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News Article | May 11, 2017
Site: www.businesswire.com

WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC, (PPD) today announced it recently has added two new leaders in product development, strengthening the global contract research organization’s therapeutic expertise and ability to aid biopharmaceutical clients in delivering life-changing therapies to patients. “PPD’s global team of scientific, medical and strategic experts provides our clients expertise that helps reduce the cost and time associated with bringing medicines to market,” said Rob Dow, senior vice president of medical affairs for PPD. “By joining this team, these leaders deepen our expertise in neuroscience, pediatrics and rare diseases – areas that are very important to PPD and our customers.” Stephen Peroutka, M.D., Ph.D., has joined PPD to serve as vice president of global product development and therapeutic area head for neuroscience. Peroutka has served as an advisor and consultant to several biopharmaceutical companies. He previously served as chief medical officer at Semnur Pharmaceuticals and as chief medical officer and executive vice president of NeurogesX Inc. Earlier, he served as vice president of neurosciences for a large contract research organization (CRO); chief medical officer of Zogenix Inc.; franchise leader for pain conditions at Johnson & Johnson Inc.; founder, CEO and president of Synergia Pharma Inc.; and founder, CEO and president of Spectra Biomedical Inc., a startup focused on identification of genes in migraine, later acquired by GSK. Peroutka served as chief of the neurology service at the Palo Alto Veteran’s Administration Hospital. He earned both a medical and doctoral degree in pharmacology and experimental therapeutics from Johns Hopkins University School of Medicine. Horacio Plotkin, M.D., FAAP, joined PPD as vice president of global product development in the pediatrics and rare diseases therapeutic area and also serves as medical lead for the Rare Disease and Pediatric Center of Excellence. Plotkin most recently served as global clinical development lead at Shire. Previously, he spent three years as chief medical officer of Retrophin, Inc., and held medical director positions at Alexion Pharmaceuticals, Enobia Pharma and Genzyme Corp. He spent 20 years as a practicing pediatrician in the field of pediatric rare diseases. Plotkin serves as adjunct associate professor of pediatrics and orthopedic surgery at the University of Nebraska School of Medicine. He earned his medical degree from the University of Buenos Aires School of Medicine. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 19,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com. Any statements made in this news release that are not statements of historical fact, including statements about the future performance of personnel, are forward-looking statements that involve a number of risks and uncertainties. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “might,” “will,” “forecast” and other similar expressions. The forward-looking statements contained in this news release are subject to and involve risks, uncertainties and assumptions, and therefore you should not place undue reliance on them. Although PPD believes these forward-looking statements are based on reasonable assumptions at the time they are made, many factors are beyond PPD’s ability to control or predict and could affect the outcome of the subject matter of this news release and our actual financial results, and therefore the outcome and results might differ materially from those expressed in the forward-looking statements. Additional factors that might materially affect the forward-looking statements include, but are not limited to: our ability to recruit, retain and motivate key personnel; the competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; rapid technological changes that make our services less competitive or obsolete; the impacts of political, economic and/or regulatory changes on the health care industry; the fact that our backlog may not accurately predict or convert into service revenue; the termination, delay or change in scope of our contracts; industry, customer or therapeutic concentration; the pricing of and cost management of customer contracts; information and communication systems failures; contractual failures; regulatory and ethical standards failures; our ability to attract investigators and enroll patients in clinical trials; violations of laws governing privacy, conduct of clinical trials and/or other pharmaceutical research; competition between existing and potential customers; management of business restructurings and acquisitions; risk relating to the performance of drug development services and our insurance coverages, if any, for such risks; U.S. or international economic, currency, political and other risks; changes in existing or interpretations of tax laws; factors impacting the value of our goodwill and intangible assets; and other factors. PPD assumes no obligation and expressly disclaims any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. PPD is not responsible for updating the information contained in this news release beyond the published date, or for changes made to this news release by wire services or internet service providers or any other party.


News Article | May 18, 2017
Site: www.businesswire.com

WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), has expanded its vaccine sciences lab in Richmond, Virginia, enhancing its ability to provide industry-leading capabilities to meet biopharmaceutical clients’ growing research needs. The laboratory expansion continues PPD’s ongoing investments in its Richmond facilities, which also include significant enhancements to its genomics, immunochemistry and automation services in recent years. PPD’s lab operations in Richmond employ nearly 700 people, including Ph.D.-level scientists, analytical laboratory staff and other scientific professionals. “The recent expansion of our vaccine sciences lab, coupled with previous enhancements to our biologics capabilities, builds on three decades of drug development expertise to support pharmaceutical and vaccine programs from pre-clinical through post-approval,” said Bob Nicholson, senior vice president of PPD® Laboratories. “During that time, we have helped our clients earn FDA approval for 15 vaccine programs and countless pharmaceuticals. We’re confident our laboratory enhancements will enable us to build on that record of success for our customers.” With nearly 17,000 square feet of new vaccines laboratory space, PPD has added significant capacity for vaccine efficacy testing using techniques such as cell-based assays and immunochemistry. PPD Laboratories’ vaccine sciences lab, with its unique capabilities within the CRO industry, offers an extensive portfolio of services that support vaccine development. Most notably, those include method development, qualification and validation; extensive statistical and regulatory expertise; and high-throughput, automated and/or multiplex assays. The lab has diverse experience with multiple assay formats, including molecular genomics, immunology, cell-based and functional assays. The vaccine sciences lab is part of PPD’s Richmond bioanalytical lab, which provides services such as small molecule, biologics and biomarker testing capabilities for all phases of drug development. PPD Laboratories’ operation in Richmond, elements of which have been in operation since 1985, has added about 50,000 square feet in recent years and now totals nearly 200,000 square feet, making it one of the largest bioanalytical labs in the world. Specific drug testing services offered at the lab include: understanding the pharmacokinetics and pharmacodynamics (PK/PD) of a drug; measuring in vivo absorption, distribution, metabolism and excretion (ADME) of the parent drug and its metabolites; monitoring for adverse drug reaction; in vivo ADME testing; dose escalation and ranging studies; immunogenicity; and immune response. In addition to the vaccine sciences, bioanalytical and biomarker labs in Richmond, PPD Laboratories includes: a bioanalytical lab in Middleton, Wisconsin; GMP (good manufacturing practices) labs in Athlone, Ireland, and Middleton; central labs in Shanghai, China; Brussels, Belgium; Highland Heights, Kentucky; and Singapore; and a biomarker lab in Highland Heights. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 19,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com. Any statements made in this news release that are not statements of historical fact, including statements about the expansion of its vaccine sciences laboratory in Richmond, Virginia, are forward-looking statements that involve a number of risks and uncertainties. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “might,” “will,” “forecast” and other similar expressions. The forward-looking statements contained in this news release are subject to and involve risks, uncertainties and assumptions, and therefore you should not place undue reliance on them. Although PPD believes these forward-looking statements are based on reasonable assumptions at the time they are made, many factors are beyond PPD’s ability to control or predict and could affect the outcome of the subject matter of this news release and our actual financial results, and therefore the outcome and results might differ materially from those expressed in the forward-looking statements. Additional factors that might materially affect the forward-looking statements include, but are not limited to: the competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; our ability to recruit, retain and motivate key personnel; rapid technological changes that make our services less competitive or obsolete; the impacts of political, economic and/or regulatory changes on the health care industry; the fact that our backlog may not accurately predict or convert into service revenue; the termination, delay or change in scope of our contracts; industry, customer or therapeutic concentration; the pricing of and cost management of customer contracts; information and communication systems failures; contractual failures; regulatory and ethical standards failures; our ability to attract investigators and enroll patients in clinical trials; violations of laws governing privacy, conduct of clinical trials and/or other pharmaceutical research; competition between existing and potential customers; management of business restructurings and acquisitions; risk relating to the performance of drug development services and our insurance coverages, if any, for such risks; U.S. or international economic, currency, political and other risks; changes in existing or interpretations of tax laws; factors impacting the value of our goodwill and intangible assets; and other factors. PPD assumes no obligation and expressly disclaims any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. PPD is not responsible for updating the information contained in this news release beyond the published date, or for changes made to this news release by wire services or internet service providers or any other party.


News Article | May 17, 2017
Site: www.businesswire.com

HORSHAM, Pa.--(BUSINESS WIRE)--Acurian Inc., the leading full-service provider of global patient enrollment and retention solutions and a subsidiary of Pharmaceutical Product Development, LLC (PPD), has launched a new consulting offering to aid pharmaceutical sponsors in advance strategic planning for clinical trials enrollment. Acurian Consulting Services provides patient-centric, data-driven insights that help drive protocol design, patient enrollment feasibility, site and country planning, CRO selection and budgeting for central recruitment. Acurian Consulting Services leverages Acurian’s patient-centric global platform, PatientPulse™, to garner both qualitative and quantitative clinical trial insights from patients. The patient perspective is uniquely highlighted, both retrospectively based on millions of data points, and prospectively through large patient surveys and personalized interviews. Acurian’s feasibility consultants have access to the company’s 100-million-household database and more than 17 million pre-screened study candidates to project how a sponsor’s protocol and study design will play out in terms of enrollment accrual rates, site performance and patient participation. “With Acurian Consulting Services, we are encouraging sponsors to think differently,” said Roger Smith, Acurian’s senior vice president and general manager. “By engaging in early strategic consulting, they can gain patient insights to plan later phase trials in a more innovative way. Our patient-first feasibility inverts the traditional site-first planning model and gives sponsors confidence to develop enrollment plans with fewer sites – without sacrificing certainty of speed, budget and quality. A smaller site footprint is more efficient and eliminates the need to over-hire sites.” Sponsors interested in more information can contact consultingservices@acurian.com. Acurian, a subsidiary of PPD, is the leading full-service provider of clinical trial patient enrollment and retention solutions for the life sciences industry. The company increases the enrollment performance of investigator sites worldwide by identifying, contacting, prescreening and referring people who live in the local community but are unknown to a research site. As a result, trial sponsors complete enrollment without incurring the unexpected expense of adding sites or time. Learn more at www.acurian.com. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 19,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com. Any statements made in this news release that are not statements of historical fact, including statements about Acurian Consulting Services, are forward-looking statements that involve a number of risks and uncertainties. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “might,” “will,” “forecast” and other similar expressions. The forward-looking statements contained in this news release are subject to and involve risks, uncertainties and assumptions, and therefore you should not place undue reliance on them. Although PPD believes these forward-looking statements are based on reasonable assumptions at the time they are made, many factors are beyond PPD’s ability to control or predict and could affect the outcome of the subject matter of this news release and our actual financial results, and therefore the outcome and results might differ materially from those expressed in the forward-looking statements. Additional factors that might materially affect the forward-looking statements include, but are not limited to: our ability to recruit, retain and motivate key personnel; the competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; rapid technological changes that make our services less competitive or obsolete; the impacts of political, economic and/or regulatory changes on the health care industry; the fact that our backlog may not accurately predict or convert into service revenue; the termination, delay or change in scope of our contracts; industry, customer or therapeutic concentration; the pricing of and cost management of customer contracts; information and communication systems failures; contractual failures; regulatory and ethical standards failures; our ability to attract investigators and enroll patients in clinical trials; violations of laws governing privacy, conduct of clinical trials and/or other pharmaceutical research; competition between existing and potential customers; management of business restructurings and acquisitions; risk relating to the performance of drug development services and our insurance coverages, if any, for such risks; U.S. or international economic, currency, political and other risks; changes in existing or interpretations of tax laws; factors impacting the value of our goodwill and intangible assets; and other factors. PPD assumes no obligation and expressly disclaims any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. PPD is not responsible for updating the information contained in this news release beyond the published date, or for changes made to this news release by wire services or internet service providers or any other party.


News Article | May 25, 2017
Site: www.businesswire.com

WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD) today announced it has been recognized for excellence in clinical research by pharmaceutical and biotechnology executives surveyed for Life Science Leader magazine’s 2017 CRO Leadership Awards. PPD earned high honors in all of the five distinct categories: capabilities, compatibility, expertise, quality and reliability. The results are based on survey responses from biopharmaceutical industry leaders responsible for making or influencing decisions to collaborate with contract research organizations (CROs) on clinical development programs. PPD’s comprehensive offerings range from integrated early development through post-market services and PPD® Laboratories, offering the most comprehensive lab services available in the industry. “PPD is committed to accelerating the generation of evidence necessary for our customers to bring life-changing therapies to society,” said David Simmons, chairman and CEO of PPD. “Pharmaceutical and biotechnology clients can rely on our expertise and tailored, quality-first services across Phase I-IV and post-approval research, with integrated and comprehensive laboratory services and industry leadership in site and patient relationships. Our strategically expanded service offerings help ensure our clients’ evolving needs are met with precision and high quality across the drug development continuum.” The survey for the 2017 CRO Leadership Awards, which encompassed 27 performance metrics, was conducted by Industry Standard Research, a full-service pharmaceutical market research firm, to help Life Science Leader assess the performance of CROs. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 19,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com. Any statements made in this news release that are not statements of historical fact, including statements about the honors and accolades PPD receives, are forward-looking statements that involve a number of risks and uncertainties. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “might,” “will,” “forecast” and other similar expressions. The forward-looking statements contained in this news release are subject to and involve risks, uncertainties and assumptions, and therefore you should not place undue reliance on them. Although PPD believes these forward-looking statements are based on reasonable assumptions at the time they are made, many factors are beyond PPD’s ability to control or predict and could affect the outcome of the subject matter of this news release and our actual financial results, and therefore the outcome and results might differ materially from those expressed in the forward-looking statements. Additional factors that might materially affect the forward-looking statements include, but are not limited to: the competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; our ability to recruit, retain and motivate key personnel; rapid technological changes that make our services less competitive or obsolete; the impacts of political, economic and/or regulatory changes on the health care industry; the fact that our backlog may not accurately predict or convert into service revenue; the termination, delay or change in scope of our contracts; industry, customer or therapeutic concentration; the pricing of and cost management of customer contracts; information and communication systems failures; contractual failures; regulatory and ethical standards failures; our ability to attract investigators and enroll patients in clinical trials; violations of laws governing privacy, conduct of clinical trials and/or other pharmaceutical research; competition between existing and potential customers; management of business restructurings and acquisitions; risk relating to the performance of drug development services and our insurance coverages, if any, for such risks; U.S. or international economic, currency, political and other risks; changes in existing or interpretations of tax laws; factors impacting the value of our goodwill and intangible assets; and other factors. PPD assumes no obligation and expressly disclaims any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. PPD is not responsible for updating the information contained in this news release beyond the published date, or for changes made to this news release by wire services or internet service providers or any other party.


News Article | May 23, 2017
Site: www.businesswire.com

HORSHAM, Pa.--(BUSINESS WIRE)--Acurian Inc., the leading full-service provider of global patient enrollment and retention solutions and a subsidiary of Pharmaceutical Product Development, LLC (PPD), announced today that Tom Privette, Ph.D., has joined the company as vice president and head of global business development. In this role, Privette will lead the commercial efforts of Acurian’s sales organization worldwide. “Tom brings more than 20 years of extensive experience in pharmaceutical and biotech management as well as clinical research and development,” said Roger Smith, Acurian’s senior vice president and general manager. “His operational and strategic background will help drive our next stage of sales growth and global business expansion, particularly as we continue to deliver a wide range of patient-centric enrollment solutions that help trial sponsors achieve budget, time and quality certainty without having to over-hire research sites simply for access to patients.” Privette was previously vice president and head of global business development for Syngene International, the largest global contract research and manufacturing organization based in India. He also has held senior business development and clinical research positions with another global contract research organization and pharmaceutical companies including Wyeth Pharmaceuticals and GlaxoSmithKline. Privette earned his Ph.D. in cell biology/neuroscience from East Carolina University and bachelor’s degrees in chemistry and psychology from the University of North Carolina at Chapel Hill. Acurian, a subsidiary of PPD, is the leading full-service provider of clinical trial patient enrollment and retention solutions for the life sciences industry. The company increases the enrollment performance of investigator sites worldwide by identifying, contacting, prescreening and referring people who live in the local community but are unknown to a research site. As a result, trial sponsors complete enrollment without incurring the unexpected expense of adding sites or time. Learn more at www.acurian.com. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 19,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com. Any statements made in this news release that are not statements of historical fact, including statements about Acurian personnel and services, are forward-looking statements that involve a number of risks and uncertainties. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “might,” “will,” “forecast” and other similar expressions. The forward-looking statements contained in this news release are subject to and involve risks, uncertainties and assumptions, and therefore you should not place undue reliance on them. Although PPD believes these forward-looking statements are based on reasonable assumptions at the time they are made, many factors are beyond PPD’s ability to control or predict and could affect the outcome of the subject matter of this news release and our actual financial results, and therefore the outcome and results might differ materially from those expressed in the forward-looking statements. Additional factors that might materially affect the forward-looking statements include, but are not limited to: our ability to recruit, retain and motivate key personnel; the competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; rapid technological changes that make our services less competitive or obsolete; the impacts of political, economic and/or regulatory changes on the health care industry; the fact that our backlog may not accurately predict or convert into service revenue; the termination, delay or change in scope of our contracts; industry, customer or therapeutic concentration; the pricing of and cost management of customer contracts; information and communication systems failures; contractual failures; regulatory and ethical standards failures; our ability to attract investigators and enroll patients in clinical trials; violations of laws governing privacy, conduct of clinical trials and/or other pharmaceutical research; competition between existing and potential customers; management of business restructurings and acquisitions; risk relating to the performance of drug development services and our insurance coverages, if any, for such risks; U.S. or international economic, currency, political and other risks; changes in existing or interpretations of tax laws; factors impacting the value of our goodwill and intangible assets; and other factors. PPD assumes no obligation and expressly disclaims any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. PPD is not responsible for updating the information contained in this news release beyond the published date, or for changes made to this news release by wire services or internet service providers or any other party.


WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), today announced the creation of a dedicated unit combining its medical affairs research operations (MARO) team and Evidera, the provider of evidence-based solutions to demonstrate the real-world effectiveness, safety and value of biopharmaceutical and biotechnology products. PPD acquired Evidera last year, uniting two best-in-class research companies to create transformative opportunities for biopharmaceutical clients. The new dedicated unit, retaining the Evidera name, will provide customers with global comprehensive and integrated solutions, including modeling and simulation, interventional studies (including expanded access/compassionate use and extended access), observational studies (including registries), health economics, outcomes research, market access, epidemiology, real-world evidence, safety and risk management. “Our clients are seeking better evidence to satisfy the requirements of both regulators and payers, and we have a tremendous opportunity to meet that need by delivering real-world evidence that bridges the gaps between efficacy, safety and value,” said William Sharbaugh, chief operating officer of PPD. “Through this new business unit we will be able to help our clients seamlessly integrate and align regulatory and peri- and post-approval research efforts, improving their ability to meet the evidence demands of both regulators and payers.” The new business unit will retain the executive and scientific leadership of both the Evidera and MARO organizations. Jon Williams, who has served as president and CEO of Evidera since 2013, will lead the new unit. “Bringing together Evidera’s scientific and consulting expertise with PPD’s global operations infrastructure creates an unparalleled ability to partner with and serve our clients in optimizing their product value and market access,” Williams said. Experts from the new unit will be present at the annual meetings of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Boston in May, and the Drug Information Association (DIA) in Chicago in June, where they will contribute more than 50 research presentations, posters, short courses and other research activities. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 19,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com. Any statements made in this news release that are not statements of historical fact, including statements about the combination of PPD’s medical affairs research operations and Evidera, are forward-looking statements that involve a number of risks and uncertainties. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “might,” “will,” “forecast” and other similar expressions. The forward-looking statements contained in this news release are subject to and involve risks, uncertainties and assumptions, and therefore you should not place undue reliance on them. Although PPD believes these forward-looking statements are based on reasonable assumptions at the time they are made, many factors are beyond PPD’s ability to control or predict and could affect the outcome of the subject matter of this news release and our actual financial results, and therefore the outcome and results might differ materially from those expressed in the forward-looking statements. Additional factors that might materially affect the forward-looking statements include, but are not limited to: the competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; our ability to recruit, retain and motivate key personnel; rapid technological changes that make our services less competitive or obsolete; the impacts of political, economic and/or regulatory changes on the health care industry; the fact that our backlog may not accurately predict or convert into service revenue; the termination, delay or change in scope of our contracts; industry, customer or therapeutic concentration; the pricing of and cost management of customer contracts; information and communication systems failures; contractual failures; regulatory and ethical standards failures; our ability to attract investigators and enroll patients in clinical trials; violations of laws governing privacy, conduct of clinical trials and/or other pharmaceutical research; competition between existing and potential customers; management of business restructurings and acquisitions; risk relating to the performance of drug development services and our insurance coverages, if any, for such risks; U.S. or international economic, currency, political and other risks; changes in existing or interpretations of tax laws; factors impacting the value of our goodwill and intangible assets; and other factors. PPD assumes no obligation and expressly disclaims any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. PPD is not responsible for updating the information contained in this news release beyond the published date, or for changes made to this news release by wire services or internet service providers or any other party.


The report Global Healthcare Analytical Testing Services Market Research Report- Industry Analysis, Size, Share, Growth, Trends And Forecast by DecisionDatabases.com . It provides the value chain analysis, market attractiveness analysis, and company share analysis along with key player’s complete profiles. The global healthcare analytical testing services market research report provides detailed information about the industry based on the revenue (USD MN) for the forecast period. This research study is a descriptive analysis of the healthcare analytical testing services market emphasizing the market drivers and restraints that govern the overall market growth. The trends and future prospects for the market are also included in the report which gives an intellectual understanding of the healthcare analytical testing services industry. Furthermore, the report quantifies the market share held by the major players of the industry and provides an in-depth view of the competitive landscape. The healthcare analytical testing services market is classified into different segments with detailed analysis of each with respect to geography for the study period. A glimpse of the major drivers and restraints affecting this market is mentioned below:   A. Drivers > Nutraceutical industry rising demand > Growing recognition of the QBD (quality by design) approach in pharma research/manufacturing   B. Restraints > Pricing competition faced by major player > Inadequate of expertise The report offers a value chain analysis that gives a comprehensive outlook of the healthcare analytical testing services market. The attractiveness analysis of healthcare analytical testing services market has also been included so as to evaluate the segments that are anticipated to be profitable during the forecast period. The report also studies the competitive landscape of the global market with company profiles of players such as Eurofins Scientific SE, SGS S.A., Charles River Laboratories International Inc., WUXI Pharmatech (Cayman) Inc., PPD Inc., Exova Group PLC, Pace Analytical Services Inc., Intertek Group PLC., Bioreliance Corporation, Source Bioscience, Envigo, Anabiotec, Medistri SA. A detailed description of each has been included, with information in terms of headquarters, inception, stock listing, upcoming capacities, key mergers & acquisitions, financial overview, and recent developments. This analysis gives a thorough idea about the competitive positioning of market players. The report also gives information of healthcare analytical testing services market’s mergers/acquisitions, partnerships, collaborations, new product launches, new product developments and other industry developments. View More about Healthcare Analytical Testing Services Market Research Report @ http://www.decisiondatabases.com/ip/6173-healthcare-analytical-testing-services-market-report   SEGMENTATIONS IN REPORT: 1. Market Analysis by Type: > Bioanalytical Testing Services > Physical Characterization Services > Method Validation > Raw Material Testing > Batch Release Testing Services > Stability Testing > Microbial Testing > Environmental Monitoring   2. Market Analysis by Sample: > Raw Materials > Finished Products > In-Process Samples > Environmental Samples   3. Market Analysis by End User: > Pharmaceutical And Biopharmaceutical Companies > Medical Device Companies > Contract Research Organizations   4. Market Analysis by Geography: > North America > Europe > Asia Pacific > Rest of the World DecisionDatabases.com is a global business research reports provider, enriching decision makers and strategists with qualitative statistics. DecisionDatabases.com is proficient in providing syndicated research report, customized research reports, company profiles and industry databases across multiple domains.   Our expert research analysts have been trained to map client’s research requirements to the correct research resource leading to a distinctive edge over its competitors. We provide intellectual, precise and meaningful data at a lightning speed.


News Article | March 2, 2017
Site: www.businesswire.com

WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD) today announced it has secured the fifth renewal of its long-standing contract with the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The original NIAID/DAIDS contract was awarded in 1990, and with the latest renewal, the relationship will extend until 2024. The renewed contract covers support for a broad scope of research related to HIV or HIV co-infections that includes monitoring therapeutic trials, prevention trials and vaccines work. As part of the relationship, PPD predicts risks to clinical trial participant safety and data integrity based on measures of site performance and other known risk factors. “The extension of this contract will allow PPD to provide important comprehensive clinical site and study monitoring services to the NIH in some of the most pivotal and exciting directions in AIDS research,” said William Sharbaugh, chief operating officer of PPD. “We are privileged to continue our collaborative relationship with the NIH, leveraging our considerable resources as one of the world’s largest CROs, while capitalizing on our in-depth knowledge of infectious diseases.” PPD’s most recent contracts, ranging between five and seven years, have involved monitoring for an average of 150 clinical studies per contract. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 18,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com. Except for historical information, all of the statements, expectations and assumptions, including statements, expectations and assumptions about PPD’s contracts awarded by the NIAID/DAIDS, contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based and could cause actual results to differ materially from the forward-looking statements. Other important factors that could cause future results to differ materially include the following: rapid technological advances that make our services or capabilities less competitive; the ability to attract, integrate, retain and train key personnel; competition in the outsourcing industry; PPD’s ability to win new business; overall global economic conditions; economic conditions, research and development spending, and outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; loss, delay or modification of large contracts; higher-than-expected cancellation rates; the rate of conversion of backlog into revenue; risks associated with and dependence on strategic relationships; risks associated with acquisitions and investments; the ability to control SG&A spending; compliance with drug development regulations; changes in the regulation of the drug development process; consolidation in the pharmaceutical and biotechnology industries; and actual operating performance. PPD assumes no obligation and expressly disclaims any duty to update these forward-looking statements in the future, except as required by applicable law. These forward-looking statements should not be relied upon as representing PPD’s estimates or views as of any date subsequent to the date hereof.


News Article | February 22, 2017
Site: www.businesswire.com

WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), today announced that it has entered into a collaboration with Frenova Renal Research, a leading drug and medical device contract clinical development services provider dedicated exclusively to renal research. “The opportunity to collaborate with Frenova enhances our ability to connect our clients with researchers recognized as world leaders in the field of nephrology and further strengthens our industry-leading global site and patient capabilities by helping to deliver seamless access to patients, sites and data sources,” said Ulrich Zoeller, vice president, project management, general medicine for PPD. “Frenova’s access to more than two-thirds of all U.S. nephrology patients, coupled with the breadth of its resources and experience in renal research, will enable PPD to continue to build on its already strong presence in nephrology trials.” As part of Fresenius Medical Care North America (FMCNA) - a leading provider of kidney care products and services, and a network of more than 2,200 dialysis centers nationwide - Frenova maintains a world-class network of resources encompassing 260 research sites with 450 principal investigators and access to more than 183,000 active ESRD patients and 390,000 active CKD patients. The breadth and depth of Frenova’s data access is rooted in FMCNA’s unmatched ability to gather and analyze immense amounts of patient data from within the company’s own care ecosystem. The company has collected data on more than 1 million patients, including data on more than 250 million dialysis treatments, more than 1 billion medication administrations and more than 1 billion laboratory results. “Our collaboration with PPD expands the reach of our nephrology experts and broadens the impact of our invaluable treatment data in clinical trials,” said Kurt Mussina, general manager, Frenova. “We are pleased to join forces with PPD through our shared commitment of improving the lives of patients living with kidney disease, around the world, through the advancement of renal research.” Through this relationship, PPD will offer its clients the therapeutic expertise of Frenova’s global nephrology experts, as well as access to F1RST Up™ (Frenova Rapid STart Up), Frenova’s exclusive alliance of research sites designed to streamline, initiate and enroll clinical studies dramatically faster than industry norms with just-in-time patient recruitment. Frenova is active in more than 260 sites across the United States, 15 of which are the proprietary F1RST Up sites with a strong track record of patient recruitment and retention. The F1RST Up sites use coordinated research processes that enable faster site startup and streamlined study execution. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 18,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com. Frenova is the world’s only drug and medical device contract clinical development services provider dedicated exclusively to renal research. As a Fresenius Medical Care North America company, Frenova manages a networked system of clinical research assets and resources including 450 principal investigators and 260 research sites with clinical trials in kidney disease and its adjacent medical conditions. For more information, visit www.FrenovaRenalResearch.com. Except for historical information, all of the statements, expectations and assumptions, including statements, expectations and assumptions about the collaboration with Frenova, contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based and could cause actual results to differ materially from the forward-looking statements. Other important factors that could cause future results to differ materially include the following: risks associated with and dependence on strategic relationships; rapid technological advances that make our services or capabilities less competitive; the ability to attract, integrate, retain and train key personnel; competition in the outsourcing industry; compliance with drug development regulations; changes in the regulation of the drug development process; PPD’s ability to win new business; overall global economic conditions; economic conditions, research and development spending, and outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; consolidation in the pharmaceutical and biotechnology industries; loss, delay or modification of large contracts; higher-than-expected cancellation rates; the rate of conversion of backlog into revenue; actual operating performance; risks associated with acquisitions and investments; and the ability to control SG&A spending. PPD assumes no obligation and expressly disclaims any duty to update these forward-looking statements in the future, except as required by applicable law. These forward-looking statements should not be relied upon as representing PPD’s estimates or views as of any date subsequent to the date hereof.


News Article | February 28, 2017
Site: www.businesswire.com

WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD) has established a Rare Disease and Pediatric Center of Excellence to oversee all rare disease and pediatric-related drug development activities. This new center of excellence provides pharmaceutical and biotechnology clients with a dedicated team of professionals focused on the design and execution of clinical trials that address the unique strategic, operational, medical and scientific challenges of clinical studies in rare disease and pediatric patient populations. PPD announced the new center of excellence on Rare Disease Day, which is observed on the last day of February each year to raise awareness of rare diseases. A disease is designated as rare in the United States when it affects fewer than 200,000 people, in Europe when it affects no more than five in 10,000 people and in Japan when it affects fewer than 50,000 people. In the U.S. and Europe alone, as many as 60 million individuals are affected by one of the more than 6,000 identified rare diseases. “Our new center of excellence builds on PPD’s longstanding expertise and experience to address the special drug development considerations of rare diseases and pediatrics,” said Karen Kaucic, M.D., PPD senior vice president and head of the center of excellence. “With a great majority of rare diseases touching children, we believe our approach will enable us to be a more connected and active partner. Our clients can depend on us for the latest trial design innovations, the ability to navigate complex trial logistics and our keen understanding of customized patient access strategies in low-prevalence, widely dispersed patient populations. We felt today was an appropriate time to introduce this new venture, as we join with the drug development community in recognizing Rare Disease Day.” Dr. Kaucic will leverage her leadership experience in rare diseases and pediatrics to drive the implementation of PPD’s center of excellence, leading a dedicated team with a wealth of expertise in rare disease trial design and execution in such disciplines as product development, clinical operations, commercial strategy and early engagement. The PPD team members in the center of excellence are seasoned pharmaceutical and clinical research professionals who have hands-on experience with rare diseases and pediatrics. The team is focused on addressing the specific challenges presented by the small, widely dispersed populations of rare disease and pediatric patients. This group of functional experts has been assembled to support end-to-end clinical trial solutions in such areas as feasibility strategy, clinical information, biostatistics, pharmacovigilance, lab operations and business analytics. PPD’s particular expertise in rare diseases stems from having conducted more than 220 studies with more than 50,000 patients over the past five years. PPD also is a leading clinical researcher in pediatric drug development, having conducted more than 400 clinical trials during the past five years, enrolling more than 97,000 patients across a wide range of therapeutic indications, including infectious diseases, respiratory, cardiology, oncology and immunology. PPD leverages a pediatric investigator network that further enhances its pediatric clinical development capabilities by providing clients with faster trial startup, more predictable patient enrollment and higher-quality data. For both rare disease and pediatric trials, PPD has deployed a purpose-built framework that ensures the application of best practices in study development and enables the company to develop a customized approach to address the unique needs of these trials. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 18,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com. Except for historical information, all of the statements, expectations and assumptions, including statements, expectations and assumptions about PPD’s Rare Disease and Pediatric Center of Excellence contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based and could cause actual results to differ materially from the forward-looking statements. Other important factors that could cause future results to differ materially include the following: risks associated with and dependence on strategic relationships; the ability to attract, integrate, retain and train key personnel; competition in the outsourcing industry; rapid technological advances that make our services or capabilities less competitive; compliance with drug development regulations; changes in the regulation of the drug development process; PPD’s ability to win new business; overall global economic conditions; economic conditions, research and development spending, and outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; consolidation in the pharmaceutical and biotechnology industries; loss, delay or modification of large contracts; higher-than-expected cancellation rates; the rate of conversion of backlog into revenue; actual operating performance; risks associated with acquisitions and investments; and the ability to control SG&A spending. PPD assumes no obligation and expressly disclaims any duty to update these forward-looking statements in the future, except as required by applicable law. These forward-looking statements should not be relied upon as representing PPD’s estimates or views as of any date subsequent to the date hereof.

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