General Biotechnology

Trends in Market Access for Specialty Biologics: Challenges & Promises

Specialty biologics are the fastest growing class of bio/pharmaceutical products in terms of the number of new brand launches and rates of health care spending in the U.S. and globally. Innovative biologics meant to treat a range of hitherto untreatable conditions in oncology, inflammation, CNS, endocrinology and other chronic conditions seek to offer radical improvements in efficacy and patient well-being. Such products can command premium prices, often costing over $100K per year per patient – triggering a raft of challenges to ensuring that eligible patients have adequate access.

 This article outlines important trends impacting market access to specialty biologics in the U.S. and globally. Particular importance is placed on evolving methods for managing specialty product utilization and reimbursement toward ensuring appropriate access. The reshaping of the specialty product market access landscape in the U.S. through the availability of oral biologic formulations distributed to patients via high-touch, high-involvement specialty pharmacies is examined. The rising role of risk sharing between specialty product manufacturers and insurers as a way to balance rewards of access with the risks inherent in radical new specialty therapeutics is discussed. Challenges posed by specialty biosimilars to traditional ways of ensuring market access and fair reimbursement are outlined. The impact of health care reforms on market access for specialty biologics in the U.S. is discussed in the context of the growing need for comparative outcomes research and the application of the principles of health technology assessments – adapted, in part from their apparent success in ensuring equitable and cost-effective access to biologics in the E.U.

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General Biotechnology

The University of Colorado Certificate Program in Bioinnovation and Entrepreneurship: An Update and Current Status

The purpose of this paper is to provide an update and report the current status of the cross-campus University of Colorado Denver program in bioinnovation and entrepreneurship, details of which were first reported in the Journal of Commercial Biotechnology in 20125.  The paper outlines the joys and challenges of implementing an inter-campus program that attempts to marry cutting-edge biotechnology innovation with a solid business foundation.  The tremendous value offered by such a program, particularly to biotechnology and life-science researchers, is outlined. Operationalization and process issues such as differential tuition rates, distance between campuses, and class timing issues are considered, and solutions are offered.   Finally, recommendations are provided for other business schools considering a similar program.

The University of Colorado Certificate Program in Bioinnovation and Entrepreneurship: An Update and Current Status Read Post »

General Biotechnology

Accelerating the Growth of Bioeconomy in Malaysia

Advances in commercial application of biotechnology worldwide over the past two decades have led to the development of a bioeconomy, whereby substantial economic outputs are from the development and use of biological materials. Bioeconomy encompasses all industries and economic sectors based on the values implicit in biological materials that can be translated into new sources of income, environmental sustainability and social well-being.

Malaysia, one of the most competitive biotechnology hubs in the Asia-Pacific region, has also taken critical early steps to coordinate and intensify national efforts to harness the potential of the bioeconomy. Most significantly, the Bioeconomy Transformation Programme (BTP) was launched in October 2012, making the country only the second in Asia, after China, and the first in ASEAN, to establish its own national bioeconomy initiative.

The BTP is in line with the Government’s objective to develop Malaysia into a high-income nation by the year 2020. The BTP aims to achieve this by focusing on bio-based industries in Malaysia, a sector that has been identified as having enormous potential to further develop the nation due to the abundance of natural resources available.

With the introduction of the BTP, Malaysia is now unlocking even greater opportunities in the local and regional biotechnology industry, and enhancing the participation of the private sector. Through effective execution strategies from the Government and BiotechCorp, the biotechnology sector is now directly contributing towards efforts to drive Malaysia towards a high-income and knowledge-based economy by year 2020.

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General Biotechnology

Biotechnology in India: Public–private partnerships

Journal of Commercial Biotechnology
This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Biotechnology in India: Public–private partnerships

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ABSTRACT: As the purpose of this study was a survey of public sector–private industry collaborations of the biotechnology sector in India, an organisational and functional overview of this sector was needed. Therefore, rather than studying a hypothetical biotech sector in India, the focus of this work was to study the public–private partnerships (PPP) that are occurring in India in the area of modern biotechnology…

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

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General Biotechnology

Assessing the history and value of Human Genome Sciences

Journal of Commercial Biotechnology
This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Assessing the history and value of Human Genome Sciences

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ABSTRACT: Human Genome Science (HGS) aspired to dominate the emergent field of genomics by discovering expressed gene sequences and developing therapeutic and diagnostic products based on proprietary genes. While HGS’ accomplishments fell short of their own lofty expectations, by the time HGS was acquired by GlaxoSmithKline, the company had extensive intellectual property and had launched a product with >$1 billion market potential…

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Assessing the history and value of Human Genome Sciences Read Post »

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