27 Januari 2010

St. Jude Medical Achieves Recognition For Security Of Patient Data And Completes Successful Testing To Streamline Connection To Patient Medical Records

January 19, 2010
St. Jude Medical, Inc. (NYSE:STJ) today announced it has successfully completed its second interoperability testing process for the company's Merlin.net™ Patient Care Network, an Internet-based repository of patient and implantable device data. The company also announced today that the Merlin.net PCN is the first medical device network to be awarded ISO 27001 certification, a stringent worldwide information security standard.

"Due to recent legislation and the changing health care environment, electronic health records (EHRs) and hospital efficiency are key issues for our customers. As the use of EHRs become central to healthcare delivery and quality, secure data transportability is becoming even more critical and as a result, connectivity is a key priority for our company," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "Receiving recognition from these two organizations demonstrates to our medical industry stakeholders the high standards St. Jude Medical has set for both the security and efficiency of our patient care network."

ISO 27001 Certification

BSI Management Systems, an international standards, testing, registration and certification organization, has awarded St. Jude Medical the information security certification ISO/IEC 27001:2005. This ISO certification recognizes that St. Jude Medical's Merlin.net PCN has established processes and standards that maintain the strictest levels of confidentiality, integrity and availability for its customers. The Merlin.net PCN is the first CRM device data network to be recognized with this certification.

ISO/IEC 27001:2005 is an information security management system (ISMS) standard, published in October 2005 by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It has become the gold standard in information security across a broad range of industries, with 96 U.S. companies earning certification. The standard specifies the methodology to enable a business to establish, implement, operate, monitor, review, maintain and improve effective information security.

ISO is the world's largest developer and publisher of international standards. It is a non-governmental network of national standards institutes of 157 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. IEC is a not-for-profit, non-governmental international standards organization, also headquartered in Geneva, Switzerland, that prepares and publishes International Standards for all electrical, electronic and related technologies. It currently has over 130 member countries.

IHE Connectathon

During the week of Jan. 11, St. Jude Medical participated in the IHE (Integrating the Healthcare Enterprise) Connectathon testing of the Implantable Device Cardiac Observation profile. This testing demonstrated the ability for the Merlin.net PCN to connect to third-party EHR systems using defined industry standards. Support for this profile allows physicians and hospitals to seamlessly share data from one system to another, thereby increasing productivity, providing tools for improved clinical decision making and quality of care, and eliminating redundant medical device management systems.

In 2007, St. Jude Medical was the first manufacturer of CRM devices to test a product for conformance with an IHE interconnectivity profile. This year, St Jude Medical became the first Cardiac Rhythm Management vendor to successfully complete Connectathon testing of the Implantable Device Cardiac Observation (IDCO) profile for a second time. In this round of testing, St. Jude Medical connected with EHR vendors including Epic, General Electric, NextGen and Medical Micrographics.

The testing process, established by the IHE, is an initiative promoting the adoption of standards that enable healthcare information to be shared seamlessly across clinical settings. The testing took place during the annual IHE Connectathon in Chicago. The organization's goal is to drive standards for interoperability, increasing efficiency and reducing cost to healthcare customers, such as those in the cardiology, radiology and laboratory markets.

About the Merlin.Net Patient Care Network (PCN)

Implantable cardiac devices are designed to capture and record information about device performance and patient heart rhythms that is vital to patient care. Merlin.net PCN organizes this information for fast analysis and easy review and allows data to be sent directly to a clinic's or a hospital's EHR system so the data are included in the patient's comprehensive personal health record.

With immediate access to patient information through the secure Merlin.net PCN website, physicians can remotely monitor and assess patient device data and determine the level of care needed. Alert notification delivery times can be customized to fit in with physician determined clinic hours, including any after-hours processes the clinic might provide.

In addition to meeting the ISO/IEC 27001:2005 standard, the Merlin.net PCN system adheres to patient privacy standards and requirements for the electronic transmission of health information, as set forth by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

The Merlin.net PCN was recognized as a silver winner of the 2009 Medical Design Excellence Awards, an award competition that is organized and presented by Canon Communications LLC and is the only awards program that exclusively recognizes contributions and advances in the design of medical products.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Quarterly Reports on Form 10-Q for the fiscal quarters ended April 4, 2009, July 4, 2009 and October 3, 2009. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Getting The Most From Preclinical Imaging

Life Science Leader, January 2010

The pharmaceutical industry continues to actively adopt imaging technologies to accelerate the
drug discovery process. Imaging methods such as magnetic resonance imaging (MRI), positron
emission tomography (PET), single photon emission computed tomography (SPECT), computed
tomography (CT), and in vivo optical imaging offer important and valuable improvements over
traditional drug discovery methods.

These improvements include providing earlier and more highly predictive in vivo data, facilitating clinical translation, and yielding highly quantitative information from the more realistic models of disease that are becoming increasingly available.

However, success in a preclinical discovery imaging program goes beyond the initial steps of
purchasing and installing the imaging equipment and hiring the skilled experts to run it. Imaging can be successful at advancing the drug discovery process only when a detailed and thoughtfully considered plan of action is soundly and strategically designed and applied.
One of the obstacles to achieving a significant ROI on imaging technology in the preclinical arena is optimization of the animal-to-animal imaging “throughput” without compromising data quality.

Since the hourly cost of imaging is dominated by large depreciation costs, imaging throughput
critically drives cost and ROI potential and also places limits on the timeline and scope of each study. An increase in animal-to-animal throughput is generally at the cost of resolution and sensitivity, one or both of which may already be limited, particularly in small animals where preclinical imaging is generally centered.

The converse is that state-of-the-art imaging hardware and protocols that enhance sensitivity or
resolution can be translated to increased throughput. It is therefore critical in an imaging program to be able to rapidly install, develop, and validate the latest hardware and software
advancements. Tools for automation of image data handling, backup, archiving, and
postprocessing also have the potential for maximizing effective data throughput. What’s more,
design of support systems for imaging — including animal preparation, anesthesia, and dosing
apparatus — can critically affect the efficiency of image data generation and the quality and
reproducibility of the image data itself and must be part of a larger plan in the installation and operation of in vivo imaging technologies. A further obstacle to the optimal use of preclinical imaging is the increasingly high rates of data generation that have occurred in parallel with imaging technology advancements.

Daily generation of gigabytes and even terabytes of data can mire the very process it was originally designed to accelerate. A network infrastructure that facilitates rapid data transfer, access, backup, and archiving must be a key part of the planning for an imaging program and not an afterthought. Facilitation of rapid and high-quality image reconstruction, segmentation, rendering, and quantification through state-of-the-art workstations and software packages are also needed.

The lifetime of each image after acquisition and before final quantification heavily influences the effective throughput and timelines related to the imaging process.
biosecurity concerns

Strategies must also be implemented for prevention of animal cross-contamination (biosecurity)
and for personnel safety concerns. Strictly conforming to the highest level biosecurity and safety can end up costing as much as the imaging equipment itself. If not thoroughly and optimally planned, both biosecurity and safety also have the potential to limit the efficiency and power of the imaging protocols. Occupational health and safety issues are a particular concern for PET, SPECT, and CT, which involve ionizing radiation. Maximization of imaging throughput, personnel safety, and biosecurity can appear to create insurmountable conflicts. All are critically related to design and layout of the lab, vivarium, radiation shielding, and support systems for anesthesia, dosing, and animal handling.

Biosecurity is a particularly pressing issue for an imaging lab, especially for the specific pathogenfree environments generally required for oncology models. If not carefully considered, the imaging lab could be a weak link in the in vivo operations of a discovery organization. Again, design of the lab and implementation of support equipment and procedures for preventing animal-to-animal contamination and for decontamination of imaging equipment is a key consideration for a successful and high-quality imaging program.

The previously mentioned obstacles have the potential to decouple a state-of-the-art imaging
center from delivering increased power and efficiency in the discovery process. However, these
obstacles also have a key similarity — their solution. Without a doubt, the single greatest asset for a successful imaging program is experience, first in the experts running and driving the program, but also in the depth of experience across animal models, therapeutic strategies, and imaging probes and protocols. By bringing together imaging and discovery experts seamlessly,
these requirements can be realized quickly and effectively, and in the process, limit potential
obstacles. Preclinical discovery imaging can then yield maximal benefit in the efficiency and
accuracy of the drug discovery process, as well as in the uniqueness of the data procured and
the questions answered. Only when approached in this way can preclinical imaging accelerate
the drug discovery process in the most cost-effective and efficient manner possible.

11 Januari 2010

Seaside Therapeutics And Vanderbilt University Enter Collaborative Research Agreement To Discover Novel Therapeutics To Treat Disorders Of Brain Development

January 6, 2010

Seaside Therapeutics LLC announced today that the Company has entered into a collaborative research agreement with Vanderbilt University Medical Center to discover and develop small molecules targeting neurologic receptors implicated in disorders of brain development, such as Fragile X Syndrome and autism. The targets, muscarinic acetylcholine subtype 1 (M1) receptors, are known to regulate learning and memory. Research conducted by the Company suggests that inhibiting M1 receptor signaling could provide therapeutic benefit for individuals with disorders of brain development.

Scientists at Vanderbilt, led by Jeffrey Conn, Ph.D., Director of the Vanderbilt Program in Drug Discovery and a member of Seaside's Scientific Advisory Board, have identified novel small molecule compounds that are M1 antagonists. Vanderbilt will work exclusively with Seaside on the discovery, development, optimization and eventual selection of lead compounds for continued study in disorders of brain development.

"Our focus on identifying the molecular pathophysiology of single-gene disorders associated with autism has provided insights for developing targeted therapeutics with the potential to correct or fundamentally alter the course of brain development and function," said Randall L. Carpenter, M.D., President and Chief Executive Officer of Seaside Therapeutics. "We believe this focused approach offers patients suffering from these disorders the best opportunity for successful treatment. Vanderbilt's expertise in drug discovery and their continued commitment to developing novel therapeutics for brain development disorders makes them an exceptional partner in this initiative and we look forward to this latest project with Dr. Conn and his team."

"Selectively inhibiting M1 receptors represents an innovative and very promising approach to treating brain development disorders," said Jeffrey Conn, Ph.D. "We are excited to partner with Seaside on this project and believe the combined expertise of the two teams may play an important role in advancing research in the field and, hopefully, in the long-term, bringing disease-modifying therapeutics to individuals suffering from Fragile X Syndrome, autism and other brain development disorders."

This agreement is the second collaborative project between Seaside and Vanderbilt. In early 2008, Seaside entered into a collaboration with Dr. Conn and other investigators in the Vanderbilt Program in Drug Discovery to develop compounds that inhibit excessive signaling through the metabotropic glutamate receptor subtype 5 (mGluR5), which Seaside believes may be responsible for the neurological and psychiatric consequences of Fragile X Syndrome.

About M1 Receptors

M1 muscarinic acetylcholine receptors are Gq-coupled receptors known to be important for learning and memory. These receptors may affect learning and memory by modulating a specific type of neuronal synaptic plasticity called protein synthesis-dependent Long Term Depression (LTD). LTD is dysregulated in animal models of Fragile X Syndrome. Therapeutics that inhibit M1 receptors may correct or improve cognition in Fragile X Syndrome and potentially other disorders of brain development.

About Seaside Therapeutics

Seaside Therapeutics is creating novel drug treatments to correct or improve the course of Fragile X Syndrome, autism and other disorders of brain development. We are dedicated to translating breakthrough discoveries in neurobiology into therapeutics that improve the lives of patients and their families. For more information, visit www.seasidetherapeutics.com.

About Vanderbilt University Medical Center

Vanderbilt University Medical Center is dedicated to patient care, education and research. It encompasses Vanderbilt University Hospital, the Monroe Carell Jr. Children's Hospital at Vanderbilt, the Vanderbilt-Ingram Cancer Center, the Vanderbilt University School of Medicine and the School of Nursing. Its biomedical research enterprise includes the Vanderbilt Program in Drug Discovery. For more information, see www.mc.vanderbilt.edu.

Ensemble Discovery Initiates Collaboration With Pfizer To Develop Novel Drugs Against Protein-Protein Interaction Targets

January 6, 2010

Ensemble Discovery today announced the initiation of a strategic alliance with Pfizer Inc. (NYSE: PFE) to discover and develop drug candidates of a novel class against a number of high-value pharmaceutical targets.

The collaboration will deploy Ensemble's proprietary drug discovery platforms and Ensemblin TM compound libraries to discover and advance drug candidates. Pfizer will provide upfront and research payments to Ensemble and will have the right to develop and commercialize any products arising from the collaboration. In addition, Ensemble will receive development milestones plus royalties based on worldwide sales of any drugs emerging from the alliance and commercialized by Pfizer.

The goal of the alliance is to develop Ensemblins against important therapeutic targets, particularly those involving protein-protein interactions. Ensemblins are a new class of oral drugs developed by Ensemble to address disease targets that cannot be modulated effectively by traditional small molecule pharmaceuticals.

"We are excited to launch our new alliance with Pfizer," said Dr. Michael D. Taylor, CEO of Ensemble Discovery. "This is our second major alliance in less than a year and it attributes a significantly increased value to our platform and its resultant products. This deal supports Ensemble's position as the leading company exploring new therapeutic opportunities between small molecules and biologics."

Tony Wood, Ph.D., Global Head of Chemistry at Pfizer said, "Pfizer is very pleased to join this collaboration. The Ensemble technology platform will give us access to an area of chemical space not currently well-represented in our file that holds the potential to be of utility in addressing novel target types."

Historically, the biopharmaceutical industry has focused its drug discovery on oral small molecules, which obey the "rule-of-five", and large protein biologics, which cannot address targets inside cells or be administered orally. A large region of molecular diversity exists between these classes, containing very few approved drugs. Ensemble aims to be the leading company in this space; Ensemblins are synthetic macrocycles designed to access this space and to have oral availability and other advantages of small molecules combined with the biochemical power of biologics.

"Our Ensemblin platform advanced massively during 2009 and our capabilities will increase further in 2010," said Nick Terrett, CSO of Ensemble Discovery. "There is a growing recognition in the large pharma companies of the need for novel chemistry capability to attack the many targets with strong biological validation that do not lend themselves to conventional small molecule or biologic drugs. Our progress has demonstrated the power of the Ensemblins to address those targets, as our leading projects have advanced to demonstrate oral efficacy in preclinical disease models."

About Ensemblins

EnsemblinsTM are a new class of synthetic macrocycles developed by Ensemble using its proprietary chemistry platforms, including DNA-Programmed ChemistryTM. Macrocyclic rings are found in many natural product-based drugs and bestow favorable pharmaceutical properties and powerful protein surface binding properties upon such drugs. Thus, macrocycles are uniquely suited to address many protein targets that cannot be modulated effectively by traditional small molecule pharmaceutical compounds. Macrocycles have been challenging to synthesize in large numbers and this has constrained their wider use in the industry. Ensemble has produced larger libraries of macrocyclic drug candidates than any previously synthesized in the pharmaceutical industry.

About Ensemble Discovery Corporation

Based in Cambridge, MA, Ensemble Discovery Corporation is deploying its proprietary chemistry platforms to develop a novel class of therapeutics known as "Ensemblins". Ensemble is the exclusive worldwide licensee from Harvard University of its patents covering DNA-Programmed Chemistry.

Ensemble is pursuing a proprietary drug pipeline and also collaborations with pharmaceutical partners. Ensemble established its first drug discovery alliance with Bristol-Myers Squibb in April 2009. Ensemble's lead proprietary programs are in the inflammatory disease field, including programs to target the TNF receptor superfamily.


07 Januari 2010

PhRMA Applauds President Obama For Highlighting Importance Of Innovation

Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin released the following statement regarding President Obama's remarks about the importance of innovation.

"We applaud President Obama for recognizing that American ingenuity and innovation are critical to help our economy grow and thrive. The President's remarks today reinforced the fact that the strength of the U.S. economy hinges on our ability to remain vibrant leaders in the research and development of innovative products – such as life-enhancing medicines – that advance and improve our way of life.

"As we begin preparations for celebrating Independence Day, we must also celebrate the fact that we are making great strides in the war against disease and are able to spend more time with family members and friends who fought hard and won their own battle against disease.

"Thanks, in part, to the men and women working in pharmaceutical research laboratories across America, life expectancy rates in the U.S. have increased nearly 10 years over the past half century. Heart failure and heart attack deaths have declined by 45 percent in the past decade and HIV/AIDS deaths dropped by nearly 70 percent since the introduction of the first antiretroviral treatments. What's more, life expectancy for cancer patients has increased by 3 years since 1980.

"Earlier this year, President Obama called for a cure to cancer in our lifetime. Finding the cures will take the collective talents of publicly-funded researchers and a lot of great academic work, but it will be the scientists who work for our companies who will innovate, develop and clinically test the actual vaccines and therapies that will one day help us win the war against cancer. The good news is that there are currently more than 800 new cancer medicines in the pipeline to help patients battling this disease live longer, healthier and more productive lives.

"The fuel feeding the engines of growth must not dry up through policies that disincentivize innovation. R&D investment by the biopharmaceutical sector is an important engine for long term economic growth: the sector's direct contribution to GDP in 2006 was $88.5B, triple the average contribution from sectors in the rest of the economy. Through the ripple effect of the sector's economic impact, every dollar that biopharmaceutical companies contributed to GDP supports another $2.33 in contribution to GDP from other sectors.

"America's pharmaceutical research and biotechnology companies remain committed to helping the U.S. remain the world leader in innovation. With President Obama's pledge to help keep our innovative spirit intact, we can collectively make this happen."

About The Pharmaceutical Research and Manufacturers of America
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.

Technical Bulletin: Understanding And Managing Cell Culture Contamination

No cell culture problem is as universal as that of
culture loss due to contamination. All cell culture
laboratories and cell culture workers have experienced
it. Culture contaminants may be biological
or chemical, seen or unseen, destructive or seemingly
benign, but in all cases they adversely affect
both the use of your cell cultures and the quality
of your research.

Feature Article: Fed-Batch Mammalian Cell Culture In Bioproduction

William G. Whitford

Originally developed for optimizing microbial
fermentation, the fed-batch approach has become a leading technology in biologics production based on animal cell culture. For manufacturing-scale
applications, we can simply address
the batch, fed-batch, and perfusion
operating modes (1). But as the
number of basic reactor types and
production modes/strategies grows,
absolute categorization and
terminology become more difficult.
That is especially true when
considering small scales and more
academic (research) approaches, in
which concepts such as “fed perfusion”
have been described (2). Such
references can be confusing to
beginners trying to make sense of
the basic approaches available.

Comparing Automated And Manual Cell Counts For Cell Culture Applications

Arun Tholudur, Luis Giron, Kohinoor Alam, Tiffany Thomas,
Eric Garr, Gresham Weatherly, Keith Kulowiec, Melissa Quick, and Scot Shepard

In biomanufacturing based on animal cell culture, cell enumeration and viability determination are often accomplished using the trypan blue dye-exclusion method (1). This method is based on the fact that viable cells exclude the dye and remain visually clear, whereas nonviable cells are stained blue.
Historically, cell counts using the technique have been performed manually using a hemacytometer. Cell culture samples are mixed (after dilution in an isotonic buffer, if necessary) with known volumes of trypan blue dye, then loaded into a hemacytometer and counted under a microscope (usually at 100× magnification). It has long been recognized that cell counts obtained using this procedure are subject to inter- and intraanalyst variability that arises from subjective assessments and cell staining, sample dilution, and





Disposables Qualification And Process Validation

Disposables Qualification
and Process Validation

Managing Risk to Address Leachables, Extractables, and More

Validation or qualification?
According to our growing
online glossary and the many
sources that have gone into its
creation so far, these terms are related
but quite distinguishable from one
another (1). Validation is documented
proof that a procedure reproducibly
gives acceptable results. And
qualification is documented evidence
that equipment is correctly installed,
does what it is intended to do, and
continues to operate within specified
parameters over time. Yet time and
again we see references to “validation
of disposable systems.” People still
want to validate objects rather than
processes, and the concept of
qualification seldom comes up. As I
researched the topic of leachables and
extractables testing, which grew into
the more general subject matter
presented here, I found that the
confusion continues. And I made the
decision to be strict about my own use
of this terminology: Production
methods using disposable components
are validated; the components
themselves must be qualified.

The Basics Of Cleaning And Cleaning Validation

Jean-Michel Cardot and E. Beyssac

During the past three years,
cleaning or cleaningvalidation
problems ranked in
the top four of the 483s and
warning letters issued by the FDA (1,
2), reflecting the agency’s emphasis on
cleaning. The main points mentioned
are a lack of documented procedures,
inadequate training of workers, and
insufficient validation of analytical
and/or cleaning methods.

Deactivation of Single-Use Bioprocessing Systems Using Aqueous Chlorine Dioxide

by Barry Wintner, Kenneth Bibbo, Anthony Contino, James Crawford, and Gary O’Neill

Aggregation Analysis of Therapeutic Proteins, Part 2

Analytical Ultracentrifugation and Dynamic Light Scattering
Tsutomu Arakawa, John S. Philo, Daisuke Ejima, Kouhei Tsumoto, and Fumio Arisaka

Aggregation Analysis of Therapeutic Proteins, Part 1

General Aspects and Techniques for Assessment
Tsutomu Arakawa, John S. Philo, Daisuke Ejima, Kouhei Tsumoto, and Fumio Arisaka

05 Januari 2010

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