Recession: Bounce Back

Beyond Patent Wars

A number of key pharmaceutical trends emerged in 2010; but their effects on the future of the industry, and whether we have finally seen the back of the recession, are yet to be seen

by Arun Kumar of Infosys

Preferred Partnerships

A New Paradigm

Survival in difficult times has been something of a mission statement for many in the last couple of years. Nevertheless, CROs are doing their bit to help biopharmaceutical companies adapt to the global recession

by Dalvir Gill of PharmaNet Development Group, Inc

UK Scene: Pfizer Closes Site

Recession Bites?

Pfizer’s recent announcement of the closure of its UK R&D function spells the loss of around 2,400 jobs, and the generation of many press headlines. What does this tell us about the current economic climate and, in practical terms, what steps need to be taken by a pharmaceutical company to close a site down?

by Esther Smith of Thomas Eggar LLP

Outsourcing Relationships

Setting the Boundaries

How hands-off can – or should – the sponsor be when partnering with a CRO in a strategic outsourcing model was the topic of discussion at Partnerships in Clinical Trials,Vienna in November 2010, with relationship building being viewed as a crucial element for fostering long-term success

by Erasmo Messina of Clearstone Central Laboratories

Paediatric Regulations: US and EU

Similar but Different

With more paediatric-specific studies occurring worldwide, it is important that sponsors are aware of the differences in the regulations governing the development of medicines for children in the US and Europe, especially regarding the approval process and timing, and keep these differences in mind when planning their studies

by Susan Bhatti and Charlene Sanders at Premier Research Group

New Drug Approval Pathways

A Rising Tide

In the 2006 fiscal year, approximately 20 per cent of new drugs were approved through the 505(b)(2) process; two years later, more than half of the new drugs approved in the US were based on this strategy. Judging from the rate at which we are filing investigational new drug (IND) applications today, it is expected that by 2012, the number of 505(b)(2) approvals will likely be 80 per cent

by Ken Phelps of Camargo Pharmaceutical Services

Regulatory: ATMPs and the EUTCD

The Potential of Advanced Therapies

Rapid and cutting-edge developments in the field of biotechnology, cell biology, (bio)material science and regenerative medicine have led to the development of what are now defined as advanced therapy medicinal products (ATMPs). They offer the opportunity for the treatment of diseases and injuries that currently have limited or no effective therapeutic options

by Jeroen Pieper at Signifix BV

Prostrate Cancer in BRIC Countries

Promising Pipelines

The prostate cancer market has a high unmet need in terms of safe and effective medicines, but a number of future therapies look set to change the therapeutic landscape, particularly in BRIC countries

by Aditi Singh of GlobalData

Rheumatoid Arthritis: Preclinical Imaging

Therapeutic Potential

Rodent models of rheumatoid arthritis (RA) have been widely used in the preclinical evaluation of novel therapeutic agents, and efficacy in these models is usually based on the assessment of clinical signs and symptoms. However, inhibition of erythema and swelling does not necessarily translate into disease modification, and histopathologic endpoints are usually required to confirm this activity

by Joseph A Cornicelli and Vinod Kaimal at Charles River Laboratories

Oncology: Imaging Techniques

From a Personal Point of View

The role of molecular imaging in personalised medicine is set to become far more prominent, especially in the field of oncology, with a wealth of techniques available to researchers and diagnosticians

by Cyril Berthet, Olivier Duchamp, Jan Hoflack and Philippe Genne at Oncodesign Biotechnology

Clinical Development: Antidiabetic Drugs

Living up to Expectation

Ensuring compliance to FDA guidance on cardiovascular risk is essential when creating a new treatment for Type 2 diabetes

by Robert B Kleiman of ERT

Biomarkers in Personalised Medicine

Precompetitive Partnerships

Biomarkers still hold promise as industry faces challenging barriers in bringing new products to market, and while this promise has not yet been fully realised, the scientific and clinical rationale remains persuasive

by Shawnmarie Mayrand-Chung, Anthony J Dickherber and Barbara Mittleman of the National Institutes of Health

Clinical Data Management

Offshoring Opportunities

The outsourcing of data management to emerging countries continues to increase, and new technologies and processes are being brought to market to bridge the gap, as pharmaceutical companies look for cost-effective ways to process clinical trial data

by Nimita Limaye of SIRO Clinpharm Pvt Ltd

Adaptive Trials Designs in Clinical Development

Vital Statistics

Are adaptive design studies a new challenge to rise up to? The author seems to think so, and highlights the benefits of these studies in clinical research – one of which is increased efficiency, especially in the learning phases – but also maintains that you must have your wits about you when embarking down this road

by Michel Hantzperg at ICTA

LIMS: ELN Integration

Electronic Advantage

Laboratory information management systems (LIMS) have played an important role in laboratory automation since the 1980s. In recent years however, a new type of software application has arrived on the scene – the electronic laboratory notebook (ELN) – but what are the important aspects to consider when introducing an ELN into a laboratory that is already using a LIMS?

by Nick Townsend at LabWare Europe

LIMS: Method Validation

Computerised LIMS

In today’s modern analytical laboratory such as a contract research organisation (CRO), a laboratory information management system (LIMS) is no longer a luxury but a necessity, critical to the management and control of laboratory data and information. Due to the rising cost in R&D and biotechnology, many companies are looking at ways to maximise efficiency and profitability in order to remain competitive

by Christine Paszko of Accelerated Technology Laboratories Inc, and Jennifer W Weller at the University of North Carolina at Charlotte