December 2011 monthly reporter
FEATURES
- Year in Review
- Federal Research and Development Panel Issues Recommendations
- Senate Committee Study on Prescription Pharmaceuticals
- Who is Canada’s best in biotechnology?
- Business Solution of the Month
POLICY & COMMITTEE WATCH - Building the bio-economy
- SEB Task Force Continues Work to Ensure Safety and Optimal Health Outcomes for Patients
MEMBER RECOGNITION
- VertexPharmaceuticals
FEATURES
Year in Review
As 2011 comes to a close, it is time to reflect with an update of
Association activities throughout the past year. Membership, with some
250 biotech companies working in all sectors, has been active in
supporting the environment for growth and sustainability of operations
in Canada. The leadership of BIOTECanada’s Board of Directors and
membership throughout 2011 can be seen in a number of highlights
reflecting progress of our national industry strategy outlined in
The Canadian Blueprint: Beyond Moose and Mountains.
This document serves as the foundation guiding our advocacy, business
development and public affairs efforts. The high level of participation
from federal and provincial governments was noticeable as we held our
National Bio-economy Roundtable earlier this year in Washington, D.C.
Throughout the Outcomes Report you will read of the increased support for growing the bio-economy in Canada. Subsequent Entry Biologics Leadership – The task force has actively pursued a full agenda focused on ensuring safety and optimal health outcomes for patients using biologics. The group is driving a strong, harmonized approach seeking a clear regulatory pathway, fair reimbursement policies and a high level of health care professional knowledge of biologics and Subsequent Entry Biologics. A full communications suite of materials has also been created to underpin the messaging. The group has held regional events with a Physician Roundtable in BC, a Breakfast Symposium in Halifax, as well as a meeting with the Ontario Rheumatology Association. Further events including a Subsequent Entry Biologics Summit are planned for 2012.
Vaccine Industry Committee – Continued to meet with key officials to discuss the role of industry and Canada's revised National Immunization Strategy. The committee actively showcased member companies and their many achievements/contributions to public health at the Canadian Public Health Association 2011 Conference in Montreal. There is also continuing work towards the implementation of vaccine bar codes on primary labels. The committee will be actively involved in the ongoing early adopter pilot projects and supporting the implementation of this program.
Investment climate – Our work to improve the investment climate has been very active this year. The flow-through shares initiative has received support from stakeholder groups (broker investment community, technology transfer offices at academic institutions, municipal economic development agencies). We are actively pursuing opportunities to educate key influencers. The Minister of National Revenue agreed to review our concern over the inadmissibility of clinical trials expenditures under SR&ED. The Minister’s office is actively reviewing specific cases of SR&ED filings from BIOTECanada member companies who were adversely affected.
Regulatory – The Biologics and Regulatory Affairs Group had a particularly active year in 2011 with much of the focus squarely on Health Canada’s Legislative and Regulatory Modernization consultations. Health Canada is working to update the 50-year-old regulatory framework for health products. The European Union and the US Food and Drug Administration have recently updated their regulations and this process will help Canada keep pace with those jurisdictions. BIOTECanada has actively engaged in the consultative process, with a keen focus on biologics, vaccines, SEBs and orphan drugs.
Orphan Products - BIOTECanada and the Canadian Organization for Rare Disorders marked Rare Disease Day February 28, 2011. The association also urged members of Parliament and senior level bureaucrats to establish an orphan drug framework for Canada during BIOTECanada’s National Biotechnology Week in September.
Bio Products Strategy - As the coordinating organization for the bio products strategy industry consultations, BIOTECanada has developed a strategic plan, which will guide us in our goal of establishing a bio-products strategy within Growing Forward II. We are working closely with Agriculture Canada to develop a more streamlined regulatory system with greater cooperation among government departments. This aims to improve the current operating environment for companies pursuing regulatory approvals in Canada for novel products in both agri-food and agri-based products.
New Economy Alliance – Together with colleagues from the Canadian Federation of Agriculture, Canadian Renewable Fuels Association, Chemistry Industry Association of Canada, CropLife Canada, Forest Products Association of Canada, and the Sustainable Chemistry Alliance we have formed the New Economy Alliance. Bringing together leaders in the areas of renewable fuels and biotechnology to promote innovation in new technologies, which add value to Canada’s vast natural resources. Producing these new bio-fuels, bio-chemicals, and biomaterials maintain and create jobs, generate economic growth, and enhance Canada’s competitiveness.
User Fees – After a lengthy consultation process Health Canada published, in Canada Gazette I, the draft regulations to implement the new cost-recovery framework for drug and device products early in 2011. The new regulations raised the fees required of manufacturers for the review and approval of health products. BIOTECanada was actively engaged in the consultation to ensure fair, and equitable treatment for biologic products. The association was successful in removing the biologics surcharge from the final proposal. In comments to Health Canada on the Gazette I publication BIOTECanada cited the need to tie any future fee increases to document measurement of performance. In addition BIOTECanada was also successful in ensuring Health Canada retained current "A Base" funding for regulatory activities. Gazette II implementation of the new fee structure occurred in April 1, 2011.
CADTH – We continue to enhance senior-level engagement between BIOTECanada and CADTH by holding regular meetings to discuss issues related to the Common Drug Review. Greater industry involvement has been facilitated with the symposium planning committee. CADTH removed their Economic Value of Health Innovation paper after our expressed concern over the analysis.
In addition to our ministerial bio-economy roundtable we showcased the collaboration among emerging and established industry with the presentation of our Gold Leaf Awards on the convention exhibit floor. We grew business networking by hosting the Canada Soirée at the Canadian Embassy in Washington D.C. We also provided members the opportunity to meet with international counterparts, thanks to our partnering with the federal government to provide 70 free passes for emerging companies to participate in the Business Forum at BIO 2011.
Aligning our interests and priorities guides our work as we convened the National Biotech Accord of regional life science groups. Key policy initiatives related to Subsequent Entry Biologics and industry financing are leveraged with our national group of organizations and their members, and has strengthened the overall engagement with governments at all levels. National Biotechnology Week is a shining example of such collaboration, bringing heightened engagement and activity for the industry. Launched at the grand opening of the Vaccine and Infectious Disease Organization’s new International Vaccine Centre in Saskatoon. The Right Honourable Stephen Harper, Prime Minister of Canada, along with the Honourable Brad Wall, Premier of Saskatchewan, joined industry leaders and the broader science community showcasing Canada’s advantage.
Federal Research and Development Panel Issues Recommendations
The month of October saw the much-anticipated report from the Federal Panel on Research and Development presented to the government. Citing six key recommendations the panel kept to its mandate of offering potential program enhancements designed to realize greater levels of commercialization success for research investment, while ensuring the government incurs no additional costs. The recommendations included changes to the SR&ED tax credit program, the creation of a national Industrial Research and Innovation Council and changes to the operations of the National Research council. The panel also cited the Business Development Bank of Canada as a mechanism for enhancing start up funding for early-stage technology companies.The report now sits with the federal government awaiting formal response from Minister of State (Science and Technology) Gary Goodyear as he has been charged with preparing the government response to the recommendations. BIOTECanada has responded to the panel with a letter from our Emerging Companies Advisory Board citing the need for enhanced funding incentives aimed directly at the full commercialization cycle for our technology. The letter can be read HERE.
A mixed response to the report can be found in the media coverage following its release. The ongoing citations of problems with the SR&ED tax credit misuse continued, while there was a series of commentaries around the report having missed an opportunity to truly address the need for strong action to secure support to the full commercialization cycle for technologies. The implications to the operations of the National Research Council also raised some flags in the media.
The federal government has a number of options in how it chooses to respond to the report if it decides to do so. The upcoming budget is one primary vehicle for action of the recommendations. BIOTECanada is engaging with key officials in follow up to our letter and our submission to the Panel.
To date there has been no indication form the government in terms of how or when the plan to respond. We are aware of internal government responses being prepared for political review throughout the coming months. We will keep you informed of any information we glean from officials going forward.
The full panel report can be found here.
Senate Committee Study on Prescription Pharmaceuticals
In response to the Auditor General’s report, the Honourable Senator Ogilvie has put forward notice from the Senate Standing Committee on Social Affairs, Science and Technology which will be examining and reporting on prescription pharmaceuticals in Canada.Log in to read the full article in the Members' Only Section of our website.
Who is Canada’s Best in Biotechnology?
As a celebration of Canadian innovation, BIOTECanada's 2012 Gold Leaf Awards program provides the opportunity to recognize both companies and individuals who have made significant achievements to our industry over the last year.Nominations will be accepted from December 1st, 2011 to March 1, 2012.
We are looking for companies and individuals with proven track records in the industry for the following categories:
- Biotech Company of the Year
- Early Stage Company of the Year – Health
- Early Stage Company of the Year – Agricultural and Industrial
- Industry Leadership Award
- Contribution to Canadian Communities
For category information, nomination guidelines, and detailed criteria, please visit the Gold Leaf Awards website and to submit you nomination: www.goldleafawards.ca
All nominations must be submitted online.
Awards presentation
The 2012 Gold Leaf Awards will be presented in the Canada Café at the BIO International Convention 2012 in Boston, MA on June 19th. To see previous winners visit www.goldleafawards.ca
Business Solution of the Month: 80% off - Must have 2012 Report for biotech executives
BIOTECanada is pleased to offer our members the BioWorld® Executive Compensation Report 2012 for $99.00 plus HST - Regular price of this publication is $499 USWhether you're a job-hunter, human resources executive, an investor, evaluating the competition, making a salary offer, or negotiating your own package the new 2012 Executive Compensation Report blazes the way to negotiate or evaluate compensation from a position of strength and knowledge.
It lets you determine your rank among your peers; make competent hiring offers; facilitate HR with annual executive review processes; or keep abreast of market salary dynamics and more.
The BioWorld Executive Compensation Report 2012 provides you with complete salary, bonus, and market capitalization data and rankings of six top-level job titles:
- Chief Executive Officers
- Chief Financial Officers
- Chief Operating Officers
- VPs of Research and Development
- Chief Legal Officers
- Heads of Business/Corporate Development
Order your electronic PDF* copy of the BioWorld Executive Compensation Report 2012 for $99.00 plus HST by contacting Winnie Han at 613-230-5585 ext. 222 or by email. Please note that only credit card orders will be accepted.
* You will receive an electronic PDF version of the publication BioWorld Executive Compensation Report 2012. This offer does not apply to the print version.
POLICY & COMMITTEE WATCH - Building the Bio-economy
SEB Task Force Continues Work to Ensure Safety and Optimal Health Outcomes for Patients
The SEB Task Force met at BIOTECanada on November 15, 2011 to complete a review of accomplishments for 2011 by the Regulatory/ IP, Payer Influence and Healthcare Professionals & Patients sub teams, and to develop strategic action plans for 2012.
Read the full article in the Members' Only Section of our website.
MEMBER RECOGNITION
VERTEX Pharmaceuticals - Focused on innovative science
Vertex Pharmaceuticals recently held an open house of its research
facility in Laval, Quebec. Vertex scientists discover, develop and
commercialize a commitment to science and a vision of transformational
medicine. Dr. Peter Mueller, Chief Scientific Officer and Executive Vice
President of Global Research & Development at Vertex
Pharmaceuticals, Louise Proulx, Vice President and Site Head of Vertex
Pharmaceuticals Canada, and Youssef Bennani, Vice President, Research
and Development, welcomed Michelle Courchesne, President of the Treasury
Board, Minister responsible for the Laval region and MNA for Fabre, and
Gilles Vaillancourt, mayor of Laval to the facility.
