STRATEGY

There is significant concern that Personalised Medicine will cause the end of the blockbuster era in pharmaceuticals. The reality is that what must evolve is the model for financial return, application of stratification in medicine and focussed research on drug safety.

The pharmaceutical industry is facing a tough road ahead in the future marketplace. Though pharmaceuticals remain the most cost-effective healthcare intervention, they should bring about a significant transformation in their organisations to realise the glorious future.

RESEARCH & DEVELOPMENT

Tropical parasitic diseases are major contributors to mortality and morbidity in the developing world, yet fail to offer a compelling market opportunity for new pharmaceutical development.

Although GPCR drug hunters can boast of a successful and glorious past, the present and future challenges remain high. Some of the changing paradigms in GPCR research that may aid in confronting the challenging environment of GPCR drug discovery are discussed here.

CLINICAL TRIALS

Trifunctional antibodies represent promising new cancer therapeutics based on a unique mode of action. The first drug candidate catumaxomab showed strong anti-tumour efficacy in a pivotal phase II / III trial in advanced cancer patients.

Selecting the appropriate method/type of Patient Reported Outcomes administration has strategic importance in the preparatory stage of clinical trials. In the results phase, PROs bring to the fore the patient’s perception of treatment benefit and its impact on function and quality of life with distinct influences from the countries and regions where data have been collected.

In response to growing pressure to improve the efficiency of the drug development process, many pharmaceutical and biopharmaceutical companies are turning to emerging markets to reduce R&D costs and speed development times.

MANUFACTURING

The article is a 30,000 feet fly-by of the essential stepping stones leading to a sustained lean deployment. This pragmatic approach, based on personal successes and failures, has been proven in several industries and across three continents by the author.

Drawing parallels with the semiconductor industry, the authors argue that biopharmaceutical firms are finally reaching a point where efficient operations are becoming critical, thus necessitating advanced research in biopharmaceutical operations.

Information Technology

IT can play a key role in cutting down the costs of production and helping biopharmaceutical companies maintain regulatory compliance.

The pharmaceutical industry is facing increasingly severe challenges to its mission of delivering novel therapeutic solutions for unmet medical needs. Today, a heightened focus is being placed on leveraging maximum value from its core asset—information.