PSI Webinar
Personalised Medicine: Statistics for Companion Diagnostics
Date for Webinar: Thursday 4th May. 2-3.30pm UK time
Personalised medicines - which are designed to treat particular groups of patients - are becoming increasingly prominent. In order to identify patients suitable for treatment a companion diagnostic assay is often needed. The Personalized Medicines Coalition (PMC) recently published an article stating that 25% of NME approved by FDA in 2016 included a companion diagnostic.
This webinar will introduce and examine some of the considerations required for statisticians working in the field of companion diagnostics and will include information from an FDA (CDRH) speaker and perspectives/ case-studies from representatives from both a pharmaceutical company and a diagnostic company.
CLICK HERE TO VIEW THE FLYER
Speakers:
Meijuan Li, CDRH
Peter Cooper, Qiagen
Rachel Hodge, AstraZeneca
Abstracts:
Meijuan Li (CDRH)
Applications of personalized medicine are becoming increasingly prominent. A companion diagnostic assay (CDx) is often desired for patient enrollment in device-drug pivotal clinical trial(s) so that FDA can ensure that appropriate clinical and analytical validation studies are planned and carried out for CDx. However, such a requirement may be difficult or impractical to accomplish. A clinical trial assay (CTA) instead of CDx may be used for patient enrollment in drug-device pivotal clinical trial(s). A supplemental agreement study of CDx and CTA will be required to bridge the clinical results from CTA to CDx. In this webinar, we will discuss statistical challenges in study design and data analysis for bridging study. Particularly, we aimed to provide statistical methods on how to estimate the drug efficacy in CDx intended use population using results from bridging study and CTA-drug pivotal clinical trial.
Peter Cooper (Qiagen)
Perspective from Diagnostic Company
Rachel Hodge (Astrazeneca)
Perspective/Case-study from Pharmaceutical Company
To access the recording, please visit the Video-on-Demand Library.
PSI Webinar
Personalised Medicine: Statistics for Companion Diagnostics
Date for Webinar: Thursday 4th May. 2-3.30pm UK time
Personalised medicines - which are designed to treat particular groups of patients - are becoming increasingly prominent. In order to identify patients suitable for treatment a companion diagnostic assay is often needed. The Personalized Medicines Coalition (PMC) recently published an article stating that 25% of NME approved by FDA in 2016 included a companion diagnostic.
This webinar will introduce and examine some of the considerations required for statisticians working in the field of companion diagnostics and will include information from an FDA (CDRH) speaker and perspectives/ case-studies from representatives from both a pharmaceutical company and a diagnostic company.
CLICK HERE TO VIEW THE FLYER
Speakers:
Meijuan Li, CDRH
Peter Cooper, Qiagen
Rachel Hodge, AstraZeneca
Abstracts:
Meijuan Li (CDRH)
Applications of personalized medicine are becoming increasingly prominent. A companion diagnostic assay (CDx) is often desired for patient enrollment in device-drug pivotal clinical trial(s) so that FDA can ensure that appropriate clinical and analytical validation studies are planned and carried out for CDx. However, such a requirement may be difficult or impractical to accomplish. A clinical trial assay (CTA) instead of CDx may be used for patient enrollment in drug-device pivotal clinical trial(s). A supplemental agreement study of CDx and CTA will be required to bridge the clinical results from CTA to CDx. In this webinar, we will discuss statistical challenges in study design and data analysis for bridging study. Particularly, we aimed to provide statistical methods on how to estimate the drug efficacy in CDx intended use population using results from bridging study and CTA-drug pivotal clinical trial.
Peter Cooper (Qiagen)
Perspective from Diagnostic Company
Rachel Hodge (Astrazeneca)
Perspective/Case-study from Pharmaceutical Company
To access the recording, please visit the Video-on-Demand Library.
PSI Webinar
Personalised Medicine: Statistics for Companion Diagnostics
Date for Webinar: Thursday 4th May. 2-3.30pm UK time
Personalised medicines - which are designed to treat particular groups of patients - are becoming increasingly prominent. In order to identify patients suitable for treatment a companion diagnostic assay is often needed. The Personalized Medicines Coalition (PMC) recently published an article stating that 25% of NME approved by FDA in 2016 included a companion diagnostic.
This webinar will introduce and examine some of the considerations required for statisticians working in the field of companion diagnostics and will include information from an FDA (CDRH) speaker and perspectives/ case-studies from representatives from both a pharmaceutical company and a diagnostic company.
CLICK HERE TO VIEW THE FLYER
Speakers:
Meijuan Li, CDRH
Peter Cooper, Qiagen
Rachel Hodge, AstraZeneca
Abstracts:
Meijuan Li (CDRH)
Applications of personalized medicine are becoming increasingly prominent. A companion diagnostic assay (CDx) is often desired for patient enrollment in device-drug pivotal clinical trial(s) so that FDA can ensure that appropriate clinical and analytical validation studies are planned and carried out for CDx. However, such a requirement may be difficult or impractical to accomplish. A clinical trial assay (CTA) instead of CDx may be used for patient enrollment in drug-device pivotal clinical trial(s). A supplemental agreement study of CDx and CTA will be required to bridge the clinical results from CTA to CDx. In this webinar, we will discuss statistical challenges in study design and data analysis for bridging study. Particularly, we aimed to provide statistical methods on how to estimate the drug efficacy in CDx intended use population using results from bridging study and CTA-drug pivotal clinical trial.
Peter Cooper (Qiagen)
Perspective from Diagnostic Company
Rachel Hodge (Astrazeneca)
Perspective/Case-study from Pharmaceutical Company
To access the recording, please visit the Video-on-Demand Library.
PSI Webinar
Personalised Medicine: Statistics for Companion Diagnostics
Date for Webinar: Thursday 4th May. 2-3.30pm UK time
Personalised medicines - which are designed to treat particular groups of patients - are becoming increasingly prominent. In order to identify patients suitable for treatment a companion diagnostic assay is often needed. The Personalized Medicines Coalition (PMC) recently published an article stating that 25% of NME approved by FDA in 2016 included a companion diagnostic.
This webinar will introduce and examine some of the considerations required for statisticians working in the field of companion diagnostics and will include information from an FDA (CDRH) speaker and perspectives/ case-studies from representatives from both a pharmaceutical company and a diagnostic company.
CLICK HERE TO VIEW THE FLYER
Speakers:
Meijuan Li, CDRH
Peter Cooper, Qiagen
Rachel Hodge, AstraZeneca
Abstracts:
Meijuan Li (CDRH)
Applications of personalized medicine are becoming increasingly prominent. A companion diagnostic assay (CDx) is often desired for patient enrollment in device-drug pivotal clinical trial(s) so that FDA can ensure that appropriate clinical and analytical validation studies are planned and carried out for CDx. However, such a requirement may be difficult or impractical to accomplish. A clinical trial assay (CTA) instead of CDx may be used for patient enrollment in drug-device pivotal clinical trial(s). A supplemental agreement study of CDx and CTA will be required to bridge the clinical results from CTA to CDx. In this webinar, we will discuss statistical challenges in study design and data analysis for bridging study. Particularly, we aimed to provide statistical methods on how to estimate the drug efficacy in CDx intended use population using results from bridging study and CTA-drug pivotal clinical trial.
Peter Cooper (Qiagen)
Perspective from Diagnostic Company
Rachel Hodge (Astrazeneca)
Perspective/Case-study from Pharmaceutical Company
To access the recording, please visit the Video-on-Demand Library.
PSI Webinar
Personalised Medicine: Statistics for Companion Diagnostics
Date for Webinar: Thursday 4th May. 2-3.30pm UK time
Personalised medicines - which are designed to treat particular groups of patients - are becoming increasingly prominent. In order to identify patients suitable for treatment a companion diagnostic assay is often needed. The Personalized Medicines Coalition (PMC) recently published an article stating that 25% of NME approved by FDA in 2016 included a companion diagnostic.
This webinar will introduce and examine some of the considerations required for statisticians working in the field of companion diagnostics and will include information from an FDA (CDRH) speaker and perspectives/ case-studies from representatives from both a pharmaceutical company and a diagnostic company.
CLICK HERE TO VIEW THE FLYER
Speakers:
Meijuan Li, CDRH
Peter Cooper, Qiagen
Rachel Hodge, AstraZeneca
Abstracts:
Meijuan Li (CDRH)
Applications of personalized medicine are becoming increasingly prominent. A companion diagnostic assay (CDx) is often desired for patient enrollment in device-drug pivotal clinical trial(s) so that FDA can ensure that appropriate clinical and analytical validation studies are planned and carried out for CDx. However, such a requirement may be difficult or impractical to accomplish. A clinical trial assay (CTA) instead of CDx may be used for patient enrollment in drug-device pivotal clinical trial(s). A supplemental agreement study of CDx and CTA will be required to bridge the clinical results from CTA to CDx. In this webinar, we will discuss statistical challenges in study design and data analysis for bridging study. Particularly, we aimed to provide statistical methods on how to estimate the drug efficacy in CDx intended use population using results from bridging study and CTA-drug pivotal clinical trial.
Peter Cooper (Qiagen)
Perspective from Diagnostic Company
Rachel Hodge (Astrazeneca)
Perspective/Case-study from Pharmaceutical Company
To access the recording, please visit the Video-on-Demand Library.
PSI Webinar
Personalised Medicine: Statistics for Companion Diagnostics
Date for Webinar: Thursday 4th May. 2-3.30pm UK time
Personalised medicines - which are designed to treat particular groups of patients - are becoming increasingly prominent. In order to identify patients suitable for treatment a companion diagnostic assay is often needed. The Personalized Medicines Coalition (PMC) recently published an article stating that 25% of NME approved by FDA in 2016 included a companion diagnostic.
This webinar will introduce and examine some of the considerations required for statisticians working in the field of companion diagnostics and will include information from an FDA (CDRH) speaker and perspectives/ case-studies from representatives from both a pharmaceutical company and a diagnostic company.
CLICK HERE TO VIEW THE FLYER
Speakers:
Meijuan Li, CDRH
Peter Cooper, Qiagen
Rachel Hodge, AstraZeneca
Abstracts:
Meijuan Li (CDRH)
Applications of personalized medicine are becoming increasingly prominent. A companion diagnostic assay (CDx) is often desired for patient enrollment in device-drug pivotal clinical trial(s) so that FDA can ensure that appropriate clinical and analytical validation studies are planned and carried out for CDx. However, such a requirement may be difficult or impractical to accomplish. A clinical trial assay (CTA) instead of CDx may be used for patient enrollment in drug-device pivotal clinical trial(s). A supplemental agreement study of CDx and CTA will be required to bridge the clinical results from CTA to CDx. In this webinar, we will discuss statistical challenges in study design and data analysis for bridging study. Particularly, we aimed to provide statistical methods on how to estimate the drug efficacy in CDx intended use population using results from bridging study and CTA-drug pivotal clinical trial.
Peter Cooper (Qiagen)
Perspective from Diagnostic Company
Rachel Hodge (Astrazeneca)
Perspective/Case-study from Pharmaceutical Company
To access the recording, please visit the Video-on-Demand Library.
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
This is an interactive online training workshop providing an in-depth review of the estimand framework as laid out by ICH E9(R1) addendum with inputs from estimand experts, case studies, quizzes and opportunity for discussions. You will develop an estimand in a therapeutic area of interest to your company. In an online break-out room, you will join a series of team discussions to implement the estimand framework in a case study, aligning estimands, design, conduct, analysis, (assumptions + sensitivity analyses) to the clinical objective and therapeutic setting.
Webinar dedicated to the topic of dissolution of oral solid dosage forms; opportunity to hear from statisticians working in the CMC field, with open question and answers. In addition, the CMC Statistical Network Europe special interest group will discuss advocacy opportunities, have your say to contribute to the future direction.
Initially a brief introduction to AI will be given, followed by a presentation of various applications in medicinal product lifecycle. Several aspects will be discussed including performance, theoretical and practical conditions and also regulatory guidelines.
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
Who is this event intended for? Statisticians with an interest understanding dose-finding in oncology. What is the benefit of attending? Learn about the state of oncology dose finding, particularly in light of current FDA guidance.
The book club’s usual focus is to read and discuss professional development books. In this short format event you can more easily develop you career without the commitment of reading the whole book - simply listen to the 1-hour long podcast before joining the interactive session on 21 May.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
The Institute of Cancer Research are seeking to appoint a Research Group Leader to join The CRUK Clinical Trials and Statistics Unit at the ICR.
The BioMarin internship programme will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, whilst gaining an insight into the pharmaceutical/biotech industry.
About cookies on this site
We use cookies to collect and analyse information on site performance and usage, to provide social media features and to enhance and customise content and advertisements.
About cookies on this site
Cookies used on the site are categorized and below you can read about each category and allow or deny some or all of them. When categories than have been previously allowed are disabled, all cookies assigned to that category will be removed from your browser. Additionally you can see a list of cookies assigned to each category and detailed information in the cookie declaration.
Necessary cookies
Some cookies are required to provide core functionality. The website won't function properly without these cookies and they are enabled by default and cannot be disabled.
CookieHub is a Consent Management Platform (CMP) which allows users to control storage and processing of personal information.
Cloudflare is a global network designed to make everything you connect to the Internet secure, private, fast, and reliable.
Amazon Web Services offers a broad set of global cloud-based products including compute, storage, databases, analytics, networking, mobile, developer tools, management tools, IoT, security, and enterprise applications.
Microsoft Azure is a cloud computing platform offering a wide range of services, including virtual machines, databases, and AI tools.
Preferences
Preference cookies enables the web site to remember information to customize how the web site looks or behaves for each user. This may include storing selected currency, region, language or color theme.
Analytical cookies
Analytical cookies help us improve our website by collecting and reporting information on its usage.
Google Analytics is a web analytics service offered by Google that tracks and reports website traffic.
Vimeo, Inc. is an American video hosting, sharing, services provider, and broadcaster. Vimeo focuses on the delivery of high-definition video across a range of devices.
Cookies used on the site are categorized and below you can read about each category and allow or deny some or all of them. When categories than have been previously allowed are disabled, all cookies assigned to that category will be removed from your browser. Additionally you can see a list of cookies assigned to each category and detailed information in the cookie declaration.
Necessary cookies
Some cookies are required to provide core functionality. The website won't function properly without these cookies and they are enabled by default and cannot be disabled.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| ARRAffinity | .psiweb.org | Session | |
This cookie is set by websites run on the Windows Azure cloud platform. It is used for load balancing to make sure the visitor page requests are routed to the same server in any browsing session. | |||
| ARRAffinitySameSite | .psiweb.org | Session | |
Used to distribute traffic to the website on several servers in order to optimize response times. | |||
| __cf_bm | .vimeo.com | Cloudflare, Inc. | 1 hour |
The __cf_bm cookie supports Cloudflare Bot Management by managing incoming traffic that matches criteria associated with bots. The cookie does not collect any personal data, and any information collected is subject to one-way encryption. | |||
| _cfuvid | .vimeo.com | Session | |
Used by Cloudflare WAF to distinguish individual users who share the same IP address and apply rate limits | |||
| __cf_bm | .glueup.com | Cloudflare, Inc. | 1 hour |
The __cf_bm cookie supports Cloudflare Bot Management by managing incoming traffic that matches criteria associated with bots. The cookie does not collect any personal data, and any information collected is subject to one-way encryption. | |||
| AWSALBTGCORS | psi.glueup.com | 7 days | |
AWS Classic Load Balancer Cookie: Load Balancing Cookie: Used to map the session to the instance. Same value as AWSELB. | |||
| PHPSESSID | psi.glueup.com | Session | |
Cookie generated by applications based on the PHP language. This is a general purpose identifier used to maintain user session variables. It is normally a random generated number, how it is used can be specific to the site, but a good example is maintaining a logged-in status for a user between pages. | |||
| History.store | Session | ||
| cookiehub | .psiweb.org | CookieHub | 365 days |
Used by CookieHub to store information about whether visitors have given or declined the use of cookie categories used on the site. | |||
Preferences
Preference cookies enables the web site to remember information to customize how the web site looks or behaves for each user. This may include storing selected currency, region, language or color theme.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| vuid | .vimeo.com | 400 days | |
These cookies are used by the Vimeo video player on websites. | |||
| AWSALBCORS | psi.glueup.com | 7 days | |
Amazon Web Services cookie. This cookie enables us to allocate server traffic to make the user experience as smooth as possible. A so-called load balancer is used to determine which server currently has the best availability. The information generated cannot identify you as an individual. | |||
Analytical cookies
Analytical cookies help us improve our website by collecting and reporting information on its usage.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| _ga_ | .psiweb.org | 400 days | |
Contains a unique identifier used by Google Analytics 4 to determine that two distinct hits belong to the same user across browsing sessions. | |||
| _ga | .psiweb.org | 400 days | |
Contains a unique identifier used by Google Analytics to determine that two distinct hits belong to the same user across browsing sessions. | |||
