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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.


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.


A chute assembly for directing cement from a cement truck is disclosed. The chute comprises an elongate chute of generally u-shaped cross section fabricated from UHMWPe and comprising an upper end and a lower end, a plurality of reinforcing rods arranged along a length of and encased within the UHMWPe, one end of each of the rods adjacent the upper end and another end of each of the rods adjacent the lower end, a pair of u-shaped collars, an upper one of the collars adjacent the upper end and a lower one of the collars adjacent the lower end, and a fastener for securing each of the collars to their respective rod ends. A method of fabrication is also disclosed.


News Article | June 27, 2017
Site: www.businesswire.com

WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD) today announced it has appointed Christopher C. Fikry, M.D., as executive vice president of PPD® Laboratories. PPD Laboratories offers the most comprehensive set of laboratory services in the industry, spanning bioanalytical, biomarkers, central lab, GMP and vaccine sciences. From preclinical studies through late stage research, PPD Laboratories’ services are designed to accelerate development for small molecules, biologics and vaccines. “Chris will apply his extensive industry experience and leadership skills to guide the continued growth of our laboratory business by ensuring exceptional quality and service for our clients,” said William Sharbaugh, chief operating officer for PPD. “With pharmaceutical and biotech companies’ needs in clear focus, Chris and our talented lab teams will continue to bring our clients world-class scientific expertise, state-of-the-art technology and a commitment to innovation in helping develop new life-changing therapies.” Fikry joins PPD from Quest Diagnostics, where he served most recently as vice president and general manager for oncology and companion diagnostics. He took on this role after having served as vice president of clinical trials, a role in which he led the company’s central laboratory, biomarker and companion diagnostic services. Previously, Fikry was with Novartis Vaccines and Diagnostics, Inc., where he developed a track record of success in a variety of roles, including director of strategic planning, head of U.S. influenza, travel vaccine and meningococcal vaccine franchises and commercial leadership roles, including vice president of U.S. marketing. He began his career as a project leader with The Boston Consulting Group. Fikry earned a bachelor’s degree in biology from New York University and a medical degree and MBA from the University of Pennsylvania. 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 PPD’s new leader of PPD® Laboratories, 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 | June 8, 2017
Site: www.businesswire.com

WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD) today announced industry accolades earned by PPD clinical research associates (CRAs), recognizing their expertise in the endeavor of developing life-changing medicines. A four-person team of PPD CRAs won the gold award for Clinical Research Team of the Year at the PharmaTimes International Clinical Researcher of the Year in London. And at the PharmaTimes Clinical Researcher of the Year—The Americas competition, two PPD CRAs were honored in Seattle, Washington. Both competitions were a culmination of a demanding year long, three-part series of tests, including real-life challenges judged by industry leaders. The industry recognition demonstrates the high caliber of PPD’s clinical research associates and PPD’s award-winning training and development programs, such as the Virtual Clinical Foundations Program 2.0, which help to prepare research professionals for successful clinical trial monitoring, and to deliver performance, quality and value to clients and their studies. “PPD’s clinical researchers are focused on and dedicated to providing the best for their clinical trials and our clients,” said Roger Newbery, senior vice president of clinical management for PPD. “I am proud that their talent and hard work has been recognized in this way.” In London, the PPD team was awarded gold at the event finale on May 18. At the celebration in Seattle, the PPD CRAs received the gold award in the Experienced CRA category and the bronze award in the New CRA category. The event was created in 1999 to provide clinical research professionals an opportunity to benchmark their professional skills against their peers in a program of competency-based exercises developed through cross-industry collaboration. 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 PPD services and the honors the company 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.


News Article | May 11, 2017
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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.


SAN FRANCISCO, CA and LONDON, UNITED KINGDOM--(Marketwired - Sep 20, 2017) - Treos Bio Limited, which is developing precision peptide cancer vaccines coupled with companion diagnostics, today announced it has entered into an agreement with Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization. As part of the agreement, PPD® Biotech, a PPD service dedicated to biotech and small to mid-sized pharmaceutical companies, will manage Treos Bio's first-in-man study of its lead therapeutic cancer vaccine for metastatic colorectal cancer. This study will be conducted in the United States and Europe. "We are advancing our lead program for metastatic colorectal cancer because patients face a grim prognosis today with existing treatment options and there is an urgent need to change that," said Dr. Dong Wei, Chief Operating Officer of Treos Bio. "We are on track to submit an application in the near term to the U.S. Food and Drug Administration to begin for these patients our first human clinical trial, which will transform Treos Bio into a clinical-stage company." Treos selected PPD because of its clinical development expertise in immune-oncology and vaccine trials. "PPD Biotech has partnered with more than 750 biotech clients to help them meet their asset and portfolio development goals," said Rob Dow, PPD's Chief Medical Officer. "Treos Bio is at an exciting crossroad of clinical development, and we are committed to helping advance this novel product candidate through clinical development." In addition to the colorectal cancer vaccine, Treos Bio has completed preclinical development of six other cancer vaccine products with companion diagnostics to select likely responders. These precision vaccines will be developed for the treatment of breast cancer, lung cancer, ovarian cancer, glioma, melanoma and leukemia. Preclinical data suggest that these products will likely have low toxicity and high disease control rates. Despite the promise of using immunotherapies to harness the body's immune system to fight cancer, most cancer vaccines have failed at the clinical stage and have benefitted only a small subset of patients. Treos Bio's research demonstrated that the failures in cancer vaccine efficacy are caused by their poor design. Treos Bio's understanding of the genetics that drive the immune responses against cancer support the digital development of vaccines that can mount a powerful immune response to kill tumor cells in a large subset of patients. Treos Bio's algorithms and databases are at the heart of its innovative Cancer Vaccine Technology used for the development of its vaccines and to predict their clinical outcomes. Each cancer consists of a diverse mix of cells and each person's immune system generates an individualized response against each specific cancer cell type. This results in extreme variabilities of interactions between people's immune systems and their cancers. Treos Bio's team of scientists has created algorithms to analyze billions of genes and compute patients' immune responses against their specific types of cancer. Treos Bio's precision vaccines expect to induce optimized immune responses to kill a broad mixture of cancer cells without attacking any healthy cells. About Treos Bio Limited Treos Bio uses computational biology to develop its precision therapeutic cancer vaccines, with substantially shortened development timeline and lowered cost. In contrast to presently available cancer immunotherapies, Treos Bio's therapeutic vaccines are designed to be safe and effective as an "off the shelf" therapy for a significant portion of patients of a particular type of cancer, identified by its companion diagnostic tests as most likely to respond. The company is headquartered in London, with operation subsidiaries in San Francisco, U.S., and in Budapest, Hungary. More information can be found at www.treosbio.com. About PPD 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 approximately 20,000 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. More information can be found at www.ppdi.com.

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