http://biotechbistro.com/forum/forum/press-releases The Business of Biotechnology en-US Mon, 06 Feb 2012 09:50:37 +0000 bbpress 1.0-alpha-4 q http://biotechbistro.com/forum/search.php http://biotechbistro.com/forum/topic/celerion-first-early-stage-contract-research-organization-to-adopt-a-participant#post-434 Thu, 02 Feb 2012 08:03:58 +0000 chelsea.scorr 434@http://biotechbistro.com/forum/ <p>FOR IMMEDIATE RELEASE</p> <p>MEDIA CONTACTS:<br /> Farzana Azam<br /> Senior Director, Global Marketing<br /> Celerion<br /> +1 (647) 261 3628<br /> <a href="mailto:media.inquiries@celerion.com">media.inquiries@celerion.com</a></p> <p>Kerri Weingard, ANP<br /> Chief Operating Officer<br /> Verified Clinical Trials<br /> +1 516 998-7499<br /> <a href="mailto:KWeingard@verifiedclinicaltrials.com">KWeingard@verifiedclinicaltrials.com</a></p> <p>Celerion First Early Stage Contract Research Organization to Adopt a Participant Verification System to Improve Participant Safety and Data Quality.</p> <p>(Lincoln, NE; Feb 02, 2012) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce it has implemented VCT Verify™ from Verified Clinical Trials, to instantaneously ensure accurate participant identification and qualification for clinical research. Celerion is the first Early Stage Contract Research Organization (CRO) to partner with Verified Clinical Trials to set the standard for the industry to adopt. </p> <p>Celerion will more effectively screen and select higher quality study participants by using this tool to instantly identify ineligible candidates for enrollment. The system searches a global clinical database registry to identify participants that are currently enrolled in other clinical studies. Clients benefit from improved participant selection and higher data integrity.</p> <p>Celerion chose to implement the VCT Verify™ product across all our global clinical facilities to solve the long recognized problem of inaccurate applications that compromise study success. The system has been reviewed and applauded by numerous Institutional Review Boards (IRBs) and Verified Clinical Trials is safe harbor certified.</p> <p>“Celerion continues to apply rigorous standards to protect the safety of participants and enhance data integrity while supporting our commitment to our clients. This implementation sets a standard in the industry to continue to improve clinical research and more effectively bring new drugs to the market,” said Phil Bach, Vice President of Global Clinical Research at Celerion. “We are excited to partner with Verified Clinical Trials, the leader in this specialized field, to take a firm stance on ensuring the highest quality data and participants for our clients.”</p> <p> “Verified Clinical Trials offers a comprehensive and unique clinical research database registry to enhance the quality of both early and late stage studies globally. The system has been designed to streamline the clinical trial process and offers protection from various other potential liabilities,” said Mitchell Efros, MD FACS, CEO at Verified Clinical Trials. “We are pleased to be working with Celerion, the first CRO to implement this product, as they continue to demonstrate their leadership position in the industry.”</p> <p>About Celerion<br /> Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to global clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, global bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit <a href="http://www.celerion.com" rel="nofollow">http://www.celerion.com</a>.</p> <p>About Verified Clinical Trials<br /> Verified Clinical Trials is a forward thinking company developed by experts active in the clinical research community to proactively improve research subject safety and data quality in clinical research trials. Verified Clinical Trials defines itself as the world's leader in the field of database registries in clinical trial research. Verified Clinical Trials is the only clinical research database registry designed specifically to enhance the quality of both early and late phase trials and has the scalability to reach all sites nationally as well as on a global level. Verified Clinical Trials offers numerous other value added services to the clinical research site, CRO, and Pharmaceutical Sponsor, that prove invaluable with regards to financial and legal issues and liabilities. For more information, visit <a href="http://www.verifiedclinicaltrials.com" rel="nofollow">http://www.verifiedclinicaltrials.com</a>.</p> <p>### </p> http://biotechbistro.com/forum/topic/theorem-clinical-research-appoints-bollwage-as-vice-president-of-global-regulato#post-429 Tue, 17 Jan 2012 09:36:42 +0000 chelsea.scorr 429@http://biotechbistro.com/forum/ <p>FOR IMMEDIATE RELEASE</p> <p>CONTACT:<br /> Shawn Clary<br /> Theorem Clinical Research<br /> 484.679.2400<br /> <a href="mailto:shawn.clary@theoremclinical.com">shawn.clary@theoremclinical.com</a> </p> <p>Theorem Clinical Research Appoints Bollwage as Vice President of Global Regulatory Affairs</p> <p>(King of Prussia, PA; January 17, 2012) –Theorem Clinical Research, a full-service contract research organization (CRO) that provides core clinical research and development services, is pleased to announce the appointment of Brian Bollwage, J.D., as Vice President of Global Regulatory Affairs.</p> <p>Bollwage previously served as Director of Global Regulatory Science at Bristol-Myers Squibb and as Executive Director and Regulatory Counsel of Global Regulatory Intelligence at i3 Research. </p> <p>“Brian brings a wealth of global regulatory leadership experience in both the CRO and pharmaceutical industries,” stated Theorem Clinical Research Chief Executive Officer John Potthoff. “I am certain that he will excel in his new role.” </p> <p>Bollwage is a food and drug law expert with published articles in Regulatory Affairs Focus, PharmaVOICE and Applied Clinical Trials, among others. A graduate of Rutgers Law School, he currently serves as an associate professor of food and drug law at Temple University in Philadelphia. Bollwage also holds a Master of Business Administration, specializing in pharmaceutical/chemical studies, and a Master of Science. </p> <p>Established in 1985, Theorem Clinical Research is one of the industry’s leading full-service, contract research organizations (CRO). A global organization with 1,000+ employees located throughout 27 countries, Theorem Clinical Research provides core clinical research and development services including statistics, data management and biostatistics for the pharmaceutical, biotech and medical device industries. Theorem Clinical Research manages complex therapeutic studies with speed, flexibility and attention to detail to drive a high-quality performance. </p> <p>About Theorem Clinical Research<br /> Theorem Clinical Research is one of the industry’s leading full-service, contract research organizations (CRO). Before launching in 2011, Theorem Clinical Research operated for nearly two decades as Omnicare Clinical Research under the Omnicare Inc. parent company. A global organization with 1,000+ employees located throughout 27 countries, Theorem Clinical Research provides core CRO services for Phases I-IV, but with niche business units in the areas of technical services, medical devices and pharmaceutics with speed, flexibility and attention to detail to drive a high-quality performance. For more information, visit <a href="http://www.theoremclinical.com" rel="nofollow">http://www.theoremclinical.com</a>.<br /> ### </p> http://biotechbistro.com/forum/topic/celerion-scientist-proud-recipient-of-scientific-and-technological-achievement-a#post-427 Wed, 11 Jan 2012 08:05:09 +0000 chelsea.scorr 427@http://biotechbistro.com/forum/ <p>FOR IMMEDIATE RELEASE<br /> MEDIA CONTACT:<br /> Farzana Azam<br /> Senior Director, Global Marketing<br /> +1 (647) 261 3628<br /> <a href="mailto:media.inquiries@celerion.com">media.inquiries@celerion.com</a></p> <p>Celerion scientist proud recipient of Scientific and Technological Achievement Award (STAA) from EPA.</p> <p>(Lincoln, NE; Jan 11, 2012) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce Don Graff, PharmD, has received the prestigious Scientific and Technological Achievement Award (STAA) from the United States Environmental Protection Agency (EPA). The award is based on the research Dr. Graff undertook while at the EPA, prior to joining the Clinical Pharmacology Sciences business at Celerion.</p> <p>The body of work submitted for the award examined the findings of epidemiological studies conducted in the US and around the world. These data show that various subsets of the population are at risk to suffer cardiopulmonary events, including death, following episodes of elevated particulate matter (PM) pollution in the air. This work addresses biological plausibility and demonstrates that various size fractions of PM may be responsible for the diverse health effects noted in previous studies.</p> <p>Dr. Graff earned a Doctor of Pharmacy degree and completed a residency in Pharmacy Practice at the University of Nebraska Medical Center. He continued his post-graduate training at the University of North Carolina-Chapel Hill where his research focused on treatment and pathophysiology of heart failure. Upon joining the EPA, his work continued in the cardiopulmonary arena through bench-top and clinical studies assessing the effects of air pollution particulate matter on human health. In his role at Celerion, Dr. Graff has applied his cardiopulmonary expertise to the design and analysis of unique clinical research studies.</p> <p>“We are extremely proud of Dr. Graff, and the work submitted to the EPA. This research is especially relevant as it aligns with Celerion’s key strategic focus in the respiratory therapeutic area and early cardiac services,” said Michelle Combs PhD, Vice President of Clinical Pharmacology Sciences at Celerion. “This award is representative of the depth and breadth of scientific expertise that Celerion’s scientists have and is reflected in the high quality work delivered to our clients.”</p> <p>Celerion has one of the most experienced Clinical Pharmacology Sciences team operating in six global locations in North America and Europe for over 40 years. The team produces more than 200 clinical study reports annually and has developed over 4000 protocols. </p> <p>The mission of the EPA is to protect human health and the environment, and air pollution is a significant area of focus for the National Health and Environmental Effects Research Laboratory (NHEERL) within the EPA’s Office of Research and Development. For over two decades scientists at NHEERL have been conducting clinical studies evaluating the effects of air pollutants in support of the Clean Air Act, leading to the implementation of ozone and PM health advisory systems commonly used throughout the US. In addition, these studies have brought about considerable improvements in air quality and air pollution-related health outcomes.</p> <p>About Celerion<br /> Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit <a href="http://www.celerion.com" rel="nofollow">http://www.celerion.com</a>. </p> http://biotechbistro.com/forum/topic/international-stem-cell-corp-how-is-parthenogenesis-done#post-413 Thu, 29 Dec 2011 16:08:35 +0000 pjbosc 413@http://biotechbistro.com/forum/ <p>San Diego Research Ethics Consortium<br /> Salk Institute for Biological Studies<br /> Parthenogenetic stem cell lines: Ethical considerations</p> <p>International Stem Cell’s Director of Research and Therapeutic Development, Nikolay Turovets, PhD, presents “How is Parthenogenesis Done?”</p> <p>How is Parthenogenesis Done? (ANIMATED)<br /> <a href="http://www.slideshare.net/turovets/how-is-parthenogenesis-done" rel="nofollow">http://www.slideshare.net/turovets/how-is-parthenogenesis-done</a> </p> http://biotechbistro.com/forum/topic/over-regulation-of-parthenotes-stifles-valuable-scientific-research-sean-kealy#post-370 Fri, 16 Dec 2011 14:11:10 +0000 pjbosc 370@http://biotechbistro.com/forum/ <p>A recent article in Scientific American questioned whether research on stem cell lines derived from unfertilized eggs was too tightly regulated by the federal government. Now that technology allows the creation of stem cells without fertilization, there is no question that federal laws and guidelines are overly restrictive, causing a detrimental effect on valuable scientific inquiry. </p> <p>Since 1996, Congress has included the Dickey-Wicker Amendment in the annual federal budget. This amendment was a conservative reaction to what some considered to be scientific research that showed little respect toward life. </p> <p>For example, speaking to the Senate in 1996, Robert Smith (R-NH) said, “Just because a private party wants to destroy life, why should Government force taxpayers to give their blessing to that act? Let private parties use private money for their ethically challenged experiments.” Similarly, Representative Jay Dickey (R-AR) said, also in 1996, that embroyonic research was “an attack on the sanctity of life,” and pointed out that several pro-life organizations supported the amendment. </p> <p>Please click link below to read the complete article. </p> <p>Source: <a href="http://www.law.upenn.edu/blogs/regblog/2011/12/over-regulation-of-parthenotes-stifles-valuable-scientific-research.ht" rel="nofollow">http://www.law.upenn.edu/blogs/regblog/2011/12/over-regulation-of-parthenotes-stifles-valuable-scientific-research.ht</a> </p> http://biotechbistro.com/forum/topic/the-avoca-group-announces-consortium-on-quality-management-and-oversight-sponsor#post-324 Thu, 08 Dec 2011 08:00:49 +0000 chelsea.scorr 324@http://biotechbistro.com/forum/ <p>For Immediate Release<br /> Media Contact:<br /> Kelly Sladek<br /> Director of Marketing Communications<br /> <a href="mailto:kelly@scorrmarketing.com">kelly@scorrmarketing.com</a><br /> 308.237.5567 </p> <p>General Information:<br /> Caryn Laermer<br /> Senior Manager, Quality Consortium<br /> <a href="mailto:caryn.laermer@theavocagroup.com">caryn.laermer@theavocagroup.com</a><br /> 609.799.0511</p> <p>The Avoca Group Announces Consortium on Quality Management and Oversight Sponsored by Eli Lilly and Pfizer </p> <p>PRINCETON, NJ (December 8, 2011) – The Avoca Group, an industry-leading research organization specializing in clinical outsourcing and client service, today announced the formation of the Quality Consortium, a pharmaceutical industry consortium focused on quality management.</p> <p>“The Avoca Group’s 2011 Report on Quality and CRO Oversight revealed some insightful data regarding industrywide dynamics between sponsors and CROs,” said Patricia Leuchten, president and CEO of The Avoca Group. “Through our analysis we identified opportunities to potentially improve outcomes through collaboration in quality management and metrics. The Quality Consortium will effectively share industry best practices and establish new standards.”</p> <p>Under the direction and guidance of Leuchten and The Avoca Group, the Quality Consortium will bring together lead sponsors Eli Lilly and Pfizer, other pharmaceutical and biotech companies, and leading CROs to create standards for quality management, initially with a focus on quality agreements and metrics. The consortium’s long-term goal is the development of a new paradigm in the industry’s approach to quality management and partnering with CROs to ensure high quality and risk mitigation.</p> <p>Jeff Kasher, Ph.D., vice president and chief operating officer, global clinical development, at Eli Lilly and co-sponsor of the Quality Consortium, said: “At Eli Lilly, we place a high priority on the success of our CRO partnerships. We are excited about our sponsorship and participation in the Quality Consortium and look forward to the possibility of quality oversight standardization. We believe that by establishing industry standards for quality oversight we can optimize our partnerships with CROs and improve our ability to ensure data integrity and patient safety.”</p> <p>In addition to sponsors Eli Lilly and Pfizer, the consortium continues adding members, including Amgen, Astellas, Biogen Idec, Bristol-Myers Squibb, Cubist, GlaxoSmithKline, Grunenthal and Purdue Pharma. Members will collaborate with industry professionals, share quality management best practices with colleagues and experts, gain specific tools and knowledge that will have immediate impact in enhancing their organizations’ approach to oversight, and identify and proactively address current gaps between pharmaceutical sponsors and CROs. </p> <p>Membership is still available for a limited time to qualifying organizations. The consortium’s work begins this month and the inaugural Quality Summit to review and share member insights and analyses, sponsored by PharmaNet/i3, is scheduled for May 2012. For membership inquiries or to become part of the consortium, contact Caryn Laermer at 609-799-0511 or visit the consortium’s website.</p> <p>About The Avoca Group<br /> The Avoca Group is an industry-leading organization providing survey research, consulting services and training in the areas of clinical outsourcing, business development, strategic alliances and client service. Founded by industry veteran Patricia Leuchten in 1999, the company works exclusively in the health care industry and has a focus on relationship management.<br /> ### </p> http://biotechbistro.com/forum/topic/cri-worldwide-and-lifetree-clinical-research-announce-new-company-name%e2%80%94cri-lifet#post-323 Wed, 07 Dec 2011 10:18:20 +0000 chelsea.scorr 323@http://biotechbistro.com/forum/ <p>FOR IMMEDIATE RELEASE</p> <p>PR Contact:<br /> Kelly Sladek<br /> SCORR Marketing<br /> 308.237.5567<br /> <a href="mailto:Kelly@scorrmarketing.com">Kelly@scorrmarketing.com</a></p> <p>CRI Worldwide and Lifetree Clinical Research Announce New Company Name—CRI Lifetree</p> <p>(Mount Laurel, NJ; December 7, 2011) – CRI Worldwide, a specialized research organization with concentrated expertise in psychiatry, pediatrics, pain and neurology, which recently acquired Lifetree Clinical Research®, has united the two companies under the new name, CRI Lifetree. Accompanying the new name is its strategically focused tagline, “Innovative Solutions. Reliable Results.”</p> <p>The company integrates CRI’s leadership in psychiatry and expertise in complex studies with Lifetree’s widely recognized clinical trial management and site expertise in Phase I-III pain management and abuse liability studies. Bringing the companies together under one unified name streamlines all branding, communication, and SOPs and processes across the two companies. </p> <p>“CRI Lifetree is grounded in sound science,” stated Alice Jackson, CRI Lifetree president. “We give our clients the innovation they are looking for—from ‘entrepreneurial’ first-in-human study design to solutions for specialized human abuse liability research.”</p> <p>“We’re off to a great start; the company is busier than ever,” commented Jeff Kinell, CRI Lifetree CEO. “Since the acquisition, our clients have continued to receive the highest quality service and results, while enriching the early stage clinical research landscape for our sponsors.”</p> <p>As a clinical research provider with more than 25 years of expertise, CRI Lifetree is a leader in specialized, multi-therapeutic inpatient and outpatient early stage research. The organization offers a broad range of Phase I-IV services and rapid access to specific patient populations to meet the requirements of complex clinical research programs.</p> <p>About CRI Lifetree<br /> CRI Lifetree is a leader in specialized, multi-therapeutic early stage research providing innovative solutions, high quality and timely results to sponsors. The company has significant expertise in psychiatry, pediatrics pain and neurology, analgesia pain model development, sleep medicine and addiction, and human abuse liability. CRI Lifetree offers a broad range of Phase I-IV services and rapid access to specific patient populations to meet the requirements of complex clinical research programs. Our team works with sponsors in the design and successful execution of drug development programs from first-in-human/MTD, clinical trial management and proof-of-concept, to clinical monitoring and data management/validation/auditing. With sites in New Jersey and Salt Lake City, the company conducts inpatient and outpatient clinical research in special populations and healthy volunteers. For additional information about CRI Lifetree, visit <a href="http://www.criww.com" rel="nofollow">http://www.criww.com</a> and <a href="http://www.lifetreeresearch.com" rel="nofollow">http://www.lifetreeresearch.com</a>. </p> <p>### </p> http://biotechbistro.com/forum/topic/camargo-plans-future-growth-of-company-with-the-addition-of-vice-president-of-co#post-286 Tue, 06 Dec 2011 10:12:53 +0000 chelsea.scorr 286@http://biotechbistro.com/forum/ <p>FOR IMMEDIATE RELEASE</p> <p>CONTACT:<br /> Kelly Sladek<br /> SCORR Marketing<br /> 308.237.5567<br /> <a href="mailto:kelly@scorrmarketing.com">kelly@scorrmarketing.com</a></p> <p>Camargo Plans Future Growth of Company with the Addition of Vice President of Corporate Development </p> <p>Cincinnati, OH; December 6, 2011) – Camargo Pharmaceutical Services, an end-to-end drug development service provider specializing in the 505(b)(2) process, has set a course for the future growth of the company by appointing Mark Bolin as vice president of corporate development.</p> <p>In his new role, Bolin will utilize over 25 years of pharmaceutical and health care industry experience to advance the company through strategic financial and technical partnerships to meet the needs of the marketplace. An increasing number of new drug approvals are using the 505(b)(2) pathway, which requires full safety and effectiveness reports but allows the use of other companies’ study results, thereby taking a fraction of the time and cost required by traditional paths.</p> <p>“Camargo’s recent expansion with the opening of our Durham, N.C., office and the potential to open additional offices will extend our company’s reach to clients around the globe, while making our extensive regulatory expertise available to meet the increasing demand in formulation, preclinical and clinical services,” stated Ken Phelps, president and CEO. “Mark will serve as the business arm and his substantial experience setting companies up for growth via financial and operational management will be an asset to Camargo.”</p> <p>Prior to his employment at Camargo, Bolin served as a founding member and chief financial officer of Ricetta Rx Holdings LLC. While there, he helped secure a long-term care pharmacy business through acquisition and organic growth. Bolin was responsible for identifying and targeting acquisition candidates, negotiating acquisition term sheets and asset purchase agreements and managing the financial operations of the company. The company was sold in a series of transactions in 2008 and 2011 to both public and private equity backed entities. Bolin is a certified public accountant and is a graduate of the University of Kentucky. </p> <p>About Camargo Pharmaceutical Services<br /> Camargo Pharmaceutical Services is an end-to-end drug development service provider specializing in the 505(b)(2) approval pathway. Camargo works with companies to develop comprehensive programs, managing every facet of the plan from formulating and testing the drug product, to conducting clinical studies and FDA application submissions. Connect with Camargo on LinkedIn, the President’s blog or visit <a href="http://www.camargopharma.com" rel="nofollow">http://www.camargopharma.com</a> for more information.</p> <p>### </p> http://biotechbistro.com/forum/topic/davita-labs-appoints-new-vice-president-and-general-manager#post-282 Thu, 01 Dec 2011 09:23:35 +0000 chelsea.scorr 282@http://biotechbistro.com/forum/ <p>DaVita Labs Appoints New Vice President and General Manager</p> <p>FORT LAUDERDALE, Fla. (Dec. 1, 2011) –DaVita Labs, a chronic kidney disease specialty laboratory, today announced the appointment of Leslie Mirani as DaVita Labs’ new vice president and general manager. </p> <p>Mirani brings to DaVita Labs™ more than 25 years experience in commercial sales and marketing – primarily renal-focused – in the pharmaceutical industry. Mirani’s previous roles included working for Human Genome Sciences as an immunology sales director and as vice president for Amgen’s nephrology business unit for 18 years. She graduated from Ohio State and is a registered clinical dietician.</p> <p>“Leslie’s extensive background will give us the momentum to move forward with our future goals and continue to provide great service, quality, technology and education to keep us at the front end of new developments within the industry,” said DaVita Labs President Chris Rucker.</p> <p>DaVita Labs has 86,700 square feet dedicated to its state-of-the-art clinical diagnostic laboratories between its two locations in Fort Lauderdale and DeLand, Fla. The laboratories feature the latest in renal-specific methodology and technology for delivering quality test results. The DaVita Labs clinical laboratory team is led by experienced scientists and pathologists, and receives formal guidance from top nephrologists in the industry.</p> <p>DaVita and DaVita Labs are trademarks or registered trademarks of DaVita Inc. All other trademarks are the property of their respective owners.</p> <p>About DaVita Labs<br /> DaVita Labs, a division operating within DaVita Inc., provides quality, on-time, accurate results to help effectively identify and manage kidney patients across the nation. As a cutting-edge chronic kidney disease (CKD) specialty laboratory, DaVita Labs features the latest in end stage renal disease-specific methodology and technology for delivering quality dialysis test results. DaVita Labs is fully accredited by the federal and state governmental agencies, and the College of American Pathologists. For more information, please visit <a href="http://www.davitalabs.com" rel="nofollow">http://www.davitalabs.com</a> or call 877-200-3181. </p> <p>About DaVita<br /> DaVita Inc., a Fortune 500® company, is a leading provider of kidney care in the United States, delivering dialysis services to patients with chronic kidney failure and end stage renal disease. DaVita strives to improve patients’ quality of life by innovating clinical care, and by offering integrated treatment plans, personalized care teams and convenient health-management services. As of Sept. 30, 2011, DaVita operated or provided administrative services at 1,777 dialysis facilities, serving approximately 138,000 patients. DaVita supports numerous programs dedicated to creating positive, sustainable change in communities around the world. The company’s leadership development initiatives and social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu. For more information, please visit <a href="http://www.davita.com" rel="nofollow">http://www.davita.com</a>.</p> <p>###</p> <p>Contact Information<br /> Media:<br /> Vince Hancock<br /> (303) 405-2272<br /> <a href="mailto:Vince.hancock@davita.com">Vince.hancock@davita.com</a> </p> http://biotechbistro.com/forum/topic/international-stem-cell-corporation-to-present-immune-matching-research-advance#post-278 Tue, 29 Nov 2011 16:16:08 +0000 pjbosc 278@http://biotechbistro.com/forum/ <p>International Stem Cell Corporation to Present Immune Matching Research Advances at Cell Science and Stem Cell Research 2011 Conference</p> <p>Executives from International Stem Cell Corporation (OTCBB:ISCO), a biotechnology company specializing in the research and development of stem cell-based therapies, will be presenting advances made in its research programs related to the use of immune-matched patient-specific parthenogenetic stem cells for neurological applications and genetic liver diseases at Cell Science 2011 in Philadelphia on November 29th.</p> <p>Vice President Ruslan Semechkin, Ph.D., will open the conference and discuss the latest trends in the use of stem cells to treat diseases of the central nervous system. A follow-on presentation will demonstrate that functional dopaminergic neurons can be successfully obtained from human parthenogenetic stem cells. Alina Ostrowska, Ph.D., the Company's Director of Translational Research, will present a new method of obtaining highly-enriched cultures of hepatocyte-like cells from pluripotent human stem cells.</p> <p>Dr Semechkin comments, "I'm honored to be opening this conference and to be debating the latest advances in stem cell therapies. ISCO will also be presenting the most recent results from two of our most important research programs, where we continue to further characterize our parthenogenetic stem cell lines and their ability to form functioning liver-like cell and functioning neuron-like cells."<br /> ISCO uses unfertilized oocytes to create human parthenogenetic stem cells, an approach that offers a number of distinct advantages over other types of human pluripotent stem cells. Like human embryonic stem cells (hESCs), hpSCs are pluripotent, i.e. they have the capacity to become almost any cell type in the body, yet avoid ethical issues associated with use or destruction of viable human embryos. Unlike hESCs, hpSCs can be created in a form such that they can be immunologically matched to millions of individuals. ISCO maintains the world's largest collection of research-grade hpSC lines.</p> <p>About International Stem Cell Corporation<br /> International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at <a href="http://www.internationalstemcell.com" rel="nofollow">http://www.internationalstemcell.com</a>.</p> <p>To subscribe to receive ongoing corporate communications, please click on the following link:http://www.b2i.us/irpass.asp?BzID=1468&#38;to=ea&#38;s=0.</p> <p>Forward-looking Statements<br /> Statements pertaining to anticipated developments, potential sales growth and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements. </p> http://biotechbistro.com/forum/topic/acr-image-metrix%e2%80%99-dr-bruce-hillman-receives-gold-medal-at-rsna-annual-meeting#post-270 Tue, 22 Nov 2011 09:45:30 +0000 chelsea.scorr 270@http://biotechbistro.com/forum/ <p>FOR IMMEDIATE RELEASE </p> <p>Contact:<br /> Shawn Farley<br /> Public Relations Manager<br /> 703.648.8936<br /> <a href="mailto:sfarley@acr.org">sfarley@acr.org</a></p> <p>ACR Image Metrix’ Dr. Bruce Hillman Receives Gold Medal at RSNA Annual Meeting</p> <p>(Philadelphia, PA; November 22, 2011) – ACR Image Metrix™, a global imaging contract research organization (CRO) with expertise in imaging trial design, is proud to announce Bruce Hillman, M.D., FACR, is one of three recipients of the gold medal, the Radiological Society of North America’s (RSNA) highest honor. Dr. Hillman, ACR Image Metrix’ founder and chief scientific officer, will accept his award at the RSNA Annual Meeting, which takes place November 27-December 2, 2011, in Chicago.</p> <p>RSNA gold medals are presented each year to individuals who have rendered exemplary service to the science of radiology and who have received unanimous approval by the RSNA Board of Directors—a tradition that originated in 1919. ACR Image Metrix will be exhibiting at booth #9346 in the McCormick Place Convention Center north building during the RSNA show. </p> <p>Dr. Hillman has authored and co-authored more than 170 studies appearing in major medical publications and has been selected Who’s Who in Medicine and Healthcare and Who’s Who in the World. Dr. Hillman formerly served as chair and principal investigator of the American College of Radiology Imaging Network® (ACRIN®). Dr. Hillman has received 22 grants and nearly $200 million in grant funding, including the National Cancer Institute (NCI) UO-1 award, which led to the founding of ACRIN in 1999.</p> <p>Dr. Hillman is a fellow of the American College of Radiology® (ACR®), a member of the ACR Board of Chancellors and an honorary fellow of three foreign national radiological societies.</p> <p>“ACR Image Metrix would like to congratulate Dr. Hillman on this honor,” stated Chief Executive Officer Dr. Harvey Neiman, FACR. “His work within the radiological industry is outstanding, and we are proud of his accomplishments.” </p> <p>As a leading imaging CRO, ACR Image Metrix specializes in providing services to assist pharmaceutical, biotech and medical device companies around the world.</p> <p>About ACR Image Metrix™<br /> ACR Image Metrix™, an imaging contract research organization (CRO) located in the American College of Radiology Clinical Research Center in Philadelphia, applies imaging techniques to improve the efficiency of drug and medical device development programs. The world-class team of radiologists and imaging scientists at ACR Image Metrix works with pharmaceutical, biotech and medical device companies to integrate the appropriate imaging technologies, modalities and clinical design techniques into their imaging studies. ACR Image Metrix has years of experience utilizing state-of-the-art technologies to provide a complete line of imaging services from site qualification and training, study initiation, image management, reader studies and much more. Connect with ACR Image Metrix™ on LinkedIn and Twitter.</p> <p>### </p> http://biotechbistro.com/forum/topic/utilizing-health-outcomes-data-to-drive-company-decision-making#post-265 Fri, 11 Nov 2011 12:16:17 +0000 MWestergaard87 265@http://biotechbistro.com/forum/ <p>In this era of pricing pressures, access barriers and strong demand from all stakeholders for more detailed outcomes information, pharmaceutical companies have come to appreciate the importance of demonstrating and articulating the value of their products. Now, stakeholders are increasingly relying on Health Economics and Outcomes Research (HEOR) information to fully understand product value in healthcare and its potential in real-world clinical practice.</p> <p>Kevin Mayo is Senior Director, Health Outcomes &#38; Pharmacoeconomics; Pharmacoeconomics (HOPE) at Endo Pharmaceuticals. Kevin has an extensive international appreciation for new product development and commercialization, Health Economics &#38; Health Outcomes Research, Health Technology Assessment and for developing Market Access &#38; Pricing Strategies gained during his 15 years working within the pharmaceutical industry in leadership roles.</p> <p>Dr. Mayo answered a series of questions written by marcus evans before the upcoming 3rd Annual Health Outcomes &#38; Pharmacoeconomics Research Conference, January 30-31, 2012 in Philadelphia, PA. All responses represent the view of the Dr. Mayo and not necessarily those of Endo Pharmaceuticals. (Note that the responses have been approved by Endo Pharmaceuticals.)</p> <p>What are some key differences in strategy and application for market access and outcomes research in the U.S. versus other major markets (i.e. South America, Europe and Asia)?</p> <p>KM: Market Access mechanisms can be classified as Supply Side (focused upon the manufacturer) or Demand Side (focused upon the physician and/or patient) cost containment / market access regulations. Today, most nations use a combination of mechanisms and there is less (relative to historically) variation among the mechanisms chosen. The major difference between nations is the methodology that is used to implement the mechanisms. Implementation tends to occur along a continuum from limited control, to control via innovation ratings / clinical comparisons and finally to control via formal health economic evaluations. The USA with the new establishment of the Patient Centered Outcomes Research Institute (PCORI) and health reform activities is currently experiencing the “(clinical) comparative effectiveness” stage of evolution. Many other countries have already or are in the process of adopting formal health economic evaluation processes as part of their new health technology assessments.</p> <p>In the years that you've been involved in the pharmaceutical industry, how has the emphasis on health economics and health outcomes research changed? How does HEOR/HOPE fit into the overall company strategy?</p> <p>KM: Since I joined the life science industry in 1997, the activities and deliverables of a Health Outcomes and Health Economics function have remained basically the same (incorporating endpoints in clinical trials, developing payer communication tools such as dossiers, budget impact and health economic models) but with improved econometric techniques and access to data. However, a profound change has occurred in our function’s involvement in internal decision making. When I first joined the industry, our departments were viewed as “support” functions to clinical development and/or managed markets organizations. Today, our team’s analyses and insights are a core consideration driving licensing, clinical development go/no go stage gates, commercial and pricing strategy decisions. Our modern contributions provide a stronger direct link to shareholder value and our insights are more understood and appreciated by senior management.</p> <p>How, in your opinion, do observational investigations relate to and impact comparative effectiveness research (CER)?</p> <p>KM: Although randomized controlled trials (RCT) are superior to quasi-experimental designs in regards to internal validity, they are also characterized by a lack of generalizability (external validity). RCTs have an important role in new product development; however, their use is often impracticable in answering the questions of most relevance to our company’s stakeholders (physicians, patients, payers and politicians). One of the most existing recent advancements from my perspective in observational research methods is the convergence of the Campbell (social sciences) and Rubin (statistics) Causal Models. Donald Campbell’s lasting legacy to our profession will be his emphasize upon the importance of quasi-experimental research designs. Donald Rubin has provided us with the statistical techniques such as propensity score matching within the potential outcomes framework that allow us to control for unobserved covariants. Merging these two great schools of thought could dramatically accelerate the creation and adoption of superior observational research methods.</p> <p>The marcus evans 3rd Annual Health Outcomes &#38; Pharmacoeconomics Research Conference will take place January 30-31, 2012 in Philadelphia, PA. </p> <p>For more information, please contact:<br /> Michele Westergaard<br /> Marketing/PR Coordinator<br /> marcus evans<br /> 312-540-3000 ext. 6625<br /> <a href="mailto:Michelew@marcusevansch.com">Michelew@marcusevansch.com</a></p> <p>About marcus evans<br /> marcus evans conferences annually produce over 2,000 high quality events designed to provide key strategic business information, best practice and networking opportunities for senior industry decision-makers. Our global reach is utilized to attract over 30,000 speakers annually, ensuring niche focused subject matter presented directly by practitioners and a diversity of information to assist our clients in adopting best practice in all business disciplines. </p> http://biotechbistro.com/forum/topic/international-stem-cell-corp-announces-the-launch-of-two-new-international-sales#post-263 Thu, 10 Nov 2011 12:09:32 +0000 pjbosc 263@http://biotechbistro.com/forum/ <p>"International Stem Cell Corporation Announces the Launch of Two New International Sales Initiatives for Lifeline Skin Care"</p> <p>International Stem Cell Corporation (OTCBB:ISCO) today announced two new international marketing initiatives. The first is the successful conclusion of an agreement in principle to distribute its Lifeline Skin Care product line in the United Arab Emirates via a strategic relationship with noted facial plastic surgeon, Dr. Gregory S. Keller MD of Los Angeles and Santa Barbara, CA. The second is the engagement of Dr. K. McIsaac who will distribute Lifeline's products in Australia and New Zealand under Lifeline's own brand name. These agreements mark the first time that Lifeline Skin Care has distributed its products overseas. Currently, Lifeline Skin Care products are sold in the United States through the Company's website <a href="http://www.lifelineskincare.com" rel="nofollow">http://www.lifelineskincare.com</a>.</p> <p>The UAE represents an attractive market of some 4.3 million people, of which nearly 75% are expatriates. This cosmopolitan market is one of the most urbanized nations in the world with about 88% of its population living in cities. It has one of the highest per capita incomes in the world and an annual GDP growth rate at 8.8%.</p> <p>"I am excited to introduce Lifeline Skin Care products to the UAE, and I am confident that our customers there will enjoy the same kind of satisfaction with the products as many of my patients in the United States report," said Dr. Keller. "Many of my American patients have been using these products since they were introduced on the market earlier this year, and the results they've seen are amazing."</p> <p>Dr. Ruslan Semechkin, CEO of Lifeline Skin Care commented: "Dr. Keller has been a faithful supporter of our developmental and commercial efforts in the United States, and he has witnessed the dramatic benefits enjoyed by our customers. We are pleased that he has offered to bring the benefits of Lifeline to the people of UAE.</p> <p>"In choosing Dr. McIsaac and his marketing team, we believe we will be able to rapidly grow sales and better serve the Australia and New Zealand markets. Dr. McIsaac brings a wealth of experience in direct to consumer sales and marketing. Together these agreements are a key part of our strategy to internationalize our brand."</p> <p>Lifeline® Skin Care is the only skin care line that is based on human parthenogenetic stem cells that stimulate your skin's own abilities to repair itself. Lifeline products are sold in pairs, including a day cream and a night cream. A complete set is sufficient for one month of regular use.</p> <p>About International Stem Cell Corporation<br /> International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at <a href="http://www.internationalstemcell.com" rel="nofollow">http://www.internationalstemcell.com</a>.</p> <p>To subscribe to receive ongoing corporate communications, please click on the following link:http://www.b2i.us/irpass.asp?BzID=1468&#38;to=ea&#38;s=0.</p> <p>Forward-looking Statements<br /> Statements pertaining to anticipated developments, potential sales growth and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements. </p> http://biotechbistro.com/forum/topic/international-stem-cell-corp-comments-on-wsj-article-%e2%80%9chope-for-stem-cell#post-262 Wed, 09 Nov 2011 15:58:37 +0000 pjbosc 262@http://biotechbistro.com/forum/ <p>International Stem Cell Corporation Comments on WSJ Article “Hope for Stem-Cell Treatment of Parkinson's”</p> <p>Hope for Stem-Cell Treatment of Parkinson's BY GAUTAM NAIK – The Wall Street Journal HEALTH</p> <p>“Researchers have used stem cells obtained from human embryos to successfully treat Parkinson's disease in mice and rats, a key step in the quest to develop a similar approach for people.</p> <p>In a study published Sunday in the journal Nature, scientists described how they converted human embryonic stem cells into nerve cells that produced the brain chemical dopamine. When these nerve cells were transplanted into the brains of mice and rats, they released dopamine and got rid of the animals' Parkinson's symptoms. The cells were also successfully transplanted into rhesus monkeys, whose biology is closer to that of humans.”</p> <p>SOURCE - To read the complete article on The Wall Street Journal HEALTH site, please click here: <a href="http://online.wsj.com/article/SB10001424052970204621904577018133476441946.html" rel="nofollow">http://online.wsj.com/article/SB10001424052970204621904577018133476441946.html</a></p> <p>Comments from International Stem Cell Corporation:</p> <p>International Stem Cell Corporation (ISCO) announced in July 2011 the initiation of a series of preclinical animal studies of neuronal cells derived from ISCO’s proprietary pluripotent stem cells. The studies will evaluate the in vivo safety and tumorigenicity of neuronal cells derived from ISCO's proprietary human parthenogenetic stem cells (hpSCs), as well as their ability to develop into functioning dopaminergic neuron–like cells, a key milestone towards creating a cell-based therapy for Parkinson's Disease (PD).</p> <p>Dr. Andrey Semechkin, Co-Chairman and CEO of ISCO, comments: “The ability of neuronal cells to become a specific type of neuron is one of the most important properties that these cells must have to be used in cell-based therapy of neurological disorders. These studies will bring us one step closer to our goal of being able to treat PD.”</p> <p>Forward-looking Statements<br /> Statements pertaining to anticipated developments, research and development goals and related potential therapeutic treatments, the potential benefits of products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward- looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.</p> <p>Source - <a href="http://online.wsj.com/article/SB10001424052970204621904577018133476441946.html" rel="nofollow">http://online.wsj.com/article/SB10001424052970204621904577018133476441946.html</a> </p> http://biotechbistro.com/forum/topic/video-stemcelltv-interviews-donna-queen-of-lifeline-skin-care#post-260 Tue, 08 Nov 2011 15:59:41 +0000 pjbosc 260@http://biotechbistro.com/forum/ <p>StemCellTV interviews Donna Queen of Lifeline Skin Care at the California Academy of Cosmetic Surgery Annual Conference in San Diego October 2011.</p> <p>Please click here to view the video - <a href="http://bit.ly/rM3Zz2" rel="nofollow">http://bit.ly/rM3Zz2</a> </p> http://biotechbistro.com/forum/topic/snbl-usa-appoints-mark-t-crane-as-vice-president-of-business-development#post-254 Mon, 07 Nov 2011 07:37:32 +0000 chelsea.scorr 254@http://biotechbistro.com/forum/ <p>FOR IMMEDIATE RELEASE</p> <p>CONTACT:<br /> Michelle Taylor, MA<br /> Marketing Manager<br /> 425.322.1950<br /> <a href="mailto:mtaylor@snblusa.com">mtaylor@snblusa.com</a></p> <p>SNBL USA Appoints Mark T. Crane as Vice President of Business Development</p> <p>Everett, WA – November 7, 2011 – SNBL USA, one of the nation’s leading providers of preclinical services, is pleased to announce new executive leadership with the arrival of Mark T. Crane as Vice President of Business Development. As the new VP, Mr. Crane will have overall responsibility for the company’s marketing, sales and business development efforts and will be tasked with driving the growth of SNBL USA's business model and fostering positive relationships with new and current customers. </p> <p>Mr. Crane joins SNBL USA from Ricerca Biosciences where he served as Vice President of Global Sales and Marketing. He has held similar positions at Bridge Pharmaceutical, Inc. (formally GeneLogic, Inc.), Quest Pharmaceutical Services, and MDS Pharma Services. With over 25 years of industry experience, Mr. Crane is an accomplished executive with extensive expertise in management, business development, and marketing. His preclinical market knowledge and experiences from the pharmaceutical and contract research organization industries will be of significant value to SNBL USA and all its customers. </p> <p>"We wanted to bring someone in to focus solely on business development and Mark is a perfect fit,” said Dr. Thomas Beck, SNBL USA president and COO. “As a seasoned industry executive, Mark’s proven leadership skills will be invaluable as we plan for the coming new year and continue to refine and execute our strategy.”</p> <p>About SNBL USA, Ltd.<br /> Headquartered in Everett, WA, SNBL USA, Ltd. is a preclinical CRO that specializes in nonhuman primate (NHP) and small animal research. Study programs range from regulatory toxicology to customized study designs and disease models. Specialized programs include reproductive toxicology, safety pharmacology, immunotoxicology and carcinogenicity. SNBL USA’s Laboratory Services division intelligently applies extensive experience, comprehensive scientific capabilities, and modern technology to bring outstanding support to all client research. SNBL USA SRC complements SNBL USA in providing quality NHP resources. Through a commitment to investment and excellence, SNBL USA strives to offer the biotechnology and pharmaceutical industries unparalleled quality in both science and service. For additional information call 425.407.0121 or visit <a href="http://www.snblusa.com" rel="nofollow">http://www.snblusa.com</a>.</p> <p>SNBL USA is a wholly-owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd. (SNBL), one of the largest CROs in Japan. Established in 1957, SNBL currently employs approximately 2,000 team members worldwide and provides full service drug development capabilities ranging from preclinical through clinical services.<br /> ### </p> http://biotechbistro.com/forum/topic/abzyme-therapeutics-licenses-sumopro-from-lifesensors#post-247 Thu, 03 Nov 2011 11:34:07 +0000 cgorsky 247@http://biotechbistro.com/forum/ <p>Abzyme Therapeutics, LLC was founded to develop human therapeutic monoclonal antibodies. They have licensed LifeSensors protein expression platform, SUMOpro™ to further their monoclonal antibody production.</p> <p>MALVERN, PA -- November 3, 2011 -- Abzyme Therapeutics, a new biotechnology company dedicated to developing methods to generate human monoclonal antibodies for the treatment of disease, announced today that they have entered into an exclusive agreement with LifeSensors to license their proprietary protein expression platform, SUMOpro™. Enhanced protein expression is key to the evolution and development of antibodies and the LifeSensors SUMOpro™ technology is a protein expression platform that can dramatically enhance overall protein production through increased protein translation, solubility, and stability.</p> <p>“The use of Abzyme Therapeutics’ systems and platforms will allow monoclonal antibodies to be used for the treatment of Alzheimer’s disease, cancer, autoimmune disease, and infectious diseases” said Dr. Tauseef Butt, co-founder and Chair of Abzyme Therapeutics Board of Directors. </p> <p>Abzyme is currently focused on treating Alzheimer’s by developing proteolytic antibodies capable of hydrolyzing and clearing beta-amyloids from the human blood stream. These antibodies are designed to hydrolyze multiple antigen target molecules and overcome the problem of resistance, providing increased benefit at reduced doses. Alternatively, the generation irreversibly and repeatedly of these antibodies in the future will be critical in the development of treatments for cancers and other diseases.</p> <p>Abzyme Therapeutics, LLC has established its headquarters in the Great Valley Technology Center, Malvern, PA and aims to exploit their platforms for the development of novel therapeutic antibodies that will offer affordable medicines with increased benefit, requiring reduced dosages. With therapeutic antibody evolution platforms based on intracellular (iHUMab)/extracellular (eHuMab) genetic selection systems, Abzyme Therapeutics is capable of generating highly diversified human antibody repertoires. For more information please visit <a href="http://www.abzymetx.com" rel="nofollow">http://www.abzymetx.com</a>. </p> <p>LifeSensors, Inc. is the leading producer of innovative research tools for the ubiquitin and ubiquitin-like protein pathways. Its prokaryotic and eukaryotic protein expression platforms SUMOpro™ and SUMOstar™ are used worldwide to overcome bottlenecks in protein production. LifeSensors’ technologies enable research once difficult to achieve by using a wide variety of high quality tools including enzymes, substrates, and inhibitors. For more information please visit <a href="http://www.lifesensors.com" rel="nofollow">http://www.lifesensors.com</a>.</p> <p>Contact:<br /> LifeSensors, Inc.<br /> Email: <a href="mailto:info@lifesensors.com">info@lifesensors.com</a><br /> Phone: (610) 644-8845<br /> <a href="http://www.lifesensors.com" rel="nofollow">http://www.lifesensors.com</a><br /> Or<br /> Abzyme Therapeutics, LLC<br /> Dr. Hiep Tran, Chief Scientific Officer<br /> Email: <a href="mailto:info@abzymetx.com">info@abzymetx.com</a><br /> Phone (610) 990-7531 </p> http://biotechbistro.com/forum/topic/ricerca-biosciences%e2%80%99-taiwan-facility-celebrates-40th-anniversary#post-246 Wed, 02 Nov 2011 19:45:42 +0000 chelsea.scorr 246@http://biotechbistro.com/forum/ <p>FOR IMMEDIATE RELEASE</p> <p>CONTACT:<br /> Kelly Sladek<br /> SCORR Marketing<br /> Phone: 308.237.5567<br /> <a href="mailto:kelly@scorrmarketing.com">kelly@scorrmarketing.com</a></p> <p>Ricerca Biosciences’ Taiwan Facility Celebrates 40th Anniversary</p> <p>(Taipei, Taiwan; November 3, 2011) – Ricerca Biosciences, an integrated preclinical contract research organization (CRO) providing services to the pharmaceutical industry, is celebrating 40 successful years of practice in its Taipei, Taiwan, location on November 11, 2011.<br /> The facility has made many significant changes and improvements throughout the last four decades, including an enhanced lab environment and extended operational capabilities.<br /> “Over the past 40 years, we have worked on more than a half-million testing substances in a wide battery of pharmacology assays,” stated Fong-Chi Cheng, Ricerca Taiwan senior director and site manager. “Because of our continuous improvements, the facility now performs studies for over 500 clients each year.”<br /> In June 2011, the Taiwan facility was awarded the Taipei Labor Bureau’s Titiana Award, or Happiness Enterprise Award, for providing a safe work environment, friendly workplace, excellent training development and good compensation and benefits to workers. Currently, the company is working to acquire its certificate from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) in 2013.<br /> “Ricerca is very proud of our Taiwan facility. It has provided top-quality service for 40 years, and we are looking forward to the future and what it holds,” said Ian Lennox, CEO of Ricerca.<br /> Ricerca Biosciences provides a full range of preclinical services from early discovery medicinal chemistry, compound screening, profiling and lead optimization through full drug safety, metabolism and efficacy development support, as well as clinical supply and commercial API production capability.</p> <p>About Ricerca Biosciences<br /> Ricerca Biosciences, offers a comprehensive suite of discovery, preclinical and development services to support drug candidates from discovery through IND and NDA on a global scale. Capabilities include molecular through in vivo screening and profiling, medicinal chemistry, IND-enabling toxicology, API process chemistry and cGMP manufacturing of clinical and commercial API. At Ricerca, our scientific excellence and reliable, cost-effective strategies help accelerate your drug discovery programs via our U.S.-based facilities in Concord, Ohio, and Bothell, Washington, and our ISO 9001-certified facilities in Taipei, Taiwan, and Lyon, France. The Lyon facility also holds AAALAC certification.<br /> ### </p> http://biotechbistro.com/forum/topic/lifeline-skin-care-video#post-242 Fri, 28 Oct 2011 01:26:32 +0000 williams_john 242@http://biotechbistro.com/forum/ <p>I have also hear about "International Stem Cell" which now a day go a lot of work for humans....Discover lot of treatment for skin care, and eye care also....<br /> Also introduce good brands for treatment..... </p> http://biotechbistro.com/forum/topic/xoma-and-aragen-bioscience-announce-antibody-humanization-services-agreement#post-240 Wed, 26 Oct 2011 10:07:28 +0000 chelsea.scorr 240@http://biotechbistro.com/forum/ <p>XOMA AND ARAGEN BIOSCIENCE ANNOUNCE ANTIBODY HUMANIZATION SERVICES AGREEMENT</p> <p>Berkeley and Morgan Hill, CA, October 26, 2011 -- XOMA Ltd. (Nasdaq: XOMA), a leader in the discovery and development of therapeutic antibodies, and Aragen Bioscience, Inc., a provider of high-content preclinical research and development services, have entered into an agreement under which Aragen Bioscience will provide its clients access to XOMA’s proprietary Human Engineering™ technology for antibody humanization. Financial terms were not disclosed.<br /> The Human Engineering technology enables the derivation of humanized variable region amino acid sequences from mature mouse variable region amino acid sequences. “Access to XOMA’s extensive technology and expertise in antibody humanization allows Aragen Bioscience to provide its customers a seamless transition from murine antibody discovery and sequencing to antibody testing, variable domain humanization, stable and transient expression, cell line development and pre-clinical production services. The addition of XOMA’s technology to our services enables our clients to quickly access antibody humanization technology that is recognized throughout the industry as cutting-edge,” commented Aragen Bioscience’s President and CEO, Rick Srigley.<br /> “We believe that pairing our Human Engineering technology and know-how with Aragen Bioscience’s cell line development experience and expertise is an excellent way to make this technology available to the pharmaceutical and biotech industries,” said Patrick J. Scannon, M.D., Ph.D., Executive Vice President and Chief Scientific Officer at XOMA.<br /> About XOMA<br /> XOMA is a leader in the discovery and development of novel antibody therapeutics. The company's proprietary product pipeline includes a premier antibody discovery and development platform that incorporates an unmatched collection of antibody phage display libraries and proprietary optimization and expression and manufacturing technologies that it uses for its own pipeline and in collaborations with pharmaceutical and biotechnology companies. XOMA's fully integrated product development infrastructure in Berkeley, California extends from preclinical science to approval. For more information, please visit <a href="http://www.xoma.com" rel="nofollow">http://www.xoma.com</a>.</p> <p>CONTACT: XOMA Ltd.<br /> Company and Investor Contact:<br /> Carol DeGuzman<br /> 510-204-7270<br /> <a href="mailto:deguzman@xoma.com">deguzman@xoma.com</a></p> <p>About Aragen Bioscience<br /> Aragen Bioscience, Inc., is a contract research and development services company located in the San Francisco Bay area. Aragen Bioscience specializes in recombinant cell line and hybridoma development, bench-scale cell culture and purification process development and production, primary and immortalized cell-based assays, in vivo models of human disease and custom immunological services. For more information, visit <a href="http://www.aragenbio.com" rel="nofollow">http://www.aragenbio.com</a>. </p> <p>CONTACT: Aragen Bioscience, Inc.<br /> Kenneth Meek<br /> 408-779-1700<br /> <a href="mailto:media@aragenbio.com">media@aragenbio.com</a></p> <p>Forward-Looking Statements<br /> Certain statements contained herein concerning product development and/or strategic goals or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market.<br /> These and other risks, including the generally unstable nature of current economic and financial market conditions; the results of discovery research and preclinical testing; the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the FDA, European or other regulators or their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data); XOMA's ability to meet the demands of the United States government agency with which it has entered into its government contracts; competition; scale-up, manufacturing and marketing capabilities; changes in the status of existing collaborative and licensing relationships; the ability of collaborators, licensees and other third parties to meet their obligations and their discretion in decision-making; market demand for products; availability of additional licensing or collaboration opportunities; international operations; share price volatility; XOMA's financing needs and opportunities; uncertainties regarding the status of biotechnology patents; uncertainties as to the costs of protecting intellectual property; and risks associated with XOMA's status as a Bermuda company, are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects.<br /> ### </p> http://biotechbistro.com/forum/topic/online-business-applications-launches-irms-mobile-application#post-239 Wed, 26 Oct 2011 08:05:26 +0000 chelsea.scorr 239@http://biotechbistro.com/forum/ <p>CONTACT:<br /> Joe Pierce<br /> Vice President of Sales and Marketing<br /> Online Business Applications<br /> (630) 243-9810 ext. 209<br /> <a href="mailto:sales@irmsonline.com">sales@irmsonline.com</a></p> <p>Online Business Applications Launches IRMS Mobile Application</p> <p>(Woodridge, IL; October 26, 2011) – Online Business Applications (OBA), a leader in the health science software industry that offers advanced solutions for pharmaceutical, biotechnology and medical device companies in the areas of medical communications and drug safety, has released its mobile request application, IRMS Mobile, for iPad, iPhone and other mobile devices.</p> <p>This efficient application enables a company’s field force to easily enter and submit medical information requests from physicians with a convenient mobile device. IRMS Mobile sends the request to the company’s IRMS (Information Request Management System) call center where it is routed to a medical information professional for fulfillment. The field sales representative or science liaison also may track the information requested and receive automatic notifications of successful receipt and completion of the request.</p> <p> “This is a great way to easily collect a physician’s signature to verify an unsolicited request and provide a timely response, ultimately allowing more opportunities for written prescriptions and higher sales,” said Joe Pierce, OBA vice president of sales and marketing. “The seamless integration of our server-based IRMS software, the world’s leading medical information system, with our mobile application allows field representatives to use the technology to its fullest. Both IRMS and IRMS Mobile are so versatile that they can easily link information from other software systems and use that information to process a request.”</p> <p>IRMS Mobile can be installed on the company’s servers where the data is stored in the company’s database or it can be hosted by OBA as a Web-based cloud service with no installation. IRMS is 21 CFR Part 11 compliant and has been fully validated. To learn more, contact Reed McLaughlin, account manager, at (630) 243-9810 ext. 225 or <a href="mailto:reed.mclaughlin@irmsonline.com">reed.mclaughlin@irmsonline.com</a>.<br /> OBA has provided advanced software solutions for the pharmaceutical, biotechnology and medical device industries in the areas of medical communications and drug safety for over 25 years. The IRMS software offers enhanced tools, including automated letter generation, flexible ad-hoc query capability with built-in custom reporting, and document and correspondence management. In addition, IRMS offers optional adverse event, quality assurance, product complaint and content management functionality. </p> <p>About Online Business Applications<br /> For over 25 years, Online Business Applications (OBA) has been committed to providing advanced software solutions for the pharmaceutical, biotechnology and medical device industries in the areas of medical communications and drug safety. Partnered with over 100 pharmaceutical and biotech companies in over 70 countries, OBA’s IRMS (Information Request Management System), the world’s leading medical information system, offers enhanced tools, including built-in custom reporting, document and correspondence management, FAQ database and built-in data and privacy protection. IRMS is designed to be 21 CFR Part 11 compliant and has been fully validated. For more information, visit <a href="http://www.irmsonline.com" rel="nofollow">http://www.irmsonline.com</a>. </p> <p>### </p> http://biotechbistro.com/forum/topic/acr-image-metrix-welcomes-new-board-of-directors#post-238 Tue, 25 Oct 2011 09:12:27 +0000 chelsea.scorr 238@http://biotechbistro.com/forum/ <p>FOR IMMEDIATE RELEASE </p> <p>Contact:<br /> Shawn Farley<br /> Public Relations Manager<br /> 703.648.8936<br /> <a href="mailto:sfarley@acr.org">sfarley@acr.org</a></p> <p>ACR Image Metrix Welcomes New Board of Directors</p> <p>(Philadelphia, PA; October 25, 2011) – ACR Image Metrix™, a global imaging contract research organization (CRO) with expertise in imaging trial design, techniques and data extraction, announced today its recent appointment of seven scientific and business leaders to its board of directors.</p> <p>The ACR Image Metrix board of directors now includes the following individuals:<br /> • Paul Ellenbogen, M.D., FACR, Chairman of the ACR Image Metrix Board of Directors, ACR Board of Chancellors Vice Chair and Partner at Radiology Associates of North Texas</p> <p>• Jonathan Lewin, M.D., FACR, Chairman, Department of Radiology and Radiological Science at Johns Hopkins University and Radiologist-in-Chief at Johns Hopkins Hospital</p> <p>• Harvey Neiman, M.D., FACR, Chief Executive Officer at ACR Image Metrix and Chief Executive Officer of the American College of Radiology</p> <p>• Donald Rosen, M.D., Co-founder of RadPharm, Inc.</p> <p>• Samuel Broder, M.D., Former Vice President and CMO of Celera</p> <p>• Carolyn Meltzer, M.D., FACR, Chair of the Department of Radiology at Emory University School of Medicine</p> <p>• Joel Morganroth, M.D., Chief Scientific Officer at EResearch Technology<br /> Expanded biographies of these leaders can be found on the ACR Image Metrix Board of Directors Web page. </p> <p>“We are pleased and very fortunate to bring such a savvy group of leaders to our board of directors,” stated ACR Image Metrix Chief Executive Officer Dr. Harvey Neiman. “Each member focuses primarily on the growth and high level of quality ACR Image Metrix provides. We look forward to the new insights and added dimensions the elected individuals will bring to our strategic vision.” </p> <p>As a leading imaging CRO, ACR Image Metrix specializes in providing services to assist pharmaceutical, biotech and medical device companies around the world.</p> <p>About ACR Image Metrix™<br /> ACR Image Metrix™, an imaging contract research organization (CRO) located in the American College of Radiology Clinical Research Center in Philadelphia, applies imaging techniques to improve the efficiency of drug and medical device development programs. The world-class team of radiologists and imaging scientists at ACR Image Metrix works with pharmaceutical, biotech and medical device companies to integrate the appropriate imaging technologies, modalities and clinical design techniques into their imaging studies. ACR Image Metrix has years of experience utilizing state-of-the-art technologies to provide a complete line of imaging services from site qualification and training, study initiation, image management, reader studies and much more. Connect with ACR Image Metrix™ on LinkedIn and Twitter.</p> <p>### </p> http://biotechbistro.com/forum/topic/intl-stem-cell-corp-scientific-american-%e2%80%9cyou-say-embryo-i-say-parthenote#post-236 Fri, 21 Oct 2011 13:15:08 +0000 pjbosc 236@http://biotechbistro.com/forum/ <p>“We at International Stem Cell Corporation (ISCO.OB) are finding it increasingly gratifying that mainstream and highly respected publications like Scientific American are now beginning to take notice of the fact that our Parthenogenetic Stem cells may well turn out to be a viable alternative to the embryonic stem cells that have dominated research and headlines for the last 10 years. </p> <p>Like embryonic stem cells, our Parthenogenetic stem cells can be converted into almost any kind of cell that might ever be needed for therapy, but can also provide a solution to the two biggest issues that have surrounded embryonic stem cell research: 1) the ethics of destroying a fertilized embryo, which our process never does, and 2) the problem of immune rejection by the patient. We hope you enjoy the attached article."<br /> Ken Aldrich, Founder and Co-Chairman, International Stem Cell Corporation</p> <p>October 21st, 2011<br /> “You Say Embryo, I Say Parthenote”<br /> Stem cells from unfertilized eggs may be too tightly regulated<br /> By Julia Galef<br /> Article: <a href="http://www.scientificamerican.com/article.cfm?id=you-say-embryo-i-say-parthenote" rel="nofollow">http://www.scientificamerican.com/article.cfm?id=you-say-embryo-i-say-parthenote</a><br /> Source: Scientific America November 2011 </p> http://biotechbistro.com/forum/topic/ricerca-biosciences-announces-partnership-with-dr-jeanne-stadler#post-230 Thu, 20 Oct 2011 06:57:24 +0000 chelsea.scorr 230@http://biotechbistro.com/forum/ <p>FOR IMMEDIATE RELEASE</p> <p>CONTACT:<br /> Kelly Sladek<br /> SCORR Marketing<br /> Phone: 308.237.5567<br /> <a href="mailto:kelly@scorrmarketing.com">kelly@scorrmarketing.com</a></p> <p>Ricerca Biosciences Announces Partnership with Dr. Jeanne Stadler</p> <p>(Concord, OH; October 20, 2011) –Ricerca Biosciences, an integrated preclinical contract research organization (CRO) providing services to the biopharmaceutical industry, is pleased to announce a partnership agreement with Dr. Jeanne Stadler, a well-known consultant who specializes in reproductive and developmental toxicology.<br /> The partnership will enhance the already high level of expertise that Ricerca has in this field and will enable it to continue to deliver excellence within the fields of toxicology.<br /> “Dr. Stadler is a well-respected expert, and her extensive experience is recognized internationally by both industry and regulatory professionals,” stated Ian Lennox, CEO of Ricerca. “This collaboration enables our clients to access the highest standard of advisory expertise and reinforces Ricerca's leadership in reproductive and juvenile toxicology.”<br /> Once the compound is selected for drug development, Ricerca professionals help companies choose the best study parameters and protocol that best suit the study at hand. Ricerca’s expertise in conducting studies and developing the requisite data package and reports for IND submission can help ensure the success of potential candidates.<br /> Ricerca Biosciences provides a full range of preclinical services from early discovery medicinal chemistry, compound screening, profiling and lead optimization through full drug safety, metabolism and efficacy development support, as well as clinical supply and commercial API production capability.</p> <p>About Ricerca Biosciences<br /> Ricerca Biosciences, offers a comprehensive suite of discovery, preclinical and development services to support drug candidates from discovery through IND and NDA on a global scale. Capabilities include molecular through in vivo screening and profiling, medicinal chemistry, IND-enabling toxicology, API process chemistry and cGMP manufacturing of clinical and commercial API. At Ricerca, our scientific excellence and reliable, cost-effective strategies help accelerate your drug discovery programs via our U.S.-based facilities in Concord, Ohio, and Bothell, Washington, and our ISO 9001-certified facilities in Taipei, Taiwan, and Lyon, France. The Lyon facility also holds AAALAC certification.<br /> ### </p> http://biotechbistro.com/forum/topic/acr-image-metrix-formalizes-imaging-biomarker-development-program#post-227 Tue, 18 Oct 2011 08:28:04 +0000 chelsea.scorr 227@http://biotechbistro.com/forum/ <p>FOR IMMEDIATE RELEASE </p> <p>Contact:<br /> Shawn Farley<br /> Public Relations Manager<br /> 703.648.8936<br /> <a href="mailto:sfarley@acr.org">sfarley@acr.org</a></p> <p>ACR Image Metrix Formalizes Imaging Biomarker Development Program</p> <p>(Philadelphia, PA; October 18, 2011) – ACR Image Metrix™, a global imaging contract research organization (CRO) with expertise in imaging trial design, techniques and data extraction, has formalized a biomarker and imaging development program.<br /> ACR Image Metrix has partnered with radiopharmacies to overcome the challenging logistics of using radiolabeled tracers as biomarkers in clinical research and has formalized a biomarker imaging development program that includes clinical strategy, trial design and execution.<br /> “ACR Image Metrix has extensive experience and understands the challenges with biomarkers,” stated Michael J. Morales, general manager. “Our strong operational expertise and infrastructure ensure our clients’ data meet regulatory requirements. Additionally, we are currently assisting several sponsors with their biomarker clinical development programs in multiple therapeutic categories. This is a new area for sponsors as well as the FDA, and ACR Image Metrix is adding incredible value to this new frontier in drug development.<br /> “Imaging is being used in earlier research phases as a biomarker to help clarify mechanisms, demonstrate drug activity and provide clinical data to determine whether a device might prove worthwhile,” Morales added. “This approach saves time and money because, if used properly, imaging can lower the variability in influencing go/no-go decisions.”<br /> As a leading imaging CRO, ACR Image Metrix specializes in providing imaging CRO services to assist pharmaceutical, biotech and medical device companies around the world.</p> <p>About ACR Image Metrix™<br /> ACR Image Metrix™, an imaging contract research organization (CRO) located in the American College of Radiology Clinical Research Center in Philadelphia, applies imaging techniques to improve the efficiency of drug and medical device development programs. The world-class team of radiologists and imaging scientists at ACR Image Metrix works with pharmaceutical, biotech and medical device companies to integrate the appropriate imaging technologies, modalities and clinical design techniques into their imaging studies. ACR Image Metrix has years of experience utilizing state-of-the-art technologies to provide a complete line of imaging services from site qualification and training, study initiation, image management, reader studies and much more. Connect with ACR Image Metrix™ on LinkedIn and Twitter.</p> <p>### </p> http://biotechbistro.com/forum/topic/scorr-marketing-to-attend-aaps-annual-meeting-and-exposition#post-226 Tue, 18 Oct 2011 08:23:32 +0000 chelsea.scorr 226@http://biotechbistro.com/forum/ <p>FOR IMMEDIATE RELEASE</p> <p>CONTACT:<br /> Kelly Sladek<br /> SCORR Marketing<br /> 308.237.5567<br /> <a href="mailto:Kelly@scorrmarketing.com">Kelly@scorrmarketing.com</a></p> <p>SCORR Marketing to Attend AAPS Annual Meeting and Exposition</p> <p>(Kearney, NE; October 18, 2011) – SCORR Marketing, a strategic marketing agency focused on drug development and life science industries, will be attending the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition October 23-27, 2011, in Washington, D.C.<br /> "Thousands of scientists will attend the exposition and we are looking forward to connecting with familiar faces and meeting potential clients," stated SCORR Marketing President Cinda Orr. "This year AAPS is celebrating its 25th anniversary—I am proud to say that I have attended the AAPS Annual Meeting for the past 20 years. SCORR's depth of experience in this industry is unprecedented since we are the only marketing firm with that level of industry experience and commitment."<br /> SCORR Marketing is a full-service marketing and public relations firm offering complete strategic communications programs to clients in a wide variety of markets and industries. For more information or to view samples of their work, visit online at <a href="http://www.scorrmarketing.com" rel="nofollow">http://www.scorrmarketing.com</a> or call 308.237.5567. </p> <p>About SCORR Marketing<br /> SCORR collaborates with energetic companies to develop “next-phase growth strategies” and utilizes a disciplined approach to marketing plans that ensures solid incremental growth year after year, creating tangible results. SCORR’s team includes dedicated talent with worldwide experience in market development, public relations and communications, customer retention and development, corporate identity/branding, broadcast and print advertising, tradeshow/event planning and promotion, and website development and hosting services. SCORR Marketing has offices in Seattle, Philadelphia and Omaha with headquarters in Kearney, Nebraska. Connect with SCORR Marketing on Facebook, LinkedIn and Twitter.</p> <p>### </p> http://biotechbistro.com/forum/topic/international-stem-cell-corp-chairman-kenneth-aldrich-comments-on-recent-time#post-221 Thu, 06 Oct 2011 18:25:14 +0000 pjbosc 221@http://biotechbistro.com/forum/ <p>“Since we at International Stem Cell Corporation (trading symbol: ISCO.OB) are licensees of some of the key intellectual property necessary to use SCNT in therapeutic products, we were delighted to read about this new discovery. However, what disappointed us somewhat was the failure of most news reports to mention that a technology already exists that solves the same ethical problems and has the potential also to solve many of the problems of immune rejection that worry scientists who are working with cells obtained from fertilized embryos.</p> <p>That technology is called "Parthenogenesis" and results in a "cell line" that can provide an essentially unlimited supply of human cells for a wide range of therapeutic purposes, yet does not involve the destruction of any fertilized embryo and results in cells that can be matched to large groups of people who may not even know the patient, much like the way blood from donors can be stored and used by accident victims as needed. Unlike the SCNT cells, parthenogenetic cells require no genetic manipulation or insertion of foreign DNA.</p> <p>Our scientists at ISCO created and patented the process for making such human parthenogenetic stem cell lines and have already successfully made liver cells, cornea cells, retina cells and nerve cells from those cell lines. Each of these applications is being studied as a possible future source of transplanted cells to treat diseases such as Parkinson's, Liver Disease, Macular Degeneration, and others. </p> <p>To learn more about parthenogenesis, visit our website at <a href="http://www.internationalstemcell.com" rel="nofollow">http://www.internationalstemcell.com</a> or click on ISCO.OB at any financial web site for information about our company.”</p> <p>Kenneth C. Aldrich<br /> Chairman<br /> International Stem Cell Corporation</p> <p>TIME Article – A Stem Cell First: Using the 'Dolly' Method on Human Cells<br /> <a href="http://healthland.time.com/2011/10/05/a-stem-cell-first-using-the-dolly-method-on-human-cells/" rel="nofollow">http://healthland.time.com/2011/10/05/a-stem-cell-first-using-the-dolly-method-on-human-cells/</a></p> <p>About International Stem Cell Corporation<br /> International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at <a href="http://www.internationalstemcell.com" rel="nofollow">http://www.internationalstemcell.com</a>.</p> <p>To subscribe to receive ongoing corporate communications, please click on the following link:http://www.b2i.us/irpass.asp?BzID=1468&#38;to=ea&#38;s=0.</p> <p>Forward-looking Statements<br /> Statements pertaining to anticipated developments, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements. </p> http://biotechbistro.com/forum/topic/international-stem-cell-names-dr-andrey-semechkin-as-co-chairman-and-kurt-may#post-220 Thu, 06 Oct 2011 14:02:07 +0000 pjbosc 220@http://biotechbistro.com/forum/ <p>International Stem Cell Corporation (OTCBB:ISCO) today announced that its Board of Directors designated Dr. Andrey Semechkin, the Company's Chief Executive Officer, as a Co-Chairman with the Company's founder, Kenneth Aldrich, and also named Kurt May as President and Chief Operating Officer, effective immediately. Mr. May is currently Senior Vice President and this represents both a promotion and the delegation of additional duties and responsibilities consistent with his increasingly important role in the future of ISCO.</p> <p>Dr. Semechkin commented, "Kurt May is an extremely capable executive who has managed both a multi-billion dollar public company and a successful life sciences startup company. His willingness to assume operational responsibilities for ISCO will allow me, as CEO, to focus more intently on scientific and strategic initiatives that are central to developing ISCO into a major force in the world of stem cell therapy. Working together with the fine team of executives and scientists already within ISCO, I have high hopes and confidence we can reach that goal."</p> <p>Prior to joining ISCO, Mr. May was a senior executive with GTE Corporation and with PriceSmart, Inc., and the founder and CEO of a privately owned biotech company, Psynomics, based on medical technology derived from the University of California, San Diego. Mr. May served as a faculty member and Assistant Dean of UCSD's Rady School of Management from 2005 to 2009.</p> <p>During his tenure as PriceSmart's Chief Operating Officer, Mr. May led the company from startup to growth over three years that included establishing 22 stores in 11 countries, reaching annual revenues of more than $500 million, achieving profitability, and expanding staff from 356 to more than 4,200.</p> <p>"In addition to its therapeutic programs, ISCO is dedicated to building its revenue-generating subsidiaries to high levels of profitability. We view Mr. May's commercial and entrepreneurial skills as an essential part of our business plan for success," said Kenneth Aldrich, Co-Founder and Co-Chairman of ISCO.</p> <p>About International Stem Cell Corporation<br /> International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at <a href="http://www.internationalstemcell.com" rel="nofollow">http://www.internationalstemcell.com</a>.</p> <p>To subscribe to receive ongoing corporate communications, please click on the following link:http://www.b2i.us/irpass.asp?BzID=1468&#38;to=ea&#38;s=0.</p> <p>Forward-looking Statements<br /> Statements pertaining to anticipated developments, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.</p> <p>International Stem Cell Corporation</p> <p>Kenneth C. Aldrich, Co-Chairman<br /> 760-940-6383<br /> <a href="mailto:kaldrich@intlstemcell.com">kaldrich@intlstemcell.com</a><br /> or<br /> Lippert/Heilshorn &#38; Associates<br /> Don Markley, 310-691-7100<br /> <a href="mailto:dmarkley@lhai.com">dmarkley@lhai.com</a> </p> http://biotechbistro.com/forum/topic/davita-labs-to-present-falcon-lab%e2%84%a2-application-at-national-renal-administrators#post-219 Mon, 03 Oct 2011 08:13:48 +0000 chelsea.scorr 219@http://biotechbistro.com/forum/ <p>DaVita Labs to Present Falcon Lab™ Application at National Renal Administrators Association 2011 Annual Meeting</p> <p>Fort Lauderdale, FL (October 3, 2011) –DaVita Labs, a chronic kidney disease specialty laboratory, will display the company’s latest version of its Web-based application, Falcon Lab™, at the National Renal Administrators Association (NRAA) 2011 Annual Meeting. </p> <p>The October 5-7 meeting will be held at the New Orleans Marriott in New Orleans, Louisiana. The company will be located at booth #202 during the meeting. </p> <p>Falcon Lab is designed as a renal-specific, Web-based application that provides 24/7 access to advanced ordering, data analysis and reporting tools for patients with CKD and ESRD. Falcon Lab demonstrations are available at NRAA by scheduling an appointment with Brenda Lavati at <a href="mailto:brenda.lavati@davita.com">brenda.lavati@davita.com</a>.</p> <p>Falcon Lab’s new regulatory reporting package provides the organizations and facilities with a detailed statistical analysis and exception reports to assist in managing QIP measures and QAPI with ease.</p> <p>“With its simplified design, Falcon Labs streamlines the reporting process,” said DaVita Labs General Manager Leslie Mirani. “This software allows physicians to access into the patient’s history and easily creates detailed patient and facility reports with trend-indicating graphs. Physicians can also build and manage commonly-ordered lab panels, generate customized panels based on co-morbid conditions and electronically sign or dispute orders with the click of a mouse.”</p> <p>Additionally, DaVita Labs provides the following:<br /> • Face-to-face onboarding support<br /> • Quarterly face-to-face visits on site<br /> • Monthly operations review<br /> • Significant infrastructure investment (IT, laboratory operations, plant &#38; equipment)<br /> • State lab reporting that meets your needs (QAPI, QIP &#38; CROWN web)<br /> • Financial stability<br /> • National insurance coverage<br /> • Industry knowledge<br /> • 24/7 resources for operational specialist support, dietitian support &#38; clinical process support</p> <p>DaVita Labs has 86,700 square feet dedicated to its state-of-the-art clinical diagnostic laboratories between its two locations in Ft. Lauderdale and Deland, Florida. The laboratories feature the latest in renal-specific methodology and technology for delivering quality test results. The DaVita Labs clinical laboratory team is led by experienced scientists and pathologists, and receives formal guidance from top nephrologists in the industry.</p> <p>DaVita is a registered trademark of DaVita Inc. All other trademarks are the property of their respective owners.</p> <p>About DaVita<br /> DaVita Inc., a Fortune 500® company, is a leading provider of kidney care in the United States, delivering dialysis services and education to patients with chronic kidney failure and end stage renal disease. As of September 30, 2010, DaVita operated or provided administrative services at 1,598 dialysis facilities, serving approximately 124,000 patients. DaVita develops, participates in and donates to numerous programs dedicated to transforming communities and creating positive, sustainable change for children, families and our environment. The company’s leadership development initiatives and corporate social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu, among others. For more information, please visit <a href="http://www.davita.com" rel="nofollow">http://www.davita.com</a>. </p> <p>About DaVita Labs<br /> DaVita Labs provides quality, on-time, accurate results to help effectively identify and manage kidney patients across the nation. As a cutting-edge chronic kidney disease (CKD) specialty laboratory, DaVita Labs features the latest in end stage renal disease-specific methodology and technology for delivering quality dialysis test results. DaVita Labs is fully accredited by the federal and state governmental agencies, and the College of American Pathologists. For more information, please visit <a href="http://www.davitalabs.com" rel="nofollow">http://www.davitalabs.com</a> or call 877.200.3181. </p> <p>###</p> <p>Contact Information<br /> Media:<br /> Vince Hancock<br /> (303) 405-2272<br /> <a href="mailto:Vince.hancock@davita.com">Vince.hancock@davita.com</a> </p> http://biotechbistro.com/forum/topic/representative-brian-bilbray-meets-with-international-stem-cell-executives#post-218 Thu, 29 Sep 2011 11:35:49 +0000 pjbosc 218@http://biotechbistro.com/forum/ <p>Representative Brian Bilbray Meets with International Stem Cell Executives to Discuss Research Funding</p> <p>International Stem Cell Corporation (OTCBB: ISCO) today announced that Representative Brian Bilbray recently met with Company executives, including Chairman Kenneth Aldrich, President and Chief Executive Officer Andrey Semechkin, and Senior Vice President Kurt May, to discuss key federal government issues relating to stem cell research. Rep. Bilbray represents California's 50th congressional district, which includes portions of San Diego's North County.</p> <p>Following the meeting, Rep. Bilbray stated, "I have tremendous respect for the innovative healthcare companies in my district, such as International Stem Cell, that are at the forefront of developing important new treatments and therapies. I'm committed to helping remove unnecessary regulations and barriers that may inhibit the research of new life science technologies, and I greatly appreciate the efforts of ISCO's management team to clarify many of the issues surrounding their work."</p> <p>Said Dr. Semechkin, "We are very pleased to have the opportunity to meet with Congressman Bilbray and explain the importance of our parthenogenesis technology and how it differs from human embryonic stem cell development, particularly from an ethical standpoint. We look forward to continued discussions with Congressman Bilbray and his colleagues regarding the Dickey-Wicker Amendment. We believe that with increased understanding of our technology the National Institutes of Health (NIH) will support parthenogenesis research and development."</p> <p>About International Stem Cell Corporation</p> <p>International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at <a href="http://www.internationalstemcell.com" rel="nofollow">http://www.internationalstemcell.com</a>.</p> <p>To subscribe to receive ongoing corporate communications, please click on the following link: <a href="http://www.b2i.us/irpass.asp?BzID=1468&#38;to=ea&#38;s=0" rel="nofollow">http://www.b2i.us/irpass.asp?BzID=1468&#38;to=ea&#38;s=0</a>.</p> <p>Forward-looking Statements</p> <p>Statements pertaining to anticipated developments, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements. </p>