Articles

February Table of Contents

Features

With overworked execs and underfunded campaigns, it is hard to believe that the ad industry has the resources to improve its creativity while churning out campaigns better, faster, and cheaper. But this year?s Rx Club Awards winners show that a more sophisticated and risqué style is emerging?direct in message, clear on benefit, and confident in execution.

Upping the Ante

I'm running as fast as I can." That describes how many pharma executives see their work-as a high-stakes race. Just as competitive runners find that a coach can be a vital part of their success, many business executives are discovering the benefits of working with a professional coach to improve their leadership skills. The result has been a transformation in the way coaching is applied and perceived. Far from being seen as a remedial step for "fixing" executives who are performing below standard, it has become widely used as a way to make already-effective leaders even better and to move them to the next level of their leadership.	

Two years ago, Novartis was looking for a way to give its senior management team in Montreal, Quebec, an extra edge. In an industry in which the competition for leadership talent is particularly fierce, the company realized that coaching was the way to both retain and develop its leaders. In the end, we called in an outside coaching firm to offer its services to all 12 members of the management team at the vice-president level. This article shares that experience and describes how leadership coaching applies in a senior-management setting. It also gives real-life examples of how such coaching is particularly applicable to a pharmaceutical environment. 	Â»	

To understand how leadership coaching can help take a management team to a higher level of effectiveness, it's important to understand some of the principles behind it.				

Custom designed. One of the most important aspects of coaching is that it is customized to the needs of the individual. Right at the start of the relationship, each leader works with the coach to discuss how he or she wants to develop.

It all comes from the client. Leadership coaches work by asking the right questions, rather than by providing answers. "The answers have to come from you, or you won't follow through," says Frances Shanahan, vice-president of information technology and one of the group who went through the coaching experience. Those conversations are opportunities to pause and reflect about management situations encountered. "Sometimes it helps just to say something out loud and have a coach facilitate your own decision making about tough subjects," she adds.

Developing greater self-awareness. Building self-awareness about one's workplace behaviors is an integral part of growth, so it is important for leaders to understand how other people see them. Just as managers believe in the power of feedback for employees, our executives were invited to align their words and actions and to model courageous leadership themselves. That process of "behavioral integrity" involved engaging the executives in soliciting and receiving feedback about their leadership from others.

We called in master certified coach Sheila Goldgrab of Goldgrab Leadership Coaching, who designed a 360-degree structured interview process, with exploration as the approach. The feedback process itself can lead to a ripple of new behaviors and attitudes across the organization. That was the case with Francis Bouchard, who at the time of his coaching was vice-president of sales in the Montreal office (he has since been promoted and transferred to an affiliate in Paris). After the team provided feedback to Bouchard about his strengths and developmental priorities, Bouchard and his coach continued to meet with all of his direct reports on a regular basis for ongoing feedback and to assess his progress.				

In part, what Bouchard heard from his direct reports was that they were impressed by his willingness to display vulnerability in front of them. At the regular follow-up sessions, Bouchard had additional opportunities to model leadership with authenticity and candor-and his senior managers had a chance to discuss and learn from what Bouchard had gained through coaching. That, in turn, fostered a feedback culture in which his sales directors made greater requests for feedback from him. 	

As Bouchard's senior managers began to imitate some of his new behaviors, the effects of leadership coaching were felt two levels below him.	

Direct report Jean-Michel Carpentier, for example, had participated in the 360-degree feedback with Bouchard, then replicated the interview process to get feedback on his own performance from his reports. He also began to meet with them regularly to learn what behavioral differences they had noticed with him. Carpentier describes how the process affected him: "I meet managers face to face only six to eight times a year, therefore each of those meetings is extremely intense and business focused. As a result of being part of my own manager's 360 sessions, I began to make it a priority to include personal development face-to-face sessions in our meeting schedules for the first time.	

"Together, in an open forum, we identify strengths and areas for improvement, then measure progress on a regular basis. The level of information I shared and my consultation process were the two common themes identified as priorities to improve our team's working relationship. We validated the progress six months later and overall feedback was extremely positive. The managers felt more valued and involved in decisions than before and shared specific examples supporting that change. 	

"As a consequence, managers started to roll out the same process with their respective teams, resulting in some very positive outcomes. To improve management skills, any manager starting this process must be humble, listen, and accept without argument the feedback from their teams. In my view, listening and accepting what the team has to say about a leaders' performance is the best demonstration of a core ability required in today's world to become a great leader."	

For Shanahan, the benefit was in helping her refine her role as a communicator of performance expectations: "It can be a fine line between supporting an associate's development and knowing when to let go. I learned that I would prefer to hang on longer than what might be useful in the long run."	

As a result of the coaching process, Shanahan launched a global group mentoring initiative and offered to help IT managers outside her own country gain momentum and get results. Mentoring topics now include development plans, performance evaluations, tying objectives into development plans and performance, replacement versus succession planning, and career paths. It also involves action items for experimentation and for practicing the skills learned. 	

Communication doesn't just flow downward, of course, and for Shanahan a key insight had to do with how she was communicating upward. "I learned from some feedback that suggested I review how I was utilizing sessions with my boss in the US, the CIO for Novartis North America," she says. "I saw that I used the time we had principally for problem solving and that I wasn't sharing any of the good news. Now, the perceptions of me and my department have shifted because of what I learned about building a profile-without changing my modest style."	

The executive team members at Novartis Canada were relatively young, and although members of our executive team had extensive management experience, many were new to the vice-president level. Young, high-performing individuals tend to have high expectations-meaning they need to be capable managers themselves, with retention strategies in place for those who report to them. The company felt that making a commitment to coaching was about creating a commitment to themselves and their own growth. Novartis positioned coaching as support for the CEO's executive development objectives. The VPs in the Canada office were encouraged to get involved in coaching as part of their overall development plans. The goal was for each of the senior individuals to design and execute a full and significant plan. Once the plan was in place, coaching introduced structure and accountability-meaning the executives were more likely to fulfill the plans they had created. Without coaching, their good intentions to design a plan might have been derailed by other priorities. 								

One important thing to remember in constructing a coaching program is that executives, even if they are relatively inexperienced at their level, are likely to have taken courses or seminars, or to have done extensive reading in management issues. They may be skeptical about what coaching will do for them, or, worse, they may think that coaching is mostly intended for executives with performance problems.				

"For a lot of executives, they've already taken all the courses," says Shanahan. "Also, in your technical area, you are already quite proficient. At this level, it's the more complex issues regarding people management."	

Organizational commitment can make a big difference in how people receive the idea of coaching. For instance, at Novartis, Stuart Kruger, vice-president of legal and corporate affairs and general counsel, had already received plenty of executive development opportunities, including Harvard Business School courses. When he was asked to consider coaching, he was skeptical.	

When he looked further, however, he found out that his immediate superior in Montreal, as well as his global superior in the Swiss head office, were both working with coaches and that the coaching experience was a priority for the company's management team. He was persuaded to start working with a coach himself. At that point, the results won him over.	

"It works better than a course because the results are about you," Kruger says. "You're not sitting there for a generic application, shared with 30 other people. It's one-on-one attention."	

Coaching often provides information not likely to be found in a course, Shanahan adds, and often is a way of quickly getting up to speed on a new way of thinking.	

In technical fields such as pharma, it is common for people to have a lot of academic experience and to be accustomed to working individually in making decisions. To Pier-Giorgio Fontana, vice-president of regulatory affairs at Novartis Canada, that is part of the reason pharma is especially ripe for coaching."We spend time on science and details," he says, stressing that pharma executives need to find their balance as leaders and that scientists and physicians in the industry may not invest enough time in personal development.				

Fontana, who has 28 years of experience in the industry, says that not all pharma companies are as willing to invest in people as Novartis is. He is impressed that Novartis would invest resources in helping him develop. He feels that the coaching sent a strong signal that the company cared about his success.	

In today's pharma sector, managing the product pipeline is a major success factor. However, there is another "pipeline" at work as well-the leadership pipeline. Companies need to develop their people and groom them to take on leadership positions. At Novartis, there is a commitment to be aggressive in the acquisition, retention, and development of leadership talent and to accelerate leadership development at the senior levels as a priority of our human resource strategy. As our experience at Novartis has shown, coaching, as part of a focused development plan, can be a key factor that gives leaders and their organizations an edge in keeping the talent pipeline flowing.	

I'm running as fast as I can." That describes how many pharma executives see their work-as a high-stakes race. Just as competitive runners find that a coach can be a vital part of their success, many business executives are discovering the benefits of working with a professional coach to improve their leadership skills. The result has been a transformation in the way coaching is applied and perceived. Far from being seen as a remedial step for "fixing" executives who are performing below standard, it has become widely used as a way to make already-effective leaders even better and to move them to the next level of their leadership.

The Case for Coaching

When Gary Cupit, vice-president of global business development and licensing at Novartis, recently told an audience at Columbia University that "we always cling to products a year longer than we should," he was referring to one of pharma's more pressing and expensive, if lesser-known, problems: failure to promptly pull the plug on unsuccessful pipeline projects. A drug in clinical trials burns about $30,000 a day. For compounds that never make it to approval, that adds up to a frittering of $11 million each. 	

"Failures are part of the process of drug development," says Ken Kaitin, PhD, director of the Tufts Center for the Study of Drug Development (CSDD). "It's what makes the process risky. It's also what ensures rewards at the end of the day. If firms aren't killing compounds, then they're not doing anything innovative." What's at  issue then is not that experimental drugs fail but when. 	

Companies concerned about declining R&D productivity have discovered that time is indeed money. As a drug moves through clinical trials, costs rise exponentially, with Phase III more than three times as expensive as Phase II. Saving out-of-pocket funds is just part of the story. The real aim is freeing up resources. If doomed drugs can dodge Phase III, Kaitin says, "You save that money to reinvest in other potentially more successful compounds." Economists are fond of saying all costs are opportunity costs. The reason there's no free lunch is not the price on the menu, but what you gave up to eat it. 	

The same logic applies to drug development. CSDD reckons that shortening phase lengths by one-quarter will cut the cost of an approved drug by 16 percent, or $129 million. They're considering capitalized costs that include returns foregone when funds get tied up for 12–15 years. That's why halving phase lengths reduces capitalized costs by 29 percent, or $235 million. If just 5 percent of all Phase III failures were terminated in Phase I, total development costs would drop 5.1–6.3 percent. 	

The industry's goal is to accelerate attrition-or, as Kaitin says: "Kill early, kill often." So what is it that makes pharmaceutical companies "cling" in the first place, and what can they do to let go sooner than later?	

After rising for a dozen years, mean clinical phase times started dropping in 1993, after the Prescription Drug User Fee Act was passed. Trials are now 24 percent shorter than they were 10 years ago, according to CSDD. But these gains vary by therapeutic class and by company. CenterWatch found that mean development cycle time (from IND filing to NDA approval) was 4.6 years at the fastest companies and 8.9 years at the slowest.				

Some blame delayed termination on "selfish-team syndrome." After all, "drug development teams are made of human beings," says Kaitin. "No one wants to see what they've been working on for years fail." Christoph Hergersberg, PhD, vice-president of research discovery systems at Amersham Biosciences, affirms that "questionable clinical data tends to get overlooked because there's such a push to do something." 	

A drug's other constituents-patients, physicians, investors -can also influence research. Take the recent failure of Repligen's autism treatment secretin to survive Phase III clinical trials-a misfortune for the small Waltham, Massachusetts–based biotech but tragic news for hopeful parents. Secretin was "discovered" by a woman whose autistic son was given the drug to diagnose a gastrointestinal problem. He and thousands of other autistic patients soon were taking it off-label. A patent assignee, she licensed it to Repligen, headed by a man with two autistic daughters. The impetus for the research was unimpeachable: there is no approved autism drug and no reason to prejudge the plausibility of secretin's efficacy (autism is often accompanied by GI defects and secretin is normally found in the brain). But the drug had already performed poorly in previous National Institutes of Health–sponsored trials. 	

Despite the appearance that Repligen was swayed by strong feelings, it's hard to assign blame. Fact is, the decision to kill a drug trial is rarely clear cut. 	

Go or no go? That is the deceptively simple binary question. The goal of drug development is also simply stated, if not easily achieved: successful administration and manufacture (low technical risk), safety and efficacy (manageable medical risk), and satisfactory profit potential (acceptable commercial risk). It follows that the reason for terminating a drug program is an actual or anticipated deficiency in any of these areas. 				

Similar issues arise over whether to halt a single trial rather than an entire program. One difference: a single trial can be wrapped up early if interim analysis reveals exceptional efficacy. Negative reasons for ending an isolated trial, according to Joachim Vollmer, executive vice-president of PRA International, include adverse health events, new competitive challenges, independent unfavorable clinical results, and a  revised portfolio strategy. The big difference between terminating one trial and shutting down an entire project is the degree to which risks are reparable. When a fix raises costs above what's recoverable, it's time to pack it all in. 	

The issues behind the go/no-go decision are numerous, interrelated, and uncertain-a web of suppositions really. (See "Factors Considered in R&D Decisions.") The two alternatives rapidly ramify, generating an indeterminate number of outcomes, too many and too "iffy" to fully or conclusively evaluate. The source of this complexity is: 	

Factors Considered in R&D Decisions(percentage rated a "great benefit" or "essential")		

 Despite astounding advances in bioscience, pharmaceutical R&D remains a sophisticated form of trial and error. That's why, FDA mandates aside, tests are run. Scientists often don't know what to expect. This makes pharma an "ultra slow industry" (like oil exploration and aircraft design). Rapid innovation is unattainable and long product development times are a fact of life, even though ideas and technology are cutting edge. "We are getting better," Hergersberg boasts, "but the diseases aren't getting easier." 	

 R&D is more art than science. Results are at times contradictory, and almost always must be interpreted, then applied. We say,"the data suggests," Kaitin points out, "not what does it tell us?" Vollmer says that although statistical rules can guide you, they don't apply to "the non-hard facts you may run into." 	

 With a long product development lag in a dynamic, competitive, and highly regulated marketplace, it's easy to be blind-sided by customers, competitors, regulators, and more. Still, bets must be placed well in advance. 	

Pharma has its share of knotty problems, but that's no excuse for getting in its own way. Some responsibility for prolonged clinical trials goes to mismanagement: 				

 Drug development draws on the expertise of many disciplines with varied vocabularies and interests. "Few firms know the best way to get people to speak a common language and then make a decision based on that mutual understanding," Kaitin says. 	

 Barriers to communication are embedded in many firms' organizational designs. Until recently, Schering-Plough's head of R&D didn't sit on its top management committee. One reason for late-stage failures, Kaitin says, is "poor communication between preclinical and clinical" researchers, permitting projects to proceed when proper analysis of the data would have predicted disappointing clinical results. 	

 Options, bonuses, etc. can promote perverse or conflicting goals among scientists and co-developers. 	

Large organizations require strong proponents to overcome internal friction. But project champions tend to become "true believers," says Hergersberg. "It's difficult to stop that truck once it's rolling." 	

Reorganize. CSDD found that economics and efficiency become kill factors in the latter stages of clinical trials. Marketing and sales should be consulted as long as two to three years before launch, they say. "Drug development teams in the past were dominated by clinicians who tended to say, 'If I could do just one more study on this drug, I can show that it works.' Now they try to get marketing people in earlier because they tend to be a little more cutthroat and a little more practical when it comes to these types of issues," Kaitin says. "There needs to be a boosted effort to have highly effective cross-functional teams." Though, it does no good, he warns, if everybody "listens to everybody," but the same core group makes all the decisions. "The key," he says, is "everyone has to feel they have a stake in making the best decision possible." 

Outsource. Contract research organizations (CROs) are not wedded to the product under investigation, says Alberto Grignolo, PhD, president of worldwide regulatory affairs for Parexel International. They don't profit from its sale so have no incentive to shape the outcome. More important, says Vollmer, they bring a wealth of practical experience to bear on clients' clinical trials.

Learn to learn. Hergersberg believes pharma must value unbiased communication and tolerate error. Grignolo says someone must fill the role of "protected pessimist" and be permitted to deliver bad news without being shot. 

Formalize. Human judgment is the most common technique for deliberating R&D matters. (See "Methods for Making R&D Decisions," page 58.) Sadly, a mounting pile of research exists-much of it under the heading of behavioral economics-showing that human intuition is subject to systematic errors when assessing risks and probabilities.

More heads are supposedly better than one, but Daniel Kahneman, a Princeton University psychologist and 2003 Nobel Prize winner in economics, says groups are "superior in recognizing a correct answer when it comes up," but tend to accentuate individual biases. He suggests that organizations learn their biases by tracking decisions and results. Others recommend decision tools that force the application of formal reasoning, impose order, and make assumptions explicit. Hergersberg favors decision trees, a form of top-down analysis. 	

Icosystems created a bottom-up, agent-based model to simulate a pharmaceutical client's R&D decision-making process. Typically, agents (employees, atoms, ants) embody a few simple rules. When they interact, unpredictable situations and emergent properties arise. Paul Edwards, Icosystems' president and CEO, says that the company adjusted agents' motivations, making some truth-seekers, and others success-seekers, and then ran the program to see what happened after decades of simulated time. The results, according to company chairman Eric Bonabeau, would have "more than doubled the risk-adjusted value of [the client's] portfolio." 	

"The new paradigm for drug development today," Kaitin says, "is risk management." The old attitude, "Let's assess medical risk up front and commercial risk at the end of Phase III," is now viewed as absolutely impossible, he says, unless you're dealing with a life-saving drug where none is available.	

Vigilant elimination of false hits is one way to boost R&D productivity. But killing early and often will almost certainly increase the likelihood of false negatives. This means late-stage surprises, such as blockbusters Prozac (fluoxetine) and Lipitor (atorvostatin), could be terminated before their time. That is just another risk pharma will have to learn to manage.	

When Gary Cupit, vice-president of global business development and licensing at Novartis, recently told an audience at Columbia University that "we always cling to products a year longer than we should," he was referring to one of pharma's more pressing and expensive, if lesser-known, problems: failure to promptly pull the plug on unsuccessful pipeline projects. A drug in clinical trials burns about $30,000 a day. For compounds that never make it to approval, that adds up to a frittering of $11 million each.

Knowing When to Pull the Plug On Your Experimental Drug

The genomics revolution may not have ushered in the age of personalized medicine the way healthcare experts predicted, but innovative diagnostics keep pushing the industry toward the ideal of the "right drug for the right person at the right time."	

One company that exemplifies that model is CeMines, a Colorado-based enterprise with an impressive, noninvasive cancer diagnostic in development. The product, which uses molecular fingerprinting to test blood samples, has had a 100 percent accuracy rate for every trial conducted. It not only determines-even in early stages-if a patient has cancer, but provides guidance for which type of treatment will work best.	

Another extraordinary thing about the company is that neither Richard Cavalli, CeMines' president, or Bailey Dotson, its CEO, has a pharma background. So how did two real-estate moguls get involved in a business based on transcription factors, molecular fingerprinting, and auto-antibodies?	

The company began the way many startups do, with a chance meeting between two innovative thinkers with the drive to combine their ideas into a successful venture. In 1999, Cavalli, a Colorado businessman, met Tom Neuman, PhD, a molecular biologist at Cedars-Sinai Medical Center in Los Angeles. Cavalli was fascinated by Neuman's 20 years of work in transcription factors (proteins involved in gene expression), and Neuman was emboldened by Cavalli's confidence in his work.	

The Minds Behind CeMines Richard Cavalli (left) founded CeMines on the strength of its lead scientis's work. Bailey Dotson (right) came on board soon after and helped fund the company.					

"So I just put it out to Tom that I was quite impressed with him," Cavalli recalls. "We seemed to have very good chemistry, and we were able to put together a business plan and start CeMines." Named for "cellular mining," CeMines was found-ed in April 2000 in Cavalli's hometown of Evergreen, Colorado. Cavalli's confidence also lead him to invest a half-million dollars from a personal trust into the startup. Soon after, Bailey Dotson, Cavalli's business associate, came on board, and the two men eventually funded the company with another combined half-million dollars from their real-estate development businesses. But CeMines isn't dependent on its founders' faith and generosity. An additional source of funding comes from sales of reagents to more than 150 research institutions worldwide, generating $1.2 million so far. CeMines was developing antibodies for its own research and saw a business opportunity to offer unique reagents to other researchers. The company has also sold $1 million in common stock.	

"Our reagents business is increasing in size and number," Cavalli reports. "We have a very good reputation in the research community for providing products that work very well. And we recently created partnerships with the top two industry leaders, Sigma Aldrich and Chemicon International, that have boosted our sales significantly and have opened doors to future increases."	

But of course, all that funding is for one greater purpose: to drive the development of the company's star project-blood tumor antibody diagnostics.	

Most cancer is currently detected through imaging or biopsies, both of which take place when the tumor is quite large and difficult to treat. A few blood-based diagnostics for hormone-related cancers are on the market, such as the PSA test for prostate cancer and the CA-125 test for ovarian cancer. Neither method is ideal or highly accurate. CeMines' technology combines the best of both worlds. Tumors, which are homogenous in the early stages, develop subpopulations of malignant cells, which trigger the body to produce unique auto-antibodies. The diagnostic tests the patient's blood against dozens of known cancer antigens, looking for a reaction with cancer antibodies. The screening identifies the highly specific molecular subtypes of cancer by analyzing a network of cell regulatory factors. In finding the tumor's cellular fingerprint in the bloodstream, the diagnostic can detect the presence of cancer very early. And by testing it against dozens of antigens, the diagnostic can determine which type of cancer is present. (See "The CeMines Technology.") Neuman, CeMines' chief scientific officer, puts it simply: "There are hundreds of published papers in which people have shown that at the molecular level there are different groups of tumors. Everybody can do it when they have a piece of tumor. What we can do is identify the different molecular groups using noninvasive techniques." 				

But the technology goes beyond that. "It not only will provide the diagnosis, it will provide a description of the tumor's structure at the molecular level so that targets can be drawn precisely," Cavalli says. "It will offer guided therapeutics, because with a known molecular fingerprint, we can access a database that will show how each specific tumor has reacted historically to specific treatment regimens."	

The result is that the company will be able determine which treatment has worked well for that cancer subgroup before. That is good news for patients, who often have to undergo multiple regimens. The diagnostic also allows oncologists to monitor patients whose cancers come back. "What happens is that tumors change," Neuman says. "The patient has one tumor type right now, and in two years, the same patient may have a modified type of the same tumor. So he actually needs a completely different treatment strategy."  Â»	

"The big payoff for the industry is in drug approval," Dotson says. "We believe the technology addresses two areas: the molecular understanding of the tumor and how various drugs interact with it, both of which help determine what the side effects are. We think there is an opportunity for pharma to take another look at some of the 400 or so drugs that didn't make it through Phase III." In theory, using the test to screen trial subjects will allow cancer drugs in development to demonstrate greater success rates.	

The CeMines Technology When the body detects an invader, such as cancer, the immune system is called to action. By checking the blood for signs of such activity, CeMines' molecular fingerprinting test can detect cancers in their earliest stages, allowing for more effective treatment.					

Other good news for the industry is that CeMines' database of molecular cancer fingerprints will eventually allow pharma companies to "design intelligent therapies that target specific signaling pathways," Neuman says. "That is our long-range goal," Dotson adds, "to develop a whole new generation of more intelligently designed drugs that are really a rifle shot to the tumor rather than the shotgun approach that we are forced to use today."	

But all that is down the road. Short term, to get FDA approval, the company must conduct large-scale trials with 1,000 people or more. And it may need an additional source of funding to make that happen. "Rather than looking to the market to raise the money," Dotson says, "we are probably looking at partnering. We've had preliminary discussions with two or three major companies."	

But the company isn't waiting around for a partner; it's moving forward full steam. "Every test we've done to date has been with hand-created slides that are labor intensive and very slow," Cavalli says. "But we are changing that. By March, we will have ramped up our lab and research capability so that we can automate the tests and create our first prototype. The numbers in our studies are going to accelerate dramatically. We have been in conversations with several well-known cancer research institutions that have clinical specimens in the freezers, and they are simply waiting for a test to be delivered. And we're looking at that happening in the first half of next year." Neuman is optimistic about a speedy FDA approval for a monitoring indication: "What we hope is that we will get all the data in the next six months. With convincing data and a 510K application to FDA, we believe we can have our first-generation monitoring test approved and available within 18 months. The test will make it possible for physicians to accurately track the progression or remission of a specific cancer type." CeMines is currently testing the diagnostic in 100 breast cancer patients, 300 gastrointestinal cancer patients, and 1,200 heavy smokers.				

The executives all have good reason to be upbeat. The results of the company's study (n=175) in September 2002 were 100 percent accurate in identifying 134 lung cancer patients and 41 control patients who were cancer free. Smaller studies-11 gastrointestinal cancer, 10 breast cancer, and 21 prostate cancer patients-have also been 100 percent accurate. 	

Ultimately, CeMines would like to see its test become part of a routine physical for everyone over 40 and anyone with a high risk profile for cancer. The executives say they plan to keep the price in the $200–$300 range, and they've consulted with reimbursement experts to ensure their product will be accepted and supported by payers.	

Now that the company is rapidly moving toward an FDA filing, the executive team is ready to turn over operations to people skilled in navigating regulatory waters.				

"Although Richard and I don't have a big pharmaceutical background," Dotson says, "we think our business experience has taken CeMines from just a theoretical concept in 2000 to a company that is flowing cash through our reagents division, is developing very promising science, and is moving into commercialization with our first generation of cancer monitoring and screening tests.	

 "Moving into 2004, we are looking for a CEO and a chief financial officer who are very experienced in biotech. Meanwhile, our chief operating officer has more than 20 years of experience in FDA regulatory affairs and bringing pharmaceutical products and devices to market, and we have the benefit of very experienced pharma and financial industry guidance from our board members," he adds.	

"After bringing in experienced people, Richard and I will then move on to being board members and members of the executive committee to stay involved. With expert biotech leadership, adequate funding, and a strong board, we believe our platform technology will change the way we diagnose and treat cancer."	

The genomics revolution may not have ushered in the age of personalized medicine the way healthcare experts predicted, but innovative diagnostics keep pushing the industry toward the ideal of the "right drug for the right person at the right time. "One company that exemplifies that model is CeMines, a Colorado-based enterprise with an impressive, noninvasive cancer diagnostic in development. The product, which uses molecular fingerprinting to test blood samples, has had a 100 percent accuracy rate for every trial conducted. It not only determines-even in early stages-if a patient has cancer, but provides guidance for which type of treatment will work best.

Pharmaceutical Executive-02-01-2004

February Table of Contents

Upping the Ante

The Case for Coaching

Knowing When to Pull the Plug On Your Experimental Drug

Better Drugs Through Diagnostics