BOSTON, DURHAM, N.C. and BRISBANE, Queensland, Australia—Parexel International disclosed today that it has completed the acquisition of Model Answers, a consultancy firm based in Brisbane, Queensland, Australia.
Model Answers provides pharmacokinetic and pharmacodynamic (PK/PD) modeling, simulation and analysis services to customers in the life sciences industry. As part of the acquisition, Model Answers’ highly specialized staff have joined Parexel’s growing Clinical Pharmacology, Modeling and Simulation team.
“Modeling and simulation have quickly become a valuable part of the drug development process, helping to reduce risk and increase the likelihood of success by predicting outcomes that can result in a more informed trial design,” said Sy Pretorius, M.D., executive vice president and chief medical & scientific officer of Parexel. “By leveraging Model Answers’ deep expertise and proven approach to modeling and simulation, Parexel will expand our ability to leverage this innovative approach, helping our customers to maximize their resources by improving understanding and decision-making at every stage of development.”
Model Answers, which was founded in 2005, has experience across many therapeutic areas — including oncology, neurology and rare diseases — and also provides important access to the growing Asia/Pacific market. The company has developed preclinical PK/PD models for effectiveness and neutropenia, scaling to first-in-human studies and supporting Phase 1 through to NDA submission. Model Answers’ team of modelers, clinical pharmacologists, data managers and programmers has supported numerous successful filing activities to the U.S. Food and Drug Administration (FDA), the European Medicines Agency, the Pharmaceuticals and Medical Devices Agency and the Therapeutic Goods Association.
“Model Answers was founded on the idea that by providing highly specialized modeling capabilities in a way that is collaborative and efficient for customers, we can increase the likelihood of success in drug development. We are excited to join an organization with global capabilities where, as part of a larger combined team, we can bring our unique modeling and simulation approach to more life sciences companies, ultimately helping bring new medicines to patients sooner,” added Bruce Green, Ph.D., founder and chief executive officer of Model Answers.
Parexel plans to employ the Model Answers Process, including best practices and proprietary software solutions that support modeling and simulation. These include Model Answers’ client-interactive tools that drive both efficient collaboration and client ownership of complex models.
Parexel also unveiled in January its Regulatory & Access consulting organization, which is designed to optimize clinical development from the earliest stages. The newly formed Regulatory & Access team encompasses more than 1,000 on-staff consultants worldwide, including ~100 former regulators and HTA assessors who are familiar with the regulations, guidances and stakeholders that companies must successfully navigate in order to ensure new therapies reach the patients who need them.
As Paul Bridges, Ph.D., corporate vice president and head of Regulatory & Access at Parexel, noted in a press release, “Achieving market authorization from a regulatory agency is only the first hurdle to a new therapy reaching the market. By more holistically considering the diverse requirements of regulators, payers and patients and aligning these insights with clinical development, companies can optimize their plans to drive smarter, more efficient and patient-focused strategies, leading to faster development and improved patient access to new medicines.”
Parexel’s Regulatory & Access consulting organization includes former regulators from global agencies, including the FDA, the U.K.’s Medicines and Healthcare products Regulatory Agency MHRA and the National Medical Products Association in China.
“We understand the goal of every drug development program is to deliver results for a patient in need. Our Regulatory & Access organization was designed with the patient in mind, helping companies advance through regulatory and market access hurdles without unnecessary delay in order to reduce the time that a patient must wait for an innovative new therapy,” stated Peyton Howell, executive vice president and chief commercial & strategy officer of Parexel.
Parexel describes the regulators as “therapeutic experts with deep technical expertise, market access specialists with proven health technology assessment (HTA) success and medical communication experts.” Parexel hopes that combining all this expertise into one team will ultimately lead to saved time and resources across the drug development lifecycle.