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< PreviousPAGE NODec 2020 10 growth across a wide range of customers, delivering deeper strategic insights and integrated expertise,” says Macdonald. The Redefined Business Model At Syneos Health, commercial and clinical solutions live under a single roof and constantly share real world insights and knowledge that leads to getting the job done better, faster and smarter to create greater success for the customers. “We call this new way of collaborative working the Biopharmaceutical Acceleration Model or BAM.” It is an end-to-end game changer solution— a CRO plus CCO solution that’s designed to deliver a better way to bring therapies to life. BAM is an end-to-end concept, working across the clinical and commercial capabilities and driven by each and every one of the company’s 24,000 employees. In addition, the solution incorporates a variety of unique Syneos Health disciplines including the Trusted Process, the Syneos Health Data Lake Ecosystem, , Syneos One, Real World Evidence and the team’s deep therapeutic expertise— providing a constant stream of insights focused on two critical areas including the process acceleration and patient behavior. The company’s Global reach, Therapeutic expertise in major categories, Adaptability and scalability based on unique customer needs, Ability to advance an asset without dilution or reduced ownership, collaborative approach to development, and Demonstrated results capability makes them stand out in the crowd. Meanwhile Dynamic Assembly— an innovative product suite— allows the team not only to solve problems, but also solve them more quickly, increasing the likelihood of regulatory approval and maximizing commercial success. At Syneos Health, the team believes that BAM is the future of biopharmaceutical development. With the drug industry evolving faster than ever before, and so is technology. For that reason, at Syneos Health the team believe the right strategy to leverage data and technology for success is via an open, source-agnostic and highly flexible architecture. That’s what they call as Dynamic Assembly. This enables Syneos’ teams to address the nuances of each customer, trial protocols as well as product launch quickly rather than being forced to bend legacy in- house assets to a task they were not originally designed to deliver. “Accelerating therapies to market requires breaking down traditional silos and creating precise, customized and connected approaches across the product development lifecycle from clinical development through commercialization,” adds Macdonald. The Data Lake Ecosystem Every drug discovery, research, and development need a huge data repository. The foundation of Syneos Health’s Dynamic Assembly Strategy is the Syneos Health Data Lake Ecosystem. Designed and Developed without the constraints of legacy architecture or technology, the solution features the company’s proven Syneos Health-designed data ingestion process that clearly focuses on the quality and incorporates decades of Syneos Health learnings, in addition to their best practices. The Syneos Health Data Lake links vast amounts of data from diverse sources that include clinical and commercial, internal and external, structured and unstructured, with the ability to harmonize data and concepts working through the Hortonworks Data Platform 11 PAGE NO Dec 2020 where Hadoop software is also a part of. This ability to synthesize multiple data types and sources, creating new “asset-customized” data propel the company’s BAM model, enabling the team to achieve deeper patient behavioral insights as well as learnings. The company’s unique, sophisticated, and highly nimble model delivers most precisely to the client requirements, where and when they expect it and in ways they can easily understand and act upon. Dynamic Assembly affects all phases of drug development, thus smoothing the process while reducing time to market and helping to improve ROI for our customers. Integrated Solutions for Easy Access To address business-critical challenges with greater precision, efficiency and effectiveness, Syneos Healths’ modern customer engagement capability—Kinetic—was built. Powered by a team of data scientists, behavioral experts and channel strategists, Kinetic deploys advanced targeting, analytics and the latest technologies to make fully integrated omnichannel solutions accessible to healthcare organizations. The team’s core focus with this is on Intelligence, experience and performance that acts as the three pillars working in unison to exceed program targets. Within these pillars, Kinetic delivers person-level relevance designed for the future of healthcare engagement via advanced targeting, a unified view of channel behavior, triggered 1:1 automation, matrixed content and performance analytics. “With Kinetic, we seek to efficiently assess the nuances of each trial protocol or product launch and respond with flexible, right-sized tech- and data-enabled solutions to improve performance,” says Mcdonald. To deepen audience intelligence, Kinetic Delivers superior and advanced targeting capabilities. The solution also comes with the ability to identify the highest value-driving stakeholders at the individual, influencer and focused cohort levels. Kinetic is designed to identify individual HCPs with the highest potential value based on more than 60 variables, including individual product adoption curves and professional influence networks. Harnessing the potential of RWD to create sophisticated models and tools, enables to truly understand which high-impact HCPs to target; what the optimal frequency of outreach is; and how to measure both, for ROI and continuous improvement. Mission, Vision and Culture With over two decades of experience in the biopharmaceutical industry, Macdonald is the man behind Syneos Health’s success. Driven by a highly skilled, experienced and dedicated senior management team with significant knowledge of the biopharmaceutical sector, the team is passionately committed to changing the drug developments industry, and, in turn, they are creating a smarter business model. An innovative model that can constantly accelerate and improve the process of bringing therapies to market and creating success for you and the patients you serve. Syneos Health strives to combine industry focus and depth of functional expertise with strong scientific and market knowledge to tackle highly complex business and market challenges and develop actionable strategies for its clients. At Syneos Health, the team is fully dedicated to elevating performance by accessing the latest in data science and technology via an open, source-agnostic and highly flexible architecture. The team efficiently assesses the nuances of a customer’s product launch or trial protocol and respond with flexible, right-sized tech- and data- enabled solutions to drastically improve the performance. “Together, we’re accelerating performance to speed therapies to patients and realize our Vision – Shortening the Distance from Lab to Life,” adds Macdonald. Each day at Syneos Health the team get to call upon some of the industry’s most dynamic, thought-provoking colleagues. Together, they share a lofty vision – to help change the way biopharma products get to market. “We continue to execute our strategy to further penetrate large pharma, enhance our small- to a mid-sized leadership position, and accelerate full-service Commercial solutions. These strategic business initiatives underpin our Value Creation plan which we believe will generate meaningful shareholder value in the years to come,” concludes Macdonald. With Kinetic, we seek to efficiently assess the nuances of each trial protocol or product launch and respond with flexible, right-sized tech- and data-enabled solutions to improve performancePAGE NODec 2020 12 RESEARCH FOR THE FASTER RELEASE KEEP DISTANCE | STAY SAFE • Wear a face cover • Wash your hands • Keep a safe distanceG iven the complexity of drug and device development and the need to bring products to market rapidly, pharmaceutical companies are increasingly outsourcing their manufacturing and research. This kind of approach across the industry has led to a recent spike in the hiring of Contract research organizations CROs. Businesses involved in CRO provide comprehensive services in drug discovery, development, and related legal issues for a wide variety of clients in the medical industry. In a nutshell, CROs specializes in specific areas of drug discovery and development for certain types of clients. According to various market reports, the global contract research organization’s market value is in constant growth and is expected to exceed $51 billion by 2024. With the rising demand, the market is becoming competitive with large CROs going for mergers and acquisitions to increase the portfolio and reach. Meanwhile, small and medium-sized CROs are becoming more prominent with their sophisticated and personalized approach, contact flexibility, and budget-friendly services. With expansions, consolidations, and innovations continuing throughout the CRO industry, the coming years are to be filled with challenges and new scopes for improvement in the pharmaceutical sectors and beyond. With this changing trend, drug developers have to look for partners who deliver reliable outcomes with comprehensive data and add support to their research. Therefore choosing the right CRO is a complex and crucial process. To bring down the complexities of choosing the right CRO, our editorial team and researchers have developed a list of ‘Top 10 CROs 2020’. The below top ten CROs to watch are listed include both industry leaders who are steadily increasing their solutions and innovations while expanding their presence through strategic partnerships and innovative service offerings. Innovators Medhealth Outlook CRO 2020 cmicgroup.com Website Japan Headquarters Jenny Lin Management COO Designation CMIC Group pioneered the CRO business in Japan over 28 years ago. Since then CMIC has continued as a leading innovator in the industry and has expanded services to encompass the entire pharmaceutical value-chain. We pride ourselves on meeting customers where they are and with exactly what they need to move their products forward. CMIC Group Description criver.com Website Wilmington, MA Headquarters James C. Foster Management CEO Designation At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guides us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. Charles River Laboratories Descriptioniconplc.com Website Ireland Headquarters Steve Cutler Management CEO Designation We are a global provider of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. I ICON plc Description medpace.com Website Cincinnati, OH Headquarters August Troendle Management President and CEO Designation Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace Description iqvia.com Website Durham, NC Headquarters Ari Bousbib Management CEO Designation IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. IQVIA Description We are a CRO providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA and 505(b)(2) submissions in global markets allowing for successful development of important therapies and products for patients. Description frontagelab.com Website Exton, PA HeadquartersManagementDesignation Song Li CEO Frontage Laboratories parexel.com Website Waltham, MA Headquarters Jamie Macdonald Management CEO Designation Parexel is focused on the development of innovative new therapies to improve the world’s health. We do this by providing a suite of groundbreaking biopharmaceutical development services that help customers across the globe transform scientific discoveries into new treatments for patients. Parexel Description namsa.com Website Northwood, OH Headquarters John Gorski Management CEO Designation Helping medical device Sponsors improve healthcare since 1967, NAMSA is the only 100% medical device-focused, full continuum Contract Research Organization (CRO). NAMSA Description syneoshealth.com Website Raleigh, NC Headquarters Alistair Macdonald Management CEO Designation Syneos Health® (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Syneos Health Description PPD.com Website Wilmington, NC Headquarters CEO Designation David Simmons Management PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations. PPD DescriptionPAGE NODec 2020 16 C MIC Inc., CMIC’s Chicago, Illinois location is a global CRO with over 30 years’ experience, the laboratory offers bioanalysis for non-clinical and clinical projects, both GLP and non-GLP within a state-of-the-art facility that has the capacity to accommodate quick turnaround for high-volume projects. CMIC’s skilled researchers provide deep expertise in small and large molecule bioanalysis, biomarker services and oligonucleotide bioanalysis expertise. Purpose built in 2010, CMIC Inc.’s contract bioanalytical and biomarker laboratory is located nearby Chicago O’Hare International Airport and is one of four global contract laboratories in the CMIC Holdings group. Current large molecule capabilities include detection of oligo, peptide, or antibody therapeutics using standard ELISA or MSD-ECL ligand-binding platforms. A variety of formats are available including but not limited to direct, indirect, sandwich, competitive, and multiplex which can be performed with off- the-shelf assays or developed in-house. For oligonucleotide detection by hybridization, CMIC Inc. brings a wealth of experience with capture and detection probe-based assays for quantitation of antisense or siRNA based therapies. CMIC Inc.’s flow cytometer has the ability to detect up to 13 colors, and is equipped with a 96-well plate loader to handle high-throughput applications. The software is 21 CFR Part 11 compliant, and displays easily viewed data. Immuno- phenotyping on whole blood, PBMC, or bone marrow can be performed with a general panel to determine the percentage of T- and B-cells, Natural Killer, and monocyte/macrophage lineage within the leukocyte population. Alternatively, specialized panels such as regulatory T-cells (Treg cells) can be characterized. Treg cells play a role in regulating or suppressing other cells in the immune system, and can be defined by the cellular markers CD25, FoxP3, and CTLA4, and the intracellular cytokines IL4 and TGFβ. Another specialized type of T-cell (one that is important for battling foreign invaders) is the CD4+ memory T-cell, which can be identified by staining CD45RA and CCR7 to determine the percentage of naïve, central memory, and effector memory T-cells within the STREAMLINING BIOANALYSIS WITH INNOVATION CMIC INC: overall T-cell population. Other flow cytometry applications include confirmation of gene expression in order to establish potency of gene therapy, or the efficacy of a treatment regimen. Real-time qPCR has emerged as a powerful tool for bioanalysis, and offers the ability to explore mRNA gene expression. RNA can be isolated from whole blood, PBMC, bone marrow, Innovators Medhealth Outlook 2020 CRO Jenny Lin COO17 PAGE NO Dec 2020 our goal is to be your top tier Bioanalysis solution provider for drug discovery, development through commercialization. Our talented team will always be there, with you, every single step away solid tissue, or matrices such as urine, saliva, or cerebrospinal fluid and then added to a reverse- transcriptase quantitative PCR to accurately quantify mRNA levels. Alternatively, DNA can be isolated and added to a qPCR to identify single nucleotide polymorphisms, for detection of known mutations, or to determine individual copy number variation. One of the more powerful applications of qPCR is the ability to multiplex, which is the detection of many targets within the same reaction. This can be leveraged for biomarker screening to determine which genes are differentially regulated in response to therapeutic treatment. CMIC Inc.’s qPCR instruments are compatible with a variety of flourophores and are fully supported by the vendor, providing for seamless design of specialized panels, thereby saving precious time and cost. Yet another application for qPCR is detection of viral nucleic acids in order to determine the remaining levels of a vaccine or gene therapy vector in order to establish washout and allow further optimization of a dosing regimen. CMIC Inc. plans to add droplet digital PCR and cell-based assays in 2021 to augment current GLP capabilities for bioanalytical support of gene therapy programs. While industry and regulatory contemporaries are building out a knowledge base for new and updated assays, CMIC Inc. will be well positioned to support large molecule biologics ranging from monoclonal antibodies, biosimilars, anti-cancer compounds, peptide- based therapies, gene therapy, and vaccines . PAGE NODec 2020 18 A mid an otherwise challenging and gloomy year for conducting research, one positive has shone through brightly: the dedication and talent consistently demonstrated by a clinical trial workforce under extreme stress. As we pull together to battle the global COVID-19 health crisis, trials have been launched in matters of days, not months, new ways of conducting trials have made it easier for patients to participate remotely, and we’ve seen promising vaccines developed at warp speed. Clearly, the clinical trial workforce has risen to the occasion and deserves our respect and applause. But there’s a cloud on the horizon that threatens the efficacy of trials and the well-being of clinical trial professionals toiling in the trenches to alleviate suffering and prolong lives. I’m referring to a growing gap between the size of the clinical trial workforce and the demand for new trials. Put simply, as an industry we aren’t keeping up with tomorrow’s expectations. ClinicalTrials.gov reports a growth from 181,274 to 299,787 of registered clinical trials between 2015 and 2019. That’s an increase of more than 65% in four years, and there’s no indication it’s going to slow down anytime soon. While clinical trial growth is exciting and bodes well for future treatments and other breakthroughs, we won’t realize its full potential if we can’t simultaneously expand the workforce quickly enough to support IT’S TIME TO DIVERSIFY THE CLINICAL TRIAL WORKFORCE By Jim Kremidas, Executive Director, Association of Clinical Research Professionals MED NSIGHTS Jim Kremidas, Executive Director19 PAGE NO Dec 2020 the work. It’s difficult to definitively declare the number of jobs in the clinical trial workforce, in part because it’s not tracked by the Department of Labor as such, and job titles are not consistent across industry. However, surveys and available data suggest that over the last three years there are signs that demand for clinical trial personnel has been increasing, with average compound annual growth in monthly job postings activity of 9.3% across all clinical research positions. But if a a nearly 10% growth in the workforce sounds robust, it obviously won’t keep pace when we recognize that the average year-over-year growth in clinical trials activities was 12.2% over roughly the same time period. At the top of our shared to-do list to address this looming shortage is finding meaningful new ways to improve the diversity of the clinical trial workforce. In a sad echo of the clinical trial patient population, minorities are generally under-represented across all categories. It’s unworthy of us as human beings on a moral level to not represent everyone; it also weakens the scientific integrity of trials. Luckily, more and more people are recognizing the importance of promoting diversity in the clinical trial workforce and the impact it would have on recruiting underrepresented populations into trial participation. This in turn, will lead to the generation of better healthcare data for these groups. Organizations are forming to address the shortage in hands- on fashion. A great example is Black Women in Clinical Research (BWICR), founded by Danielle Coe in 2019. In an October 9, 2020 discussion with ACRPtv, she outlined why organizations such as hers are vitally important to improving clinical trials, and how BWICR has already made a positive impact by generating more interest in clinical trials as a career. We need to thank and encourage the proactive people like Coe in the clinical trial industry because they are tackling this problem at the source. But our industry must do a better job on a bigger scale by more proactively reaching out to all segments of the population in all parts of the country. It is incumbent upon sponsors and the entire clinical trial industry to make wider employee outreach not just a priority in word, but also a priority in action. Closer to home, ACRP and others are active on this front. The ACRP Partners in Workforce Advancement (PWA) is a multi-stakeholder, collaborative initiative to grow and diversify the clinical research workforce and to set and support standards for workforce competence. PWA membership includes more than 30 organizations representing sponsors, contract research organizations, sites, regulatory agencies, academic institutions, suppliers, and more. Most recently, the PWA launched a new outreach campaign designed to raise awareness of clinical research as a career option among minority college students called the “Find Your Element” campaign. It began in February in Miami and the Research Triangle Park region of North Carolina. In November, the program expanded to Atlanta, Washington, D.C., Baltimore, and San Francisco. The expansion is designed to grow interest in and awareness of the clinical research profession among college students, including diverse and multicultural students, to help make clinical trials more representative of the patient population. The pilot campaign will reach nearly 400,000 students currently enrolled in healthcare and life sciences programs at colleges and universities across those markets. It’s early days yet for these programs, but the anecdotal evidence is strong that when people hear about careers in clinical research, they are often interested to learn more. Clinical trials are in the news today as never before. We have an unprecedented opportunity to raise awareness of their importance even as we reach out to the new professionals who will fuel their future growth. It’s our chance and it’s our responsibility to enrich the clinical trial workforce with a new diversity. I hope you can find ways to contribute to this most worthy endeavor. Next >