PPD, Inc. provides drug development services to the biopharmaceutical industry, focused on helping its customers bring their new medicines to patients worldwide.
The company provides a comprehensive suite of clinical development and laboratory services to pharmaceutical, biotechnology, medical device, and government organizations, as well as other industry participants. It serves across a broad range of rapidly growing areas of the drug development industry and engages with its customers throug...
PPD, Inc. provides drug development services to the biopharmaceutical industry, focused on helping its customers bring their new medicines to patients worldwide.
The company provides a comprehensive suite of clinical development and laboratory services to pharmaceutical, biotechnology, medical device, and government organizations, as well as other industry participants. It serves across a broad range of rapidly growing areas of the drug development industry and engages with its customers through a variety of commercial models, including both full-service and functional service partnerships and other offerings tailored to address the specific needs of its customers.
Segments
The company operates through two segments, Clinical Development Services and Laboratory Services.
The company’s service offerings include both clinical development and laboratory services. Its clinical development services include all phases of development (i.e., Phases I-IV), peri- and post-approval and site and patient access services. The company’s laboratory services offer a range of high-value, advanced testing services, including bioanalytical, biomarker, vaccine, good manufacturing practice (GMP) and central laboratory services.
In 2019, the company were involved in 87 drug approvals. The company, through its Accelerated Enrollment Solutions (AES) delivery model, it focuses on meeting the unique feasibility, site start-up and patient recruitment needs of each study. The company address these complex needs by leveraging large data sets, including identified and consented personal data and its global site network spanning five continents
In 2020, AES developed and deployed an innovative technology platform to prescreen clinical trial patients online, in real time and worldwide, without having to visit a clinical research site in person, allowing the clinical trials that AES supports to continue largely uninterrupted during the novel coronavirus disease (COVID-19) pandemic.
During 2020, in connection with new COVID-19 vaccines and therapeutic studies, the company leveraged its scientific expertise and data to optimize and adapt study design and site selection to account for new and emerging COVID-19 pandemic hotspots.
The company has collaborated with two of its investees, Science 37, Inc. and Medable, Inc., to enable the application of digital technologies to the clinical trial process, to reduce patient burden, and to remove inefficiencies. The company maintains a strong presence of experienced professionals in all key regions and countries necessary to support its customers’ global drug development programs.
Strategy
The key elements of the company’s growth strategy are to further strengthen its offerings in existing and new markets; expand leading therapeutic expertise in existing and novel areas; build upon its existing dedicated biotech offering; increase use of its innovative site network and patient enrollment platform; and developed a significant and growing number of assays to address the testing needs of gene therapy, and several molecular, serology and functional assays; and continue to invest in innovation.
Services
The company provides drug development services to the biopharmaceutical industry, offering comprehensive, integrated clinical development and laboratory services to its customers. It provides its services through its Clinical Development Services and Laboratory Services segments. Within each segment, the company offers numerous services and solutions for its customers, and across segments its offerings are complementary so that customers may optimize their development programs and maximize value and outcomes by accessing its full suite of offerings.
Clinical Development Services
The company’s Clinical Development Services offerings span the lifecycle of clinical product development and include:
Product development and consulting services
The company specializes in developing integrated product development strategies that provide biopharmaceutical companies with interdisciplinary preclinical, chemistry, manufacturing and controls, clinical and regulatory road maps for the development and marketing of their products and product candidates through the global product life cycle. Its services are designed to speed its customers’ product candidates to market with reduced operational risk and increased visibility of reimbursement and commercial potential. The company’s team of physicians, scientists, regulatory professionals and biostatisticians with pharmaceutical expertise offers specialized guidance across all major therapeutic areas, including oncology, cardiovascular disease and critical care, neurology and psychiatry, infectious diseases, inflammatory and metabolic diseases and across a range of specialized disciplines, including cell and gene therapies, vaccines, biosimilars, pediatrics and rare diseases.
Early development services
The company provides comprehensive support to early clinical development programs, including Phase I trials. It conducts early-phase studies at in-patient clinical facilities in Austin, Texas, Las Vegas, Nevada and Orlando, Florida. The company complements these Phase I clinical research units with a global network of affiliated clinical trial sites, which provide access to numerous special populations and disease indications and a fully integrated early development services team that provides streamlined program management, clinical monitoring, data management, biostatistics, clinical pharmacology, medical writing, regulatory and pharmacovigilance support. The company has particular experience in the conduct of first-in-human studies and has specialized capabilities for laboratory assessments, including advanced flow cytometry, allowing rapid measurement of cell surface biomarkers. It also has capabilities to conduct glucose clamp and other endocrinology and metabolic study assessments.
Phases II-IV clinical trial management
The company provides full service protocol management for Phases II-IV clinical research studies for investigational new drugs, biologics and medical devices. The core of its Clinical Development Services offering is a comprehensive global suite of services for Phases II-IV clinical trials. These services include protocol design; clinical trial strategic feasibility and investigator site selection; project management; site study startup activities; patient recruitment; clinical monitoring and data capture; data management; biostatistics; safety medical monitoring/pharmacovigilance; regulatory affairs; medical writing; gobal clinical supplies, including depots in Kiev, Ukraine; Moscow, Russia; Johannesburg, South Africa; and Athlone, Ireland; eClinical services; quality assurance; and virtual and digitally enabled trial solutions.
The company provides these services under a variety of outsourcing models, including the traditional full-service model for which it provides all or substantially all of these services to its customers by trial or asset. The company also offers its services through an functional service provider (FSP) model in which it provides specific services by function ranging from staff augmentation to functional services across multiple trials, globally or by region. The company provides bespoke offerings with tailored services that are flexible and innovative to meet the specific needs of its customers.
In addition to managing trials for biopharmaceutical and biotechnology customers, the company provides clinical trial services to the U.S. government, including the National Institute of Allergy and Infectious Diseases (NIAID) under the National Institute of Health. It provides support to the NIAID Division of AIDS, including monitoring services at domestic and international sites, laboratory audits, Good Laboratory Practice (GLP) training and quality management, biostatistics and data management. The company also supports other U.S. government research priorities, such as developing a vaccine for the Zika virus and assisting in the development of a vaccine for COVID-19 and the ongoing development of COVID-19 therapies, through subcontracts with other U.S. government contractors.
The company has extensive expertise and experience in numerous therapeutic areas, including oncology/hematology, infectious diseases, vaccines, respiratory diseases, metabolic/endocrine, neuroscience, pediatric, cardiovascular, analgesia, gastroenterology, rare diseases, and general medicine, including chronic ambulatory conditions.
Accelerated Enrollment Solutions
The company’s AES business unit includes a unique-in-industry patient recruitment capability, coupled with a large independent network of dedicated clinical research investigator sites. Through AES, the company offers services to complement the traditional site selection model, speeding study enrollment through efficient and predictive centralized recruitment while leveraging its network sites exclusively or in conjunction with independent investigators. This model allows it to identify patients who may benefit from specific trial participation at significantly higher rates than a traditional site model alone. Its SynexusPlus offering is an adaptable solution that allows the company to provide more patients per site, with faster study startup and a reduction in the number of sites using a results-based single-price-per-patient model. SynexusPlus may be combined with its core global clinical trial management services to create PatientAdvantage, a fully outsourced trial solution that is designed to offer patient enrollment and budget certainty, as well as speed and cost savings, through streamlined contracting terms, capitated budget constructs, fewer sites and reduced recruiting time.
Peri- and post-approval services
The company, through this offering, it provides real-world research and evidence-based solutions to demonstrate the real-world effectiveness, safety, and value of biopharmaceutical and biotechnology products. It provides its customers with critical scientific expertise and insight across the development continuum of a product, from early development through loss of exclusivity, with a primary focus on demonstrating the real-world effectiveness, safety and value of treatments. The company specializes in engaging with key market constituents early in the development process to create an evidence strategy that will meet the needs of all relevant stakeholders.
Medical communications
The company provides industry inbound and outbound peri- and post-approval contact center solutions focused on medical and clinical support to the biopharmaceutical industry. Its multidisciplinary team, consisting of highly trained health care professionals, including physicians, pharmacists, nurses and life science graduates, provides medical and technical information to its customers’ patients with a focus on compliance, quality and delivery. It supports full portfolios of marketed products, providing local language expertise, as well as a global reach. Live customer question and answering services are provided in multiple languages covering the major markets in which the company’s customers sell their pharmaceutical products. Using dedicated teams, its programs are customized and flexible to meet each customer’s evolving needs.
Laboratory Services
The company owns and operates an integrated and scaled suite of laboratory services. It offers a range of high value, advanced testing services, including bioanalytical, biomarker, vaccines, GMP and central laboratory infrastructure to support research and development (R&D). Throughout the drug development cycle, its customers benefit from global, comprehensive laboratory services. The company’s laboratory services accelerate drug development for small molecules, biologics and cell and gene therapies. It provides in each of the GMP, bioanalytical and central laboratory services sectors, as well as in the growing vaccines market.
Bioanalytical Laboratory Services
The company provides bioanalytical services through its highly automated locations in Richmond, Virginia and Middleton, Wisconsin that are designed to be compliant with GLPs. Its bioanalytical laboratories analyze drug and metabolite concentrations from biological fluid and tissue samples within preclinical and human clinical studies. The company’s bioanalytical methods include liquid chromatography combined with mass spectrometry (LC-MS) and high-resolution mass spectrometry, high performance liquid chromatography, ligand-binding, enzyme-linked immunosorbent assay, radioimmunoassay, flow cytometry and cell-based assay support. Its bioanalytical laboratories support the complete service necessary for biologic, small molecule, oligonucleotide and cell and gene therapy development. This includes pharmacokinetic evaluation of the therapeutic agent, immunogenicity testing to determine the presence of antibodies, and cell-based assays to determine the neutralizing antibody effect of the antibodies. The company has the proven ability to handle an increasingly diverse range of large molecules, which include therapeutic peptides, monoclonal antibodies and antibody drug conjugates (ADCs), as well as new areas, such as glycans and biotransformation.
Biomarker laboratory services
The company’s biomarker laboratory core facility is located in Richmond, Virginia. The laboratory is closely aligned with both the central laboratories and bioanalytical laboratories to provide customized solutions for biomarker projects. The capabilities include LC-MS, ligand binding, flow cytometry and molecular genomics. Its technologies and applications enable the biomarker laboratory to develop or transfer methods and either perform sample analysis within the biomarker laboratory or transfer validated methods to the central laboratory or Phase I clinic as needed.
Vaccine science services
The company performs testing for vaccines in its dedicated facility located in Richmond, Virginia. Its scientists perform immunogenicity testing to evaluate the efficacy of vaccines in inducing cellular and humoral immune responses and employ molecular detection methods, such as polymerase chain reaction testing to detect the absence of pathogens or to characterize attenuated vaccine strains following administration of a vaccine. The company’s service offering also includes providing dedicated laboratory space to conduct complex proprietary assays in support of multiple vaccine programs.
GMP Laboratory Services
The company provides early preclinical development through post-approval testing services and product analysis laboratory services through its locations in Middleton, Wisconsin and Athlone, Ireland that are designed to be compliant with GMPs. Its product analysis services include analytical method development and validation, stability and quality control testing of product and pharmaceutical ingredients and impurities characterization for small molecules and biologics for all dosage forms, as well as analytical testing of biopharmaceuticals, inhalation devices and cell and gene therapies. The company’s Athlone laboratory offers the advantage of proximity to its growing number of European customers and allows it to conduct release testing of products to be marketed in Europe for its global customers.
Central laboratory services
With facilities in Highland Heights, Kentucky, Brussels, Belgium, Singapore and Shanghai, China, the company’s central laboratories provide highly standardized safety and biomarker testing services with customized results databases for its customers. The company focuses on providing long-term, large-scale studies where laboratory measurement of clinically relevant endpoints is critical. Its central laboratories utilize the same standard operating procedures and maintain identical instruments in every facility. All of its facilities are College of American Pathologists (CAP) accredited, and National Glycohemoglobin Standardization Program (NGSP) and Centers for Disease Control and Prevention (CDC) lipid standardization survey (LSP) certified. All its facilities run the same CAP proficiency tests on a quarterly basis. In addition to these industry quality standards, the company runs its own unique global laboratory assay standardization survey program monthly on its most common analyses, ensuring continuity and consistency of data at all stages of a clinical project. It also standardizes data collection and reporting on a global basis utilizing the same software platform, its Preclarus central laboratory database. This platform provides real-time data and eliminates the need to merge data sets from different regions. The company’s laboratories provide on-site biorepository services that enable storage and archiving of samples for future testing, including specialized biomarker testing of specific patient populations to speed drug discovery and development efforts. In 2018, the company formed a global strategic alliance for pathology and molecular testing solutions with NeoGenomics to provide a fully integrated global pathology and molecular testing solution to its customers, further expanding its central laboratory services related to oncology clinical trial activities.
Intellectual Property
The company has applied for and/or obtained and maintain registration in the United States and other countries for numerous trademarks, including PPD, PPD Biotech, PPD Laboratories and Preclarus.
Government Regulation
Regulation of Drugs and Biologics
The development, testing, manufacturing, labeling, storage, approval, promotion, marketing, distribution and post-approval monitoring and reporting of pharmaceutical, biological and medical device products are subject to rigorous regulation by numerous governmental authorities in the United States at the federal, state and local level, including the United States Food and Drug Administration (FDA), as well as those of other countries, such as the European Medicines Agency (the EMA) in the European Union, the Medicines and Healthcare products Regulatory Agency (the MHRA) in the United Kingdom, the National Medical Products Administration (NMPA) in China and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. These regulations apply to the company’s customers and are generally applicable to it when the company is providing services to its customers, either as a result of their direct applicability, through a transfer of regulatory obligations from its customers, or as a consequence of acting as local legal representative on behalf of its customers in a particular country or countries. Consequently, the company must comply with all relevant laws and regulations in the conduct of its Clinical Development Services and Laboratory Services segments.
The company’s global standard operating procedures are written in accordance with all applicable FDA, EMA, MHRA, NMPA, PMDA, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP) requirements. This enables its work to be conducted locally, regionally and globally to standards that meet all applicable regulatory requirements.
Regulation of Testing Facilities
The company’s laboratories that provide information included in investigational new drug applications (INDs), New Drug Applications (NDAs), Biologics License Applications (BLAs) and other regulatory submissions must conform to regulatory requirements designed to ensure the quality and integrity of the testing process and data. The company’s bioanalytical laboratories follow the GLP requirements adopted by the FDA, the Ministry of Health in the United Kingdom and by similar regulatory authorities in other countries, as applicable. Its product analysis laboratories follow the GMP requirements adopted by the FDA and by similar regulatory authorities in other countries. Both GLPs and GMPs require standardized procedures for all equipment, processes and analytical tests, for recording and reporting data, and for retaining appropriate records. To help ensure compliance with GLPs and GMPs, the company has established standard operating procedures, working practice documents and processes, and has quality assurance personnel at its laboratory facilities to audit test data and inspect testing procedures, laboratory equipment and facilities. The possession, retention, use and disclosure of such information is highly regulated, both in the United States and the other jurisdictions the company is subject to, including applicable regulations arising from the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH), and the Privacy, Security and Breach Notification Rules, 45 C.F.R. Parts 160-164, that implement those laws; U.S. state privacy, security and breach notification and healthcare information laws; and the E.U. General Data Protection Directive (the GDPR) and the U.K. Data Protection Act 2018.
Other Regulations
The company is subject to numerous additional national laws, rules and regulations, including those enforced by the following U.S. agencies, such as Occupational Safety and Health Administration; Nuclear Regulatory Commission; Environmental Protection Agency; Department of Transportation; International Civil Aviation Organization; Department of Health and Human Services; and U.S. Drug Enforcement Administration (the DEA).
The company’s laboratories registered with the DEA may receive and manage controlled substances for research purposes. The DEA regulates controlled substances under the Controlled Substances Act, the Controlled Substances Import and Export Act and other laws and the regulations that implement such laws. Its laboratories registered with the DEA include clinical pharmacology units in Austin, Texas and Las Vegas, Nevada; bioanalytical laboratories in Middleton, Wisconsin and Richmond, Virginia; and GMP laboratory in Middleton, Wisconsin.
The company’s laboratory in Athlone, Ireland is registered with the Irish Health Products Regulatory Authority and may receive and manage controlled substances.
Anti-Corruption Laws and Regulations
The company is subject to various U.S. and non-U.S. anti-corruption laws, including the U.S. Foreign Corrupt Practices Act (the FCPA) and the U.K. Bribery Act 2010 (the Bribery Act). The FCPA and the Bribery Act prohibit the company and its officers, directors, employees and third parties acting on its behalf, including agents, from corruptly offering, promising, authorizing or providing anything of value to a foreign official for the purposes of influencing official decisions or obtaining or retaining business or otherwise obtaining favorable treatment. The FCPA further requires the company to make and keep books, records and accounts that reflect transactions and dispositions of assets and to maintain a system of adequate internal accounting controls. The Bribery Act also prohibits commercial bribery and accepting bribes.
The company’s global business operations also must be conducted in compliance with applicable export controls and economic sanctions laws and regulations, including those administered by the U.S. Department of the Treasury’s (the U.S. Treasury) Office of Foreign Assets Control, the U.S. Department of State, the U.S. Department of Commerce, the United Nations Security Council, the European Union, Her Majesty’s Treasury and other relevant sanctions authorities.
Significant Event
In April 27, 2021, PPD, Inc., a leading global contract research organization (CRO), and Science 37, developer of the Decentralized Clinical Trial Operating System (DCT OS), today announced a collaboration in which PPD will be fully enabled to design, build, test, implement, and execute digital trials using Science 37's DCT SaaS-based technology platform.
History
PPD, Inc. was founded in 1985. The company was incorporated in 1989.
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