Bench to Bedside for Biotherapeutics (B3) Workshop

(Contents are available in English only/Contenu disponible en anglais uniquement)

On October 5, 2017, the Clinical Translation Education Group (CTEG) held its first collaborative workshop in Toronto. Over 100 trainees were able to learn on the various opportunities and hurdles you can be faced with when developing new therapies and especially about ways to overcome these challenges, from translation to reimbursement.

Fortunately, if you missed this workshop, its contents are available here.  

All the presentations are from the Bench to Bedside for Biotherapeutics (B3) Workshop held in Toronto on October 5, 2017.

How do I take my research and make it into a marketable product?

A presentation by Paul Santerre, PhD (University of Toronto) 

In this seminar, Dr. Santerre discusses the entrepreneurship ecosystem and how the researcher can start thinking about their research from a commercialization prospective. This seminar provides an overview to better understanding the local translational resources, including training and mentorship, support for intellectual property, planning and executing a commercialization plan and assessing if a clinical research program can generate a marketable product.

How can you predict if your discovery is translatable?

A presentation by David Kaplan, PhD (SickKids Research Institute)

In this seminar, Dr. Kaplan shares lessons learned through translating basic research findings into commercial products and clinical trials. Dr. Kaplan highlights his experience in developing two companies from work generated in his lab as well a meeting with key stakeholder to develop guidelines and set a “bar” to determine when their basic lab research was ready to move forward into a clinical trial.

Designing pre-clinical studies to support in-human trials. (Part 1 of 2)

A presentation by Manoj Lalu, MD, PhD (Ottawa Hospital Research Institute)

 In this seminar, Dr. Manoj defines validity and discusses the different considerations researchers should be considered when establishing research protocols. Through a series of examples, Dr. Manoj highlights internal, external and constructive validity as well as consideration on how to implement a method in the lab to address the validities.

Designing pre-clinical studies to support in-human trials. (Part 2 of 2)

A presentation by Julia Pomoransky, PhD (Turnstone Biologics) 

In this seminar, Dr. Pomoransky discusses the translational continuum of moving pre-clinical studies towards in-human trials. Through a series of examples, Dr. Pomoransky discusses the considerations of pre-clinical development including; pre-clinical POC, GLP toxicology, process and assay development, GMP manufacturing and testing, stability testing and regulatory interactions.

 Making the goods: Cleanliness, orderliness, scaling and other considerations.

A presentation by Gayle Piat (Alberta Cell Therapy Manufacturing Facility) and Friederike Pfau, PhD (Laboratory of Experimental Organogenesis, University of Laval) 

In this seminar, Gayle Piat discusses Good Manufacturing Practices (GMP) and how to transition from a research lab environment to a GMP Facility. This seminar focuses on understanding what being GMP implies, understanding the difference between Quality Assurance (QA) and Quality Control (QC) as well understanding Quality Management Systems and the importance of record keeping. Next, Dr. Pfau delves deeper into understanding the realities of GMP Clean Rooms, how these facilities work to control air and reduce contamination as well as establishing and implementing operating and equipment handling procedures and lastly how to deal with changes.

What’s the process of designing and applying for a clinical trial?

A presentation by Lauralyn McIntyre, MD and Josee Champagne (Ottawa Hospital Research Institute) 

In this seminar Dr. McIntyre provides an overview of the clinical trial pipeline, highlighting the goals and rational of each stage. Through a series of examples from the CISS Trial, Dr. McIntyre discusses the basic design principles of starting a Phase 1 Clinical Trial. Josee Champagne next examines the regulatory challenges for Investigator-led Clinical Trials and provides an overview of the Clinical Trial Application Process and considerations when preparing for Health Canada approval.

Understanding clinical adoption: How a therapy is reimbursed.

A presentation by Nancy Sikich, MSc (Health Quality Ontario) 

In this seminar, Nancy Sikich discusses the role of Health Quality Ontario (HQO) in assessing and implementing innovations within a healthcare framework. Through a series of examples, this seminar covers how health technologies are assessed, evaluated for adoption and the reimbursement pathway of new technologies.

How do I communicate where I’m at in the clinical translation continuum?

A presentation by Mary Sunderland, PhD (Foundation Fighting Blindness) and Dawn Richards, PhD (Clinical Trials Ontario) 

A candid discussion with Dawn Richards from Clinical Trials Ontario talking about the importance of how communicating with patients and key stakeholder along the clinical pipeline in invaluable for clinical adaption. Speaking as both a patient advocate and through her role with CTO, Dawn Richards has a unique and important perspective for researchers.