Using adaptive trial design for a flexible, more intuitive approach to advance drug development programs
WILMINGTON, N.C. & COLLEGE STATION, Texas--(BUSINESS WIRE)-- PPD, Inc. (Nasdaq: PPDI) and Berry Consultants, LLC today announced they have entered into a collaboration in the area of Bayesian statistics, providing biopharmaceutical companies an innovative, efficient way to improve the speed and quality of decision making for their clinical development programs.
As part of the agreement, Berry Consultants will collaborate with PPD in Bayesian design and analysis, areas of adaptive trial design that are bringing significant changes to how clinical research is conducted. In return, PPD will assist in expanding Berry Consultants’ client base within the biopharmaceutical industry.
The agreement strengthens PPD’s ability to deliver flexible, efficient adaptive trial designs across the full drug development continuum, including biosimilars, through its PPD® Consulting services. PPD has supported adaptive designs across a number of pharmaceuticals and biologics spanning several indications, including inflammatory and infectious diseases and cancers. The company’s expertise encompasses trial design and endpoints, nonclinical comparability, regulatory strategy, and statistical design and consulting. Expanding its capabilities in Bayesian design allows PPD and its clients to use statistical inference, or evidenced-based methods, to calculate the probability of a hypothesis and make faster, more accurate development decisions based on that hypothesis.
Berry Consultants are experts in Bayesian statistics, a mathematically rigorous and principled methodology that provides increased flexibility and modeling. It allows companies to make better decisions in drug development and frequently reduce the time and expense needed to obtain more scientifically rigorous results.
“There is a strong need across the pharmaceutical industry to continue to evolve the use of flexible trial designs based on predictive modeling and real-time information processing, while continuing to protect scientific integrity,” said Christine Dingivan, M.D., chief medical officer of PPD. “With world-renowned experts in Bayesian statistics, Berry Consultants has set the standard for this type of design and analysis across our industry. We are pleased to extend our capabilities in this area and foster product development innovation through this collaboration.”
Don Berry, Ph. D., founder and senior statistical scientist of Berry Consultants, said, “The Bayesian approach is an innovative way to design clinical trials, providing biopharmaceutical companies an efficient model in which to make informed decisions about progressing their clinical programs. Incorporating Bayesian statistical models into clinical designs, frequently through adaptive designs, can often save valuable time in clinical development by reducing the number of patients required for participation in a clinical study, but more importantly by using an appropriate number to make critical development decisions.”
Earlier this month, PPD announced it had expanded its PPD Consulting services across four practice areas—adaptive trial design, biosimilars, cardiovascular outcomes studies and China regulatory strategy—building on the company’s ability to help clients meet unique product development challenges across multiple disciplines.
PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 44 countries and more than 11,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com.
About Berry Consultants
Berry Consultants is a statistical consulting group specializing in adaptive clinical trial design in pharmaceutical and medical device research and development. We are leaders in the Bayesian approach to medical statistics. This approach is radically changing the way research is done throughout the medical industry (device and drug development). We employ world renowned experts in Bayesian statistics and strive to set the standard for Bayesian design and analysis in the statistical and medical communities.
Except for historical information, all of the statements, expectations and assumptions, including expectations and assumptions about the collaboration between PPD and Berry Consultants, 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 which could cause future results to differ materially include the following: risks associated with and dependence on strategic relationships; research and development spending and outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; compliance with drug development regulations; changes in the regulation of the drug development process; the ability to attract, integrate and retain key personnel, including a new CEO; competition in the outsourcing industry; rapid technological advances that make our services less competitive; PPD’s ability to win new business; and risks associated with acquisitions and investments, such as impairments and integration. These and other PPD risk factors are set forth in more detail from time to time in our SEC filings, copies of which are available free of charge upon request from PPD’s investor relations department. PPD assumes no obligation and expressly disclaims any duty to update these forward-looking statements in the future, except as required by applicable securities laws. 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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