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WCBP 2018: Scientific Program
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 To view the final program, click here.

 To view the program overview, click here.





Plenary Session 1

Technical Innovations to Support Development and Global Regulatory Approval for Biological Products and Vaccines
Session Chairs: Aston Liu, GlaxoSmithKline and Ned Mozier, Pfizer, Inc.

The development and regulatory approval of a biological product or a vaccine in global markets requires technical achievements during product development. Cases are provided that demonstrate the value of investments made by companies early in development that resulted in successful late stage approval and led ultimately to an enhanced quality of product. Innovations in vaccine as well as biologics products will be shared, including formulation development leading to a more patient-friendly and globally useful product and how late stage technologies revealed quality information about products. These improvements in product knowledge were made possible by increasingly powerful analytical technology which led to further process development. These cases illustrate how the integrated functions of process, formulation and analytics work together for successful presentation to regulators, ultimately to improve the quality and consistency of the products. Patient needs and regulatory guidance in various countries mandate that manufacturers innovate in order to meet the unique needs of these markets.


Parallel Session 2

Not Your Ordinary mAB
Session Chairs: Rohini Deshpande, Amgen Inc. and Marjorie Shapiro, CDER, FDA

Monoclonal antibody pharmaceuticals revolutionized treatments in the 20th century. The analytical and regulatory challenges for these new biologics were one of the drivers for creating the WCBP conference. Many of those challenges have been met and the manufacturing, characterization, and filing of MAbs has a high feasibility across the industry.  Indeed, the number of mAb approvals is at its highest level and is expected to continue at this level for several more years. Now we are in the Biocentury and on the verge of a second revolution; this new frontier of precision medicine includes engineered proteins and live modalities, including antibody- based constructs such as bi- or multi-specifics, ADCs and other types of conjugates, antibody cocktails, masked antibodies, mAbs engineered to enhance/reduce effector functions or target binding to a specific Fc receptor, Fc-Fusion proteins and CAR T cells, to meet ambitious patient outcomes. Many opportunities are ahead of us to advance this multimodality pipeline; which product quality attributes really matter in a molecule? what measurements do we need and at what sensitivity to ensure suitable product quality? how are industry peers addressing them? What will the regulators like to see in our submissions? This plenary session will provide perspectives and case studies related to product quality attribute measurements for release, stability and characterization for the emerging modalities and problem solving in regard to 'not your ordinary mAb'.

Parallel Session 3

Integrated Control Strategies for Biologics and Vaccines
Session Chairs: Reed Harris, Genentech, a Member of the Roche Group and Ping Hu, Janssen R&D, LLC

Session Objectives:
Control Strategy design, development, implementation and maintenance span across the entire product lifecycle, and are pivotal for a successful regulatory submission. This session will discuss how to utilize product and process understanding to integrate different control elements (e.g., raw materials, process parameters, process validation, in-process and release tests, facility/equipment control, continued process verification) to ensure product quality, while allowing flexibility for post-licensure manufacturing changes.

Discussion Points:

• Industry and regulatory perspectives on phase-appropriate integrated control strategies, and how to apply these.

• How to control product quality beyond release/stability testing?  How to incorporate raw materials controls, process control and problem validation to justify an overall control strategy?

• When is validation sufficient, and when is release testing also needed even for validated processes. 

• Are newer technologies and systems, such as PAT and adaptive process control, enabling new regulatory strategies?  Can the newer approaches be used for older products?

• Integrated control strategy development for early stage projects




Parallel Session 4

Q12 Pharmaceutical Product Lifecycle Management
Session Chairs: Andrew Chang, Novo Nordisk Inc. and Wassim Nashabeh, F. Hoffmann-La Roche Ltd.

While the implementation of ICH Q8, Q9, Q10 and Q11 provided opportunities for a more science- and risk-based approach for assessing changes across a product lifecycle, the main emphasis, however, of these guidelines was on development stage of a product lifecycle. Opportunities and benefits have not been fully realized/enabled for post-approval changes, and the envisioned “operational flexibility” has not been achieved. Effective product lifecycle management remains a critical and visible focus for both regulators and the regulated pharmaceutical industry. This session will cover the ICH Q12 draft guideline (Step 1/2a document) on technical and regulatory considerations of pharmaceutical product lifecycle management, with more focus on the commercial manufacturing phase of the lifecycle. ICH Q12 EWG Experts will describe in sufficient details the main chapters of Q12 draft guideline (Step 1/2a document), and proposed next steps.

Learning Objectives:

• ICH key quality objectives

• Describe the scope, objectives and regulatory tools and enablers of ICH Q12;      

• Explain the linkage between ICH Q12 and other quality guidelines (ICH Q8, Q9, Q10, and Q11);      

• Discuss the transformational achievement of ICH Q12.

Parallel Session 5

Critical Quality Attributes (CQAs) and their Relationship to Structure/Function
Session chairs: Nomalie Jaya, Seattle Genetics and Kenneth Miller, AstraZeneca

ICH Q8(R2) defines CQAs as “A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality”. The structural and functional complexity of therapeutic proteins makes identification of CQAs challenging given the sheer number of quality attributes that need to be evaluated.

This plenary session will address the following aspects of CQAs:

• Efficiently utilizing platform knowledge, literature and risk ranking and filtering approaches to establish potential CQAs (pCQAs);

• Use of product characterization knowledge including forced degradation and MOA studies to establish structure/function relationships to confirm CQAs, develop a control strategy and justify specification setting in support of licensure;

• Regulatory expectations and approaches for managing CQAs through the product lifecycle including post licensure.



Parallel Session 6

Evolving Regulatory Environment in China
Session Chairs: TBD

Starting from 2015, the State Council of China and the China Food & Drug Administration (CFDA) have collaborated on a series of multifaceted regulatory reforms with significant goals, including improving the quality of drug review and approval, safeguarding the quality of generic drugs, enhancing regulatory transparency, and encouraging new drug research and development. In the last 1.5 years, CFDA has issued an unprecedented series of new regulations and taken several important measures, intending to improve the efficiency of the agency and transform the pharmaceutical industry in China to focus on quality and innovation. Globally, these initiatives support the conduct of multiregional clinical trials, both inside and outside of China, and use of the data for product registration in China, thus creating a regulatory framework that supports pharmaceutical product development and innovation, and access of high quality products to patients in China and around the world.

The biopharmaceutical industry, as one of the key development areas in China’s 13th five-year planning cycle, has gone through rapid growth in recent years and brought many new challenges to the regulatory system. In this session, you will get to know the progress of regulatory reform in China, and the regulatory initiatives that could benefit the biopharmaceutical industry development. The following topics will be discussed: 

• CFDA’s priorities in the next 3-5 years;

• CFDA’s policy to encourage biopharmaceutical innovation;

• Key considerations on regulatory reform on biopharmaceuticals related policies;

• China’s policy on biosimilars, and considerations on biosimilar review from a CMC perspective;

• Regulatory requirements on post approval CMC change and how that will evolve considering recent international development (e.g. WHO guideline on post-approval changes for bio-therapeutics).

Parallel 7

From Unrequited to Expedited: Managing the Pathways to Accelerate Global Approval for Vaccines and Biologics
Session Chairs: Michael Chang, Shire, Kimberly Duffy, Merck & Co., Inc. and Kimberly Wolfram, Biogen

This plenary session will focus on technical and regulatory approaches to accelerated CMC development for biologics and vaccines. To support development and review of new drugs to address unmet medical needs, several health authorities have implemented expedited regulatory pathways. These programs aim to increase collaboration between industry and regulators and reduce filing review timelines to advance life-saving therapies to patients faster. Reduction in clinical timelines can result in condensed timelines for CMC development and increased pressures to meet global regulatory requirements. Though the same expedited regulations govern both biologics and vaccines, various CMC development approaches may need to be implemented to meet the needs of the product and indication. With evolving regulations developing globally, more sponsors are utilizing expedited pathways and are encountering both similar and unique CMC challenges. Sustained transparency and collaboration throughout the expedited development ensures that the shared goal of delivering life-changing therapies to patients is met.

In this plenary session, regulatory pathways, specific CMC topics, and case studies will be presented and discussed such as:

• Global regulatory framework to help enable accelerated CMC development such as US FDA expedited pathways, EU EMA PRIority MEdicines (PRIME) and Japan PMDA SAKIGAKE;

• Overall technical and CMC considerations for accelerated development, specifically;

• Process validation approaches including process design, qualification, and continuous verification;

• Product stability;

• Historical manufacturing experience;

• Platform knowledge;

• Post-registration approval challenges;

• Industry and Regulator case studies for vaccines and biologics approaches have been successful with industry and global regulators?




Plenary Session 8

Clinical Relevance of Specifications for Biologics and Vaccines
Session Chairs: William Egan, GlaxoSmithKline Vaccines and Mark Schenerman, CMC Biotech-MAS Consulting

Commercial product specifications are based on clinical as well as manufacturing experience. However, establishing a clinical basis for specifications is challenging because changes in safety and efficacy may be caused by multiple factors. This session will explore some of the factors that affect clinical relevance and discuss approaches used to address the key questions for therapeutic proteins as well as vaccines. Topics to be covered include a new consortium for studying correlates between quality and safety data, the FDA view of clinical relevance of specifications, and a discussion of clinical trial design in the setting of vaccine specifications.


Plenary Session 9

New Technology: The Potential for Transforming the Biopharmaceutical Industry
Session Chairs: John Frenz and William Hancock, Northeastern University

Rapid developments in medical science and manufacturing technology, alongside the unprecedented global increase in demand for high quality drugs and biologics, will have dramatic effects on innovation policies and have the potential to shift the current biopharmaceutical paradigm. The challenge is to assess, support and exploit those developments that will have the most impact on maximizing the supply of, and access to, biotherapeutics in a cost-effective manner. This session will focus on aspects of new technologies that will impact the biopharmaceutical industry through progressive stages of the effective treatment of disease.

Presentations will be focused on the following topics:

• New diagnostic approaches aimed at cheaper, faster patient identification and monitoring of treatment;

• Continuous manufacturing with the potential to transform bioprocessing; and

• New instrumentation to provide the ability to detect product substitution and adulteration.

Such technical innovations have the potential to facilitate both expansion of existing markets as well as promote improved treatment of non-communicable diseases (NCDs) in lower and middle-income countries (LMIC).






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