November 2011 monthly reporter
FEATURES
Federal Panel on Research and Development Submits Report to Government
As expected, the much-anticipated report from the yearlong review of federal spending on research and development focused on the value equation and implications of SR&ED. With a mandate to provide advice on how to enhance federal programming in support of a more innovative economy, the Jenkins panel met with more than 160 stakeholders across Canada.As stipulated by their mandate, the review could neither increase nor decrease overall funding, nor could it touch regulatory research done by federal laboratories or basic research conducted by institutions of higher education.
The panel was asked to review the following:
1. Tax incentive programs such as the Scientific Research and Experimental Development (SR&ED) program.
2. Programs that support business R&D through: general support (e.g., Industrial Research Assistance Program), and sector-specific support (e.g., Strategic Aerospace and Defence Initiative).
3. Programs that support business-focused R&D through federal granting councils and other departments and agencies, including research at universities and colleges (e.g., Centres of Excellence for Commercialization and Research).
Generally, the Jenkins report recommends more funds be allocated through direct funding (i.e. grants, loans, procurement) and less through indirect funding (i.e. SR&ED tax credits).
Overall, the Panel has recommended the government should rebalance the mix of direct and indirect funding by decreasing spending through the SR&ED program. The Panel suggests directing the savings to complementary initiatives strategically focused on serving the needs of innovative Canadian firms.
As it impacts the SR&ED program, the report is recommending several changes for small and medium-sized enterprises including basing the tax credit only on labour-related costs. The report further suggests extending this approach over time to large corporations (but with compensatory assistance to offset negative impacts).
We are assessing the best way to respond to the Panel’s findings. Based on the feedback from our members, our Board, and the National Biotech Accord, we will be submitting a formal response to the Government and will be available for consultation as the Government develops their plans for action. BIOTECanada will offer updates via our committees and our association newsletters in the months to come. We will also be directly working with members to assess how these recommendations may impact your business operations.
The report is now submitted to the Government. BIOTECanada staff are working with Federal Officials to determine plans for the Government to respond and implement any of the recommendations in the Panel’s report.
BIOTECanada has signed onto a letter to the Government from the Canadian Manufacturing Coalition, which supports the SR&ED tax credit and demonstrates how this tool can be improved. The full letter can be found here.
Read our original submission to the Panel
Send any feedback or comments on the Panel’s recommendations to Cate McCready
Pre-Budgetary Consultations in Saskatoon - Phenomenome Discoveries
Mr. John Hyshka, Chief Financial Officer of Phenomenome Discoveries
appeared before the Standing Committee on Finance in Saskatoon Thursday
October 27. Mr. Hyshka, showcased the Canadian biotechnology industry
accounts for 11% of all business-sector R&D. Biotechnology companies
spend over $1.5 billion each year on research and development in
Canada. Moreover biotechnology innovations have become core to
supporting over 1 million Canadian jobs and $86 billion of the Canadian
economy.BIOTECanada has recommended the following 3-step action plan to create sustainable long-term economic growth in Canada.
- Enable Risk Capital Formation for Domestic Spending: Expand the flow-through shares program to junior biotechnology companies in Canada.
- Improve Global Competitiveness for All Domestic R&D Jobs: Remove the Canadian- controlled private company (CCPC) restriction from the Scientific Research and Experimental Development (SR&ED) tax credit program.
-
Sustain Federal Vaccine Funding for Healthcare Savings: Invest in
new vaccines that provide world-class care and save costs in our health
care system.
Mr. Hyshka’s remarks to the committee can be found here.
Business Solution Feature - Mercer Canada - Employee engagement: Do benefits make a difference?
Mercer recently released its 2011 What’s Working – Inside Employees’ Minds survey on employee engagement. The survey asked more than 2,000 Canadian workers for their views on various aspects of the employment deal including pay, benefits, careers, leadership, performance and engagement. The survey analyzes differences by workforce demographics and includes a conjoint analysis to determine what employees value most. Read morePOLICY & COMMITTEE WATCH - Building the Bio-economy
Access and Benefit Sharing
BIOTECanada recently submitted perspective on Canada's potential signature of the Nagoya Protocol on Access to Genetic Resources. We provided our perspective on Canada’s potential signature of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity. Read the full letter here.SEBs on the Agenda in Halifax
Dalhousie held their 47th Annual Pharmacy Refresher along with the Pharmacy Association of Nova Scotia October 28 – 30. BIOTECanada hosted a breakfast Symposium where Dr. Agnes Klein from Biologics and Genetic Therapies Directorate of Health Canada provided the gathering with the current status and practice of SEBs in Canada. Health Canada had received enquiries about the filing of Subsequent Entry Biologics in Canada and the requirements for viable and approvable submissions. Health Canada has developed a guidance document entitled: “
Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics”. The purpose of the document is to enable sponsors to satisfy the requirements for the filing of SEBs. These guidelines are also tailored to enable sponsors to satisfy the information and regulatory requirements under the Food and Drugs Act and Regulations. For more information contact Lynn Buchanan. Ontario's Chief Medical Officer of Health Meets with VIC Members
Members of the Vaccine Industry Committee (VIC) met with Dr. Arlene King, Ontario's Chief Medical Officer of Health, on October 18th in Toronto to address a number of issues facing vaccine manufacturers. Read the full article in the Members' Only section.BIOTECanada Continues Work on Addressing Drug Shortages
Through its members BIOTECanada has been working with a number of key associations since April 2011 to provide pharmacists, physicians, and most importantly, Canadians, with more information on the issue of drug shortages. The organizations include BIOTECanada, the Canadian Association for Pharmacy Distribution Management (CAPDM), the Canadian Association of Chain Drug Stores (CACDS), the Canadian Generic Pharmaceutical Association (CGPA), the Canadian Medical Association (CMA), the Canadian Pharmacists Association (CPhA), Canada's Reseach-Based Pharmaceutical Companies (Rx&D), and the Canadian Society of Hospital Pharmacists (CSHP).The establishment of a Canadian drug shortages monitoring system is a complex undertaking, requiring the involvement of hundreds of companies, the creation of a standardized definition of a drug shortage, all while operating within a very complex health care environment. However, working group members recognize that health practitioners are demanding this information as quickly as possible to allow them to address drug shortages and prepare better care plans for their patients. In the short term, Rx&D and CGPA are prepared to start collecting information within the next month on current and impending drug shortages. This information would include name and dosage form of the drug in short supply, reason for shortage, expected duration of the shortage, and notification that the shortage is resolved. BIOTECanada is encouraging members to collect and report this information on an individual basis. This national-level information would be provided to two existing drug shortages websites, the Saskatchewan Drug Information Service and Vendredi.PM. Other sites requesting this information would be evaluated on a case by case basis. These websites that host shortages information would be promoted and communicated by CPhA, CSHP, and CMA to their respective memberships, and to the broader health community using other communications vehicles such as the media, possibly with the promotional assistance of Health Canada. These promotional efforts would commence as soon as confirmation is received as to when the supplementary information provided by manufacturers can be posted.
This remains a work in progress but there is a commitment and determination from all the members of our Working Group to put in place a reporting system that provides timely, accurate, and comprehensive information that will provide value to all health care practitioners and patients across Canada.
CADTH-Industry Hold Productive Workshop Reviewing CDR Engagement
Stemming from the CADTH-Industry Liaison Forum (ILF), the Engagement Working Group held a facilitated workshop on Wednesday, October 26th aimed at reviewing the entire common drug review (CDR) process and finding one or more topics in which the group could work on. In addition to the CDR, pre-submission and post-submission engagement opportunities were also addressed. Read the full article in the Members' Section of our website.If you have any questions about the workshop, please contact Gibril Muddei.
Phil Jennings Talks SR&ED, CETA in Latest HAB Meeting
As part of the last Health Advisory Board (HAB) meeting, held on October 14th, BIOTECanada was pleased to welcome Associate Assistant Deputy Minister of Industry Canada, Mr. Phil Jennings. Ms. Leah Clark, Director General of the Life Sciences Branch at Industry Canada, accompanied Mr. Jennings to the second last HAB meeting of the year.The HAB sought to understand Industry Canada’s priorities with respect to the biotechnology and pharmaceutical industries. Mr. Jennings provideed a summary of the department’s current priorities with a focus on strengthening Canada’s intellectual property regime, capitalizing the Canada-EU Free Trade Agreement, and addressing issues with respect to the Scientific Research and Experimental Development (SR&ED) Tax Credit program.
Prior to the meeting, Mr. Jennings requested an opportunity to learn more about the filiing issues corporations performing clinical trials were experiencing with respect to SR&ED claims. BIOTECanada provided a synopsis of the issue and elaborated on the association’s engagement with the Canada Revenue Agency (CRA) and the responses received by biotechnology and pharmaceutical companies. Mr. Jennings and Ms. Clark both expressed a high-level of support for addressing the issue and also explained that inter-departmental meetings between the CRA and Industry Canada were currently taking place.
The next HAB meeting is scheduled for Monday, November 28th in Ottawa. Teleconference is also available for individuals unable to attend the meeting in-person. If you have any questions about HAB activities, please contact Gibril Muddei.
NEW MEMBERS
3SIXTY PUBLIC AFFAIRS
3Sixty Public Affairs is a government relations and public policy consulting firm based in Ottawa, Canada, serving the health, life-sciences, agri-food and consumer products sectors. 3Sixty represents a new approach to government relations. We recognize that every stakeholder brings a unique perspective to issues, each is compelled by different motivations, and all resolve problems or act on opportunities in various ways. We strive to bridge differences between how governments and businesses communicate and make decisions. 3Sixty has extensive experience working with the biotechnology industry, a sector that providing solutions to the most significant international policy and business challenges: feed the world, provide healthcare solutions and protect the environment. www.3sixtypublicaffairs.com
ASMACURE Ltée.
Asmacure Ltée is a clinical-stage biopharmaceutical company focused on the development of novel, proprietary nicotinic receptor modulators for the treatment of inflammatory diseases, particularly in the respiratory field. Asmacure’s lead compound, the small molecule ASM-024, is in Phase II development for the treatment of asthma. In in vitro, in vivo, and ex vivo studies, ASM-024 has demonstrated the dual capabilities of anti-inflammation and bronchodilation. ASM-024 presents a potential new mechanism for the treatment of respiratory inflammatory diseases, notably asthma, a disease with significant unmet clinical needs that afflicts 8-10% of the general population in most developed countries.
Asmacure is studying ASM-024 in a solution for nebulization formulation in the current Phase II trials. The company has initiated pre-clinical toxicology studies for a dry powder for inhalation (DPI) dosage form and plans to conduct a Phase I study utilizing the DPI formulation in the first half of 2012.
www.asmacure.com
Member Recognition
Health Canada Clears Immunovaccine for Ovarian Cancer Trials
Immunovaccine, Inc. recently announced that Health Canada has cleared its Clinical Trial Application (CTA) for a phase I/II study with DPX-Survivac, a therapeutic cancer vaccine. The decision allows the Company to proceed with preparations in Canada to test the safety and efficacy of its immunotherapeutic vaccine in patients with advanced stage ovarian cancer. The Canadian clinical trial application is part of the Company’s strategy for a multi-centre phase I/II study for DPX-Survivac in patients with ovarian cancer. Immunovaccine has previously received approval from the FDA to proceed with a phase I/II study with DPX-Survivac in the U.S. The strong interest from Canadian oncologists in Immunovaccine’s approach to treat ovarian cancer prompted the Company to pursue clearance of the same study protocol in Canada ahead of schedule.
"By combining a promising cancer target like survivin with our vaccine delivery platform, we hope to create an immunogenic vaccine that will provide a clinical benefit in patients with ovarian cancer,” said Marc Mansour, Ph.D., Chief Science Officer and Chief Operating Officer at Immunovaccine.
The phase I/II study is designed to assess the safety, immunogenicity and clinical efficacy of the DPX-Survivac vaccine. Patients will be treated with the DPX-Survivac vaccine after completing debulking surgery and chemotherapy treatments.
Baxter – 2011 Canada Awards for Excellence
Excellence Canada presented the Silver Award for Excellence, Innovation and Wellness to Baxter Corporation at the 2011 Canada Awards for Excellence ceremony. The annual awards program recognizes business excellence in quality, customer service and a healthy workplace. “ For an organization to be awarded the prestigious Silver Award in Excellence, Innovation and Wellness , they have to be committed to continuous improvement and excellence in all the drivers of the comprehensive and holistic Canadian Framework for Organizational Excellence. Baxter Corporation has clearly demonstrated that it is not only a ‘Quality’ organization, but also a Healthy Workplace®. In short, they are truly an excellent company,” said Allan Ebedes, President and CEO, Excellence Canada. Congratulations Baxter. This award is based on excellence Canada’s Progressive Excellence Program® (PEP) for Quality and Healthy Workplace®, which is a target-driven, incremental approach to applying excellence criteria. To receive the Silver recognition, organizations must be at the equivalent of PEP Level 3. Baxter’s Alliston, Ontario manufacturing facility was first recognized in 1996 with the National Quality Institute’s Quality Award. Baxter Corporation has since achieved all three levels of NQI Quality and Healthy Workplace PEP® certification.
“ Each day at Baxter we strive to help advance the best in healthcare for Canadian patients and professionals and are honoured to have earned this recognition of Baxter’s continuing excellence journey,” says Barbara M. Leavitt, President, Baxter Corporation. “As we continue on this path to business excellence, we remain committed to a healthy workplace that fosters integrity and innovation, and helps us consider what truly adds value and contributes to our vision of saving and sustaining lives.”
Dow AgroSciences Recognized with International Award for Best Novel Agricultural Biotechnology
Dow AgroSciences, was recognized for industry-leading technology and innovation with an international Agrow Award for " Best Novel Agricultural Biotechnology." The prestigious Agrow Awards honor corporate and individual excellence in the crop protection and production industry.
Dow AgroSciences won in the Best Novel Agricultural Biotechnology category for SmartStax(R) hybrids. SmartStax technology benefits millions of corn growers across North America by delivering multiple modes of action for the broadest spectrum of insect control ever available, combined with the most complete herbicide tolerance currently available. On July 20, 2009, SmartStax received registration from the U.S. Environmental Protection Agency (EPA) granting a reduced refuge of only five percent in the United States Corn Belt for both above and below ground insect pests, a decision based on the multiple modes of action delivered by SmartStax. SmartStax was commercially launched in 2010 in the United States and Canada, with further global launches expected to follow.
" We're honored and excited to be recognized again this year for our achievements in creating and delivering the best solutions to meet grower's needs," said Daniel R. Kittle, Ph.D., global leader, R&D for Dow AgroSciences. " This is also great recognition for our creative and hard-working R&D employees all around the globe who are constantly using the newest technologies, advancing science and delivering breakthrough solutions that serve the needs of the world's growing population."
