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About Penny Field

Penny Field has worked in the pharmaceutical industry for 25 years; the past 23 years have been focused on the development and registration of medicinal products. Penny has consulted on the regulatory strategy and development of monoclonal antibodies, immunotherapeutics, recombinant proteins, gene therapies and biosimilars. Additionally Penny has experience in the registration of New Chemical Entities (NCE) and generics. She has prepared Investigational New Drug (IND), Clinical Trial Exemption (CTX) and Marketing Applications for recombinant proteins, vaccines, NCE, generics and blood products.

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 […]

Regulatory Evaluation of Biosimilars

The first challenge with understanding the regulation of biosimilars is to recognise the broad array of terminology which is used i.e.

Similar Biological Medicinal Product (SBMP) (the term used by the European Union);
Follow On Biological (the term initially used by the FDA);
Subsequent Entry Biologics (the term used by Health Canada);
Similar Biotherapeutic Product (the term used […]

Shared Evaluation of Generic Applications

The past decade has seen numerous drugs come “off patent” and a consequent increase in the number of generic products seeking approval.

In April 2012 the International Generic Drug Regulators Programme (IGDRP) instigated a pilot programme for the shared evaluation of generic applications. The European Decentralised Procedure (DCP) was used as the model for data […]

By |February 10th, 2015|Generic Medicines|0 Comments

Global Development of Biosimilars

The major regulatory challenge for biosimilars is to prove that there are sufficiently similar to the innovator biologic such that the safety and efficacy are comparable. The similarity of two molecules is determined using the comparability exercise with four key parameters being addressed: safety, efficacy, quality and biological activity which are established. The choice […]

By |January 27th, 2015|Biosimilars|0 Comments

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

Australia and New Zealand Therapeutics Product Agency (ANZTPA) – What Next?

Again the proposed joint regulatory agency between Australia and New Zealand – the Australia New Zealand Therapeutic Products Agency (ANZTPA) has faltered. There has been discussion with regard to forming this joint agency since the initial agreement was signed between the two Governments in December 2003. The first attempt at establishing ANZTPA was unsuccessful […]

By |November 21st, 2014|Drug Regulation|0 Comments

Data exclusivity

Data exclusivity is a vexed issue: how to protect new innovations and additional clinical studies without the advantage of patent protection? Data Exclusivity in Australia is aimed at providing a 5 year window whereby a company can enjoy exclusive use of the data that they have generated without competition from generics.  The requirements are […]

By |November 13th, 2014|Drug Regulation|0 Comments

Biotherapeutics Manufacturing

I’m attending the BioProcessing Network Conference (21-23 Oct 2014) in Melbourne this week. It’s got me thinking about the major changes to biotherapeutics manufacturing. One of these significant changes has come about as a consequence of increased yield; when the quantity of product increases from mg/L to g/L then the scale of manufacturing can […]

By |October 21st, 2014|Manufacturing|0 Comments

Tissue and Cell Therapies

The TGA introduced the Biologicals Regulatory Framework in 31 May 2011. This new regulatory guidance had a three year transition which finished in May 2014. There is some confusion with regard to the terminology – ‘biologicals’ by the TGA definition include human tissue and cell therapies which are termed Advanced Therapies in other jurisdictions […]

By |October 13th, 2014|Biologicals and Biopharmaceuticals|0 Comments

Cell Banks: the Foundation of Biotechnology/Biological Products

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By |October 10th, 2014|Biologicals and Biopharmaceuticals|0 Comments