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By John McCulloch
Money for pharmaceutical drugs

The popular view of drug development is that it is fantastically expensive undertaking.  The most recent cost estimate (according to research published by the Tufts Center for the Study of Drug Development) is a whopping $1.3 billion.

Some would say that such a high cost is advantageous to the pharma industry since it creates a powerful argument for premium pricing and patent term extension.

But is the number true?

A recent report in the London School of Economics journal BioSocieties by Donald Light (University of Medicine & Dentistry of New Jersey/Stanford University) and Rebecca Warburton (University of Victoria) casts doubt on the hefty price tag.

In an interview with the Burrill Report (listen here), the authors cited the following problems with way the pharma development costs are calculated:

  • Incomplete sampling of pharma companies
  • Incomplete sampling of drugs for cost estimation
  • Focus on new chemical entities only (only 22% of all drug approvals)
  • Use of the mean cost instead of the median cost
  • Use of an unrealistically high cost of capital (11%)
  • Failure to deduct tax credit from the total cost (R&D is an expense)
  • Inclusion of discovery costs (a large proportion of which were underwritten by public funds for academic research)

So what is the true cost?  The authors believe the actual cost of developing a new drug to approval is $59 million (or less) plus discovery cost.  Indeed, audited numbers for all trials reported to the IRS by pharmaceutical companies in the late 1990s put the figure even lower at $22.5 million (download the PDF report: “Evidence regarding research and development investments in innovative and non-innovative medicines”).

So who’s telling the truth?  One way to conclusively put the issue to rest would be for the pharma companies (who strongly dispute the authors’ findings) to disclose their audited R&D expenses for all drugs approved in the past five years.

Expect this issue to grow and grow as national health-care budgets come under increasing pressure.

Reposted from MaRS

John provides assistance to life sciences entrepreneurs in business strategy, management, intellectual property, financing and licensing.

The RIC blog is designed as a showcase for entrepreneurs and innovation. Our guest bloggers provide a wealth of information based on their personal experiences. Visit RIC Centre for more information on how RIC can accelerate your ideas to market.



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Consumer-centered digital health solutions are transforming the future of health care. Technologies such as mobile, the web and wireless monitoring are converging to empower patients and offer physicians countless new ways to deliver health care.

The market intelligence team at MaRS recently completed a report on “New Models of Innovation in Life Sciences”.  On Apr 20th, 2011 MaRS will be hosting a breakfast panel that will examine the open innovation approach and identify opportunities and challenges for health-care stakeholders.

This breakfast briefing will spotlight emerging business models in the consumer digital health industry as well as the perspectives of different stakeholders.

Entrepreneur, investor or interested health consumer? Come and learn more about this growing sector!

Want to learn more? Download Consumer Digital Health—the new Market Insight report by MaRS.

Speakers:

Veronica Piacek, Director of Consumer Communications and Relations, Pfizer Canada
Veronica spearheaded the launch of Pfizer Canada’s acclaimed More than Medication initiative which is dedicated to empowering and inspiring Canadians to take charge of their health ― and actively create healthier, balanced lives.
Zak Bhamani, Director of Consumer Digital Health, Telus
As Director-Consumer Health, Zak is responsible for contributing to the product strategy, and product marketing activities for TELUS’ consumer health portfolio, as well as for market and business development. He joined the TELUS team in 2005, with a focus on wireless solutions for the Health vertical. Zak is an active volunteer in the community.   

Sanjay Sharma, Chief Executive Officer, Insidermedicine
Sanjay Sharma, MD, FRCS, MSc (Epid), MBA is the creator and CEO of Insidermedicine, a leading physician-led news and patient education network. Insidermedicine has created over 4,000 videos and creates 10 minutes of original evidence-based medical programming each day that reaches over 150, 000 patients per month.
Michael Mathews, MHA, National e-health Leader and Associate Partner, Deloitte
Michael is Deloitte’s eHealth practice leader and health technology advisor for the health practice. He is a leader in the field of eHealth with over 15 years of experience in the planning, design, implementation and operation of pragmatic, high-performance eHealth architectures and technology infrastructures.

The event is free but registration is required.

The RIC blog is designed as a showcase for entrepreneurs and innovation. Our guest bloggers provide a wealth of information based on their personal experiences. Visit RIC Centre for more information on how RIC can accelerate your ideas to market.

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You still have an opportunity to participate in Innovation 2 Growing Globally,’ a unique event at the Mississauga Convention Centre on October 5 that  explores innovation in manufacturing and international markets for small business.

The Honourable Perrin Beatty, President and CEO of the Canadian Chamber of Commerce, and David Pascoe, Vice-President of Electric Vehicle Technology for Magna E-Car Systems, are the keynote speakers.

The half-day business forum brings together key industry leaders from the manufacturing and trade sectors to share best practices and insights on how to expand markets through innovation and international trade. As a participant you have two options to explore

1. Innovation in Manufacturing

Thinking Outside the Box
– Jayson Myers: Canadian Manufacturers and Exporters

Industry Champion Panelists
– Martin Harry: Virox Technologies
– Brad Bourne: FTG Corporation
– Peter Stein: Piller Meats

Solutions Through Research
– John MacRitchie: Ontario Centres of Excellence

2. Growing Your Business Globally

Growing Globally: Business Presentations
Featuring experts from leading local companies such as Pat Stanghieri from UPS

Resources and Services Presentations
– Debbie Walker – Ministry of Economic Development and Trade
– Bill Macheras – Department of Foreign Affairs and International Trade
– Robert Sanders – Export Development Canada

The Research Innovation Commercialization (RIC) Centre and the Mississauga Board of Trade (MBOT) are jointly hosting the forum from 7:30 a.m. – 1:30 p.m. Registration is $75 and includes breakfast and lunch. There will also be a trade show featuring resources and programs to support innovation and international trade.  Register at www.riccentre.com

The forum is presented in partnership Business Development Bank of Canada, City of Brampton, City of Mississauga, IRAP, Sheridan College and Town of Caledon.

The RIC blog is designed as a showcase for entrepreneurs and innovation. Our guest bloggers pro vide a wealth of information based on their personal experiences. Visit RIC Centre for more information on how RIC can accelerate your ideas to market.

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The Honourable Perrin Beatty, President and CEO of the Canadian Chamber of Commerce, and David Pascoe, Vice-President of Electric Vehicle Technology for Magna E-Car Systems, are the keynote speakers at Innovation 2 Growing Globally,’ a unique event at the Mississauga Convention Centre on October 5.

The half-day business forum brings together key industry leaders from the manufacturing and trade sectors to share best practices and insights on how to expand markets through innovation and international trade.

The Research Innovation Commercialization (RIC) Centre and the Mississauga Board of Trade (MBOT) are jointly hosting the forum from 7:30 a.m. – 1:30 p.m. Registration is $75 and includes breakfast and lunch. There will also be a trade show featuring resources and programs to support innovation and international trade.  Register at www.mbot.com.

The Honourable Perrin Beatty is the President and Chief Executive Officer (CEO) of the 192,000-member Canadian Chamber of Commerce, Canada’s largest and most representative national business association.

Prior to joining the Canadian Chamber in August 2007, Mr. Beatty was the President and Chief Executive Officer of Canadian Manufacturers & Exporters (CME).

His political career started in 1979 as the youngest person ever to serve in a federal Cabinet, first as Minister of State (Treasury Board) in the government of Joe Clark, and then in six additional portfolios in subsequent Progressive Conservative governments, including National Revenue in 1984, Solicitor General in 1985, National Defence in 1986, Health and Welfare in 1989, Communications in 1991, and Secretary of State for External Affairs in 1993.

David Pascoe is the Vice-President of Electric Vehicle Technology for Magna E-Car Systems where he participates in Magna International’s electric and hybrid vehicle development and integration programs.  He also manages Magna International’s Corporate Engineering group at Magna’s global headquarters campus in Aurora, Ontario, Canada.

Pascoe joined Magna in 1987 and has been involved in advanced engineering projects, business case development, production programs, company acquisitions and advising on business opportunities.

In 2009, Pascoe was elected to the Board of Directors of Electric Mobility Canada.

Pascoe will kick-off the forum with an address on “Managing Innovation Effectively for Growth”. Beatty will speak at lunch.

This forum will explore how innovation and creativity can lead to business growth and international trade, and provide strategies for growth in global markets.

Breakout sessions at the event will include:

  • Innovation for Manufacturing, which targets manufacturing firms (aerospace, automotive, food & beverage, and life sciences) seeking innovative ideas to grow their business
  • Growing Your Business Globally, which will help businesses looking to enter the international arena with finding trade and business opportunities, as well as with the exporting of information and services.

The forum is presented in partnership Business Development Bank of Canada, City of Brampton, City of Mississauga, IRAP, Sheridan College and Town of Caledon.

For more information and to register, visit www.riccentre.com

The RIC blog is designed as a showcase for entrepreneurs and innovation. Our guest bloggers pro vide a wealth of information based on their personal experiences. Visit RIC Centre for more information on how RIC can accelerate your ideas to market.

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By Jeremy Grushcow

An announcement Monday from the Ontario Emerging Technologies Fund (OETF) — Ontario’s (née) $250 million co-investment fund – shows positive signs for potential matching investments in the life sciences.

First, the OETF announced an investment in Natrix Separations. BDC wore the “Qualified Investor” hat on that one, but Natrix is in GrowthWorks’ Canadian Fund portfolio, so we know at least one life sciences VC has found a way to access the OETF funds.

Second, the OETF announced that Lumira Capital and CTI Life Sciences Fund are now Qualified Investors. Both have extensive life science portfolios (Lumira, CTI) and recent successful exits (Lumira: Resonant, Ception; CTI: TargeGen).

So, is this the tip of the biotech iceberg for the OETF? The level of disclosure required to qualify has been cited as a barrier to VC participation in OETF investments and some structural challenges remain for life science companies hoping to leverage the fund’s money; so it’s too soon to say. It sure is encouraging to discover that these challenges aren’t prohibitive.

Stay tuned…

Re-posted from the Cross-Border Biotech Blog

Jeremy Grushcow  is a Foreign Legal Consultant practising corporate law at Ogilvy Renault LLP. He has a Ph.D. in Molecular Genetics and Cell Biology. His practice focuses on life science and technology companies.


The RIC blog is designed as a showcase for entrepreneurs and innovation. Our guest bloggers pro vide a wealth of information based on their personal experiences. Visit RIC Centre for more information on how RIC can accelerate your ideas to market.

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Dr. Theo Kapanadze

Implementation of new analytical technologies plays a crucial role in designing and controlling manufacturing processes for raw, in-process materials and final product quality. Introduction of new analytical initiatives helps build quality into the product and manufacturing processes, as well as continuous process improvement.

As Charles Darwin told us, it is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.  Both the FDA and industry experts expect benefits over conventional manufacturing practices: higher final product quality, increased production efficiency, decreased operating costs and better process capacity. Correspondingly, fundamental changes are also expected within the analytical services CRO’s which have to modernize their analytical capabilities, scientific expertise and compliance/regulatory standards.

The future of pharmaceutical production will require innovative technological approaches and more science-based processes. Introduction of a new generation of analytical technologies will boost collaboration between research and development and manufacturing departments both inside companies as well as with analytical CRO’s and increase overall efficiency. Approvals and inspections will increasingly focus on scientific and engineering principles. As a result, regulators will set higher expectations for new products from the outset.

Pharmaceutical companies are facing growing demands for increased productivity and reduced manufacturing costs. They also have to meet the evolving need for higher quality standards and higher drug expectations. Therefore, the role of independent analytical experts and CRO’s equipped with the new technology is significantly increasing. The cost factors (affordability) and the higher scientific throughput of the new technologies that have recently been introduced dictate that manufacturers build closer collaborations with specialized analytical CRO’s.

In recent years, a trend of change has been observed within pharmaceutical industry. As modern drug discovery has reached a remarkable level of complexity and drugs need to be discovered, developed and produced against strict timelines and within cost and regulatory constraints, industry seeks “lean”solutions to increase productivity. Among them, increasing the sample throughput of the ever-growing number of necessary (routine) analyses has become a popular target to cut costly time.

For the last thirty years, High-Performance Liquid Chromatography (HPLC) has been the leading technology when it comes to various analyses in the pharmaceutical industry.  However, the necessity of serial analyses taking typically 10-45 minutes has been a sample throughput-limiting barrier.

Lately, the fundamentals of HPLC have been exploited to raise new technologies that can speed up analyses to ground breaking limits, without compromising separation efficiency. The Ultra-Performance Liquid column with 1.7μm particle size handling pressures up to 15000 psi and High Temperature Liquid Chromatography (HTLC) have the potential to take liquid chromatography to the next level in pharmaceutical industry. As each analytical method has its own demands, the advances of the above technologies has different applications in pharmaceutical analysis where high-throughput analysis can be meaningful, as in drug discovery, development and in quality operations. Both chemical and biological pharmaceuticals have considered the perspectives of these technologies and their realizations up to now in high-throughput pharmaceutical analysis.

Since its introduction to the pharmaceutical industry, liquid chromatography linked to tandem mass spectrometry (LC-MS/MS) has played an important role in pharmacokinetics and metabolism studies at various drug development stages. Newly introduced techniques such as Ultra-Performance Liquid Chromatography offer improvements in speed, resolution and sensitivity compared to conventional chromatographic techniques.

Accurate quantification of pharmaceuticals in biological fluids facilitates the correct determination of the pharmacokinetics of a medicine. Low-systemic-exposure compounds such as inhaled products or those undergoing extensive metabolism require very high sensitivity assays to accurately define the elimination phase of the pharmacokinetics curves. This need challenges the sensitivity of modern LC/MS/MS instrumentation.

The recently lunched Xevo TQ-S is an ultra-high-sensitivity tandem quadrupole mass spectrometer. It is equipped with StepWave optics featuring a revolutionary off-axis ion source design. The design of this source significantly increases the efficiency of ion transfer from the source to the quadrupole analyzer while the off-axis ion path eliminates neutral contaminants. These two factors combine to dramatically increase the sensitivity of the LC/MS/MS system.  Also, very valuable results have obtained by capillary electrophoresis and MALDI-TOF mass spectrometry for GLP studies of macromolecules in biological matrices.

Reposted from DiTeba Research Laboratories Inc.

Dr. Theo Kapanadze, D.Sc., Ph.D. Chief Scientific Officer, Executive VP Science Dr. Kapanadze is a co-founder of Diteba Research Laboratories Inc. He has more than 30 years experience as an academic researcher, university professor and leading research scientist at major Canadian pharmaceutical and CRO companies.

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By Ingo Koenig

Big Pharma is running out of patented blockbusters, CROs for clinical trials phase 2 and 3 had a boom year in 2009 (!), CROs for phase 1 or pre-clinic and Biotechnology companies are struggling to survive without any financing for early stage companies or early stage drugs.

Does that make sense? Unfortunately it does. Big Pharma is still not (with the famous exceptions) able to use and digest the discoveries of the modern biotechnologies into their product portfolios. The culture is limited to “mega mergers” and “survival mode” not prone to agility and innovation. Or as a Biotech CEO after hearing about the next mega-merger put it: “The dinosaurs are moving deeper into the swamp.”

…and the “valley of death” for early biotechnology discoveries and their companies is widening and not shrinking. How could it be changed?

Big Pharma should stop all their internal preclinical research immediately as it has not produced any significant innovations over the last 10-15 years and rather spend all the money on financing phase 1 and earlier biotech products and companies. But do not buy the company and try to implement the “Big Pharma”-culture. Keep the innovative spirit alive. Let them do their own thing. Just help with clinical studies (clinical study directors are an un-payable, scarce resource to most Biotechs), marketing and lobbying – today’s core competencies of the pharmaceutical industry.

Ingo studied business administration and economics at Kiel University where he received a PhD in economic policy and also earned an MBA from the University of Southern California in Los Angeles, USA. Visit www.koenigconsultants.ca

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