2012 and beyond

What lies ahead

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.

Anticipating the Future

Biorepositories hold the key

To fully realise the potential gains of human genome diversity and its relationship to human disease, biorepositories must play an integral role. Through optimal utilisation of such repositories, comprehensive human phenotype data can be united with corresponding genomic and proteomic samples to shed new light on the underlying basis of human disease and offer new hope for a better understanding of how to diagnose and treat patients.

Research and Development

When medical need is not matched by market opportunity

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.

Oral Inhalation Technology

Impact of nanotechnology

Regulatory awareness has led to the need for new approaches when regulating nanotechnology in the inhaled area. Opportunities as well as challenges exist. If addressed, they can open the doors for new IP to be generated along with considerations that can be incorporated in Life Cycle Management.

New Drugs in Japan

Conditional authorisation and early post-marketing phase vigilance systems constitute an integral part of new drug approval and risk management in Japan. They intend to ensure safe launch and early access to patients of new drugs.

Changing Face of GPCR Drug Discovery

Opportunistic future

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.

Case Study

Transforming Drug Development

A fully outsourced model

The pharmaceutical industry is not transforming fast enough to address the persistent decline in productivity. Alternative drug development models are being explored in an effort to jumpstart transformation.

Clinical Trials

Asian Clinical Trials

Managing patient reported outcomes

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.

Paediatric Drug Development

Taking a practical approach

Conducting clinical studies in children is often a difficult undertaking. However, with proper planning and using the right resources, one can run safe, timely and successful trials in this challenging population.

Optimising Development Costs

Trifunctional Antibody Format

Concept and first drug candidate

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.

Offshoring

Cost-effective clinical research

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.

SPECIAL FEATURE

The Biomarkers Consortium

Advancing Biomarkers Research

The Biomarkers Consortium is an opportunity for public and private entities to join forces and pool resources in order to advance biomarkers research, an exciting and challenging mission. This novel experiment is an exciting and challenging endeavour that is presently undergoing evaluation and restructuring in some areas, to improve and optimise the identification, funding, and implementation of cross-sector biomarker projects.

Manufacturing

Demand-driven Manufacturing

Designing profitable supply chain

n life sciences, traditional supply chains were designed from the inside-out perspective. To adaptively meet actual demand from the customer and translate it into global trade-offs, supply chains need to be designed from an outside-in perspective.

Biopharmaceutical Operations

Developing the science

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.

Buying into Lean Pharma

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.

Information Technology

Case Study

Data Mining in Clinical IT

A real life industrialised model

Data mining has always been important to our industry. Having the ability to mine across the entire product lifecycle has always been the goal. To date, data and systems' 'non-interoperability' has been one of the major challenges to this effort. This case study will describe how data mining capability was enabled initially by Clinical IT.

A compliant IT environment with IT service management

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

Innovative IT

Enabling pharmaceutical Research & Development

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.