As small biotechs make their way through the drug development process they do not always have the expertise necessary to develop new drugs and then jump through the required regulatory hoops. Henrik Rasmussen, president and CEO of Rasmussen Biotech and Pharma Consulting, based in Research Park, says the average cost of bringing a new drug to market often exceeds $1 billion.

It also is very high-risk. “A lot of companies fail at various stages throughout the process,” Rasmussen says. “When people talk about all the money pharma is making, they need to consider that it is a very risky business. You can spend hundreds of millions and a drug can fail.”

To help companies successfully maneuver through the process, Rasmussen hung his own shingle as a biotech and pharma consultant in 2009 and decided to use his experience with drug development in small biotechs. “The time seemed to be right to start,” he says. “I knew that there was a big need for good consulting advice. You have a large number of small biotechs who couldn’t afford someone with my level of experience on a permanent basis.”

After spending two decades in biotechs, Rasmussen had developed the extensive connections he needed to go out on his own. In contrast to the ingrained cultures of large pharma, in his work at biotechs he always had to reach outward, whether to raise money from venture capitalists and hedge fund managers or to convince big pharma to develop his company’s drugs. “You are continuously interacting, and it allows you the opportunity to establish a tremendous number of contacts,” he says.

Rasmussen started his business at home, confident that his connections in biotech and pharma would help him succeed. A year later he moved into Research Park.

Rasmussen’s connections also have turned up the help he needs to run his business, which is structured around nine or ten consultants who work with him on a contractual, hourly basis. “Within drug development, even areas where I don’t have interest or expertise, I know people who do,” he says. For example, he does not know much about manufacturing but has two people on site who specialize in this area.

The firm’s work focuses primarily on small biotechs, although he also does work for larger clients — particularly due diligence on smaller companies the bigger companies might wish to collaborate with or acquire. Much of his work is in drug development for European clients, and he works with biotechs in the Netherlands, Denmark, and Germany.

Rasmussen also helps companies with regulatory submissions, for example, the investigational new-drug filing required to prove that a new drug will be well tolerated before taking it into human studies. Once all the studies are completed Rasmussen’s company helps pull together all the data in a new drug application.

Because the United States is the largest pharmaceutical market in the world, most companies submit to the FDA. But many also want to commercialize in Japan, Canada, and Europe, which now has a centralized review process through the European Medicines Agency, rather than requiring OKs country by country.

Other markets are also growing more attractive. In China, for example, the government wants to provide free health care for its 3 billion citizens by 2014. India and Brazil are still poor but upcoming markets, and Russia is also growing rapidly. But the African continent remains of no interest to pharmaceutical companies in the United States. “There is no money in selling drugs in Africa because nobody can pay for them,” says Rasmussen. “In poor countries, that’s where the Bill & Melinda Gates Foundation comes in. They are doing a great job in making drugs available.”

Rasmussen also provides advice on clinical trials and protocols. “It is an advantage to put together the smartest possible development strategies and make sure you are meeting the regulatory requirements,” says Rasmussen. But, he adds, most small companies do not know what the requirements are, and because he spent 20 years managing clinical development, he can help them out.

Rasmussen also has expertise in business development, with connections in the venture capital community.

Lately Rasmussen’s company has been expanding in the direction of the contract research organization model and helping companies conduct clinical studies. Right now he is working with a Dutch company to set up a Phase 2 study in women with sexual dysfunction. He is identifying the clinics and hospitals that will be doing the study and setting up contracts with the various sites. “People in my company are going to be the link between the sites and the company in Holland,” he says.

Rasmussen is a native of Denmark. His mother was always a housewife, but his father was an entrepreneur, first setting up a heating company and then a small travel agency. But the atmosphere in Denmark did not support entrepreneurship, Rasmussen says. “Here the whole culture is based on supporting small business.”

Perhaps it was his father’s desire to be his own boss that finally inspired Rasmussen to start his own business. “That is certainly one of the attractions,” he says. “I can make my own appraisals. If I thought I had a good year last year, I can give myself a bonus. It’s nice not to have a single boss, and it’s nice to be able to select your clients.

“You can focus on taking clients you know and people you want to work with.”

Rasmussen went directly from high school to medical school at the University of Copenhagen, as is Danish practice. He received a doctorate in cardiovascular disease, an entirely research-based degree earned while practicing medicine.

Under socialized medicine, Rasmussen found his work as a young doctor difficult and not very well-paid. “It was socially unsustainable — 100 hours a week and no money,” he says. His wife, a nurse, wanted to stay home with their two small kids, and in 1988 he jumped at an opportunity to join Pfizer in southeast England.

After six years in charge of Pfizer’s cardiovascular drug development group, he moved to the United States to join British Biotech in Annapolis, Maryland, in 1994. Rasmussen wanted to try out the promising biotech industry, and he was also drawn to the higher salaries in the biggest pharma market in the world.

British Biotech focused on clinical development of cancer drugs. “I wanted to get away from cardiology, and I thought cancer was fascinating, with a big medical need,” says Rasmussen. The company, headquartered in the United Kingdom, was looking for someone who could build up its development organization in the United States, and Rasmussen fit the bill. “It was attractive to me to start something from scratch,” he says. “It appealed to my entrepreneurial spirit.”

After four years, British Biotech’s cancer drug unfortunately proved ineffective, and the company was bought out. Rasmussen moved on to Genvec, another biotech in Maryland, based on gene therapy in cancer, cardiology, and ophthalmology. There he supervised about 80 people and helped take the company public.

As he had with British Biotech, Rasmussen helped build Genvec’s drug development organization. As chief medical officer, he was responsible for designing and setting up the elaborate studies required by the Food and Drug Administration to approve a drug.

He also handled regulatory affairs — the company’s interactions with the FDA, Health Canada, and European and Japanese regulatory bodies.

Rasmussen was “head hunted” for his next position, as chief medical officer for NABI, where he worked on vaccines for smoking cessation and staphylococcus infection. He then moved to Novo Nordisk, his first major pharma employer in years.

“After 12 years in a small biotech continually struggling to raise money from public equity markets, the notion of going back to a company that was actually making money was attractive,” says Rasmussen. He became head of development, overseeing about 500 people. After two and a half years at Novo Nordisk, Rasmussen started Rasmussen Biotech and Pharma Consulting.

As for Rasmussen’s future plans, he would like to get his company to the point where his primary role is business development, general management, and oversight over subcontractors. He would also like to make sure that these subcontractors do a significant portion of their time for his company, and he notes that the people listed on his website work predominantly for him.

One of those listed is his daughter, Camilla. After graduating from the University of Maryland in 2003 with a double major in biology and psychology, she worked as a lab technician in cancer research at Johns Hopkins University. Having previously helped write papers for companies where Rasmussen was employed, she now does medical writing for his company while she attends nursing school at the University of Utah.

“Often small companies don’t have in-house resources, and she is one of three medical writers in the company,” says Rasmussen.

As for challenges, the most significant Rasmussen foresees is controlling growth, which thus far has been faster than anticipated. Soon after he started up, so many people came to him for advice and help that he quickly started bringing in subcontractors. Most of them, he says, are people he had worked with in the past and knows well, and he understands that it is critical for his business that he continue to provide high-quality advice.

But given the different therapeutic areas and aspects of development and commercialization he has worked on, he feels confident that he will always be able to find the right people. “The only potential risk is that we take on more than we can handle,” he says.

He also notes that he has many competitors as a result of layoffs through large mergers and acquisitions among big pharma. For example, there is Merck’s purchase of Schering Plough, accompanied by a layoff of 2,000 employees, and Pfizer’s purchase of Wyeth, with a 1,600-person layoff.

“There are a fair number of people who were laid off as a consequence of these mergers who are doing independent consulting,” says Rasmussen. But so far he has had no problems. Having done no advertising, many clients have come to him by word of mouth through people he has worked with previously. “A lot of those people are now in senior positions with other companies— CEOs or presidents of small biotechs,” he says. “And they’re the ones coming to me.”

#b#Rasmussen Biotech and Pharma Consultants LLC#/b#, 352 Wall Street, Second Floor, Princeton, 08540; 609-466-3161. Henrik Rasmussen, president and CEO.

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