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 | A summary of the top news impacting the pharma industry. |
| November 7, 2007 |
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- Lean practices could save pharma industry billions
Historically robust profits have made most pharmaceutical manufacturing firms hesitant to change processes once manufacturers rate them as compliant, but the potential global savings from efficiency improvement has been estimated as high as $90 billion. The Lean Six Sigma management approach, which has been effective in other industries, focuses on three areas for improvement: Operating systems, management systems, and mindsets/behaviors. Contract Pharma
(10/2007) 
- INphoton technology could benefit drug industry
Indianapolis-based INphoton has developed an intravital multiphoton microscopy system that allows researchers to monitor an animal's response to drugs. The technology, which can detect nonperforming drugs, could allow drugmakers to halt development of ineffective therapies and reduce R&D costs. The Indianapolis Star
(10/9)
- Asian outsourcing offers possibilities, challenges
Outsourcing is an attractive option for the pharmaceutical industry to maintain growth and innovation, and the Asia-Pacific region has become a hot spot for it. However, experts say Western firms must address the challenges that come with working in the region, such as the need to meet regulatory compliance, the potential for competition and a limited ability to transfer production risk to a CMO partner. Contract Pharma
(10/2007)
- Applied Biosystems launches SOLiD sequencing platform
Applied Biosystems unveiled a new gene sequencing instrument months ahead of its original release date due to positive feedback from beta testers in what it calls a "new era of life-science research." The system uses dual coding readout to discriminate sequencing errors from polymorphisms and has a reported 99.95% accuracy rate. Bio-IT World
(10/24)
- Survey: Patient consent key concern for research study participation
Most people think obtaining patient consent is a key requirement for public participation in research projects, according to a survey. Thirty-eight percent of respondents said they would require researchers from each study to describe the study and obtain specific consent, and only 19% would agree to have their personal information used without consent, even if the study was supervised and never revealed personal identities. Modern Healthcare (free registration)
(10/22)
| In Market | | |
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- Sanofi CEO calls for new drug price controls
Drugmakers should work on regulating new drug prices in order to boost sales, as greater "volume will dominate over price," Sanofi-Aventis chief executive Gerard Le Fur said in an interview with the Financial Times. Le Fur predicts that the price of biological, protein-based drugs will soon level down to the price of older drugs. Le Fur also spoke about Sanofi's future, adding there was opportunity for new acquisitions in the near term, especially in the biotech realm. Financial Times (tiered subscription model)
(10/15)
- Commentary: Clinical supply units help speed new products to market
Clinical supply departments have begun to capitalize on IT information gathered in early development to improve product quality and speed up pharmaceutical production. Experts say clinical supply management systems with enterprise-wide integration capabilities can reduce complexity and help firms take advantage of clinical information from all stages of development. Bio-IT World
(10/15)
- Analysis: Investment in biotech startups continues
With Big Pharma showing an interest in acquiring biotech startups to boost their pipelines amid upcoming patent expirations, venture capital backers are investing heavily in the startup biotech sector. However, if prices continue to rise for early-stage, risky products, partnerships may again become the preferred route to accessing new drugs for major drugmakers, this Financial Times analysis says. Financial Times (free content)
(10/10)
| Technology & Informatics | | |
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- FDA's electronic filing could streamline process
Submissions to the Center for Drug Evaluation and Research must be made in the new electronic common technical document format as of Jan. 1, 2008. Some experts feel the change will provide a more-streamlined and reviewer-friendly assessment process for drug candidates. The paperless eCTD approach means that related submissions will be managed as single applications with integrated histories. Bio-IT World
(10/25)
- NIH launches Web-based SHARe
The NIH has unveiled the Web-based SNP Health Association Resource, a database that allows researchers to access genetic and clinical data from large population-based studies. "SHARe represents a major milestone in moving toward an era of personalized health care," HHS Secretary Mike Leavitt said in a statement. The Washington Post/HealthDay News
(10/14)
- Computing power helps predict shape of proteins
Donated time from 150,000 home PCs has enabled scientists to model a protein based on its amino acid sequence, a breakthrough that researchers say may eventually lead to faster development of vaccines to retrain the immune system to fight viruses such as HIV. Nature News
(10/16)
- Scientists conclude Phase II of HapMap project
Experts from six countries have completed the second phase of the HapMap project, which includes published studies on new genetic contributors to diseases such as Type 2 diabetes and prostate cancer. HapMap's second milestone comes two years after the conclusion of the first phase, which helped identify 50 genes linked to common diseases and led to techniques used in searching for those genes. Forbes/HealthDay News
(10/17)
| Regulatory Affairs | | |
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- Critics cite risks in new FDA research hub
Industry experts are expressing doubts on whether the FDA's Reagan-Udall Foundation, a research center aimed at improving the development of drugs and medical devices, will be effective in finding safer and more affordable health care products for consumers. The appointed board could allow drugs to be developed more cheaply, but questions remain on who will own patents from the research and how profits might be shared or distributed. The Washington Post/Associated Press
(10/14)
- China drafts rule to speed approval of four categories of new drugs
China's State Food and Drug Administration has drafted a rule that would speed approval for four categories of new drugs, including biologics, HIV/AIDS and cancer therapies, and drugs that target diseases without effective treatments. Companies of fast-tracked drugs would be required to study postmarket safety and effectiveness, including submitting an analysis of adverse drug reactions. FDC Reports/Health News Daily
(10/15)
- New trade agreement to fight counterfeit pharmaceuticals
The U.S., European Union and countries elsewhere are seeking a new trade agreement to combat the rising number of counterfeit pharmaceuticals in the marketplace. The new Anti Counterfeiting Trade Agreement would strengthen intellectual property rights and protect consumers from potentially dangerous fake medicines. In-PharmaTechnologist.com
(10/24)
- Small drugmakers object to FDA crackdown
Some small pharmaceutical companies, whose products were "grandfathered in" when the current approval process was created and did not go through stringent FDA approval, are challenging the agency's crackdown on their drugs. A trade group has submitted a bill to Congress that proposes a simpler and more affordable process for obtaining FDA approval to help address small businesses' woes over the potential cost of the FDA's new requirements. NYTimes.com
(10/18)
| i3 News | | |
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Partnerships in clinical trials Nov. 5 to 8, 2007
i3 will be participating as an exhibitor and sponsor at the sixth annual Partnerships in Clinical Trials Congress in Amsterdam. The conference offers eight conference streams, plus multiple symposia and interactive workshops covering topical issues for clinical development outsourcing professionals. Learn more here.
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ICR European Conference and Exhibition Nov. 8 to 9, 2007
Join i3 at the Institute of Clinical Research third European Conference and Exhibition in Brussels, Belgium. The conference focuses on geographic issues in clinical study. Patient recruitment, investigator expertise and regulatory environments for clinical research around the world will be compared and contrasted. Learn more here.
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Webinar: New Ways to Identify Risk Factors for Adverse Outcomes, Nov 15, 2007, 11 a.m. to 12 noon EST
Our newest i3 Drug Safety Web conference will feature Arnold Chan, M.D., Sc.D., and Marsha Wilcox, Ed.D., Sc.D., who will lead a discussion about the utility of novel methods to identify risk factors for adverse outcomes in pharmaceutical risk management and signal detection. This timely and complimentary live online event will take a closer look at available tools for uncovering and describing relationships between risk factors and adverse outcomes in various settings. For more information and to register, visit http://www.i3global.com/Events/.
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The American Society of Hematology Annual Meeting Dec. 8 to 11, 2007
i3 will be exhibiting at the 49th annual meeting of ASH in Atlanta. The Society's annual meeting provides hematologists from around the world a forum for discussing critical issues in hematology. The four-day meeting offers many educational programs and cutting-edge scientific sessions dealing with the latest and most exciting developments in scientific research. Learn more here.
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| About i3 |
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well-being companies in the world.
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