• 9 November 2006
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USFDA issues guidance on quality systems

USFDA issues guidance on quality systems

The United States Food and Drug Administration (USFDA) has issued a final guidance on quality systems, a set of formalized practices and procedures to ensure quality of human and veterinary drugs and human biological drug products during manufacturing.

The guidance will enhance FDA's current requirements for ensuring manufacturing quality known as the current Good Manufacturing Practices (cGMP) regulation.

Dr Janet Woodcock, deputy commissioner for operations, FDA, said, "This guidance incorporates modern quality principles into FDA's approach to manufacturing, encouraging industry adoption of new technological advances and integrated quality systems."

The document also contributes to the goals of the agency's Critical Path initiative, which seeks to modernize the development of new drugs. This will help take a drug from laboratory development to mass production in a way that can better assure its initial success and continued quality production.

Source: www.nzbio.org.nz


NZTE announces Biotechnology Fund

New Zealand Trade and Enterprise (NZTE) has announced that the Australia New Zealand Biotechnology Partnership Fund (ANZBPF) was opened for the 2006/07 year. The fund is designed to assist and accelerate trans-Tasman biotechnology industry collaboration, with a focus on economic return to New Zealand and creating strong alliances between the two nations, ultimately helping New Zealand and Australian biotech companies access global market opportunities.

There are four categories of funding, with total grant funding for the 2006/07 round of NZD$3 million (including GST).

Source: www.nzbio.org.nz


BIA guidance on financial and regulatory regime

The BioIndustry Association (BIA), having over 300 members, has come up with a new guidance for its members to assist in compliance with the current financial and regulatory regime. The BIA has also introduced a foundation course in corporate communications for small and early-stage bioscience companies starting from September 1, 2006. The guidance, supported by the Financial Services Authority, London Stock Exchange, and Bioscience Unit of Department of Trade and Industry, aims to ensure continued investor confidence, an essential requirement for the UK bioscience sector's continued growth and future stability.

Since the BIA's Code of Best Practice was first published in 1999, the financial and corporate governance landscapes have changed dramatically. The new guidance reflects the introduction of the 2005 Listing Rules, Combined Code and other regulations.

The consultation process has involved working closely with financial regulators, and gathering advice on best practice from financial and legal advisors and member companies.

The key points of the Best Practice Guidance include public communications about products, public communications about the regulatory process, effect of communication on patients and others and use of scientific or technical terms in public communications.

On the new guidance, Aisling Burnand, chief executive of the BIA, said, "In an industry where many companies are valued on the strength of their R&D pipelines and commercial strategy rather than product sales, timely and transparent communication is the key. This guidance represents a natural progression and a continuation of the BIA's firm commitment to the maintenance of high standards. We anticipate that this will assist members, with the implementation of the most recent regulations, to communicate appropriately for their own benefit and that of the broader industry."

Source: www.bioindustry.org


Canadians support use of biotech products and process

A majority of Canadians, almost 80 percent, have supported the use of products and processes that involve biotechnology. While Canadians generally feel good about biotechnology, more than one-third of them do not regard Canada as a biotechnology leader, or able to keep pace with the rest of the world. Canadians want to see the biotechnology industry grow and produce results.

This is the outcome of the second annual national poll conducted by POLLARA during the first week of September. Releasing the results of the poll, Peter Brenders, president and CEO, BIOTECanada, the national association for the biotechnology industry, said, "Canadians see the benefits biotechnology offers in agriculture, health and to the environment. However, our industry is not regarded, by Canadians, as a world leader. The potential is certainly here, and action by our federal government can help in the development of a more successful industry."

The poll results also indicate that the federal government has an increasingly important role to play in the development of Canada's biotech industry. Over 80 percent of Canadians agree the federal government should find ways to help support Canadian biotechnology companies develop new products. Almost 90 percent say Canada's health care system should be willing to pay more for advances in new health biotechnologies.

Source: www.biotech.ca


BIO joins New Biomarkers Consortium

Biotechnology Industry Organization (BIO) has joined the Food and Drug Administration, the National Institutes of Health and a host of patient groups, industry organizations and private companies in forming the New Biomarkers Consortium under the auspices of the Foundation for the National Institutes of Health. Biomarkers will help to fulfil the promise of personalized medicine that tailors treatments to individual patients by helping to predict which individuals have a greater chance of benefit or risk when they use a particular therapy

New biomarkers will improve the process of drug development in several important ways. For example, biomarkers demonstrate potential to greatly improve drug safety both pre and post market. Biomarkers can be used to help identify potential toxicities associated with experimental compounds much earlier in the drug development process. Biomarker-based clinical tests can help physicians decide which therapies to use and monitor their safety and effectiveness.

Jim Greenwood, president and CEO, BIO said, "As leaders in the development of safe, effective and innovative new therapies, BIO members look forward to contributing to the success of the Biomarkers Consortium. Our industry will bring expertise in research and development to assist the Consortium in identifying and validating new biomarkers, and then bring to market innovative products that will help enable improved treatments and the earlier and more accurate detection of diseases."

He further said, "Our members are leaders across a spectrum of areas critical to advancing personalized medicine and the science of biomarkers. We are enthusiastic about contributing our expertise to the achievement of the Consortium's goals and optimistic about the promise of this joint effort for improving health and medicine."

Source: www.bio.org


BRIC awards £5 million for biological drug development

Bioprocessing research in the UK has been given a £5-million boost following the announcement of the first research awards from the Bioprocessing Research Industry Club (BRIC), set up to help academia and industry better support the rapidly growing biological medicines market.

The new three-year projects at ten universities seek to improve techniques for faster and more efficient development and manufacture of biological medicines. These projects aim to improve the development and production of therapeutic proteins and vaccines and cell production for regenerative medicine. The funding has been awarded to research teams from the Universities of Bath, Birmingham, Cambridge, Durham, Kent, Manchester, Sheffield, Southampton, King's College London and University College London.

Biological medicines, commonly termed biopharmaceuticals, account for 10 per cent of global drug sales and 30 percent of products in the development pipeline. In 2005, the global market for biopharmaceuticals was estimated at $85 billion.

However, the efficient production of these drugs presents a challenge. To address this, the Biotechnology and Biological Sciences Research Council (BBSRC), the Engineering and Physical Sciences Research Council (EPSRC) and the UK biopharmaceutical industry, with support from bioProcessUK, established BRIC to support research using bioprocessing where living cells are harnessed as manufacturing units to produce biological medicines to help overcome barriers to efficient manufacture of these new drugs.

The BRIC funding addresses the two priority areas of research in bioprocessing; improving the biological understanding of the bioscience underpinning bioprocessing so that bioprocessing can be enhanced, and developing improved tools for bioprocessing, to accelerate bioprocess development.
Dr John Birch, chairman of the BRIC steering group and chief scientific officer at Lonza Biologics in Slough, said, "The UK is a leader in bioprocessing and it is vital that the groundbreaking research being conducted in our universities is adequately funded and applied to industry needs. BRIC's work in identifying and funding these projects will ensure that our academic capabilities are translated into real benefits, both for companies developing and manufacturing these innovative medicines and, ultimately, for patients."

Source: www.bioindustry.org


Kenya adopts National Biotechnology Policy

The government of Kenya has adopted a comprehensive national policy to guide the research, development and trade in biotechnology products, the National Biotechnology Development Policy 2006, which comes into effect immediately. According to Kenyan laws, a Policy, unlike a Bill, does not have to go through parliamentary debate. The policy has been the result of several years of debate involving all major biotechnology stakeholders and relevant government departments.

Noah Wekesa, Kenyan minister for science and technology, said, "The policy is one of the measures the government is putting in place to chart its vision on biotechnology development and application in the country. This policy will provide those developing and applying the technology a clear framework in which to operate in order to address fears on their safety.

She further added that the government is determined to explore the use of biotechnology for the benefit of Kenyans, and to ensure that the country becomes a key participant in the international biotechnology enterprise within a decade.

The approval and adoption of the policy now clears the way for fast-tracking the enactment of biosafety and biotechnology laws to enable the country to be compliant with international instruments governing trade in biotechnology products.

Source: www.biosafetykenya.co.ke

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