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.

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

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

Harmonized Safety Monitoring of Immunization Pregnancy
International Consensus Conference

March 29-30, 2016
National Institutes of Health
Bethesda, Maryland, USA

Aim

• The aim of this conference is to highlight progress in harmonizing safety monitoring of immunization in pregnancy and to develop consensus recommendations for a globally concerted approach.

Objectives

• To discuss new safety data from immunization in pregnancy studies
• To identify converging stakeholder needs and requirements for high quality data
• To review new standards and tools for safety monitoring, including terminology
• To build consensus on best practice guidance for monitoring vaccine safety in pregnancy

Outcomes

• Shared understanding of the challenges of monitoring immunization in pregnancy
• Shared understanding of potential solutions for a collaborative way forward
• Consensus on the need for a globally concerted approach
• Recommendations for a road map towards optimal safety data based on a globally harmonized approach

This conference is inspired by the work performed within the GAIA project by partners and volunteers worldwide. This meeting will bring together regulators, scientists, academia and industry experts to help resolve existing challenges of safety monitoring of immunization in pregnancy and to reach conclusions that will be valuable to a globally concerted approach.

Read more: 29-30 March, 2016 - Bethesda, Maryland

Emerging Diseases in Animals:
Strategies in Surveillance, Control and Eradication

Budapest, Hungary
28 - 30 September 2016

Budapest, Hungary

Emerging animal diseases challenge the health of domestic and wild animals. These highly contagious or transmissible diseases may spread easily, irrespective of political and geographic borders. This spread is fostered by the increased global movement of domestic animals and food produced from animals, as well as by vectors such as man, wild animals, intermediate hosts, and contaminated materials of all kind. This spread is also influenced by other factors such as changes in climate.

Outbreaks of diseases in livestock have a negative impact on economies, individuals’ livelihood and quality of life, as well as global safety of food produced by animals.

Although there is permanent progress in the development of new vaccines against a wide range of diseases, emerging infections and transboundary spread pose specific challenges in terms of surveillance and prophylactic interventions.

The goal of this meeting, to be held in 2016, is to update current experience in the identification, tracking, and control of these animal diseases. This includes experience thus far with licensing of vaccines required for emergency situations or scenarios. An additional area of discussion will focus on fostering rapid availability of vaccines.

folder Slides available here !

3rd Statistical and Data Management Approaches
for Biotechnology Drug Development

USP Headquarters, Rockville, Maryland
October 11-12, 2016

Co-organized by IABS and FDA

The 3rd annual stats & data management meeting will bring together regulators, and scientists, or those interested in statistics from academia and industry, who have a background in statistics, to continue exploring how best to resolving 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.

folder Slides are available here

3rd IABS CONFERENCE on CELL THERAPY
MANUFACTURING AND TESTING

This meeting provided an important update on the
Regulation and Standardization of Cell Therapies

November 2-3, 2016
The Wellcome Collection
London, United Kingdom

The 2016 Cell Therapy conference will identify the key issues to be addressed for the manufacture of cell therapies and provide scientific consensus on selected aspects to inform the drafting of future guidance. The meeting will bring together representatives from industry, academia, health services and regulatory bodies.

It is intended that the conference output should provide core elements that will be useful in establishing international consensus on the requirements for manufacture of cell based medicines and enable progress towards a potential future WHO endorsed guidance.

  folder Slides are available here

 Click on the link for all the slides and meeting agenda :

folder Human Challenge Trials

folder Stats & Data