International Regulatory Endeavour Towards Sound Development of Human Cell Therapy Products

Date: February 18-19, 2015

Venue: Hitotsubashi Hall

Organized by IABS with the support of Pharmaceuticals and Medical devices Agency (PMDA); Japan Science and Technology Agency (JST); National Institute of Biomedical Innovation (NIBIO); World Health Organization (WHO)

Under the auspices of Forum for Innovative Regenerative Medicine (FIRM); Japan Pharmaceutical Manufacturers Association (JPMA); The Japanese Scoiety for Regenerrative Medicine (JSRM)

Scope and objective:

This meeting will bring together an outstanding and diverse group of speakers from regulatory agencies, industry, and academia, all of whom are at the forefront of the cell therapy field.The major objective of the meeting is to highlight the important regulatory considerations that are unique to human cell therapy products, as well as to promote international dialogue and exchange of information and points of view in this evolving field.The scope of the cell therapy products that will be covered in this meeting are human cell derived and substantially manipulated cell therapy products (hCTPs). The meeting will also identify special points/issues to consider for specific type of products, as well as very critical points/issues for various type of products, which have to be resolved, improved, and/or developed in terms of sound scientific regulation in order to facilitate the availability of products in a rational and timely manner, and which will be valuable globally to public health.

View the Workshop website

  folder Slides and documents

2nd Statistical and Data Management Approaches for Biotechnology Drug Development

Date: 29-30 September, 2015

Venue: US Pharmacopeia Conference Center, Rockville, Maryland

Organized by: IABS anad FDA

Scope and objective:

This meeting is to bring together regulators, scientists, academia and industry to help resolve existing challenges in ensuring the quality of biotechnology medicinal products and to bring high quality medicines to patients. Guidance on how to use statistics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability, biosimilarity exercises and stability program development. In addition, the complexity of the types of data and the volume being analysed is ever increasing and how best to manage such data will be discussed. The meeting will bring the right experts together to discuss the issues and through roundtables attempt to reach conclusions that will be valuable globally to public health.

 Among the challenges that will be explored :

• Statistical Challenges with showing Comparability and Biosimilarity (Equivalence, small data sets, tolerance intervals etc.)
• Using statistics for Assay Methods (Statistics for development, qualification, validation and transfer of methods)
• The use of statistics and modelling when using Quality by Design (DoE, Bayesian, partial least squares, prior knowledge data sets)
• Managing large and/or complex data sets (Large data sets for monitoring variation, complex analytical methods – Mass Spec, NMR, historical data sets)

folder Slides and documents

2nd Progress and Challenge in Protein Particles and Immonogenicity of Biotherapeutics

Date: 12-13 November, 2015

Venue: US Pharmacopeia Conference Center, Rockville, Maryland

Organized by: IABS and Health Canada

Scope and objective:

 In 2009, IABS and FDA cosponsored a conference which focused on:

• the mechanism of protein folding
• the characteristics of sub visible and visible protein particles that may influence immunogenicity including the size, type (reversible, protein class), composition, amount, and conformational status)
• the risks associated with the propensity to generate immune responses including the route of administration, dose, and frequency, duration of administration and indication
• the factors that influence the formation of large protein aggregates and methods to reduce protein aggregation (approaches in formulation, and protein design) including case studies of occurrence of these particulates in manufacturing
• analytical methods that are useful in quantifying these particles and approaches to the design of suitable control strategies that mitigate the risk to product quality.

IABS and Health Canada will revisit these topics in light of what has been learned in the past 6 years. Progress in understanding the science of protein particle formation, the evolution of the analytical technologies for characterization and measurement of sub-visible protein particles, the advances in standardization of protein particle measurements, and their possible relationship of protein particle attributes to safety and efficacy of biotherapeutics will be highlighted. The goal of the meeting is to assess the progress of the past half-decade, and its implications for risk management during biotherapeutic product development.

folder Slides and documents

2nd Human Challenge Trials Conference

Venue: Hilton Hotel, Rockville, Maryland
September 28-30, 2017

Our world needs safer, more effective drugs and vaccines to prevent and treat infectious diseases.  Controlled human infections (CHIs) have served as an effective tool to promote this objective. For example, CHIs have led to progress in developing interventions against respiratory pathogens, enteric pathogens, and parasites. The most frequent application is the conduct of human challenge trials (HCTs), which can safely assess the value of novel or improved drugs and vaccines much more rapidly and efficiently than field trials, particularly if efficacy against CHI bridges to the field.  Progress against an infectious threat is greatly hampered when the field lacks a supporting human challenge model, such as is the case for human immunodeficiency virus and Mycobacterium tuberculosis.

Based on the premise that optimal use of CHIs is one of the best, most efficient ways to achieve rapid progress against infectious diseases, IABS is hosting a workshop to review the use of HCTs to promote the development of new drugs and vaccines, the benefits and risks of this approach, the regulatory framework within which HCTs are conducted, and novel CHI applications that would open new translational pathways.  This workshop follows two and a half years after the first such workshop hosted by IABS in Strasbourg, France, September 2014.

Read more: September 28-30, 2017 - Rockville, Maryland, USA

Next Generation Sequencing for
Adventitious Virus Detection in Biologics

Venue: USP Pharmacopeia, Rockville, Maryland
October 26-27, 2017

The 2017 NGS conference will discuss current perspectives on NGS for adventitious virus detection in biologics with focus on applications for human vaccines and lessons learnt from veterinary vaccines. The meeting will include data presentations and discussions for developing a scientific consensus to draft points for consideration for using NGS for virus detection in selected applications of biologics.  The meeting will bring together representatives from industry, academia, service providers, and regulatory bodies.

4^th Statistical and Data Management Approaches
for Biotechnology Drug Development

Venue: USP Pharmacopeia, Rockville, Maryland
October 30 - November 1, 2017

This meeting is to bring together regulators, and scientists, or those interested in statistics from academia and industry, who have a background in statistics, to help resolve existing challenges in ensuring the quality of biotechnology medicinal products and to bring high quality medicines to patients. Guidance on how to use statistics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability, biosimilarity exercises and stability program development will be provided by the speakers and panel members. In addition, the complexity of the types of data and the volume being analysed is ever increasing and how best to manage such data will be discussed. The meeting will bring the right experts together to discuss the issues and through roundtables attempt to reach conclusions that will be valuable globally to public health.

Click here to  learn more about the meeting

Advancing Analytics for Biotechnology Products

An IABS - FDA international meeting
co-sponsored by NIST

Venue: NIST, Gathersburg, Maryland
Green Auditorium
Gathersburg, Maryland
November 6-8, 2017

This meeting is to bring together regulators, and scientists, or those interested in analytics from academia and industry to help resolve existing challenges in ensuring the quality of biotechnology medicinal products and to bring high quality medicines to patients. Guidance on how to use current and novel analytics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability and process development and execution will be provided by the speakers and panel members. In addition, the complexity of the types of data and the volume being analysed is ever increasing and how best to manage such data will be discussed. The meeting will bring the right experts together to discuss the issues and through roundtables attempt to reach conclusions that will be valuable globally to public health.

NON U.S. CITIZENS PLEASE NOTE: All foreign national visitors must supply additional information. Failure to provide this information prior to arrival will result in significant delays in entering the facility. Authority to gather this information is derived from United States Department of Commerce Department Administrative Order (DAO) number 207-12. Please fax the following NIST 1260 form to Myesha Steadman as soon as registration is complete: fax (301) 975-4629.

 Click here to learn more about the meeting

Autogenous Vaccines and Their Role
in Animal Health Strategy

September 25-26, 2017
Venue: Het Pand, University of Ghent

Co-organized by IABS-EU and University of Ghent / PROVAXS

 The purpose of this conference is to start from an overview on the current situation and needs from the perspective of regulators, scientists, manufacturers and the end-user (veterinarians). The main focus will be on food producing animals, including fish. Further, proposals will be presented for a harmonized approach which will lead to a better understanding of the rational for the intended use, better knowledge on the nature of isolates and improved production and quality of the final products. In addition, advanced techniques and methods will be presented and discussed to identify and propagate isolates, to upgrade production and to quickly estimate safety and even efficacy of autogenous vaccines by in vitro methods.

Recommendations will be drafted on how to improve the EU-legislation and communication between the EU-Member States on autogenous vaccines and on ways to increase transparency on quality and safety of the vaccines.

Read more: September 25-26, 2017 - University of Ghent, Belgium

4^th Cell Therapy Conference
Manufacturing and Testing of Pluripotent Stem Cells

   Organized by
The International Alliance for Biological Standardization
IABS
with support from and in collaboration with the
California Institute for Regenerative Medicine
CIRM
Los Angeles, California
June 5-6, 2018

Objectives and Expected Outcomes

The 2018 Cell Therapy conference will identify key unresolved issues that need to be addressed for the manufacture and testing of pluripotent stem cell-based therapies and provide scientific consensus on selected aspects to inform the drafting of future national and international guidance. The meeting will bring together representatives from industry, academia, health services and regulatory bodies.

The overall goal of the conference is to provide the target audience with an appreciation of the importance of a well-controlled manufacturing process for cell therapies that are in development, and to highlight specific areas that should be considered during early product development in order to avoid issues in later stages. The target audience includes those individuals and organizations actively pursuing research and development of cell therapies with the intent of achieving pluripotent stem cell therapy products that meets regulatory requirements for approval, thus becoming generally available to treat patients with unmet medical needs. 

We will build on previous meetings that generally addressed broader themes of cell therapy studies and manufacturing issues. In addition to reviewing information on the state-of-the-art and recently generated data, this conference ill drill down to key practical issues facing cell therapy developers and regulators to expedite the safe and efficient introduction of new treatments for important diseases where unmet medical needs exist.

More specifically, the conference is expected to provide a basis for new and/or additional guidance on regulatory expectations for developing acceptable pluripotent cell therapy products including testing requirements during manufacture. Concrete conclusions and recommendations will be important outcomes, which are expected to stimulate the field to move forward in a transparent and coordinated manner.

Narcolepsy and Pandemic Influenza Vaccination
What we know and what we need to know before the next Pandemic

 March 26-27, 2018
Eurostation II, Place Victor Horta
Brussels, Belgium

In partnership with
Federal Agency for Medicines and Health Products (FAMHP)
Vaccine Center of Excellence

This meeting will be held under Chatham House Rule

Influenza Pandemics occur when an influenza strain circulates that humans have not been exposed to before. This may lead to widespread circulation and a high case fatality rate.

In 2009 pandemic, several H1N1 vaccines were developed against the new H1N1 virus and were extensively used. In Finland and Sweden an increase in narcolepsy was noted after the mass vaccination with one of these vaccines.  Disparate results were seen in other countries with other vaccines.  In addition, an increase of narcolepsy has been reported in countries in Asia following wild type influenza infection.

The goal of this meeting is to be prepared for the next pandemic:

• What are the latest data on the risk of narcolepsy following exposure to 2009 pandemic vaccines?
• What scientific data are available and what data are lacking to explain the phenomena that was seen in 2009-10?
• What additional work is needed to prepare for potential use of adjuvanted vaccines for a future pandemic ?  

 View the Agenda