aaiPharma Inc. has launched a new identity for its pharmaceutical development services division.The former AAI International has been rebranded as AAI Development Services. As part of the new identity, AAI Development Services has realigned its entire customer interface to enhance and focus the salesforce, project management, customer service, and related functions to best meet the needs of its clients. In addition, aaiPharma has reinvested in several key aspects of the AAI Development Services business to increase the speed,efficiency, and capaci ty of AAI Development Services. These investments include a larger stability operation in Wilmington,N.C.,which increased its stability capacity by 50%;sig nificant software upgrades with Oracle Clinical for its Clinical Trials Division in Natick, Mass., which will increase the productivity and efficiency of its clinical trials datamanagement activities; the addition of an overencapsulation machine for use in placebocontrolled clinical trials in Germany; and the upgrading of its manufacturing facility in Charleston,S.C.,and expansion of its manufacturing facility in Wilmington,N.C.,including the recent addition of a second shift. “Our renewed commitment to exceeding customers’ expectations is sup ported by targeted internal initiatives and incentives and a bold,new identity and marketing campaign to reinforce with our customers that AAI Development Services is the provider capable of meeting their service needs along nearly the entire pharmaceutical product development continuum,” says Vijay Aggarwal, Ph.D., president of AAI Development Services. NEW IDENTITY ANDBUSINESS INITIATIVE for aaiPharma Development Division Realignmentof customer interface enhances focus of salesforce,project management,customer service,and related functions Dr. Vijay Aggarwal: “Our renewed commitment to exceeding customers’ expectations is supported by targeted internal initiatives and incentives and a bold, new identity and marketing campaign.” A team of nationally recognized physicians and researchers has joined with awardwinning market ing experts and writers to launch MedPharm Communications, a healthcare communications compa ny with amission of guiding pharma ceutical clients through all phases of product development from pretrial through product launch. The company was founded by NormaJeanne Hennis, MS, formerly editorial leader at Parexel, senior medical writer at Integrated Commu nications, and editor of The Journal of Spinal Cord Medicine; and Marc Henis, M.D., a boardcertified cardiologist and a fellow of the American College of Cardiology (ACC), with more than 20 years of experience in drug devel opment. Their mission is to unite marketing and science in a new way that strengthens both scientific accu racy and the delivery of key ideas. “Our clients don’t deal with middlemen; they deal with upper management, people who can make decisions on the spot, and who can live by them,” Ms. Hennis says. “In addition to partnering with upper management, clients get to work directly with writers. Writers are at the initial intake meetings and are avail able throughout a project, at any time. Also, our marketsavvy M.D. and Ph.D. writers are dedicated to specific thera peutic areas. Clients do not pay for a learning curve; writers jump right in and produce. Since our editors are published authors in their own right, the final versions of all our communi cations are easily and eloquently stat ed to get your word out.” MedPharm also offers its own,inter nal key opinion leader advisory board of more than 40 academic and com munitybased physicians in every ther apeutic area. In addition, MedPharm boasts a staff who has presented to the Food and Drug Administration, know what the decisionmakers at the regulatory agency want, and how to produce materials for them. MedPharm Communications Offers NEWBUSINESSMODEL for Healthcare Communications PPD CONSOLIDATES Informatics Groups PPD Inc. has consolidated its informatics services under the new name of CSS Informatics Inc., repre senting the integration of PPD Informatics andCom plete Software Solutions Inc. (CSS). CSS was a pri vately held technical consulting firm acquired by PPD in 2002. CSS Informatics provides pharmaceutical and biotechnology companies with consulting services and etechnologies for clinical and safetydata man agement, including implementation,development, training, validation, and regulatory consulting ser vices.The division has more than a decade of experi ence with various pharmaceutical product suites for Oracle and Phase Forward.The company was select ed by Oracle as its first authorized application service provider (ASP) in 2001. “Integration of our informatics groups enhances our ability to serve our clients across key markets,” says Larry Kaufman, VP of CSS Informatics.“We look forward to continuing our success by providing clients with the highquality tools and services they have learned to expect, while helping them reduce costs and improve their clinical and safety data han dling and validation.” Specialized software products offered by CSS Informatics include eLoader, a tool that automates the loading of external data into Oracle Clinical used by leading pharmaceutical companies, and PPD Patient Profiles, a graphic display technology devel oped in collaboration with the Food and Drug Administration and the pharmaceutical industry for drugsafety evaluation. NormaJeanne Hennis: “Since we were out to change the way the busi ness was done, we changed the way we do business. We eliminated whole layers of personnel to make ourselves lean and responsive.” 55 PharmaVOICE A ug u s t 20 03 WHAT’S NEW NEW HEALTHCARERELATED PRODUCTS, SERVICES, AND COMPANIES 56 A u gu s t 2 00 3 PharmaVOICE AMP to Measure PHYSICIANS’OPINIONS ONMEDICALADS In an effort to underscore the importance of professional advertising, The Association of Medical Publications (AMP) has launchedThe Doctor’s Choice Awards.The program, which is based on a groundbreaking sur vey of medical advertising, will recognize excellence in medical journal advertising. The study,the first of its kind, will use email to survey practicing physi cians, asking them to rate about 150 representative ads that appeared during 2002.Each physician will be asked to evaluate 10 of the ads, based on each ad’s ability to communicate, provide information, generate excitement, and prompt action. “Most award programs ask the creators of the ads — not recipients — about their effectiveness,” says Alan J. Imhoff, general manager of the International Medical News Group,and president of AMP.“We wanted the doctors themselves to judge the effectiveness of the ads.The awards will be based on reactions from the tar get audience — prescribing physicians — and not a group of advertising professionals.” Plans for the awards began last fall, when AMP began using email to conduct a survey of attributes physi cians value in journal advertising.The attributes were used in a successful pilot test, which confirmed the prac ticality of email as a research technique. The Doctor’s Choice Awards will be presented on October 22 at a dinner in New York honoring the win ning pharmaceutical manufacturers and their advertising agencies. Wolters Kluwer Health has com pleted the realignment of its business into four customeroriented divisions as part of its strategy to become a leading global provider of information for medical and health professionals and the industries serving them. Wolters Kluwer Health began this transition ayear ago,with the decision to divest its science holdings to focus purely on the health and medical information market and the individual customer groups within this sector. “The health and medical informa tion market is on the vergeof significant change, with a growing demand for contentrich workflow tools and indus tryfocused information solutions that help healthcare professionals do their jobs more effectively and efficiently,” says Christopher Ainsley, president and CEO of Wolters Kluwer Health. Wolters Kluwer Health now includes four cus tomerfocused divisions that incorporate its leading brands.The Clinical Tools Division develops and sells drug and medical information tools that are inte grated into hospital, pharmacy, and insurer informa tion systems to deliver clinically relevant information at the point of practice or point of care. Clinical Tools includes two of the bestknown brands for drug information,MediSpan and Facts & Comparisons, as well as the electronic decisionsupport, pointofref This campaign is being used to invite doctors to survey the ads in The Doctor’s Choice Award Program. Prescription Solutions ADDS PHASE IV RESEARCH Capabilities Prescription Solutions, a national pharmacy and medi cal management company, has added Phase IV research to its RealWorld Outcomes Research capabilities. “Over the past decade, we have built extensive expertise in outcomes research as a service designed to help our PBM clients make important decisions about their pharmacy benefit pro grams,” says Ed Feaver, Pharm.D.,president of Pre scription Solutions. “ We believe this expertise can provide useful information to a broad range of companies involved in clinical research. The data and analysis provided through our approach to Phase IV will help our research clients better understand how their products work in the real world and better communicate the value their products deliver.” Prescription Solutions’Phase IV research consid ers the full range of outcomes — clinical,humanis tic, and economic — and is designed and conduct ed to reflect provider and payer perspectives. Prescription Solutions’ Phase IV studies focus on marketed products within their labeled indications. These studies may address questions not answered or adequately addressed during Phase I to Phase III studies, including comparisons with other drugs, costeffectiveness, quality of life, and studies that explore outcomes by patient groups. Prescription Solutions Phase IV research access es the company’s proprietary Physician Research Network (PRN), which consists of practicing physi cians, many of whom are in a managedcare set ting. A managedcare environment is important in assessing how the product will be used in the real world and provides more accurate and relevant information to study sponsors than traditional research that collects and analyzes data in a con trolled clinical setting. “We work with our research clients to develop and design all elements of a study, including research protocols,” says Jeff White, Pharm.D., M.S., director of clinical research for Prescription Solu tions. “Prescription Solutions’ approach to Phase IV research provides value to our research clients in a number of ways traditional research has not. Most importantly, our studies can help our research clients ensure that plan members and payers get the best outcomes at the best price.” Wolters Kluwer Health REALIGNS INTO FOURDIVISIONS erence products Clineguide and Sko lar MD. The Medical Research Division focuses on institutional customers, such as medical schools,hospitals,and medical and academic libraries. The division includes Ovid Technologies, an online information provider for hospitals and medical schools world wide, and the primary online source for all Wolters Kluwer Health content. Medical Research also includes the clinical journals published under the Lippincott Williams & Wilkins brand and sold primarily to institutional cus tomers. The Pharma Solutions Division provides business and clinical intelli gence, communications support and peerreviewed literature, and database tools to the pharmaceutical industry. The division includes the combined resources of Adis International and Lip pincott Williams &Wilkins Healthcare. The Professional & Education Division produces critical information for medical and health profes sionals and students, including many leading text books, electronic reference tools, and related prod ucts. This division includes all text and reference products produced under the Lippincott Williams & Wilkins brand for doctors, nurses, allied health pro fessionals, and students in these fields. Christopher Ainsley: “Our new strategy and new structure allows us to more quickly understand and respond to the information needs of each of the professional markets that rely on us.” “Prescription Solutions’ approach to Phase IV research provides value to our research clients in a number of ways traditional research has not,” Dr. Jeff White says. WHAT’S new 57 PharmaVOICE Au gu s t 2 00 3 WHAT’S new PharmaNet, an international drug development company, has consolidated its technology products and services under a new division named Pharma Soft.PharmaSoft offers a suite ofWebbasedandWeb accessible products that facilitate the collection,man agement,and reporting of clinicaltrial information. The PharmaSoft division of PharmaNet compris es professionals with expertise in clinical research, data management,regulatory,project management, information technology support, and software development. PharmaSoft technologies are devel oped and supported by these professionals who have access to the global resources of the Phar maNet organization. Products currently available from PharmaSoft includeWebSys,an electronic data capture and adata management system;FaxSys, a facsimile data capture system; TeleSys, an interactive voice response system;SafetySys, a serious adverse event system; and PROMIS, a project manage ment information system. “Combining the best tech nology with practical clinical management expertise is what differentiates PharmaSoft,” says Steve George, VP of information technology for PharmaNet. “PharmaSoft offers clients a vari ety of flexible solutions to fit their specific clinicaldevelopment needs. Solutions include EDC and inhouse entry, in addition to many peripheral tools that aid in every thing from project management to SAE reporting.” NEWCRO Prometrika Understands Keys to Successful Collaborations Prometrika LLC is a newly formed contract research organization that specializes in biostatistics,data manage ment,medical writing,and regulatory submissions for pharma and biotech industries. The company com prises former members of the drugdevelopment division at a midsize international pharmaceutical company.The group has a10year history of success ful collaboration in the drugdevelopment arena, including new drug application approvals by the FDA and European regulatory authorities. “Our size and low overhead allow us to be cost competitive and efficient,” says Miganush Stepani ans, Ph.D., president and CEO of Prometrika. “We take pride in our proven track record of meeting timelines and delivering study reports within bud getary constraints. Furthermore, as former pharma ceutical company staff members, we understand the keys to successful sponsorCRO collaborations.” The new company’s mission is to help its clients achieve their goals of efficient and successful drug development by providing innovative perspectives on the design of their clinical trials and by deliver ing highquality databases, study reports, and final dossiers for regulatory submission. ASAP Productions Provides MEDIA SERVICES ASAP Productions,a mediaservices com pany that assists pharmaceutical and medical businesses in meeting their film and video needs,has been launched.The company pro vides production services across a broad range of technologies, including everything from Internet video to high definition. In addition to providing custom pro ductions, the company also offers two spe cialized services: a rapid response package, for those times when a video is needed as soon as possible, and a public service announcement package. ASAP senior staffers have 30 years of experience in pharmaceutical sales and mar keting, as well as nearly a decade in media production services. The company pri es itself on taking a customer orientation. PHARMANET CONSOLIDATES Information Technology Divisions PharmaNet, which has been developing clinical software solutions for more than six years, is now offering its products through its PharmaSoft division, headed by Steve George. Justin Tormey, president of ASAP Productions says, “We help clients crystallize their goals and together develop a plan to achieve those goals as quickly as possible. We then provide them with the highest quality product available.” “Our size and low over head allow us to be cost competitive and effi cient,” says Dr. Miganush Stepanians. AAI DEVELOPMENT SERVICES, Wilmington,N.C., a division of aaiPharma Inc.,offers a full range of preclinical and clinical development service solutions to pharmaceutical,biotechnology, and medicaldevice companies.For more information, visit aaidevelopment.com. ASAPPRODUCTIONS,New Hope, Pa., is a mediaservices company that assists pharmaceutical and medical businesses in meeting their film and video needs.For more information, visit asapnow.com. THEASSOCIATION OFMEDICAL PUBLICATIONS (AMP),Westfield, N.J., is a nonprofit organization with 23 member publishing organizations, representing more than 230 publications.For more information, visit amponline.org. CSS INFORMATICS,Wilmington,N.C., a division of PPD Inc.,provides expert consulting services and leadingedge software to pharmaceutical, biotechnology, medicaldevice, and CRO companies to speed and improve clinical and safetydata handling,and validation.For more information, visit csscomp.com. MEDPHARMCOMMUNICATIONS, Randolph,N.J., is a comprehensive medical education and communications agency. Follow up For more information,visit medpharmcom.com. PHARMANET,Princeton,N.J.,provides a complete range of clinical development and consulting services to the pharmaceutical,biotechnology, and medicaldevice industries. For more information,visit pharmanet.com. PRESCRIPTION SOLUTIONS,San Diego,a wholly owned subsidiary of PacifiCare Health Systems Inc., is a pharmacy and medical management companymanaging the prescription drug benefit of commercial,Medicare, and governmental health plans,as well as those of employers and unions.For more information,visit rxsolutions.com. PROMETRIKALLC,Cambridge,Mass., is a CRO serving the pharmaceutical and biotechnology industries in the areas of biostatistics, data management,medical writing,and regulatory submissions.For more information, visit prometrika.com. WOLTERS KLUWER HEALTH,Chicago, is a part of Amsterdambased Wolters Kluwer NV and is a leading provider of information for professionals and students in medicine, nursing, allied health,pharmacy,and the pharmaceutical industry.For more information, visit wolterskluwer.com.
An article from
