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The Feldan Shuttle technology is a novel peptide-based delivery method that enables the highly efficient introduction of foreign proteins into cells. Elasmogen's soloMER's are the smallest naturally occurring binding domains. Their small size and robust nature, particularly the resistance to changes in pH and ability to bind in intracellular conditions makes them the perfect complement to Feldan's technology. "Currently all approved biologic antibody therapeutics act on extracellular targets but intracellular delivery enables access to a much greater number of targets," said François-Thomas Michaud, CEO, Feldan Therapeutics. "Intracellular delivery and binding of biologics can bridge the gap between small molecules and biologics." "This is an exciting opportunity to demonstrate the performance and capabilities of the combined Shuttle-soloMER technology. The expertise provided by Amgen will significantly accelerate the development of this potential new class of therapeutics," said Caroline Barelle, CEO, Elasmogen. In 2016, Feldan and Elasmogen established an exclusive partnership for the development of intracellular biologics. Working together, their research teams have demonstrated both intracellular and intranuclear delivery of soloMER binding domains. Elasmogen, a spin-out from the University of Aberdeen, is a drug discovery and development, biopharmaceutical company developing soloMERs, fully humanized, next generation, single chain biologics for auto-inflammatory diseases, ophthalmology, oncology and intracellular delivery. soloMERs are proprietary humanized clinical candidates derived from VNARS (variable new-antigen receptors) which exist naturally in sharks as high affinity binding domains. With a different ancestral origin from antibodies this example of 400 million year old convergent evolution places VNARs outside of the complex patent landscape that describes and protects antibody drug discovery. soloMERs are the smallest (9% of the size of an antibody) and most robust naturally occurring binding domain which makes them ideal for binding to intracellular targets. The Company's technology has been endorsed through partnerships with Almac, Amgen and Merck. Elasmogen is unique in its capacity to isolate and develop soloMERs, with a multi-layered IP position covering the platform, products and process including an exclusive license to over 20 patents granted in the US, Europe and other territories together with the entire know-how and VNAR pipeline from the Scottish Biologics Facility, University of Aberdeen. More information is available at www.Elasmogen.com Feldan Therapeutic is a Canadian company dedicated to the development of regenerative medicine therapeutic applications based on the Feldan Shuttle platform, a breakthrough peptide-based delivery method that allows the introduction of foreign proteins inside cells. The Feldan Shuttle overcomes delivery obstacles in therapeutic context by providing a safe and highly efficient approach that alleviates manipulation complexity and that is associated with low regulatory burden. The Shuttle platform has been successfully used to transfer active nucleases and transcription factors inside several types of cells; moreover, preliminary results in rodents suggest that the Shuttle has a promising potential for in vivo applications. Work is currently ongoing to further develop the Shuttle technology in order to promote the internalization of antibodies (or antibody-like domains) to modulate cellular pathways. In addition, Feldan has an in-house therapeutic pipeline centered on the generation of hyperactive NK cells for oncology applications. More information is available at www.feldan.com


The Feldan Shuttle technology is a novel peptide-based delivery method that enables the highly efficient introduction of foreign proteins into cells. Elasmogen's soloMER's are the smallest naturally occurring binding domains. Their small size and robust nature, particularly the resistance to changes in pH and ability to bind in intracellular conditions makes them the perfect complement to Feldan's technology. "Currently all approved biologic antibody therapeutics act on extracellular targets but intracellular delivery enables access to a much greater number of targets," said François-Thomas Michaud, CEO, Feldan Therapeutics. "Intracellular delivery and binding of biologics can bridge the gap between small molecules and biologics." "This is an exciting opportunity to demonstrate the performance and capabilities of the combined Shuttle-soloMER technology. The expertise provided by Amgen will significantly accelerate the development of this potential new class of therapeutics," said Caroline Barelle, CEO, Elasmogen. In 2016, Feldan and Elasmogen established an exclusive partnership for the development of intracellular biologics. Working together, their research teams have demonstrated both intracellular and intranuclear delivery of soloMER binding domains. Elasmogen, a spin-out from the University of Aberdeen, is a drug discovery and development, biopharmaceutical company developing soloMERs, fully humanized, next generation, single chain biologics for auto-inflammatory diseases, ophthalmology, oncology and intracellular delivery. soloMERs are proprietary humanized clinical candidates derived from VNARS (variable new-antigen receptors) which exist naturally in sharks as high affinity binding domains. With a different ancestral origin from antibodies this example of 400 million year old convergent evolution places VNARs outside of the complex patent landscape that describes and protects antibody drug discovery. soloMERs are the smallest (9% of the size of an antibody) and most robust naturally occurring binding domain which makes them ideal for binding to intracellular targets. The Company's technology has been endorsed through partnerships with Almac, Amgen and Merck. Elasmogen is unique in its capacity to isolate and develop soloMERs, with a multi-layered IP position covering the platform, products and process including an exclusive license to over 20 patents granted in the US, Europe and other territories together with the entire know-how and VNAR pipeline from the Scottish Biologics Facility, University of Aberdeen. More information is available at www.Elasmogen.com Feldan Therapeutic is a Canadian company dedicated to the development of regenerative medicine therapeutic applications based on the Feldan Shuttle platform, a breakthrough peptide-based delivery method that allows the introduction of foreign proteins inside cells. The Feldan Shuttle overcomes delivery obstacles in therapeutic context by providing a safe and highly efficient approach that alleviates manipulation complexity and that is associated with low regulatory burden. The Shuttle platform has been successfully used to transfer active nucleases and transcription factors inside several types of cells; moreover, preliminary results in rodents suggest that the Shuttle has a promising potential for in vivo applications. Work is currently ongoing to further develop the Shuttle technology in order to promote the internalization of antibodies (or antibody-like domains) to modulate cellular pathways. In addition, Feldan has an in-house therapeutic pipeline centered on the generation of hyperactive NK cells for oncology applications. More information is available at www.feldan.com


Dublin, May 08, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global Emerging Cancer Diagnostics (Tumor Biomarker Test) Market Analysis & Forecast 2017-2023 (Focus on Biomarker Test Type, Application & Market Trends)" report to their offering. This report is focused on emerging cancer diagnostics market specifically on biomarker tumor test. The market growth is propelled due to factors such as: increasing number of cancer cases, technological innovation and advancements, increasing awareness among people, and medicare & reimbursement policies, among others. This study includes an overview and analysis of the emerging cancer diagnostics market, by test type, applications, and geography, allowing the research to develop a comprehensive outlook of the market. The market report presents a detailed and analytical study of the entire market and provides a comprehensive insight into various forms of developments, trends and key participants. The type of cancer, their incidence and prevalence rate has been discussed in the report. While highlighting the key driving and restraining forces for this dynamic market, the report also provides a comprehensive section of the prominent consortiums, associations, and regulatory bodies, and their involvement in the emerging cancer diagnostics market. The answers to the following key questions can be found in the report: - What are the major drivers, challenges and opportunities of the tumor biomarker test market and their use cases? - How is the tumor biomarker test market evolving? - What are the market shares of the leading segments of the tumor biomarker test market in 2015? - How will each test of the tumor biomarker test grow over the forecast period and how much revenue will these account for in 2023? - How will the market shares of the leading national markets change by 2023 and which country will lead the market in 2023? - How the industry will evolve during the forecast period between 2017 and 2023? - What are the key developmental strategies implemented in different applications across all regions? - How will the key market players leverage on key developments such as mergers & acquisitions, partnerships, and product launches among others? - Which geographical region will lead the global tumor biomarker test market by the end of the forecast period? - Who are the key players in the tumor biomarker test market? - What are different application in this market and how are they categorized? - What are the market trends and key developments in different geographical regions? - What are all market available cancer biomarker test? - What is the current market size and future projection for emerging cancer technologies in the major countries? - What are the key sources of information about emerging cancer technologies? - What is the incidence rate of major cancer type? Key Topics Covered: Executive Summary 1 The Research Scope and Methodology 2 Introduction to Global Emerging Cancer Diagnostics Market 2.1 Overview 2.2 Analysis of Lifestyle Factors 2.2.1 Obesity/Weight 2.2.2 Physical Activity 2.2.3 Food Habits 2.2.4 Alcohol & Cancer 2.2.4.1 Countries with Highest Consumption of Alcoholic Drinks 2.2.5 Salt Consumption 2.2.6 Breastfeeding 2.3 High and Low Developed Countries 2.3.1 Men 2.3.2 Women 2.4 Data for Cancer Frequency by Country 2.4.1 Men 2.4.2 Women 2.5 Worldwide Cancer Data 2.5.1 Men 2.5.2 Women 3 Market Dynamics 3.1 Market Drivers 3.1.1 Increase in Prevalence Rate of Cancer 3.1.2 Increase in Sedentary Lifestyles 3.1.3 Robust Technological Advancement 3.1.4 Environmental Hazards 3.1.4.1 Five Primary Categories of Carcinogens are: - 3.1.5 Government Initiatives and Investment 3.2 Market Challenges 3.2.1 High Capital Investment 3.2.2 Dearth of Skilled Professionals 3.2.3 Lack of Awareness 3.3 Market Opportunities 3.3.1 Nanotechnology Applications in Cancer 3.3.2 3D Printing in Cancer Diagnostics 3.3.3 Robotics in Cancer Diagnostics and Treatment 3.3.4 Fluid Biopsy 3.3.5 Real Time Cancer Diagnostic iKnife 4 Competitive Insights 4.1 Key Market Developments & Strategies 4.1.1 Product Launch and Development 4.1.2 Collaborations, Joint Ventures & Partnerships 4.1.3 Business Expansion and Contracts 4.1.4 Patents, Approvals and Certifications 4.1.5 Mergers and Acquisitions 4.1.6 Other Strategies 4.2 Industry Attractiveness 4.3 Global Market Share Analysis 4.3.1 Market Share Analysis 5 Industry Analysis 5.1 Patent Analysis 5.2 Consortiums, Associations and Regulatory Bodies 6 Global Emerging Cancer Diagnostics (Tumor Biomarker Test) Market, Analysis and Forecast 6.1 Assumptions & Limitations for Analysis and Forecast 6.2 Market Overview 6.3 Global Emerging Cancer Diagnostics Market by Tumor Biomarker Test 6.3.1 Prostate Specific Antigen Tests 6.3.2 CTC Tests 6.3.3 Alpha-Fetoprotein (AFP) Tests 6.3.4 CA Test 6.3.4.1 CA 19-9 Tests 6.3.4.2 CA 125 Tests 6.3.5 HER2 Tests 6.3.6 BRCA Test 6.3.7 Anaplastic Lymphoma Kinase (ALK) Tests 6.3.8 EGFR Mutation Tests 6.3.9 KRAS Test 6.3.10 Others 6.3.10.1 National Rental Affordability Scheme (NRAS) Testing 6.3.10.2 RET Gene Testing 6.3.10.3 ROS Testing 6.3.10.4 PIK3CA Tests 6.4 Global Emerging Cancer Diagnostics Market by Application 6.4.1 Lung Cancer 6.4.2 Breast Cancer 6.4.3 Colorectal 6.4.4 Prostate Cancer 6.4.5 Blood Cancer 6.4.5.1 Leukaemia 6.4.5.2 Lymphoma 6.4.5.3 Myeloma 6.4.6 Others 6.5 Global Emerging Technologies in Cancer Diagnostics Market by Geography 7 Company Profiles - Abbott Laboratories, Inc - LabCorp Of America Holdings - Luminex Corporation - Myriad Genetics Inc - NanoString Technologies Inc - Neo Genomics Inc - Quest Diagnostics Incorporated - Qiagen, Inc - Roche Holding AG-BR - Siemens Healthineers - Thermo Fisher Scientific - Agilent Technologies - Biotheranostics, Inc - Almac group - GeneNews Limited (formerly ChondroGene Limited) - Rosetta Genomics - Epigenomics - Exact Sciences Corporation - Ignyta,Inc - Interpace Diagnostics - Leica Biosystems - BioTime, Inc - Pathway Genomics - Sysmex Corporation - AstraZeneca - Becton Dickinson & Co - Biocept Inc - Cancer Genetics Inc - Danaher Corporation - Foundation Medicine Inc - Illumina Inc For more information about this report visit http://www.researchandmarkets.com/research/d3w5r6/global_emerging


Dublin, May 08, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global Emerging Cancer Diagnostics (Tumor Biomarker Test) Market Analysis & Forecast 2017-2023 (Focus on Biomarker Test Type, Application & Market Trends)" report to their offering. This report is focused on emerging cancer diagnostics market specifically on biomarker tumor test. The market growth is propelled due to factors such as: increasing number of cancer cases, technological innovation and advancements, increasing awareness among people, and medicare & reimbursement policies, among others. This study includes an overview and analysis of the emerging cancer diagnostics market, by test type, applications, and geography, allowing the research to develop a comprehensive outlook of the market. The market report presents a detailed and analytical study of the entire market and provides a comprehensive insight into various forms of developments, trends and key participants. The type of cancer, their incidence and prevalence rate has been discussed in the report. While highlighting the key driving and restraining forces for this dynamic market, the report also provides a comprehensive section of the prominent consortiums, associations, and regulatory bodies, and their involvement in the emerging cancer diagnostics market. The answers to the following key questions can be found in the report: - What are the major drivers, challenges and opportunities of the tumor biomarker test market and their use cases? - How is the tumor biomarker test market evolving? - What are the market shares of the leading segments of the tumor biomarker test market in 2015? - How will each test of the tumor biomarker test grow over the forecast period and how much revenue will these account for in 2023? - How will the market shares of the leading national markets change by 2023 and which country will lead the market in 2023? - How the industry will evolve during the forecast period between 2017 and 2023? - What are the key developmental strategies implemented in different applications across all regions? - How will the key market players leverage on key developments such as mergers & acquisitions, partnerships, and product launches among others? - Which geographical region will lead the global tumor biomarker test market by the end of the forecast period? - Who are the key players in the tumor biomarker test market? - What are different application in this market and how are they categorized? - What are the market trends and key developments in different geographical regions? - What are all market available cancer biomarker test? - What is the current market size and future projection for emerging cancer technologies in the major countries? - What are the key sources of information about emerging cancer technologies? - What is the incidence rate of major cancer type? Key Topics Covered: Executive Summary 1 The Research Scope and Methodology 2 Introduction to Global Emerging Cancer Diagnostics Market 2.1 Overview 2.2 Analysis of Lifestyle Factors 2.2.1 Obesity/Weight 2.2.2 Physical Activity 2.2.3 Food Habits 2.2.4 Alcohol & Cancer 2.2.4.1 Countries with Highest Consumption of Alcoholic Drinks 2.2.5 Salt Consumption 2.2.6 Breastfeeding 2.3 High and Low Developed Countries 2.3.1 Men 2.3.2 Women 2.4 Data for Cancer Frequency by Country 2.4.1 Men 2.4.2 Women 2.5 Worldwide Cancer Data 2.5.1 Men 2.5.2 Women 3 Market Dynamics 3.1 Market Drivers 3.1.1 Increase in Prevalence Rate of Cancer 3.1.2 Increase in Sedentary Lifestyles 3.1.3 Robust Technological Advancement 3.1.4 Environmental Hazards 3.1.4.1 Five Primary Categories of Carcinogens are: - 3.1.5 Government Initiatives and Investment 3.2 Market Challenges 3.2.1 High Capital Investment 3.2.2 Dearth of Skilled Professionals 3.2.3 Lack of Awareness 3.3 Market Opportunities 3.3.1 Nanotechnology Applications in Cancer 3.3.2 3D Printing in Cancer Diagnostics 3.3.3 Robotics in Cancer Diagnostics and Treatment 3.3.4 Fluid Biopsy 3.3.5 Real Time Cancer Diagnostic iKnife 4 Competitive Insights 4.1 Key Market Developments & Strategies 4.1.1 Product Launch and Development 4.1.2 Collaborations, Joint Ventures & Partnerships 4.1.3 Business Expansion and Contracts 4.1.4 Patents, Approvals and Certifications 4.1.5 Mergers and Acquisitions 4.1.6 Other Strategies 4.2 Industry Attractiveness 4.3 Global Market Share Analysis 4.3.1 Market Share Analysis 5 Industry Analysis 5.1 Patent Analysis 5.2 Consortiums, Associations and Regulatory Bodies 6 Global Emerging Cancer Diagnostics (Tumor Biomarker Test) Market, Analysis and Forecast 6.1 Assumptions & Limitations for Analysis and Forecast 6.2 Market Overview 6.3 Global Emerging Cancer Diagnostics Market by Tumor Biomarker Test 6.3.1 Prostate Specific Antigen Tests 6.3.2 CTC Tests 6.3.3 Alpha-Fetoprotein (AFP) Tests 6.3.4 CA Test 6.3.4.1 CA 19-9 Tests 6.3.4.2 CA 125 Tests 6.3.5 HER2 Tests 6.3.6 BRCA Test 6.3.7 Anaplastic Lymphoma Kinase (ALK) Tests 6.3.8 EGFR Mutation Tests 6.3.9 KRAS Test 6.3.10 Others 6.3.10.1 National Rental Affordability Scheme (NRAS) Testing 6.3.10.2 RET Gene Testing 6.3.10.3 ROS Testing 6.3.10.4 PIK3CA Tests 6.4 Global Emerging Cancer Diagnostics Market by Application 6.4.1 Lung Cancer 6.4.2 Breast Cancer 6.4.3 Colorectal 6.4.4 Prostate Cancer 6.4.5 Blood Cancer 6.4.5.1 Leukaemia 6.4.5.2 Lymphoma 6.4.5.3 Myeloma 6.4.6 Others 6.5 Global Emerging Technologies in Cancer Diagnostics Market by Geography 7 Company Profiles - Abbott Laboratories, Inc - LabCorp Of America Holdings - Luminex Corporation - Myriad Genetics Inc - NanoString Technologies Inc - Neo Genomics Inc - Quest Diagnostics Incorporated - Qiagen, Inc - Roche Holding AG-BR - Siemens Healthineers - Thermo Fisher Scientific - Agilent Technologies - Biotheranostics, Inc - Almac group - GeneNews Limited (formerly ChondroGene Limited) - Rosetta Genomics - Epigenomics - Exact Sciences Corporation - Ignyta,Inc - Interpace Diagnostics - Leica Biosystems - BioTime, Inc - Pathway Genomics - Sysmex Corporation - AstraZeneca - Becton Dickinson & Co - Biocept Inc - Cancer Genetics Inc - Danaher Corporation - Foundation Medicine Inc - Illumina Inc For more information about this report visit http://www.researchandmarkets.com/research/d3w5r6/global_emerging


Under the terms of the license agreement, Almac Discovery has granted exclusive global rights to its Wee-1 patent families and related subject matter expertise to Debiopharm International SA. Almac Discovery is eligible to receive an upfront payment with further development and commercial milestone payments in addition to receiving royalties from Debiopharm. The area of DNA damage response and cell cycle regulation has seen notable activity from the pharmaceutical industry recently, including some high profile drug approvals for cell cycle kinase inhibitors. Many cancer treatments such as radiation, antimetabolites, alkylating agents, DNA topoisomerase inhibitors and platinum compounds damage DNA in cells. The cellular response is to arrest the cell cycle temporarily to allow for DNA repair, hence reducing the efficacy of chemotherapy. The Wee-1 kinase is a key regulator of a number of cell cycle checkpoints and inhibition of Wee1 can force arrested cells through the cell cycle leading to cell death. The Almac Discovery Wee-1 inhibitors exhibit good drug-like properties, high potency, excellent selectivity and demonstrate potent anti-proliferative activity in vitro and in vivo, both as single agents and in combination with genotoxics, in several cancer models. "We are thrilled to pursue the outstanding work of Almac Discovery on this promising target," said Dr. Bertrand Ducrey, CEO of Debiopharm International SA, who added "Almac Discovery's compelling expertise in medicinal chemistry and drug discovery is very complementary with Debiopharm business model and we look forward to developing these compounds to offer an innovative treatment for patients with high medical need." Dr Stephen Barr, Managing Director & President, Almac Discovery commented, "We are extremely pleased to announce this agreement with Debiopharm who have proven expertise and an impressive track record of developing drug candidates. The professionalism, dedication and commitment of their team is aligned perfectly with our own core values making them the number one choice to develop our Wee-1 inhibitor. Agreements of this nature enable both companies to continue to strive to improve human health worldwide and we look forward to working with them." Almac Discovery is a research driven oncology company dedicated to the discovery and development of novel and innovative approaches to the treatment of cancer. Almac Discovery focuses on the discovery to preclinical stage seeking to license programs early with a pharmaceutical partner for further development. For more information, please visit http://www.almacgroup.com/discovery or e-mail media@almacgroup.com Part of Debiopharm Group™ - a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management - Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide. For more information, please visit http://www.debiopharm.com We are on Twitter. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews


Under the terms of the license agreement, Almac Discovery has granted exclusive global rights to its Wee-1 patent families and related subject matter expertise to Debiopharm International SA. Almac Discovery is eligible to receive an upfront payment with further development and commercial milestone payments in addition to receiving royalties from Debiopharm. The area of DNA damage response and cell cycle regulation has seen notable activity from the pharmaceutical industry recently, including some high profile drug approvals for cell cycle kinase inhibitors. Many cancer treatments such as radiation, antimetabolites, alkylating agents, DNA topoisomerase inhibitors and platinum compounds damage DNA in cells. The cellular response is to arrest the cell cycle temporarily to allow for DNA repair, hence reducing the efficacy of chemotherapy. The Wee-1 kinase is a key regulator of a number of cell cycle checkpoints and inhibition of Wee1 can force arrested cells through the cell cycle leading to cell death. The Almac Discovery Wee-1 inhibitors exhibit good drug-like properties, high potency, excellent selectivity and demonstrate potent anti-proliferative activity in vitro and in vivo, both as single agents and in combination with genotoxics, in several cancer models. "We are thrilled to pursue the outstanding work of Almac Discovery on this promising target," said Dr. Bertrand Ducrey, CEO of Debiopharm International SA, who added "Almac Discovery's compelling expertise in medicinal chemistry and drug discovery is very complementary with Debiopharm business model and we look forward to developing these compounds to offer an innovative treatment for patients with high medical need." Dr Stephen Barr, Managing Director & President, Almac Discovery commented, "We are extremely pleased to announce this agreement with Debiopharm who have proven expertise and an impressive track record of developing drug candidates. The professionalism, dedication and commitment of their team is aligned perfectly with our own core values making them the number one choice to develop our Wee-1 inhibitor. Agreements of this nature enable both companies to continue to strive to improve human health worldwide and we look forward to working with them." Almac Discovery is a research driven oncology company dedicated to the discovery and development of novel and innovative approaches to the treatment of cancer. Almac Discovery focuses on the discovery to preclinical stage seeking to license programs early with a pharmaceutical partner for further development. For more information, please visit http://www.almacgroup.com/discovery or e-mail media@almacgroup.com Part of Debiopharm Group™ - a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management - Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide. For more information, please visit http://www.debiopharm.com We are on Twitter. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews


CARY, NC--(Marketwired - February 08, 2017) - The 2nd edition of Industry Standard Research's (ISR's) Drug Product Contract Manufacturer Quality Benchmarking report reveals that buyers of outsourced drug product manufacturing services value a strong regulatory history and reliable on-time delivery more than low cost when selecting a CMO for drug product manufacturing. The report includes information on respondents' outsourcing philosophies and practices, CMO perceptions and interactions and CMO selection drivers before diving into a series of in-depth performance analyses specific to the drug product offerings of 70 contract manufacturing organizations. 302 respondents provide rating assessments on 673 service encounters. "A strong regulatory track record topped the list of attributes as the most important factor influencing drug product CMO selection," said Kate Hammeke, Vice President, Market Research at Industry Standard Research. "Reliable on-time delivery placed second and a track record for meeting quality performance metrics came in third. Low cost had fewer than one-in-ten respondents mention it as the most important selection driver. We are hearing this more and more from service buyers. Cost is not necessarily becoming less important, but that multiple factors beyond project price impact overall costs and consequently those attributes outweigh 'low cost' as a selection criterion." The report provides a Consumer Reports-style analysis where each of the 70 CMOs included in the research is evaluated across 27 service quality attributes, making this report the most comprehensive assessment of quality in the contract manufacturing space. These performance metrics are categorized into four 'scorecards': Delivery Factors, Organization Factors, Capabilities and Staff Characteristics. From these performance evaluations, respondents indicated how well the manufacturers performed with respect to expectations specific to their experience working with the manufacturer(s). For buyers of outsourced services, the report includes highly valuable information to help guide CMO selection for drug product manufacturing projects. There are several stand-out CMOs this year: Pfizer CentreOne placed among the leaders across each of the four scorecards (Delivery, Organizational, Capabilities and Staff Characteristics) and Samsung BioLogics received top scores for its Organization Factors and Capabilities. Fareva received top marks for its Delivery Factors and among emerging market CMOs, Wuxi AppTec appeared among the leaders for its Organization Factors. CMO performance attributes evaluated by respondents include Full range of manufacturing for the dosage forms we require, Reliable on-time delivery, Regulatory History, Quality performance metrics, Scale-up and tech transfer abilities, Scientific knowledge, Right-first-time measurements, and many others. Data include an in-depth analysis of 20 of the 70 featured contract manufacturers, including AbbVie Contract Manufacturing, Albany Molecular Research Inc. (AMRI), Almac, Baxter BioPharma Solutions, Boehringer Ingelheim, Capsugel, Catalent, Dr. Reddy's CPS, Evonik, Fareva, GSK Contract Manufacturing, Patheon, PCI Pharma Services, Pfizer CentreOne, Piramal Pharma Solutions, Samsung BioLogics, Sandoz, Sanofi CEPiA, Vetter and Wuxi AppTec. For more information on ISR's "Drug Product Contract Manufacturer Quality Benchmarking" report, please visit ISR's report page at https://www.isrreports.com/reports/drug-product-contract-manufacturer-quality-benchmarking-2nd-edition/. Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR's off-the-shelf intelligence and custom research offerings, please visit the company's website at www.isrreports.com, email info@isrreports.com or follow ISR on Twitter @ISRreports.


Kitson S.L.,Almac
Current radiopharmaceuticals | Year: 2013

Targeted alpha therapy (TAT) is an investigational procedure which utilises monoclonal antibodies (mAbs), peptide conjugates and/or other chemical compounds. These bio-vectors are able to transport a dose of alpha particles to destroy cancer cells. Radionuclide antibody-conjugates (RACs), labelled with beta emitters, have already been used in humans. More recently, TAT has been introduced to treat oncological diseases mainly leukaemia and lymphoma. Encouraging results have also been obtained in solid neoplasms with the administration of anti-tenascin. This chimeric antibody labelled with astatine-211 was delivered in patients with recurrent brain tumours into a surgically created cavity. Conversely, a clinical trial using a standard TAT approach to treat patients with metastatic melanoma, observed the shrinkage of the solid tumour mass. This response in melanoma may lead to an alternative mechanism for TAT, called tumour-antivascular- alpha-therapy (TAVAT), and forms the basis of a novel approach to the treatment of cancer disease states. In this paper, we will concentrate mainly on the application of TAT using antibodies. In particular, an investigation into the major general features connected with the use of alpha emitters in cancer therapy will be discussed. The prospective role of TAT with RACs will also be outlined briefly, especially focussing on the most important therapeutic strategies to date based on antibodies radiolabelled with beta emitters.


News Article | February 15, 2017
Site: www.prweb.com

Matthew Regulski, D.P.M., the Director of the Wound Care Institute of Ocean County, announces a new clinical trial for those suffering from chronic venous leg ulcers. Those interested in participating in the study should call the Wound Care Institute of Ocean County immediately at 732-736-5509. The study, officially titled “A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial Comparing Two Doses of VF001-DP to Placebo as an Adjunct to Standard Care in Patients with Chronic Venous Leg Ulcers,” is being sponsored by Factor Therapeutics Ltd., alongside the following collaborators: Parexel, ARANZ Medical and Almac Clinical Services LLC. “The objective of this study is to demonstrate the effectiveness and safety of VF001-DP as an adjunct to standard care (SC) in the treatment of chronic venous leg ulcers (VLUs) compared to placebo with SC over the course of the 12-week Treatment Phase,” according to ClinicalTrials.gov (Identifier: NCT02973893). This clinical trial is targeted at the following conditions: Ulcers, leg ulcers, varicose ulcers, pathologic processes, skin ulcers, skin diseases, varicose veins, vascular diseases and cardiovascular diseases, and will consist of three phases: Screening (two weeks), treatment (12 weeks and follow-up (12 weeks). Only patients whose study ulcer does not exhibit more than 30 percent change (increase or decrease) in ulcer size post-debridement between the screening phase visit (S1) and the treatment phase visit (T1) and who continue to meet eligibility criteria at the treatment phase visit (T1) will be randomized to receive either the Active Treatment Group (VF001-DP low or high dose plus standard care) or the Control Treatment Group (placebo plus standard care) in a ratio of 1:1:1, according to ClinicalTrials.gov. “This study will help us determine if this new course of treatment improves wound healing in chronic venous leg ulcers compared to standard care alone,” said Regulski. “Anyone with an ulceration between their knee and their ankle may be a candidate for this study and is encouraged to contact our office immediately to discuss this exciting new biological treatment.” This clinical trial plans to recruit 168 patients (56 per treatment group) at 26 centers in the United States, including the Wound Care Institute of Ocean County. To enroll in this study or to check eligibility requirements, please call the Wound Care Institute of Ocean County at 732-736-5509. About the Wound Care Institute of Ocean County The Wound Care Institute of Ocean County is the leader in wound care management, and is dedicated to the diagnosis and successful treatment of chronic and debilitating wounds. The Wound Care Institute follows the highest levels of evidence-based medicine and offers various treatment algorithms using the most advanced cellular therapies, as well as vascular services and surgical reconstruction. The Wound Care Institute of Ocean County is also involved in multiple clinical trials that have tremendous impact on the way wound healing is performed. To learn more, visit http://www.woundcareinstituteofoceancounty.com.


News Article | February 15, 2017
Site: www.marketwired.com

CARY, NC--(Marketwired - February 09, 2017) - The 2nd edition of Industry Standard Research's (ISR's) Small Molecule API Contract Manufacturer Quality Benchmarking report reveals that the top performing CMOs relative to expectations, and based off customer feedback on recent service encounters, are contract manufacturers with a drug innovator as its parent company. "For the second year in a row, Pfizer CentreOne has been a top performer across all four scorecards," explained Kate Hammeke. "This year, AbbVie Contract Manufacturing placed among the leaders in three of the four scorecards. This is a sign that customers working with embedded CMOs are having their expectations exceeded, but so are respondents who outsource to small and midsize CMOs. Aesica, SAI Life Sciences and Wockhardt received top marks across two scorecards each, which is a sign that regardless of project size or company budget, one can find a CMO whose quality matches your organization's needs." The report includes information on buyers' outsourcing philosophies and practices, CMO perceptions and interactions, and CMO selection drivers before diving into a series of in-depth performance analyses specific to the small molecule offerings of 36 contract manufacturing organizations. 241 respondents provide rating assessments on 689 service encounters. The report provides a Consumer Reports-style analysis where each of the 36 CMOs included in the research is evaluated across 27 service quality attributes, making this report the most comprehensive assessment of quality in the contract manufacturing space. These performance metrics are categorized into four 'scorecards': Delivery Factors, Organization Factors, Capabilities and Staff Characteristics. From these performance evaluations, respondents indicated how well the manufacturers performed with respect to expectations specific to their experience working with the manufacturer(s). For buyers of outsourced services, the report includes highly valuable information to help guide CMO selection for small molecule projects from early clinical stages to commercialization. CMO performance attributes evaluated by respondents include Ability to manufacture small molecule API, Reliable on-time delivery, Regulatory history, Quality performance metrics, Scale-up and tech transfer abilities, Scientific knowledge, Right-first-time measurements, and many others. Data include an in-depth analysis of 27 of the 36 featured contract manufacturers, including AbbVie Contract Manufacturing, Aesica, Albany Molecular Research Inc. (AMRI), Alcami, Almac, AMPAC Fine Chemicals, Aptuit, Ash Stevens, Cambrex, Dr. Reddy's CPS, Evonik, GSK Contract Manufacturing, Halo Pharma, Lonza, Novasep, Patheon, Pfizer CentreOne, PharmaCore, Piramal Pharma Solutions, Recipharm, SAFC, SAI Life Sciences, Sanofi CEPiA, Siegfried, Wockhardt and Wuxi AppTec. For more information on ISR's "Small Molecule API Contract Manufacturer Quality Benchmarking" report, please visit ISR's report page at https://www.isrreports.com/reports/small-molecule-api-contract-manufacturer-quality-benchmarking-2nd-edition/ Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR's off-the-shelf intelligence and custom research offerings, please visit the company's website at www.isrreports.com, email info@isrreports.com or follow ISR on Twitter @ISRreports.

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