Author Archives: micah

Knowing the Pathway and Establishing the Plan: H2i Regulatory, Clinical and Quality Workshop

If you are thinking about bringing a healthcare technology to market, it is essential that you establish your regulatory pathway from day one!

H2i is supporting an upcoming workshop series focused on essential regulatory, clinical, and quality requirements for bringing new health care technologies to market. The goal of the workshop series is to provide participants with an understanding of the necessary processes, data, timelines and costs that are directly associated with securing market authorization within the US, EU and Canadian regulatory jurisdictions.

 

The workshop series includes the following 3 modules conducted by our team of experts (see below):

Wednesday Jan 31, 2018: Product classification and regulatory pathways in the US, EU, and Canada
Wednesday March 7, 2018: Developing a regulatory strategy from product concept through to market authorization application
Wednesday April 25, 2018: Executing a regulatory strategy towards market authorization
Each module will run  from 4:00 PM to 8:00 PM at ONramp RBC innovation hub @ 100 College St in the Banting Institute

There are only 50 available spots so registration will be on a first come first serve basis and is looking for your commitment to all 3 sessions.

Register here

2018 Sci Innovation Competition

The Canada Confederation of Shenzhen Associations (CCSA) and the Sino-Canada International Innovation Centre (Sci Innovation Centre) have announced the launch of The Second China (Shenzhen) Innovation & Entrepreneurship International Competition, Toronto Division, on March 24, 2018. Initiated by the Municipality of Shenzhen, the international competition is sponsored globally by local governments in Toronto, San Francisco, Sydney, Tokyo, Boston, Tel Aviv, London, Stockholm, and Berlin. The divisional competition in Toronto offers prize awards totalling C$2.09 million. A venture capital pool of C$4 billion has been set up by 34 investment institutions for all the nine global divisions. The 2018 Sci Innovation Competition in Toronto will feature 20 finalists from Canada who will pitch ideas to a panel of high-profile judges and First, Second, and Third place prizes will be awarded. Ten of them will be qualified for the final Second China (Shenzhen) Innovation & Entrepreneurship International Competition in Shenzhen in April 2018. This year, the Sci Innovation Competition is partnering with Toronto-based MaRS Discovery District, one of the world’s largest urban innovation hubs supporting innovators and entrepreneurs, which will host the competition at its downtown Toronto facility. Click here for more information or to register for the competition.

Accelerator Weekend 2018

The Entrepreneurship Hatchery’s Accelerator Weekend allows students to experience the life of an entrepreneur in the span of 28 hours. All students are invited to join this challenge that brings together multidisciplinary teams, who with the guidance from successful entrepreneurs, develop a business model around an idea. This journey will be reflected in a pitch that will be presented to the participants and mentors at the 24th hour.

Date & Time: 7:30pm on January 19, 2018 until 9:00pm on January 20, 2018

Location: Sanford Fleming Building (10 Kings College Road, Toronto, ON) and Fields Institute (222 College street, Toronto, ON)

Registration: https://secureca.imodules.com/s/731/event/index.aspx?sid=731&gid=36&pgid=13379&cid=22469 

ImmunoBiochem Corporation Announces the Completion of a New Round of Financing and Residency at Johnson & Johnson Innovation, JLABS @ Toronto

TORONTO, Dec. 11, 2017 /PRNewswire/ — ImmunoBiochem Corporation, a Canadian biopharmaceutical company developing novel biological therapeutics, has completed a new round of financing led by angel investors and the company’s founding investor. ImmunoBiochem has also expanded its operations and is now located at Johnson & Johnson Innovation, JLABS in Toronto (JLABS @ Toronto).

ImmunoBiochem is solving the problem of tumor heterogeneity by targeting a novel class of proteins in the tumor microenvironment with Antibody Drug Conjugates (ADCs) – a promising class of anticancer therapeutics that combine the selectivity of targeted biologics with the potency of highly cytotoxic small-molecule drugs. ImmunoBiochem’s R&D is focused on the cancer cell secretome – the totality of proteins secreted by cancer cells. Select cancer targets are only secreted by cancer cells and accumulate in tumors, and can be exploited for targeted and selective delivery of cytotoxic payloads with ImmunoBiochem’s therapeutics platform. ImmunoBiochem’s highest priority is to transform the life of patients with triple-negative breast cancer (TNBC) – an aggressive disease with poor survival that does not respond to major therapies. Continue reading

Innovation machine: How one U of T researcher is having an outsized impact on the health startup space

Paul Santerre recently flew to Boston to help launch a cerebral catheter that incorporates an anti-clotting polymer additive created by Interface Biologics, the company he co-founded nearly two decades ago based on his University of Toronto lab work.

It was the sort of business trip that should be routine for the U of T biomaterials professor, given that Interface, by his count, has previously made five such announcements.

But that didn’t dampen the enthusiasm of one of the university’s most prolific entrepreneurs.

“For Interface Biologics to be entering the neural area is big,” says Santerre, who has appointments in U of T’s Faculty of Dentistry and the Institute for Biomaterials and Biomedical Engineering. “A lot of imaging tools are starting to rely on catheter technologies to peer into spots where they can’t get the resolution they need with an MRI.

“This is an innovative product in an area that’s going to be a game-changer. It sets the stage for the next phase of growth for this local company of ours.”

The extra-ventricular catheter drain in question is designed by Knoxville, Tenn.-based startup Arkis Biosciences. Called CerebroFlo, the catheter will employ Interface’s Endexo technology, which a press release states “has been proven to be highly effective for reducing catheter occlusions and thrombosis,” including in a recent study of 656 patients at the Ottawa Hospital.

Endexo grew out of Santerre’s lab research in the 1990s. It’s a polymer additive that essentially tricks the body to ignoring its presence, preventing the formation of blood clots that can break off and lodge in blood vessels. It’s already being used in everything from flexible PICC catheters to dialysis machine membranes – basically anywhere that patients’ blood and medical instruments come into contact for extended periods.

The technology also helps reduce the chance of infection, since blood clots tend to be a breeding ground for bacteria – a feature Santerre says is critical for neurological applications.

“You can imagine what happens if you get a bug crawling up those catheter lines into the brain,” he says. “It’s over, very fast.” Continue Reading