Evaluating Practices and Performance Relative to Drug Development Benchmarks
Tufts CSDD has a rich history conducting benchmark assessments for drug development organizations in the public and private sector. Our studies are based on proprietary data capturing organizational practices, performance, economics, and other critical outcome variables. Tufts CSDD regularly updates its proprietary datasets and is always adding new baseline and benchmark measures based on de-identified data from recently completed grant-funded research studies. Comparison groups in Tufts CSDD benchmark assessments are customized for each study. The results of our benchmark studies are used to diagnose performance, cost, and quality issues and inform strategy, productivity, efficiency, scientific and operational optimization. Tufts CSDD faculty also provides subject matter expertise and prepares expert reports based on benchmark data to inform the resolution of disputes.Examples of customs studies compared with industry benchmarks:-
Evaluating protocol design practices in specific disease conditions -
Assessing patient participation burden associated with protocol designs -
Quantifying portfolio program cycle times, costs, and success rates -
Assessing data management startup through close-out cycle time -
Evaluating investigative site burden associated with protocol design and execution -
Benchmarking patient recruitment and retention effectiveness in select therapeutic areas
Contact Tufts CSDD to learn more about our Drug Development Benchmarking Research Quantifying ROI/ENPV
Tufts CSDD has extensive experience conducting return on investment (ROI) assessments based on proprietary performance, economic, and quality benchmark data as well as primary and secondary data sources.During the past decade, Tufts CSDD has also been modeling and quantifying the net financial impact of new practices and solutions applied to an investigational drug in comparison to a conventional drug. For these expected net present value (ENPV) studies, Tufts CSDD populates and tests each model using proprietary data on development timelines, costs, and risks. Data from primary and secondary sources are also gathered to populate the model. Tufts CSDD prepares the value drivers — including the investigational drug’s revenue potential; direct and indirect development costs; development and regulatory phase durations; scientific risk; regulatory risks; and operating risks — for a baseline drug in a major disease condition (e.g., oncology, CNS or infectious diseases). Next, Tufts CSDD will use qualitative and empirical data to derive adjustment factors and investment estimates.ENPV modeling is widely used and accepted by the pharmaceutical industry. Tufts CSDD utilizes a framework where net present value is defined as the after-tax, inflation-adjusted present value of the future net cash flow for a drug that is granted regulatory marketing approval and is launched for sale in the marketplace. Once the model has been populated with data, adjustment factors, and investment estimates, Tufts CSDD will assess multiple drug development outcomes with the revenue and costs multiplied by the likelihood of each outcome occurring. Tufts CSDD will analyze the data on an expected net present value basis reflecting the sum total of risk for each of the various outcomes and their associated impact on revenue and development cost.Contact Tufts CSDD to learn more about our Quantifying ROI/ENPV Research Facilitated Consortia and Meetings
As an independent academic research group, with deep and broad drug development knowledge, Tufts CSDD is uniquely positioned to assist organizations in planning and facilitating consortia and meetings. Our in-depth knowledge of drug development and our extensive connections with regulatory agencies, health and research professional communities, societies, associations, and industry executives ensure active, relevant and valuable exchange of ideas and deliverables.Tufts CSDD facilitates and manages consortia and meetings virtually and on-site. The virtual format, in particular, is highly cost-effective, convenient, and ensures international representation. Examples of recent initiatives include:-
Formation and management of the PACT consortium gathering empirical evidence on actual DCT use and impact -
Creation and facilitation of PALADIN, a consortium focusing on optimizing patient advocacy group - sponsor collaborations -
Facilitated meetings focusing on ICH E6 R3 guidelines among global regulatory and industry professionals -
Establishment and facilitation of a working group focusing on responsible AI use in drug development
Contact Tufts CSDD to learn more about our Facilitated Consortia and Meetings
Organizational and Individual Coaching
During the past several years, Tufts CSDD has developed a systematic coaching process designed to assist organizations and individuals in planning and implementing change management initiatives to optimize team dynamics and performance. Coaching — based in part on empirical research conducted by Tufts CSDD and/or published in peer-review literature — is offered as a single or series of interactive, facilitated sessions. Organizational and Individual Coaching has recently helped organizations and individuals embrace and implement new approaches to improve diversity, equity and inclusion among clinical teams; accelerate adoption of risk-based quality management practices; increase use of agile project strategy and execution; and improve more effective and efficient management of custom/hybrid technology use in clinical trials.
Contact Tufts CSDD to learn more about our Organizational and Individual Coaching