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WCBP 2019: Scientific Program
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NEW -- To view the online searchable program, click here

To view the final program agenda, click here.
To view the bird's eye view, click here.

Impact of Government Shutdown on CMC and WCBP 2019

We expect you are aware of the partial shutdown of the US government, including non-essential activities of the FDA.  Unfortunately,  we have been informed that, due to the prolonged and uncertain nature of the situation, the FDA leadership regretfully made the decision to withdraw participation from the conferences. 

Anticipating that this could be a possibility, we had already begun working with the conference co-chairs to re-configure the program.  Updates, as they become available, will be reflected on the Scientific Program pages.

Featured Keynote Speaker

Infectious Disease – Designing Biological Therapies for Global Patient Access
Michael Kamarck, Vir

 Wednesday, January 30
8:15 – 9:15

Michael Kamarck, PhD, is Chief Technology Officer at Vir. Vir integrates diverse innovations in science, technology and medicine to transform the care of people with serious infectious diseases. Vir is taking a multi-program approach to applying these breakthroughs, including the development of treatments that induce protective and therapeutic immune responses.

Vir’s initial focus is in three areas of significant unmet need: chronic infectious diseases including hepatitis B, tuberculosis and HIV; respiratory disease, including influenza, RSV, MPV; and health-care acquired infections. The company was founded by Robert Nelsen and ARCH Venture Partners and seeded by ARCH, the Bill & Melinda Gates Foundation, Altitude Life Sciences and Alta Partners. 

Before joining Vir, Dr. Kamarck was senior vice president of Global Vaccines and Biologics Manufacturing and president of Merck BioVentures where he was responsible for the establishment of Merck’s global biosimilars business. Prior to joining Merck BioVentures, Dr. Kamarck held positions of increasing responsibility in Biotechnology and Vaccines Operations at Wyeth, including leading the development of the global biotechnology network with $3.5 billion of capital investment. While at Wyeth, he also was responsible for global technical operations for all of the company’s businesses. Dr. Kamarck began his career in biotechnology and pharmaceutical research at Bayer AG.

Dr. Kamarck graduated from Oberlin College where he currently serves as a Trustee. He received his PhD in biochemistry from the Massachusetts Institute of Technology and is the author of more than 50 peer-reviewed publications and 20 issued patents. He also holds an Honorary Doctorate of Science from University College Dublin.


Session Information
Tuesday, January 29, 2019

Successes and Challenges of Drug Development When Speed is Critical for the Patient
Session Chairs: Anthony Lubiniecki, University of Maryland, Baltimore County and Jennifer Mercer, BioMarin Pharmaceutical Inc.

Regulatory pathways have been extablished to enable development and approval of drugs in a shorter timeframe to serve patients in critical need. With these successes have come challenges meeting current CMC expectations and global regulatory requirements. The balance of speed and sufficient time to develop the necessary data required for a commercial product can be challenging compared to traditional drug development timelines. This session will focus on three case studies that will outline the clinical regulatory pathway, implications when development time is shortened and how these unique strategies enabled approval, while keeping focus on the patient. 

Clinically Relevant Specifications and Quality Standards
Session Chairs: Nina Cauchon, Amgen Inc. and Reed Harris, Genentech, a Member of the Roche Group   

Selection of specifications and other quality standards remains challenging for the development and licensing of vaccines and biologics. Clinical relevance requires understanding mechanisms of action (often linked to potency) and quality attributes potentially associated with adverse effects (often linked to purity), as well as range impacts for the identified quality attributes. This plenary session will focus on how to identify what to measure and the associated test acceptance criteria needed to ensure appropriate product quality, based on presumed and/or validated safety and efficacy models. 

New Rapid Analytics and the Path to RTRT
Session Chairs: Catherine Eakin, Seattle Genetics, Inc. and Kenneth Miller, AstraZeneca

Real-time release testing (RTRT), as defined in ICH Q8(R2), is “the ability to evaluate and ensure the quality of in-process and/or final product based on process data, which typically include a valid combination of measured material attributes and process controls”. Strategic use of RTRT has multiple benefits including improved quality, reduced costs and shortened product development and manufacturing timelines. This plenary session will include regulatory and industry perspectives on rapid analytical technologies and RTRT and provide specific examples of how rapid analytical technologies are being implemented in the biopharmaceutical industry to ensure the quality of in-process and/or final product.


Wednesday, January 30, 2019

The Use of Advanced Computational Tools in the Biopharmaceutical and Vaccines Industries 
Session Chairs: Julia O’Neill, Direxa Consulting Timothy Schofield, CMC Sciences, LLC

CMC professionals integrate knowledge from across the product lifecycle to develop supporting evidence for product submissions and ongoing management.  Advanced computational tools have become critical to discovery and development of biopharmaceuticals and are rapidly gaining traction in manufacturing control. Scientists and regulators must understand these tools in the context of CMC, to properly present and assess their findings.

These computational tools are already established in many industries including information sciences, diagnostics, and medical care.  In biopharmaceuticals, those tools provide value in molecular and antigen design, incorporation of prior knowledge, and advanced control.  In contrast to classical empirical and statistical approaches, they often require larger amounts of data and greater computational power to mine and analyze the data.  

Their value is measured in their predictive power and the ability to utilize diverse sources of information.  A key tool is Bayesian statistics, which can be used to combine prior knowledge with the results of development studies, to improve the predictions made from those studies.  Other approaches use machine learning to perform analyses using algorithms in an iterative manner, to quickly converge on potential solutions to complex problems.

This session will highlight case studies from the biopharmaceutical and vaccines industries to illustrate the application of advanced computational tools to current challenges in CMC. 

New Technologies for New Modalities
Session Chairs: Andrew Weiskopf, Biogen and Heidi Zhang, Juno Therapeutics, A Celgene Company

Technological advancements applied to new product development and to analytics have led to an expanded repertoire of drug candidates, presenting opportunities to design therapeutics with diverse functionalities. In the recent years, novel vaccine antigens, somatic cell therapy, gene therapy, and tissue engineered products have emerged as new classes of pharmaceutical agents. While these drug modalities we are exploring are new, many of the key industry and regulatory considerations for CMC development and review are not. In this session, we will explore examples of some innovative technologies and how they are enabling and informing the future of new therapeutic modalities:
1. New technology enabling the manufacturing of new modalities;
2. New technology enabling the analysis and control of new modalities;
3. Regulatory approaches to new technologies/new modalities.

Global Access through Transformative Technology
Session Chairs: John Frenz and William Hancock, Northeastern University

Despite life-saving innovations in pharmaceutical development, large groups of underserved patients lack access to essential biotherapeutics, even in the presence of existing therapeutic availability. A classic example is provided by rDNA-derived human insulin: prior to its development, the diabetic patient population relied on a constrained supplies of animal insulins. However, the greatly increased availability of recombinant insulin resulted in a substantial expansion of the treated patient population as well as more optimal dosing. Similarly, the rapid rise in non-communicable diseases (NCDs) represents an emerging crisis for global health care systems. Such a linked business and humanitarian challenge has a number of barriers which can be addressed with technology innovation. 

This plenary session will provide a combination of presentations that will address the broad scope of global therapeutic solutions, including innovative approaches to overall system analysis as well as focusing on specific needs such as effective disease diagnosis in disperse populations, efficient modular manufacturing systems and systems for medical treatment in crisis situations in low- and middle-income countries. 

Advances in Process Control Plans and the Definition of CMC “Established Conditions”
Session Chairs: Kristopher Barnthouse, Janssen R&D, LLC and Shannon Holmes, Biogen

Advanced process controls have transformed the speed, reliability, and quality of biologics manufacturing. Fault detection and control tools such as PAT, feedforward controls, at-line testing, and multivariate models can all be used to ensure process consistency, improved product quality, and faster release of batches which ultimately improves patient supply. In order to implement these improvements, how can ICH Q12 with Established Conditions be used to navigate the global regulatory landscape? What elements of advanced process controls would be considered Established Conditions and what elements would not be subject to regulatory approval but be managed solely by the Pharmaceutical Quality System? The speakers at this session will focus on examples and benefits of various advanced process controls tools for the manufacture and testing of biologics, and further, how the Established Conditions concepts could be applied in the regulatory submission strategy for these controls. The session will close with a panel discussion and Q&A session.


Thursday, January 31, 2019

Improving Patient Access and Public Health: How Global Health Authorities and Industry Can Collaborate on CMC Expectations
Session Chairs: J. Christopher Love, Koch Institute, MIT and Robert Sitrin, PATH

This interactive plenary session aims to explore how we could improved access to biopharmaceuticals and vaccines globally through holistic considerations of product development and lifecycle management, including the path through manufacturing. Through a series of short talks and an open panel discussion, the session will explore the technical, business and regulatory considerations for providing high quality products to meet truly global demands. Topics for discussion will include how to align target product profiles with regional expectations to opromote adoption or market expansion, the challenges of reaching both scale and cost and potential advancing technologies to address both, as well as regulatory risks and opportunities for CMC to advance access to medicines. Perspectives will include leaders from different vantage points in the global industry, health authorities and academia. 

Manufacturing of the Future: The Journey to Flexible and Modular Facilities and the Use of PAT in Continuous Manufacturing
Session Chairs: Rohini Deshpande, Amgen Inc. and Stacey Kaneshiro, Eli Lilly and Company 

Flexible and modular facilities utilizing advances in continuous manufacturing methods and leveraging new PAT capabilities and integrated analytics can enable a biopharmaceutical manufacturing facility that is faster to build, cheaper, and more efficient to operate. Such facilities will only augment our ability to increasingly supply current biotherapeutics in a cost-effective fashion and create more nimble manufacturing options to meet the needs of emerging modalities. This session will illustrate ways in which these advances are being implemented and some of the industry/regulatory challenges and points-to-consider that are being encountered on the journey.

WCBP 2019 is co-sponsored by the US Food and Drug Administration.

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