BiotechBistro Forums Tag: oncology

BiotechBistro Forums Tag: oncology http://biotechbistro.com/forum/tags/oncology The Business of Biotechnology en-US Mon, 06 Feb 2012 09:31:42 +0000 bbpress 1.0-alpha-4 <![CDATA[Search]]> q http://biotechbistro.com/forum/search.php chelsea.scorr on "DaVita Clinical Research Launches New Advisory Committee Preparation Services" http://biotechbistro.com/forum/topic/davita-clinical-research-launches-new-advisory-committee-preparation-services#post-215 Tue, 27 Sep 2011 08:06:12 +0000 chelsea.scorr 215@http://biotechbistro.com/forum/ DaVita Clinical Research Launches New Advisory Committee Preparation Services MINNEAPOLIS (Sept. 27, 2011) – DaVita Clinical Research® (DCR®), a provider of clinical research services focused on kidney research as well as a multitude of specialty therapeutic populations, will launch their new Advisory Committee Preparation Services at the 2011 Regulatory Affairs Professionals Society (RAPS): The Regulatory Convergence. DCR will be at booth #107 during the Oct. 22-26, 2011, meeting in Indianapolis. DCR’s team helps lead drug and device sponsors from presentation outlines through execution at FDA Advisory Committee meetings. Sponsors benefit from a strategic partnership with dedicated presentation experts who translate messages into powerful slides in real time. DCR’s team, which has participated in more than 20 advisory committee meetings during the past six years, works side-by-side with sponsors to help ensure advisory committee communication is complete and effective. The Advisory Committee Preparation Services are divided into two segments: presentation development and presentation execution. DCR’s role in presentation development is to create slides for sponsors that serve as powerful visual aids. Then, through presentation execution services – mock rehearsals, Q&A preparation and slide retrieval – the DCR team facilitates the effective delivery of those slides for sponsors. Similar services are available for other face-to-face meetings between sponsors and FDA, such as type A/B/C meetings. DCR is pleased to announce as a part of this expansion the addition of Lesley M. Smith to the DCR team. Smith has distinguished herself as both an able practitioner and scholar in the area of strategic communication. She recently earned a M.A. in strategic communication from the University of North Carolina at Chapel Hill. She is the only slide developer in the advisory committee preparation industry to write academically on the topic, conducting research on the presentation of data at drug advisory committee meetings. “Successful slide development is a coordinated effort between clinical, regulatory and communication expertise,” stated Mahesh Krishnan, vice president of clinical research at DCR. “Professional communicators move pharmaceutical teams toward their goal in a way no other function can – a lesson I learned from my own experience preparing for an advisory committee meeting.” -more- With a staff that is fully committed to advancing the knowledge and practice of kidney care, DCR brings unsurpassed knowledge, skill and expertise to pharmaceutical research, helping ensure the success of clinical trials. DaVita, DaVita Clinical Research and DCR are a registered trademarks of DaVita Inc. All other trademarks are the property of their respective owners. About DaVita Clinical Research DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is committed to advancing the knowledge and practice of kidney care. DCR brings unsurpassed knowledge, skill, and expertise to pharmaceutical research, ensuring the success of their clients’ clinical trials. DCR’s clinical expertise ranges from designing the study to preparing and submitting the final report. DCR’s Early Clinical Research unit (Phase I-IIa) and Clinical Development network of physicians and investigative sites, Health Economics and Central Laboratory are focused on providing world-class clinical research in both complex/specialty populations and therapeutic areas as well as CKD and ESRD populations needed to meet clinical goals. To learn more about DCR, visit <a href="http://www.davitaclinicalresearch.com" rel="nofollow">http://www.davitaclinicalresearch.com</a>. About DaVita 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 June 30, 2011, DaVita operated or provided administrative services at 1,669 dialysis facilities, serving approximately 131,000 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>. ### Contact Information Vince Hancock (303) 405-2272 <a href="mailto:Vince.hancock@davita.com">Vince.hancock@davita.com</a> chelsea.scorr on "DaVita Clinical Research Central Laboratory Expands its Services and Technology" http://biotechbistro.com/forum/topic/davita-clinical-research-central-laboratory-expands-its-services-and-technology#post-211 Thu, 15 Sep 2011 07:55:00 +0000 chelsea.scorr 211@http://biotechbistro.com/forum/ DaVita Clinical Research Central Laboratory Expands its Services and Technology MINNEAPOLIS (Sept. 15, 2011) – DaVita Clinical Research® (DCR®), a provider of clinical research services focused on kidney research as well as a multitude of specialty therapeutic populations, has announced the company’s expansion within its Central Laboratory. DCR’s Central Laboratory is focused on providing world-class clinical research in both complex/specialty populations and therapeutic areas, as well as chronic kidney disease (CKD) populations. By year’s end, the lab’s test menu will increase by 43 percent, maintaining the company’s leadership position in advanced renal care while ensuring critical coverage in the areas of oncology, immunology, endocrinology, cardiology and anemia. The testing facility has expanded its technology through the addition of two new testing platforms, the IMMULITE 2000 XPi Immunoassay System and the AB SCIEX QTRAP 5500 LC/MS/MS system. Other additions include increased specimen management and storage capabilities for both short- and long-term testing. The Central Laboratory facilitates satisfaction with continuous IT advancements, allowing for clean, timely data and ease of customer access to laboratory results. DCR’s commitment to “Excellence Through Innovation” is evident by its continual, selective additions of scientific and operational staff coming from the CRO and pharma communities. In addition, DCR recently announced the launch of its Biorepository Services. The biorepository contains collections of biological material and their pertinent databases that are systemized for the purpose of research. This new, one-of-a-kind, state-of-the-art biorepository dramatically improves the odds of a breakthrough discovery by combining samples meticulously collected from our nationwide network of over 1,700 sites richly annotated with patient-level heath information. “We are proud of our recent investments in equipment and assay development,” stated DCR Vice President of Commercial Development Kevin J. Goudreau. “These investments will allow us to supply central laboratory services outside of renal care. We will continue to invest heavily in assay development until the breadth of our offering covers virtually all therapeutic indications.” DaVita and DCR are trademarks or registered trademarks of DaVita Inc. All other trademarks are the property of their respective owners. About DaVita Clinical Research (DCR) DaVita Clinical Research (DCR) is committed to advancing the knowledge and practice of kidney care. DCR brings unsurpassed knowledge, skill, and expertise to pharmaceutical research, ensuring the success of their clients’ clinical trials. DCR’s clinical expertise ranges from designing the study to preparing and submitting the final report. DCR’s Early Clinical Research unit (Phase I-IIa) and Clinical Development network of physicians and investigative sites, Health Economics and Central Laboratory are focused on providing world-class clinical research in both complex/specialty populations and therapeutic areas as well as CKD and ESRD populations needed to meet clinical goals. To learn more about DCR, visit <a href="http://www.davitaclinicalresearch.com" rel="nofollow">http://www.davitaclinicalresearch.com</a>. About DaVita 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 June 30, 2011, DaVita operated or provided administrative services at 1,669 dialysis facilities, serving approximately 131,000 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>. ### Contact Information Media: Vince Hancock (303) 405-2272 <a href="mailto:vince.hancock@davita.com">vince.hancock@davita.com</a> chelsea.scorr on "DaVita Clinical Research Announces New Biorepository Services" http://biotechbistro.com/forum/topic/davita-clinical-research-announces-new-biorepository-services#post-207 Tue, 13 Sep 2011 08:06:14 +0000 chelsea.scorr 207@http://biotechbistro.com/forum/ DaVita Clinical Research Announces New Biorepository Services MINNEAPOLIS (Sept. 13, 2011) – DaVita Clinical Research® (DCR®), a provider of clinical research services focused on kidney research as well as a multitude of specialty therapeutic populations, announces its one-of-a-kind Biorepository Services. These services offer the pharmaceutical industry unique collaborative research opportunities that combine access to high-quality samples combined with well-characterized patient data annotation. DCR’s distinctive Biorepository Services support industry trends toward personalized medicine, empowered drug discovery and productive drug development for biotechnology and pharmaceutical sponsors, as well as platform technology companies. This unique approach is at the forefront of changes with the biorepository industry that will provide meaningful advances toward the future of more effective drug discovery and development. “We are excited to begin this new chapter and believe the biorepository we are creating will set a new standard in the industry and add value to the drug discovery efforts of our partners,” stated DCR President Chris Rucker. “We believe that the unique characteristics of our offering will position us to meet a need in the discovery community that is currently not being satisfied by the existing biorepositories.” DCR’s unique biorepository provides customized sample sets from patient populations collected nationally. These samples are collected under an IRB-approved protocol with the consent of patients. The high-quality samples contain high RNA and DNA yields and are suitable for genomic analysis. In addition, DCR collects samples under the same rigorous conditions that allow proteomic and metabolomic testing. “Our unprecedented levels of operational excellence ensure that our partners not only have a sample for testing of the highest level of sample integrity, but the well-characterized data associated with it, including patient health history, treatment data, prescription data and hospitalization data,” said Dr. Mahesh Krishnan, M.D., DCR vice president of clinical research. “It is the characterization of our data and the annotation of this data to our sample sets that distinguish our biorepository services from the majority of the industry.” With a staff that is fully committed to advancing the knowledge and practice of kidney care, DCR brings unsurpassed knowledge, skill and expertise to pharmaceutical research, helping facilitate the success of clinical trials. DaVita, DaVita Clinical Research and DCR are registered trademarks of DaVita, Inc. All other trademarks are the property of their respective owners. About DaVita Clinical Research (DCR) DaVita Clinical Research (DCR) brings unsurpassed knowledge, skill, and expertise to pharmaceutical research, facilitating the success of their clients’ clinical trials. DCR’s clinical expertise ranges from designing the study to preparing and submitting the final report. DCR’s Early Clinical Research unit (Phase I-IIa) and Clinical Development network of physicians and investigative sites, Health Economics and Central Laboratory are focused on providing world-class clinical research in both complex/specialty populations and therapeutic areas as well as CKD and ESRD populations needed to meet clinical goals. To learn more about DCR, visit <a href="http://www.davitaclinicalresearch.com" rel="nofollow">http://www.davitaclinicalresearch.com</a>. About DaVita 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 June 30, 2011, DaVita operated or provided administrative services at 1,669 dialysis facilities, serving approximately 131,000 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>. ### Contact Information Media: Vince Hancock (303) 405-2272 <a href="mailto:Vince.hancock@davita.com">Vince.hancock@davita.com</a> BiotechBlog on "HUYA to Collaborate on Pre-clinical and Clinical Studies for Chinese Drugs" http://biotechbistro.com/forum/topic/huya-to-collaborate-on-pre-clinical-and-clinical-studies-for-chinese-drugs#post-10 Mon, 23 Feb 2009 14:48:41 +0000 BiotechBlog 10@http://biotechbistro.com/forum/ San Diego, CA, February 18, 2009 – HUYA Bioscience International, the leader in US/China pharmaceutical co-development, today announced a partnership agreement with the Beijing Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College (collectively – The Beijing Institute of Materia Medica, BIMM). The agreement grants HUYA the opportunity to collaborate with BIMM on pre-clinical safety and efficacy, and clinical trial protocols. The agreement also provides HUYA with the right of first review and negotiation for the licensing and development of certain new compounds owned or controlled by BIMM. This right includes drugs in discovery and development for use in the areas of cardiology, endocrinology, oncology, immunology, hematology, neuroscience and anti-infectives. The agreement represents one of the first official collaborations between a U.S. and a Chinese institution to co-develop multiple pharmaceuticals on an ongoing basis. “HUYA is highly experienced and uniquely positioned in China to leverage the emerging biotech industry through strong collaborations. This is the culmination of years of relationship-building and exchange of knowledge between HUYA and BIMM,” said Mireille Gingras, PhD, CEO, HUYA. “We are proud that the Institute of Materia Medica is our official partner and together we hope to bring new drugs to market.” “For BIMM, our partnership with HUYA signifies an opportunity to bring our expertise and our efforts in pharmaceutical development to the Western market,” said Xiaoling Wang, MD, PhD, Director, BIMM. “We will be working closely with Dr. Gingras and her team to ensure that our study designs mirror FDA and EMEA agency protocol. This is a great opportunity for us and for HUYA as it will enable new pharmaceutical compounds to more efficiently reach a global market.” HUYA currently has two Chinese drugs undergoing preclinical development in the US – HBI-3000 and HBI-8000. Both drugs, for cardiac fibrillation and oncology respectively, have successfully passed US FDA pre-IND consultations. The Institute of Materia Medica is dedicated to discovering and developing treatments for serious diseases by isolating natural remedies and leveraging modern technology to develop therapies based on molecular structure and untapped compounds. HUYA’s innovative co-development model HUYA was one of the first companies to recognize China’s potential to help meet the global need for pre-clinical and clinical stage compounds for the drug development process. Leveraging the HUYA Integrated Co-development Model for partnering with Chinese research institutions and pharmaceutical companies, HUYA identifies and licenses the most promising pre-clinical and clinical stage compounds in China. Through collaborations with its Chinese partners, the company provides a bridge into the Western development process and biopharma market. Compounds are validated through a rigorous discovery, selection and development process in China, streamlining and accelerating development in the West. HUYA’s model relies on longevity of relationships with its Chinese partners to provide a continuous source of compounds rather than a one-time single compound strategy. One of the key differentiators of HUYA’s approach is the assembly of a high-level team of scientific and clinical advisors for each new compound. The team collaborates with its Chinese partners to discuss and design clinical trials as the compounds move through the Chinese and the U.S. development process, speeding the process and mitigating risk. HUYA’s global team of scientist and clinician advisors includes Benedict Lucchesi, PhD MD, Peter R. Kowey, MD, Dennis Roy, MD, Jefferson L. Anderson, MD, Eric J. Topol, MD, and Stanley Nattel, MD, John McHutchison, MD, Alex Adjei, MD, PhD, Alan List, MD, Patricia LoRusso, DO, Jackie Walling, MD, PhD, and Michael Robertson, MD. About HUYA HUYA is the leader in U.S./China pharmaceutical co-development. With three strategic offices in China, the broadest Chinese compound portfolio, and more exclusive agreements with premier Chinese biotech centers than any other company, HUYA has pioneered the most innovative and productive approach for pharmaceutical co-development between the U.S. and China. HUYA has joint headquarter offices in San Diego, CA, and Shanghai. Additional information about the company is available at <a href="http://www.huyabio.com" rel="nofollow">http://www.huyabio.com</a> <http://www.huyabio.com/> . About BIMM The Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College is one of the premier institutions for drug research in China. It was founded in 1958 and now has more than 400 employees, of which approximately 300 have scientific or technical backgrounds. The Institute staff includes more than 100 professors and associate professors, three members of the Chinese Academy of Sciences and two members of the Chinese Academy of Engineering. The main task of the Institute is discovery of new drugs for the treatment of commonly occurring diseases that seriously threaten people’s health. At the same time, emphasis is put on the application and development of modern medical theory and high technology. Since the establishment of the Institute, more than 270 prizes have been awarded for its research achievements and more than 100 new drugs have been developed.