Foreword

Clinical Trial Supply Chain

Key to success

An efficient Clinical Trial Supply Chain ensures that all variations arising out of the huge disconnect that exists between the clinical trial supply demand planning, forecasting and the supply process are accounted for and dealt with in real time.

Strategy

Global Risk Management

Meeting the challenge

A changing regulatory environment and difficult targets present significant challenges for biopharmaceutical companies seeking a balanced approach to risk management.

Getting from Challenge to Change

How far, how fast?

Metrics for cost, time and success rates show that the current level of investment is challenging industry's viability. Success rates are an attractive target for effecting overall change. Getting from challenge to change, however, will demand migration from primary care market to specialty market, process redesign, outsourcing of clinical trials to emerging economies, and offshoring of ancillary pharma business segments.

Case Study

Sustainable Drug Discovery

Galapagos’ alliance strategy

A changing regulatory environment and difficult targets present significant challenges for biopharmaceutical companies seeking a balanced approach to risk management.

Indian Patent Law

Relevance to global pharmaceutical industry

The Section 3 of Indian Patent Act is considered as a roadblock for patenting invention by many global pharmaceutical industries. Here is the brief analysis of this section and its impact on the Global pharmaceutical industry with some recent cases.

Drug Development Challenges

The drug development model today is under increasing pressure as the number of drugs approved for marketing has dwindled to an all time low. Drug developers must acknowledge this trend before initiating the development process. However, for a developing biotechnology or pharmaceutical company, where resources are usually limited, it is critical to have an absolute appreciation of the industry trends.

Research and Development

Antibacterial Research

Bright future?

New antibacterial drugs have been few and far between due to a slump in the R&D activities and also due to many unique challenges in this area. However, of late, there is renewed interest in this field and many innovative concepts and targets are being looked into.

Targeted Delivery

Photosensitiser conjugated gold nanoparticles

Biocompatible gold nanoparticles have been explored as a new vehicle to deliver photosensitiser to tumour cells. The use of gold nanoparticles can significantly increase the accumulation of photosensitiser in tumour cells and lead to a high efficiency in destroying the tumour cells.

Adjuvant Systems

Next stage of rational vaccine design

Although vaccines helped in improving healthcare globally, significant disease challenges still remain. As such, new solutions are required where classical vaccine approaches are insufficient to provide optimal protection for specific populations and against certain diseases.

Early Formulation

Shortening the development timelines

Formulators are faced with an increasingly competitive industrial environment and very challenging compound properties. Smart development strategies, like frontloading are needed in order to increase the R&D productivity and to bring new chemical entities earlier onto the market. Key factor for success is the intensified cooperation between research and development.

Enhancing Antibody-based Cancer Therapy

Antibody combinations and dual-targeting bispecific antibodies

Monoclonal antibodies are becoming an important class of antitumour agents, as they have been shown to enhance the efficacy of various therapeutic regimens without significantly increasing systemic toxicity. Further, results from preclinical and early clinical studies suggest that combination of antibody-based therapeutics may be more efficacious than each individual antibody alone with still minimal and acceptable toxicity. Antibody combinations and dual-targeting bispecific antibodies represent promising approaches to more efficacious antitumour therapy.

Unleashing the Industry’s True Potential

Closed loop clinical trial supply chain

Clinical trial supply chain will play a significant role in launch of new products in a globalised environment of clinical trials and clinical supplies manufacturing.

Clinical Supplies

Adapting to trial demand

In today’s clinical trial environment, change is at the front lines acting as an obstacle to the success of a clinical supply plan. How many times has the clinical trial design changed after supplies are already packed and labelled? Preparing clinical supplies in this environment is challenging supply chains to create adaptive supplies that can easily respond to the changes in today’s clinical trials.

Clinical Trial Supply Chain

Streamlining information management

Consolidating and integrating data across systems and relationships can help manage some of the challenges associated with supplying investigational and comparator drugs for clinical trials.

Clinical Trials

Personalised Healthcare

Hitting the mark

The concept of Personalised Healthcare (PHC) is being driven by the idea of improved patient outcomes and also to contain soaring healthcare costs. It is only when the right patients receive the right treatment that the true value of PHC is realised. To achieve this, biomarkers that are quantifiable need to be identified to select the right patient populations. The challenges of implementing this new research strategy are complex and would require a multifaceted approach.

Proteomic Biomarkers

Transforming drug development

The success of many investigational drugs is dependent on matching treatments with the appropriate target populations. Such “personalised medicine” is now possible with recent advances in proteomics for the discovery and validation of biomarkers of disease and drug efficacy.

Global Clinical Development

Reducing Japan’s drug lag

Japan’s Ministry of Health, Labour and Welfare is adjusting its policies to accommodate the current trend of global clinical development to promote public health of the Japanese, especially in terms of quicker delivery of new drugs to patients.

Case Study

Human Antibody Discovery

VelocImmune - A novel platform

The direct replacement of the unrearranged genomic DNA encoding in the variable regions of the mouse heavy and kappa light chain with the equivalent human genomic sequences creates a more efficient platform for the discovery of antibody therapeutics.

Outsourcing CRO Services to China

The staffing challenge

The ability to utilise Asia-based CRO capabilities can make it easier and more cost-effective for pharmaceutical and biotech companies to develop and market new products for the burgeoning pharmaceutical market in Asia.

Manufacturing

Moving from R&D to Manufacturing Excellence

Relative separation of manufacturing and R&D (siloed thinking) continues to characterise the pharmaceutical industry. Managing operations in a holistic manner by investing on a common platform that meets the existing standards and integrates innovative technologies across plants and different functional departments can help the pharma industry keep ahead of future trends.

Controlling Production Process

Incorporating analytical methods

Taking new regulative guidance into account, the motivation for increasing process analytical technology systems from a scientific and administrative point of view is addressed here. Based on freeze-dried macromolecular systems, the current gains and challenges of NIR and Raman spectroscopy are discussed. The potential of spectroscopic techniques is described in more detail using the common excipient mannitol as an example.

Process Analytical Technology

Application in precipitation processes

Precipitation is a commonly used purification method when a pure crystalline Active Pharmaceutical Ingredient (API), excipient or intermediate with specific particle properties needs to be isolated from a multi-component process solution after a synthesis, extraction or bio-process. The main factors affecting precipitation processes and in-line process monitoring when Process Analytical Technology (PAT) based on in-line / on-line spectroscopic methods is applied, is discussed here.

Information Technology

Business Intelligence in Pharma

A key enabler of industry transformation

Business intelligence solutions, proven in other industries, offer the troubled pharmaceutical industry the potential to enable both operational excellence and better technical management to support drug development for the future.

Expert Talk

Biopharmaceutical Manufacturing

The challenges

Asia is emerging strongly in the area of biopharmaceutical manufacturing. More and more companies are confident of offering quality products and / or services. In the span of past two years, the perception of having an Asian manufacturing partner has been very positive, with nearly 80 per cent of small and large companies eyeing to outsource manufacturing to Asian biopharmaceutical companies.

Public Private Partnerships

PPPs is being seen as an effective strategy to reduce pipeline stress and also keep the spiralling cost of drug discovery and development under control.