26 minute read
Regulatory
Canadian ExCEllEnCE
in Leadership in the Life Sciences
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Rational drug design, target driven therapeutic approaches, biologics, individualized therapy, molecular diagnostics and biomarkers are the stateof-the-art in a new drug development area, one could think when reading the headlines, but wait – no, we are not quite there yet!
But why are we progressing so slowly in bringing innovative approaches to the patients? There are a few very good reasons that can be summarized as a serious lack of smart money for early stage commercial development in Canada. • Firstly, it is true, the collective global biomedical knowledge has exploded since the beginning of the genomics area and the number of data mines (e.g. Genomics, Proteomics and Metabolomics etc.) ready to exploit is growing exponentially.
But who is actually exploiting them? Well, it’s that small, early stage and chronically under funded Biotech industry. Few companies indeed eventually do find gold nuggets but most others rapidly retract to making better tools or providing research services to those who still hope, keep digging and persist. • Secondly, those who have shaped and dominated the drug development industry in the past, Big Pharma and their CROs, are spoiled by decades of success with blockbuster small molecule drugs, and have build close to no knowledge on how to develop innovative biologicals. Most
Pharma giants have only very recently or not even yet recognized and accepted
how important it will be for their future survival to adopt new drug development strategies and processes (from the Biotech industry). • Thirdly, most investors are risk adverse and have burnt their fingers when the
IT bubble burst and thus prefer to act as interested bystanders, hesitantly dipping their toes into the water here and there, and only jointly and slowly move forward, while seeking advice from the experts in drug development, mostly retired Pharma managers now turned into consultants. What will it take for the Canadian Biotech industry to rise from the valley-of-death, lift off and deliver on its promise to innovate and create new and better diagnostics, therapies, and drugs?
Now, there is lots of buzz about what everyone is doing (e.g. patent filings, preclinical and clinical research, tools, technologies, etc.) but little to hardly ever it is talked openly about the how and, more precisely, about how the ones (i.e. CEOs) that orchestrate those tools and systems lead, enable and perform. At Koenig & Consultants Inc.,
we share the view of the majority of the decision makers in the industry that the management’s team competence is the most important predictor for success, more so than all the rest (see above). But what identifies excellent management? And how do excellent CEOs lead their team to excellence?
These questions were the inspiration behind CELL – A Management Study™, the first of its kind. CELL™ is a, for now, Canadawide study that probes into the management practices of Biotech companies, in the areas of Strategy, Marketing, Communication and Leadership. The questions addressed to the CEOs included in this study were designed to elucidate the processes and the how-doyou-do rather that the results and successes. In the course of the study, CEOs of 23 Canadian companies, that have been recognized with national awards and accolades and thereby serve as role models for the Life Science industry were interviewed about their management practices.
Vision, passion & a sincere interest in people
viewed rely on two pillars to achieve these goals - systems and structures, and efficient and transparent communication with their people. An international experience and understanding of global culture supports these CEOs in communicating with and motivating a diverse team. Many of the companies we interviewed have very well defined internal communication guidelines including the conduct of meetings, email correspondence, use of Blackberries, etc. These ensure a steady, reliable and transparent flow of information while still encouraging informal and creative discussions.
Although unanimously considered very important, Leadership development is the area (of the four we discussed) that suffers the most currently. In today’s tight economic environment, leadership and management development programs are red-taped. About half of the companies in our study included ‘leadership performance’ as an assessment criterion in the employee appraisal process, but only a third organized or invested in some kind of leadership & management skills training for their employees.
It seems that being a great leader in Biotech does not depend on academic background or former professional experience. It rather depends on the personality and the conviction and dedication for leading the company, by leading its people towards their common goals. The excellent leaders we inter-
Adaptable strategy & customer benefit
A clear vision is not only an important starting point for developing a strategy, later down the road it serves to re-engage the team when the going gets tough. 70 per cent of the CEOs interviewed make use of the power of vision & mission statements, leaving still a significant number of 30 per cent without it. As one CEO pointed out, “If we know where we are heading, we have a much better chance of getting there”. The majority of the CEOs saw it as their core duty and responsibility to guide a systematic development and review process of their strategy and thus enabling and allowing for adaptation to changing market environments, whenever appropriate. A few of the companies we interviewed have truly understood that the scientists are the ones who must understand the customers’ needs and benefits, because it is their job to generate a product that delivers. It is understood by this group of CEOs that definition and communication of the customer benefit to be delivered is most effective at the interface of product developers/scientists and their champions in the target market. In many cases, the CEOs themselves take care of the marketing and/or business development function by overseeing this interface. However, in the majority (60 per cent) of the companies in our study, this responsibility was taken on by a dedicated marketing/business development function. A vast majority (80 per cent) of the companies included in the study consistently do a product portfolio analysis. This tool helps the CEO monitor and communicate the potential and progress of the portfolio, thereby facilitating the strategic decision-making.
Enabling Excellence
The excellent Canadian Life Science managers act as ‘enablers’, driving their company’s strategy and policies, establishing efficient processes in internal and external communication, marketing and business development, and above all, motivating and engaging their people and partners in creating their company’s future. The interviews performed with a select group of recognized companies proved that there are indeed exceptional leaders with outstanding leadership and communication abilities. Many of those are not ‘home-grown’, but have an international background.
As analogized earlier, results in the way of revenues, stock prices, or other business performance indicators are too premature to serve as evaluation criteria for management practices. Which is why an evaluation model such as the one adapted for this study might serve as a fairer approach to analyse the Life Sciences companies and their management, at least at this stage of the industry.
Dr. Christine Koenig PhD is a Managing Partner Koenig & Consultants Inc. The fully comprehensive management report based on the analyses of these interviews, along with a collection of show-cases of good practices was released in March 2010. To receive a hard copy or a PDF mail to: info@koenigconsultants.ca
www.bioscienceworld.ca
Grand ChallEnGEs Canada
INNovatIoN aNd foREIgN aId oN thE samE pagE
Ambitious, altruistic and one-of-a-kind; these are just some of the descriptions that have been thrown around Grand Challenges Canada, a new non-profit organization.
Governed by its own board of directors and guided by a scientific advisory team (made up of some of the world’s most distinguished medical scientists from both the developed and developing world), the organization has a mandate of identifying and launching five grand challenges over a five-year period.
In all, the Government of Canada committed $225 million over five years to Grand Challenges Canada when it was launched May 3, 2010 through its Development Innovation Fund. The fund was set up to “support the best minds in the world as they search for breakthroughs in global health and other areas that have the potential to bring about enduring changes in the lives of the millions of people in poor countries.”
Grand Challenges Canada is working with Canada’s International Development Research Centre (IDRC), the Government of Canada’s lead on the Development Innovation Fund, the Canadian Institutes of Health Research, and other global health foundaGrand Challenges Canada’s Chief Executive Officer (CEO) Dr. Peter A. Singer hands Canada’s Finance Minister Jim Flaherty (R) a microscope after Flaherty announced the Government of Canada’s commitment of $225 million dollars to Grand Challenges Canada, in Toronto, May 3, 2010. Grand Challenges Canada is a new not-for-profit organization aimed at solving health problems in the developing world. REUTERS/Mark Blinch
tions and organizations in this endeavor.
CIHR will be responsible for the administration of international peer review, according to international standards of excellence. The results of CIHR-led peer review will guide the awarding of grants by Grand Challenges Canada from the Development Innovation Fund.
Additionally, The McLaughlin-Rotman Centre for Global Health based at University Health Network and University of Toronto will be the Home for the organization.
The first challenge is “to create a new class of point-of-care (POC) diagnostics that will be easy to use, low cost, multiplex and able to assess disease stage and provide information on prognosis.” In the case of this first Grand Challenge, the Bill & Melinda Gates Foundation is also a partner.
To give our readers a better understanding of how this new organization will work, Biotechnology Focus sat down with Dr. Peter Singer, director of the McLaughlinRotman Centre for Global Health and Chief Executive officer of Grand Challenges Canada. We asked Dr. Singer what makes Grand Challenges Canada unique, how the organization will be governed and most importantly how the organization will make good on its commitment to find sustainable solutions to the world’s most pressing health needs.
Q: What makes this organization unique from other national science organizations?
Peter Singer: For starters this is a very unique venture in that it is an independent not-for-profit organization dedicated to improving the health and well-being of people in developing countries.
Secondly Grand Challenges Canada relies on a strategy of integrated innovation. And what we mean by that is we’re looking for solutions at the sweet spot between science and technology, the social innovation that’s needed to bring things to scale in health systems and the business innovation that’s needed to create new technologies. As such, these are projects that must integrate scientific, technological, business and social innovation both in Canada and in the developing world towards a common goal. What that’s really trying to say is that science and technology is necessary but not sufficient on its own. You need the business innovation in companies to produce the goods and services, and you need the social innovation and health systems to make sure that those goods and services reach those who need them. And our interest is in taking innovation all the way from the labs to villages because the people we serve are the people who die unnecessarily and who suffer needlessly in the developing world because of the challenges in global health that they face.
Another important thing to note is where the money to support Grand Challenges Canada is coming from. Grand Challenges Canada falls under the international assistance envelope of the Canadian government meaning this is not your usual R&D fund. Meaning this is foreign aid funding, and it comes from a financial envelope that is at roughly $5 billion a year. The reason that’s important is that one of the things people want in foreign aid is they want to know that in ten years we’re not going to be funding exactly the same things we’re funding today. The way to accomplish this is innovation or research and development.
Lastly, Grand Challenges Canada is unique in its approach. Through Grand Challenges Canada we are funding a global community of researchers and related institutions on a competitive basis to address the world’s most pressing challenges by developing breakthrough solutions and ensuring that these solutions are available to those who need them the most. And the people that need these solutions the most can be found in the developing world, where about eight
million children die every year before their fifth birthday. When you think about that one fact alone, that eight million children die before their fifth birthday; that should give a sense of the size of the problems we’re tying to tackle, the size of the challenges we face. Grand Challenges Canada offers an opportunity to bring positive and sustainable change in overcoming this challenge.
Q: How do you define a Grand Challenge?
PS: A Grand Challenge is really a critical barrier between where we are and where we need to be in global health. Our primary focus is on the comparable inequities in global health. The people in the developing world who are dying prematurely and suffering unnecessarily are the primary community that we serve. It’s about global excellence and impact we believe innovation saves lives.
Q: Why is diagnosing diseases such as malaria more quickly in developing countries through novel tests the first challenge to be tackled by the organization?
PS: It’s about finding the sweet spot between science and technology innovation, social innovation, health systems innovation and business innovation. Point of care diagnostics fits this mold. It involves serious science and technology, it makes things much better and cheaper in the health system and it requires companies to innovate and develop the product.
As a practicing physician I can tell you that diagnosis is the prelude to effective treatment. Diagnostics has also been relatively neglected in global health and that’s why we focused on it. For malaria at the point of care alone, we estimate that diagnostics can save roughly 100,000 lives, and prevent 365 million unnecessary treatments which drives up costs, wastes resources and causes drug resistance.
Imagine there’s a child under five who comes to see a health provider in the developing world. The questions immediately asked are: is it malaria, what kind of malaria, how severe is it and what drugs is it resistant to? And if it’s not malaria, is it pneumonia or one of a number of other things that can cause fever. What happens next is a sample is taken but it has to be sent hundreds of miles away to a laboratory to be tested. By the time the attending physician gets the results back, often times it’s too late. But, if you bring that diagnostic to the patient’s bedside, it’s like a glucometer for global health. It’s right there with instant results and could really help with treatment. The goal is by bringing diagnostic tools to the patient’s bedside we are saving lives, wasting less resources, providing better care, faster and cheaper. The novelty here is that we are developing point of care diagnostics, at the patient’s bedside and there’s a real need for this in the developing world. And its not just tools that diagnose malaria we’re interested in, we’re interested in diagnostics that can diagnose a number of conditions at the same time.
Q: What is the process of being selected? What proposals will get first priority?
PS: We are looking for global excellence and the one’s that will get priority are the ones that meet standards of global excellence and have the likeliest chance of impact.
We will be funding, identifying and putting out applications for and helping innovators come up with solutions for five Grand Challenges over a period of five years. Diagnostics is only the first one, and the request for proposals there of up to $12 million that’s targeted at developing world innovators is only the first step in that first challenge. We will be funding ten to 20 proposals and up to $12 million for this part of the first of the five Grand Challenges. The deadline for the first round of applications is July 12, 2010 at 11:59 pm EST. In all, there will be five Grand Challenges identified and launched over a five year period. The challenges will be determined through an exploration process by Grand Challenges Canada, based on advice from its International Scientific Advisory Board. The applicants can be either not-forprofit organizations such as universities or for-profit organizations.
On this particular Grand Challenge we are also working with the Bill & Melinda Gates Foundation and they’ve announced a competition of up to $30 million targeted at anybody in the world. We’ve announced $12 million for the time being targeted to innovators in the developing world and so together we’re going to create a community supported up to $42 million focused on the problem of point of care diagnostics for global health and because we’re focused particularly on developing world investigators, we’re enriching that community with respect to developing world innovators or people who are actually face-to-face with the challenges of diagnosis in global health. We’ll also be linking those investigators from the developing world to innovators in Canada. Canada has a very strong diagnostics community in the country, and what we will be doing subsequently which isn’t part of the request for proposals yet but it is mentioned, we will be encouraging the developing world innovators to link with innovators in Canada where that will be helpful.
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1 Biotechnology Focus Weekly 2 Laboratory focus Weekly 3 Drug Discovery 4 Commercialization 5 Bio-energy 6 Nutritional Products Q: There is no doubt that Grand Challenges Canada will help redefine Canada’s role in helping the developing world solve some of its most persistent health challenges, but what are the benefits to Canadians and Canadian innovation?
PS: There are three benefits to Canadians. One is that Canadians are generous people; they realize that it’s just not right that a child in the developing world is more than ten times as likely to die under the age of five as a child in Canada is. So there are benefits in terms of the generosity of Canadians, which is really in part why we give foreign aid in the first place. Canadians recognize the enormous need in the developing world and support our country’s efforts to solve those challenges. As well, Canadians want our country to demonstrate leadership.
There is a second benefit though when you think about global health, you just have to think about SARS, or pandemic influenza to realize there are no safe houses in the global village. Diseases have no borders. The problems of health in the developing world are our problems. So there is some self interest in improving health there as well as here. In Canada we may not have been globally minded enough in our approach to innovation, but Grand Challenges Canada does represent a window to be more involved.
The third benefit is that some of the solutions that can apply in the developing world can also apply to communities in Canada, especially in remote areas. Some of the solutions are transferable to communities in Canada and vice versa, and it represents a type of globalization of Canadian Innovation.
I think when we look back five or ten years from now, we’ll look back and say that this was really a real bold, special and effective move that Canada took and what this actually begins to do is it enhances Canada’s brand as an innovating country among nations, outwardly looking towards the world.
www.bioscienceworld.ca
JUNe 2010
June 21-25
Nanotech 2010 Venue: Anaheim, CA Tel: (508) 357-2925 Email: info@nsti.org Web: http://www.techconnectworld. com/Nanotech2010/
June 21-25
BioNano 2010 Venue: Anaheim, CA Tel: (508) 357-2925 Email: info@nsti.org Web: http://www.nsti.org/ BioNano2010/
June 23-24
ChinaBio Partnering Forum Venue: Suzhou, China Email: mrannertshauser@ ebdgroup.com Web: http://www.ebdgroup.com/ cbpf/index.htm
June 24-28
Focis 2010 Venue: Boston, MA Tel: (414) 359-1670 Email: info@focisnet.org Web: http://www.focisnet.org
June 27-30
World Congress on Industrial Biotechnology and Bioprocessing Venue: Washington, DC Tel: 202-962-6630 Email: worldcongress@bio.org Web: www.bio.org/worldcongress
June 28-30
Euro-Biotech Forum Venue: Paris, France Tel: (203) 838-4401 Ext. 237 Email: conferences@windhover.com Web: http://eurobiotechforum.com/ content/main.aspx
June 28-July 1
Microscience 2010 Venue: London, England Tel: +44-1865-254-764 Email: allison@rms.org.uk Web: http://www.rms.org.uk
aUgUst 2010
August 15-19
International IUPAC Conference on Green Chemistry Venue: Ottawa, ON Email: info@icgc2010.ca Web: http://www.icgc2010.ca/
sePtemBer 2010
september 12-15
ABIC Saskatoon Venue: Saskatoon, SK Tel: 306-975-1939 Fax: 306-955-0545 Email: abicfoundation@abic.ca Web: www.abic.ca/abic2010
september 15-17
BioPharm America Venue: Boston, MA Tel: 760 930 0500 Email: hmersy@ebdgroup.com Web: www.ebdgroup.com/bpa
september 17-24
IMAGENENATION-National Biotechnology Week www.biotech.ca
september 21-22
BIO India International Partnering Conference Venue: Hyderabad, India Email: tdalal@bio.org Web: http://bioindia.bio.org/ opencms/bioindia/2010
OctOBer 2010
october 5-7
CanBio National Conference Venue: Vancouver, BC Tel: (705) 472-2280 Email: info@canbio.ca Web: www.canbio.ca
october 6-7
BioContact Venue: Quebec City, QC Tel: (418) 694-8778 Fax : (418) 694-0614 Email :lysbeth@biocontact.qc.ca Web: www.biocontact.ca
Company & advertiser index
cOmPaNY Page rc
a5 Labs .................................................. 12 ................................
amorfix Life sciences............................. 12 ................................
BIotECanada........................................... 8 .................................
Bioniche Life sciences Inc. ...................... 8 .................................
Bio-processing alliance Inc. ................... 12 ................................
Biosyntech Inc. ...................................... 11 ................................
BioTalent Canada.................................... 18, 19 ........................ 4747
Biovail Corporation ................................ 11 ................................
BioVectra ...................................................... 7 ............................ 4742
Caledon Labs ............................................. 8, 9 ................ 4743, 4744
Canada foundation for Innovation ......... 9 .................................
Cirion Clinical Trial Services Inc. .......... 14, 15 ........................ 4745
Cortex pharmaceuticals ......................... 11 ................................
Cytochroma........................................... 10 ................................
Dalton Pharma Services........................ 16, 17 ........................ 4746
Epigenomics ag..................................... 11 ................................
Epitomics............................................... 12 ................................
Eppendorf.................................................31,32.............. 4750, 4751
Ernst & Young ........................................ 12 ................................
Fisher Scientific......................................... 2, 3 ................4739, 4740
i3 .................................................................22,23......................... 4749
Intellipharmaceutics ...................................................................
International Inc..................................... 10 ................................
National Research Council of Canada ..... 9 .................................
POI ................................................................. 4 ............................ 4741
pugenesis technologies Inc................... 10 ................................
stellar pharmaceuticals Inc. ................... 12 ................................
stem Cell therapeutics Corp. ................ 10 ................................
therapure Biopharma Inc. ..................... 12 ................................
University of toronto............................. 10 ................................
viron therapeutics ................................ 12 ................................
vida pharma........................................... 12 ................................
viterra Inc. ............................................. 11 ................................
VWR/Zygem ............................................ 20, 21 ........................ 4748
Warnex Inc. ............................................ 11 ................................
We Know the What and the Why.
NOW WE NEED THE HOW.
I don’t expect any readers of this issue to recognize the name of Dr. John Dessauer. His immense contribution to the methods we use for innovation, product development and business management was made a generation ago. He built and directed the research team that commercialized a patent for ‘electrophotography’ and turned a little company in Rochester, NY into the Xerox Corporation. The phenomenal growth and success of Xerox in those days has been largely forgotten in the six or seven decades that have since passed. My reason for recalling Dessauer’s contribution is its relevance to what we can do together to maximize the growth of the biotech industry in our province and our country.
Dr. Dessauer and the CEO he worked under believed their work had great signifi cance not only for the success of their company, but also for the well-being of mankind. They were aligned in their vision, and their alignment, dedication, enthusiasm and incredible persistence, it took 16 years, was transmitted to the rest of the company and to the stakeholders. One of these stakeholders was the original inventor, Chester Carlson, who provided a pivotal idea at a crucial stage in the product development. The president managed long-term debt, depreciation, irate shareholders and other business challenges in ways that became a model for future North American executives. Dr. Dessauer introduced new R&D practices that we now take for granted, one of these, is the expectation that company engineers must also be inventors. Another is now known as PERT (Performance Evaluation and Review Technique), which originated as a goal-setting and following up type of system.
We all know what we want to achieve in Ontario: a fl ourishing biotech industry whose growth matches or exceeds that of any other global centre and one in which the benefi ts of this collective growth fl ow to all of the participants, including established enterprises, new ventures, service providers, suppliers, educational institutions and the community. The question has always been HOW can we make this happen?
I have long been convinced we collectively need to embrace the umbrella of basic principles that turned that little Haloid Company into Xerox. These principles consist of shared vision, alignment around this vision, dedication to succeed, responsible goal setting to create a path for success and regular evaluation of the progress towards these goals.
At the 2010 BIO International Convention in Chicago last month, I had an opportunity to experience this approach in action. It was, I must confess, an eye-opener. Not only did it involve the application of all of the elements I have just mentioned but the participants exhibited a genuine shared enthusiasm. It was infectious! I was part of a group that met with a top level delegation from the Australian province of Victoria. At 5.4 million people, Victoria is comparable in population to Ontario, and the capital city of Melbourne is in many ways similar to Toronto. I was able to probe many aspects of what they were doing to build biotech in their province. During these discussions the offi cials from Victoria were fully engaged, aligned and focused on their area. The mission of building biotech in Victoria appeared to be run as a business with an overall strategy, clear objectives, and a program of critical review of progress toward these objectives. A major goal for 2010, for example, was the creation of ten fi rms with a market cap of over AUS$250 million. Victoria’s strategy and objectives are closely connected with the existing, the new, and the evolving national programs of Australia for biotech growth. There is a lot more that could be said about how Victoria is striving for excellence and if you are committed to achievement in Ontario, I strongly recommend that you take a close look. Start with www. ausbiotech.org and www.business.vic.gov.au.
One of the keynote speakers at BIO was former US President Bill Clinton. I was not able to attend his lecture, but what I have heard him say on other occasions has struck a resonant chord. After leaving offi ce he established the William J. Clinton Foundation to deal with worldwide issues that demand urgent action. What he tells infl uential people who want to become involved in one of the causes of the Foundation, be it global warming or AIDS, is “Tell me HOW you are going to turn your good intentions into measurable results?” “I am”, he has said, “going to spend the rest of my life asking ‘How?’”.
A few highlights from my own ‘HOW TO?’ list for biotech growth is given below: • Create a long term road map and plan with 3 year evaluation period with clear priorities • Pick technology areas where we are strong, that are leading edge and make big bets • Align Provincial programs with Federal and Regional initiatives to ensure maximum impact • Support innovative export oriented companies • Support the venture community and make it easier to invest in and create innovative companies • Improve research tax credit programs • Appoint a chief scientifi c offi cer for the province and federal governments (Ontario is already doing this) • Leverage investment in research centers of excellence by giving vouchers to industry to use service providers in our provinces • Create a Federal SBIR program like that in the US and deliver the funds through IRAP • Convert Heath Care spending to investment in home grown innovation • Have government departments put out calls to solve their problems and give grants to Canadian companies to solve them • Tell stories about our leaders and people helped by technology celebrating our entrepreneurs
By Peter Pekos
Peter Pekos, President and CEO, Dalton Pharma Services
— John h. dessauer, 1971
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