LEGAL

An Overview of Available Regulatory Systems For a Drug in Canada Aperçu des systèmes de réglementation des médicaments au Canada

by/par Beverley Moore, Jennifer Raoul, Chantal Saunders, Jennifer Ponton, and Zosia Zielinski.

WHEN BRINGING A DRUG TO MARKET IN CANADA, WHETHER A BIOLOGIC OR A SMALL MOLECULE, THERE ARE A NUMBER OF regulatory systems to consider in addition to the drug regulatory process itself. We summarize these regulatory systems to highlight the importance of strong internal communication at a company to effect the best strategy.

DATA PROTECTION

Canada’s Food and Drug Regulations provide an 8-year data protection period for marketed innovative biological and chemical drugs. Data protection exists independently of the patent system, and is thus a powerful benefit.

An “innovative drug” contains “a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or

AVANT DE METTRE UN MÉDICAMENT BIOLOGIQUE OU À PETITES MOLÉCULES SUR LE MARCHÉ CANADIEN, LES FABRICANTS doivent tenir compte de plusieurs systèmes réglementaires en plus du processus de réglementation des médicaments lui-même. Le présent article offre un résumé de ces systèmes et souligne l’importance d’une bonne communication lorsqu’il est question de mettre en œuvre la meilleure stratégie possible au sein d’une entreprise.

PROTECTION DES DONNÉES

Le Règlement sur les aliments et drogues du Canada prévoit une période de protection des données de huit ans pour les drogues innovantes, qu’elles soient biologiques ou chimiques. Comme elle existe indépendamment du système des brevets, la protection des données constitue un avantage considérable.

On entend par « drogue innovante » toute drogue qui « contient un ingrédient médicinal non déjà approuvé dans

polymorph.” Other situations can meet the definition so applicability of this scheme should be considered early.

A submission for approval of a generic or biosimilar drug cannot be filed for six years after the issuance of the first Notice of Compliance (NOC) or regulatory approval for the innovative drug. It cannot be approved for a further two-year period after filing. Six additional months is available if the results of pediatric clinical trials are submitted to Health Canada within five years of the first NOC.

LINKAGE REGULATIONS

Canada has regulations linking generic and biosimilar regulatory approval to the clearance of patent hurdles. Under the Patented Medicines (Notice of Compliance) Regulations (Regulations), patents containing at least one claim to the medicinal ingredient, a formulation containing the medicinal ingredient, the use of the medicinal ingredient, or the dosage form of the medicine, matching the commercial product, can be listed on the Patent Register. Strict timing requirements apply.

Health Canada will not approve a generic or biosimilar drug that makes direct or indirect comparison to a drug with a listed patent until the patent(s) have been addressed through the Regulations. The generic or biosimilar filer can await patent expiry, or can make non-infringement and/or invalidity allegations. Such allegations can either be accepted by the innovator, or become the subject of litigation. If the innovator chooses to start an action, an NOC cannot issue to the generic or biosimilar filer until either the action is dismissed or two years have passed,

une drogue par le ministre et qui ne constitue pas une variante d’un ingrédient médicinal déjà approuvé tel un changement de sel, d’ester, d’énantiomère, de solvate ou de polymorphe ». Puisque d’autres situations peuvent répondre à la définition, l’applicabilité doit être examinée dès le début.

Un fabricant ne peut pas demander l’approbation d’un médicament générique ou biosimilaire pendant six ans après la date du premier avis de conformité (AC) ou de l’approbation réglementaire de la drogue innovante. Une fois la présentation déposée, elle ne peut pas être approuvée avant deux ans. Une prolongation supplémentaire de six mois est possible si les résultats d’essais cliniques pédiatriques sont transmis à Santé Canada dans les cinq années suivant le premier AC.

RÈGLEMENTS DE LIAISON

Le Canada dispose de règlements qui établissent un lien entre l’approbation réglementaire des médicaments génériques et biologiques et l’élimination des obstacles à l’obtention d’un brevet. En vertu du Règlement sur les médicaments brevetés (avis de conformité) (le « Règlement »), les brevets contenant au moins une revendication de l’ingrédient médicinal, une revendication de la formulation qui contient l’ingrédient médicinal, une revendication pour la forme pharmaceutique ou une revendication pour l’utilisation de l’ingrédient médicinal, qui correspond au produit à usage commercial, peuvent être ajoutés au Registre des brevets. Des exigences strictes en matière de délais s’appliquent.

Santé Canada n’approuvera pas un médicament générique ou biosimilaire qui établit une comparaison directe ou indirecte avec un médicament breveté tant que le ou les brevets n’auront pas été examinés conformément au Règlement. L’entité déposante peut attendre l’expiration du brevet ou encore invoquer l’absence de contrefaçon ou l’invalidité. De telles allégations peuvent être acceptées par l’inventeur ou faire l’objet d’un litige. Si l’inventeur choisit d’intenter une action, un AC ne pourra être délivré au fabricant du médicament générique ou biosimilaire avant que l’action soit rejetée ou que deux ans se soient écoulés, selon la première éventualité. De plus, si l’inventeur obtient gain de cause, le médicament générique ou biosimilaire ne pourra être approuvé avant l’expiration du brevet.

Ce lien entre l’approbation réglementaire des médicaments génériques ou biosimilaires et le brevet protège la part de marché du produit en question jusqu’à ce que la décision soit rendue. Si l’action de l’inventeur aboutit, une injonction permanente sera accordée et protégera la part de marché de ce dernier jusqu’à l’expiration du brevet. Toutefois, si l’action n’aboutit pas, des dommages-intérêts pourraient être réclamés en raison du report de la mise en marché du médicament générique ou biosimilaire. Il convient donc de se demander si ce recours est avantageux. Afin de tirer le meilleur parti de cet avantage, un service des brevets

whichever is sooner. Furthermore, if the innovator is successful, the generic or biosimilar cannot be approved until the patent expires.

This linkage of generic or biosimilar regulatory approval to the listed patent protects market share until the decision issues. If the innovator is successful, a permanent injunction will issue, protecting market share until patent expiry. If unsuccessful, damages can flow from keeping the generic/biosimilar filer off the market. Thus, consider whether triggering this scheme is beneficial. In order to maximize the benefit, the patent division should communicate with the regulatory team to ensure eligible subject matter in the claims, and critical timing and relevance to the commercial product restrictions are met.

PATENT TERM RESTORATION

The patent term restoration period is intended to restore time lost due to delays in drug approval at Health Canada. Up to two years of time can be “restored” to a patent through the issuance of a Certificate of Supplementary Protection (CSP). One CSP can be issued per drug and the company chooses the patent to which the CSP is applied.

In the context of most regulatory systems, the CSP will have essentially the same effect as the patent for the original term of the patent, albeit its scope is limited to the medicine in question. CSPs can be listed on the Patent Register, and must be reported to the Patented Medicines Prices Review Board (PMPRB), discussed more fully below.

The eligibility requirements for a CSP are strict. The patent must pertain to a medicinal ingredient or combination of medicinal ingredients in a drug for which the NOC was issued, and contain a claim for: the medicinal ingredient or combination; the medicinal ingredient or combination as obtained by a specified process; or the use of the medicinal ingredient or combination.

If Canada is not the first country in which an application for marketing approval has been submitted, the Canadian application must have been filed within 12 months of the earliest foreign application for marketing approval in certain countries.

Communication between internal teams is critical to ensure the patent contains the necessary claims, and so that if a CSP is desired, the timing of the regulatory filing in Canada complies.

PRICE CONTROLS

The PMPRB oversees a regime designed to ensure patented medicines are not sold at an excessive price in Canada. The PMPRB determines the maximum price at which a patented medicine can be sold. Patentees are obligated to report relevant patents to the PMRPB under the Patent Act. The PMPRB only takes jurisdiction once a relevant patent issues. But, once issued, the jurisdiction goes back to the publication date.

doit collaborer avec son équipe de réglementation pour s’assurer que les revendications sont admissibles, que les délais sont respectés et que les restrictions liées au produit à usage commercial sont prises en compte.

PROLONGATION DE LA DURÉE DES BREVETS

La période de prolongation de la durée des brevets vise à compenser le temps perdu en raison de retards avant l’approbation des médicaments par Santé Canada. Une période additionnelle de deux ans peut être accordée à un brevet au moyen d’un certificat de protection supplémentaire (CPS). Un CPS peut être délivré par médicament; l’entreprise choisit le brevet auquel le CPS s’applique.

Dans la plupart des systèmes réglementaires, un CPS aura essentiellement le même effet que le brevet initial, mais sa portée sera limitée au médicament en question. Les CPS peuvent être ajoutés au Registre des brevets et doivent être déclarés au Conseil d’examen du prix des médicaments brevetés (CEPMB), que nous aborderons ci-dessous.

Les critères d’admissibilité liés aux CPS sont stricts. Le brevet doit porter sur un ingrédient médicinal ou une combinaison d’ingrédients médicinaux dans un médicament pour lequel l’AC a été délivré et contenir une revendication de l’ingrédient médicinal ou de la combinaison, de l’ingrédient médicinal ou de la combinaison tels qu’ils sont obtenus au moyen d’un procédé déterminé, ou de l’utilisation de l’ingrédient médicinal ou de la combinaison.

Si le Canada n’est pas le premier pays dans lequel une autorisation de mise en marché a été demandée, la demande canadienne doit avoir été déposée dans les 12 mois suivant la première demande. Cela s’applique à certains pays seulement.

Les équipes internes doivent communiquer entre elles pour s’assurer que le brevet contient les revendications nécessaires et, si elles souhaitent obtenir un CPS, que les exigences relatives au moment du dépôt réglementaire au Canada sont respectées.

CONTRÔLE DES PRIX

Le CEPMB a conçu un régime visant à empêcher la vente de médicaments brevetés à un prix excessif au Canada. Il fixe en effet le prix maximum auquel un médicament breveté peut être vendu. Les titulaires de brevet sont tenus de déclarer les brevets pertinents au CEPMB en vertu de la Loi sur les brevets. Celui-ci n’a compétence qu’à compter de la délivrance du brevet. Toutefois, une fois le brevet délivré, cette compétence s’applique à partir de la date de publication de la demande.

Il est important de souligner que les obligations de déclaration englobent beaucoup plus que les brevets admissibles à un CPS ou au Registre des brevets. En outre, le CEPMB exige une déclaration, que l’invention contenue dans le brevet soit utilisée ou non en relation avec le produit commercial.

Importantly, the reporting obligations encompass a much broader range of patents than those that are eligible for a CSP or for listing on the Patent Register. Furthermore, the PMRPB requires reporting whether or not the invention in the patent is used in relation to the commercial product.

Business decisions relating to patent coverage should be made with respect to all ongoing innovation. A perceptive innovator should weigh the additional protection of a patent versus negative impacts of price control.

NAMING A MEDICINE

Health Canada conducts premarket regulatory drug name review, which includes a confusion assessment with both approved brand names and generic names. Health Canada focuses on whether medication errors are likely to result, and the potential for harm. Published guidance documents address “look-alike sound-alike” (LASA) names and the factors that will be considered during the premarket review. The most recent guidance document indicates that when testing a proposed brand name for LASA attributes, any names in the drug and natural health product databases having a POCA score of 50% or greater will need to be identified and considered.

Trademark issues can arise in the Trademark Office and in the Courts despite a clearance from Health Canada. In such cases, there tends to be a focus on the resemblance between trademarks in appearance, sound and idea suggested and any possible overlap in patient populations. Less weight may be given to distinctions in the nature of pharmaceutical products, including their marketing status, e.g., prescription vs. over-the-counter, their dose form and routes of administration, etc., unless such details are referenced in the descriptions of the pharmaceuticals contained in the trademark application at issue and the prior third party trademark application or registration. The test for trademark confusion is whether a doctor/pharmacist/patient with a partial recollection of a pharmaceutical product trademark, upon encountering a product branded with the proposed pharmaceutical name (but not taking the time to study them closely), would assume that the two products come from the same source.

CONCLUSIONS

It is critical that internal groups at pharmaceutical and biotechnology companies communicate and co-ordinate in order to allow the implementation of the best strategy for the regulatory systems above. Also, consider including your external team early. They have invaluable expertise in developing strategies to negotiate these regulatory systems, including the timelines.

Les décisions commerciales relatives à la couverture d’un brevet doivent être prises en fonction des inventions en cours. Les inventeurs perspicaces sauront peser les avantages qu’offre la protection supplémentaire d’un brevet par rapport aux répercussions du contrôle des prix.

NOM D’UN MÉDICAMENT

Avant la mise en marché, Santé Canada effectue un examen réglementaire du nom des médicaments et évalue notamment si les noms de marque approuvés et les noms des versions génériques portent à confusion. L’objectif est de déterminer si des erreurs d’administration de médicaments ou des préjudices sont susceptibles de survenir. L’organisme a justement publié des lignes directrices à propos des « produits de santé à présentation et à consonance semblables » (PSPCS) et des facteurs qui seront pris en compte lors de l’examen préalable à la mise en marché. Selon la plus récente version, lors de l’évaluation de noms de marque de PSPCS, tout nom figurant dans les bases de données des produits pharmaceutiques ou naturels ayant un résultat supérieur ou égal à 50 % en matière de similitudes orthographiques et phonétiques combinées doit être examiné.

Des dossiers peuvent être portés devant l’Office de la propriété intellectuelle du Canada ou devant les tribunaux malgré une autorisation de Santé Canada. Dans de tels cas, l’accent semble mis sur la ressemblance entre les marques en matière d’apparence, de consonance et d’idée suggérée et sur un éventuel chevauchement des populations de patients. Une importance moindre pourrait être accordée à la nature des produits pharmaceutiques, y compris en ce qui a trait à la commercialisation (médicament sur ordonnance ou en vente libre, forme pharmaceutique, mode d’administration, etc.), à moins qu’il en soit mention dans les descriptions des produits pharmaceutiques contenues dans la demande de marque de commerce en question ou dans la demande de marque de commerce ou l’enregistrement antérieur d’un tiers. La comparaison entre les marques de commerce consiste à déterminer si un médecin, un pharmacien ou un patient ayant un souvenir partiel de la marque d’un produit pharmaceutique et tombant sur un produit portant le nom proposé, sans prendre le temps de l’étudier de près, supposerait que les deux produits sont les mêmes.

CONCLUSION

Il est essentiel que les équipes internes des sociétés pharmaceutiques et biotechnologiques communiquent entre elles et coordonnent leurs efforts afin de mettre en œuvre la meilleure stratégie possible quant aux systèmes réglementaires susmentionnés. Pensez également à inclure vos conseillers externes tôt dans le processus; ils possèdent une expertise inestimable dans l’élaboration de stratégies de négociation, notamment en ce qui touche les délais.

At Path Therapeutics, unexpected targets open new drug discovery

THREE YEARS AFTER CREATING A GROUND-BREAKING DRUG DISCOVERY PROGRAM, CALGARY-BASED PATH THERAPEUTICS is having a moment. “Over the past nine months or so, interest in the platform and in the company has risen dramatically,” says Path Therapeutics co-founder and CEO Dr. Deborah Kurrasch. “We’ve increased our discussions with investors, and the response has been overwhelmingly positive.”

Most of the interest focuses on MitoREAD, their novel neurometabolic phenotypic drug discovery platform that identifies new protein targets against which de novo drug discovery can be conducted. After decades of discounting, neurometabolism is now having its day in the sun. It is now appreciated that neurometabolism plays a central role across most brain diseases, making Path Therapeutics’ first-of-its kind platform technology well positioned.

Historically, says Dr. Kurrasch, drug discovery starts by targeting a particular protein that research has shown is associated with disease. However, sometimes that protein turns out to be a poor drug target, leading to failures in clinical trials. This has been seen in Alzheimer’s Disease and the targeting of ß-amyloid. Path Therapeutics’ approach, she says, is to ignore the research hypotheses of a particular disease and instead let the neuron’s neurometabolic profile inform when a protein target improves disease burden, thereby uncovering novel druggable pathways.

She cites epilepsy as one example. Although relatively common – it afflicts approximately one in every 100 Canadians – effective treatment for epilepsy remains elusive for over a third of patients. Given that some 90 per cent of antiseizure drugs now on the market target a handful of channels and receptors localized to the synapse, drugs with new mechanisms of action are needed. Similar needs exist for the treatment of diseases like Alzheimer’s, depression, or even Autism Spectrum Disorders, where a paucity of new drug targets has stalled progress.

For Path Therapeutics, a small molecule biotech company focused on neuroscience therapeutics, the drug discovery platform can be a game-changer, both for the company and for patients. But it turned out that Path Therapeutics’ platform did not fit into big pharma’s way of thinking. “While the pharmaceutical industry regards actual drugs as assets, it does not view new drug targets the same way,” says Dr. Kurrasch, who initially had hoped to sell the new pathways they discovered to pharma.

Path Therapeutics responded not with disappointment but with determination. The company immediately took steps to develop its own discovery program using their new drug targets for brain diseases that they will advance into the clinic. Now, with emerging backing from strategic investors and a growing interest in pharmaceutical partnering, those efforts are achieving real results. “We’ve been reaching out where and when we can,” says Dr. Kurrasch. “As a result, an ever-increasing number of investors are showing real interest in our approach.”

It appears that Path Therapeutics, as it did when designing MitoREAD years ago, has once again identified the most promising path to success.

GLOBAL BIOPHARMACEUTICALS SOCIÉTÉS BIOPHARMACEUTIQUES MONDIALES

AbbVie Canada Alexion Pharma Canada Alnylam Pharmaceuticals Canada ULC Amgen Canada Inc. AstraZeneca Canada Inc. Bayer Inc. Biogen Canada Inc. BioMarin Pharmaceutical Inc Bristol-Myers Squibb Canada Inc. CSL Behring Eisai Limited Eli Lilly Canada Inc. Ferring Canada Genentech Gilead Sciences Canada Inc. Grifols Hoffmann-La Roche Limited Horizon Therapeutics Canada Incyte Biosciences Canada Ipsen Biopharmaceuticals Canada Inc. Janssen Inc. Jazz Pharmaceuticals Canada Inc. Merck Canada Inc. Mitsubishi Tanabe Pharma Canada (MTP-CA) Novartis Pharmaceuticals Canada Inc. Novo Nordisk Canada Inc. Pfizer Canada Inc. Sobi Canada Inc. Takeda Canada Inc. Teva Canada Innovation UCB Canada Inc. Ultragenyx Pharmaceutical Vertex Pharmaceuticals Inc.

AGRICULTURE & INDUSTRIAL BIOTECH BIOTECHNOLOGIE INDUSTRIELLE

Aqua Bounty Canada Inc. Bioenterprise Corporation Bioindustrial Innovation Canada EVAH Corp. Okanagan Specialty Fruits Inc. Renaissance Bioscience Corp.

AI, DIGITAL, AND COMPUTATIONAL MEDICINE IA, MÉDECINE NUMÉRIQUE ET INFORMATIQUE

Adapsyn Biosciences Inc. Augurex Life Sciences Corp. Deep Genomics Modelis Inc. Molecular Forecaster Phenomic AI Skymount Medical Inc. Ventus Therapeutics

ANTIBODIES, IMMUNOTHERAPY, AND INFECTIOUS DISEASE ANTICORPS, IMMUNOTHÉRAPIE ET MALADIES INFECTIEUSES

Appili Therapeutics Aurinia Pharmaceuticals Inc. Bright Angel Therapeutics Cura Therapeutics Inc. D5Pharma Inc. Immune Biosolutions Innovative Targeting Solutions Inc. KisoJi Biotechnology Inc. Nobelex Biotech Inc. Notch Therapeutics Pattern Pharma Inc. PlantForm Corporation Red Leaf Medical Inc. Tentarix Biotherapeutics Inc. Turnstone Biologics Inc. Virogin Biotech Ltd.

GENETIC AND PRECISION MEDICINE MÉDECINE DE GÉNÉTIQUE ET DE PRÉCISION

Chinook Therapeutics Inc. Giiant Pharma Mediphage Bioceuticals Precision NanoSystems Inc. ProMIS Neurosciences Specific Biologics Inc.

NEUROLOGICAL AND CNS DISORDERS TROUBLES NEUROLOGIQUES ET DU SNC

Alpha Cognition Inc. GoodCap Pharmaceuticals Inc. HDAX Therapeutics Path Therapeutics Xenon Pharmaceuticals Inc.

NUCLEAR MEDICINE AND RADIOPHARMACEUTICALS MÉDECINE NUCLÉAIRE ET PRODUITS RADIOPHARMACEUTIQUES

Abdera Therapeutics Alpha9 Theranostics Inc. Centre for Probe Development & Commercialization (CPDC) Fusion Pharmaceuticals

ONCOLOGY ONCOLOGIE

Alpha Cancer Technologies Inc. BeiGene (Canada) ULC BioMark Diagnostic Solutions Bold Therapeutics Inc Delta-Fly Pharma Inc. Domain Therapeutics NA Inc. Entos Pharmaceuticals Epitopea Inc. ESSA Pharma Inc. FORUS Therapeutics Inc. Kintara Therapeutics, Inc. KOP Therapeutics Corp Medicenna Therapeutics Corp. QurCan Therapeutics Repare Therapeutics SeaGen Canada Sierra Oncology Soricimed Biopharma Inc. Taiho Pharma Canada Temple Therapeutics B.V. Triphase Accelerator Corp. Zymeworks Inc

OPHTHALMOLOGY OPHTALMOLOGIE

Mannin Research Inc. Naegis Pharmaceuticals Inc. Oak Bay Biosciences, Inc. Ripple Therapeutics TALLC Inc.

PAIN AND INFLAMMATION DOULEUR ET INFLAMATION

AmacaThera Antibe Therapeutics Inc. Edesa Biotech Qu Biologics Tetra Bio-Pharma Vasomune Therapeutics Wex Pharmaceuticals Inc.

REGENERATIVE MEDICINE MÉDECINE RÉGÉNÉRATIVE

Aspect Biosystems Feldan Therapeutics NervGen Pharma Corp. Sernova Corporation Spiderwort Bio Targa Biomedical Inc.

SPECIALIZED THERAPEUTICS TRAITEMENTS SPÉCIALISÉS

Avir Pharma Inc. BELLUS Health Inc. Cyclenium Pharma Inc. Inversago Pharma JN Nova Pharma Inc LQT Therapeutics Medicure Inc. Primary Peptides Inc. Verity Pharmaceuticals Inc. Zucara Therapeutics Inc.

VACCINES VACCINS

Defence Therapeutics Inc. IMV Medicago Inc. Sanofi Canada Seqirus Vaccine and Infectious Disease Organization-International Vaccine Centre (VIDO) Valneva Canada Inc. VBI Vaccines Inc. Virica Biotech

FINANCE, INVESTOR, VENTURE CAPITAL FINANCE, INVESTISSEUR, CAPITAL DE RISQUE

Alexandria Venture Investments AmorChem II Ventures Inc. Amplitude Ventures Bloom Burton & Co. CTI Life Sciences Fund Fonds de Solidarité FTQ Genesys Capital JP Morgan Lumira Ventures Novateur Ventures Inc. Quark Venture LP Royal Bank of Canada Silicon Valley Bank Teralys Capital inc. Versant Ventures Canada Ltd.

LEGAL SERVICES JURIDIQUES

Blake Cassels & Graydon LLP Blanchard Law Borden Ladner Gervais LLP DLA Piper Canada LLP Eversheds Sutherland Farris LLP Fasken Martineau Dumoulin LLP Gowling WLG (Canada) LLP Smart & Biggar Wilson Sonsini Goodrich & Rosati

RESEARCH, ACADEMIC & ECONOMIC DEVELOPMENT RECHERCHE, ENSEIGNEMENT ET DÉVELOPPEMENT ÉCONOMIQUE

adMare BioInnovations Applied Pharmaceutical Innovation BioTalent Canada Canadian Advanced Therapies Training Institute (CATTI) Canadian Alliance for Skills & Training in Life Sciences (CASTL) Canadian Glycomics Network (GlycoNet) Centre for Commercialization of Regenerative Medicine (CCRM) CQDM Genome Canada Institute for Research in Immunology and Cancer-Commercialization of Research MaRS Discovery District Research Canada Toronto Innovation Acceleration Partners University Health Network

SCIENTIFIC SERVICES AND PRODUCTS SERVICES ET PRODUITS SCIENTIFIQUES

A&C American Chemicals Ltd. Biodextris BioSignal2 Inc. BioVectra Inc. Evik Diagnostic Innovations Inc. Genvira Biosciences Inc. IQVIA KreaMedica Inc. PBR Laboratories Inc. Pholoho Biotechnology Group Inc. Quality & Compliance Services Inc. Stiris Research Inc. VWR, Part of Avantor

CONSULTING & BUSINESS SERVICES CONSEILS ET SERVICES AUX ENTREPRISES

3Sixty Public Affairs Inc. Back Bay Life Science Advisors BrevisRefero Corporation case Market Access Consulting Inc. CBRE Limited Deloitte Eversana Global Public Affairs Guthrie Insurance Brokers MORSE Consulting Inc. Pangaea Group PDCI Market Access Inc. Shadow Lake Group SPharm Inc.

NATIONAL BIOTECHNOLOGY ACCORD ACCORD NATIONAL DE BIOTECHNOLOGIE

Ag-West Bio Inc. BioAlberta BioNB BioNova BIOQuébec Bioscience Association Manitoba Life Sciences Ontario (LSO) LifeSciences British Columbia Newfoundland and Labrador Association Of Technology Industries Ontario Bioscience Innovation Organization PEI BioAlliance

AFFILIATE ORGANIZATION ORGANISATIONS AFFILIÉES

Agri-Food Innovation Council AusBiotech Ltd. Biotechnology Innovation Organization Canada's Venture Capital and Private Equity Association Korea Biotechnology Industry Organization Medtech Canada New Zealand Biotech Seeds Canada

BIOTECanada

AVANTAGES DE L’AFFILIATION

BIOTECanada est une association sectorielle nationale comptant près de 200 membres situés un peu partout au pays et reflétant la nature plurielle des secteurs biotechnologiques de la santé, de la fabrication et de l’agriculture. Quand elle se joint à BIOTECanada, une entreprise devient membre à part entière d’un mouvement de défense et de réglementation de l’industrie canadienne de la biotechnologie qui veille à l’intérêt collectif de ses membres.

Nous disposons des outils dont votre entreprise a besoin pour réaliser son plein potentiel : relations avec les gouvernements, communications, marketing et services aux membres.

PROGRAMME D’ÉCONOMIES DE COÛTS

Nos membres peuvent réaliser des économies en participant à notre programme de réduction des coûts. En fonction du type d’adhésion choisi, vous pouvez économiser jusqu’à 10 000 $ par an.

Parmi les avantages, il est possible de bénéficier de ce qui suit : • Réductions sur les fournitures de laboratoire avec Avantor, gérées par VWR • Réductions sur les assurances pour les administrateurs et les dirigeants, les assurances habitation et les assurances automobile avec InsurePlus par Guthrie Insurance • Réductions sur les communiqués multimédias et plus encore avec

Business Wire

• Remises sur les frais d’expédition avec FedEx (des remises entre 8 et 33 %) • Réductions sur la publicité dans le magazine insights • Réduction de 30 % pour les nouveaux abonnés à BioCentury • Remise de 20 % sur ShareVault (partage sécurisé de documents et salle de données virtuelle) • Réduction de 25 % sur les guides nationaux en matière de rémunération de BioTalent Canada • Tarifs d’entreprise auprès de GoodLife Fitness • Remise de 10 % sur les services de PSC Biotech®, une entreprise spécialisée dans les services professionnels de conseil en sciences de la vie

EXPANSION DE L’ENTREPRISE ET RÉSEAUTAGE

BIOTECanada coordonne la présence canadienne au congrès international BIO. Les membres qui font partie de la délégation se rendant à BIO peuvent économiser sur les frais d’inscription, assister à des événements de réseautage et profiter de l’accès à l’espace de réunion réservé aux membres dans le pavillon canadien. Par ailleurs, BIOTECanada et certains de ses partenaires organisent des activités de réseautage à l’occasion de toutes les principales manifestations sectorielles.

UN MOUVEMENT DE DÉFENSE ET DE RÉGLEMENTATION

BIOTECanada agit par l’intermédiaire d’une série de comités en vue d’élaborer des politiques qui façonneront les questions de réglementation, d’accès aux produits, de propriété intellectuelle, de financement et de développement industriel ayant une incidence sur le secteur de la biotechnologie au Canada.

Pour obtenir de plus amples informations sur les avantages de l’adhésion, veuillez communiquer avec : Shaely Williams – Gestionnaire principale de l’adhésion et des événements shaely.williams@biotech.ca 613-230-5585, poste 222 biotech.ca

CSL Seqirus:

On the front lines of influenza

by/par Gillian Stafford, Director of Commercial Operations for Canada

EACH YEAR, APPROXIMATELY 12,000 CANADIANS WILL BE HOSPITALIZED WITH INFLUENZA. AND 3,500 WILL LOSE THEIR LIVES TO IT.1

While these numbers are startling, Canada is making strides to protect more people against the flu each year through seasonal influenza vaccinations, while also preparing for future pandemic influenza challenges.

Annual vaccination is an effective way to prevent seasonal influenza. Despite an unprecedented rise in influenza vaccine uptake in 2020,2 work continues to reach national vaccine goals. Encouragingly, in a poll conducted ahead of the 2021 flu season, Canadians said they were more likely to get vaccinated against influenza over the next five years compared to the previous five.3 Moreover, among those who had never received a flu vaccine, 16 percent said they would now be more likely do so within the next five years.3

Providing choice with respect to flu vaccines can help Canada continue this momentum. For instance, in Canada, there are various types of influenza vaccines available such as trivalent, quadrivalent and adjuvanted vaccines.4 Likewise, influenza vaccines can be made using either egg-based or cell-based technology.4

CSL Seqirus has been dedicated to the fight against influenza for more than 100 years, and this year will be no different. We have a long-standing, well-established relationship with the Canadian government supplying approximately 20 million doses of seasonal influenza vaccine since 2010. And as the back-up supplier for pandemic influenza vaccines, we continue to work side-byside with the Government of Canada.

Earlier this year, we renewed a five-year agreement with the Biomedical Advanced Research and Development Authority (BARDA) in the United States. Through this agreement, CSL Seqirus will provide influenza vaccines and adjuvants for pre-pandemic stockpiling to support rapid responses to an influenza pandemic or other public health emergencies.

We are involved in influenza vaccine development including our adjuvanted and cell-based manufacturing technologies. And we know that keeping up with evolving threats takes ongoing investment in dedicated scientific research. We recently announced an investment of a new custom-built R&D facility in Massachusetts, which will support the development of new influenza vaccine technology, including the self-amplifying mRNA (sa-mRNA) technology platform.

As a company dedicated to the fight against influenza, we are committed to standing together on the front lines with our public health partners. We are proud of the strides we’ve made so far and our ongoing efforts in Canada and worldwide.

1. Government of Canada. (2021). Flu (influenza): Prevention and risks. Retrieved from: https://www.canada.ca/en/public-health/services/ diseases/flu-influenza/prevention-risks.html. Accessed August 2022. 2. Kupfer, Matthew. (2020, October 30). Frustration grows as flu vaccine supply shrinks in Ottawa. CBC News. Retrieved from https://www.cbc.ca/news/ canada/ottawa/flu-vaccine-availability-causing-frustration-ottawa-1.5781750 3. Seqirus. (2021). Canadian attitudes and behaviours to flu vaccination: one year later. Unpublished internal company document. 4. Government of Canada. Canadian Immunization Guide Chapter on Influenza and Statement on Seasonal Influenza Vaccine for 2022–2023. Retrieved from: https:// www.canada.ca/content/dam/phac-aspc/documents/services/publications/ vaccines-immunization/canadian-immunization-guide-statement-seasonal-influenzavaccine-2022-2023/naci-2022-2023-statement.pdf, Accessed September 2022.

Flourishing Health and Life Sciences Sector Attracting Excellence to Brampton

THE HEALTH AND LIFE SCIENCES SECTOR IN BRAMPTON IS HOME TO SOME 2,300 COMPANIES -including access to more than 100 biotechnology firms – that employ over 13,000 people. Situated within a 30-minute drive of Pearson International Airport, Brampton has established strong credentials within Canada and the international community.

In the centre of Canada’s Innovation Corridor, Brampton is the fastest-growing big city in Canada and is recognized globally for its connectivity, diverse community, exceptional talent, vibrant city lifestyle, and dedication to innovation. Brampton has a young, talented professional population. It also offers rapid access to a vast array of facilities and businesses.

Brampton is home to many large, established global companies.

Ken Spears is the vice-president and general manager of Boston Scientific Ltd. (Canada) in Brampton.

“We are very excited by our decision to locate our new Canadian hybrid-collaboration head office and national product replenishment centre in Brampton,” says Spears. “It is one of the fastest-growing and most innovationfriendly cities in Canada.”

“We look forward to drawing on the diverse talent pool within the Brampton Innovation District to do our important work of serving Canadian health care provider heroes and enabling improved health outcomes for Canadian patients,” he adds.

Taro Canada is a subsidiary of Taro Pharmaceutical Industries Ltd., a large multinational company that produces dermatology products. Their manufacturing facility in Brampton employs about 600 people.

The Brampton campus of Medtronic of Canada Ltd., a global medical technology company, is the company’s Canadian headquarters, handling various corporate functions, including training and education, sales, marketing, and administrative duties.

The Stephens Company Limited is a Brampton-based company that distributes medical supplies and equipment to the health care sector. Dynacare, which provides medical laboratory services essential to Canada’s health care system, is also headquartered in Brampton. Canadian Blood Services operates its State of the art blood testing lab and collections facility in Brampton for all of eastern Canada, and is the operational head-office as well.

HEALTH-TECH INNOVATIONS

“The start-up scene is very hot right now in Brampton, especially in health and life sciences,” says Martin Bohl, the sector manager for health and life sciences in the City of Brampton’s Economic Development Office (EDO).

Bohl notes that the city has invested financially in the Innovation District in Brampton, which is focused on creating a strong culture for start-ups and entrepreneurship. One of the key partners in the District is B-Hive, a start-up accelerator that attracts many international companies in multiple sectors by helping them navigate the visa/immigration process.

Following a recent rebranding, Toronto Metropolitan University (TMU) is embarking on a new chapter that will help shape the future of health care in Ontario, says Bohl. A key player in the growth of Brampton’s health and life sciences industry, TMU has received a planning grant from the provincial government to develop a proposal for a medical school in Brampton that will take an innovative approach to

health education by addressing the growing gaps in primary care across the province and the country at large.

Systemic cultural inequities within the healthcare system contribute significantly to unmet care needs in Ontario, a fact that has been laid bare by the COVID-19 pandemic. TMU’s proposed School of Medicine will be designed from the ground up to provide a new model for primary care — one that is community-driven, intentionally inclusive, and that trains doctors whose cultural awareness and humility are as crucial as their medical skills.

The proposed school will be designed around five key pillars: • community-centric primary care and the social determinants of health; • culturally respectful care to diverse communities; • the use of innovation and technology to improve quality of care and patient outcomes; • support for the health and well-being of seniors as our population becomes older; and • equipping physicians with the skills to develop interprofessional health care networks to achieve better outcomes for patients.

Besides its medical school proposal, TMU already has a significant presence in the Innovation District with its entrepreneurship accelerator, Brampton Venture Zone (BVZ) at TMU.

Usha Srinivasan is director of the BVZ.

“We partner with local health and wellness stakeholders such as Dynacare, Medtronic, LMC healthcare, CanHealth, the William Osler Health System, and SE Health, among others,” she says. “Our goal is to support the adoption of innovative technology solutions for the greater good of the sector.”

“The City of Brampton has a visionary plan to bring focus to the innovation and technology cluster to match the already vibrant industries in the region,” says Srinivasan.

“This combination creates a powerhouse of opportunities for new businesses to thrive and create jobs for economic growth in the region,” she stresses.

For more than 50 years Sheridan College Institute of Technology and Advanced Learning has been a landmark institution in Brampton, committed to growing health and life sciences talent in the city.

Since 2019, over 100 Brampton employers have welcomed Sheridan students for field placements for healthrelated programs.

“As a leader in post-secondary education, Sheridan is home to diploma programming in Practical Nursing, Personal Support Worker, Pharmacy Technician, and two Bachelor Degrees in Kinesiology and Health Science and Athletic Therapy,” says Michael O’Leary, Dean of the Faculty of Applied Health and Community Studies. “We also offer graduate certificates in Clinical Research and Regulatory Affairs,” he says. “These critical human resources continue to serve the local, provincial and national communities in providing high-quality care and health services.” In the summer of 2021, Sheridan, in partnership with Peel Public Health, the City of Brampton and community agencies, hosted CommUNITY clinics that helped deliver 35,000 COVID-19 vaccine doses into the arms of Bramptonians.

Looking down the road, Sheridan plans to build a new Centre for Healthy Communities, thanks in large part to a $2.5 million planning grant approved by Brampton City Council.

“In its ultimate form, the Centre will be a beacon of upstream, preventative care that transforms the lives of those living with chronic diseases such as diabetes,” says O’Leary.

This new space will provide students with a world-class learning environment, and serve as a community hub where those with chronic disease can receive holistic, culturally-relevant care that places the needs of the patient/individual first.

The research generated from the Centre for Healthy Communities will also inform care practices across Canada and the globe, he adds.

“Looking forward, Sheridan seeks to find even more opportunities to bring our community into the campus,” says O’Leary. “We will leverage our outstanding faculty and staff resources to support our learners’ success, and contribute to making Brampton healthier, safer and the best place to work and live.”

The incubator is situated in the center of Greater Montreal’s Biotech City

Incubating the best for business

The Quebec Biotechnology Innovation Centre supports startup companies make it big in biotech and life sciences.

IN ITS 25 YEARS OF EXISTENCE, THE QUEBEC BIOTECHNOLOGY INNOVATION CENTRE (CQIB) HAS SUPPORTED 100 COMPANIES and raised $500 million in investment for the province’s biotech companies. Last year alone, it raised $50 million in venture capital financing for startups.

Founded in 1996 by the City of Laval, Que., and the National Institute for Scientific Research, CQIB was the first life-science incubator in Canada. It aims to facilitate the acceleration, growth and success of the next generation of life sciences and medical technology businesses. Today, it has 26,000 square feet of labs within the Laval Biotech City.

Among its alumni is Bio-K Plus, which makes drinkable probiotics as well as capsules was acquired by a multinational firm, catapulting co-founder Isabelle Chevalier to the status of a dragon on the Québec version of Dragon’s Den.

In addition, the incubator is leveraging the fact that American biotechnology giant Moderna Inc. is building a new facility less than a kilometre from the CQIB’s headquarters and has accepted a new U.S. company — RNA Therapeutics — into the incubator program, said Perry Niro, executive director of CQIB.

The organization has had several successes in 2022, starting with an agreement announced in May between CQIB and the Ontario Bioscience Innovation Organization, to enable Québec companies who need to test and prove their products in real-world healthcare situations to do so as part of OBIO’s Early Adopter Health Network.

Later the same month, CQIB announced the creation of a new consortium that aims to accelerate technology validation within the Quebec health network. CQIB will lead the consortium, which includes Admare BioInnovations, Centech, District 3, CTS, ACET and QuantINO, and which will be supported by $2 million in financing from the Quebec ministry of economy and innovation.

“Marketing in the health-care system requires a lot of effort and a thorough knowledge of the industry,” Niro said. “The consortium’s role will be to facilitate this process.”

Finally, in June, the organization announced it would expand its laboratory facilities in Laval by 3,000 square feet through a $3.6 million project financed by federal and provincial government as well as the City of Laval. “This project confirms our role as a driving force in the emergence of the new generation of life sciences entrepreneurs,” Niro said. “This is illustrated in the fact that graduates from the incubator have built nearly 70,000 square feet of new laboratories in greater Montreal.”

Powering Canada’s Biotechs

The women behind two of Canada’s innovative biotech start-ups

TRADITIONALLY POWERED BY STEM CELLS, REGENERATIVE MEDICINE (RM) FOCUSES ON REPLACING, REPAIRING OR REGENERATING HUMAN CELLS, tissues and organs. In the coming decade, regenerative medicine therapies and technologies will improve and transform health for all as researchers work to deliver innovative treatments with improved patient outcomes. Canada is home to several leading-edge companies in the RM field, with many emerging companies joining the ranks recently such as Notch Therapeutics, Mesintel Therapeutics, Aspect Biosystems, and AmacaThera Inc.

For its part, Canada’s Stem Cell Network (SCN) has been leading the way in building national capacity in stem cell and RM research, supporting the commercialization of RM research and early-stage biotechnology companies through its Fueling Biotechnology Partnerships Program and training early-career researchers. Recently, SCN had the opportunity to speak with two inspiring women in biotech about their career journeys and how their companies are making a difference for Canadians.

ACCELERATING THE DEVELOPMENT OF INNOVATIVE THERAPIES FOR LIVER REGENERATION

From 10 years of age, Dr. Lesley Hill, Co-founder and Chief Operating Officer of Mesintel Therapeutics, would tell people that she was going to find a cure for cancer when she grew up, which at the time, to a burgeoning young scientist, meant becoming a physician.

“During my undergrad, I realized that many groundbreaking treatments come from lab-based research,” said Dr. Hill. “One of the most exciting, and surprising, aspects of my post-doctoral fellowship, was that I had the opportunity to become a co-founder in a biotech start-up.”

Mesintel Therapeutics focuses on fibroblasts, a cell type that has vital roles in health, and their dysfunction underlies numerous diseases with unmet medical needs, including cancer and fibrosis. Mesintel has developed a platform to accelerate the discovery of novel therapeutics for these diseases. The platform is also being leveraged in complementary therapeutic areas, including rare diseases, tissue regeneration and aging. The liver regeneration program is a high priority for Mesintel and is expected to significantly improve millions of lives globally.

“The Fueling Biotechnology Partnerships award from the Stem Cell Network is playing a huge role in supporting our company to develop therapies to improve liver regeneration,” said Dr. Hill. “With liver disease quickly reaching epidemic proportions, new approaches are desperately needed to improve liver health.”

Mesintel is decoding fibroblast biology at an unprecedented pace. The discovery platform has already yielded foundational insights into fibroblast dysfunction, their role in disease, and new therapeutic targets. The ongoing incorporation of more sophisticated computational approaches, including machine learning, is accelerating Mesintel’s discovery and development programs, enabling the creation of superior therapeutics.

MAKING STEM CELL THERAPY MAINSTREAM

For Dr. Emily Titus, Senior Vice President, Notch Therapeutics, her career path has been about passion and

Created in 2001, with support from the Government of Canada, the Stem Cell Network has grown from a few dozen labs to more than 230 world-class research groups, supporting over 225 research projects and more than 25 clinical trials. Since its inception, over 20 biotech companies have been catalyzed or enhanced and more than 5,000 highly qualified personnel have been trained. stemcellnetwork.ca

A snapshot of some of the biotech start-up companies catalyzed or enhanced through SCN

building a fulfilling career – one with impact. After completing a Bachelor of Applied Science, Emily transitioned to the field of pluripotent stem cell biology. Following her PhD, she landed her first job at the then newly launched Centre for Commercialization of Regenerative Medicine (CCRM).

“A turning point in my career came when I had the opportunity to focus on new areas of CCRM’s business, including the formation of companies,” said Dr. Titus. “One of my projects was the predecessor of Notch Therapeutics.”

Notch Therapeutics is developing a pipeline of allogenic T cell therapies from induced pluripotent stem cells, specifically engineered to address the underlying biology of complex diseases, including cancer, and overcome the limitations of autologous therapies. The goal is to make T cell therapies accessible to more people, creating an off-the-shelf medicine that ultimately offers transformational health benefits over the existing standards of care in cancer.

“The Stem Cell Network was integral to my early career,” said Dr. Titus. “As a trainee I was sponsored to attend the annual Till and McCulloch Meeting. It was a great introduction into Canadian stem cell and RM science and allowed me the opportunity to interact and network with peers.”

Since its inception, Notch has grown to a company with 80 staff at three sites: Toronto, Vancouver, and Seattle. Support and belief in the technology from the founding institutions in Canada made Notch a reality and the company looks forward to revolutionizing the landscape of T cell therapies for the benefit of Canadians.

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