Best Practices for Therapeutic Translation: Optimizing Pre-Clinical Research Rigor and Reproducibility
Workshop date: February 25-26, 2020
Workshop location: Toronto, Ontario
Deadline for Applications: January 29, 2020
To apply to this workshop, click here. The deadline to apply is 11:59 pm (sender’s time), January 20, 2020. More details can be found in the application document. 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.
$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, Gayle Piat|
|9:05 – 10:00 am||Introduction to Quality Management, Gayle Piat|
|10:00 – 10:45 am||Research and Documentation: Accurate and reproducible data records, Rebecca Davies and Gayle Piat|
|10:45 – 11:00 am||Break|
|11:00 – 12:00pm||Research and Documentation: SOPs, electronic data and reporting, Rebecca Davies and Gayle Piat|
|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, Richard Vaillancourt|
|2:30 – 3:00 pm||Method Validation: Q&A|
|3:30 – 3:45 pm||Break|
|3:45 – 4:45 pm||Experimental Troubleshooting and Solutions – Root Cause Analysis, Bruno Noussibotche|
|4:45 – 5:30 pm||Troubleshooting and Solutions: Q&A|
|5:30 – 5:45 pm||QMS Wrap-up & Resources|
|Evening Networking Meal|
Day 2: Preclinical Experimental Design and Reporting (PEDR)
|8:30 – 9:00 am||Breakfast|
|9:00 – 9:05 am||Opening Remarks, Manoj Lalu|
|9:05 – 9:15 am||NIH Core – Standards, Joshua Montroy|
|9:15 – 9:40 am||Speaking from Experience, Carolina Ilkow|
|9:40 – 9:55 am||Validity of Experimental Design, Joshua Montroy|
|9:55 – 10:35 am||NIH Core – Replicates, TBD|
|10:35 – 10:45 am||Break|
|10:45 – 11:45 am||NIH Core – Reporting Statistics & Intro Sample Size Estimation, Dean Fergusson|
|11:45 – 12:15 am||NIH Core – Inclusion/Exclusion Criteria, TBD|
|12:15 – 1:00 pm||Lunch Break|
|1:00 – 1:45 pm||NIH Core – Randomization, Manoj Lalu|
|1:45 – 2:30 am||NIH Core – Blinding, Carolina Ilkow|
|2:30 – 2:50 am||Closing Remarks & Resources, Manoj Lalu|
|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 29, 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
BioCanRx, CellCAN, OIRM, StemCell Network 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 BioCanRx-eligible participants. Please contact your network contact for specific award details.
We will be accepting applications from currently funded BioCanRx Network Investigators, those applying for funding (have submitted an LOI), or those who had applied to a BioCanRx Catalyst or Enabling award. Attendees must have a biotherapeutic discovery with intended applications for cancer treatment. Note: It is not mandatory that your discovery and associated strategic plan relate to a currently funded BioCanRx-funded project; however, priority will be given to projects currently funded by BioCanRx. 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 (BioCanRx only):
- Applicants associated with BioCanRx or partnering organizations will automatically considered for awards from respective organizations.
- The BioCanRx Travel 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 BioCanRx 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 BioCanRx Travel 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:
- BioCanRx: Megan Mahoney, Manager of HQP Training Programs, email@example.com, 613-737-8149
- SCN: Jon Draper, Program Director, Research and Partnerships, firstname.lastname@example.org, 613-298-5802
- 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