Flexible Phase I Study Designs: Expediting Early Clinical Drug Development

Valerie Harding, Quanticate’s Communications Account Director, explains that Phase I marks a significant milestone in the development of any new medicinal product. A target has been identified, a compound has been discovered that hits the target, and it has been refined to ensure it has good properties for development. In-vivo safety pharmacology and toxicology studies have been conducted and the compound has been tested in pre-clinical models of the disease. This process will have taken many years. A multi-disciplinary team has evaluated all the data, and decided to take the plunge and invest in clinical development. And now, the drug is ready to be tested in humans.

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Promotion of aggregation via agitation as a Means of assessing the stability of antibody Molecules

Alison Turner, Principal Scientist at UCB (Celltech), explains in this detailed article how in the process of antibody candidate selection it is important that during manufacture and shelf-life the antibody shows aggregation stability. Hence it is necessary to be able to measure and predict the propensity of aggregation of different antibody molecules in a pre-screening assay.

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Fighting rare Diseases

Shirley Johansson of Midfield Media estimates that 6%-10% of the world’s population will suffer from a rare disease at one point in their life, and approximately one out of five people personally know an individual suffering from a rare disease. She goes on to explain that finding a cure or improved treatments for such patients is fundamental, not only to their lives, but also to society as a whole. The journey has begun, and there is great potential to improve the work amongst all stakeholders: patient organisations, governmental authorities, health technology assessment organisations, payers, and orphan drug developers. On 14th–16th September 2011, many of the key stakeholders will be represented at the Orphan Drugs Summit in Copenhagen, a hub for pharmaceutical development, to discuss challenges and alternatives to support the fight against rare diseases.

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RGCC: A Leading Company in Analysis of CSCs as Progenitors of All Cancer Relapses

Ioannis Papasotiriou explains in this article that RGCC Ltd is a leading company in analysis of circulating tumour cells (CTCs) as well as cancer stem cells (CSCs). Through their analysis, the organisation is able to offer services in the clinical field as well as in R&D in the pharmaceutical industry. By using the most advanced and innovative technologies of molecular and cellular biology, RGCC Ltd manages to overpass several restrictions and difficulties that the analysis of CTCs and CSCs involve. Through such an approach a massive amount of information and data has been generated in order to be used for identifying new «druggable» targets as well as offering methods in clinical practice like new and precise assays, risk scale and classification of cancer patients.

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Improving the human relevance of Preclinical trials

A fundamental of drug development is the provision of safe and effective medicines. The safety and efficacy of a drug can only be demonstrated through large-scale trials in humans. However, as Emma Sceats, Business Development Manager at Zyoxel Ltd explains, using humans as test subjects for drugs whose safety is unknown would be unethical. Instead, legal and regulatory guidelines require a plethora of studies to be conducted prior to clinical trials, so that all reasonable steps have been taken to mitigate risk to trial participants. Drug developers are also expected to give evidence of the expected effectiveness of the drug for treating human disease. Scientists have therefore needed to develop non-human models that can help to predict how patients will respond to a drug.

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A highly regulated environment for biomarker and biopharmaceutical testing

Nicola Gaskell, Client Manager in Bioanalytical Sciences at Quotient Bioresearch, explains that this article provides a current overview of how high throughput diagnostic analyser platforms and research-based analysis within a regulatory environment can be used to seamlessly deliver high quality data to the pharmaceutical industry, helping to drive the drug development process for the pharmaceutical industry.

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Insect Models for Drug Discovery

Is the insect hemolymph-fat body-Malpighian-metabolising-excretion system a relevant model for highly efficient documentation of some key ADMET parameters in the early drug discovery phase? Peter Aadal Nielsen, CEO at EntomoPharm, and Gunnar Andersson, CSO at EntomoPharm, answer this question and direct us to how in the future insect models could potentially be used as a filter between in vitro and in vivo models, filling the gap between the ‘quick’ in vitro models and the ‘slow, expensive but more reliable’ in vivo models.

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Recent trends in Personalised Medicine

Steve Poile, the founder and chief executive officer of Wildwood Ventures Ltd explains in this article that personalised medicine has recently grown in importance as drug companies and regulators alike come to terms with optimising resources on the right interventions for responsive patients, as well as improving early diagnosis of those patients susceptible to certain diseases before they become manifest.

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The challenges of e-Publishing in regulatory affairs

The change to e-publishing has brought about many challenges for regulatory affairs professionals. Conventionally, the end result was the focus of consideration – the electronic submission, and therefore the capability of a company to submit electronically. But e-publishing is much more. As an end-to-end process, it defines the critical capability a company needs to create and fine-tune.
The move towards e-publishing has come in waves, and went hand in hand with the advancements in technology and the evolution of standards. Raoul-A. Lorenz, CEO of LORENZ Life Sciences Group, expands further in this article.

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Risk Management of Drug safety: Pre-Approval Planning and Research will Ensure Success

Dr William C. Maier and Dr Carl de Moor of Registrat-Mapi explain that the last decade has witnessed an increase in the power of national regulatory authorities to require explicit programmes to control and mitigate risks related to the use of new and existing drugs. The impact on the pharmaceutical industry is substantial, because these new laws and regulatory powers will require a significant change in the way drugs are developed and supporting research is done prior to the filing of new drugs. This detailed article concludes that this new era of risk control and accountability requires that companies obtain evidence of the likely effectiveness of their proposed risk control programmes prior to the submission of an application for drug marketing.

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