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With more than 75% of all clinical trials failing to meet enrollment deadlines, costing drug makers more than a million dollars a day in potential sales, Mark Eisenach’s mission is to help solve the industry’s chronic problem surrounding patient and investigator recruitment. Mark LEADER of a THE 65
MARK Eisenach first as a consultant with The Boston Consulting Group, then as a top executive with Covance Inc., and now as the new CEO of Acurian Inc., Mark Eisenach’s mission is to help companies bring new medications to patients as quickly and efficiently as possible. Only 39, Mr. Eisenach’s influence has been profound in improving the mechanism of the clinicaltrial process. “Looking forward 20 to 30 years, healthcare is the industry where fundamental and radical change will happen with great speed,” Mr. Eisenach says. “It’s a good place to be from a career standpoint. I have always wanted to be in an industry where there is momentum, because the thing I do best is anticipate change. What drives me is being in a position to lead an organization to where it needs to be in the future.” Throughout his career, Mr. Eisenach has made it his mission to antic ipate change and build an infrastructure to adapt to the future. In all his roles at Covance — leading corporate development, marketing strategy, and ultimately launching Nex igent — and as CEO of Acurian, Mr. Eisenach has sought ways to help the healthcare industry improve efficiencies within clinical research. “My role has been to look for opportunities that can have a significant impact on the way clinical research gets done, provide services along the way, and create some very good and attractive businesses from that,” he says. “My goal is to ensure that the teams I work with leave a footprint on the way clin ical trials get conducted now and in the future. “New medicines have dramatically changed the way medical care is delivered,” Mr. Eisenach says. “As a result, people are living healthier, longer lives. Continuing those advances means bringing new medicines to patients as quickly as possi ble. My personal contribution to improving medical care is to help com panies bring new medicines to patients as effectively as possible.” Mr. Eisenach has been at the forefront of many of the innovations that help companies improve the speed and efficiency of discovering new compounds. He sees the bigger picture, understands the intricate nature of the business, and recognizes the need for a cohesive approach to conducting a clinical trial. “A clinical trial is one of the more complex industrial relationships that one can imagine,” Mr. Eisenach says. “It’s a largescale initiative with a distributed workforce. Essentially, a clinical trial comprises a team that comes together for one purpose and then disbands. There aren’t many more difficult business operations to organize and pull off.” TIMING is Everything For the CEO of a growing company, time is often scarce. Then again, saving time — helping pharmaceutical companies streamline the process of clinical trials — is a key part of Mr. Eisenach’s mission, both as head of Acurian, which works to accelerate the launch of clin ical trials for biopharmaceutical companies, and in his previous role as a senior executive at Covance, a large and comprehensive drugdevel opment services company. Covance helps phar maceutical companies advance drug development through science, service, and shaping technology solutions. “At Acurian we focus very much on patient physician recruitment, but at the end of the day we exist to make clinical research more effective,” he says. “We focus on improving the economics of our customers. “At Covance and now at Acurian I have been focused on the same set of problems that the phar maceutical industry is constantly facing — how to get clinical trials done more swiftly and less expen sively than they are done today.” Even before embarking on a fully fledged career in the healthcare industry, Mr. Eisenach’s work as a consultant centered around providing effective timesaving solutions to various industries. While at The Boston Consulting Group, Mr. Eisenach was involved with, and ulti mately led, projects that addressed the most pressing concerns facing executives in the business world — the burgeoning costs of research and True innovators leave an impression. Dissatisfied with the status quo, MarkEisenach has spent more than a decade initiating change within the healthcare arena, specifically in the area of fostering improvements in the clinicaltrial process. F I have always wanted to be in an industry where there is momentum,because the thing I do best is anticipate change. E I S E NACH BY KIM RIBBINK sidiary, which Mr. Eisenach founded and led from 1999 until leaving Covance to head Acurian. “Covance, which is in the business of supporting clinical development, already had some existing businesses that did pieces of the clinicalresearch process,” Mr. Eisenach says, explaining the origins of Nexi gent. “With its involvement in investigator sites, Covance was wellpositioned to look for new technologybased services that would connect the participants of a clinical trial. Nexigent brought that together.” In 1999, Mr. Eisenach founded Nexigent Inc., Cov ance’s ebusiness subsidiary for the development of technology enabled clinicaltrial services, which he built into a 100per son organization generating multimillion dollar revenue in its first year.. The core objectives of Nexigent are to more effectively develop, brand, and market Inter netenabled capabilities for enhancing clinical trials. Nexigent offers Webbased services and tools to address major bottlenecks in conduct ing clinical trials, such as the capture and management of voluminous patient data from development, ensuring products enter the marketplace effectively and seamlessly, and visualizing corporate growth. “At Boston Consulting Group I worked with several clients who were looking to improve their processes to get more out of their research and devel opment investments,” Mr. Eisenach explains. Many of those early clients were pharmaceuti cal companies, which undoubtedly fostered Mr. Eisenach’s interest in being a part of the health care industry. But ultimately, the attraction to the health care industry for Mr. Eisenach had its roots in a deeply personal need to play a part in the business of saving lives. A PERSONAL Journey “A member of my family died 15 years ago from ovarian cancer and since that point I’ve been looking for opportunities to participate in, and support healthcare,” Mr. Eisenach says. With a background in business and eco nomics, rather than in science, the gogetter executive found other ways to contribute to the advancement of healthcare. “The opportunity to be a part of the health care industry presented itself while I was working as a consultant at BCG,” Mr. Eise nach explains. “It became clear that, while I am not a physician, I could contribute to the area of research and development by helping the pharmaceutical industry find ways to bring therapies to market more quickly and effec tively. That has been a challenge for the industry, given how wildly expen sive research and develop ment has become. At the same time, the need for innovative therapies is as pressing as ever.” Although working as a consultant to the indus try enabled Mr. Eisenach to have some involvement, he desired a role that would allow him to have more of a direct impact. In 1997, Mr. Eisenach joined Covance. This allowed the executive, motivated by a personal desire to see more treatments brought to market, to join an organization whose busi ness it is to drive R&D — and that proved to be an ideal fit. While at Covance, Mr. Eisenach identified the need for a more efficient method of deliv ering clinicaltrial services. From that sprang Nexigent Inc., Covance’s ebusiness sub MARK Eisenach 66 M a r c h 2 0 0 2 PharmaVOICE I could contribute to the area of research and development by helping the industry find ways to bring therapies to market more quickly and effectively. E I S E NACH SINCE JOINING ACURIAN INC. AS CEO IN OCTOBER 2001, MARK EISENACH HAS BEEN BUSY MANAGING AND EXPANDING THE COMPANY’S DATABASES, OFFERED SERVICES, AND PARTNERSHIP AGREEMENTS. Making an impression OCT.10,2001.Acurian partners with FDC Reports to provide authoritative drug development news to healthcareinformation seekers and to consumers for the first time;FDC Reports publishes The Pink Sheet. OCT.16,2001. Acurian launches its enhanced clinicaltrials Website with advanced customization,easeofuse features supporting 215 medical conditions; the site seamlessly integrates clinicaltrials access with relevant news and drug information to more effectively connect Acurian’s rapidly expanding user base to relevant clinical trials and related medical information. OCT.22,2001.Acurian hires Scott Ballenger, as VP of sales. Mr.Ballenger brings nearly 12 years of outsourcing and pharmaceutical sales experience to Acurian,where he is leading all corporate sales activities focused on assisting pharma ceutical and biotechnology companies that are facing a severe bottleneck in the launch phase of clinical trials. Before joining Acurian,Mr.Ballenger was VP, sales and marketing for Pharmaceutical Research Plus, a clinicaltrial outsourcing company focused on providing patient recruitment services to pharmaceutical and biotech nology companies. many disparate sources, and enhance commu nications among the broad and diverse range of trial participants — patients, investigators, sponsors, and service providers. Mr. Eisenach’s experiences with Nexigent made him uniquely suited to be Acurian’s next CEO. Armed with indepth knowledge of the pharmaceutical outsourcing industry, and, in particular, his experience as the founder and chief operating officer of Nexi gent he had exactly the attributes Acurian was seeking in a CEO. Many of the advances in clini caltrial support, including the for mation of Nexigent as well as Acu rian’s business of matching clinicaltrial participants to inves tigators, according to Mr. Eise nach, have been made possible by the accelerated advancement of information technology. “Communications technology is changing the way to connect all the participants to make a clinical trial happen,” Mr. Eisenach says. Advances in information tech nology coinciding with capital growth and huge increases in sci entific breakthroughs have been hugely advantageous for the indus try, enabling companies to investi gate innovative therapies for an array of diseases. Yet at the same time, the rapid nature of those advances — the large amount of capital that upandcoming companies have managed to raise in the past couple of years, together with the genomic revolution — has meant more challenges for the industry. Find ing ways to meet those challenges is what motivates Mr. Eisenach. “This is a very different industry than it used to be, and that is putting increased demands and stresses on a clinicaltrial system that was already challenged and cumber some,” he explains. “As a result, it takes too much time and too much money to get a trial done. “While the pressures on drug companies to innovate and advance medicine increase, com panies like Acurian can simplify matters because we can help find the physicians and the patients that enable research to get done,” Mr. Eisenach says. Acurian employs databasedriven solutions that have helped to accelerate the launch of more than 60 clinical trials. Using proprietary, Webenabled databases and software, Acurian allows sponsors to select the highest perform ing investigators while at the same time reach ing out to interested, prescreened clinical trial candidates. Acurian’s proprietary physi cian investigator database, the largest of its kind, includes detailed profiles on more than 41,000 experienced physician investigators in the U.S. In addition, Acurian maintains a pro prietary patient database of more than 1.3 mil lion individuals across more than 200 thera peutic areas. When a pharmaceutical or biotechnology company contracts with Acurian to help launch a clinical trial, Acurian is able to quick ly contact the appropriate individuals in its patient database based on a person’s expressed area of therapeutic interest and geographic location and match them to a highperform ing physician investigator. Mr. Eisenach understands the hurdles the healthcare industry faces. While he and the company he leads cannot run the race for the MARK Eisenach 67 PharmaVOICE M a r c h 2 0 02 NOV.13,2001. Acurian enters into a partnership with Health ology, Inc., a developer of high quality text, broadcast,and Web cast health programs using an extensive network of respected physicians from across the coun try, to be the first clinicaltrials resource to blend streaming media technology with indepth information relating to emerging treatments.Under the agreement, individuals who visit www.acurian.com for clinical trial and related information now can access more than 1000 compelling,accurate,and timely healthinformation programs that span a range of medical conditions. NOV.14,2001.Acurian is selected to receive a “Company to Watch”Award at the 9th Annual Enterprise Awards Gala by the Eastern Technology Council, which is sponsored by industry leaders, including PricewaterhouseCoopers;the Enterprise Awards recognize excellence in the field of technology. DEC.4,2001. Acurian announces an agreement with CaP CURE, the world’s largest private source of prostate cancer research funding.Under the agreement,Acurian now reaches the thousands of patients, physicians,and researchers who visit the CaP CUREWebsite at www.capcure.org,enabling them to access the latest medical treatments and clinical trials options to fight prostate cancer. DEC.11,2001.Acurian enters into an agreement with Glaxo SmithKline to begin work on the patient recruitment phase of two key clinical trials. drug developers they can provide the tools that facilitate achieving desired results. “Within the area of clinical development, the biggest challenge for the pharmaceutical and biotechnology industries is firstly testing their clinical hypotheses, then proving that the drugs that they bring to market are safe in appli cations on a large scale,” Mr. Eisenach says. “Time and money are working against the industry. It costs tens, even hundreds of millions of dollars to bring products to market. The longer this process takes, and the more expen sive it is, the greater the likelihood that the product won’t be a commercial suc cess. Either a competitor will bring a similar product to market, the company conducting the trials will go out of business, or the prod uct will have to be abandoned because by the time the research is completed it will no longer be economically viable to bring the drug to market.” According to Mr. Eisenach, the single biggest area of opportunity for improvement in the clinicaltrial process is patientphysician recruitment. “By having a target patient and investiga tor audience, companies can shorten the time line of clinical trials without having to alter the rest of the R&D pro cess,” he says. Many of the business challenges healthcare and pharmaceutical companies encounter are faced by other indus tries. That outside per spective, the ability to absorb and translate lessons learned from one industry into another, has been a huge boon to the companies in which Mr. Eisenach has been a part. “Many people in the pharmaceutical indus try have spent their working lives in the industry, and have not participated in other sectors where many of the same problems exist,” Mr. Eisenach says. “Granted, we have a whole host of issues, from privacy to the fact that we’re providing human healthcare in a regulatory environment that constrains how we go about introducing change,” he says. “But the fact is the problems we’re trying to solve exist in other industries and one of the things I bring is a broader per spective on how to bring solutions from an unrelated business to the pharmaceutical industry.” A PROGRESSIVEAttitude During his years at Covance, Mr. Eisenach played several central roles in shaping the company’s business. He led Covance’s world wide business strategy, before going on to lead global marketing and business strategy. Next, he founded Nexigent and oversaw the sub sidiary as chief operating officer. After a few years of progressively more demanding and increasing responsibilities at Covance, Mr. Eisenach felt he was ready for the next big leap — leading a young company. Acurian, with a growing reputation for matching investigators and patients for clini cal research through its vast databases, seemed the perfect fit. “For me, the attraction of Acurian was that the company is the market leader in new MARK Eisenach 68 M a r c h 2 0 0 2 PharmaVOICE WHATARE THEBIGGEST CHALLENGES FACINGTHE PHARMACEU TICAL OUTSOURCING INDUSTRYTODAY? Oneof the biggest challenges is the issue of supply anddemand.There are not enough investigators with experience, and finding the right ones to conduct a trial is a huge problem. Also, there are not enough patients enrolling in clinical trials. By some estimates, there is a gap of 300,000 patients between the number of people who are actively par ticipating in trials and those who are needed. HOW CAN THE INDUSTRY BEST HANDLETHE GROWING ISSUE OF PATIENT PRIVACY? Privacy is ahugely complicated area,but in my view the tenets are real ly simple.The individual who entrusts Acurian with his or her informa tion for the purpose of learning about clinicaltrial opportunities is always in charge. Information should never be used for a purpose other than for what it is intended, and those involved in gathering the information must never disclose data to parties other than those directly involved in the clinicaltrial process. If the industry adheres to the highest possible standard of privacy, a lot of those other concerns disappear. It’s when companies or indi viduals try to deviate from one of those core tenets that there is trou ble. Privacy laws are attempting to ensure those tenets work in all cir cumstances. Faster,better, more … IN ANEXCLUSIVE INTERVIEWWITH PHARMAVOICE,MARK EISENACH,CEO OFACURIAN INC., SHARESHISVIEWS ON IMPROVINGTHECLINICALTRIAL PROCESS. HOW DOES ACURIAN DIFFER FROM OTHER COMPANIES IN ITS APPROACHTO FINDING PARTICIPANTS FOR CLINICALTRIALS? We have come up with a creative set of solutions for finding individuals who are interested in participating in clinical research. Our ability to get a clinical trial started quickly is vastly enhanced because we don’t have to start from scratch to find those patients. In essence it is like trying to assemble a team.On the onehand,there is the Acurianstyle modelwith a roster of people who have interest and experience,on the other hand there is, essentially, a whitepages phone directory offering no clues as to where to find those people. Acurian can fill that team much more quickly because through our databases we can target directly the peo ple who might be interested in participating. WHATAREYOURGROWTHTARGETS FOR ACURIANTHISYEAR? We’ve made a number of management changes since I’ve joined, and wenowhave in place a team that workswell together.We expect to start growing pretty rapidly before too long. Currently we have about 50 employees and by the end of 2002, we expect to have about 70 to 80. We also are in the process of transitioning our technology team from St. Louis to Horsham, Pa., so our whole team is in one place. HOWHAVEYOU SHAPEDTHE COMPANY SINCEYOURARRIVAL? When I arrived at Acurian, I took a look at our offerings and reclarified Communications technology is changing the way to connect all the participants to make a clinical trial happen. E I S E NACH MARK Eisenach approaches to patient/physician recruitment, he says. “Furthermore, the financial backers of this company are unbelievable. I have never seen a venturebacked company with as strong an investment group as the one that Acurian has.” Founded in 1998, Acurian secured the backing of bluechip investors including Euclid SR Partners, ProQuest Investments, JP Morgan Partners, Flatiron Partners, Merck Capital Ventures, and Sofinov. “The fact that two pharmaceutical concerns also have invested in Acurian is a huge valida tion of our approach, and an indication of the standard that we present to our customers,” he says, referring to CDP Sofinov and Merck Capital Ventures. Being part of a young company, also appealed to Mr. Eisenach. Acurian was found ed in 1998. “Setting up a subsidiary like Nex igent, or joining a young company like Acuri an is exciting as it offers an opportunity to start with a fairly clean sheet of paper and build a business for the future without being overly constrained by the past,” he says. “We can adapt to the marketplace without having to undo a lot of the infrastructure that has out lived its usefulness.” For Acurian, the attraction of bringing Mr. Eisenach on board in October 2001 was his proven track record in the business of find ing innovative solu tions for the healthcare industry. “I have been work ing in this area for a long time and so I know it very, very well,” he says. “I creat ed the new business within Covance, Nexigent, which was of a similar scale to Acurian, so I had a demonstrated record of building a new enter prise. Additionally, I knew the industry well and had been focused on it for some time, solv ing the same types of problems. Also, I had the demonstrated general management back ground that was required to lead this company.” Keeping It SIMPLE Since its inception, Acurian has been build ing Webenabled databases to support the clin ical recruitment of physicians and patients. Additionally, the company has formed partner ships with several organizations to enrich its database resources (see box on page 66). With the necessary resources and partner ships in place, Mr. Eisenach’s goals for the company are, he says, straightforward. “We’re trying to keep it reasonably simple, focusing on our three major offerings. We can’t do everything for everybody.” Firstly, Acurian offers investigator profil ing — the service offering that the company was founded on more than three years ago — which has at its core the investigator database, offering information about physicians and 69 PharmaVOICE M a r c h 2 0 02 them, laid out exactly what they are, making it easier for the salesoper ation team to go out and talk to customers about what we do and how we do it. Now that the company has the resource and asset base that we want, we can move forward. We are trying to keep everything reason ably simple at the company by offering three straightforward services to our clients. We’ve got three variants that weworkwithhere andwe’veorganized our operations around those three variants — investigator profiling, patientidentification service, and directtopatient, where we identify patients whomay be interested in the clinical trial. MARK EISENACH FACT: More than 75% of trials fail to meet patient enrollment deadlines FACT: More clinical trials are taking place per newdrug FACT: Acurian is MatchingQualified Investigators withTargeted Patients Source: CenterWatch Inc.,1999 Ahead On