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Key Sessions

Matt Shields

Engineering Aspects and Practical Experience from Amgen’s Singapore Next Generation Manufacturing Facility

Amgen Singapore Manufacturing, Singapore

John Lambert, Ph.D.

The Success and Future of ADCs

ImmunoGen, Inc.

7 am 7:55 am (55 mins)

Registration and Coffee

7:55 am 9:30 am (95 mins)

Session Sponsored by 3M

7:55 am 8 am (5 mins)

Chairperson’s Remarks

  • Amitava Kundu, Associate Director, Technical Operations, Takeda Pharmaceutical

8 am 8:30 am (30 mins)

Across the Great Divide: The Upstream Origins and Downstream Ramifications of a Newly Discovered Contaminant Class

  • Peter Gagnon, Vice President, Peregrine Pharmaceuticals Inc.

8:30 am 9 am (30 mins)

Comprehensive Study of Different Harvest Technologies Under Several Biological Systems

  • Juan Lagos, Senior Scientist, Upstream Process Development, Patheon Biologics

9 am 9:30 am (30 mins)

Comparison of Clarification Technologies & Selection for Viral Vector-based Vaccines

  • Dr. Paul Ko, Senior Scientist, Cell Technologies , Janssen Research & Development

7:55 am 8 am (5 mins)

Chairperson's Remarks

  • Susan Jones, Ph.D., Vice President and Principal Consultant, BioProcess Technology Consultants

8 am 8:30 am (30 mins)

Optimizing Transition Points for Multiple Modalities - Thinking Beyond mAbs

  • Martin J. Allen, Ph.D., Senior Director, BioProcess Research & Development, Pfizer

8:30 am 9 am (30 mins)

Early Risk and Developability Assessment Approaches

  • Sheri Nidositko, Ph.D., Fellow/Lab Head, Cell Line Development and Protein Production, Integrated Biologics Profiling, Novartis

9 am 9:30 am (30 mins)

Application of Process Optimization in Preclinical Manufacturability to Achieve Stable High Level Expression of Protein Therapeutics

  • Lynette Buck, Senior Associate Scientist, Drug Substance PD, Amgen Inc.

7:55 am 8 am (5 mins)

Chairperson’s Remarks

  • Kevin Maloney, Director, Technical Development, Biogen

8 am 8:30 am (30 mins)

Challenges from Drug Substance to Drug Product, A Case Study on Resolving Solubility and Stability Issues of a Tough Protein Molecule

  • Weiqiang Cheng, Ph.D., Senior Scientist, Drug & Combination Product Development, Shire

8:30 am 9 am (30 mins)

Lyophilization Cycle Tech Transfer – Strategies to Ensure Success

Transfer of lyophilization cycles must carefully consider characteristics of the lyophilizers in question to design an appropriate lyophilization cycle.   A paradigm that focuses on product temperature profile, rather than equipment recipe maximizes the probability of success.   This talk provides a list of considerations during scale up, including a case study depicting analysis of data from an engineering run and modifying the process prior to production.

  • Dan Dixon, Senior Manager, Technical Services, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.

9 am 9:30 am (30 mins)

Drug Product Manufacturing Challenges Due to Dissolved Gas in Drug Substance & Mitigation

Drug substance (DS) manufacturing steps can lead to an increase indissolved gas and entrapment of bubbles. These bubbles can be stabilized in theDS when stored in stainless steel tanks under positive pressure, which cancause challenges during the Drug Product (DP) manufacturing process. Forexample, bubbles can accumulate in the filling line and cause significant fillweight fluctuations, potentially leading to product or lot rejection. Here, wepresent a case study describing manufacturing challenges due to the presence ofbubbles and investigate DS degassing as a mitigation option. The parametersthat were evaluated at development and manufacturing scale included DS volume,temperature, degassing pressure, tank size and protein concentration on bubblereduction and degassing efficiency. Results from this study were used todevelop an empirical predictive model for degassing effectiveness as a functionof these parameters. Subsequently, the degassing process was successfullyimplemented at the DP manufacturing site.

  • Suresh Choudhary, Associate Scientist, Formulation Sciences, MedImmune LLC

7:55 am 8 am (5 mins)

Chairperson’s Remarks

  • Bill Whitford, Strategic Solutions Leader, BioProcess , GE Healthcare Life Sciences

8 am 8:30 am (30 mins)

DOE and Predictive Modeling to Improve Decisions on the Manufacturing Floor

Biopharmaceutical manufacturing often involves many unit operations. The efficiency and robustness of these processes can determine both the quality of product produced and the overall efficiency of the manufacturing floor. This talk will introduce the statistical tool of Design of Experiments and how they can enable a more profitable manufacturing process while reducing waste and inefficiency.

  • Martin Kane, Managing Data Scientist, Exponent

8:30 am 9 am (30 mins)

The Use of Predictive Models to Transform Drug Product Development Paradigms – A Case Study on Drug Product Mixing

Advanced first principle models like CFD modeling are used to transform the way we approach traditional Drug Product Development. Here, we present a case study on how CFD models were used in combination with experiments to generate data packages for single use mixers, that helped us transform our development and tech-transfer strategies.

  • Suresh Nulu, Senior Engineer II, Biogen

9 am 9:30 am (30 mins)

Maximizing the Value of Commercial Scale Data: A Case Study

Product lifecycle management is a critical enabler to allow the full realization of the commercial potential and long term value of a product. It is typical to associate product lifecycle management with major changes such as new formulations, new delivery devices, next generation processes etc., however, an important facet of this process is the enhancement of value derived from the improvements that are possible from continued process verification (CPV). Commercial bioprocess manufacturing facilities generate considerable amounts of process data which are routinely used for process monitoring. These process data also provide significant opportunities to further understand the interaction between operating parameters, process equipment and raw materials to enable improved process control and optimization. This talk will present case studies whereby significant process improvements were implemented for a complex protein biologic through the introduction of new process analytical technology and through the application of knowledge derived from CPV. These improvements led to significant increases in overall process robustness and increased overall yield by >25% with minimal regulatory impact.

  • Tom Mistretta, Principal Engineer, Process Development, Amgen, Inc.

7:55 am 8 am (5 mins)

Chairperson’s Remarks

  • Ming Lei, Senior Research Associate, Protein Analytical Chemistry, Genentech

8 am 8:30 am (30 mins)

Analytical Assay Design and Automation for CAR T-cell Therapy

Entering a new era of innovation for CAR-T therapy, we moved on from the era of a cottage industry in relation to manufacturing science and now realizing true scalability of autologous T cell therapies. Unknown attributes in manufacturing process enhance risk for product quality. Exponential increase in the complexity of analytics requires speed up innovation in assay development toensure consistent and quality cellular products for patients. In a short term,we developed a series of ground breaking and innovative analytical assays including a single cell based tumor antigen-specific potency assay, which is rapidly converted to an automated high-throughput platform for a walk away operation.

  • Junxia Wang, M.D., Ph.D., Principal Scientist, Cell and Gene Therapy, Novartis Institutes for BioMedical Research

8:30 am 9 am (30 mins)

Use of Slope Measurement for Increased Throughput of Concentration Determination of Antibody-drug Conjugates (ADCs)

The traditional approach to measuring antibody, payload and ADC concentration is based on fixed pathlength measurement by UV-Vis absorption spectroscopy, which requires use of dilutions that are time consuming and prone to error. With the use of variable pathlength technique, sample dilution is no longer required, thus allowing for much faster turnaround time. In this presentation, we will review our evaluation of SoloVPE UV-Vis spectrophotometer, and discuss its applicability for use in supporting ADC manufacturing.

  • Sonia Taktak, Ph.D., Analytical Scientist III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

9 am 9:30 am (30 mins)

Analytical Characterization of ADCs Conjugated through Lysines

Antibody-drug conjugates (ADCs) have been explored as novel cancer therapies due to their targeting ability.  For ADCs conjugated through lysines, a highly potent cell-killing agent, called a payload,  is attached via a stable linker, such as SMCC, to monoclonal antibodies through modification of ε-amino groups of lysine amino acids. The goal for lysine conjugated ADCs (e.g., mAb-SMCC-DM1) is an average of three to four payload molecules per antibody molecule. Besides the regular mAb physicochemical parameters, additional parameters need to be characterized for ADCs conjugated through lysines since the small molecule conjugation adds more complexity to the antibody. In this talk, these specific parameters for the SMCC-DM1 conjugates such as average payload molecule to antibody ratio (known as DAR), drug distribution, free drug, occupancy sites and level on modified lysines are assessed by UV, SEC/MS, imaging cIEF, RP and peptide mapping respectively. Characterization of the SMCC-DM1 conjugates with three different DAR values (1.7, 3.0 & 4.8) will also be presented.

  • Hongling Han, Ph.D., Principal Scientist, Integrated Biologics Profiling, Novartis

9 am 5 pm (480 mins)

CMC Analytical, Comparability and Stability Studies

This course provides a comprehensive overview of the phase-specific requirements for CMC analytical characterization, comparability, release and stability of biotechnology products from the preclinical phase through clinical trials to commercialization and post-approval. Analytical considerations for a wide variety of biopharmaceuticals are discussed, including monoclonal antibodies, therapeutic proteins, gene therapy, vaccines, and complex products (e.g. antibody drug conjugates). Details are presented on establishing and maintaining product reference standards, designing successful comparability tests (including specifics for biosimilar studies), setting meaningful product specifications, conducting forced degradation studies, technology transfer and bridging changes in analytical methods and generating effective stability protocols. Critical elements of laboratory quality practices that significantly impact the reliability of test data from R&D through cGMP are illustrated.

  • Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC

9 am 5 pm (480 mins)

Introduction to Biopharmaceutical Manufacturing

This course provides a fundamental understanding of biopharmaceutical manufacturing. Organized along the development path, the course will describe the activities necessary to bring a biopharmaceutical from discovery to market. Included in the course will be the analytical, quality and regulatory challenges as well as the technical activities required. The instructors will discuss how development activities integrate and the best practices for drug substance and drug product production. At the conclusion of the course the attendee will have learned the steps needed to develop and produce a safe and effective biopharmaceutical that meets industry and patient needs. Identified during the course will be how to implement QbD in development and communicating with regulatory agencies throughout development.

  • Sheila G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants
  • Frank Riske, Ph.D., Senior Consultant, BioProcess Technology Consultants

9:30 am 10:30 am (60 mins)

Pall Biopharmaceuticals' Leader Provides an Update on Significant Technology Advances Enabling Integrated Continuous BioProcessing

  • Michael Egholm, VP and General Manager, Pall Pharmaceuticals

10:25 am 10:30 am (5 mins)

Chairperson's Remarks

  • Andrew Tustian, Eng.D., Associate Director, Preclinical Manufacturing and Process Development, Regeneron Pharmaceuticals, Inc.

10:30 am 12 pm (90 mins)

Session Sponsored by 3M

10:30 am 11 am (30 mins)

Single-Use Primary Capture Technology with the Promise to Deliver New Standards for the Economics, Convenience and Reliability of mAb Bioprocessing

  • Oliver Hardick, Ph.D., CEO, Puridify Ltd., United Kingdom

11 am 11:30 am (30 mins)

Process Development for the Enzyme- Mediated Manufacture of a Site-Specific ADC for Early Clinical Trials

  • Birte Nolting, Ph.D., Senior Principal Scientist, Biotherapeutics Research and Development, Conjugation and Polytides Process Development, Pfizer

11:30 am 12 pm (30 mins)

Hybrid Filters: An alternative to Chromatography?

  • Dr. Abhiram Arunkumar, Scientist I, Biologics Process Development, Bristol-Myers Squibb Company

10:30 am 12 pm (90 mins)

Session Sponsored by Pall Life Sciences

10:30 am 11 am (30 mins)

Presentation Title and Presenter TBA

11 am 11:30 am (30 mins)

Hi-Intensity Upstream Processes Enabling an Integrated Continuous Bioprocess

  • Matthew Gagnon, B.Eng, Senior Scientist, BioProcess Research & Development, Pfizer, Inc.

11:30 am 12 pm (30 mins)

End-to-End Integrated Continuous BioProcessing Platform for Biologics Manufacturing

  • Engin Ayturk, Ph.D., R&D Manager, BioPharm Applications R&D, Pall Corporation

10:30 am 11 am (30 mins)

INTACT Filling: A Safer Drug Product Filling Technology in a CNC environment

  • David Miller, Manager, Device Performance Engineering , Medinstill Development LLC

11 am 11:30 am (30 mins)

Stability Test Work to Show Vaccine Compatibility with Aseptic Blow/Fill/Seal Technology

Blow/Fill/Seal technology (BFS) is a known advanced aseptic technology within the pharmaceutical industry.   In recent years it has been introduced to the biotech and vaccine industries as an alternative to pre-formed glass and plastic containers.   The BFS aseptic fill/finish system offers a robust single use container with integral closure system that can be customized to the delivery volume of the product.

As part of a Bill & Melinda Gates Foundation grant the, objective is to test a set of prioritized vaccines (IPV, HPV, PCV, Penta RSV, Ebola, HIV, and Malaria) with Blow/Fill/Seal technology to determine if the products are compatible with the filling process, primary packaging materials and demonstrate stability upon storage.   Currently there are very few vaccines that have been tested and to date no injectable vaccines.   By filling the various vaccines in BFS a data set will be produced that would allow vaccine manufactures to consider using BFS technology commercially.    BFS technology offers formats that have small cold chain footprints, are very robust and that are unit-of-use doses – reducing wastage that is associated with multi-dose packaging. The presentation will show data that has been generated by the study at the time of the conference.   The study runs until ten vaccines have been tested.

  • Tim Kram, General Manager, Rommelag Engineering
  • Otto Schubert, General Manager, Rommelag CMO

11:30 am 12 pm (30 mins)

Controlled Nucleation for Lyophilization – Ensuring Robustness of Nucleation through a Mechanistic Understanding of the Technology

Controlled nucleation is a technology which promises improvements in lyophilization process throughput and consistency.   In this talk, we further examine the benefits of the technology for high fill-volume configurations and present new data regarding the mechanism of the Praxair ControLyoTM technology.   A more complete understanding of the mechanism of nucleation ensures more robust freezing when scaling from the lab to commercial-scale.

  • Jacob Luoma, Engineer 1, Pharmaceutical Processing and Technology Development, Genentech, A Member of the Roche Group

10:30 am 12 pm (90 mins)

Session Sponsored by GE Healthcare

10:30 am 11 am (30 mins)

Practical Considerations for Bioproduction Expansion into China

Capacity expansion is a dynamic process that involves analyses of production technologies, automation integration schemes, technology transfer, and ongoing support planning. When this expansion involves entering new regions, the planning as well as execution becomes even more thought-provoking. In this presentation we will present some dynamics that influenced our expansion strategy in China.

  • Matt Roberge, Senior Director of Emerging Markets, Global Technical Services, Pfizer

11 am 11:30 am (30 mins)

A Global Technology Roadmap for Biopharmaceutical Manufacturing: An Update from BPOG

  • Bert Frohlich, Ph.D., Director, Strategy and Technology Lifecycle, Manufacturing Sciences & Technology, Shire
  • Thomas Ryll, Ph.D., Vice President, Process and Analytical Development, Immunogen

11:30 am 12 pm (30 mins)

Footprinting our Drugs: Biologics Process Mass Intensity Tool

  • Bonnie Shum, Engineer, Global Biologics Manufacturing Sciences and Technology, Genentech, Inc., A Member of the Roche Group

11 am 11:30 am (30 mins)

Innovative Methods in Quantitating Host Residual DNA in Biologic Drugs

The manufacturer of biologic drugs has a regulatory obligation todemonstrate the level of host cell impurities, such as, host cell DNA, in thepurified drug. The current method for the host residual DNA (hrDNA)quantification is DNA extraction followed by qPCR. We have developedextraction-free qPCR method so that drug samples can be digested with aprotease and directly subjected to qPCR with high accuracy for hrDNAquantification. We have applied similar extraction-free methodology with Droplet DigitalTM PCR (ddPCRTM)technology in orderto further improve the hrDNA quantification method.

  • Musaddeq Hussain, Ph.D., Principal Scientist, BioProcess Development, Merck Research Laboratories

11:30 am 12 pm (30 mins)

An Automated High Throughput AlphaLISA Assay for Host Cell Protein Quantitation in Early Stage Bioprocessing

Quantitation of Host Cell Protein (HCP) is critical for bioprocesssamples to ensure drug product safety. In early stage bioprocessing, testing alarge number of samples in various conditions is essential. Since theconventional ELISA method is expensive and labor-intensive, an automated andcost-effective AlphaLISA assay is developed to perform high throughputscreening. Compared to ELISA, the AlphaLISA assay has a 10 times broaderdynamic range and 30% of the cost. When coupled with a robotic liquid handler,the fully automated AlphaLISA assay not only improves the efficiency andreproducibility but also reduces the assay variability and hands-on operationtime significantly. This assay is further optimized to achieve better accuracyand robustness, and generate comparable results to the standard ELISA method. Havingperformed this method in several campaigns, we conclude that the AlphaLISAassay is suitable for HCP quantitation in early stage bioprocessing.

  • Zhichao Fang, Ph.D., Scientist, Process Development, Bristol-Myers Squibb

12:05 pm 12:35 pm (30 mins)

BIA Separations: HPLC fingerprinting approach for increased speed and flexibility of PAT

High complexity of the samples also reflects in complex chromatograms what makes their analysis particularly challenging. Modern computational algorithms enable us to overcome the obstacles of analysing complex sets of data efficiently and enable us to extract the patterns which are intricately masked in the abundance of chromatographic fingerprints of protein and virus related samples.

  • Sebastijan Peljhan, Ph.D.

12:05 pm 12:35 pm (30 mins)

A Systematic Approach to Engineering Antibody Expression

  • Claes Gustafsson, Ph.D

12:05 pm 12:35 pm (30 mins)

Accelerating Biotherapeutic Development using Scalable CHO Cell Transfection

MaxCyte’s high performance, scalable electroporation technology has the unique ability of facilitating rapid identification and progression of superior candidates, as well as accelerating the generation of stable cell lines for manufacturing.  This workshop presents data using flow electroporation for CHO-based production of multiple grams of antibodies, its scalability, and its use for generation of high-yield stable cell lines.

  • Joan Hilly Foster, Senior Field Application Scientist, MaxCyte, Inc.

12:05 pm 12:35 pm (30 mins)

IgG purification: Better, Faster, Cheaper.

This case study will highlight the obstacles in antibody purification that make it more difficult than it needs to be, and illustrate methods that enable the levels of performance modern purification tools should be capable of. Extensive analytical data from purification of biosimilar candidates will be presented demonstrating adaptation to batch and continuous processing formats

  • Peter Gagnon, Vice President, Peregrine Pharmaceuticals Inc.

12:05 pm 12:35 pm (30 mins)

Strategies for optimized cell culture medium design

Cell culture media play an important role in the design of biopharmaceutical processes. Many factors contribute to an optimal medium performance. Here, we highlight how high-throughput methodologies and strategic statistical design were implemented in our medium optimization efforts. We present case studies using this approach to increase titer and influence product quality.

  • Kalle Johnson , Manager , Ge

12:40 pm 1:40 pm (60 mins)

Go Beyond: How the Biopharma Risk Equation is Changing and Strategies to Manage for the Future

  • Andrew Bulpin, Ph.D., Executive Vice President, Head of Process Solutions, MilliporeSignma

12:40 pm 1:40 pm (60 mins)

Fast Track to Your Qbd Approach – Integrated Bioreactor, Sensor and Software Platform to Accelerate Antibody Development

  • Dr. Christel Fenge, VP Marketing and Product Management, Fermentation Technologies, Sartorius Stedim Biotech GmbH

12:40 pm 1:40 pm (60 mins)

Sample automation on Cedex Bio HT with SEG-FLOW

Panel Discussion: Factors Merck considered for selection of an auto-sampling technology and process management systems: lessons learned (sterility, workflow, sampling time, efficiency gains, etc) with Flownamics SEG-FLOW on-line sampling system and Cedex Bio HT and Cell counter analyzers.

 Panel Members:

  • Panellist Kristin O'Neill, Associate Principal Scientist , Merck
  • Panellist Ankit Mehta, Scientist, Merck
  • Panellist Paul Strand, Application Engineer, Flownamics
  • Panellist Steve Grimme, Field Application Consultant, Roche Diagnostics

1:50 pm 1:55 pm (5 mins)

Chairperson’s Remarks

  • Michael Butler, Ph.D., Chief Scientific Officer, National Institute of Bioprocessing Research & Training (NIBRT)

1:55 pm 2:25 pm (30 mins)

Novel Technologies to Characterize Clone Productivity

  • Tanner Nevill, Ph.D., Director, Product Applications, Biopharma, Berkeley Lights, Inc

2:25 pm 2:55 pm (30 mins)

Enhancements to the CHOZN Expression Platform: Faster and Safer Expression of Biologics Through Cell Line Engineering

  • Scott Bahr, Senior Scientist, Cell Line Development & Engineering, MilliporeSigma

1:50 pm 3:10 pm (80 mins)

Session Sponsored by 3M

1:50 pm 1:55 pm (5 mins)

Chairperson's Remarks

  • Nripen Singh, Ph.D., Senior Scientist, Biologics Development Organization (BDO), Bristol Myers Squibb

1:55 pm 2:25 pm (30 mins)

Development of an Acidic/Neutral Antibody Flow-Through Polishing Step Using Salt-Tolerant Anion-Exchange Chromatography

  • Rajesh Ambat, M.S., Principal Associate, Process Development - Downstream, Eli Lilly

2:25 pm 3 pm (35 mins)

Platforms for Continuous Processing

  • Natraj Ram, Ph.D., Associate Director, Purifiaction, Manufacturing Sciences, AbbVie Inc.

1:50 pm 1:55 pm (5 mins)

Chairperson’s Remarks

  • Kevin Maloney, Director, Technical Development, Biogen

1:55 pm 2:25 pm (30 mins)

Integrating Drug & Device Development for Best-in-class Patient Treatment Experience

Progressive discovery research focus on immuno-inflammation relatedchronicle diseases has led to a paradigm shift with regard to drug productdevelopment strategy. This shift is triggered first by the increase of devicemediated self-administration of biologic modalities, and secondly by theemerging penetration of the digital eco-system into the drug delivery worldthrough in particular connectivity. Consequently, integrating drug and devicefrom Discovery Research to Commercial Development is providing a strategicopportunity to design best-in-class patient treatment experience improvingoverall health outcomes. However, this new paradigm is raising new challengesthat need to be overcome.

  • Didier Pertuy, Vice President, Global Head Drug-Device Integrated Development, Sanofi, France

2:25 pm 3 pm (35 mins)

Component Selection Strategies for PFS- Risk Mitigation, Performance, and Injection Volume Driving Innovative Solutions

An in depth perspective on selection of PFS components for self- administration systems.   A case study will provide design criteria and how challenges were managed for high volume injections and high viscosity solutions. The audience will be shown data on product and process development, break-free and travel force during use, and transit movement comparisons of plungers under several test conditions.

  • Andrea Straka, Supervisor, Project Management, West Pharmaceutical Services

1:50 pm 1:55 pm (5 mins)

Chairperson’s Remarks

  • Miriam Monge, Director of Process Development and Bioprocess Platform, Sartorius Stedim FMT SAS

1:55 pm 2:25 pm (30 mins)

BPOG Leachables Best Practice Testing Guide for Industry

This presentation outlines the key components of the Leachables Best Practice Testing Guide being launched this year by the BPOG biopharmaceutical end user community. It has been developed by practitioners who are routinely involved in determining what testing may be required for single use systems. The guide focuses on risk assessment, study design and analytical methods and is intended as a practical guide for industry and to build upon the benefits of the BPOG Extractable Protocol.

  • Ping Wang, Ph.D., Principal Scientist, Materials Sciences, Pharmaceutical Development and Manufacturing Sciences, Janssen Research & Development
  • Seamus O'Connor, Manager Chemistry Method Development, Analytical, Regeneron Pharmaceuticals, Inc

2:25 pm 3 pm (35 mins)

Microbial Monitoring for Biological Drug Substance - An Industry Perspective

  • Brian Bell, Ph.D., Manager, Process Microbiology, Process Lifecycle Management, Manufacturing Science & Technology, Bristol-Myers Squibb

3 pm 3:10 pm (10 mins)

Chairperson’s Remarks

  • Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare Life Sciences, BioProcess Division, Sweden

3:10 pm 3:50 pm (40 mins)

Engineering Aspects and Practical Experience from Amgen’s Singapore Next Generation Manufacturing Facility

This presentation will discuss our experiences with the design and operation of Amgen’s Next Generation Manufacturing facility in Singapore.

An emphasis on engineering aspects and lessons learned from operating the plant will be presented.

  • Matt Shields, Executive Director, Amgen Singapore Manufacturing, Singapore

3:50 pm 4:30 pm (40 mins)

The Success and Future of ADCs

ADCs offer a strategy for developing anti-cancer drugs of great promise. In creating effective, well-tolerated, ADCs, each of the elements in their design, from target selection, selection of the antibody, the cytotoxic “payload”, and the linker, are important. These elements will be illustrated with examples from ImmunoGen’s clinical pipeline, and with examples from the newest developments in payload-linker chemistry in preclinical research.

  • John Lambert, Ph.D., Executive Vice President and Distinguished Research Fellow, Research, ImmunoGen, Inc.

4:30 pm 6:30 pm (120 mins)

Opening Night "Celebration of Science" Reception in the Exhibit Hall

Kick off your conference experience at the Opening Night Party to celebrate the launch of Biotech Week Boston!Explore our "Celebration of Science" theme with a taste of molecular gastronomy from Boston’s celebrity chefs.The party will feature "Dueling DJ’s", from the theater zone while you catch up with colleagues and friends, network with attendees, exhibitors and sponsors. Participate in several interactive activities and/or relax in one of the themed lounge areas. Enjoy a fun evening with food, drinks and entertainment.

6:45 pm 9:30 pm (165 mins)

Women's Executive Leadership Dinner

Women in positions of senior leadership within life sciences have truly completed an awesome feat in a male dominated space. At this year’s Women’s Executive Leadership Symposium Dinner, we honor these women by recognizing their accomplishments across various stages of the life science ecosystem. Join us for an inspiring and insightful discussion over dinner as executives share their journeys of rising to the ranks of senior leadership in life sciences. Learn how to find the right mentor for your desired career path.  You don’t want to miss out on this opportunity to engage with women that are breaking barriers and taking life science to heightened levels of success.

AGENDA

6:45-7:15pm Gathering Drinks Reception

7:20pm Opening Remarks 

Christina Bodurow, Ph.D., Senior Director, External Sourcing Medicines Development, Lilly

7:30pm Keynote Presentation

Creating a Collaborative & Diverse Workforce: A Challenge for Life Sciences

This presentation will discuss the opportunity that the Life Sciences represents as key growth sectors of the economy, as well as address the diversity gap that exists in the U.S. Life Sciences workforce. I will provide an update on the Massachusetts Life Sciences Center and initiatives underway by the Center to close these diversity gaps here in Massachusetts. Finally, I will draw on my own career to share some insights that have helped me prepare for and succeed in executive leadership roles over the years.

Susan Windham-Bannister, President and CEO, Biomedical Growth Strategies LLC and Managing Partner, Biomedical Innovation Advisors LLC; Immediate Past President and CEO, Massachusetts Life Sciences Center

8:00pm Dinner Served -  Networking Dinner 

8:45pm Dessert and Coffee Served during After-Dinner Panel Discussion:

Accelerators & Barriers: How Can We Ensure that Leadership in the Life Sciences Industry Reflects the Diverse Talent Pool?

Panelists will provide insights from their careers, as well as examples of programs and initiatives that they have seen work.

Panel Moderator:

Christina Bodurow, Ph.D., Senior Director, External Sourcing Medicines Development, Lilly

Panelists:

Toni Hoover, Ph.D., Director, Strategy, Planning, and Management for Global Health, Bill & Melinda Gates Foundation

Kristi M. Sarno, Senior Consultant, Latham BioPharm Group and National President, Women In Bio

Trudie Lang, Professor, Global Health Research Director, University of Oxford, UK

9:30pm Closing Remarks

  • Keynote Susan Windham-Bannister, President and CEO, Biomedical Growth Strategies LLC
  • Dinner Chairwoman / Moderator Christina Bodurow, Ph.D., Senior Director, External Sourcing Medicines Development, Eli Lilly and Company
  • Panelist Toni Hoover, Ph.D., Director, Strategy, Planning, and Management for Global Health, Bill & Melinda Gates Foundation
  • Panelist Kristi Sarno, Senior Consultant, Latham BioPharm Group
  • Panelist Rachel Morgan, Global Head Clinical Sciences and Innovations , Novartis Institutes for BioMedical Research
  • Panelist Trudie Lang, Professor, Global Health Research and Director, Global Health Network, University of Oxford, UK

7 pm 10 pm (180 mins)

2016 BioProcess International Awards Gala Dinner and Ceremony

Recognizing Excellence in Bioprocessing

Where the heart, technology and business of science gets the recognition it deserves. Join BioProcess International Magazine as we honor the individuals, organizations and technologies that have significantly impacted, and advanced the efficiency of biotherapeutic development and manufacturing process. Don’t miss this year’s Red Carpet Reception. Enjoy a sit down dinner and experience the presentation of the 2016 BioProcess International Awards. Have some fun and laughs with a very special comedy show you will be talking about for months to come! Complete this special evening with a Martini and Champagne Dessert reception.

Sponsored By:

  • GE Healthcare
  • Pall Life Sciences
  • JSR Life Sciences
  • WuXi AppTec