EUGM 2018: East Symposium & User Group Meeting

This year's East Symposium and User Group Meeting will bring together industry experts and thought leaders to discuss the future of innovative clinical trials. Day 1 will feature a series of presentations from some of the top names in biostatistics exploring key statistical and operational topics. Adding to the program this year are discussions on applications of Data Science to drug development.

The East user group meeting on day 2 will entail training sessions on existing and new developments in East version 6.5. Use the link below to register and  view the complete agenda. 

Clinical Operations in Oncology Trials (EU)

2018 Clinical Operations in Oncology Trials EU attendees can debate the practical strategies to help their company improve operational efficiencies in conducting oncology clinical research. Cytel adaptive trial and data science experts will again contribute at this year's conference. 

Partnerships in Clinical Trials EU

Partnerships in Clinical Trials (PCT) Congress brings together trial stakeholders searching to improve clinical research. Visit us at booth #C51. Ursula Garczarek, Associate Director of Strategic Consulting, is a panelist in the discussion "Real World Evidence, Paediatrics, Trial Design & Big Data" which will discuss the future developments in clinical trial design. 

14th Annual Scrip Awards

The 2018 Scrip Awards categories range from rewarding the broader achievements of drug development leaders to innovations in deal-making, advances in R&D and the more personal accomplishments of teams and individuals.

BioData World Congress 2018

Cytel will again sponsor this important gathering of Life Science professionals. Visit us at booth #28 to learn how our Data Science experts are helping biopharma companies to formulate optimal program development strategies. Cytel's Rajat Mukherjee will be speaking in the presentation "Adaptive Power Enhanced Multiple Testing" which will discuss the advantage of adaptive methods in multiple hypothesis testing. 

Basket Trials Webinar: Overcoming Design and Implementation Challenges

Confirmatory trials especially may improve access to therapy for both rare diseases and defined patient subpopulations in cancer by creating cost effective development options. They may also enhance health authority evaluations of risk & benefit of targeted agents designed for these indications.

Join basket trial authority Robert Beckman together with Cytel Statistical Consultant Sam Hsiao for a methodologies briefing followed by a design and implementation considerations examination of a generalizable confirmatory study.

SCOPE Annual Summit

Cytel experts will reveal new tools and techniques at the largest gathering of clinical study professionals in North America.  Our own Charles Liu will speak on the use of simulations to predict recruitment in  "Accurate patient enrollment forecasting using Enforesys: Case studies and lessons learned".

Stop by our booth #207 to learn how a biometrics focus can improve your own program's chance of clinical success.

PhUSE US Connect 2019

After a successful conference in June 2018, PhUSE US Connect 2019 will take place in Baltimore, MD, in February. Cytel will again be contributing to the program. Stop by Cytel's booth to speak with one of our expert Statistical Programmers.  

ASCPT Annual Meeting

Cytel Pharmacometric team-members will again contribute to the 2019 meeting agenda.  Stop by the Cytel booth #46 to learn their 2019 schedule and to discuss how you could gain even greater insights from your data.

EUGM 2017 Presentations

The 5th annual East User Group Meeting (EUGM) in Cambridge, MA, featuring expert contributions from hosts Biogen, AstraZeneca, Pfizer as well as Cytel. Their presentation topics included designing basket trials, new methods for optimizing the distribution of sites and utilizing safety statistics in adverse event monitoring.

2017 ASA Biopharma Regulatory Industry Statistics Workshop

See Cytel expert presentation slidesets:

• Sample Size Re-Estimation: Controlling Type-1 Error, by Yannis Jemiai 
• Bayesian Study Design to Leverage Informative Prior Information, by Jim Bolognese and Sam Hsiao
• Efficiency Promising of Zone Designs, by Cyrus Mehta, Sam Hsiao & Lingyun Liu
• PS4b Parallel Session, by Caroline Morgan

Innovative Trial Design Symposium: Adaptive Designs and Improving Operational Efficiency

Hear Jim Bolognese and Narinder Nangia from Alkermes on designing Phase 2 trials based on program-level optimization (i.e., optimizing the entire Phase 2/3 drug development strategy). You'll learn how:

• Phase 2 sample size can be optimized to yield maximum eNPV when selecting 1 or 2 doses for Phase 3
• Studying more doses in Phase 2 can improve Probability of Success, yielding higher product eNPV, unless AE rates low for all doses

Symposium: Development in Oncology and Orphan Indications

Download the slidesets and watch the presentation replays from the Cytel and Pfizer open seminar and applied trial design workshop focused on oncology and rare disease clinical development.  In addition to biostatisticians, clinicians and R&D leadership as well will find the expert talks and trial design workshop enlightening.

Watch Demo: Dual-Agent Phase 1 Trials with East^®

East^® Escalate version 6.4 adds two dose escalation design methods to support single- and dual-agent studies:
(1) BLRM method extension for dual-combination trials
(2) Product of Independent beta Probabilities Escalation (PIPE).  Demonstration highlights:
- Simulate and compare designs under different dose-toxicity profile assumptions
- Determining best dose for next patient cohort based on modeling the accumulating data
- Communicating effectively with clinicians to guide dosing decisions, increase success rates

Watch: Asking the Right Questions of Your Data: Experiences with Model-informed Development

Cytel experts reveal how QPP (Quantitative Pharmacology and Pharmacometrics) -based insights can guide the determination of the optimal program development strategy. Presented by Cecilia Fosser, Director, Quantitative Pharmacology & Pharmacometrics and Chuck Gelb, Sr. Business Development Director.

Watch: Trial Innovation and Implementation with East^® Training

In March 2016, biostatistical and drug development operations innovators met to help bridge the gap between newer methods and the medical, operational and regulatory realities.

Watch: Know the Risks You Need to Manage in Clinical Outsourcing

Time and again, we hear “Outsourcing key clinical functions is a clinical development risk mitigation strategy”. But do you really know the risks you need to mitigate in today's clinical research? Little wonder why the results so often disappoint: Sponsors don't know well what they should be considering to succeed.

Watch: Innovative Design and Optimal Trial Decision-Making

The Cytel and Sanofi trial design symposium presented ways to implement innovative approaches to dose finding and dose escalation trials, ultimately to better support confirmatory efforts. Hear expert presentations from trial and decision experts at AstraZeneca, Sanofi, Takeda and Cytel.