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A busy end to 2017
WILMINGTON, N.C.—The fourth quarter of 2017 saw Pharmaceutical Product Development LLC (PPD) sharing news that the Clinical Research Support Services (CRSS) program of the Division of AIDS in the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, had awarded the company a seven-year contract. The contract covers support for the assessment and auditing of investigative sites and laboratories, as well as capacity building, biostatistics, site training and data management. Under the agreement, PPD will offer a variety of clinical and related research support services for the NIAID/DAIDS-supported clinical research portfolio, as well as other infectious diseases relevant to those with or at risk for HIV.
“We are pleased to help NIAID develop and maintain a strong clinical infrastructure to meet the needs of DAIDS’ scientific agenda,” said William Sharbaugh, chief operating officer of PPD, in a press release. “Our dedicated professionals are committed to supporting the agencies’ initiatives to improve health.”
This is hardly the first time PPD has worked together with a division of the NIH. PPD announced in March 2017 that they had extended their existing work with NIAID/DAIDS through 2024. This is the fifth renewal of that contract, which was originally established in 1990. The contract consists of support for a range of research related to HIV or co-infections, including monitoring therapeutic trials, prevention trials and vaccines work. In addition, PPD predicts safety risks to participants in clinical trials as well as risks to data integrity.
In other ‘extension’ news, Evidera, PPD’s peri- and post-approval business unit, recently announced that it had expanded its patient-centered research services to help clients better gather and incorporate patient perspectives into their drug development programs. Evidera’s offerings now include clinical outcome assessment; burden of illness studies; perceptions of treatment and quality of care; patient engagement; patient-centered benefit-risk assessment, preference, utility and adherence studies; technology (m/eHealth) validation studies; and related strategic and regulatory consulting. The new complement of services is expected to allow companies to gain a more complete grasp of the patient experience, from burden of illness to unmet needs and treatment preferences, in order to produce more patient-centered trial designs.
“The patient’s voice always has been core to Evidera’s work,” Dr. Nancy Kline Leidy, Evidera’s senior vice president of scientific affairs, remarked in a press release. “Our team of health outcomes research scientists is the largest in the field, with more than 20 years of experience in COA science and strategy. This new suite of patient-centered services builds on this expertise and will enable our clients to effectively navigate this new world of patient-focused drug development and value-based market access.”
“Evidera’s emphasis on patient engagement addresses the need for patient-centered evidence, which is increasingly required by key stakeholders and decision-makers,” added Dr. Margaret Vernon, vice president and general manager of the patient-centered research team. “Our aim is to leverage our regulatory insights and scientific expertise to help our clients successfully engage patients throughout the drug development process.”
The end of 2017 brought some awards with it as well for PPD. At the 2017 TOPRA (The Organization for Professionals in Regulatory Affairs) Awards in London, also held in the fourth quarter of the year, PPD took home two honors for excellence in regulatory affairs.
Evolus Inc. nominated the Evolus-PPD team for the TOPRA Award for Support, which acknowledges the pivotal role of supporting organizations in drug developing. PPD has provided Evolus with an end-to-end service solution that includes scientific advice through to clinical trials and the filing of global marketing applications.
The second award, the TOPRA Award in the Contribution category, was received by Dr. Clare Ryder, PPD’s associate director of regulatory affairs. This award highlights significant, consistent contributions to a team, project, regulatory science or the profession. Ryder, a member of the Evolus-PPD team, was acknowledged for meeting clients’ deadlines with regards to submitting marketing applications.
“PPD’s regulatory affairs teams are committed to the pursuit of excellence in providing regulatory intelligence for product development and registration strategies and ensuring high-quality submissions to regulatory authorities,” Sharbaugh remarked. “Congratulations to our employees for being recognized as industry leaders for their expertise and efforts to help our clients improve patient health.”
PPD was recognized at another award event in the same quarter. The fourth annual World ADC Awards, which celebrate distinction within the field of antibody-drug conjugate research, were held in conjunction with the 2017 World ADC San Diego Conference. At the event, PPD was named Best CRO Provider, an award that “acknowledges the excellence and dedication of PPD Laboratories professionals in supporting clients’ antibody-drug conjugate research to develop new anticancer therapies,” as noted in a press release.
“This award is evidence that PPD Laboratories’ employees are at the leading edge of ADC research and are driven to help clients succeed in combating cancer,” Dr. Chris Fikry, executive vice president of PPD Laboratories for PPD, commented in a statement. “In the past five years, the bioanalytical lab has completed more than 5,000 studies, providing vital pharmacokinetic, pharmacodynamic and immunogenicity data to support our clients’ efforts to develop new medicines to improve health.”