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SAN DIEGO, Feb. 21, 2017 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a three-dimensional biology company focused on delivering scientific and medical breakthroughs using its 3D bioprinting technology, today announced the publication of data in Frontiers in Physiology showing the company’s 3D bioprinted proximal tubule tissue model exhibits key characteristics of renal physiology that allow for in vitro kidney toxicity testing. “Traditional preclinical models often fall short in their ability to inform clinical outcomes accurately, largely due to the limited functionality of simple in vitro models and species differences,” said Dr. Sharon Presnell, chief scientific officer, Organovo.  “Our newly published data demonstrate that Organovo’s 3D bioprinted human kidney tissue has great potential to assess the toxic effects of compounds and the development and progression of complex, multicellular processes such as fibrosis.” Key findings and attributes described in the publication include the following: In addition to the kidney publication, the Company noted a recent article published in ILAR Journal.  The publication explores new technologies that could reduce both dependency on animal models and occurrence of liver toxicity in clinical trials.  The article, written by scientific executives and experts from the Food & Drug Administration (“FDA”), Merck & Co., Inc and LifeNet Health, provides a thorough review of human tissue models and how they can accelerate drug development across all discovery stages, including Organovo’s 3D bioprinted liver model. The authors reference Organovo’s technology as a “significant innovation in the study of drug-induced liver injury, as it addresses many of the shortcomings associated with traditional in vitro culture models and animal models.”  They also state that 3D bioprinted tissues “exhibit a broad range of highly differentiated in vivo like features and functions.” The authors reference results from Organovo’s drug-induced liver injury studies that have shown “very good reproducibility and concordance with observed outcomes in vivo at the functional and histological levels” and that treatment of the bioprinted human liver model with known fibrotic agents “mimicked closely that of patient liver samples with drug-induced fibrosis.” “Both liver and kidney drug toxicities are significant challenges for pharmaceutical companies working to advance safe and effective therapeutics,” said Mr. Keith Murphy, CEO, Organovo. “Previous validation data of our 3D bioprinted human liver tissue, combined with the data published in the peer-reviewed journal, Frontiers of Physiology, on our 3D bioprinted kidney proximal tubule tissue, clearly show that Organovo’s technology can address the unmet needs of our pharma customers and partners by providing timely, cost-effective, and more accurate human tissue models for evaluating drug toxicity and drug-induced fibrotic disease.” Organovo’s publication titled “3D Proximal Tubule Tissues Recapitulate Key Aspects of Renal Physiology to Enable Nephrotoxicity Testing,” was published online on February 15, 2017 and can be found on the journal’s website: http://journal.frontiersin.org/article/10.3389/fphys.2017.00123/abstract The review titled “The Promise of New Technologies to Reduce, Refine, or Replace Animal Use while Reducing Risks of Drug Induced Liver Injury in Pharmaceutical Development,” was published December 31, 2016 and can be found on the journal’s website: https://academic.oup.com/ilarjournal/article-abstract/57/2/186/2806701/The-Promise-of-New-Technologies-to-Reduce-Refine Organovo designs and creates functional, three-dimensional human tissues for use in medical research and therapeutic applications.  The Company develops 3D human tissue models through internal development and in collaboration with pharmaceutical, academic and other partners.  Organovo's 3D human tissues have the potential to accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost.  The Company’s ExVive Human Liver and Kidney Tissues are used in toxicology and other preclinical drug testing.  The Company also actively conducts early research on specific tissues for therapeutic use in direct surgical applications.  In addition to numerous scientific publications, the Company's technology has been featured in The Wall Street Journal, Time Magazine, The Economist, Forbes, and numerous other media outlets.  Organovo is changing the shape of life science research and transforming medical care.  Learn more at www.organovo.com. Forward-Looking Statements Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.  Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties.  The factors that could cause the Company's actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to develop, market and sell products and services based on its technology; the expected benefits and efficacy of the Company's products, services and technology; the Company’s ability to successfully complete studies and provide the technical information required to support market acceptance of its products, services and technology, on a timely basis or at all; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies, including its use of third party distributors; the Company's ability to successfully complete the contracts and recognize the revenue represented by the contracts included in its previously reported total contract bookings and secure additional contracted collaborative relationships; the final results of the Company's preclinical studies may be different from the Company's studies or interim preclinical data results and may not support further clinical development of its therapeutic tissues; the Company may not successfully complete the required preclinical and clinical trials required to obtain regulatory approval for its therapeutic tissues on a timely basis or at all; and the Company’s ability to meet its fiscal year 2017 outlook and/or its long-range outlook.  These and other factors are identified and described in more detail in the Company's filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on June 9, 2016 and its Quarterly Report on Form 10-Q filed with the SEC on February 9, 2017.  You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made.  These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future.  Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances or to reflect the occurrence of unanticipated events.


DUBLIN--(BUSINESS WIRE)--Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat oncology, autoimmune and other inflammatory diseases, today announces the preliminary results from its ongoing prospective, open label Phase I/II study being conducted with OPN-305 in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) which created interest when presented recently at the 58th Annual Meeting of the American Society of Hematology (ASH) in San Diego by Prof Garcia-Manero from the MD Anderson Cancer Center. OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a key target within the innate immune system. Opsona has recently received orphan drug designation from the United States Food and Drug Administration for MDS. The study in patients with lower risk, red cell transfusion dependent, MDS who have failed hypomethylating agents (HMA) ± an erythropoiesis stimulating agent is ongoing in collaboration with MD Anderson Cancer Center in Houston USA with additional sites now being added in the USA. As of December 2016, 24 eligible patients have been enrolled, 11 at 5 mg dose and 13 at 10 mg/kg. A total of 15 (75%) patients are evaluable for response. Hematological improvement has been seen in 53% (8/15) with 3 (20%) patients achieving transfusion independence and of these 2/5 (40%) were receiving 10 mg/kg while on OPN-305 monotherapy. 12 patients remain on study. Median age was 72 years (range 42-87). Nine (43 %) patients were classified as Low risk and 15 (63%) as Intermediate-1 risk by IPSS. Thirteen patients (61%) had diploid cytogenetics, 8 (38%) RAEB,5 (23%) RCMD, 3 (14%) RA, 2 (10%) RARS, and 1 (4%) 5q-, RCMD-RS, CMML. The median number of prior HMA therapies was 2 (range 1-4) with a median duration of prior therapies from time of diagnosis to enrollment of 22.7 months (range 6.3-56.1). The median number of OPN-305 cycles administered is 5 (2-22) with 5 of 9 (55.5%) patients having received azacitidine add-back after 16 weeks of OPN-305 monotherapy. A total of 5 (29%) patients developed AEs related to OPN-305 all grade 1 with gastrointestinal disorders being the most frequent (23.5%). At this point, no significant drug related toxicity or unexpected infectious complications have been seen and combination with azacitidine has been well tolerated. To date three (20%) patients were taken off study due to progression to AML and 4 (27%) due to no response all at the 5 mg/kg dose. There is no evidence of treatment related anti-drug antibodies or statistically significant dynamic changes in cytokines in any of the patients. Myelodysplastic syndromes are a complex and heterogeneous group of bone marrow failure disorders characterized by ineffective hematopoiesis and poor prognosis. There is an urgent need for the development of well tolerated, novel therapies in the treatment of MDS which can delay progression, improve patient survival and quality of life and reduce the social and economic burden of transfusion dependence. Commenting on today’s announcement Mary Reilly VP Pharmaceutical Development & Operations said “OPN-305 data emerging in this heavily pre-treated group of patients is very encouraging, the unmet need for a safe and tolerable product for this patient population is significant and we are happy to be in collaboration with the MD Anderson Cancer Center one of the leading clinical center’s in this hematological area” Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including cancer, autoimmune and other inflammatory diseases. The company was founded in 2004 by three world-renowned immunologists at Trinity College, Dublin. Opsona has a strong international investor consortium including: Amgen Ventures, BB Biotech Ventures, EMBL Ventures, Enterprise Ireland, Fountain Healthcare Partners, Inventages Venture Capital, Novartis Venture Fund, Omnes Capital, Roche Venture Fund, Seroba Life Sciences, Shire and Sunstone Capital.


MIAMI, Feb. 16, 2017 (GLOBE NEWSWIRE) -- The Female Health Company / Veru Healthcare (NASDAQ:FHCO) today announced the appointment of Matthew C. Gosnell, Ph.D., as Senior Vice President of Manufacturing, Preclinical and Pharmaceutical Development, effective February 15, 2017.  Gosnell has a Ph.D. in analytical chemistry and more than 20 years of experience in pharmaceutical manufacturing, development and sourcing.  His experience ranges from preclinical and investigational new drugs (INDs) through 505(b)(2) and 505(b)(1) New Drug Applications (NDAs) and commercialization.  He will be responsible for identifying clinical and commercial manufacturing partners, chemical synthesis and process scale up development, development and clinical trial materials manufacturing and processes, documentation and submissions related to chemistry, manufacturing and control. “An accomplished scientist and drug developer, Dr. Gosnell brings hands-on experience in strategic planning and execution of process development and manufacturing of both early and late stage drug products,” said Mitchell Steiner, M.D., President and Chief Executive Officer of The Female Health Company / Veru Healthcare.  “He has extensive knowledge and expertise in leading multiple projects in various stages of development and identifying and managing new drug manufacturing sites for clinical development and commercial supply.  Over his career, Dr. Gosnell has made significant contributions to several 505(b)(2) and 505(b)(1) NDAs including Celebrex®, Risperdal® Consta® and Vivitrol® and served in senior level positions with GTx, Alkermes, Pharmacia, McNeil Specialty Products (a division of Johnson & Johnson) and Miles (a unit of Bayer AG).” Prior to joining the Company, Dr. Gosnell served as Senior Director, Product Development and Analytical Sciences for GTx, Inc., where he advanced multiple drug candidates into successive clinical stages of development.  Earlier in his career, he was Director, Quality Technical Services (Analytical Development and Stability) for Alkermes, Inc., Analytical Team Leader for Pharmacia Research and Development and Senior Scientist at McNeil Specialty Products Company.  Dr. Gosnell began his career as Scientist with Miles, Inc., after earning a Doctoral degree in Analytical Chemistry from Oklahoma State University and a Bachelor of Science degree in Chemistry and Mathematics-Computer Science from Manchester College. About The Female Health Company / Veru Healthcare The Female Health Company / Veru Healthcare is a pharmaceutical and medical device company, with a focus on the development and commercialization of pharmaceuticals that qualify for the FDA's 505(b)(2) accelerated regulatory approval pathway as well as the 505(b)(1) pathway.  The Company does business both as "Veru Healthcare" and as "The Female Health Company" and is organized as follows: More information about the Female Health Company and its products can be found at www.femalehealth.com, www.veruhealthcare.com and www.femalecondom.org.  For corporate and investor-related information about the Company, please visit www.FHCinvestor.com.


John Lambert, Executive Vice President at ImmunoGen, to present at 2nd Antibody Drug Conjugates Conference. Boston, MA, November 18, 2016 --( John M. Lambert joined ImmunoGen as Senior Director of Research in 1987 and was promoted to Vice President, Research and Development in 1994, to Senior Vice President, Pharmaceutical Development in 2000, to Senior Vice President, Research and Development and Chief Scientific Officer in early 2008, and to Executive Vice President, Research and Development and Chief Scientific Officer in July 2008. In 2014 he was named Distinguished Research Fellow. Prior to his tenure with ImmunoGen, Dr. Lambert was Assistant Professor of Pathology at the Dana-Farber Cancer Institute in Boston, MA. Dr. Lambert received his doctorate in Biochemistry from Cambridge University in England. With the field of antibody drug conjugates rapidly expanding and the increasing number of ADC clinical trials, novel therapeutics are emerging. The ADC therapeutic area combines synthetic chemistry with rationale biology and is advancing monoclonal antibody treatments into the realm of precision medicine with improved effectiveness and therapeutic indices. This event will bring together an exciting balance of industry and academia, so that delegates have the unique opportunity to network with colleagues from different sectors and gain a fresh perspective on the emergence of recent data from ADC clinical trials, new linkers and payloads, personalized healthcare, site specific attachment, and ADC therapeutics. Sessions include: I. Novel Payloads & Linkers in Antibody Drug Conjugates II. Enhancing ADC Efficacy Through Combination Therapy with Immuno-oncology and Other Agents III. Regulatory Trends & Challenges in Antibody Drug Conjugates IV. Preclinical to Clinical Developments in ADC V. Antibody Conjugate Therapeutics in Precision Medicine, Current Developments, and Future Potential Don't miss important insights on how to overcome the many hurdles that are associated with the production of proteins. GTCbio 635 W. Foothill Blvd Monrovia, CA 91016 www.gtcbio.com/ Email: infogtcbio@gtcbio.com Phone: (626) 256-6405 Fax: (626) 466-4433 Boston, MA, November 18, 2016 --( PR.com )-- John Lambert, Executive Vice President at ImmunoGen will give a presentation in the “Antibody Conjugate Therapeutics in Precision Medicine, Current Developments and Future Potential” session at GTCbio’s 2nd Antibody Drug Conjugates conference to be held on December 5-6, 2016 at the Hyatt Regency in Boston, MA.John M. Lambert joined ImmunoGen as Senior Director of Research in 1987 and was promoted to Vice President, Research and Development in 1994, to Senior Vice President, Pharmaceutical Development in 2000, to Senior Vice President, Research and Development and Chief Scientific Officer in early 2008, and to Executive Vice President, Research and Development and Chief Scientific Officer in July 2008. In 2014 he was named Distinguished Research Fellow.Prior to his tenure with ImmunoGen, Dr. Lambert was Assistant Professor of Pathology at the Dana-Farber Cancer Institute in Boston, MA. Dr. Lambert received his doctorate in Biochemistry from Cambridge University in England.With the field of antibody drug conjugates rapidly expanding and the increasing number of ADC clinical trials, novel therapeutics are emerging. The ADC therapeutic area combines synthetic chemistry with rationale biology and is advancing monoclonal antibody treatments into the realm of precision medicine with improved effectiveness and therapeutic indices.This event will bring together an exciting balance of industry and academia, so that delegates have the unique opportunity to network with colleagues from different sectors and gain a fresh perspective on the emergence of recent data from ADC clinical trials, new linkers and payloads, personalized healthcare, site specific attachment, and ADC therapeutics.Sessions include:I. Novel Payloads & Linkers in Antibody Drug ConjugatesII. Enhancing ADC Efficacy Through Combination Therapy with Immuno-oncology and Other AgentsIII. Regulatory Trends & Challenges in Antibody Drug ConjugatesIV. Preclinical to Clinical Developments in ADCV. Antibody Conjugate Therapeutics in Precision Medicine, Current Developments, and Future PotentialDon't miss important insights on how to overcome the many hurdles that are associated with the production of proteins.GTCbio635 W. Foothill BlvdMonrovia, CA 91016www.gtcbio.com/Email: infogtcbio@gtcbio.comPhone: (626) 256-6405Fax: (626) 466-4433 Click here to view the list of recent Press Releases from GTCbio


News Article | November 18, 2016
Site: www.24-7pressrelease.com

BOSTON, MA, November 18, 2016 /24-7PressRelease/ -- John Lambert, Executive Vice President at ImmunoGen will give a presentation in the "Antibody Conjugate Therapeutics in Precision Medicine, Current Developments and Future Potential" session at GTCbio's 2nd Antibody Drug Conjugates conference to be held on December 5-6, 2016 at the Hyatt Regency in Boston, MA. John M. Lambert joined ImmunoGen as Senior Director of Research in 1987 and was promoted to Vice President, Research and Development in 1994, to Senior Vice President, Pharmaceutical Development in 2000, to Senior Vice President, Research and Development and Chief Scientific Officer in early 2008, and to Executive Vice President, Research and Development and Chief Scientific Officer in July 2008. In 2014 he was named Distinguished Research Fellow. Prior to his tenure with ImmunoGen, Dr. Lambert was Assistant Professor of Pathology at the Dana-Farber Cancer Institute in Boston, MA. Dr. Lambert received his doctorate in Biochemistry from Cambridge University in England. With the field of antibody drug conjugates rapidly expanding and the increasing number of ADC clinical trials, novel therapeutics are emerging. The ADC therapeutic area combines synthetic chemistry with rationale biology and is advancing monoclonal antibody treatments into the realm of precision medicine with improved effectiveness and therapeutic indices. This event will bring together an exciting balance of industry and academia, so that delegates have the unique opportunity to network with colleagues from different sectors and gain a fresh perspective on the emergence of recent data from ADC clinical trials, new linkers and payloads, personalized healthcare, site specific attachment, and ADC therapeutics. Sessions include: I. Novel Payloads & Linkers in Antibody Drug Conjugates II. Enhancing ADC Efficacy Through Combination Therapy with Immuno-oncology and Other Agents III. Regulatory Trends & Challenges in Antibody Drug Conjugates IV. Preclinical to Clinical Developments in ADC V. Antibody Conjugate Therapeutics in Precision Medicine, Current Developments, and Future Potential Don't miss important insights on how to overcome the many hurdles that are associated with the production of proteins. GTCbio 635 W. Foothill Blvd Monrovia, CA 91016 http://www.gtcbio.com/ Email: infogtcbio@gtcbio.com Phone: (626) 256-6405 Fax: (626) 466-4433


News Article | December 21, 2016
Site: www.prweb.com

FierceMarkets (http://www.fiercemarkets.com) today announced the winners of its inaugural Fierce Innovation Awards: Life Sciences Edition. The goal of the program is to identify and showcase outstanding innovation that is driving improvements and transforming the biotech, digital health, and pharma industries. Rebecca Willumson, Publisher of FierceBiotech and FiercePharma, said, “We were overwhelmed by the response to our inaugural awards program. Almost 200 applications were received and judges commented that the technology presented and the quality of applications was very impressive. The winners truly embody products and services that are forward thinking and have the greatest opportunity to have a big impact on our industry.” Winners were announced across 5 distinct categories. The judges ultimately selected 3 companies and their solutions from the pool of individual category winners for special recognition as “Best in Show” winners. Honorees were selected by a distinguished panel of judges from Amgen, Medidata, Otsuka Pharmaceuticals, Pharmaceutical Development Group, PPD, PwC, Thread Research, Valeo Partners, and Verily. More information about our judges can be found here. Judges evaluated submissions based on Effectiveness, Technical Innovation, Competitive Advantage, Financial Impact and True Innovation. Digital Health Solution: ContextMedia for The Digital Exam Room Wallboard, Infusion Room Tablet and Patient Mobile Connect The Best in Show Winners are: Best New Product or Service Recursion Pharmaceuticals for Computationally Intelligent Phenotypic Screening Platform At FierceMarkets, our mission is as clear today as it was at our founding in 2000: be the first place to turn to for information-hungry executives in dynamic industries and a trusted partner for the marketing teams that need to reach them. Back then, we saw the coming power of blogs, web journalism, digital marketing and email communications, and launched our first email newsletter, FierceWireless, to begin fulfilling that mission for the mobile telecommunications industry. Today, our family of over 100 email newsletter publications and websites carries out that same mission for many more industries and millions of users, while we also evolve to address the latest trends in digital media -- mobile devices, social media, native advertising and content marketing. Regardless of what the next trend may be, however, we remain fiercely committed to independent insights for our readers and marketing success for our customers. Learn more at: http://www.fiercemarkets.com .


News Article | November 3, 2016
Site: phys.org

A team headed by scientists from the Department of Biosystems at ETH Zurich in Basel has developed a cell culture technology platform for testing interactions between chemical and pharmaceutical compounds and three-dimensional body tissue samples. While conventional cell culture experiments are performed using a two-dimensional cell layer in a petri dish, the new technology relies on a chip that accommodates small three-dimensional tissue spheroids that are barely half a millimetre in diameter. "The three-dimensional microtissues better mimic organ tissue behaviour in a living body in comparison to conventional cell cultures and thus provide more meaningful results," says Olivier Frey, who is senior assistant in ETH Professor Andreas Hierlemann's lab and was largely responsible for developing the new method. Another unique feature of the new technology is that scientists are able to combine spheroids made from different tissues in one chip so that they can easily test compound interactions and impact on various tissue types. More complex experiments now possible More specifically, the new technology will allow scientists to test the efficacy of compounds to see, for example, whether a potential cancer drug inhibits the growth of tumour cells. By combining tumour and liver tissue in a single chip, researchers are additionally able to test whether the hepatic metabolism decreases or enhances the activity of the active agent, and whether the respective agent is toxic to the liver. In addition to testing drug candidates, it may also be possible to use the newly developed technology in personalised medicine. In addition to combining cancer and liver tissues, which scientists have tested in their proof-of-concept study, other tissue combinations are conceivable. Researchers are now planning to work on a system including microtissues of organs affected by diabetes: pancreas and liver. In contrast to conventional cell culture experiments, the microtissue-based method is useful for providing more comprehensive answers to complex biomedical questions, many of which required animal experiments up to now. The technology offers the potential to reduce the number of animal experiments in biomedical research. On 2 November, an international panel of experts therefore awarded the consortium around the ETH scientists the Global 3Rs Award/Europe, an international prize for research efforts to reduce animal experiments (see box). This is the second prize of this type that goes to the research group; in 2014 the group received an award from the UK-based National Centre for the Replacement, Refinement & Reduction of Animals in Research for an alternative system. The new technology was developed as part of an EU research project called "Body on a Chip", which was coordinated by the ETH spinoff Insphero and which involved other European project partners. The name "Body on a Chip" alludes to the term "Lab on a Chip", which describes miniaturised laboratory analysis platforms. The main features of the cell culture chips developed by the ETH scientists include four (or six in the latest chip generation) wells in which tissue spheroids are placed and two reservoirs for the nutrient medium. A microchannel connects all wells and the reservoirs. Rocking or tilting motions of the chip or well plate slightly move the tissue spheroids and enable continuous perfusion and supply of nutrients and dosage of compounds. The new technology is currently being used in a project supported by the Swiss Federation's Commission for Technology and Innovation (CTI) in collaboration with Insphero and the pharmaceutical company Roche. "If this test phase in industry is successful, it will be possible to think about marketing the device," says ETH professor Hierlemann. Efforts towards a more humane, ethical handling of laboratory animals are often subsumed under the term "3R". The three Rs stand for "replacement" (replacing animal testing with experiments that do not require animals), "reduction" (reducing the number of animals that are used for testing) and "refinement" (limiting the impact on the animals during a trial along with better experimental planning). More and more organisations on the national and international level are stepping forward to support these principles, including the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International), which confers the Global 3Rs Awards in cooperation with the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ). Explore further: Mimicking the body on a chip for new drug testing More information: Jin-Young Kim et al, 3D spherical microtissues and microfluidic technology for multi-tissue experiments and analysis, Journal of Biotechnology (2015). DOI: 10.1016/j.jbiotec.2015.01.003


News Article | November 3, 2016
Site: www.eurekalert.org

A team headed by scientists from the Department of Biosystems at ETH Zurich in Basel has developed a cell culture technology platform for testing interactions between chemical and pharmaceutical compounds and three-dimensional body tissue samples. While conventional cell culture experiments are performed using a two-dimensional cell layer in a petri dish, the new technology relies on a chip that accommodates small three-dimensional tissue spheroids that are barely half a millimetre in diameter. "The three-dimensional microtissues better mimic organ tissue behaviour in a living body in comparison to conventional cell cultures and thus provide more meaningful results," says Olivier Frey, who is senior assistant in ETH Professor Andreas Hierlemann's lab and was largely responsible for developing the new method. Another unique feature of the new technology is that scientists are able to combine spheroids made from different tissues in one chip so that they can easily test compound interactions and impact on various tissue types. More specifically, the new technology will allow scientists to test the efficacy of compounds to see, for example, whether a potential cancer drug inhibits the growth of tumour cells. By combining tumour and liver tissue in a single chip, researchers are additionally able to test whether the hepatic metabolism decreases or enhances the activity of the active agent, and whether the respective agent is toxic to the liver. In addition to testing drug candidates, it may also be possible to use the newly developed technology in personalised medicine. In addition to combining cancer and liver tissues, which scientists have tested in their proof-of-concept study, other tissue combinations are conceivable. Researchers are now planning to work on a system including microtissues of organs affected by diabetes: pancreas and liver. In contrast to conventional cell culture experiments, the microtissue-based method is useful for providing more comprehensive answers to complex biomedical questions, many of which required animal experiments up to now. The technology offers the potential to reduce the number of animal experiments in biomedical research. On 2 November, an international panel of experts therefore awarded the consortium around the ETH scientists the Global 3Rs Award/Europe, an international prize for research efforts to reduce animal experiments (see box). This is the second prize of this type that goes to the research group; in 2014 the group received an award from the UK-based National Centre for the Replacement, Refinement & Reduction of Animals in Research for an alternative system. The new technology was developed as part of an EU research project called "Body on a Chip", which was coordinated by the ETH spinoff Insphero and which involved other European project partners. The name "Body on a Chip" alludes to the term "Lab on a Chip", which describes miniaturised laboratory analysis platforms. The main features of the cell culture chips developed by the ETH scientists include four (or six in the latest chip generation) wells in which tissue spheroids are placed and two reservoirs for the nutrient medium. A microchannel connects all wells and the reservoirs. Rocking or tilting motions of the chip or well plate slightly move the tissue spheroids and enable continuous perfusion and supply of nutrients and dosage of compounds. The new technology is currently being used in a project supported by the Swiss Federation's Commission for Technology and Innovation (CTI) in collaboration with Insphero and the pharmaceutical company Roche. "If this test phase in industry is successful, it will be possible to think about marketing the device," says ETH professor Hierlemann. Efforts towards a more humane, ethical handling of laboratory animals are often subsumed under the term "3R". The three Rs stand for "replacement" (replacing animal testing with experiments that do not require animals), "reduction" (reducing the number of animals that are used for testing) and "refinement" (limiting the impact on the animals during a trial along with better experimental planning). More and more organisations on the national and international level are stepping forward to support these principles, including the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International), which confers the Global 3Rs Awards in cooperation with the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ). Kim JY, Fluri DA, Marchan R, Boonen K, Mohanty S, Singh P, Hammad S, Landuyt B, Hengstler JG, Kelm JM, Hierlemann A, Frey O: 3D spherical microtissues and microfluidic technology for multi-tissue experiments and analysis. Journal of Biotechnology 2015. 205: 24-35, doi: 10.1016/j.jbiotec.2015.01.003


News Article | November 29, 2016
Site: www.marketwired.com

2016 saw more industry recognition and new lines of business NEWBURYPORT, MA--(Marketwired - Nov 29, 2016) - PCI Synthesis, Inc. (www.pcisynthesis.com), a drug substance Contract Manufacturing Organization (CMO) of new chemical entities (NCEs) and generic active pharmaceutical ingredients (APIs), announced that it won the 2016 Healthcare and Pharmaceutical Award for "Best NCE Manufacturer". Conducted by Global Health & Pharma (GHP), a global information sharing platform & a multi-disciplinary community of more than 260,000 readers, the Healthcare & Pharmaceuticals Awards seek to spotlight the talent and dedication of the individuals, departments and organizations that work tirelessly throughout the industry. GHP established "the awards (to) recognize all levels and all aspects of the healthcare and pharmaceutical sectors, choosing to focus not just on the obvious candidates -- the practitioners and scientists at the cutting edge of these rapidly evolving industries -- but also on the supporting cast ... without whom many of the life-changing innovations and developments we see on an almost daily basis would simply not be possible." PCI Synthesis, which provides small and mid-sized companies with the expertise to manufacture complex small molecules to be used as APIs, offers three class 100,000 cGMP suites for pre-clinical and clinical manufacturing and 23 reactors with a total of 20,000 gallons of manufacturing capacity. "This award, along with the eight CMO Leadership Awards that we've won over the past few years, continues to validate our approach," said Edward S. Price, President of PCI Synthesis. "We spend a lot of time and money staying abreast of the latest technologies, processes, and FDA guidelines, but being named Best NCE Manufacturer is a tribute to our skilled and dedicated staff, who provide our emerging pharma customers with the expertise to manufacture complex small molecules as part of drug discovery and development." PCI Synthesis also announced the formation of its cGMP Advanced Polymer Development and Manufacturing Group, which is currently developing and manufacturing more than a dozen advanced polymer-based projects. As the largest independent cGMP-equipped CMO in New England, the company's advanced polymer-based materials development and manufacturing capability significantly expands the company's customer base and reach within this growing market. Earlier this year, PCI Synthesis obtained registration and certification from the U.S. Drug Enforcement Administration (DEA) to handle Schedule II, III, IV and V controlled substances. About PCI Synthesis PCI Synthesis is a Pharmaceutical Development CMO (Contract Manufacturing Organization) based in Newburyport, MA and is the largest small molecule drug substance manufacturer in the New England area. PCI is also a commercial manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products for the medical device industry. As a contract manufacturing organization (CMO), PCI provides emerging and mid-sized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules. To learn more about PCI Synthesis, its proprietary NCE development activities and process R&D capabilities please visit www.pcisynthesis.com.


News Article | December 19, 2016
Site: www.marketwired.com

Tighter capacity, more consolidation and unknown regulatory impact of FDA will affect the sector NEWBURYPORT, MA--(Marketwired - Dec 19, 2016) - PCI Synthesis, Inc. (www.pcisynthesis.com), a pharmaceutical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products, issued its annual list of trends that will affect the emerging biotech and generic drug sectors, as well as Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) in 2017. "We see the potential for significant change in 2017, including a possible reduction in FDA red tape, tighter capacity because of the industry's current growth, and a speedier FDA approval process that could reduce its backlog by the end of next year. But we also expect significant uncertainty due to the new administration," said Ed Price, president of PCI Synthesis. "To successfully navigate the uncertainty, which includes a promise to reduce drug prices, companies need to remain agile and creative to find ways to keep down costs." Here is the list of trends that will impact the industry next year: About PCI Synthesis PCI Synthesis is a Pharmaceutical Development CMO (Contract Manufacturing Organization) based in Newburyport, MA and is the largest small molecule drug substance manufacturer in the New England area. PCI is also a commercial manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products for the medical device industry. As a contract manufacturing organization (CMO), PCI provides emerging and mid-sized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules. To learn more about PCI Synthesis, its proprietary NCE development activities and process R&D capabilities please visit www.pcisynthesis.com.

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