The 2011 UPS “Pain in the (Supply) Chain” survey explores top business and supply chain concerns at pharmaceutical, biotech and medical device companies worldwide. Findings show changes in healthcare legislation, reform and intellectual property protection are major concerns as the industry’s pace accelerates globally. View Report.

Product Class Quality, Bioassays, Regulatory Issues Related to Monoclonal Antibodies, Cell Therapies, and Other Biologics to Be Addressed

Rockville, Md., September 6, 2011 — Increasingly used to treat certain advanced-stage cancers, chronic inflammatory diseases, and complex disorders such as cystic fibrosis, biologic and biotechnology products are providing answers to some of the unmet needs for a growing list of diseases. Collectively referred to as “biologics,” these therapies are also being used in some cases where traditional medical treatments are no longer viable options for patients. This year, the U.S. Pharmacopeial Convention (USP) will dedicate its annual scientific symposium to the important area of quality standards for biologic and biotechnology-based drugs.

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The following videos provide highlights of the 2011 USP Science & Standards Symposium on Biologics & Biotechnology, "Advancing Quality Standards through Analytics & Assays," October 3-6, 2011, in Seattle.

For event information, visit: http://www.usp.org/meetings/asMeetingIntl/seattleEvent.html.

For anyone who will be attending the USP conference, so will I - on behalf of Life Science Leader. Please feel free to contact me regarding the event through the editors, LinkedIn or directly, This email address is being protected from spambots. You need JavaScript enabled to view it. .
Thank you.
Wayne Koberstein
Contributing Editor

GE Healthcare, a unit of General Electric Company (NYSE:GE), today announced it has reached an agreement to acquire PAA Laboratories, a developer and supplier of cell culture media for biomedical research and the fast-growing biopharmaceutical and vaccine manufacturing industry. The acquisition of PAA Laboratories will allow GE Healthcare to expand its offering of products and services for cell biology research and for the discovery and manufacture of biopharmaceuticals including recombinant proteins, antibodies and vaccines. The strong strategic fit between the two businesses, combined with expanded capabilities in product development and marketing, will offer significant long-term customer benefits. Financial terms were not disclosed.

PAA Laboratories develops and manufactures specialized and innovative cell culture products such as media, sera, growth supplements and reagents for use in biomedical research and in the production of protein-based pharmaceuticals. The company, which has world-class manufacturing facilities registered with the FDA, has recently implemented one of the world’s leading manufacturing facilities for powdered cell culture media to meet the growing demand for these products from the biopharmaceutical industry. PAA Laboratories’ products are complementary to GE Healthcare’s established technologies for cell biology research and biopharmaceutical purification. Combining the expertise of the two companies will enable GE Healthcare to offer a substantially wider range of integrated products and services to the biopharmaceutical manufacturing industry.

“The acquisition of PAA Laboratories is a significant step forward for our Life Sciences business and for biopharmaceutical manufacturing globally,” said Kieran Murphy, President and CEO of GE Healthcare Life Sciences. “GE Healthcare Life Sciences is well known for its expertise in the “downstream” processes of biopharmaceutical manufacturing. Adding “upstream” capabilities will enable us to provide an end-to-end, fully integrated service to our customers. We believe that an integrated approach, where we can help customers optimize every stage of their manufacturing process, has the potential to reduce cost of entry, deliver higher yields of finished product and reduce time to market.”

The global demand for media, sera and reagents for cell culture is predicted to grow from $2.3 billion in 2009 to an estimated $3.9 billion by 2015*. The acquisition of PAA Laboratories is consistent with GE's strategy to invest in high-technology, innovative businesses that deliver strong top-line growth and expanded margins. The acquisition also supports GE healthymagination, GE’s global initiative to reduce cost, increase access and improve the quality of healthcare worldwide.

Welcoming the acquisition, Rainer Burian, long-term CEO, PAA Laboratories said, "This is a great opportunity for the professional team of staff at PAA Laboratories and we are very excited to become part of GE Healthcare’s Life Sciences business. The Board of Directors of PAA Laboratories strongly believes that joining such a well-respected and recognized organization will give us significant opportunities to grow our business further with new technologies, products and services. The entire PAA Laboratories team looks forward to joining GE.”

The acquisition, which is subject to customary closing conditions including regulatory approvals, is expected to close in Q3 2011.

*Source BCC Research “The Dynamic Media, Sera, and Reagent Market in Biotechnology” July 2010

About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our “healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com

For our latest news, please visit http://newsroom.gehealthcare.com

About PAA Laboratories
PAA Laboratories, founded in 1988, specializes in the manufacture and worldwide distribution of cell culture products for research, development, diagnostic and biopharmaceutical production. The company processes and manufactures sera, synthetic media, protein-free media, biochemical supplements and reagents, all of which are used as cell nutrients in cell culture technology. PAA also actively develops new products to satisfy the demands of industrial customers. Today, the company’s products are manufactured in GMP-certified facilities based in Austria, Australia and Canada and are distributed through PAA subsidiaries and a network of exclusive and non-exclusive distributors. The company employs 215 people and had revenues of approximately $55 million in 2010. More information is available at www.paa.com
CEO Cynthia (Dohmen) LaConte announced today that the Dohmen Company has acquired Centric Health Resources, Inc. Based in Chesterfield, Mo., Centric is a nationwide, Patient-Centered Health Management® organization, serving patients with rare, ultra-orphan disorders. Centric provides service offerings to biotech and pharmaceutical manufacturers, including reimbursement expertise, direct-to- patient dispensing, delivery of specialty pharmaceuticals, peer health coaching and clinical support from registered nurses.

LaConte said Dohmen acquired Centric as part of its strategy to join together a series of exceptional healthcare companies dedicated to reducing cost, complexity and conflict within the healthcare supply system.

“Centric’s services cut healthcare costs by providing a single-point, fee-for-service direct model that has been constructed to better connect patients with biopharma innovators. In addition, Centric increases security within the supply chain-- from point-of-production to patient-- through its closed-loop distribution process. Finally, patient compliance is improved through Centric’s coaching, clinical support and education programs,” said LaConte. “Like all Dohmen companies, Centric is conflict-free. It is not owned by a payor or distributor, does not own product or work on margins, and aligns solely with the interests of manufacturers and patients. We’re very proud to have Centric join the Dohmen family of companies.”

Craig Kephart, Centric’s former CEO, will serve as division president. “Becoming a Dohmen company strengthens our future and our ability to serve our patients and clients. Dohmen is a perfect fit for us. Our business models align, we share their values, and we’re pleased to join an organization with a longstanding reputation for integrity and accomplishment,” said Kephart.

This is the third acquisition this year for Dohmen. In February, it acquired PlanIt, Inc., a healthcare analytics company based in Germantown, Wis., and in June, it acquired MedComm Solutions, a medical information company based in the San Francisco Bay area.

About Dohmen

Since 1858, Dohmen has been helping people access safe, high-quality healthcare product, first as an apothecary, then as a manufacturer, later as a wholesaler and today as a provider of outsourced business services. Our companies reduce cost and complexity for healthcare producers and payors. DDN helps life science companies eliminate channel redundancies and get products to market quickly, efficiently and safely, while MedComm Solutions provides clinician-to-clinician integrated medical communications, and DDN Medical Affairs offers drug safety, medical information and regulatory affairs services. Restat, Align and PlanIT simplify the purchase and use of healthcare products and provide value for payors and employers.

Monday, 08 August 2011 04:32

Gore Expands Its PharmBIO Business

As part of Gore's expansion plans, Gore PharmBIO Products is combining a portfolio of products sold into the pharmaceutical, biopharmaceutical and life science markets. This integration of products will focus and expand the business by unifying sales, operations, quality and technical support functions.

“The reorganization will connect our core technologies, capabilities and competencies with the needs of drug and non-implantable device manufacturers. This will allow us to develop next generation products that solve problems for our customers, based on our deep understanding of fitness for use and what the customer values,” says Terri Kelly, CEO.

Gore PharmBIO Products markets filtration media, vents for non-implantable medical devices, tubing, and components used in single-use bioprocessing. Gore has manufactured many of these products for over 20 years. Gore is also developing a number of new products and technologies that will be commercialized in the next few years. By leveraging their fluoropolymer knowledge and expertise, Gore expects to solve significant industry challenges.

As part of the expansion and continuous improvement effort, Gore plans to operate under an ISO 13485 system and relevant pharmaceutical cGMPs. This new quality system will better enable Gore to meet future customer needs, including the ever increasing regulatory requirements for suppliers. The start of integrated operations is expected to begin in early 2012.


About W. L. Gore & Associates, Inc.
Founded in 1958, Gore is an uniquely creative, technology-driven company that serves a variety of global markets. Gore is a leading manufacturer of thousands of advanced technology products for electronics, industrial, consumer, pharmaceuticals and healthcare markets. With sales of approximately $3 billion, the company is headquartered in Newark, Delaware, and employs approximately 9,500 associates in more than 30 countries throughout the world.

GORE and designs are registered trademarks of W. L. Gore & Associates, Inc.

For more information about W. L. Gore & Associates, Inc. and Gore PharmBIO Products, visit www.gore.com.

Waters Corporation (NYSE:WAT) today welcomed the metabolomics program at Georgetown University Medical Center (GUMC) into its Centers of Innovation Program and recognized Albert J. Fornace Jr., MD, and Amrita Cheema, PhD., the directors of this pioneering program at Georgetown Lombardi Comprehensive Cancer Center, part of GUMC, in Washington, DC.

In a ceremony at Georgetown Lombardi, Waters recognized Prof. Fornace, Professor of Oncology at Georgetown Lombardi and Professor of Biochemistry and Molecular and Cellular Biology at GUMC, for his research on stress signaling in molecular oncology and various other diseases.

Waters’ Centers of Innovation Program supports the efforts of scientists facilitating breakthroughs in health and life science research, food safety, environmental protection, sports medicine and many other areas.

“Professor Fornace and his laboratory have made important and highly-cited contributions to the understanding of key signaling events in cancer and the cellular responses to carcinogens and other damaging agents. His research in disease metabonomes and biomarker research is state of the art,” said Tim Riley, PhD, V.P. of Strategic Innovation, Waters Division and Program Director of Waters Centers of Innovation program. “We are very pleased to be associated with Dr. Fornace’s laboratory and an elite academic medical center such as Georgetown University Medical Center.”

Professor Fornace, who is also GUMC’s first Molecular Cancer Research Chair, has authored or co-authored more than 280 scientific papers, holds eight patents for technologies to develop therapeutic targets and models for cancer prevention and treatment, and is ranked among the top 1% of the most cited life science researchers (http://www.isihighlycited.com). His laboratory’s research is focused on learning what happens to cells when they are stressed or injured by toxic agents such as ionization radiation, and which underlying processes cause cancer and other disorders. Professor Fornace directs a variety of funded projects for stress-signaling studies, which include major metabolomics components. One such study involves a $5 million award establishing a NASA Specialized Center of Research to study the risk of gastrointestinal cancer by space radiation; this study will investigate some of the health risks of astronauts by space radiation. Prof. Fornace is the director of this Center, and Jerry Shay, PhD, at UT Southwestern is co-director.

Professor Fornace’s team is also active in the field of metabolomics, studying the metabolites or small molecules produced by the human body in response to an outside influence such as a drug, a disease like cancer, or radiation. New technology is enabling scientists to map these subtle changes in body chemistry over time in ways never before possible. These biomarkers may one day help scientists better understand the environmental factors that cause certain diseases.

“The field of metabolomics has really taken off in the last six years or so, and a lot of the credit goes to Waters with its pioneering Q-Tof™ technology,” said Prof. Fornace. “It’s a demanding area of science, and since quadrupole time-of-flight mass spectrometry came on line, there has been an exponential increase in interest in metabolomics and the number of publications in this field. We are very pleased Waters has taken an interest in our research.”

Metabolomics data generated by the Fornace Laboratory’s Waters ACQUITY UPLC and Xevo G2 QTof LC-MS systems will also have a significant contribution to the Georgetown Database of Cancer (G-DOC®), a pioneering project that has compiled metabolomics data and other information from 4,000 breast cancer patients in order to glean information about why certain patients relapse and why others don’t. The goal of the research is to one day be better able to predict the response of patients to various cancer therapies based on their unique genetic profile using a combination of metabolomics, proteomics, transcriptomics, and genomics information and an advanced bioinformatics platform.

In remarks made at the ceremony, Robert Clarke, PhD, DSc, Dean of Research and a Principal Investigator at Georgetown Lombardi, said, “To receive this designation from Waters is a wonderful badge of honor for our institution. We intend to use the facilities Waters has made available to us as heavily as we possibly can.”

About Georgetown Lombardi Comprehensive Cancer Center
The Georgetown Lombardi Comprehensive Cancer Center, part of Georgetown University Medical Center and Georgetown University Hospital, seeks to improve the diagnosis, treatment and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists of the future. Georgetown Lombardi is one of only 40 comprehensive cancer centers in the nation, as designated by the National Cancer Institute, and the only one in the Washington, DC, area. For more information, go to http://lombardi.georgetown.edu.

About Georgetown University Medical Center
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC’s mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization (BGRO), which accounts for the majority of externally funded research at GUMC including a Clinical Translation and Science Award from the National Institutes of Health. In fiscal year 2009-2010, GUMC accounted for nearly 80 percent of Georgetown University's extramural research funding.

About Waters Centers of Innovation Program
Waters Centers of Innovation Program recognizes and supports the efforts of scientists facilitating breakthroughs in health and life science research, food safety, environmental protection, sports medicine and many other areas.

The Centers of Innovation Program previously recognized the research of Prof. Arthur Moseley of Duke University, Durham, North Carolina; Prof. John Engen of Northeastern University, Boston, Mass.; Prof. Jeremy Nicholson of Imperial College London; Prof. Julie Leary of the University of California – Davis; Prof. James Scrivens of the University of Warwick, Coventry, UK; and Prof. David Cowan of Kings College London.

These leading scientists, in partnership with Waters, are using liquid chromatography and mass spectrometry to take research down new paths and help unlock the mysteries of science.

About Waters Corporation (www.waters.com)
For over 50 years, Waters Corporation (NYSE:WAT) has created business advantages for laboratory-dependent organizations by delivering practical and sustainable innovation to enable significant advancements in such areas as healthcare delivery, environmental management, food safety, and water quality worldwide.

Pioneering a connected portfolio of separations science, laboratory information management, mass spectrometry and thermal analysis, Waters technology breakthroughs and laboratory solutions provide an enduring platform for customer success.

With revenue of $1.64 billion in 2010 and 5,400 employees, Waters is driving scientific discovery and operational excellence for customers worldwide.

For additional information:

Waters Centers of Innovation Program

http://www.waters.com/waters/nav.htm?cid=10176245&locale=en_US


Albert J. Fornace Laboratory

http://www9.georgetown.edu/gumc/lombardi/fornacelab/

Waters, Xevo, and ACQUITY UPLC are trademarks of Waters Corporation.


Laureate Biopharmaceutical Services, Inc. announced today that the U.S. Food and Drug Administration (“FDA”) approved its application for an Electronic Submissions Gateway (ESG) to the Agency. The gateway will allow Laureate to offer clients a validated, direct electronic path for IND (Investigational New Drug), NDA (New Drug Application) and BLA (Biologic License Application) submissions and builds upon a previous commitment to provide submission-ready CMC (Chemistry, Manufacturing and Control) documentation for client biological drug substance projects. Creation of this electronic, new product filing path, was spearheaded by the Regulatory Services Group, who have extensive experience generating eCTD documents and publishing regulatory submission in XML format.

Commenting on this development Laureate’s CEO, Michael A. Griffith, said, “We believe the future of new drug development will rely on adoption of better, more cost-effective ways of doing business and the ESG is a perfect example.” Continuing on he said, “Being able to eliminate paper reports, batch records and submissions just makes sense and apparently the FDA agrees. Now, we will be able to provide clients with submission-ready CMC documentation AND offer a path for submission to the FDA. If that is not a first in the industry it certainly underscores our commitment to provide each client with the best possible value for their CMC dollar.”

Robert Burford, Ph.D., Vice President Regulatory Services said, “Besides publishing and submission services, Laureate will offer a wide range of regulatory support activities to its clients including high level consulting services for regulatory strategy, IND completion, report generation and regulatory submission reviews.” Continuing he said, “When a client chooses Laureate as its contract manufacturing organization, it gets a committed partner capable and ready to see a project through to submission.”

About Laureate Biopharmaceutical Services, Inc.
Laureate Biopharmaceutical Services, Inc. is a full-service biopharmaceutical contract development and manufacturing organization. Laureate Biopharma’s scientists are expert in process development and cGMP production of therapeutic proteins including monoclonal antibodies and Fc-fusion proteins. In addition, the company’s portfolio of services includes aseptic filling, cell line development, analytical and stability testing, and regulatory support. Laureate Biopharma has served a global client base from its Princeton, New Jersey facility since 1981 and is a portfolio company of Saints Capital, LLC. For more information, please visit www.LBioS.com.


About Saints Capital, LLC
Saints Capital is a leading direct secondary acquirer of venture capital and private equity investments in emerging growth companies around the globe. It also makes traditional direct venture capital investments on a primary basis and in special situations in technology, healthcare, consumer and industrial companies in the United States. Founded in 2000, Saints provides liquidity for private investors in such markets as investment and commercial banks, buyouts, corporate venture capital and hedge funds. Saints has more than $1 billion of committed capital under management, over 50 completed portfolio transactions and investments in more than 200 companies. For more information, please visit www.saintsvc.com.

For more information, contact: Robert Burford, Ph.D., Vice President, Regulatory Services Group, Laureate Biopharmaceutical Services Inc., at (609) 919-3332, or email This email address is being protected from spambots. You need JavaScript enabled to view it. , or visit www.LBioS.com.
The challenges and solutions for the bioanalysis industry were top of the agenda for last week’s exclusive bioanalysis seminar organised by Quotient Bioresearch in Munich, Germany.

The seminar was attended by representatives from pharmaceutical and biotechnology organisations across Europe and featured debates and panel discussions from leading industry speakers on new techniques and hot topics including the latest industry guidelines.

Richard Houghton, Principal Scientist for Bioanalytical Sciences at Quotient Bioresearch, opened the seminar with a discussion on the validation of DBS methods for use in regulated bioanalysis. He highlighted the advantages and disadvantages of DBS and talked about the relevant regulatory considerations addressing several specific issues including blood spot volume and haematocrit assessment.

“Interest in the use of DBS continues but harmonisation in the approach to validation of method is required,” explained Richard. “There is a real concern that the regulatory authorities will not accept the data and the European Bioanalytical Forum (EBF) is bringing together a topic team to discuss how to take the technique forward.”

The seminar also featured a senior level speaker from a leading pharmaceutical company who is actively involved in the EBF and led a very interesting discussion of new and emerging guidelines for method validation. Other contributors included Sigma-Aldrich, looking at mobile phase considerations for analysis of peptides and proteins with LC-MS and Waters, focusing on the application of an integrated microfluidic device for the high sensitivity analysis of pharmaceutical and endogenous compounds in biological fluids.

Richard added: “The debates and discussions which took place at the seminar and the level of interaction from the delegates were far better than we anticipated and resulted in a very valuable seminar for all those who attended.

“This is the first seminar we have hosted in mainland Europe and from the response we’re already making plans for another.”

Quotient’s next seminar will be held at the Fordham, Cambridgeshire, UK site on 5th October 2011, further details will be available on the website soon.

For further information about Quotient Bioresearch Ltd. visit the website at www.quotientbioresearch.com/bioanalytical-sciences or for copies of the seminar presentations email This email address is being protected from spambots. You need JavaScript enabled to view it. .


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