermentation

Speaker TBA, Roche

Case Study: Accelerated Late Stage Cell Culture Process Development to Facilitate Tech Transfer and Ensure Success at Scale with Accelerated Timelines
Yunling Bai, Ph.D., Senior Research Scientist, Upstream Process Development, Gilead Sciences, Inc.

Cell Therapy Bioprocessing Track

Automated iPSC Culture Process
Wen Bo Wang, Ph.D., Vice President, Process Sciences, Cellular Dynamics International (CDI)

Development of a Lentiviral Vector Production Process by Transient Transfection in Serum-Free Suspension Culture for CAR-T Immunotherapy
Qi Wei, Ph.D., Senior Scientist, Cell and Gene Therapy, Novartis

ADC Development & Production Track

Overcoming Challenges and Enhancing Production of Antibodies for Site-Specific Antibody-Drug Conjugates
Marie Zhu, Ph.D., Head of Process Sciences & Manufacturing, Process Sciences & Manufacturing, Agensys Inc.

Charles River