What’s New

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Carolyn Gretton

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New healthcare-related products, services, and companies

By Carolyn Gretton

Parexel Adds Commercialization to Repertoire Trend: A growing number of clinical development service providers are using their rich store of data and experience gleaned from clinical trial management to expand into commercialization. Parexel International has expanded and fully integrated its commercialization services to help biopharmaceutical clients maximize regional and global market access opportunities. These solutions align reimbursement strategies with clinical development to gather the precise data required to demonstrate product value. “Biopharmaceutical companies need to address commercialization goals as early as possible to develop products and acquire the right data to receive reimbursement approval in the most efficient way,” says Gadi Saarony, corporate VP and worldwide head for Parexel Consulting and Medical Communications Services. “We help clients prepare the product for the market and the market for the product through the alignment and integration of regulatory, clinical, and commercialization strategies.” Parexel’s commercialization services support the evolving needs of health economics and outcomes research, medical affairs, marketing, reimbursement, and managed markets functions at biopharma company organizations. Clients also benefit from Parexel’s access to a global network of key opinion leaders. Mr. Saarony observes that as a CRO, Parexel can draw on its experience developing products across all phases and a broad range of therapeutic areas to inform clients’ commercialization strategies with meaningful scientific and clinical considerations. “Through the expansion of our services, we are well-positioned to help our clients optimize their products for efficient development and regulatory approval, as well as to achieve commercial success,” he adds. { For more information, visit parexel.com. Pearl Pathways Extends ­Business to Compliance, ­Consulting Services Pearl Pathways is a newly created parent company comprised of Pearl IRB, a privately owned commercial institutional review board, and two new business units: Pearl ReGXP and Pearl Ideas. Pearl IRB offers several wraparound services, including medical writing, on-demand clinical research staffing, and research process and regulatory training, in addition to its core IRB board review services. Pearl ReGXP accelerates global product registrations and approvals and supports clients’ quality compliance initiatives with a team of regulatory compliance experts. “We listened to the needs of existing and potential clients and developed a family of businesses to support the regulatory and product development challenges facing biopharma and device companies of all sizes,” explains Diana Caldwell, president and CEO of Pearl Pathways. In other news… Triangle Research Labs (TRL) is a contract research services joint venture created by The Hamner Institutes for Health Sciences, a nonprofit leader in toxicology and human health, and PBM Capital, an investment firm. TRL focuses on predictive toxicity testing, which involves screening drug compounds before clinical studies to identify compounds that are harmful to humans. Leading the venture are Chief Operations Officer Ivin Silver, Ph.D., formerly director of drug metabolism and pharmacokinetics at GlaxoSmithKline; and Shiloh Barfield, TRL’s executive VP and general manager. As part of the Triangle partnership, PBM has shifted the contract research service resources of its GigaCyte subsidiary to The Hamner’s facilities. “It is our belief that this research collaboration will lead to innovative science and advances in developing and gaining adoption of the next generation of predictive tools to aid in chemical toxicology and drug discovery and development,” says Paul Manning, CEO of PBM Capital. “We are pleased that the science being developed at our GigaCyte subsidiary can contribute to these advances. ” { For more information, visit triangleresearchlabs.com. Abbott has unveiled plans to separate into two publicly traded companies: one focused on diversified medical products, and the other focused on research-based pharmaceuticals. The diversified medical products company retains the Abbott name and consists of Abbott’s existing diversified medical products portfolio, including its branded generic pharmaceutical, devices, diagnostic, and nutritional businesses. The research-based pharmaceutical company, which has yet to be named, includes Abbott’s current portfolio of proprietary pharmaceuticals and biologics. Miles White remains chairman and CEO of Abbott, the diversified medical products company. Richard Gonzalez, currently Abbott’s executive VP, global pharmaceuticals, has been named chairman and CEO of the research company. { For more information, visit abbott.com. Chiltern International has opened a new office in Bannockburn, Ill., as part of the global CRO’s effort to increase its strategic footprint. Barry Simms, Chiltern’s country manager, North America, says the new office is well-situated to support efforts to recruit top-notch staff and be strategically near its North American clients. “Our new office supports Chiltern’s mission to deliver high-quality services around the world, while demonstrating our commitment to clients’ needs,” says Jim Esinhart, Ph.D., senior executive VP, global scientific services, Chiltern. { For more information, visit chiltern.com. Pharmacy benefits management organization ­OptumRx and the American Pharmacists ­Association (APhA) have launched Pharmacy is Right for Me, an educational initiative aimed at propelling students in grades 8 through 12 toward careers in pharmacy. The program is designed to provide students, their families, and educators with information and resources about career opportunities available in the pharmacy field. The program’s centerpiece is an interactive web site, pharmacyforme.org, with engaging, easy-to-read and use features, including a self-assessment test, fun facts, and career profiles. “We created Pharmacy is Right for Me to inspire students — particularly minorities and young people from underserved communities — to explore and learn about the diverse and innovative careers pharmacy has to offer,” explains John Jones, advisory board chair for Pharmacy is Right for Me and senior VP, professional practice and pharmacy policy, OptumRx. “The Pharmacy is Right for Me program is helping to increase young people’s understanding and appreciation of the broad career opportunities that exist within the pharmacy profession,” adds Thomas Menighan, Sc.D., executive VP and CEO of APhA. { For more information, visit pharmacyforme.org. DFH Pharma, a newly formed company focused exclusively in the HIV-1 therapeutic space, has obtained an exclusive research license with an option for worldwide commercial rights to a second-generation HIV maturation inhibitor program. The focus of a second-generation program is to identify drug candidates with potent activity against all HIV-1 strains, including those that exhibit reduced sensitivity to first-generation compounds. Second-generation maturation inhibitors that overcome the resistance-related problems of the first-generation candidates could provide the basis for the further clinical development of this novel class of HIV drugs. DFH’s founders are Carl Wild, Ph.D., who serves as president and CEO, and David Martin, Pharm.D., who has been named chief development officer. { For more information, email cwild@dfhpharma.com. ON THE SHELVES JOURNAL OF BRAND STRATEGY is a new professional journal from Henry Stewart ­Publications offering in-depth, peer- reviewed articles on all aspects of brand ­strategy and brand management written by and for brand and marketing professionals in a wide range of industries, including the life ­sciences. Each quarterly 100-page issue — ­published in print and online — provides ­articles from ­professionals on strategies, ­techniques, and trends, together with applied ­research in branding and detailed analysis of how brands are managed around the world. { For more information, visit ­henrystewart.com. Parexel International has announced the ­publication of the new edition of ­ACCELERATING GLOBAL DRUG ­DEVELOPMENT: THE SCIENCE AND ­PRACTICE OF ETHNOBRIDGING. The book, which since 2002 has served as a reference for global drug developers dealing with ethnically sensitive clinical programs, focuses on accelerating development for the Asia-Pacific market and ­saving time and cost for early-phase programs. The expanded edition also addresses the ­increasing importance of Asian countries in global development strategies and the ­registration of drugs in the Asia-Pacific region. { For more information, visit parexel.com. SOCIAL MEDIA ANALYTICS, authored by WCG Senior Manager Marshall Sponder and published by McGraw-Hill, offers tools and best practices for measuring comprehensive data from social media analytics and aligning results with overall business strategy. In the book, Mr. Sponder presents case studies from a diverse arena of online business activity to answer the questions every marketer is asking: How many customers did we get? How many products did we sell? What were our sales margins? Mr. Sponder also presents a cost/benefit analysis and detailed guidance on achieving a high social media ROI through analytics. { For more information, visit wcgworld.com. CATALENT PHARMA SOLUTIONS has opened a European development and clinical services laboratory in Swindon, U.K. This ­opening comes after Catalent’s recently ­expanded clinical supply service capabilities in Schorndorf, Germany. { For more information, visit catalent.com. COBRA BIOLOGICS is the ­relaunched version of the contract ­manufacturing organization formed by Cobra Biologics Holding AB’s ­acquisition of Recipharm AB’s biologics ­business. Cobra Biologics supports the global life-sciences industry in the development and manufacture of monoclonal antibodies, ­recombinant proteins, DNA, viruses, and ­cell-line derived products. The company has GMP-approved facilities in Södertälje, Sweden, and Keele, U.K. { For more information, visit cobrabio.com. PAREXEL ACADEMY, a Parexel International-operated provider of education and ­professional training for the biopharmaceutical industry in the field of clinical research, has ­entered into an agreement with the National University of Singapore (NUS) to offer an ­academic program in Singapore. The program is bieng offered through the National University of Singapore Academy of GxP Excellence. { For more information, visit parexel-akademie.de/english. AROUND THE GLOBE

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