Johnson & Johnson - Articles and news items

Ortho-McNeil-Janssen Pharmaceuticals, Inc. Announces Oncology Research Collaboration Agreement with the Koch Institute for Integrative Cancer Research at MIT

Industry news, News / 28 June 2010 / Johnson & Johnson

Ortho-McNeil-Janssen Pharmaceuticals, Inc. today announced the signing of a five-year collaboration agreement with the David H. Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology. Called TRANSCEND, the collaboration agreement will foster oncology research and technology development in the areas of cancer diagnostics, cancer biology pre-malignancies, genetic models of disease, and profiles of the tumor microenvironment.

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Biomarkers in the development of novel medicines for the treatment of cancer

Issue 3 2010, Past issues / 24 June 2010 / Hans Winkler, Global Head Oncology & Biomarker Programs, Ortho Biotech Oncology Research & Development, Johnson & Johnson

The pharmaceutical industry has reached a critical phase in its evolution. The cost and time to develop novel medicines has become unsustainable3. Reasons for this may include a much higher demand on evidence of safety and efficacy, rapidly increasing costs of contract research and the tremendous pressure on pricing and reimbursement from regulators and payers expecting higher benefit rates than the current average for newly launched products. Concomitant with these pressures we observe an ever decreasing R&D productivity which acerbates the problem2.

In this context, it is important to remind ourselves of the task to be achieved. First, a suitable target has to be identified whose inhibition will result in major effects on tumour growth and survival. (more…)

Applying PAT in Chemical Process Development

Issue 3 2009, Past issues / 29 May 2009 /

As the time-to-market of pharmaceutical products has elongated, while its prices are under big pressure, cost saving is currently essential in the pharmaceutical industry.

Therefore, the manufacturing of pharmaceutical products is forced to change to a more efficient and qualitative production. Since the introduction of the PAT guideline in September 2003, even regulatory environment is driving the industry to change their manufacturing from a Quality by Inspection to a Quality by Design state, which has led to quality improvements and cost savings in other industries. Within the concept of Quality by Design, Process Analytical Technology (PAT) is a powerful tool for achieving an optimal manufacturing process. The main goals of PAT are to gain a thorough understanding of the manufacturing processes and to learn how to control them₁. When processes are understood, opportunities for continuous improvement (quality and efficiency), cycle time reduction, cost reduction and QC lab test replacement arise. In this article, the strategy of Johnson & Johnson Pharmaceutical Research & Development (J&J PRD) towards the implementation of PAT in Chemical Process Development is explained and clarified by case studies. (more…)

Biomarkers and the tumour microenvironment

Issue 1 2009, Past issues / 7 February 2009 /

The current cost of developing a new medicine for the treatment of human disease has been estimated at $1 to $2 billion (€750-1.5 million1,2). Given progressive increases in the cost of developing new drugs, pharmaceutical companies are facing significant pressure to streamline discovery methods and increase the translational efficiency of their newly discovered compounds. (more…)

Utilisation of secondary screening

Issue 3 2008, Past issues / 19 June 2008 /

European Pharmaceutical Review has brought together four individuals from different sides of the scientific palette to discuss current and future issues surrounding secondary screening and maximising its potential. (more…)

PAT: not a purpose in itself

Issue 2 2008, Past issues / 19 March 2008 /

The process analytical technology guidelines have been a hotly debated topic within the pharmaceutical industry ever since they were made public in 2004. This also holds true at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), Division of Janssen Pharmaceutical N.V. In recent years, the company has introduced PAT tools in its manufacturing operations and in its development organisation on a project-by-project basis. Several of these projects have resulted in a better insight into critical manufacturing processes and have led to significant optimisations.

Despite these promising results, the company feels a more sector specific approach will be needed to ensure optimal integration of the PAT principles. “Constant monitoring, adjusting, and optimising of manufacturing processes – the very essence of PAT – is not always that obvious in a strongly regulated environment. That is why the implementation strategies that have been successful in other industries do not necessarily apply for the pharmaceutical industry,” says Peter Van Broeck, Senior Director New Product Introductions at Johnson & Johnson.

European Pharmaceutical Review recently brought together four PAT specialists from different departments within Johnson & Johnson. Each of them has their own particular experience with the use and implementation of PAT tools. An interesting conversation on the current view of PAT within Johnson & Johnson ensued. (more…)

The role of phospho-proteomics in drug discovery and development

Issue 1 2007, Past issues / 25 January 2007 / Ze’ev Gechtman, Ph.D., formerly of Johnson & Johnson

While scientific discoveries can be turned into financial assets, the scientific process itself has proven difficult to harness to efficiently create marketed products bringing profits. This translation is especially challenging for the pharmaceutical and biotechnology industries owing to the tremendous complexity of biological systems.

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