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PPD Expanding Clinical Development and Laboratory Capabilities in China

2020年01月09日 PM11:00
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WILMINGTON, N.C.

PPD, Inc. (PPD) has expanded its operations and leadership team in China to provide enhanced clinical development, laboratory, regulatory, site conduct, patient access and post-approval services for international and China-based biopharmaceutical companies.

PPD’s expansion includes enlarging its clinical development offices in Beijing and Shanghai and opening new offices in Guangzhou and Shenyang. In 2020, PPD® Laboratories plans to open a multifunctional lab in China offering bioanalytical, biomarker and vaccine sciences services. In addition, the company’s Accelerated Enrollment Solutions (AES) business – which offers distinctive site conduct and patient access solutions – added China to its global footprint for delivery of performance-based enrollment solutions for chronic ambulatory trials, leveraging its partnership with more than 300 hospitals in China.

PPD’s growing operations in China are being led by a new in-country leadership team with extensive experience across the pharmaceutical and biotech industry and in China and the Asia-Pacific region.

“Recent regulatory changes streamlining the drug development approval process in China have positioned the country as a key location for conducting clinical trials for many global studies,” said David Johnston, Ph.D., executive vice president, global clinical development at PPD. “Our expanded operations in China enhance our ability to provide multinational pharmaceutical companies with expanded access to the country’s evolving drug development and post-marketing ecosystem and to support Chinese biotechnology companies conducting trials in the global market.”

To oversee the expansion in China, PPD named Ding Ming, Ph.D., as vice president and general manager of the company’s China operations, bringing more than 20 years of industry experience. Dr. Ming provides leadership for the spectrum of PPD services within China, including global clinical development, PPD Laboratories, AES, Evidera – PPD’s peri- and post-approval business – and China-based commercial and functional support teams.

Di Cindy Wu has been named executive director of PPD Laboratories to provide direct oversight of the company’s lab operations in China and Singapore, maintain global consistency and continuity across the company’s lab operations, and ensure high-quality data for trials. Wu has 18 years of contract research organization experience.

“The new laboratory we plan to open in China this year will significantly enhance our capabilities in the Asia-Pacific region, where we already have central labs in Shanghai and Singapore,” said Christopher Fikry, M.D., executive vice president of PPD Laboratories. “Because it will include bioanalytical, biomarker and vaccine laboratory capabilities combined in one location, this new facility will enable us to better support the global needs of our customers and further establish PPD as a leading drug-development laboratory in China.”

PPD renovated and significantly enlarged the size of its clinical development operations in Beijing and Shanghai, and opened new offices in Guangzhou and Shenyang last year to support the increased number of ongoing clinical trials and help develop optimized regulatory and access strategies. In August 2019, PPD launched a pharmacovigilance hub in Shenyang to provide centralized services, such as full lifecycle safety monitoring capabilities and extensive expertise in China’s regulatory environment, to support growing clinical research needs in the country.

PPD’s regulatory affairs team is experienced with the continuing regulatory reforms in China and has a strong track record in helping customers achieve success in the country. The company’s established foundation of full-service support in conducting trials in China for more than 20 years positions PPD to facilitate efficient and robust generation of the evidence of value, safety and effectiveness needed to obtain approval and access in the Chinese market. PPD contributed to more than 25 regulatory approvals in China last year.

About PPD

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and approximately 23,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help customers bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health. For more information, visit www.ppdi.com.

This news release contains forward-looking statements. These statements often include words such as “anticipate,” “expect,” “suggest,” “plan,” “believe,” “intend,” “project,” “forecast,” “estimates,” “targets,” “projections,” “should,” “could,” “would,” “may,” “might,” “will,” and other similar expressions. Although we believe that these forward-looking statements are based on reasonable assumptions at the time they are made, you should be aware that many factors could affect our actual financial results, and therefore actual results might differ materially from those expressed in the forward-looking statements. Factors that might materially affect such forward-looking statements include: the fragmented and highly competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; our ability to keep pace with rapid technological changes that could make our services less competitive or obsolete; political, economic and/or regulatory influences and changes; any failure of our backlog to predict or convert into future revenue; the fact that our customers can terminate, delay or reduce the scope of our contracts with them upon short notice or with no notice; the impact of industry, customer and therapeutic area concentration; our ability to accurately price our contracts and manage our costs associated with performance of such contracts; any failures in our information and communication systems, impacting us or our customers, clinical trial participants or employees; any failure to perform services in accordance with contractual requirements, regulatory standards and ethical standards; our ability to recruit, retain and motivate key personnel; our ability to attract suitable investigators or enroll a sufficient number of patients for our customers’ clinical trials; any failure by us to comply with numerous privacy laws; our dependence on third parties for critical goods and support services; our dependence on our technology network, and the impact from upgrades to the network; any violation of laws, including laws governing the conduct of clinical trials or other biopharmaceutical research, and anti-corruption laws; competition between our existing and potential customers and the potential negative impact on our business; our management of business restructuring transactions and the integration of acquisitions; risks related to the drug development services industry that could result in potential liability; any failure of our insurance to cover the potential liabilities associated with the operation of our business and provision of services; our use of biological and hazardous materials, which could result in liability; international or U.S. economic, currency, political and other risks; economic conditions and regulatory changes from the United Kingdom’s proposed exit from the European Union; any inability to adequately protect our intellectual property or the security of our systems and the data stored therein; consolidation amongst our customers, and the potential for rationalization of the combined drug development pipeline, resulting in fewer products in clinical development; any patent or other intellectual property litigation we might be involved in; changes in tax laws, or interpretations of existing tax laws; our investments in third parties; the substantial value of our goodwill and intangible assets, which we might not fully realize, resulting in impairment losses; difficult and volatile conditions in the capital and credit markets and in the overall economy; risks related to our indebtedness; the significant influence of certain significant stockholders over us; and other factors. We assume no obligation and disclaim 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200109005493/en/

CONTACT

Media:

Randy Buckwalter

+1 919 456 4425

randy.buckwalter@ppdi.com

Investors:

Thomas Wilson

+1 910 558 6423

thomas.wilson@ppdi.com

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