6 Month Update

It’s been nearly six months since API was launched as an accelerator for innovation and economic development and we are pleased to announce some of our early successes.

17 PARTNERSHIPS WITH SMES, PHARMA, AND THE CANNABIS INDUSTRY - since our launch we have started partnerships with over 17 companies in a wide range of areas, from pharmacokinetics work for large Canadian and international pharmaceutical companies, ADME and toxicology for spinoffs within the TEC Merck Accelerator, to formulation, analytical work, and clinical trials for many of the major players in the cannabis industry.

OVER 15 POST DOCTORAL FELLOWS AND GRADUATE STUDENTS HIRED - we have begun training over 15 employees for the pharmaceutical industry as part of our partnerships, working on real world projects, providing support for local SMES and putting Alberta and Canada on the map with large pharma R&D.

ATTRACTION OF TWO INTERNATIONAL PHARMACEUTICAL COMPANIES TO ALBERTA - through our work we have developed partnerships that are beginning to bring the pharmaceutical industry to Canada. As a result of our collaborations one of our partners made the decision to be headquartered in the province and is buying a manufacturing facility in Edmonton to be staffed with current trainees working with API.

We’ll continue to keep you updated in the months to come as we’re currently working on much more.

Fighting Superbugs - A partnership for the future of anti-infectives

Though the discovery of antibiotics transformed patient outcomes, saving millions of lives since the creation of Penicillin in 1928, it also started a clock. By their nature, bacteria and other infection-causing micro-organisms continually adapt to antimicrobial treatments, reducing their effectiveness and becoming more resistant to treatment over time.

For much of the 20th century this was combatted by the development of new classes of antibiotics to which disease-causing microbes had not been previously exposed. However, the most recent class of antibiotics in use today is based on a discovery made 33 years ago or earlier [1]. As a result, the world faces a growing threat from the rise of antimicrobial resistance (AMR).

It is estimated that over 700,000 people die annually as a result of AMR infections [2]. This number is expected to grow to 10,000,000 by 2050[3] if new ways of combating microbes that are becoming AMR— or “superbugs” [4]—are not found. Canada has recognized this urgent need for action, and in 2017 the Public Health Agency of Canada released its Pan-Canadian Framework for Tackling Antimicrobial Resistance and Antimicrobial Use based on input from concerned experts in academia, government, and industry.

One team working to fight these superbugs is the partnership between Fedora Pharmaceuticals Inc. (Fedora)—a biotech in Edmonton dedicated to the discovery and development of novel antimicrobial drug candidates that challenge AMR—and the laboratory of Dr. Carlos Velazquez-Martinez, Associate Professor in the Faculty of Pharmacy and Pharmaceutical Sciences. Spurred by a grant from Alberta Innovates, and implemented by API, the partnership between Fedora and the faculty is focused on developing a new pipeline of antibiotic drugs that will be effective against multi-drug resistant pathogens.

“This is an exciting and timely field of research considering the significant amount of evidence reported worldwide on the increasing incidence of chemoresistance, and the challenges associated to the hunt for new antibiotics,”[5] says Velazquez-Martinez.

Fedora is no stranger to anti-infectives or to the faculty. Its CEO, Chris Micetich and his team have over 120 years of cumulative experience in the area. Chris’ father, Dr. Ron Micetich, a former faculty member, created the beta-lactamase inhibitor Tazobactam in partnership with Japan’s Taiho Pharmaceutical Company, which is now a blockbuster drug with over one billion US dollar sales annually.

“We are proud to continue the longstanding relationship with the faculty. This partnership will serve as a model for all university-industry interactions across the country, resulting in highly skilled and educated candidates being sought after to enter the work force. As a team, we’re working closely together to bridge the transition gap between academia and industry,” says Chris.

The partnership between Fedora and the faculty is a pilot project in applied learning and one of the first collaborations facilitated by API since its launch. Working in the lab of Velazquez-Martinez, post-doctoral students, Dr. Myron Wilde and Dr. Yasin Tabatabaei, funded by Alberta Innovates, are taking part in a once in a lifetime project. With Fedora, they are working on the chemical synthesis of a series of drug molecules with potential antibacterial activity, specifically against gram-negative strains resistant to current antimicrobial treatments that, if successful, will go on to save countless lives. In the process, they will receive direct industry experience and be positioned to start meaningful careers in the pharmaceutical industry, continuing on to contribute to this critical area for the future of health care worldwide.

“This educational model is expected to provide postdoctoral fellows with a high-level vision not only on technical aspects related to synthetic organic chemistry, but also the approach followed by entrepreneurs in the high-risk drug development business,” says Velaquez-Martinez.

Beyond the training opportunity, he says that their goal is the production of at least one lead molecule with a potent, selective and safe profile for its potential use as an antibacterial agent.

“For the first time since I started my research career at the University of Alberta, my group will have the opportunity to learn the wide variety of translational considerations guiding the design and development of new drug candidates,” says Velazquez-Martinez. “We consider this an exciting opportunity to work with industry, and at the same time, bring funds to carry out research from sources other than traditional granting agencies. This model has the added benefit of a commercial partner willing to help us with the much needed translational jump, moving ideas to high-value products that save lives.”

1 Daptomycin, which was discovered in 1984.

2, 3, 4 The Review on Antimicrobial Resistance. Tackling drug-resistant infections globally, 2016. Available: amr-review.org

5 Chemical & Engineering News, volume 96, issue 49. The hunt for new antibiotics grows harder as resistance builds, 2018. Available: https://pubs.acs.org/toc/cgeabj/96/49

Advisory Committee Members

API has launched its Advisory Committee. With a broad group of expertise from multiple areas of the drug development world our committee includes the following members:

Advisory Committee

Launa Aspeslet

CEO, TRIO

Brian Corrigan

Global Head, Clinical Pharmacology, Pfizer

Matt Coffey

CEO, Oncolytics

Salma Jutt

Chief Commercial Officer, Acer Therapeutics

Sailaja Bhaskar

Executive Director, R&D, Purdue Pharma

Robert Foster

CEO, ContraVir

Jamie Lucien

Biotech Patent Lawyer

Majid Vakilynejad

Senior Director, Takeda

A bridge across the "Valley of Death"

The challenge faced by academic innovators

In the biotech community, there is a problem so common and so frustratingly difficult for many innovators to overcome that it is called the “Valley of Death”. The Valley of Death is where laboratory discoveries and cutting edge innovations die; running out of traction before they ever receive the opportunity to become potential life-saving treatments and provide value to our society.

Drug development is an extremely costly endeavor with a multitude of complex and specialized areas in which a potential drug can fail along its path to commercialization. Even when an innovation has received large-scale investment, the odds are still stacked against it ever coming to market. As a result, knowledgeable investors in the space do everything they can to ensure their dollars are placed in areas where there is the highest chance of success.

With this in mind, there are many steps that a discovery in a test tube or petri dish must go through before it will gain traction with potential partners who can bring it to market. Unfortunately, many of these steps lie outside the areas of expertise of the academic investigators who have made the initial discovery. This is the Valley of Death: a skills and expertise gap that includes many of the following aspects.

Business Case and Patent Strategy

A potential drug requires thorough market, intellectual property, pharmacoeconomic, and financial analysis. This analysis differs from the standard business case that can be analyzed by staff in a university commercialization accelerator due to the immensely complex regulatory frameworks and industry specific hurdles that drug candidates must overcome. It requires business strategies that are built into the scientific work and strategically managed in a holistic manner. It is seldom a straightforward route and requires expertise that can understand all aspects of drug development and is engaged as early as possible in the drug development process. A lead compound may demonstrate spectacular efficacy, but it will fail if there is not a strong market and patent strategy behind it.

Pharmaceutical Sciences

The steps between a discovery in the lab and successful testing in humans lies within the disciplines of the pharmaceutical sciences. To develop a drug requires a team of experts in toxicology, pharmacokinetics and dynamics, formulation, pharmacology, and medicinal chemistry. While other disciplines touch on some of the concepts found within these areas, there are a myriad of subtleties that can be missed and cripple a development program.

Regulatory Compliant Science

A very common reason that potential drugs fail is that development and pre-clinical study results do not meet regulatory requirements. While an idea may show promise in a university lab, studies must be performed in accordance with a properly documented quality control system to ensure that the results are consistently reliable and reproducible. The pharmaceutical industry no longer accepts standard academic laboratory results even as proof of concept. In order to be of interest, research on a drug candidate must be done at a GLP/GMP/GCP level. This work also needs to be structured in a manner that will address as questions about a drug candidate’s efficacy and safety as early in the development process as possible.

A Proof of Concept with Time for Development

Once there is a patent on a drug candidate, a clock begins ticking. The longer it takes an innovator to develop a very solid proof of concept at a regulatory compliant level, the less likely it is that s/he will find investment. The period of market exclusivity diminishes with each passing day. Generally, a drug candidate needs to finish a regulatory compliant Phase II clinical trial before it will attract a licensing partner or investment, but if it gets there with not much time left on its patent, there won’t be a strong case for an investor to spend the hundreds of millions of dollars required to move through Phase III.

With all of these factors in mind, researchers are faced with a seemingly insurmountable challenge if they choose to move down the path of drug development. Current frameworks in Canada simply do not provide the support to move biotech innovation forward. Researchers faced by this Valley of Death are left looking for funding to hire a professional contract research organization (CRO) to meet some of these requirements—something that can cost millions of dollars simply for a proof of concept that could determine a drug candidate to be nonviable. Even if they are successful in achieving regulatory compliant proofs of concept, if they missed something in their business case and patent strategy, or have run out the clock on their market exclusivity, they will be faced with a dead end in their ability to gain investment required to complete Phase III. Life-saving discoveries are trapped, public investments made in post-secondary innovation are crippled, and world-class researchers spend years on a dead end.

Bridging the Gap with API

Applied Pharmaceutical Innovation (API), an institute working closely with the University of Alberta’s Faculty of Pharmacy and Pharmaceutical Sciences and institutions across Canada, provides a framework that bridges this gap, offering the relevant expertise, infrastructure, and capacity at all stages of the drug development process.

API provides researchers with the capabilities of a large industry drug development program in a structure that removes barriers for success. Following an initial consultation program, participants are provided with:

  • Expertise in regulatory support, business and patent strategy

  • GLP/GMP/GCP compliant clinical pharmacology, computational biology, medicinal chemistry, pharmacology, pharmacokinetics and dynamics, pharmacometrics, and toxicology

  • Access to resources in a cost recovery model that leverages public funding to achieve milestones towards a regulatory compliant completion of pre-clinical work and Phase I and II clinical trials

For more information on how to access the services of API please click below.

API Soft Launch

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After extensive industry engagement that included over 150 consultation meetings with members of the pharmaceutical industry, government partners, and stakeholders, API is now active.

We have piloted our model with over $4M in successful partnerships over the past year, and have now launched the capacity to provide a full service one-stop-shop for industry and academia alike.

We look forward to partnering as we work to unlock the potential of university research and build a vibrant pharmaceutical industry in Canada.