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Biotechnology in the pharmaceutical industry by design, not by accident.

Biotechnology in the Pharmaceutical Industry: By Design, Not by Accident

The pharmaceutical industry has long been looking for a way to tailor-make drugs and eliminate of the `hits and miss' aspects of development. Not only is this process time consuming, it is also very expensive. A new therapeutical drug or vaccine can take up to 10 years and $50-million to get to market. Biotechnology, and its applications in this field, is seen as a way of producing a `designer' drug specifically intended for an application, environment, and delivery system that can shorten the development and clinical testing periods while reducing costs.

Biotechnology is defined as the application of the biological processes of microbial, plant and animal cells to the development of new products and the improvement of processing techniques. Included in this definition are the techniques of genetic engineering and gene splicing.

By using biotechnology to understand what is going on in the body (whether or not it is reacting to a disease) and developing a drug that takes aims at those bodily functions, the result can be a product so specific, so effective and without major side-effects that it has been referred to as being a `magic bullet'.

Cecil Pickett, executive director of research at the Merck Frosst Centre for Therapeutic Research, says he defines biotechnology as having an impact on biomedicine. He describes the two major applications as monoclonal antibodies and gene splicing. Monoclonal antibodies, he says, recognizes very specific portion of a protein and can be used to fight infections or as a diagnostic tool.

Gene splicing or genetic engineering, Pickett says, has actually had more of an impact to date on biomedicine in terms of getting results on the market. Six different products, he says, are currently on the market based on gene splicing techniques which combines portions of the DNA of different organisms. All have been approved for clinical use since 1982. One is human insulin approved in 1982. It was developed by Genentech in California, working with the Eli Lilly. Another is human growth hormone, also developed by Genentech, which is used to correct hormone deficiencies that results in dwarfism. Merck in the US had a hepatitis B vaccine approved in 1986. [Alpha]-interpheron, the fourth of these products, was developed for the clinical treatment of hairy-cell leukaemia. The fifth is another Genentech project, tissue plasminogen activator (TPA), which is used in the treatment of acute occlusion on the coronary arteries. The sixth Amgen's erythroprotein which was recently approved in the US for treatment of anaemia associated with chronic renal failure.

Biotechnology in Canada Our biotechnology industry is about 15-years old and, as can be expected, had its ups and downs. Most activity in this area has been concentrated in the health care and agricultural industries, with waste treatment coming in third. Most companies are small, with less than 50 employees in biotech R&D. Only a handful have over 100 working on such activities. Large companies often have biotechnology units working as part of their overall R&D effort. Overall, there are just under 200 companies in Canada doing biotechnology research. About 30%, or some 52 companies, are working exclusively in the health-care field. These companies spent about 45% of the estimated $200-million total spent in this country on biotech R&D. What follows is a description of some health-care biotechnology research activities in Canada. It is not intended to be representative but to show the variety of what is being done.

Allelix Inc. One of the better known companies doing biotechnology research is Allelix Inc. of Mississauga, Ont. In business since 1983, it has now evolved into three quite separate and different companies, involved in applying biotechnology to the development of products for agriculture and health care. Allelix Biopharmaceuticals is concerned with developing novel biopharmaceuticals. Company head Graham Strachan, MCIC, sees biotechnology as a way of applying the modern tools of biology to commercial purposes. It is often a means to an end rather than the end itself. His company's strategy has been to work in tandem with major pharmaceutical companies to develop more effective drugs, through the application of modern biotechnology.

One such project has been in the area of understanding tissue repair (for healing of wounds and fractures) and bone disease such as osteoporosis and to develop therapeutics for such conditions. This work has been funded by Glaxo Canada Inc. Another area of interest is receptors. Receptors are the specific sites in the body upon which a drug reacts. Allelix is working for example to isolate the receptors in the central nervous system which are involved in diseases such as schizophrenia and anxiety. Strachan says that advances in biotechnology have now reached a degree of sophistication which has opened the door for a productive relationship between this technology and that of the more traditional approaches to pharmaceutical development. Biotechnology, says Strachan, is improving screening systems through the use of genetically-engineered receptors, as well as providing other research tools necessary for a detailed understanding of physiological processes which form the basis for the design of novel therapeutics agents.

IAF BioChem International Growing out of the Institut Armand-Frappier in Montreal in 1986, IAF BioChem has been putting much of its emphasis on research. The company's activities, says Gervais Dionne vice-president for scientific affairs, can be divided into three major areas: diagnostic kits, drugs and vaccines.

IAF BioChem recently announced the development of an AIDS diagnostic kit that uses synthetic peptide technology to detect both strains of the HIV virus. The kit will also detect the presence of the virus six to eight weeks earlier than kits currently on the market and with fewer failures. According to Dionne, the technology has been licensed to Behring in West Germany and is on the market in Europe.

In drugs, of most interest recently at IAF BioChem has been the development of BCH-189. Although still in the trial stage, this compound has been found to be more effective and less toxic in AIDS treatment than AZT, the only drug proven to delay the progression of the disease. BCH-189 is still being developed for use in humans but the man in charge of the project, Bernard Belleau, FCIC, is continuing to work on his idea of fighting viral infections by interfering with viral DNA without affecting that of the human host. There is also some long-term work being done at IAF BioChem on arthritis, using peptides to act on the immune system which attacks rather than defends in this disease.

In vaccines, IAF BioChem is part of a consortium just now completing the purchase of the vaccine division of the Institut Aramand-Frappier. The company is also working with Harold Jennings, FCIC, at the NRC in Ottawa on a new semi-synthetic vaccine for use in bacterial diseases.

Merck Frosst Merck Frosst is a major international pharmaceutical company will apply biotechnology to all its research efforts, according to Pickett. The company has a specific area of responsibility and Montreal's is in respiratory diseases (including asthma). Pickett says the biotechnology research effort in Montreal is just getting started. The group currently numbers 10 people and Pickett says, when hiring is completed, 30 scientist will be employed.

According to Pickett, Merck Frosst is using the techniques of biotechnology, specifically genetic engineering, to understand how enzyme inhibitors work.

Quadra Logic Technologies One company that has been making the headlines recently is Quadra Logic of Vancouver. It has just announced filing clinical data for a new drug submission with the Health Protection Branch of Health and Welfare Canada for an anti-cancer drug tradenamed Photofrin for treating some forms of lung and bladder cancer. The company has also been given orphan drug status by the US Food and Drug Administration for the treatment of esophageal cancer. This designation is part of an incentive programme to help pharmaceutical companies develop and market drugs for rare diseases or conditions. While meeting all standard safety and effectiveness criteria, `orphan drugs' usually receive the necessary US-FDA approvals about one year sooner than other drugs.

Photofrin, derived from beef blood, is used in photodynamic therapy, a medical technology also developed by Quadra Logic. According to company president James Miller this technology uses compounds activated by certain light wavelengths. The patient is injected with these compounds which have a high tendency to collect in a tumour. Then a low-powered laser in a fibre-optic probe is aimed at the tumour and the compounds emit oxygen free-radicals that destroy it. Basically, Miller says, the tumors are blown apart. Unlike most other forms of cancer treatment, he says, this a one-shot treatment.

According to Miller, Quadra Logic is working on other aspects of photodynamic technology including one project with the Canadian Red Cross that will eliminate viruses in blood. Another venture in this area is the treatment of skin diseases, including cancer.

At the Federal Level The federal government has long considered biotechnology as an important component in Canada's technological development. In 1983 the Liberal government, under Pierre Trudeau, created the National Biotechnology Strategy and the Technology Policy Branch of the Department of Industry, Science and Technology Canada was given the responsibility for implementing the strategy.

The strategy's goals are to create a strong research base for the development of biotechnology, increase the supply of qualified personnel, enhance scientific cooperation and technology transfer, and foster an economic and regulatory climate conducive to commercial biotechnology investment and activities.

Since 1983, five steps have been taken to further this initiative. First was the establishment of the National Biotechnology Advisory Committee, made up of people from industry and academia, to advise the Minister of State for Science and Technology. Second was the Biotechnology R&D Networks, set up to make communication between segment of the research and development community. Each network, there are seven, is administered by a federal science department and membership is open to anyone working on a plan for public and private investment in biotechnology. A cost-sharing programme, administered by the NRC'S Industrial Research Assistance Programme (IRAP), has been set up to encourage technology transfer to the industrial sector. The technology can come from a number of sources: universities, federal laboratories, provincial research organizations, or international collaborations. The fourth step is the encouragement of collaborative scientific projects between all organizations doing biotechnology research. This includes government departments, university labs and private industry. Last, but not least, in this support package is the establishment of the Biotechnology Research Institute in Montreal as well as additional activities at the NRC and Agriculture Canada.

Bionet, the human and animal health-care products network, is split into two sections. Agriculture Canada handles the animal side while National Health and Welfare Canada in charge of the human products. Keith Bailey, MCIC, has been the contact person since the network started up in 1983. He has seen membership rise from zero to its current level of between 400 and 500. The idea of the network, he says, is to facilitate technology transfer and bring people together to share the work and results from universities, commercial operations and government labs. The network is run with a $25,000-budget and provides a quarterly newsletter, puts on an annual general meeting, and sponsors symposiums and speakers.

IRAP One funding source is IRAP and, according to John Jaworski, group manager of the Biotechnology/Life Sciences Section, projects eligible for funding are those that entail some risk for the companies involved. Clinical trials are ineligible, he says, but projects that take a process from laboratory scale to pilot plant or commercial scale can receive funds. Projects that require further chemical research, such as fine-tuning a chemical structure, will also qualify.

According to Jaworski, IRAP sees itself as a technology brokerage operation, not a bank. We're not just a source of money, he says, we can provide companies with access to expertise, technology and even testing facilities. IRAP has an information and technology network that includes government labs, universities (seen as a prime source for technology transfer to private industry), provincial research organizations along with private industry. It even has international contacts through the External Affairs Canada.

IRAP sees itself as being more proactive than most government departments, says Jaworski. One of the five project managers will sit down with companies and help them develop proposals for funding. Once a proposal has been worked through in this way and gets past the project manager (who functions as `devil's advocate'), it has a better chance for success when going through the approvals process at IRAP. There are three funding types available through IRAP: contract, grants and contributions. Under a contract, the government provides all of the funding, accepts all of the risk and owns the technology once work is complete. In a grant, this usually applies to research activities in universities, the government still gives all of the money and takes all of the risk but does not direct the research and does not own the technology upon completion. The third type, contributions, means the government provides only partial funding and reserves the right to reassign the technology developed if it is not commercialized. The idea of this type of funding says Jaworski is to create jobs and exports.

The Medical Research Council and the Natural Sciences and Engineering Research Council provide the major portion of the funding for university/industry collaborations.

The NRC The National Research Council is considered to be the major player in biotechnology research in the government. Its Division of Biological Sciences (Ottawa) and the Plant Research Institute (Saskatoon, Sask.) are part of that effort. The Biotechnology Research Institute in Montreal was set up specifically to work on in this area and is still working its way up to full strength. Luis Martin, head of the Immunology Section at the BRI says he sees the institute as collaborating with both academia and industry. Funding, he says, is slated towards industrial applications of biotechnology. BRI has an extensive in-house research programme which forms the basis for external projects, many collaborations are already underway with companies from all across Canada. These range from advising clients to taking an active role in the implementation of their research. BRI can, for example, go from the initial laboratory isolation of a monoclonal antibody to the pilot-scale production and packaging required for clinical trials.

Another project, this time in conjunction with Biomira of Edmonton, is the development of several antibodies for use the treatment of cancer patients. Using gene-cloning techniques, the antigen binding domains of the mouse monoclonal antibodies are being combined with human antibody constant domains. These `humanized' chimeric antibodies will be more effective while minimizing side-effects. Martin says there are currently five Biomira employees working in the BRI labs in Montreal.

Trained Personnel In its infancy, biotechnology was short on qualified laboratory personnel. Strachan at Allelix says that when his company started up he had to look abroad for molecular biologists, who often were Canadians studying abroad and anxious to return to this country. Now that Canadian educational institutions are filling that gap, there are other shortages opening up. According to Strachan, there is currently a lack of staff downstream from the labs; bioengineers and chemical engineers capable of handling the production process.

At IAF BioChem, Dionne says he sometimes has trouble filling positions that require considerable experience in medicinal chemistry. One recent advertisement, he says, was answered mostly by people from the US.

At the BRI in Montreal, Martin says training personnel is part of its efforts. In collaborative research, such as the project with Biomira, employees are trained in the technology used, and at the end of the project will form the nucleus of a larger research group at the company involved.

Future Impact The effect of biotechnology on the pharmaceutical industry can not be underestimated, says Pickett at Merck Frosst. He calls it absolutely essential in the development of new drugs over the next 10 years. Biotechnology is now being used by all ethical pharmaceutical companies all over the world, he continues, and it will speed up the search for new drugs.

According to Strachan at Allelix, biotechnology will be very profound effects on the pharmaceutical industry in the next five to 15 years. Biotechnology, he says is a means of understanding of what is happening at the molecular level in physiological processes.

However, not everyone is enthusiastic about biotechnoloyg's track record. Dionne at IAF BioChem says its impact to date has been less then anticipated. Not many products have emerged from the industry, he says and the public did expect more.

Over at IRAP in the NRC, Jaworski is also cautious. Biotechnology is everyone's darling at the moment he says, but some of the bloom may come off the rose when people keep pouring money into this field and find that the products and the profits are years, if not decades away.

As to what areas the pharmaceutical industry will be using biotechnology to concentrate on in the future, most industry people say that recombinant-DNA is of considerable interest as is protein engineering.

PHOTO : This chemical engineer is examining biomass production in a benchtop fermentor.

PHOTO : The man at the centre of this photograph is also at the centre of the biotechnology

PHOTO : research effort at Merck Frosst.
COPYRIGHT 1989 Chemical Institute of Canada
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1989 Gale, Cengage Learning. All rights reserved.

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Author:Hollingshead, Sandra
Publication:Canadian Chemical News
Date:Jul 1, 1989
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