Best Practices for Therapeutic Translation: Optimizing Pre-Clinical Research Rigor and Reproducibility
Workshop Date: February 25-26 2020 & Location: Toronto, Canada
Application Deadline: January 7, 2020
Notification of Award: mid-January 2020
[click here for the application to attend the workshop]. Please note that all individuals attending must complete an application to attend. If you are associated with one of the partnering organizations, you will automatically be considered for financial support to attend the workshop (details below).
The translation of discoveries into new clinical therapies is a multi-step process that requires careful planning and rigor at all stages. The Stem Cell Network and BioCanRx are excited to host, in conjunction with our partner sponsoring organizations CellCAN, OIRM and ThéCell, a new 2-day training workshop that will provide attendees with foundational knowledge in two key areas that are critical to establishing the robust experimental evidence necessary for successful clinical or commercial translation: Quality Best Practices and Preclinical Experimental Design and Reporting, both of which are cornerstones in achieving reproducibility, reducing experimental waste and improving the translational prospects of a discovery.
Quality best practice oversees all activities and tasks needed to maintain a desired level of excellence. Recent concerns in the reproducibility of published experimental observations is fueling the adoption of standardized quality practices within the laboratory that improve the credibility of experimental observations by harmonizing the way research is conducted. A Quality Best Practices (QBP) system provides a framework for planning, recording, reporting and archiving experimental processes and data, such as the identity, potency and sterility of experimental reagents or samples. Implementation of QBP in the laboratory is recognized as a necessary step that enables improvements in interpreting experimental outputs, troubleshooting, transparency and reproducibility.
Preclinical Experimental Design and Reporting. Assessments of the reporting quality of preclinical research have consistently found that important elements of research design are often missing from published work, including the use of design elements such as blinding and randomization. To address the incomplete reporting of research design, new reporting guidelines, such as the widely endorsed NIH Principles and Guidelines for Reporting Preclinical Research, have been developed and are being implemented by funding agencies, universities, publishers and journals. These new reporting requirements, such as randomization and blinding, are intended to promote change in how experiments are designed and conducted by investigators.
The purpose of this workshop is to provide scientists with the knowledge to implement good quality practices in their experimental work, and to design, perform and report on preclinical studies that adhere to the new NIH Principles and Guidelines for Reporting Preclinical Research (and design).
By the end of this workshop, participants will:
- Have a working knowledge of quality assurance and quality control systems, and their implementation in the laboratory.
- Have a working knowledge of basic experimental design and reporting for the NIH core items, as well as working knowledge on how to implement these in the design of their experiments.
- Be aware of the available quality management, research design and reporting resources that will further support deployment of these approaches in their own laboratory.
The workshop content will be delivered by subject matter experts drawn from Canada and the USA, and will use presentations and interactive sessions, supplemented with case studies and experiential anecdotes, to illustrate the real-world applications and benefits of Quality Management and Preclinical Experimental Design and Reporting. The interactive sessions will enable participants to obtain advice and feedback on implementing the workshop subject matter in their laboratories and project scenarios.
This workshop is targeted at Investigators and HQP who are seeking to lay the foundation for successful clinical translation studies in their laboratories or institutions. Applications from two persons teams comprising an Investigator and a HQP from their lab will be given priority, although applications from individual Investigators or HQP are also welcomed. Successful applicants will be financially supported to attend by their respective network.
Workshop Cost: $250 CAD per individual
Evening before Day 1
Welcome dinner and networking
Day 1: Quality Best Practices (QBP)
|8:30 – 9:00 am||Breakfast|
|9:00 – 9:05 am||Opening Remarks|
|9:05 – 10:00 am||Introduction to Quality Management|
|10:00 – 10:45 am||Research and Documentation: Accurate and reproducible data records|
|10:45 – 11:00 am||Break|
|11:00 – 12:00pm||Research and Documentation: SOPs, electronic data and reporting|
|12:15 – 1:00 pm||Lunch Break|
|1:00 – 1:30 pm||Research and Documentation: Q&A|
|1:30 – 2:30 pm||Rigorous Method Development: “Why” and “How” Guidelines for Method Validation|
|2:30 – 3:00 pm||Method Validation: Q&A|
|3:30 – 3:45 pm||Break|
|3:45 – 4:45 pm||Experimental Troubleshooting and Solutions|
|4:45 – 5:30 pm||Troubleshooting and Solutions: Q&A|
|5:30 – 5:45 pm||QMS Wrap-up & Resources|
Day 2: Preclinical Experimental Design and Reporting (PEDR)
|8:30 – 9:00 am||Breakfast|
|9:00 – 9:05 am||Opening Remarks|
|9:05 – 9:15 am||NIH Core – Standards|
|9:15 – 9:40 am||Speaking from Experience|
|9:40 – 9:55 am||Validity of Experimental Design|
|9:55 – 10:35 am||NIH Core – Replicates|
|10:35 – 10:45 am||Break|
|10:45 – 11:45 am||NIH Core – Reporting Statistics & Intro Sample Size Estimation|
|11:45 – 12:15 am||NIH Core – Inclusion/Exclusion Criteria|
|12:15 – 1:00 pm||Lunch Break|
|1:00 – 1:45 pm||NIH Core – Randomization|
|1:45 – 2:30 am||NIH Core – Blinding|
|2:30 – 2:50 am||Closing Remarks & Resources|
|2:50 – 3:00 pm||Workshop Evaluation – Help us improve|
|3:00 pm||Workshop end|
Application Procedure (all participants):
- Application deadline is 11:59pm (sender’s time), January 7, 2020.
- All applications should be directed to Rebecca Cadwalader, Stem Cell Network by emailing firstname.lastname@example.org.
- Evaluation and review of applications will be performed by each organization’s Adjudication Committees, and applicants will be informed of the competition outcome by mid-January 2020.
Financial Support Available
The Stem Cell Network, BioCanRx, CellCAN, OIRM and ThéCell are offering a limited number of awards to enable eligible teams to attend this workshop. All those who submit an application to attend will automatically be considered for travel support by the appropriate network. More details will be circulated with application notifications. Outlined below are the award details for SCN-eligible participants. Please contact your network contact for specific award details.
Applications will be accepted from Investigators from a Canadian lab who are seeking to translate a discovery in the field of stem cells and regenerative medicine. Applicants must clearly demonstrate that they will apply the techniques learned at the course to their own research project within one year.
Travel Support Award Conditions (Stem Cell Network only):
- Applicants associated with the SCN or partnering organizations will automatically considered for awards from respective organizations.
- The SCN award will cover travel expenses associated with attending the course, for teams not based in Toronto:
- Travel to/from the course location
- Up to three nights accommodation at our designated hotel, dependent on the location of the team.
- The SCN award will also cover the workshop registration fee.
- Successful applicants will be sent a link to register upon acceptance of the award.
- Reimbursement will be processed following the course, in accordance with the SCN Travel Booking & Reimbursement Policy (policy will be provided to the selected applicants).
- Accommodation during the course will be provided for Investigators and trainees not based in Toronto. Two trainees of the same gender may be required to share a room.
Reporting and Communication Requirements:
By accepting an award, the recipient agrees to provide the organization providing the award with a report describing the value of the training and networking opportunities made available through the award. This information will be used at the discretion of the organization on their websites, newsletters and for the purpose of reporting to the organization’s funding agency. By accepting an award, attendees also accept to have their pictures taken during the workshop, which may be used in the reporting tools mentioned above. Please note that expense reimbursement will be processed only once the completed report is received.
Please direct your questions about workshop content, the application process and/or travel support eligibility reimbursement to your appropriate network contact:
- SCN: Jon Draper, Program Director, Research and Partnerships, email@example.com, 613-298-5802
- BioCanRx: Megan Mahoney, Manager of HQP Training Programs, firstname.lastname@example.org, 613-737-8149
- OIRM: Marc Frigault, Senior Manager, Business Operations, email@example.com, 647-546-6479
- CellCAN: Marie-Ève Desormeaux, Project manager & Communications Coordinator, firstname.lastname@example.org, 514-252-3400, ext. 6196
- ThéCell: Friederike Pfau, Coordinator, Friederike.Pfau@crchudequebec.ulaval.ca, 418 525 4444 extension 61685