The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

Cytel Co-Founder Cyrus Mehta Presents at the Heart Failure Collaboratory, a Public-Private Partnership with FDA

September 4, 2020

On Friday September 11, Cyrus Mehta, co-founder of Cytel, will be delivering a talk to the Heart Failure Collaboratory, on how adaptive designs can be utilized to salvage trials disrupted by COVID-19. The Heart Failure Collaboratory is a public-private consortium with FDA, and will be hosting a day long symposium online, on the application of innovative methods for drug and device studies in the age of COVID-19.


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FSP Navigator – Building the Team that Brings Success

September 1, 2020

In this blog, Cytel's SVP Corey Dunham’s talks about our Functional Services teams and the qualities we seek in new hires. As our FSP division continues to grow, we are looking to hire programmers and biostatisticians. Cytel's recruitment and FSP teams are hosting a one hour long Virtual Careers Open Day on Thursday, September 10th at 11:00AM EDT. Join us to learn more about our expanding FSP team, open career opportunities and what it means to be part of Cytel. Click on the button to register for the virtual event.

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Adopt innovative and computationally intensive designs with East Alloy

August 31, 2020

Pantelis Vlachos, Principal, Strategic Consultant at Cytel, conducted a webinar to introduce the capabilities of East AlloyTM. East Alloy is a new East environment that enables rapid access to innovation with the trust and support you have come to expect from Cytel. The cloud-native software makes it practical to apply computationally intensive Bayesian methods.

This blog is a part of the new blog series on technology and Bayesian decision-making by Pantelis. Continue reading to learn about the methods and capabilities, such as, Bayesian meta-analytic priors, Bayesian MAMS, adaptive dose-finding and others, available to all East Alloy users. Click the button to access the on demand webinar.

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Career Perspectives: Interview with Yannis Jemiai, Chief Scientific Officer

August 26, 2020

As Chief Scientific Officer, Dr. Yannis Jemiai plays a pivotal role in maintaining Cytel’s well-established reputation for statistical excellence and our track-record of bringing innovative analytic approaches to the development of medicines for human health. With oversight for the corporate-level Scientific Agenda, Yannis ensures Cytel continues to be known for thought leadership in adaptive designs while expanding its reputation in Bayesian statistics, Complex innovative designs, and the use of Real-World analytics for regulatory and post-approval purposes. Yannis’ research interests include adaptive trial design, causal inference, decision theory, and regulatory affairs.

In this blog we talk to Yannis about his long-standing association with Cytel, his views on adaptive designs and their future; and we get some tips from him for young statisticians, programmers and those interested in pursuing a career in this field.

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Nitin Patel on Designing Clinical Trials from a Program Perspective

August 25, 2020

It is important to take a strategic approach to clinical development in order to minimize the potential for Phase 3 attrition. In our next webinar from the ‘Introduction to Complex Innovative Trial Design’ webinar series, Nitin Patel, co-founder of Cytel, will provide an overview of the concepts of program optimization. As a case study, we will describe a Phase 2 trial design based on program-level optimization. We utilize a hybrid Bayesian-frequentist framework to evaluate the impact of Phase 2 design choices on the probability of Phase 3 success, clinical utility, time to market, trial costs and expected net present value (ENPV) of the product. These factors include Phase 2 sample size, dose selection and go-no go decision rules for Phase 3, and Phase 3 sample size. 

Click the button to register for the webinar on August 26, 2020.

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In this blog, we talk to Nitin about his journey since co-founding Cytel; and gain insights on program optimization, the challenges for both big and small pharmaceutical/biotech companies, and how to go about the planning process.

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Bayesian Borrowing and Real World Data: The Fundamentals

August 21, 2020

As uses of real world data become more familiar for trial design and regulatory submission, sponsors might become more interested in techniques related to Bayesian borrowing. Sophisticated uses of this technique have been applied to COVID-19 vaccines development and complex oncology trials. Simpler versions can be used to optimize across existing datasets, design trials with lower enrollment targets, accelerate the time to regulatory submission, and strengthen the power of a trial. Here we provide an overview of the potential benefits.

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Webinar on Adaptive Designs for Dose Finding: Part 2

August 19, 2020

Bjoern Bornkamp, Statistical Methodologist at Novartis and Jose Pinheiro, Senior Director, Johnson & Johnson provided their insights on adaptive designs for dose finding in Cytel’s latest webinar. The webinar demonstrates how adaptive and Bayesian techniques can be implemented for optimal dose-finding.

This two-part blog series provides a summary of the webinar. Read the first part to get key highlights from the presentation by Jose Pinheiro on the need to conduct dose finding Phase 2 studies, dose selection comparisons and the use of MCP-Mod for dose finding. 

Continue reading this second part to learn about the methods of adaptive dose-finding, presented by Bjoern. Click the button to access the webinar recording and download the presentation slides

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Career Perspectives: Interview with Mrudula Joshi, Associate Director, Statistical Programming Services

August 18, 2020

Mrudula Joshi joined Cytel in July 2005 as a young SAS programmer. Last month, she celebrated her 15th year work anniversary at the company. In this blog we talk to Mrudula about her journey so far, her current role, and achievements; and we get some tips from her for young statisticians, programmers and those interested in pursuing a career in this field.

Cytel’s Biostatistics and Statistical Programming team for Functional Services provides integrated solutions, by blending the expertise of programming and the experience of statistics. As our FSP division continues to grow, we are looking to hire programmers and biostatisticians. Cytel's recruitment and FSP teams are hosting a one hour long Virtual Careers Open Day on Thursday, September 10th at 11:00 AM EDT. Join us to learn more about our expanding FSP team, open career opportunities and what it means to be part of Cytel. Click on the button to register for the virtual event.

Register

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Webinar: Adaptive Designs for Dose Finding

August 13, 2020

Bjoern Bornkamp, Statistical Methodologist at Novartis and Jose Pinheiro, Senior Director, Johnson & Johnson provided their insights on adaptive designs for dose finding in Cytel’s latest webinar. Finding the right dose in Phase 2 gives a potential new therapy its best chance to demonstrate efficacy during Phase 3. A well-executed dose-ranging trial therefore has the potential to alter the course of the entire clinical development program. This webinar demonstrates how adaptive and Bayesian techniques can be implemented for optimal dose-finding.

This two-part blog series will provide a summary of the webinar. In this first part, get key highlights from the presentation by Jose Pinheiro on the need to conduct dose finding Phase 2 studies, dose selection comparisons and the use of MCP-Mod for dose finding. Click the button to access the webinar recording and download the presentation slides

Access Replay

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