Evidera’s experience and expertise extends across all major therapeutic areas, and as part of PPD we’ve extended that expertise with access to a global network of clinical experts.
Evidera scientists are experienced in many areas of oncology, including extensive contributions to hundreds of successful submissions to regulatory agencies and payers, most notably we helped to influence the reversal of a NICE decision in metastatic castration-resistant prostate cancer (mCRPC). We have substantial experience in health-related quality of life and other clinical outcomes assessments (COAs), burden of illness, cost-consequence, cost-minimization, cost-benefit, cost-utility, and prospective economic studies, as well as the development of Academy of Managed Care Pharmacy (AMCP) and global value dossiers.
We publish 50+ peer-reviewed articles, research posters, and presentations per year on methods, studies, and industry trends in oncology, including an issue of our own publication, The Evidence Forum, dedicated to oncology. Evidera experts play an active role in relevant societies and other oncology organizations (e.g., American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO), etc.) and contribute to ISPOR’s Oncology Special Interest Group, working to identify specific oncology outcomes research issues and to develop recommendations to address these issues.
Evidera staff is experienced in the area of neurological disorders, including Parkinson’s disease, multiple sclerosis (MS), cognitive impairment and dementia, epilepsy, migraine, stroke, and restless leg syndrome. We publish 30+ peer-reviewed articles, research posters, and presentations per year on methods, studies, and industry trends in neurology.
Evidera leveraged more than two decades of experience in modeling in Alzheimer’s Disease (AD) to develop the AD ACE, a comprehensive multi-application disease simulator designed to address evolving commercial and regulatory needs. Driven by the the latest science in the field, it is extensively validated and well documented and was designed to address the complex interactions between multiple components of AD pathology (e.g., biomarkers, cognition, behavior, function) and their role in disease progression.
Evidera scientists have expertise in a variety of research methods and study types across all of the major respiratory indications, including: chronic sinusitis, chronic obstructive pulmonary disease (COPD), acute exacerbation of chronic bronchitis (AECB), allergic rhinitis, and asthma, respiratory syncytial virus (RSV), and smoking cessation. We publish 25+ peer-reviewed articles, research posters, and presentations per year on respiratory methods, studies, and industry trends.
Evidera researchers have developed models, including budget of impact, cost-of-illness, cost-minimization, cost-benefit, and cost-utility analyses, for treatments in respiratory indications, as well as AMCP and global value dossiers to aid in approval and reimbursement decisions. We have conducted numerous quality-of-life analyses in respiratory conditions including psychometric instrument development and validation, patient preference evaluation using conjoint analyses, multi-attribute utility functions, and direct elicitation techniques.
Evidera developed the first consortium-developed PRO instrument, the EXACT-PRO, with qualification statements from both the FDA and EMA, as well as the second instrument with draft qualification statements from the FDA and EMA, the E-RS, a derivative of the EXACT-PRO.
We were proud to be recognized with the COPD Foundation’s COPD Biomarker Qualification Consortium (CBQC) for their work leading to the FDA’s qualification of plasma fibrinogen as a biomarker for clinical trials of COPD – the first biomarker for COPD and the seventh biomarker qualified by the FDA to date.
Evidera staff members have a long history of meeting the unique needs of clinical development and commercialization of treatments for rare and orphan diseases. Our work, performed globally, has included strategic planning support, designing, and implementing a variety of studies, and communicating our findings in publications and conference presentations. Evidera has supported nearly 50 drugs for rare and orphan indications in the past five years, including the validation and regulatory submission of COAs used as important efficacy endpoints in rare disease drug development programs that have achieved FDA and EMA labeling claims, and also contributing to submissions to payers and health authorities. Many orphan drugs fall into the category of specialty pharmaceuticals and Evidera scientists are well-versed in the unique requirements for developing and communicating the value of specialty products.
An Evidera scientist served on the subcommittee responsible for developing the first Academy of Managed Care Pharmacy (AMCP) guidelines for specialty pharmaceuticals. We have been awarded the best market access drug programme by the Rare Orphan Advocacy and Research Awards, and we also publish frequently in the space, including 20+ peer-reviewed publications, research posters and presentations per year, as well as an issue of our own publication, The Evidence Forum, dedicated to rare and orphan disease topics.
