Eighty thousand pharmaceutical reps crowd US waiting rooms vying for the opportunity to see physicians. Meanwhile, managed care companies require contracted physicians to churn through a growing number of patient appointments each day. And regulatory forces have removed from the marketer's toolbox many effective tactics for gaining access to doctors outside their offices. With less physician face time available, stiffer competition for each moment, and tight restrictions on access, pharma marketers find themselves hamstrung in their efforts to move product and meet aggressive sales goals.		

In December 2002, PPN Wireless queried 150 top-decile prescribers-primary care and specialty physicians-over their wireless handheld devices about their pharmaceutical sales interactions. Based on their response, this article outlines tactics that will help pharma companies target their most valuable physician customers and establish ongoing access to them. 	

It provides strategies for evaluating both new and traditional media tools and demonstrates how marketers can structure their marketing programs to meet the needs of busy physicians while creating high-quality messages that will leave them wanting more interaction with the company.  	

Pharma marketing and sales executives have long struggled to gain access to hard-to-see physicians. In 1987, PE published "The Myth of the No-See Physician," which encouraged marketers to use more precise techniques to reach high-value physicians who managed to elude even their best sales reps. The article focused on the need to tailor messages to the preferences of individual doctors. That strategy is even more important today and should be expanded to include four primary tactics:				

Segment physicians according to their value and focus resources on those with the greatest worth.

Find out how doctors prefer to receive information. Many high-value physicians will give permission to interact with them regularly, providing a critical advantage in gaining share of voice with that physician.

Assess the tried-and-true communications tools that are currently used and evaluate the new tools available to marketers. An appropriate mix can maximize the company's share of voice with high-value physicians.

Tailor the message to the individual physician. Listen to what he or she says. That's as important today as it was 15 years ago.

In a time when marketing and sales purse strings are pulled tight, it's important to acknowledge that not all physicians are equal. Therefore, reps should not detail an allergy product to cardiologists, who clearly will have no effect on that product's sales. Marketers should focus on primary care physicians and respiratory care specialists who treat patients needing allergy medicines.	

Going a step further, not all PCPs and specialists are equal when it comes to prescribing a product. Some are more valuable than others simply because they see more patients who will benefit from using the product. A simplified market case study illustrates the point:	

An allergy product costing $60 is refilled three times, meaning each new script is worth $240 in sales. Two physicians, a PCP and a respiratory care specialist, see 4,500 patients each year. Being a generalist, the PCP treats a wide array of diagnoses, for which the product is indicated in only 5 percent of the cases. Of her 4,500 patients, she sees only 225 who can use the product. She represents $54,000 in potential sales.			

Because of the nature of specializing, the respiratory care physician treats a much narrower range of diagnoses. The product is indicated for 20 percent of his cases, or 900 of his 4,500 patients. As such, he has the potential of creating $216,000 in sales for the company. 	

In his June 2002 article in PE's Successful Product Management supplement, Archibald Anderson discusses physician "persuaders," suggesting that the personal communication network among physicians is the most powerful influence on how widely and quickly the medical community accepts a product. According to Anderson, doctors watch each other and have a tendency to mimic the prescribing patterns of respected peers.	

Applying Anderson's theory to the allergy product case study further extends the potential value of the respiratory care specialist. Not only does he have 400 percent higher direct sales potential, he also has indirect influence over the prescribing habits of the specialists in his practice. His influence even spreads to his referring base of primary care physicians who read his referral letters as they update the files of their shared patients.  	

Busy specialists run in and out of examination rooms, seeing 25–30 patients a day. To keep to that schedule, some offices have restricted sales reps' access to one hour a day or less. Sales reps know the routine: they sit down and rehearse product messages, glance nervously at their watches, and hope they get a chance to present their spiel. But more often than not, they have to settle for a quick handshake, a hurried signature, and a "thanks for the samples." (See "Got a Minute?")				

Sales reps shouldn't take that personally. The survey physicians indicated that they often find the sales reps' messages helpful in keeping current on medical issues and scientific breakthroughs. (See "At  Your Service," page 62.)			

Reaching the busiest doctors during office hours is not an option. Until very recently, pharmaceutical marketers could compensate for that by reaching key physicians through after-hours activities such as golfing and other sporting events, meetings at resorts, and fancy dinners. In response to PhRMA's new code released in July 2002, most companies have agreed to refrain from such activities.   	

So, what is the best way to gain access to key high-volume  physicians? Permission-based marketing is the foundation for successful interactions with physicians who want the information offered but need it delivered in ways that better fit their busy schedules. In such a system, marketers offer something physicians consider useful. In exchange, doctors "opt-in" or agree to provide some of their time.  	

In 2001, an Ohio physician practice experimented with one type of permission-based marketing. Believing that a physician's time is worth money, it required sales reps to pay $50 to deliver a ten-minute product detail. The pharma industry refused to comply.  	

Permission-based marketing does not require the exchange of money. In fact, according to the survey, physicians indicated that they value high-quality messages, such as new clinical data, as the most important aspect of interactions with pharma companies.  	

In the survey, 80 percent of the physicians indicated they would accept permission-based sales interactions with a representative who had a track record of making good use of their time by supplying useful information. Even more said they would be willing if the information was good (84 percent) and the scheduling was convenient (90 percent). More than half of the physicians who answered the survey are already participating in convenient new forms of electronic detailing including e-detailing, handheld wireless detailing or call-center based detailing. The key to those new forms of sales interactions is that they are scheduled with the permission and at the convenience of physicians.	

Although the permission-based model works in many relationships between sales reps and physician customers, it often requires a high degree of flexibility to meet doctors' scheduling constraints. To obtain permission for ongoing sales interactions, the survey results suggest electronic media are most likely to meet physicians' needs. 	

That is not to suggest that sales reps don't serve an important purpose in marketing to physicians. On the contrary, the rep is the marketer's hammer-a sure-fire tool for tapping out consistent and ongoing messages. But physicians have varying preferences for communication media, and primary targets are valuable enough to warrant finding and using the tools that work best with their individual tastes. The ultimate goal is to increase share of voice to improve the return on the investment made in marketing to physicians.  				

Scott Neslin, a professor at the Tuck School of Business at Dartmouth, conducted the comprehensive ROI Analysis of Pharmaceutical Promotions (RAPP) study in May 2001. The study analyzed the ROI from a variety of marketing tactics including physician meetings, sales rep detailing, and medical journal advertising. Neslin found that the mix of marketing approaches and the stage of the product lifecycle had significant impact on effectiveness and ROI. Neslin concluded that detailing's ROI was affected significantly by the amount of money invested in physician meetings and medical journal ads over the same period of time.	

Neslin also found, on a macro level, that the campaigns using a calculated mix of marketing tools realized higher returns. Messages delivered through various touch points-the internet, advertising, wireless transmissions, and sales reps-have a greater chance of sticking with physicians. That integrated approach is the cornerstone of successful marketing programs in any industry.			

On the micro level, pharmaceutical executives must determine which of their precision one-to-one tools are most likely to produce a favorable response with high-value physicians. Through call centers, the internet, and handheld technology, marketers can simultaneously share information with, and collect information from, high-value doctors.   	

The marketing and sales teams that make the best use of such tools understand that they cannot segregate high-value physicians into disconnected projects. Rather, they must coordinate projects to ensure a continuity of message and to ensure that the information they gather from each target can be organized to help with the next interaction. It is an iterative process in which each interaction builds on the last. 	

To maximize access, pharmaceutical companies should increase their knowledge of each high-value physician, monitor his or her changing preferences, mix the media approaches to fit, and tailor their messages appropriately.	

Individualized message creation can be the most difficult part of one-on-one marketing. Generating content is time consuming and challenging. Marketers must seek approval for every product message, and the process of wrangling with company attorneys and regulatory bodies can take months. But once they have identified target physicians, received permission for ongoing access, and selected an appropriate media mix, the success of a physician marketing campaign still relies on the quality of the message and how tailored it is to physicians' preferences. (See "Timing is Everything," page 62 and "New Details," below.)				

For example, a doctor participates in an e-detailing program with a major drug manufacturer. In addition to product information, the e-detail contains questions that get to the heart of the physician's attitudes about the product. The questions are designed to uncover a particular negative impression the physician may have that prevents him or her from prescribing the drug. The sales rep has access to the information regarding that bias, then can prepare materials and respond accordingly in the next office visit. In that way, sales reps can tailor their product messages for any physician whose preferences they understand.  	

The survey physicians said they resented time spent with sales reps who had nothing interesting to share. That sentiment holds true no matter what channel marketers use. If doctors agree to an e-detail campaign but find the content irrelevant, they won't participate in another one. And if a journal ad is innocuous, they'll  pass it by without a glance.	

It takes a high degree of cooperation among pharmaceutical marketers, legal departments, creative agencies, vendors, and technologists to devise methods of approaching high-value target physicians with a mix of media and messages customized to their preferences. But the payoffs for pharma companies that put forth the effort are phenomenal.				

A Big Pharma executive recently shared one of his experiences. He had impressive clinical data demonstrating a safety point that distinguished his product from a major competitor. The executive knew that the high-value physician wrote many prescriptions for a competitive product, but he also knew the physician enjoyed keeping up with the latest clinical studies. Using a combination of sales details and messaging through a wireless handheld device, he shared data with the physician several times in different packages.	

After a couple of months, the executive received a call from a sales rep, exclaiming, "He finally got it!" The physician had reviewed the material over the wireless device and greeted the sales rep enthusiastically, saying "Why haven't you told me this?  You should be telling every physician!" Overnight, the physician switched from the competitor to become an advocate of the company's product. Mission accomplished.	

Articles

Features

Eighty thousand pharmaceutical reps crowd US waiting rooms vying for the opportunity to see physicians. Meanwhile, managed care companies require contracted physicians to churn through a growing number of patient appointments each day. And regulatory forces have removed from the marketer's toolbox many effective tactics for gaining access to doctors outside their offices. With less physician face time available, stiffer competition for each moment, and tight restrictions on access, pharma marketers find themselves hamstrung in their efforts to move product and meet aggressive sales goals.

How to Target Top Prescribers

I received a letter recently from an AARP member in Carrolton, Kentucky, who wrote: “Medicare will not help seniors with medicine costs. My husband’s a diabetic, has had two heart surgeries and asthma since childhood. He is 68 years old. I am 65 and have congestive heart failure and a lung disease. We have to spend so much on medicine, we barely live-can’t go anywhere except to the doctors and grocery. Please help people like us.”

AARP wants to help this woman and the millions like her who need more affordable prescription drugs. I’m sure the pharma industry wants to help her as well. We share a common goal:  prescription drug coverage for older Americans and those with disabilities. But we don’t always agree on the best way to achieve that. For the good of the nation, we must work together to figure it out.

I have heard people say, and seen newspaper articles claim, that AARP is at war with the pharma industry. That just isn’t true. Our members and their families need and value the products the industry develops and produces. I, personally, have great respect for pharmaceutical companies and have worked with them in health promotion, disease prevention and pharmaceutical product marketing for virtually my whole career.

We have much to be grateful for-and a lot to look forward to-as research into Alzheimer’s, Parkinson’s, and other diseases progress. But our members and their families cannot afford current drug costs. When I say we need pharma’s products, I’m also saying we need them to be affordable. The marketplace is out of balance, and spending on these wonderful drugs that combat disease and ease suffering is too high. I know the industry probably disagrees. But, here’s what I’m talking about:

Spending on prescription drugs rose, on average, about 13 percent a year between 1993 and 2001. For the next decade, it is expected to rise about 12 percent a year.

Prices of brand name prescription drugs have been rising at nearly four times the rate of general inflation.

Nearly one American woman in five between the ages of 50 and 64 failed to fill a prescription because it was too expensive.

Millions of seniors are skipping doses or splitting pills to save money.

Prescription drugs are the fastest growing item in many state healthcare budgets, not just because the prices are higher but because more people are using them-and often demanding the Cadillac when the Chevy would work just as well.

A recent Harris Interactive study found that high out-of-pocket drug costs cause massive noncompliance in medication use. Millions of Americans fail to ask doctors for the prescriptions they need, fail to fill the prescriptions they get, fail to take their full doses, or take the medicines less often than they should. Moreover, the higher patients’ out-of-pocket costs are, the more likely that patients will be noncompliant. The problems affect not just low-income seniors but middle-class people on fixed incomes as well. 

AARP’s goal is affordable Medicare drug coverage, with some cost containment so that a Medicare benefit can be sustained. We are also concerned about the states’ abilities to sustain Medicaid programs. Forty states face Medicaid shortfalls driven by unsustainable drug costs, and those costs continue to drive the increase in Medigap premiums. 

Businesses large and small are feeling the squeeze as well, causing many to drop drug coverage altogether or to require employees and retirees to pay significantly more.

The problem won’t solve itself. Efforts to provide relief through discount cards and other means, though laudable, are simply not enough. The problem is much bigger than that, and we must solve it systemically. At the same time, we must continue research into new lifesaving and life-prolonging drugs that will improve the quality of life for everyone.

Last year, Congress came close to establishing Medicare drug coverage. They laid the foundation for success. The House passed a bill, though in our view, it needed improvement. Although the Senate failed to pass its own legislation, 99 senators voted for some form of Medicare prescription-drug benefit. The Senate reached an implicit bipartisan agreement on several key issues, including the need to contain spiraling drug costs.  

But they could not agree on the following:  

whether to target the limited dollars to seniors most in need-those with low incomes and/

the role of private insurers versus government in delivering the benefit and controlling the cost.

Although those differences are substantial, they are not insurmountable. Both public and private insurance can co-exist, just as they have in Medicare under the Medicare Plus Choice program.  

The immediate pressures of electoral politics are gone.

One party controls both houses of Congress and the White House, providing fewer excuses for failure.

Virtually all elected senators and representatives have pledged to work for a Medicare drug benefit.

President Bush has taken steps to ensure that lower cost generic drugs become available to Americans without improper delays and has stated his support for prescription drug coverage through Medicare. Of his generic drug action, the president said: “Our message to brand name manufacturers is clear: You deserve the fair rewards of your research and development; you do not have the right to keep generic drugs off the market for frivolous reasons.”

I said this was a new day, but a lot of the old politics remain. We are well aware of pharma’s heavy spending and successes in the November elections. Nevertheless, we assume that the industry’s leaders know that drug pricing and costs are changing and that they want to control them as much as they can. 

I believe it is a good time for the industry and AARP to work together to pass reliable, affordable Medicare prescription-drug coverage. We are interested in a pragmatic, bipartisan, workable solution for politicians, the industry, the states, and America’s healthcare consumers, including our more than 35 million members and their families.

It may be possible to integrate drug coverage into a total benefit package. We are concerned, as the industry is, that a drug-only benefit in Medicare may be unstable because of rising costs. We are also concerned that it may not offer a benefit that is generous enough to attract an adequate number of enrollees. If that happens, the risk pool will be too small to hold down premium costs and to sustain the program over the long term.

But we seem to be at an historic moment, when the landscape regarding Medicare prescription drug coverage is about to change. Rather than being on opposite sides of the fence, I hope that AARP and pharma can change the landscape together-for the good of all our constituents and the nation. 

I received a letter recently from an AARP member in Carrolton, Kentucky, who wrote: ?Medicare will not help seniors with medicine costs. My husband?s a diabetic, has had two heart surgeries and asthma since childhood. He is 68 years old. I am 65 and have congestive heart failure and a lung disease. We have to spend so much on medicine, we barely live?can?t go anywhere except to the doctors and grocery. Please help people like us.?

Shake Hands on Rx Drugs for Medicare

The product still in naming, a potential Big Pharma partner, and a foothold field force in North America-those were the works in progress when we toured Eisai Co.'s headquarters and operations in Japan a few years ago.  	

(See "Eisai's Haruo Naito," PE, July 1996.) Now PE visits the company's US headquarters in Teaneck, New Jersey, for an update on its rapid growth in the world's largest market.	

In 1996, in partnership with Pfizer, Eisai carried out its first major US launch-for Aricept (done-pezil), still the leading therapy for Alzheimer's disease. Since then, Eisai has used the product as its main anchor in the United States. In turn, its US subsidiary Eisai Inc. is playing a major role in building a global base for the Japanese company.	

Combining its traditional go-it-alone philosophy with practical partnering, the company is constructing facilities and creating new jobs at its Teaneck, NJ, headquarters and formulation research and production site in Research Triangle Park, North Carolina. An affiliated basic research operation, Eisai Research Institute, is located near Boston. In 2002, with a sales force of 250, Eisai passed the hallmark of $1 billion in US sales-"only the fourth US pharma company to do so in five years or less," it says proundly. Eisai Inc. began 2003 with an ambitious two-year plan to more than double its US force. 	

Soichi Matsuno, chairman and CEO, and Bill Sheldon, president and COO of Eisai Inc., tell a determined story of the growth strategy for the US business. (See "Converging Paths," page 42.) They describe how the business surpassed "one-hit-wonder" status to turn itself into an integrated specialty pharma company in the United States in record time. 		

In 1999, two years after taking Aricept to the US market, Eisai Inc., with its co-promotion partner Janssen Pharmaceutica, launched another major product, Aciphex (rabeprazole) for erosive gastroesophageal reflux disease (GERD). It also has a pipeline with expanded indications for Aricept and Aciphex, as well as new compounds for cancer, sepsis, and stroke. (See "In the Pipeline," page 40.) Together, Matsuno and Sheldon share details of the Aricept campaign, including a huge senior-care manual produced with the advice of AARP and other associations, along with further actions and plans for building up Eisai's reputation, products, and operations in the United States, all-as the company likes to add-in record time.	

Eisai Co. has a long history in Japan but a relatively short one in North America. Only with FDA approval of Aricept in 1996 did the company move beyond research to build its own business organization in the United States. At that point, it braved cultural challenges and a new competitive environment to become a significant player here. But the company has made impressive strides since then.				

Matsuno gives credit where it is due: "Aricept is a driving force for Eisai," he says. "It's at the top of our strategy for realization of the business in this country. With that product, and newer ones, we want to build our US sales and marketing organization."	

Despite the go-it-alone instincts of the Naito family founders, partnering became a means to that end, according to Matsuno. "Eisai wanted to build a company in the United States, but doing so alone would take a long time. We knew that we might lose the opportunity or a competitor might come from behind. We wanted to buy time, so we decided to look for a partnership. We were lucky that we chose Pfizer as our partner." 				

He observes that earlier research contacts and Eisai's desire to obtain the benefit of Pfizer's tutorship informed its choice. "We wanted to learn about doing business in the United States," he says. "And we wanted to learn from the best of the best." Matsuno also says that previous personal experience with Robert Neimeth, former president of Pfizer International, helped seal the deal.	

Sheldon adds another factor: Pfizer would not dominate the partnership. "We conceived a strategy that we were 50–50 partners, that we would create a virtual company between our two organizations that would be in charge of Aricept across all functions. And there would be equal numbers of Pfizer and Eisai people who would make decisions as a team. We have done that successfully, making sure that both companies have a powerful vested interest in the outcome."		

Although the Aricept co-promotion served Eisai Inc.'s purpose well, the US unit quickly moved on to the next realms of integration even as it established new marketing alliances. Five years ago, it built a plant in Research Triangle Park to produce Aricept, theretofore imported from Japan or supplied through contract manufacturing. Eisai expanded the plant's size in 2000 by nearly a third, and a current expansion will make it double the size of the original. When that is completed, the facility will supply all US demand for Aricept and Aciphex. It currently also conducts formulation research to produce batches of products in development for use in clinical trials.				

In January 2003, Eisai announced a 60 percent boost in its US sales force, hiring 150 new reps by spring and aiming for a force of more than 500 strong over two years. As a chief reason for the growth, the company cited its desire to increase its role in the promotion of existing products and to independently market future products it develops or licenses from other companies.	

Still requiring greater marketing muscle for Aciphex, in 1997 Eisai again made the pragmatic and logical choice of Janssen as a co-promoter because of its expertise in the gastrointestinal market. Sheldon gives the subsequent alliance high grades: "It has been run on the same partnering principles as our relationship with Pfizer-both parties are heavily involved in the product's welfare."	

Matsuno considers both partnerships epitomes of his company's good fortune. "We found two unique, gigantic, textbook-type leaders: one, the New York City-based Pfizer; the other, the diversified, New Jersey-based Johnson & Johnson [Janssen's parent]," he says.	

As Eisai Co. entered into those alliances, it also invested in its core research and manufacturing functions-Eisai Research Institute in Andover, Massachusetts and Eisai Inc.'s production plant in Research Triangle Park. Matsuno emphasizes that the company bought rather than leased the respective properties and built its own facilities from the ground up. "In both cases, Eisai Co. wanted to buy a piece of property and build there because of the company's long-term commitment to the US market," he explains. "It's a gamble to build and start a manufacturing facility. But it was worth the risk." 	

Eisai's independent approach hardly offers comfort to the industry's outsourcing supporters, especially in manufacturing. But Sheldon explains that the philosophy is essential to the company's sense of responsibility: "We've tried as quickly as we can to take over the manufacturing and packaging of our products, because we do want high quality. It means a lot to us. It's one of our values. Therefore, I would say we want control." Eisai also assumed all US distribution of Aricept in January 2003.	

Sheldon notes that Eisai's independence impetus extends to all the functions of an integrated pharma company, reflecting the Eisai model in Japan: "We want to play a strong role in marketing strategy with our partners, and we want to play a powerful role in how all of our products are produced."	

For that reason, he says, from the beginning the company focused on recruiting people who could help construct a high-quality integrated US organization: "During the past eight years, we have hired people who add those values and skills to the company. The positions are more knowledge-based. We wanted to recruit the knowledge we needed to build a fully integrated pharmaceutical company. That's where we have invested-in R&D, marketing, sales, and production. We've worked very hard at that and we've succeeded."	

To every rule there are exceptions that prove it. As Eisai expands internal clinical development, it still uses contract research organizations (CROs)-though with the plans and protocols under its strict control. Eisai sometimes conducts its own backup studies, and ts biometrics group does all the company's statistical data analysis.				

Also, in expanding and integrating its R&D, the US unit has reached a global threshold. Last year, Eisai Inc. spun off the US clinical development operation to become a separate entity, Eisai Medical Research, headed by Mindell Seidlin, MD. It now works in collaboration with Eisai's research centers in Japan, London, and other places around the globe.	

"We have several products in development, all designed to be global," Sheldon says. "Therefore, we may conduct a single trial, but we will do it in Europe, Scandinavia, Australia, and the United States." He says the move realizes Eisai Co.'s long-term dream to globalize its R&D. 	

R&D globalization is another hallmark, according to Sheldon. Eisai can now move beyond explosive US growth to a global strategy as a "specialty" drug development company. "All of the compounds coming next in our pipeline are specialty products in neurology, oncology, GI, or acute care-sepsis and stroke," Sheldon explains.	

"Our sales force is designed to meet the needs of our specialty focus. We will continue to partner, because partnering is something we're good at. But along the way, we're going to build a more independent capability to manage our business." As an example, he cites Eisai's April 2002 agreement to acquire exclusive US rights to promote Pfizer's Cerebyx (fosphenytoin), an anti-convulsive treatment for epilepsy.	

Matsuno restates the strategy in philosophical terms that makes it clear Eisai does not quite fit the emerging specialty model. "Our mission is to provide good medicine to the patient as efficiently as possible. Each time a new product comes into our pipeline, we can develop it by ourselves or decide to partner. Eisai has a unique business model."	

Fortunately for Eisai, as it grows to whatever size it may attain in time, its first two products will enjoy extended lifecycles. Aricept will remain on patent until 2010. The Aciphex patent expires in 2013. during that time, the company will continue to develop new indications for both. In September 2002, Eisai submitted an NDA for Aricept in treating vascular dementia, which accounts for about 30 percent of dementia cases worldwide-compared with 60 percent caused by Alzheimer's and 10 percent by Parkinson's and other conditions. It also has Phase III clinical trials underway to study Aricept for the treatment of "severe" Alzheimer's.				

Development of Aricept has also continued with numerous post-marketing studies into short- and long-term results, including customer-driven questions of cost-effectiveness, caregiver burden, and delay in delivery to nursing homes. Several studies asked for both physician and caregiver assessments of patient progress.	

Eisai's research into Alzheimer's has led to more general insights into senior care. With AARP and other organizations as advisors, Eisai assembled such knowledge into a thick but easy-to-use training manual called "Caring to Help Others." (See "Caring, the Book," page 44.) Used by community-based organizations to train volunteers to assist primary caregivers, the award-winning training program also has obvious public relations and marketing value for the company, Aricept, and any subsequent product for the senior audience. 	

Aciphex is a late entrant in the proton-pump inhibitor (PPI) class, but Eisai believes the product shows advantages over others. Previously approved for erosive and symptomatic GERD, Aciphex was cleared by FDA in November 2002 as part of the first seven-day treatment for H. pylori infection, the most common cause of peptic ulcers. Taken in combination with antibiotics, Aciphex can treat H. pylori in up to half the time of current treatments. 	

"Aciphex has done very well," Sheldon says. "In fact, it surpassed Aricept in sales, and it will soon become our first $1 billion drug."	

Eisai and Janssen have focused on detailing and educational symposia to highlight the product's advantages-with success out of proportion to their size, Sheldon believes. Against a large field of competitors, some with giant sales forces and DTC budgets, Aciphex has won about a 10 percent market share, he says. 	

Partly by design, partly by history, Eisai has focused nearly all of its research on four therapeutic areas: neurology, GI, oncology, and acute care. But Matsuno demurs from calling them franchises; mainly, because the focus is of such recent origin. Only neurology and GI were deliberate strategic choices when the company sharpened its research aims four to five years ago, according to Matsuno.				

Aricept, he says, forced the issue of neurology. GI promised to have more commercial value than scientific potential and-with Aciphex capping a series of Eisai discoveries in the area-seemed too important to leave behind. Oncology arose by virtue of several discoveries in Eisai's global R&D program. Six compounds are now in development, ranging from preclinical to Phase II. Critical care evolved from the company's 15-year research into sepsis, the dedicated purpose of the Andover center, and has produced a second-generation compound now in Phase II.	

With the sepsis product and some oncology candidates employing new technology such as angiogenesis, Eisai has assumed a high level of difficulty-and the associated risk. But Sheldon argues that those areas fit perfectly into Eisai's mission of "human healthcare," which seeks to balance commercial growth with medical need.	

"Some of these products-for sepsis, stroke, restenosis, and cancer-are tough to develop," he says. "One way we can try to make them more successful is to hire the best people we can get and let them do some pretty avant garde science."    				

Besides Lilly's Xigris (drotrecogin alfa), the only approved treatment for sepsis, the road to success in that area is littered with casualties. Eisai's E5564 is a second-generation endotoxin antagonist. "It works a little differently than Xigris, which targets the latter part of the septic cascade," Sheldon says. "We believe our product works at the beginning of what happens when people get sepsis."	

"It's a very big molecule, requiring complex chemistry," Matsuno adds. "It's quite difficult to produce." Sheldon explains that the company's analytic research group has made good progress in reducing the number of steps required to produce the molecule. "Now," he says, "their job is to get that down to 16 or 18 steps so that we can produce it in commercial quantities. And they're making progress." 	

Although the compounds in Eisai's pipeline came exclusively from its own research, the company continues to seek new products through licensing, acquisitions, and even partnerships when appropriate. Sheldon says Eisai Inc. has recently begun to build up its business development group to look for those opportunities.	

Having attained most elements of full integration, Eisai Inc. operates without daily supervision from Tokyo. Matsuno believes it enjoys an unusual degree of independence compared with other Japanese companies in the United States. Once Eisai develops a plan or strategy for the US unit, he says, the home office keeps its eye on results rather than the daily details.				

President Naito travels to the US office periodically, but according to Matsuno and Sheldon, his visits are far from stressful checkups. Naito mostly comes to interact with employees and discuss progress in general. He and the employees say they even find the exchanges "energizing."	

Matsuno maintains that the same spirit of delegation holds for company management as a whole. "Our parent has a pretty long-term focus. And they don't give up on it. That helps, because it gives us time to achieve long-term goals. It's a good relationship."	

Tokyo's measure of trust in the US unit reflects its reliance on the US market for future growth. Already its US sales equal 37 percent of worldwide revenue. Only four years ago, the figure was 21 percent. Matsuno says it took 30 years for Eisai to reach $1 billion in sales-a goal that the US unit accomplished in five.	

At that rate, how much longer will it take for Eisai's US unit to dominate the entire company or at least profoundly alter its Japanese character? Matsuno and Sheldon hint that the answer may depend on how the US business defines itself. Sheldon has charge of a "vision" campaign that may depart from the traditional Japanese model but is in keeping with Eisai Co.'s goal to globalize.				

"We'll continue to be a partnering company," he says. "That's a core strength. We're building an independent capability alongside so we can partner when we choose and go alone when we choose."	

A goal of doubling sales within the next five years means any strategy must accommodate rapid growth-with new employees coming from a variety of companies and cultures in the New Jersey area and beyond. When PE visited Eisai in Japan five years ago, intercultural exchange was still primarily an external challenge. Now and in the future, the challenge is internal.	

Matsuno appears to have no fear of that future: "My aim is to make the United States the number-one market for Eisai."	

Executive Profile

Tne product still in naming, a potential Big Pharma partner, and a foothold field force in North America-those were the works in progress when we toured Eisai Co.'s headquarters and operations in Japan a few years ago.

Eisai Rises in the West

A decade ago, pharma companies typically launched new products, observed how well they sold, and, if necessary, modified their marketing strategy and launched again. In today's competitive marketplace, there is only one rule: Get it right the first time.	

Increasing price pressures in Europe, Japan, and the United States make it tough for companies to command the new-product premiums they need to sustain high levels of investment. So they must find new ways to justify their products' value and to maximize ROI as quickly as possible. Sometimes they must establish a product's market position in as few as 36 months. After that, according to IMS data, the ability to rapidly acquire share and defend price premiums diminishes sharply.	

To find out what pharma companies must do to launch products successfully, Innovara conducted a global benchmarking study between September 2001 and April 2002. (See "Study Parameters," page 48.) Based on the results, this article examines	

how major pharma companies are organized and managed globally to develop and bring new products to market 

the relationship between companies' R&D/commercialization interface processes and their commercial results/market leadership

the key components of their new global product commercialization success.	

Companies such as AstraZeneca and Pfizer, the study's two mostly highly rated, identify the unique medical and scientific rationale for their products, then work to create the need for whatever that advantage may be well in advance of commercialization. 	

John Patterson, AZ executive vice-president of product strategy and licensing, believes that shaping the product and its market early are key to his company's success. "We were fortunate," he says, "following our 1999 merger, to retain the top global marketing talent from both Astra and Zeneca. We also have a strategic global planning group that assists our R&D and global marketing teams in producing target product profiles (TPPs) and target product claims (TPCs) early in each candidate's lifecycle. The thinking behind those TPPs and TPCs is not only the foundation for the success of our brands but for the success of our business."  	

The classic case for the result of that kind of thinking comes from the other top-rated company: Pfizer. Before commercializing Lipitor (atorvastatin), Pfizer created a perception of the importance of triglycerides, which, at launch, seemed to be the only medical differential between the new medicine and other leading statins. During that time, Pfizer underspent the competition in basic R&D and, instead, invested heavily in  Phase III studies that would, on approval, be necessary to support the commercial-medical position through launch and post-launch phases.	

Three main operating principles appear to shape products and markets to assure global commercial success:	

Medical and scientific excellence and creativity to establish the rationale for the product

Highly skilled commercial personnel to prepare the market for the new brand, accelerate market adoption, and maximize share of voice at launch

Seamless organizational alignment and cross-functional teamwork to minimize time to launch and maximize medical and commercial impact.

"What is most surprising about this study is not that Pfizer was crowned as the leader of best practices," says David Beadle, executive director of global pharmaceutical research for UBS Warburg, "but rather the extent of its lead over the majority of other industry players. Pharma companies must be prepared to manipulate decades-old marketing rules to create the blockbusters of the future." 	

So, what are the new rules? Following, in the order of importance, are the 12 best practices in which companies must excel to create blockbusters.	

As soon as a company suspects it has a major new drug-as early as Phase I-the patent-life clock is ticking. From that moment on, everyone even remotely involved in new product commercialization must focus on developing the product's potential. And all participants in the three operating principles-medical/scientific excellence, aggressive commercial execution, and seamless organizational alignment-must not only know what they need to do but how to do it quickly.				

Who has it? Genentech does. Dr. Colin Goddard, CEO of OSI Pharmaceuticals, who selected Genentech over many larger oncology companies to license Tarceva (erlotinib), gives the best example of what a sense of urgency means: "Speed of development, willingness to invest heavily in the development of the product, talent, and a bet on who would be the market winners were the main ingredients we were looking for. What made the difference for us was that, at Genentech, speed was seen as a key reason not to lose the deal. "	

Yet, companies need to balance medical and ethical responsibility with their desire to maximize a new product's lifetime value or to boost shareholders' flagging confidence in the company.	

For new products,  three public relations strategies are critical to global commercial success: 	

consumer-to-patient preparedness-educating consumers so they are prepared to convert to the product at launch.

What comes easiest to most companies is the development of medical community advocacy and thought leadership. Even the strictest governments allow pre-launch PR for major new products through medical congresses, research, and more. In that respect, companies must merely match share of voice and share of spend in pre-launch PR-related medical marketing activities to be fairly assured of achieving the 60 percent unaided recall brand awareness level that most companies aim for by launch time.	

But the effectiveness of pre-launch PR depends on nurturing and using global, regional, and local medical thought leaders as advocates. From a PR perspective, those thought leaders must rally around a common message that is highly credible while helping to prepare a global platform for the company's brand. Pfizer, 	

AstraZeneca, and-until recently-BMS have been masters at that.	

More challenging is the PR mission to the investment community, which begins with the earliest clinical testing-or even with discovery and translational research. The companies that do that well take it seriously, right from the top. Merck's Ray Gilmartin, Pharmacia's Fred Hassan, and Genentech's Art Levinson are three CEOs known for their strong shareholder loyalty and investment community PR skills. As a result, they are able to sustain the shareholder community's confidence, even through periods of dry pipelines. 	

Finally, PR preparedness-so necessary in today's DTC-driven marketplace as a way to raise physicians' interest and to expand the market- is often the industry's Achilles heel. The well known story of Novartis' Gleevec (imatinib) provides a stunning example of how important it is for companies to monitor-and respond to-patients' reactions to a product.  	

Says Gloria Stone, director of global PR for Novartis Oncology, "With Gleevec, public relations proved to be one of the most effective means of communicating the drug's status to a global audience." 	

"First and flexible" describes a company's willingness to try new things. Specifically, it means being top of mind with biotech companies and inventors when they are ready to sell or license new technologies. How does a company get to be first on their list?				

Dr. Jason Fisherman, managing director of Advent International, a global venture cap firm that works with biotech companies and biotech-related funds, explains: "A critical factor in the decision process is identifying a partner, who not only has a real commitment to scientific and clinical innovation but who can relay a clear vision for how the alliance will lead to mutual commercial success. That includes a shared sense of 'disciplined urgency' and focus as well as an openness to bi-directional learning."	

Only two companies make it to best-practice status in that regard: Genentech and Pfizer. Genentech's ability to come through with a thorough and flexible offer shows the licensor they genuinely care for mutual success and rapid commercialization. And, being able to take the plum oncology product Tarceva away from bigger contenders also showed a willingness to build an oncology program around high science that many larger companies would find too complicated or beyond their core therapeutic areas of interest.	

Pfizer makes the "first considered" list as an acquisition partner for a different but compelling reason. Five of six of its most recent product launches have come from other companies' R&D efforts.	

Many companies want to be on the "preferred partner" list but fall short for two main reasons: First, they have no processes to enable them to rapidly consider new technologies or products outside of defined therapeutic franchises. Second, they are much more rigorous in their analysis of external candidates than they are of their own R&D products, making the hurdle for a positive evaluation  much higher-sometimes impossibly so. After one or two rounds of negotiations, licensors quickly lose interest.	

Retail guru John Wanamaker is famous for saying, "Half the money I spend on advertising is wasted. Unfortunately, I don't know which half." The same could be said of R&D's "deep pockets." Ken Kaitin, director of Tufts University's Center for the Study of Drug Development, estimates that, of the total R&D spending on new products, less than half relates to the cost of developing the successful compound. "Of every five products that enter human testing, only one will succeed," reports Kaitin. Then, each of those must be approved by a country's regulatory agency. And the odds of success after approval are even worse. The study shows that, in the increasingly generic market, only one in twelve newly approved products will survive five years of commercialization and only one in sixty will become a new market leader.				

The lack of courage to pull the plug-especially in the earlier stages-on new therapies that fail to demonstrate strong performance throughout the development process points to a basic lack of clear decision points and other accountability measures. But the real reason for the high cost of R&D may be much simpler: "No one wants to be the bearer of bad news when it comes to a new drug that the company is counting on," says one scientist who evaluates new compounds for Pfizer. "So, at Pfizer we had to change the system. Now we do very aggressive early testing. Better an early stage "no" than an incredibly expensive later-stage one. If it passes, it is "canned," meaning it will now enter our early-stage candidate tracking system."	

Most companies face a near-term shortage of exciting new global brands, but a few not only have good new products to develop but good long-term prospects as well. They include Novartis and Wyeth, which plan to launch some exciting therapies in the next three to four years. In particular, Wyeth has new oncology and diabetes combinations and other compounds for launch possibly as early as 2004, all of which have huge global market potential. Although it has fewer new potential billion-dollar brands, GSK is collectively impressive with a range of products, each one with  a potential value of half a billion per year and co-marketing agreements for some dynamic new products that are well positioned to use the company's global marketing muscle. 	

Aventis has significant near-term growth potential with new products Lantus (insulin glargine) and Ketek (telithromycin) and new indications for Taxotere (docetaxel). AstraZeneca should blossom with Nexium (esomeprazole) and Crestor (rosuvastatin)."We all know that the secret to a successful product launch is good drug, good drug, and good drug," says AstraZeneca's Patterson. "No one disputes that our R&D has been productive."	

Most companies in the study showed the ability to develop a clear global brand commercialization strategy from a relatively early stage of development. But brand profiling is not only about name and product positioning. Companies must develop core brand marketing strategies that will shape the market to prepare for widespread acceptance of the product as rapidly after launch as possible.  				

Merck's Fosamax (alendronate) is a classic "best practice" example. If left to the definition of osteoporosis at the time of initial clinical investigations-mainly in post-menopausal women who suffer a confirmed vertebral or other fracture and other factors-the market potential for Fosamax would be tiny. However, Merck redefined the market to include both men and women at risk of osteoporosis prior to a first fracture. In doing so, it created a product potential 20–50 times greater than the previously defined market was expected to reach before Fosamax's launch.	

To be successful, companies must study a product to evaluate its ability to define and expand the market. They must establish target brand profiles early and apply them consistently throughout the development process so managers can strategically design and coordinate clinical research, brand awareness, and market shaping activities to achieve maximum commercial results. Companies must have clear global strategies that translate well into local ones and brand imagery and core messages that will essentially remain the same from country to country.	

Cross-functional teamwork and alignment with a common purpose is like good sex: everyone talks about it but few have it. One exception is AstraZeneca, whose global business teams are totally cross functional, meaning that the key decision makers are involved in all decisions about all products in all therapeutic franchises from the start. Those teams include representatives from most major countries of the world. Although at times that may appear to complicate communications, in the end it ensures top-down commitment to the new product throughout the company.								

Pfizer has such clearly established processes and discipline in evaluating and preparing new products for commercialization that cross-functional communications and effort are automatic. Only the most experienced people at Pfizer are involved in new products, and the company does not worry about therapeutic area competencies. Instead, at the corporate level, it has a highly centralized team of new product commercialization experts who can move from one product and therapeutic area to another with ease and alacrity. 	

Another question the study addressed was geography. Is it better to have a small team, centrally located, focused on decisions for only the largest markets? Or should companies have those involved in launching a new product consider input from around the world-or at least from all major markets and regional operations? 	

A clear trend is emerging to answer that question. More companies are migrating to smaller, tighter, new product global launch teams-including R&D and commercialization personnel-based in a major market. That has brought more global new product commercialization teams to the United States.	

AstraZeneca bases its global oncology team outside of Manchester, England, but its global CNS team is in the United States. "We try to locate our R&D and global marketing teams together," explains AZ's Patterson. "The United States produces most of our CNS sales, so we made it our R&D center of excellence for CNS research. That makes it easier for our CNS commercialization team to begin collaborating with the R&D team as early as possible." 	

A decade ago, pharma companies typically launched new products, observed how well they sold, and, if necessary, modified their marketing strategy and launched again. In today's competitive marketplace, there is only one rule: Get it right the first time.

Benchmarks for Blockbuster Launches

First, slice the political sausage into thin cross-sections, throw in your favorite exploding spices-issues nobody can agree on-and mix thoroughly. Then stir fry with vegetables-or rather, plants, as in the conventional, biological, chemical, and nuclear weapon variety. Add age-old staples like cultural and religious hostility, territorialism, poverty, disease, and ignorance. And, if your tastes tend toward the new and exotic, fold in a little faux cloning and junk science at the end. Finally, put the whole ensemble over a slow but searing flame: the endlessly burning cycle of brutality and revenge, terror and war. It's this year's wintertime stew-an international dish sure to keep you warm on the coldest nights.        

So what does that have to do with the price of pharmaceuticals? (You ask.) Three critical hot spots: public opinion, healthcare costs, and scientific innovation. And that's just for starters; countless ingredients of the industry's competitive base will bubble and churn along with the wider turmoil.	

Public opinion has seldom seemed positive to industry partisans. Some simply dismiss the situation as hopeless; others gush with so much goodwill they scare people. Most industry insiders would rather have a positive image than a negative one-if only for the sake of peace at family picnics. But war and world upheaval will push companies toward more secrecy just as they were learning to become publicly transparent. Rx prices, already under fire, will feel greater heat from the general expectation of universal sacrifice in time of war. Even the slightest appearance of selfish behavior will stand out in stark relief. All companies, like all individuals, will have to do their duty. That means relieving human suffering on all fronts, with less leeway for big profits.	

Healthcare costs will only rise on a steeper curve in the wartime environment-despite increased use of "cost-effective" pharmaceuticals. In the US market, where Rx prices have traditionally ranged free, customers will demand that industry share some of the growing burden. From regional HMOs to state–government alliances, customers are taking pharma, the stock market's favorite bull, by the horns to force its prices down.	

Scientific innovation faces several dangers, despite some opportunities, in this winter's harsh stew. Though some US companies may prosper from an infusion of federal dollars into counter-terrorist research, the price of secrecy may be to impede the same and other research. Much of the cutting-edge science now under potential government purview cradles the next generation of medical breakthroughs. Early US resistance to, and misconceptions about, therapeutic cloning of stem cells-similar to how the country first reacted to in vitro fertilization-may impose further delays on innovation. You can't keep justifying high prices with breakthroughs that never materialize.	

To the question of how this stew of events and issues affects the industry, there is an 	underlying answer: We all feast from the same kettle. This season, we're not just feasting; we're swimming in this war-fired stew. Everyone, even the industry, must adapt to the 	soup du jour-or risk drowning in the brew. 	

We all feast from the same kettle-and this season, we're not just feasting; we're swimming in a war-fired stew of events and issues.

Wintertime Stew

The historic divide between academic research and the pharmaceutical industry is disappearing as new research collaborations, drug discovery programs, partnerships, and an evolution in attitudes erases the distinctions that have kept the two at arm's length. Partners HealthCare Systems (PHS), a non-profit healthcare provider in Boston that integrates primary and specialty care, community hospitals, and academic medical centers affiliated with Harvard University, is helping to lead that revolution with programs that are breaking new ground in the arena of academic–industry partnerships. (See "Academic Alliances," PE's Priming the Pipeline supplement, November 2002.)	

Far-reaching changes in academia/industry interactions are underway, and the PHS model coupled with the peculiar problems of treating neurodegenerative diseases illustrates how those changes stand to benefit pharma and biotech companies. John Montana, business development manager at Partners' Research & Ventures group, fills in the details about the prototype initiatives and discusses the state of neurodegenerative disease treatment development. 	

Historically, academic research related to medicine focused on basic science, generally avoiding marketing decisions. Industry, on the other hand, has focused on drug discovery and product development. PHS is bridging the gap between those disparate roles, using its Program in Neurodegenerative diseases (PND) as a test model for promoting applied science and industry partnerships. (See "Discovery: Neurology," PE, February 2001.)	

Representing more than 100 neuroscientists and clinicians, the program focuses on building industry relationships in four major disease areas: Alzheimer's, Parkinson's, ALS (Lou Gehrig's disease), and Huntington's disease. At the PHS hospitals, which include the Harvard-affiliated Brigham and Women's and Massachusetts General hospitals, investigators are doing cutting- edge research in basic neurology, neurodegeneration, neuroregeneration, and therapy development. "All of which," Montana maintains, "show promising results and the likelihood of making a quick jump to a drug discovery program." The best example of that translational style of academic research exists at the Laboratory for Drug Discovery in Neurodegeneration (LDDN), a unique academic neuroscientific drug discovery facility founded in 2001 by the PND and now operating within the newly established Harvard Center for Neurodegeneration and Repair. 		

Montana explains, "Until recently, assay miniaturization, high-throughput screening, medicinal chemistry, and lead compound optimization have been the exclusive province of biopharmaceutical companies. LDDN is one of the earliest-if not the first-academic drug development programs to encompass all of those components and to seek viable lead compounds for eventual clinical testing. We aren't just looking for interesting science; we are developing novel therapeutic agents for currently untreatable diseases." 	

In contrast to industry drug-screening programs, which address conservative targets that have been rigorously investigated, LDDN focuses on alternative approaches and targets that, though high-risk, offer high rewards in potential breakthrough discoveries. Although the approach, from a market perspective, is too perilous for the pharmaceutical industry, Montana and the LDDN leadership believe that its intellectual merit, benefit to society, and potential fiscal rewards are great enough for an academic center to justify its use. (See "Spreading the Risk," page 72.)	

With LDDN, PHS and its affiliated institutions have almost all of the components in place to bring a medication to market, excluding manufacturing, which could be subcontracted. "Although it is the dream of many at PHS to bring a drug to market by ourselves," says Montana, "the most important thing for LDDN is the quick transition of our discoveries into marketed treatments for disease."	

To that end, the Research and Ventures group is developing a variety of commercialization models, including the traditional industry partnership. Montana has begun discussions with several pharma companies about a variety of options and is emboldened by their responses: "We're exploring a range of forms for these partnerships to take," he says. One approach is to develop a strategic alliance with a single company, providing it with an exclusive "first look" at LDDN's pre-publication data, while PHS retains the intellectual property rights, publishing rights, and the ability to build its drug library.	

Another paradigm has LDDN identify and approach companies on the more typical case-by-case basis, depending on the disease state and lead compound involved. In that model, the collaboration would reflect the development state of a specific project. A late-stage lead compound could be out-licensed directly, while a promising early- stage compound could be jointly developed through an industry-like partnership between the company and LDDN. Companies are eager to buy validated leads that can fit directly into their pipeline, but they appreciate the decreased costs of collaborating on early-stage projects. Montana says there is room for both at LDDN. 	

Montana is excited by the recent high-profile developments taking place in the field of neurodegenerative diseases. "The first wave of testable neuroprotective agents for Alzheimer's and Parkinsons's are in the clinic." That is relevant because, until now, the treatments available for those diseases have been palliative in nature, not curative. Many clinicians argue that existing treatments do nothing to stall the diseases' progress. And eventually, when much of the brain has been destroyed, symptomatic treatments simply stop working.				

"Neuroprotection is the big thing in neurodegenerative disease research at the moment," Montana says. What is extremely interesting to scientists at PHS are the incredible similarities in the pathogenesis of all the neurodegenerative diseases. Although completely different in genetic pathway and clinical manifestation, each disorder appears to involve an abnormal protein aggregation in the brain. The proteins are different in each case, but the chemistry is similar. One theory is that a therapeutic strategy that is effective in one disorder may prove effective in the others. 	

"We're all holding our breath for the release of the first product with an indication for neuroprotection," Montana states. "How that medication is received by patients, payers, and the public, and how doctors use it, will set the stage for all those next-generation treatments that follow and will tell us if these neuroprotective strategies will be effective." 		

He is concerned about more than just the efficacy of this first generation of drugs. He points out a major barrier to commercial success beyond "simply" bringing new therapies for the disorders to market: "Neurologists believe strongly that the efficacy of treatment for neurodegenerative diseases will be proportional to how early the disease is diagnosed, and diagnosis in this field is a major problem."	

Currently, by the time Alzheimer's is diagnosed, patients have already lost a formidable portion of their brains' critical neurons. For newly diagnosed Parkinson's patients, the loss of dopaminergic neurons is more than 50 percent. Although neuroprotective therapies prevent further neuronal loss, they cannot regenerate the neurons that are already dead. So treating patients when the disease manifests itself is generally too late for maximum effectiveness. Therefore, early diagnosis is critical to the therapeutic process-and to the financial success of the therapies.	

Having neuroprotective drugs available will ultimately change how doctors diagnose and treat the diseases. And, given that symptomatic treatments already sell well, Montana believes, "neuroprotective treatments that really work will sell through the roof." It is only a matter of time before they are available. (See "Disturbing Growth Predicted.")	

Despite solving significant medical problems, such treatments are likely to cause a slew of payer issues. The diagnostic tests for Alzheimer's, Montana notes, are extremely expensive and relatively unvalidated. Once early-intervention neuroprotective agents become available, developing and making validated diagnostic tools are unlikely to be inexpensive. Given that the Alzheimer's patient population is elderly and, therefore, largely covered by Medicare and Medicaid, some difficult funding issues will have to be resolved.	

Although some people view dealing with a funding problem as the main barrier to treatment as a luxury rather than dealing with a lack of treatment options, what remains is that the pathway to treatment availability is changing as a result of new approaches such as PHS'. "The formerly hostile division between industry and academia is quickly and quietly disappearing," Montana says, "and these developments are being well received in both industry and academia."				

Montana observes that attitudes have definitely changed, as "academics no longer see having industry ties as 'selling out.'" He indicates that a large number of academic scientists sit on the advisory boards of companies and participate in both worlds. "Doing a post-doc fellowship in industry is no longer seen as career suicide," he says. "It used to be that once an academician went into industry, he or she never returned to academia, and that's not necessarily the case now. Academia is beginning to see industry more on a peer level, and I think you'll continue to see a blurring of the divide between the two as we move forward." 	

What is being lost as those two worlds increasingly overlap? Montana says it is clear that academic research is becoming more market-driven, and, as industry becomes a more significant funder of academic research, the for-profit sector's influence on what gets studied will grow correspondingly. What is needed, he suggests, is stepped up funding from the National Institutes of Health and private foundations to support basic scientific research, especially in diseases with low market potential, to prevent market forces from redirecting critical and limited academic resources elsewhere.	

"I believe that academia will always remain a safe haven for risk-taking and alternative approaches to scientific problems, and that industry recognizes the innate value in preserving that role for academia," Montana says. He adds that there is real value, from an industry perspective, in letting academia absorb the risks and costs of critical upfront work and stepping in at a later stage to in-license or partner on significant developments.	

Yet, Montana believes that the trend is clearly for greater collaboration between academic and industry researchers and that the opportunities for significant disease breakthroughs are much greater as a result.	

The historic divide between academic research and the pharmaceutical industry is disappearing as new research collaborations, drug discovery programs, partnerships, and an evolution in attitudes erases the distinctions that have kept the two at arm's length.

Pharmaceutical Executive-02-01-2003

How to Target Top Prescribers

Shake Hands on Rx Drugs for Medicare

Eisai Rises in the West

Benchmarks for Blockbuster Launches

Table of Contents

Wintertime Stew

The Case For Collaboration