Strategy

Rethinking R&D

Novel approach to partnering

With a decrease in R&D productivity, increase in the cost of late-phase drug development and a greater competition for licensing opportunities, the stakes are high for the major players in the pharmaceutical industry.

Shaping the Future of Drug Development & Marketing Strategies

Payer perspectives

Two questions from patients about drug therapy-does it fix my problem? does it cause other problems?-suggest three new pharma strategies to address payers' priorities for improved results. These strategies are affected by payer perspectives as they shape the future of drug development and marketing strategies.

Twenty-first Century Crime

Counterfeit, illegally diverted and stolen pharmaceuticals

The rise in counterfeit medicines worldwide, with concomitant problems of toxicity, instability and ineffectiveness, is often underestimated. It is a hidden risk because counterfeit medicines are largely overlooked in the official public health statistics.

Personalised Genetic Diagnostics

Warrants global expansion

Direct-to-consumer genetic tests should be advertised as 'genomic art' to avoid the increase in general anxiety that they will introduce without including a properly informed healthcare provider.

Next Generation Pharmacovigilance

For enhanced patient safety

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

Indian Pharmaceutical Industry

On the cusp of a great opportunity

Leading research-based Indian pharmaceutical companies spend less than 10 per cent of their sales on research. In the interest of overall public health, India should allow patents for incremental innovation. Incremental innovation, or innovation by sequential steps, is essential to pharmaceutical development of new and improved medicines and public health and is indeed the major way in which medical science has progressed.

Mega Mergers

Are they turning pharma companies into Zombies?

Biotech consolidation through acquisition was the primary trend in 2007 for the big pharma and the global financial crisis in 2008 has driven the pharmaceutical industry towards adopting a short-term myopic M&A approach. The Innovation Gap for new drugs has widened to a cavern. In 2009, the industry has some interesting questions to answer. How to close this innovation cavern and how will the pharmaceutical industry manage short-term perceived benefits at the expense of long-term woes in building sustainable drug pipelines?

Pharma and Biotech

Collaborative models

Collaborations are a common business practice within the pharmaceutical and biotechnology industry. This article discusses both the strategic and tactical drivers for engaging in collaborations as well as some of the distinguishing features of the various types of collaborations used in this industry.

New Patents for Old Drugs

Label-based strategies in the United States

Repurposed pharmaceuticals are attractive candidates for clinical development, but only with sufficient marketing exclusivity. Patents that focus on the uses and compositions in the product label can provide up to 20 years of exclusive marketing rights.

Innovation

The key growth mantra

The Indian life sciences industry has been innovating within its means right from its early days by mastering the art of process re-engineering during the process patent regime.

Personalised Medicine

End of the Blockbuster?

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.

Drug Discovery and India

A force to reckon with

The pharmaceutical industry is going through a tough time due to drying R&D pipeline, poor productivity, spiralling cost of research and cash crunch.

Asia's Antibody Market

Realising the potential through strategic alliances

The antibody market is a key growth area for biologics, re-energising pharma R&D and delivering next-generation medicines.

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.

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.

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.

Empowering Patients in Asia

Persistent changes in the healthcare landscape in Asia are driving the demand for increased information to patients to empower them as consumers. Better access to information, more patient responsibility and a greater focus on prevention of disease should be the basis for modern healthcare in Asia.

Breaking Down Borders

Asian biotechnology industry

Cross-border collaboration in biotech industry has been emphasised by both the public and private sectors of many Asian countries. Although there are still many obstacles to overcome, such efforts have started to bear fruits.

The Arab Drug Industry

Challenges and future potential

Though Arab drug industry is increasingly contributing to the production of biotechnology products, particularly vaccines and herbal medicines, the main challenge is to achieve the regional objective of self-sufficiency in the production of essential drugs and vaccines.

Open Source Drug Discovery

A feasible business model?

The concept of open source model which is a huge success in the software industry holds great promise for the pharma industry as it strives to lower the cost of drug discovery and improve the bottom lines.

Pharma and Biotech

Is it possible to continue growing?

While the industry still performs on a high level, growth prospects are not as they had been in the past.

Partnerships

Win-Win Strategy

Among the options available to the pharma companies, partnerships and strategic alliances seem to have the potential to open the doors for synergic collaborations to create win-win situations in the long-run.

Drug Research and Development

Bridging the innovation gap

What needs to be done to improve or change the R&D productivity of the pharmaceutical industry? Is biotech consolidation the answer, and if not, what is?

US Biotech and Indian Pharma

Is there a win-win partnering strategy?

Due to emerging factors such as escalating financial risks, lack of new blockbuster drugs and evolving global capabilities, the time is right for US biotechnology firms and Indian pharmaceutical companies to join forces in the pre-commercial phases of drug research and development.

Finding the Way in China

Critical issues for partnership and investment

Multinational pharmaceutical companies are rushing to China with an aim to access the low-cost scientific talent and also claim a stake in Asia's largest pharmaceutical market. But the Chinese business climate is far from what one normally encounters in the West.

Challenges for Pharmaceutical Sales Forces

Lessons from other sectors

Pharmaceutical sales forces can overcome their challenges by learning how companies from other sectors have dealt with similar challenges.

Liver Caner Treatment in Asia

From little acorns

Oncology is currently one of the most exciting but demanding areas for developing successful brand strategies. Companies entering smaller and niche markets in this area should clearly differentiate their products from competition to command and sustain a premium price.

Generic to Innovative

Transition of Indian pharmaceutical companies

While generics continue to drive the Indian pharmaceutical industry, it is set for rapid growth in its new avatar as a supplier of finished dosage forms to the world. However, challenges abound.

International Strategic Alliances

Positioning the Asian biotechnology company

Asian biotechnology companies' lack of experience in pharmaceutical alliances can be quickly overcome by deliberate preparation, careful identification of potential partners and anticipation of the due diligence process of partnering.

Fulfilling the Promise of China

Sustained economic growth and tremendous unmet needs in important therapeutic areas in China are creating huge potential for the industry but the ability to adapt successful practices to the nuances of the local market will be critical.

Treating Neglected Diseases

The role of orphan drugs

The Institute for OneWorld Health has developed Paromomycin IM Injection to treat visceral leishmaniasis in India. In the future, similar models can be used to bring new drugs to the people suffering from neglected diseases
in the developing countries.

Pharmaceutical Marketing

Strategies for Asia Pacific

Success in Asia will depend upon the ability of marketers to navigate the local environment with globally developed products.

Pharmacoeconomics

Introducing patient-centred Models

Companies preparing for the implementation of pharmacoeconomic guidelines in Asia have an opportunity to use those resources for purposes other than justifying government reimbursement.

Understanding the psyche of Asian pharma consumers

The pharmaceutical industry needs to revisit its ‘doctorheavy’ marketing strategies to succeed in this continent.

Indian Pharma

The Discovery Metamorphosis

A New Paradigm for the Indian Pharma Industry

Our strategy is based on our belief that Indian scientists can become creators of intellectual property rather than be copiers.

Innovation - The Key Driver

In the next five years, Indian pharma will do well in terms of gaining a fair understanding and being able to further evolve the drug discovery environment in India.

Drug Discovery & Development

An Indian Perspective

India is on the threshold of drug discovery research where the next few years are going to be the most critical.

The Indian Pharmaceutical Industry

Promises and perils

The pharmaceutical industry needs to revisit its ‘doctorheavy’ marketing strategies to succeed in this continent.

IPRs

Negotiating with the USTR

Should it be impossible to exclude the issue of intellectual property from a bilateral negotiation with the USTR, much care should be taken in setting the terms of negotiation.

Outsourcing preclinical and clinical R&D to China

In the coming years, China will become an important player in local and global healthcare, from both provider and utilisation perspectives.

Patents and Global Drug Development

US patent laws enable a patent holder to obtain damages as a result of the use of a non-infringing product that is exported from the USA and used in another country as part of a US patented process.

Pharmacoeconomic Requirements in Asia

Pharmacoeconomic guidelines have now been developed in Korea and it is likely that pharmacoeconomic evaluations will increasingly influence drug funding across the region over the coming decade. Peter Davey discusses the potential implications.

Going for Growth in China

With China on target to join the world's leading pharmaceutical markets in the near future, Ray Hil highlights the factors that challenge success in this market, and the opportunities for pharmaceutical companies that tailor their sales and marketing effectively.

Chinese Competitiveness in a Global Context

The emerging markets - Central and Eastern Europe, India and China - are attracting increasing attention both as future markets and as sources for R&D. Of these, China is the one that appears to be pharma's greatest opportunity for growth.

Outsourcing opportunities in China

The global pharma industry is increasingly outsourcing its production processes to service providers in developing countries. China is a major target due to its lower cost structure. William Xia Guo explains how his company aims to become one of the leading providers of drug development outsourcing services.

Growth Spurt

It is widely believed that Asia offers the strongest prospects for pharma growth. Stephen Phua of IMS Asia and Ted Saeki of IMS explain how and why the major markets in the region are expanding at such a rapid rate.

Eastern Promise

With trailblazers India and China leading the way, Asia is the hot pick for bulk manufacturing and, increasingly, clinical trials and R&D. Jim Banks looks at the competition for market share and the race to find the best regional and international partnerships.

China seeking Protection

China's accession to the WTO in December 2001 has resulted in more transparent regulation of its pharma industry, a gradual opening up of markets, more enforcement of IP rights and greater opportunities for outsourcing.

Under development

Asia still evolving

With all eyes firmly focused on pharma growth in Asia Pacific, Shailesh Gadre and Yehong Zhang, IMS's vice president of Greater China, review current performance across the various markets and consider the emerging opportunities.

Leader of the Pack

Investors are watching the evolution of India's pharmaceutical industry with great interest. Rising standards and a developing regulatory infrastructure are creating new opportunities, while the well-established bulk manufacturing market is benefiting from more investment in R&D and clinical trials.

Tracking CRO growth

As interest in Asia Pacific increases, CRO offshoring is beginning to make an impact in the region. Alan Davies and Janet Jones of Kendle International explore the various options.

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Raising the Bar for Clinical Research

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A New Phase of Outsourcing

Western companies opting to work with partners in Asia rather than setting up their own operations there are finding a better choice of service provider, but the China vs India debate rumbles on.