Global Clinical Research Organization | Precision for Medicine

Time 2020-06-29 09:03:52

Web Name: Global Clinical Research Organization | Precision for Medicine

WebSite: http://www.precisionformedicine.com

ID:13946

Keywords:

Research,Clinical,Global,

Description:

Shift the possibilitiesTargeted therapies, biomarker-driven insights, cutting-edge data sciences, and advanced clinical trial designs and implementation can all drive the likelihood of greater success. Let s get started.Precision is an accelerator of innovation, devoted to supporting the development of new treatmentsAs a precision medicine clinical research services organization, we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.Precision is an accelerator of innovation, devoted to supporting the development of new treatmentsAs a precision medicine clinical research services organization, we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.Precision Convergence, the combined power of trials, labs and data sciences to drive faster clinical developmentWhat sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences. This is Precision Convergence: maximizing insights into patient biology and accelerating the pace of scientific discovery and approval.First-in-human through regulatory approval global expertise2000+ dedicated professionalsOncology, cell and gene therapy, rare and orphan diseaseCustom assays to full-scale GxP and CLIA validationGlobal biospecimen and lab footprintDeeper biological insights enriched by dataInnovative analytics empower critical clinical development decisionsOperational visibility and management enabled by dataOncology Immuno-OncologyThrough 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem-solving abilities that advance even the most challenging clinical development programs.Rare Orphan DiseaseWith experience built on 150+ orphan disease projects covering 80+ rare diseases, we know how to anticipate logistical and regulatory obstacles and craft bold solutions that drive rare disease development programs.Cell Gene TherapyWith team members who are global thought leaders in cell and gene therapy development, Precision brings together scientific, clinical and regulatory expertise that is advancing the development of these programs as well as oncolytic viruses, cancer vaccines and radiolabeled ligands.NeurologyWe combine advances in neurology biomarkers and biomarker detection technology for robust therapeutic development.Autoimmune AllergyWe support development programs with state-of-the-art immune monitoring solutions and immunogenicity testing expertise.COVID-19We are engaged in COVID-19 research with comprehensive solutions for all areas of therapeutic, vaccine and diagnostic development.PediatricAdvanced clinical trial design expertise and sensitive biomarker detection technologies accelerate pediatric therapeutic development.Companion DiagnosticsOur integrated clinical development, biomarker assay, regulatory strategy and commercialization capabilities deliver unique value for CDx programs.Precision covers the globe, supporting trials at every stageFrom early development to regulatory approval, from sea to sea, Precision is a global partner to many of the most innovative life-sciences companies in the world.Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.Senior Vice President, Clinical OperationsRespected leader managing the execution and delivery of all oncology clinical trials to ensure the highest quality service.Chief Medical Officer, Clinical SolutionsOncologist, hematologist and veteran expert in clinical research, clinical practice and development of pharmaceuticals, biologic products and immune modulation therapies. Primary consultant to the Moonshot 2020 program and an authority in optimizing clinical trial designs to accelerate product approval. Significant experience and credibility with the FDA as well as regulatory authorities in Europe, Japan and other countries.Andrea Cotton-Berry, MScGlobal Head of Strategic Development, Clinical SolutionsNotable authority in global operations, dedicated to fostering team spirit of excellence and collaboration with internal and external partners. Veteran of the quest to improve oncology therapies and extend lives, including 15+ years in oncology drug development, building on 10 years in obstetrics and women’s health.Kristi Clark, MBASenior Vice President, Project Management and Clinical Operations Rare and Orphan SolutionsGlobal business strategist with more than 20 years of project and clinical management experience in the biopharma and CRO industries, spanning the full scope of studies. In-depth expertise in many therapeutic areas, including pediatric oncology, pediatric chronic pain, cancer pain, oncology, cardiovascular, CNS, biomarkers, infectious disease, gastroenterology, ophthalmology, Cystic Fibrosis, pediatric auto-inflammatory disorders, genetic sampling and medical device. Passionate about exploring ways to lessen the patient burden.Senior Vice President, European SolutionsIndustry leader in managing large global clinical trials. Co-founder of Argint International, a CRO providing clinical research and regulatory services to the pharmaceutical industry throughout central and south eastern Europe. Holds a masters in biology from Johannes Gutenberg-University in Mainz, Germany.Senior Director, Europe Lead BiologicalLeading expert in flow cytometry and systems biology and senior bioinformatics scientist. Core focus on exploratory immunological biomarker data analyses. Long-standing experience in the pharmaceutical industry. Holds a doctorate in cell biology from Friedrich Miescher Institute in Basel, Switzerland.Ali SadighianSenior Vice President, Business Operations Rare and Orphan SolutionsAccomplished and versatile leader with clinical development and R D experience gained from academia, biopharma, and several top CROs. Unique skills developed as a laboratory researcher at the UCSD School of Medicine, in quality control in the biotech industry, in clinical operations, and as a senior executive. Dedicated to helping innovative companies bring new therapies to patients and families in greatest need.Senior Director, Translational Biology Biomarker DevelopmentAuthority in utilizing human primary biological tissue and cells in research and drug discovery. Developer of translational biomarkers for Phase I/II clinical programs in autoimmunity, inflammation and cancer. Expert in phenotypic cell-based assays using multiple primary cell systems such as T/Th17/T-regs, NK-T, B/Plasma/Plasmablasts, Myeloid cells, Dendritic cells (pDCc/mDCs), and MDSCs. Strategist in multi-parametric single-cell flow cytometry and analysis of flow cytometry data. Broad network of contacts at clinical sites and research hospitals, experienced with IRB submissions and clinical protocols. Scientific leader for Precision’s Biomaterials commercial sourcing.PresidentRecognized industry leader focused on combining cutting-edge technology, strategic program design, and operational excellence to help life sciences companies effectively address the increasing evidence demands and need to accelerate research initiatives. Previous experience spans the execution of phase I-IV clinical trials, specialty lab services, biospecimen logistics and banking, risk management, and patient support initiatives.Medical Director, Biospecimen SolutionsVisionary dedicated to enabling collaborations that help facilitate efficient translational research, discovery and development. Full-time pathologist and founder of the uniquely consultative biospecimens company Glas. Believes that forward-thinking pathologists and laboratorians should play a critical role in realizing the promise of translational medicine.Senior Vice PresidentVisionary leader with more than 25 years of distinguished biotechnology and clinical translational research experience. Founded ApoCell in 2004 and later was instrumental in developing and commercializing the ApoStream® rare-cell liquid biopsy technology. Globally recognized cancer researcher and the author of more than 100 peer-reviewed publications. Dedicated and committed to improving the lives of patients with debilitating diseases.Senior Vice President, Diagnostics SolutionsStrategic visionary and healthcare industry veteran operating at the intersection of reimbursement, health economics, clinical science, and marketing strategy. Expertise encompasses all aspects of market access, reimbursement, and evidence development strategy, with a particular focus on personalized medicine, advanced molecular and companion diagnostics, and targeted therapies. Has launched successful products, guided major investment and acquisition decisions, and driven favorable coverage and payment determinations by public and private payers alike. Speaker and author.Senior Vice President, Research ServicesPharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy.Elizabeth Ludington, PhDSenior Vice President, Biometrics Rare and Orphan SolutionsSeasoned veteran of the pharmaceutical and biotech industries both through CROs and sponsor companies. Provides statistical, technical, and strategic expertise for preclinical studies, INDs, Phase I-IV clinical studies, eCTDs, and postmarketing studies. Statistical expertise includes study design, protocol review, and writing and reviewing analysis plans and statistical reports. Skilled at representing clients at meetings with regulatory authorities, and as a statistical consultant for programs at all phases of development.Senior Advisor, Rare Disease SolutionsIndustry leader and founder of Agility Clinical, passionate about helping underserved patient populations. Keenly focused on orphan drug development with extensive experience in biostatistics, data management, and clinical operations. Accomplished executive leader with numerous awards, including, “Most Admired CEO”, “100 Most Inspiring People in the Pharmaceutical Industry”, “Athena Pinnacle Award for Women in Science and Technology”, and Ernst Young “Entrepreneur of the Year” Finalist. Prior positions include founder and CEO of Synteract, a full-service, international contract research organization serving biopharma companies.Senior Vice President, Operations Customer SolutionsExtensive industry expertise across the pharmaceutical and biotech space-translational research, data management, and statistical support-with a focus in precision medicine-guided efforts in drug and diagnostic development. Subject matter expert in genomics. Pioneered approaches in biomarker data management and has led Biometrics operations on over 70 clinical studies.Senior Vice President, Business DevelopmentClinical research veteran with a focus on strategic initiatives in the laboratory and biospecimen arena. Dedicated to helping pharmaceutical and life sciences clients innovate, develop, and commercialize next generation medical products.Scientific LiaisonRespected scientist and research investigator with expertise spanning biotechnology, medical science, technology development, and data analysis. Partners cross-functionally to identify and advance projects related to validation studies, method development, and reference standards.Vice President, Biospecimen SolutionsPioneer in the field of biospecimen procurement and co-founder of ProMedDx. Leader in the delivery of services for organizations in the biotechnology industry, including clinical study support and biostorage. Experienced executive with a demonstrated career of building innovative patient-centric biotech clinical programs. Focused on addressing the growing need for highly annotated, regulatory-compliant human biospecimens by the life science research communities.Vice President, Biospecimen SolutionsLong-standing leader in the life sciences and in-vitro diagnostics industries. Co-founder of ProMedDx, a full suite of biospecimen solutions connecting biopharma teams to 1000s of clearly stratified and annotated cohorts. Expertise spanning operations, finance, human resources, government grant applications, and corporate strategy.Senior Vice President, Laboratory OperationsExperienced senior leader spanning the academic, pharmaceutical, and CRO industries. Specific expertise in biotherapeutics and vaccines for preclinical and clinical development programs and in identifying the appropriate immunochemistry assays for new development programs. Broad record of accomplishment leading global teams, delivering business strategies, developing business, and ensuring operational excellence.Chief Operating Officer, Oncology SolutionsExpert strategist for the pharmaceutical, CRO, and healthcare industries. Offers extensive multi-disciplinary drug development experience at the project, compound, and portfolio levels. Takes a sophisticated approach to the operations, infrastructure, and growth of Precision’s oncology division.Senior Vice President, In Vitro Diagnostics and QualityLeader and innovator in the GMP/ISO/FDA/EU-regulated in vitro diagnostic (IVD) industry. Spearheads regulatory approvals worldwide for both novel and traditional IVD assays and products, as well as laboratory developed tests in the United States. Builds ground-up quality systems, meeting the requirements of US FDA, ISO 13485, CLIA, and CAP.Senior Director, Europe Lead InformaticsRespected expert in mathematics and fundamental and theoretical computer science. Strong focus on genetics. Developer of innovative bioinformatics algorithms for SNP analyses and genome-wide association studies. Avid proponent of and proactive contributor to the open source community.Senior Director, Europe Lead OperationsDistinguished expert in the analysis of large-scale, high-throughput genomics and genetics data. Statistical programmer combining computational and experimental methods in various therapeutic areas, including oncology and autoimmune disease.Senior Director, Business DevelopmentInfluential strategy expert in end-to-end bioinformatics and artificial intelligence solutions for biomarker-guided drug development, maximizing the value and utility of biomarker data in clinical trials, CDx, and diagnostics. Previously CEO of SimplicityBio. Holds a doctorate in molecular and cellular biology from the University of Lausanne.President, Clinical SolutionsWidely respected industry leader and founder of ACT Oncology. Guides strategic protocol design and study optimization on behalf of sponsors. Has extensive experience in Phase I-IV trials for most indications, including solid tumor and hematologic malignancies. Leads integrated teams to combine the strength of biomarker insights with clinical outcome data to optimize the development pathway.Senior Director, Business Development, Oncology Solutions30+ year healthcare industry veteran bridging business development efforts and program implementation for optimal client satisfaction. Serves as the primary business development contact for biotech and pharmaceutical clients on the west coast.Senior Director, Client SolutionsIndustry leader with deep expertise in healthcare technology focused on using artificial intelligence to help biopharma and diagnostic companies solve the question, Which therapy, when, and for which patient?” Extensive industry knowledge across the pharmaceutical and biotech space—translational informatics, biomarker R D. Holds an MBA and is passionate about exploring interfaces between people and technology for effective communication.General Manager, Biospecimen SolutionsRespected vetran of the biospecimen and biomarker laboratory services industry. Honed his expertise through leadership roles in organizations including Roche, Cancer Genetics, and BioServe. Holds a Master of Public Health and a Masters of Business Administration from the Johns Hopkins University.Senior Vice President, Business OperationsVetran with deep knowledge of the contract research/pharmaceutical services industry. Provides project leadership and executive support to clients. Directs operational functions, resourcing, and business strategy internally, structuring oncology operations to match client needs.Executive Director, Business OperationsLong-standing international CRO authority in the oncology drug development industry. Expertise spanning commercial operations, oncology and clinical operations, partnership development, and investigator networking.Senior Director, Business DevelopmentResearch professional in both academia and industry, focused on bringing immune monitoring services to autoimmunity and tumor-immunology clinical trials. Specialist in innate and adaptive immunity, immunoassay development, onco-immunology, autoimmunity, target validation and preclinical biomarker discovery, and workflow and SOP design.Scott Marshall, PhDManaging Director, Translational Informatics and Diagnostic SciencesIndustry expert, leading regulatory submissions, translational informatics, and biomarker R D for pharmaceutical and biotechnology companies. Focus on precision medicine-guided efforts, strategy, and medical device/diagnostic development. Global responsibility for translational informatics R D efforts. Has led the development of novel methodologies for patient stratification and biomarker guided clinical trial design.Director, Neurology SolutionsTrusted leader driving multi-site research programs that leverage proprietary state-of-the-art technologies to identify, validate, and integrate next-generation biomarkers to advance clinical trials for a wide range of neurological indications. Able to generate novel hypotheses, then identify and develop the right methods to answer the right scientific questions.Senior Vice President, European SolutionsIndustry leader with expertise managing large multinational clinical trials in 20+ countries across Europe, North America and APAC. Dedicated to providing quality, flexible and cost-effective solutions for clinical development programs.Co-founder of Argint International, a full-service CRO for phase I-IV clinical research trials. Holds a degree in microbiology from University of Warwick, United Kingdom.Senior Vice President, ResearchInventor, industry expert, founder and leader of Epiontis. Developed the patents forming the basis of Epiontis’s intellectual property. Conducted pre- and postdoctoral research at the Center for Molecular Biology and Biomedicine (ZMBH) of the University of Heidelberg, Germany, and the R.W. Johnson Pharmaceutical Research Institute, San Diego, California, USA. Received a BSc from the Imperial College of Science, Technology, and Medicine, London, and a PhD in Biochemistry from the University of London.Vice President, Oncology Solutions Site NetworkIndustry vetran and leader of Precision Oncology Site Network. Clear focus on consistently optimizing start-up at both academic and community-based sites across the United States and Europe. Oversaw the world’s largest phase 1 program for cancer research and treatment at the renowned University of Texas MD Anderson Cancer Center.Tobias Guennel, PhDSenior Vice President, Product Development Systems IntegrationDistinguished expert working across the pharmaceutical and biotech space, leading regulatory submissions, translational informatics, and biomarker R D. Clear focus on precision medicine-guided efforts, strategy, and medical device/diagnostic development. Led numerous analytical R D efforts and developed novel methodologies to harmonize and analyze data from high-throughput assays, translating it to value at the patient level.Vice President Immune Monitoring SolutionsVeteran biochemist, industry expert, cofounder of Epiontis. Holds a Master’s in Biochemistry from Humboldt University, a PhD from the Charité University Clinic receiving the Charité Research Award, and an MBA from the Berlin School of Economics and Law, Berlin, Germany.

TAGS:Research Clinical Global 

<<< Thank you for your visit >>>

Precision is a clinical research organization that brings together advanced technologies to help our clients maximize insights into patient biology.

Hot Websites