What’s New

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Ann Grey

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What’s New New Healthcare-related Products, Services, and Companies Featured Briefs: New Janssen Group To Target Unmet Global Health Needs Caplan Associates Launches Grad Advantage New Agency Network Deloitte Launches ConvergeHealth PDR Launches 4th Channel FDA and European Medicines Agency Strengthen Collaboration in Pharmacovigilance BBK Worldwide Releases Bio Notifier Plus Synergistix Unveils CATS Express Mobile CRM Solution Sidebar: AROUND THE GLOBE TrendIng Now: Global public health strategy addresses portfolio of transformational medicines. Janssen, the pharmaceutical companies of Johnson & Johnson, has formed Janssen Global Public Health (Janssen GPH), a new group unifying Janssen’s commitment to research, develop, and deliver transformational medicines to address the world’s greatest unmet public health needs. Janssen GPH aligns the company’s groundbreaking science and innovative access models under a single entity to drive better health outcomes, improve quality of life for patients, and sustainably advance health for people all over the world. “To solve today’s greatest public health challenges, it’s essential that we emphasize the needs of the developing world in equal measure to those of the developed world,” says Paul Stoffels, M.D., chief scientific officer, Johnson & Johnson and worldwide chairman of Janssen. “With this new group, we’ve adopted a more focused approach to further develop and introduce our most promising medicines, and with other like-minded organizations, we look forward to advancing a sustainable platform that will make a significant impact on the lives of people around the world.” Janssen GPH is one part of Janssen and Johnson & Johnson’s shared response to the world’s global public health challenges. Other organizations and operating companies within the company have launched and continue to support comprehensive efforts toward strengthening the health of communities, improving maternal and child health, and preventing the spread of infectious and preventable diseases worldwide through vaccination. Janssen GPH will partner with other organizations within the company as appropriate to advance global public health goals. Adrian Thomas, M.D., VP of global market access, global commercial strategy operations, and global public health, and Wim Parys, M.D., VP, R&D global public health, jointly lead Janssen GPH. Janssen GPH is responsible for clinical and product development and creating and implementing innovative new access strategies for a growing portfolio of pharmaceuticals, diagnostics, and services for diseases significantly impacting resource-limited countries and emerging markets, and includes: Sirturo, approved by the FDA as part of combination therapy in adults with pulmonary multi-drug resistant tuberculosis (MDR-TB); long-acting rilpivirine (TMC278-LA, RPV-LA), an injectable version of the HIV medicine; dapivirine microbicidal ring, an investigational HIV medicine for use as a monthly vaginal microbicidal ring designed to prevent sexual transmission of HIV — the first product of its kind; reformulated flubendazole, a potential new treatment against parasites that cause lymphatic filariasis (elephantiasis) and onchocerciasis (river blindness); reformulated mebendazole, a new, chewable formulation of Vermox (mebendazole) that will facilitate treatment of intestinal worms in younger children. Beyond research and development, Janssen GPH will cultivate and help implement innovative pricing and results-based financing models that improve access to these medicines for patients in resource-limited and emerging markets, while also creating sustainable, long-term solutions based on country ownership and accountability for health services and outcomes. These new strategies will be integrated with those developed by Janssen’s Global Access and Partnerships Program (GAPP), which currently ensures affordable and sustainable access to the company’s portfolio of HIV medicines in resource-limited countries. Caplan Associates Launches Grad Advantage With hundreds of thousands of students graduating every year, it is imperative that they know all the dynamics of searching for a job. Caplan & Associates has launched Grad Advantage, which takes the time to teach recent college graduates the skills they need to gain a competitive edge. Grad Advantage is available in a one-on-one coaching program or in a small seminar session. Caplan Associates can assist graduates in: creating a winning resume to present undergrad experiences to stand out from all the rest; the art of networking to make the most of the one’s contacts and turn them into job referrals; creating a skills assessment to learn how to list strengths and understand why they are an asset; developing an introductory one-minute speech to impress people with a one-minute overview, either while networking, randomly meeting someone new, or at the beginning of an interview; prepping for an interview and learning what’s really important and why; interviewing skills learn all of the psychological nuances that are taking place in an interview, and how to successfully present oneself; and following up after an interview. { For more information, visit caplanassoc.com. New Agency Network Sandbox, a new marketing and advertising agency startup network based in Chicago, has entered into a partnership with its founding member, Chicago-based GA Communication Group. Sandbox CEO John Hilbrich and President Mark Anthony, long-time agency veterans who have spent the entirety of their careers in the advertising and marketing profession, established the network to fill a void in an advertising industry dominated by large holding companies, and will continue to build its network with mid-size marketing and advertising agencies worldwide. GA Co-owners Joe Kuchta and Mark Goble will continue to manage the day-to-day operations of GA while assuming a leadership role in the strategy and development of Sandbox. { For more information, visit sandboxww.com. Deloitte Launches ConvergeHealth ConvergeHealth is part of a $150 million to $200 million investment Deloitte is making in life-sciences and healthcare analytics, including new analytics platforms, informatics services, and talent to help healthcare and life-sciences clients apply data-driven insights to support transformation to value based, personalized healthcare. This investment comes at a critical time as healthcare and life-sciences organizations are facing new challenges driven by changing reimbursement models, technological, and scientific innovation and increased regulatory and safety pressures. “As a result of the shift toward value-based reimbursement and personalized health care, our clients are facing new challenges that fundamentally change the way they will operate,” says Brett Davis, principal, Deloitte Consulting and general manager of ConvergeHealth. “To survive and thrive in this new paradigm, new solutions are required that combine strategy and transformational services with data, content, analytics, and insights along with new business and operating models. ConvergeHealth is committed to bringing these innovative, integrated solutions to our clients.” { For more information, visit deloitte.com. PDR Launches 4th Channel PDR Network has launched a new division — 4th Channel — that offers communications strategies, deployed within PDR’s expansive provider network, to deliver industry-leading communication solutions for bio/pharmaceutical clients. By providing a full breadth of multi-channel communication tactics — leveraging print, online, mobile, email/electronic, and electronic health record (EHR) systems — 4th Channel delivers comprehensive, proactive marketing communication solutions that reach providers inside and outside of workflow throughout their day, including clinically relevant information through EHR at the point of prescribing when with patients, as well as online via their tablet in the morning, on their mobile device in the afternoon, and through their email in the evening. “What it means to effectively communicate with today’s healthcare providers is rapidly evolving and our response to meet these changing needs is led by 4th Channel,” says Jeffrey Davis, senior VP of sales at 4th Channel. “We recognize that bio/pharmaceutical clients want to inform providers about the benefits of their products and, through this new division, we are able to deliver the marketing and promotional support that reaches those providers at the right time and through the right channel.” Named for the four primary provider communication channels — print, online, mobile, email/electronic — 4th Channel provides scalable, targeted communication programs tailored to each client’s needs with measurable results; multi-channel communication programming, including print, online, mobile, email/electronic, and EHR-based tactics reaching more than 700,000 physicians and more than 1.3 million healthcare providers; communication through a growing network of EHR/ePrescribing partners, delivering content via more than 225 EHR platforms that reach more than 160,000 EHR-based prescribers; and program support from strategic development to implementation/management and results measurement/analysis. { For more information, visit pdr.com. FDA and European Medicines Agency Strengthen Collaboration in Pharmacovigilance The FDA and the European Medicines Agency (EMA) have set-up a new cluster on pharmacovigilance (medicine safety) topics. Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration. Building on the experience of previous regular videoconferences between the FDA and the EMA in this area and on the recent creation of the EMA’s Pharmacovigilance Risk Assessment Committee, this cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines. The FDA and the EMA have already set-up such clusters to discuss issues related to biosimilars, medicines to treat cancer, orphan medicines, medicines for children, blood-based products, among other topics. Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency are also involved in some of these clusters. “The work of protecting the health and safety of the American people cannot be done in isolation,” says Janet Woodcock, M.D., director, of the FDA’s Center for Drug Evaluation and Research. “It is part of a larger collaborative global effort between the FDA and its international regulatory partners to ensure the health and safety of all our citizens.” As part of the new cluster, discussions on shared pharmacovigilance issues will now take place between the agencies on a monthly basis by teleconference. This increased degree of interaction will allow the agencies to work swiftly in the area of the safety of medicines and to coordinate communication activities. The creation of this cluster is the latest step in the FDA’s and the EMA’s broader approach to expand and reinforce international collaboration. { For more information, visit fda.gov. BBK Worldwide Releases Bio Notifier Plus A three-pronged effort, BBK’s BIO Notifier Plus uses a global opt-in physician database, a proprietary rating and ranking system, and in-country direct physician contact to bring best-in-class specialists to the clinical trial arena. BBK’s patented patient recruitment portal, TrialCentralNet, stores detailed recruitment data for hundreds of trials. “It is clear that the art and science of matchmaking physicians to trials requires a combination of technology and service to maximize efforts,” says Matt Kibby, principal, technology and innovation, BBK Worldwide. The new service addresses in-site selection, physician referral networks, and patient panels, which are particularly critical when the doctor is less inclined to accept advertising-referred patients; patient flow at the site level, in and of itself, is not a correct indicator of potential enrollment success; the greater the attention that sites pay to recruitment data-sensitivity, the greater the likelihood of enrollment success; performance during the first third of the enrollment period is a strong indicator of site ability to attain recruitment goals; and activity at the site level increases study awareness and leads to higher enrollment. { For more information, visit bbkworldwide.com/products/bio-notifier-plus. Synergistix Unveils CATS Express Mobile CRM Solution Synergistix has launched the newest member of its customer analysis and targeting system (CATS) software suite: CATS Express, a smartphone version of its CRM solution. With an easy-to-use interface, CATS Express allows field-based users to capture and record interactions with healthcare professionals and institutions quickly and accurately when laptops or tablets are unavailable. CATS Express enables sales, clinical, and other life- science teams to use any smartphone, including Apple and Android phones, to view practitioner profiles, quickly record calls or visits, and capture PDMA/Part 11-compliant electronic signatures for sample transactions. It offers rapid, convenient, and secure access to data and can eliminate the need for paper forms. CATS Express is fully compatible with the architecture of all CATS products, including CATS Mobile (the iPad/Windows 8 tablet version of the software) and CATS 3 (the PC-based version). “Our clients’ workforces are becoming increasingly mobile,” says Don Schenker, president and CEO of Synergistix. “Life-sciences professionals often work offsite and in the field, so it’s important that their CRM keeps up with their needs. The CATS Express solution puts customer relationships in the palm of the rep’s hand.” Around the Globe Global AbbVie has made a $320 million investment to establish operations in Singapore for small ­molecule and biologics active drug substance manufacturing. The completed facility provides manufacturing capacity for emerging ­compounds within AbbVie’s oncology and ­immunology pipeline to serve markets globally. The investment establishes the first ­manufacturing presence in Asia by AbbVie. Other AbbVie operations in Asia include research and development (R&D) functions in Tokyo, Japan, and Shanghai, China, as well as commercial ­operations throughout the region. AbbVie’s ­existing presence in Singapore includes 120 ­personnel, supporting commercial operations, global R&D, and general operations. “As Asia’s fastest-growing bio-cluster, ­Singapore is an ideal location to expand our manufacturing network while maintaining ­rigorous standards of quality and delivery for the patients we serve around the world,” says Azita Saleki-Gerhardt, Ph.D., senior VP, operations, ­AbbVie. “Our presence in Singapore will help ­assure geographic balance and continuity of product supply as well as increased capacity to deliver on our growing biologics and small ­molecule product pipeline.” { For more information, visit abbvie.com. Clinipace Worldwide, a global digital contract ­research organization (dCRO), has merged with Choice Pharma, a Pan-Asian contract research ­organization. Bringing these organizations ­together strengthens Clinipace Worldwide’s ­operational and therapeutic expertise in Asia. With the merger, Clinipace extends its global footprint to include 20 operational offices in 15 countries, including new offices in Taiwan, China, Hong Kong, South Korea, Vietnam, Singapore, and Malaysia. { For more information, visit clinipace.com. ZS Associates, a global sales and marketing ­company, has opened n aoffice in São Paulo. With a physical base in the sixth largest economy and pharmaceutical market in the world, this a natural progression of its global growth plans. { For more information, visit zsassociates.com.

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