Ken Lawless

Canada needs to consolidate lead in global biopharmaceutical sector

By Ken Lawless

Canada’s lead in biotechnology, and biotech’s rising influence, is providing a “second chance” at establishing a leading role in the global pharmaceutical industry. Why does that equate to a “second chance?” Well, with the knowledge and physical manufacturing processes so completely different from the chemical synthesis of drug manufacture, the global pharma industry is re-tooling both its people and its facilities. Canada must leverage its leading biotech position to propel the biopharmaceutical industry forward in the changing landscape.

Biotechnology’s transformative impact on the global pharma industry landscape relates to the manufacturing challenges, requiring new skill sets and organizational capabilities and competencies. This period of transformation presents a chance for Canada to capitalize on its position of strength in early stage biopharmaceutical development and build national economic advantage.

CBI – A NATIONAL BIOPHARMA MANUFACTURING STRATEGY

A $450-million investment is required over the next seven years if Canada is to retain its leading position in the rapidly growing biopharmaceutical industry and capitalize on the $15 billion the country has already invested in the development of 700 new biologically based drugs.

Canada’s apparent success at starting companies must be matched by a resolve to grow them – commercialization cannot be a success without sustainability. To achieve this, the challenges of bringing biopharmaceuticals to market must be addressed. Availability of production facilities for clinical trial materials (pilot scale capacity), development of an economically viable and scaleable process and access to highly qualified personnel are the critical challenges facing biopharmaceutical SMEs.

In releasing the Canadian Bioprocessing Initiative, developed over the past two years by more than 70 government, academic and private-sector stakeholders, the recommendations form a “Made-in-Canada” biopharmaceutical manufacturing strategy that integrates the activities in universities and colleges, with capacities in several semi-industrial scale public facilities, and with industry’s research and training needs.

The work identified bottlenecks in Canada’s commercialization infrastructure and recommends an investment of $450 million over seven years to build capacity in biomanufacturing, research and training in major clusters across the country. The recommendations require support from all levels of government and private industry, and participation from the academic community.

These investments will cement Canada’s position at the forefront of a biotechnology revolution that is changing the way new drugs are made.

RECOMMENDATIONS HAVING NATIONAL IMPACT

The recommendations provide an initial injection of resources to kick start the engine for biopharmaceutical manufacturing industry growth across Canada. Almost all of our biopharma firms are in Canada’s largest cities, in clusters across the country. One of the primary guidelines of the CBI recommendations is to ensure that all of these regionally-distributed clusters are strengthened and that they are able scale to continue to support their clusters’ growth. Helping these biopharma clusters succeed will expand job growth and economic health in these cities.

The investment is projected to yield $1 billion of direct economic impact by 2010 and $2 billion each year thereafter, and reverse a trend that has seen Canada develop a persistent and growing trade deficit in pharmaceuticals.

AND, IF WE DO NOTHING …

The status quo sees Canada productive in biopharmaceutical discovery, launching small companies to start the development process and then selling out at low value to international players. Canada effectively acts as a publicly subsidized intellectual property supply chain whose real benefits will then be realized elsewhere. Time is of the essence since some of our critical challenges will require many years of sustained effort to correct.

Doing nothing is not an option. With over $15 billion invested in the past 10 years, commercialization of our 700 biopharma drugs within Canada is a must.

In helping our biopharma firms to develop Canada’s 700 biopharmaceuticals successfully, Canada will support the national health care system, consolidate its international biotech leadership, and enable the Canadian public to capture the benefits of its innovation investments. And that’s a fix that will provide benefits to several generations.

A summary of the Canadian Bioprocessing Initiative recommendations and support materials are available at www.olsc.ca.

Ken Lawless is president and CEO of the Ottawa Life Sciences Council and chair of the CBI Founders Committee.