Proposed Changes to Immunogenicity Requirements for Biopharmaceuticals (Part 1)

In light of experience, since the original guidance document was published in 2006, there are a number of changes under consideration in the draft guidance document ‘Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins’[i].

Broadly these include:

More specific requirements for immunogenicity assays
Investigation into the clinical significance of immunogenicity
Risk-based approach to immunogenicity with requirements for both […]

Traversing the valley of death: regulatory challenges in the transition from discovery to development

The transition from drug discovery to drug development is aptly termed the ‘valley of death’. Its earned this name due to the difficult journey, and high failure rate, between these two major activities. This journey can be exacerbated if there is a cultural divide between discovery, which often occurs in an academic environment, and […]

By |September 15th, 2015|Drug Development|0 Comments

The Challenges of Immunogenicity

One of the big issues facing biotherapeutics is potential for generation of unwanted immune response. Biologicals have a propensity to elicit immune responses as a consequence of many factors including being protein-based macromolecules. Immunogenicity is relevant for both proteins and peptides including those generated by recombinant DNA technology as well as synthetic peptides. For […]

Adaptive Pathways for Drug Development

There has been much discussion about the lengthy and expensive development pathway for bringing new medicines to the market; maybe the time has come for a paradigm shift?

The European Medicines Agency (EMA) has recently released information on the use of adaptive pathways to expedite the drug development pathway. The idea behind this novel approach […]

By |December 23rd, 2014|Drug Development|0 Comments

What guides the development of new medicines?

From a regulatory point-of-view the pivotal guidance documents for the development of medicines are whose of the International Conference on Harmonisation (ICH). These guidelines are usually adopted by other regulatory agencies such as European Medicines Agency (EMA) and Therapeutic Goods Administration (TGA); thus guidance documents are also found on country specific regulatory website. Whatever […]

By |August 31st, 2014|Drug Development|0 Comments

International Conference on Harmonization (ICH): A global collaboration

No discussion of the regulation and development of medicinal products is complete without mentioning the critical role of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Prior to 1990, the technical requirements for registration of drugs were significantly different between the three major pharmaceutical jurisdictions – namely […]

By |August 30th, 2014|Drug Development, Drug Regulation|0 Comments