Joel Denis

Engagement with the Government regarding the Life Science Fund seeking partnership and funding to support completion of Phase I and Phase II clinical research program associated to AMR (antimicrobial resistance) Antimicrobial Resistance (AMR) - Seek funding and support for pilot projects making anti-infective medications available to equity seeking populations, helping to combat AMR. Also discuss any applicable conditions regarding this funding. Programs and policy to support Canadian biomanufacturing and access to medicines and vaccines for Canadians. National Immunization Strategy and policies and programs that impact public access to vaccines and disease prevention in Canada. Patented Medicines Review Board (PMPRB), certified under the Patent Act and whose guidelines seek to ensure a balance between the prices set by manufacturers for patented medicines sold in Canada and the maintenance of an attractive environment for pharmaceutical research and development. Engagement with federal officials regarding the Biomanufacturing & Life Sciences Strategy and policies and programming related to biomanufacturing in Canada Access to medicines - government policies, processes, legislation, and/or regulation with potential impact on access to medicines in Canada. Trade-related matters, including policies and tariffs impacting medicines and vaccines. Policies and programs related to the health of new immigrants to Canada. Policies, programs, and funding related to Canada's Sexually Transmitted and Blood-Borne Infections (STBBI) Action Plan 2024-2030. Engagement with federal officials regarding Health Emergency Readiness Canada. The National Pharmaceutical Strategy (NPS) as agreed by First Ministers in 2004. Advocacy for ways to increase access to medicines and vaccines for Canadian patients. The Common Drug Review (CDR) process for reviewing new drugs and providing listing recommendations to publicly funded drug benefit plans in Canada. Ensuring the access needs of Canadian patients are met by advocating on activities undertaken in the context of the CDR. Science and Technology (S&T) Strategy: Mobilizing Science and Technology to Canada's Advantage. Advocacy for measures which will allow for commercialization in health care to occur and for Canada to remain competitive internationally on Intellectual Property and other fronts. Public Services and Procurement Canada (PSPC) Integrity Framework - Clarifying the process for procurement of vaccines and possibly pharmaceuticals under the evolving procurement framework. Patented Medicines (Notice of Compliance) Regulations which seek to balance the protection of Intellectual Property (IP) and patents with cost containment. Advocacy to ensure that IP rights are respected and internationally competitive in order to promote Research and Development. Legislation, regulations, policies and programs concerning the federal government's response to COVID-19, including pandemic preparedness, pharmaceutical and vaccine supply-chain management, and general administration of justice. Food and Drugs Act and the bill formerly known as Bill C-51: An Act to amend the Food and Drugs Act and to make consequential amendments to other Acts. Specifically, with respect to the renewal of the drug approval process. Advocacy to ensure that Canada's review and approval process is timely, safe, effective, competitive and consistent with other jurisdictions. FedDev Ontario Advanced Manufacturing Fund - advancing manufacturing of innovative pharmaceutical products in southern Ontario Engage with government to strengthen the Priority Review for Drug Submissions process. Engage the Government regarding the need for clear and efficient procurement processes for COVID-19 medical countermeasures, including COVID-19 therapeutics, to ensure access for Canadians. Engagement with the Government regarding the Strategic Innovation Fund Drug Re-importation - Raise awareness regarding the potential risks to drug and vaccine supply fo

Discussion of upskilling cyber security capabilities within the workforce of law enforcement to combat domestic and transnational crime. A conversation regarding AI-focused data centre infrastructure in Canada, including dedicated sovereign capacity, to retain economic value, strengthen domestic innovation capacity, and reinforce Canada’s position as a global AI leader. Introduction to the Rogers' Cybersecure Catalyst's mandate and scope of work across cybersecurity training, entrepreneurship, research, policy development, and public education for individuals, entrepreneurs, and organizations of all sizes. Discussion to support robust government regulation to curb harmful content, with calls for measures addressing online harms such as removing child sexual abuse material, labelling AI-generated content, and increasing parental controls. Discussion regarding the development of an AI Intelligence Unit to supplement the work of Artificial Intelligence (AI) and Technology Measurement Program (TechStat) Briefed about community based seniors services sector. Discussed Aging with Dignity bilateral agreements. Suggested amendments on Bill C-16 about coercive control to include non-intimate partner relationships (relatives and caregivers) to ensure equal protection for older adults. Email with an endorsed letter supporting TMU's National Institute on Aging's proposal for amending the Canadian Pension Plan to implement a Pension Delay Guarantee policy Conversation about TMU's Creative School and the implications of Artificial Intelligence and workforce development, SME adoption, applied research, and sector-wide innovation in the creative sector Conversation about TMU's National Institute on Aging's proposal for amending the Canadian Pension Plan to implement a Pension Delay Guarantee policy Discussion about the innovation economy, emerging technology, and business adoption with government leaders as part of the Innovative Economy table with the Canadian Chamber of Commerce Discussion of National Cyber Strategy and its integration with specific needs for small and medium businesses related to workforce development Discussion of cyber capacity building in Indo-Pacific Region and Latin America Conversation about innovation in housing as a follow-up to funding that was received from Federal Economic Development Agency for Southern Ontario for the Centre for Housing Innovation Conversation regarding the development and adaption dual-use technology Conversation about IP Clinic Program, specifically regarding client and student experiences within the program and about Canada’s IP landscape. Conversation with FedDev ON to discuss a funding proposal for building national defence capacity and a discussion about programming to include supporting ON based SMBs to position themselves to sell into Canadian defence supply chains Discussion to introduce the Diversity Institute and it's work to the policy team at WAGE Conversation about the Industrial Research Program with the new advisor to help with advice, connections, and to help with Canadian small and medium-sized businesses increase their innovation capacity. Discussion about a potential project at TMU's School of Engineering Discussing artificial intelligence, adoption, and impacts on workforce skills/labour market. Conversation about veteran transition and mental health initiatives that the university offers Conversation about financial literacy and tax education research Conversation about arctic and northern community research Conversation about workforce development to drive innovation and collaboration in the labour market by developing digital solutions and fostering partnerships that enhance connectivity and inclusivity and creating Northern Ontario partnerships Conversation about the modernization of student financial aid and digital inclusion Discussion about school of medicine and health force expansion Conversation around capital funding and student housing Conversation about primar

Through Innovation, Science & Industry discuss opportunities to enhance the Canadian life sciences sector including, biomanufacturing, partnerships, R&D investments. The Canada-European Union Comprehensive Economic and Trade Agreement (CETA) negotiations with respect to biopharmaceuticals and intellectual property right protection. Scientific Research and Experimental Development (SR&ED) Tax Incentive Program with regard to expansion of eligible expenditures to recognize the impact on innovation and the research and development (R&D) investment by the pharmaceutical industry in Canada. Science and Technology (S&T) Strategy with regard to ensuring that the implementation of that strategy encourages a public policy environment that attracts business investment in innovation and enhances the ability of Canadian industry to compete internationally. Representation with Ministry of Health and Public Service Procurement Canada to achieve emergency approval, procurement and utilization of the AZD1222 vaccine (Covishield) and long-acting antibody (LAAB) combination AZD7442 to fight the Covid-19 pandemic. Public policy issues related to Health Canada's review of NCE Patented Medicines Price Review Board (PMPRB) with regard to ensuring that PMPRB Guidelines, Policies and Procedures reflect PMPRB mandate to ensure that prices charged for patented medicines in Canada are not excessive and that potential changes consider impact to the pharmaceutical industry. Patented Medicines (Notice Of Compliance) Regulations with regard to ensuring that Canada's intellectual property (IP) laws and regulations are internationally competitive and continue to provide a stable and predictable business environment to encourage continued pharmaceutical investment in Canada. Patented Medicine Prices Review Board (PMPRB) with regard to ensuring guidelines also provide incentives for innovation through research and development in addition to PMPRB mandate of protection from excessive prices. National Pharmaceutical Strategy (NPS) with regard to ensuring development or implementation of any policies or programs include consultations with all affected stakeholders and focus on bettering access to medicines for Canadians. Cost Recovery Initiative, ensuring a framework where user fees adequately fund a safe and efficient review process. Canada's Food and Consumer Safety Action Plan with regard to ensuring that patient safety is a priority in a modern, efficient and internationally harmonized regulatory system that must be evidence-based, efficient and continuous while supporting timely access to innovative medicines and vaccines for Canadians, protecting intellectual property rights and preserving competitive research advantage. Canada's Access to Medicines Regime (CAMR) with regard to ensuring that the program allows for the delivery of timely access to needed medicines to the developing world supported by a business climate in Canada that continues to encourage research into further treatment and prevention of disease. Blueprint for Renewal with regard to ensuring a modern, efficient and internationally harmonized regulatory system that must be evidence-based, efficient and continuous while supporting timely access to innovative medicines and vaccines for Canadians, protecting intellectual property rights and preserving competitive research advantage.

Government Bill (Senate)- Bill S-5 - Connected Care-An Act respecting the interoperability of health information technology and to prohibit data blocking by health information technology vendors Federal guidelines with respect to procurement of medical technologies and adoption of innovation in the healthcare industry, and economic development and promotion for the life sciences sector Public Bill (Senate) S-243- National Framework for Women's Health Federal life sciences strategy with respect to patient safety, managing high-risk drugs, medication errors, healthcare worker safety, infection and disease prevention, health system planning and resilience. Canadian-United States-Mexico Agreement (CUSMA) with respect to provisions relating to medical devices and technologies Federal life sciences strategy with respect to global value chain and supply chain management and investment towards medical technology manufacturing and export. Federal budget with respect to medical technology and device innovation and adoption, support and delivery of new models of care, equitable healthcare access, innovation, women’s health, and investments in long-term care and home care Discuss policies around healthcare system resiliency, health system planning, infection prevention, medication errors, women's health, and health equity including access Regulations under the Food and Drugs Act, including the Medical Devices Regulation, with respect to the approval of medical technologies Federal life sciences strategy, focusing on promoting collaboration with respect to clinical and scientific research in the healthcare industry and accelerating innovation to improve health and economic outcomes.

Regulatory approval process, in respect to the egg supply management system Agriculture as a strategic priority, in respect to economic growth and tools to support the agriculture sector and support food security. Policy on Salmonella Enteritidis in Canadian shell eggs, in respect of on-farm testing and vaccination pilot program Availability of animal health products and tools, in respect to disease response and preparedness in Canada Agriculture inputs into egg supply chain, in respect to pricing and availability for farmers Sustainability initiatives as they relate to agriculture, including emissions reduction programs and on-farm green transition Trade policy, in respect of supply management and international and domestic trade Programming to mitigate the market impacts caused by trade agreements Private sector risk management program, in respect of insurance Growing forward, in respect of suite of business risk management and supply management Egg regulations, in respect to egg grades, weights and labelling Consumer Packaging and Labelling Regulations with respect to production claims on labels Canadian Food Inspection Agency On-Farm Food Safety Recognition Program, in respect to program development for pre-lay sectors Agriculture international development projects, in respect to supporting vulnerable communities and empowering egg farmers around the world

Suivi des négociations commerciales actives afin de défendre l'exemption culturelle Loi sur la radiodiffusion: favoriser des changements pour que la loi s'applique à l'environnement numérique Loi sur le droit d'auteur: assurer la protection effective des droits Convention de l'UNESCO sur la protection et la promotion de la diversité des expressions culturelles : échange avec les représentants gouvernementaux sur l'évolution des débats et les programmes nationaux qui en découlent

Policy and Programs Health Canada and Public Health Agency of Canada policies and programs to prevent and treat HIV and eliminate hepatitis as a public health threat by 2030, as part of Canada's commitments under the Global Viral Hepatitis Strategy and therapeutic efforts against the fight for COVID-19. Patent Act Regulations as they relate to the regulation of intellectual property for therapeutic products, specifically the Patented Medicines (Notice of Compliance) Regulations Patented Medicine Prices Review Board (PMPRB) Regulations with regard to reporting requirements, pricing, guidelines and dispute resolution. Innovation Agenda, particularly with respect to initiatives to support and attract investments in the life sciences sector Federal Government First Nations and Inuit Health Branch program with respect to health services. Federally-funded Public Drug Plans, with respect to reimbursement for drug products for federal plan beneficiaries. Canada Agency for Drugs and Technologies in Health (CADTH) as it relates to health economics assessment and recommendations made on new medicines.

Regulations, policies and programs related to the reimbursement recommendations decision-making process and framework done by the Canadian Agency for Drugs and Technologies in Health (CADTH)/Common Drug Review as well as the review times and processes conducted by Health Canada for the purpose of obtaining a notice of compliance. National Strategy for Drugs for Rare Disease as it relates to separate regulatory pathways for drugs for rare diseases and the government strategy. Monitoring and engaging the Government and Parliamentarians on policies and programs that would provide greater clarity and predictability in the tax outcomes and improvements to tax measures such as the Manufacturing & Processing (M&P) credit and the Scientific Research & Developmental (SR&ED). Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework. Federal Public Drug Plans, with respect to the reimbursement of therapeutic products for Federal plan beneficiaries Policies related to the National Strategy for Drugs for Rare Disease as it relates to separate regulatory pathway for drugs for rare diseases and the government strategy. Policies related to Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors; Information and Submission requirements for SEBs, regulations and intellectual property policies, naming conventions Monitoring and engaging on the Government’s commitment (Budget, SFT, Fall Economic Update) to create a national strategy for drugs for rare diseases; create a new Canadian Drug Agency; and the implementation of national, universal pharmacare. Pharmaceutical policy and any negotiations of a Health Accord or agreement with the Provinces/Territories, as it relates to National Pharmacare/universal or catastrophic drug coverage, Drug policies & Pricing. The Department of Innovation, Science and Economic Development and the Innovation Agenda for the life sciences sector: policy or program initiatives to support life science research and development conducted in Canada and manufacturing capability, and as it relates to Canada’s Biomanufacturing and Life Sciences Strategy. Monitoring and engaging the Government and Parliamentarians on policies and programs related to Canada's biomanufacturing and life sciences sector strategy National Pharmacare (Bill C-64, An Act respecting pharmacare) Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies. Patent Act as it relates to reporting requirements and pricing guidelines, and the protection of intellectual property in biopharmaceutical products. Income Tax Act as it relates to biopharmaceutical industry. Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry, and related updates and to Federal budgetary policy. Discussions around the World Trade Organization consideration of a TRIPS Patent Waiver - Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility". The Food and Drugs Act, or the Export and Imports Permits Act (Export Control List) or any other legislative and regulatory means in order to protect the Canadian supply of drugs in light of importation legislation in the United States. Standing Committee on Finance (FINA) as it relates to pre-budget consultations. Pharmaceutical intellectual property protection as it relates to international trade agreements Patent Act and Patented Medicines (Notice of Compliance) Regulations, as it relates to the regulation of intellectual property, approval for therapeutic products, changes to modernize the Right of Appeal House of Commons Standing Committee of Science and Research (SRSR) as it relates to Science in Canada and/or any other pertinent legislative proposal before the committee House of Commons Standing Committee of Industry and Technology (INDU) as it

The government’s Pandemic Preparedness Strategy as it relates to the corporation’s future operations in Canada Health Canada and Public Services and Procurement Canada policies regarding the development, procurement, and distribution of Moderna’s COVID-19 vaccine to various segments of the population, including future distribution models Government policies regarding innovation, research and development, and messenger ribonucleic acid (mRNA) biotechnology

Policies regarding the availability of Novavax's COVID-19 vaccine throughout Canada. Engagement with federal officials regarding Innovation, Science and Economic Development Canada’s plans for the Biomanufacturing and Life Sciences Strategy with a focus on the importance of vaccines for public health in Canada. Canada’s Strategic Innovation Fund, led by Innovation, Science and Economic Development Canada, with respect to ensuring that the life sciences sector is a focus of the government’s post-COVID recovery plan.