Made with FlowPaper - Flipbook Maker
< PreviousPAGE NO 10 manufacturers and medical device companies throughout the product development and commercialization process. Parexel supports the development of innovative new medicines to improve the health of patients. The company provide services to help life sciences and biopharmaceutical clients from decentralized clinical trials to regulatory consulting services to leveraging real world insights. “From at-home care options to decentralized clinical trial services to direct-to-patient shipments of drug products, we are making trials more accessible to more patients in ways that work best for them,” explains Jamie Macdonald, CEO, Parexel International Corporation. Transforming Discoveries Parexel is focused on the development of innovative new therapies to improve the world’s health. By providing a suite of groundbreaking biopharmaceutical development services the company help customers across the globe transform scientific discoveries into new treatments for patients. From clinical trial design to regulatory and consulting services to commercial and market access, their therapeutic, technical, and functional ability is underpinned by a deep conviction. “We deliver DCTs with patients at the heart of our approach. Our fully virtual and hybrid DCTs (inclusive of home nursing) demonstrate the Parexel Promise – our commitment to treating patients and caregivers as an essential part of our team of clinical research organization experts,” adds McDonald. Parexel’s Clinical Research Services are driven by the Parexel Promise. Which is more than just a promise, it’s a commitment to keep patients and their insights at the heart of everything they do. So, the clients feel like they’re one of Parexel’s team of experts. What makes this possible is the company’s Patient Innovation Center that works to reduce barriers to patient participation for more engagement, higher recruitment and retention, better data, and reduced timelines. Furthermore, all Parexel clinical studies are done in accordance with ICH Clinical Practice (GCP) which is an international ethical and scientific quality standard for the conduct of trials. The company also follow the regulatory guidelines set by the country that the study is being conducted in. By volunteering for a Parexel clinical research trial, clinics are not only helping to benefit the wider community through the development of better medicines, and also be paid for the time and any inconvenience. Whatever the size or scope of a client’s study is, Parexel provides the comprehensive clinical development services required, from First-in-Human through Phase IV and post-marketing follow-through. The company also have From at-home care options to decentralized clinical trial services to direct- to-patient shipments of drug products, we are making trials more accessible to more patients in ways that work best for them11 PAGE NO the regulatory expertise, clinical trial operations management, payer and market access planning, medical education, and communications capabilities to see their customer journey through efficiently and effectively. The company’s clinical trial supplies and logistics team put their hearts into making sure the right supplies get to the right people at the right time. No matter the complexities or locational challenges, Parexel’s team solve logistical challenges before they become a problem. As they operate globally, the team have a deep understanding of the specifics of operating between countries – navigating everything from customs to local delivery. This end-to-end clinical logistics management makes use of industry-leading supply chain tools to find every opportunity for a more efficient, compliant clinical trial. A Winning Culture As one of the world’s leading global clinical research organizations (CRO), Paraxel provide the clinical development capabilities and integrated consulting expertise it takes to streamline development every step of the way faster and more cost-effectively. From decentralized clinical trials to regulatory consulting services and leveraging real-world insights, the company’s therapeutic, technical, and functional ability is underpinned by a patient-first culture embedded in the Paraxel DNA. On a closer view, what drives the company is its team’s deep conviction in what they do. Together with its customers, Paraxel’s teams are shaping the next generation of therapies, one patient at a time. “Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference. From the smallest detail to the largest, we take quality seriously. We focus in on the detail while never losing sight of the big picture to drive the best possible outcome.” At Parexel, the team recognize and uphold the importance of all people, the way they do things, the quest for innovation and most importantly, its patients. “We follow our hearts, we do the right thing and we have the courage to own the outcome.” With a focus on streamlining CRO operations for its clients, Parexel also has the Paraxel academy. Parexel Academy education and learning solutions blend theory and practice at the highest level - latest scientific, practical, and market insights from industry experts. It works with a mission to support clinical facilities and organizations in developing industry- leading capabilities that impact patient lives. Parexel proudly supports the Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research and the role each party plays in the process. Driving Innovation in CRO While innovations across many industry sectors are driving better returns and more efficiency at lower costs, this is not the case with pharmaceutical drug development. To galvanize action on this critical issue, Parexel commissioned the Economist Intelligence Unit (EIU) to gather and interpret hard evidence of the impact of selected innovations against specific success metrics, and also to assess the most powerful enabling factors around the adoption of innovation for the industry. This project is distinctive in publicly quantifying the impact of the most promising innovations in drug development and market access. The study aims to stimulate broad discussion on how the industry can evolve to support these drug development innovations. The company initially focused on supporting German and Japanese pharmaceutical firms but has expanded and now has clients in more than 100 countries worldwide. Parexel partnered with data-focused marketing technology company Datavant earlier in September this year. The aim of the partnership is to enhance its clinical study design and capacity by allowing the linking of healthcare data from different sources. “We’re proud of our 18,000 colleagues worldwide whose passion and commitment have made these efforts possible and have made a difference for patients every day. Our performance in the ISR survey is an important validation of their work and Parexel’s ability to differentiate and deliver on our Patients-First focus.” Another achievement of the company is that Parexel was named “Best Contract Research Organization” in December 2020 by an independent panel for Informa Pharma Intelligence. “This award belongs to our exceptionally talented staff—the people working tirelessly to deliver critical insights for our customers and improve patient outcomes,” said Macdonald. “We are honored to be recognized as the industry’s Best CRO by Scrip and even more pleased to see our industry—in the face of a global pandemic—take this opportunity to accelerate the adoption of a real-world, data-driven approach to clinical trial design to bring new therapies to patients sooner,” he concludes. EXPLORE THE NEW HEIGHTS OF MEDICAL RESEARCH www.medhealthoutlook.comA s a result of the increasing advantages of clinical studies in emerging countries and the strong emphasis of the governments towards public healthcare, modification has proliferated the demand for contract research organization services. Adding to this is the acceleration of investments in the research & development activities. The high advancements of IT are leading to a major development in clinical trials while influencing the global CRO space. Meanwhile, CROs gain flexibility and speed the drug development process with the advent of digital health and disruptive technologies such as AI and Protocol design complexity. The transition to decentralized clinical trials as a result of the pandemic has also increased the reliance on CROs. From a business point of few the complexity to streamline the operations are also on the rise. Additionally, leading CROs have developed significant expertise in the field of early-phase development, and CROs are leveraging this expertise to offer highly efficient and accurate early-phase development services. CROs also allow small- and mid-size firms to enter the complex drug development process without significant investment in capital equipment. With a lot of noise existing in the industry, to help healthcare professionals and businesses looking for the right CRO solution provider, MedHealth Outlook Magazine’s experts, editors, and the research team have shortlisted some of the most innovative providers. The companies listed below are creating an impact in the CRO space with their cutting-edge offerings. Innovators Medhealth Outlook CRO 2021 acmgloballab.com Website Rochester, NY Headquarters Brian Wright Management President Designation ACM is a leading laboratory specializing in clinical trials, central lab services and toxicology. The company’s full-time staff of laboratory experts performs more than 20 million tests annually. ACM Global Laboratories operates in more than 65 countries around the globe, with wholly owned facilities in the U.S.A., England, India, and Singapore. ACM Global Laboratories Description API is a not-for-profit that works closely with academic and health institutes across Alberta and Canada. API draws on an interdisciplinary network of over 100 pharmaceutical scientists, clinicians, regulatory, patent, and market experts in a variety of fields and disease areas. Description appliedpharma.ca Website Edmonton, Ca HeadquartersManagementDesignation Andrew MacIsaac CEO Applied Pharmaceutical Innovationcpc.com Website Hauppauge, NY Headquarters Matt Wolf Management CEO Designation Contract Pharmacal Corp. (CPC) develops, manufactures and packages solid dose drugs and dietary supplements. CPC employs more than a thousand highly skilled professionals in its Hauppauge, NY facilities totaling 500,000 square feet and to date has commercialized over 5,000 products. The company develops approximately 100 new products per year, and has capacity to support manufacturing 15 billion tablets and capsules annually. CPC’s customers rank among the world’s top pharmaceutical companies, retailers and wholesalers. Contract Pharmacal Corp Description frontagelab.com Website Exton, PA Headquarters Dr. Song Li Management Chairman & CEO Designation Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Frontagelab Description innovaderm.com Website Quebec, Ca Headquarters Dr. Robert Bissonnette Management Founder & CEO Designation As a CRO (Clinical Research Organization) specialized in dermatology, Innovaderm provides scientific guidance, accurate results and customer satisfaction. Innovaderm unique service offering combines specialized Contract Research Services, knowledge of dermatology sites in North America and Europe reach and the extended capabilities of a large clinical research site. Innovaderm Description linicalamericas.com Website Stuart, FL Headquarters Vita Lanoce Management CEO Designation Linical provides the full spectrum of drug development services from early stage to large-scale, multinational studies. Their areas of focus include Phase I-IV studies in oncology, infectious disease, and CNS. Rather than be all things to the market, this intentional design allows us to provide our clients the right size, right reach, and right team. Linical Americas Descriptionparexel.com Website Newton, MA Headquarters CEO Designation Jamie Macdonald Management Provides services to help life science and biopharmaceutical clients everywhere transform scientific discoveries into new treatments. Parexel International Corporation Description sironadx.com Website Oswego, OR Headquarters Andrew Brown Ph.D Management Chief Commercial Officer Designation A CLIA accredited technical contract research organization (CRO), Sirona Dx specializes in high complexity genomics and single cell proteomics services to support pharmaceutical companies with their drug discovery and development programs. SIRONADX Description syneoshealth.com Website Morrisville, 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. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together approximately 28,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Syneos Health Description tech-res.com Website Bethesda, MD Headquarters Nora Lee Management President & CEO Designation Technical Resources International (TRI), provides a unique range of support services to private industry, government agencies, and associations. It is a one of its kind company whose range of services encompasses the areas of communications, health, and information technology. TRI’s reputation for excellence springs from the knowledge, experience, and commitment of its staff. Technical Resources International DescriptionPAGE NO 16 I nnovation is a curious aspect. It often tests the mettle of the practitioners. There can be disruption in any monolithic industry where legacy processes have overshadowed perpetual advancement for years. But without tangible enterprise impact, innovation quickly wears off, leaving the effort and investments in vain. On a closer inspection, impactful industries like healthcare - especially dentistry, innovation should be life-changing developments like new-age abutments, esthetic enhancements, and futuristic prosthetic tools. The real doers are always people, the innovators who mold innovation and bring it to life. “It’s simple - ours is a humans-for-humans approach, and we strictly believe in only patient-centric innovation, no hearsay or fancy marvels. Noris Medical fills in the chronic gaps between clinicians and patients leveraging advanced technology stack and smart devices,” describes Liran Hagbi, CEO, Noris Medical. Noris Medical is directed by experienced physicians and professional engineers focusing on developing, designing, and building innovative products for the medical field. “At the heart of our business is the idea of helping clinicians execute a predictable minimally invasive surgery. Plus, provide the doctor with prosthetic options to complete a reliable prosthetic restoration for their patient,” describes Hagbi. Noris Medical’s uniform restorative platform for the implants comprises ‘Classic’ and ‘Challenge’ lines. It ensures all restorative components are compatible and interchangeable - from simple single dental implant cases to complex multi- implant to zygomatic and pterygoid implants. What’s more, as the company bases on their home-grown Hex platform, a patient can experience the same level of treatment. Thanks to Noris Medical’s appetite for disruption. What makes the smile sweeter Here’s a comprehensive list of their implants and solutions that help patients relive their smiling and joyous gestures: One-Piece implant: These unique implant designs allow the clinician and the patient to benefit from a restoration (whether one or multiple teeth) besides providing reliable support to a long-time denture wearer while introducing great value to the doctor and the patient. All this in a real-time and on-demand basis. Graft-less solution: Many patients, due to various reasons or circumstances, lose bone. With time the loss becomes worse. The doctor and patient previously fought this challenge by grafting the bone back from other sources. Now that had to be used to regain bone volume to allow for implant placement and restoration. This procedure lengthened the time of treatment and increased treatment morbidity. “We provide a solution for patients to have implants placed in their residual bone and allow those implants to support a prosthetic (teeth-bearing) device within a relatively short time, sometimes even the same day,” points out Hagbi. “This is where Noris’s main innovations come into play.” We dive deeper into the graft-less solution suite: Zygomatic implants: Noris was one of the first dental implant companies to embrace, improve the extra-maxillary approach to zygomatic implant surgery. It allows a better prosthesis fabrication that will be easier maintained by the patient and should provide them healthy years THE ART OF DENTISTRY: NORIS MEDICAL Liran Hagbi, CEO OF THE YEARCOMPANY17 PAGE NO Innovators Medhealth Outlook 2021 CRO Pterygoid implants: Just like the Zygomatic implants provide anchorage for dental devices with bone outside the oral cavity, so do the pterygoid implants find their support in the pterygoid bone. Noris developed implants, instruments, and devices to predictably anchor implants in this bone. The bracing of implants into the pterygoid, when done properly provides a tremendous amount of torque support for the immediately loaded prosthesis. Multi-Unit abutments (MUA): Implants are only part of the equation to graft- less solutions. To compensate for the variability in residual skeletal deformity of the patient’s jaw prosthetic components were developed by Noris Medical to help anchor dental prostheses to Zygomatic/Pterygoid/Routine implant placement combinations. EZgoma: The EZgoma is a surgical guide and is a patented innovation developed and created by Noris Medical to predictably facilitate the placement of zygomatic pterygoid and routine implants all at once. In addition, the design allows attachments of supporting prosthetic components while the guide is still in place. The happy innovation culture Hagbi attributes the success to an extraordinarily collaborative culture and a legacy built on trust and expandable strategy to help patients every time. A great mention is Noris Medical’s customer support, which Hagbi thinks “support is second to none.” During COVID, they foresaw an imminent surge in supply, so they started ramping up their inventory way earlier than other companies. On the human resource side, Noris Medical adopted a two-prong approach. “We trained our staff to improve production, inventory management, internal workflow, and synchronization with the outside international sales force. At the same time, we launched a free webinar series led by worldwide experts to ready the clinicians for the upcoming,” he informs. “In our courses and webinars, we integrate our sales, marketing, and biomedical personnel to avail ourselves to first person opinion and constructive dialogue in a continuous and on-going effort to improve and enhance our products and services.” Future smiles back at Noris Medical It was a humble start for them as an organization dedicated to bringing smiles back to people and ease the often-intricate medical processes. The beginning was in Israel and Europe, but right now, “we have opened in North and Latin America as well as Asia and the Middle East.” Regarding future development and innovation, they have pipelined products to enhance the clinician surgical experience and the patient outcome. “We are in the process of forming alliances with companies and OEMs to power up the doctors’ performance and execute rewarding and less- invasive graft procedures to help their patients,” concludes Hagbi.. Noris Medical fills in the chronic gaps between clinicians and patients leveraging advanced technology stack and smart devices of service. The aggressively tapered thread allows reliable anchorage in the zygomatic bone for remote prosthetic support, and the machined extension supports the patient’s soft tissues. “The usage of prosthetics of customized range accommodates patients with maxillofacial deformities and gives them their life back in a day,” he adds. Liran Hagbi, CEO PAGE NO 18 HEALTH, HEALING AND HOPE ACM GLOBAL LABORATORIES : J ust like every other industry, the COVID-19 pandemic has been the largest curveball in recent history, creating a global and industry- wide shift impacting the way people will do business for years to come. One of the many obstacles all industries have faced during the COVID-19 pandemic is disruptions to the global supply chain, which affected the smooth operations of clinical trials and labs. Businesses had to work closely with couriers and logistics service providers to enact programs and protocols that ensure samples arrived on-time and at the proper temperature. Organizations like ACM Global Laboratories—a provider of state-of-the-art central lab services to clinical trials programs—strived to ensure that the Clinical Research operations worked smoothly. “We’ve also partnered with our clients and sites to reduce the risk of any impact by providing specialized training on how to properly pack shipments, coupled with enhanced tactics to continuously monitor and track shipments on a daily basis,” begins Brian Wright, President, ACM Global Laboratories. In a nutshell, the pandemic pushed ACM and the healthcare sector as a whole to be more flexible and adaptable, further optimizing business processes to support the needs of our clients worldwide. ACM’s purposefully patient-driven approach has supported the launch of thousands of new therapeutics to the market over the course of half a century. We passionately work to serve our customers, embracing change within our organization and empowering our employees and partners to always drive towards excellence. Talking about the company as a whole, ACM is a recognized leader in global clinical trials testing. Through wholly-owned facilities, subsidiaries, and a huge network of partner labs, ACM supports clinical trials in more than 65 countries. The organization’s full-time staff of laboratory experts perform more than 20 million tests annually, spanning all medical disciplines, including routine safety testing, bioanalysis, flow cytometry, pathology, assay development and validation, molecular diagnostics, toxicology, and more. What makes the company stand out is its unique biological sample collection kits that are custom designed in-house, allowing to seamlessly meet the protocols of each specific clinical trial. The company also has a global team of logistics experts who track the status and location of every single package from the moment it leaves the investigator site to the instant it reaches the lab. “We offer all of the global logistics services that one might expect from a large central laboratory, including multiple carrier options, real-time sample tracking, access to a comprehensive shipping manifest, and various service option levels,” explains Wright. ACM’s clinical trials testing and toxicology business segments combine to position ACM as one of the most Innovators Medhealth Outlook 2021 CRO19 PAGE NO dynamic central labs in the world. The company’s team uses that strength to remain focused on its mission of partnering with clients to bring health, healing, and hope to patients around the globe. Offering state-of- the-art global lab services with the feel and flexibility of a client’s favorite local lab, ACM’s advanced biological sample collection kits provide unique aesthetic and adaptability to meet the protocols of each specific clinical trial. In addition, utilizing the ACM client portal, clients are able to securely and instantly access their study-specific data anywhere in the world, at any point in the trial. This kind of approach is paramount to a successful trial and allows for constant study optimization and quick pivots where necessary. ACM’s global logistics team and clinical data managers are an integral part of every trial team and help to ensure that logistical planning is integrated into the entire trial process, so the supply system aligns seamlessly with trial requirements and timelines. This close coordination of logistics will accelerate site readiness, minimize supply and distribution issues, and reduce the risk of delays. With strong clinical logistics support, we are able to focus resources on the patient and trial itself, with a larger, even more, profound impact of lowering total drug development costs, improving regulatory compliance, and reducing overhead costs. Since opening its doors in 1975, ACM has been working closely with its clients at every point of their clinical trial, from routine safety testing and bioanalytical support to flow cytometry services or other specialized laboratory testing. Throughout the pandemic, ACM supported hundreds clinical trials and initiated support of over 105 new clinical trials across more than 20 therapeutic areas, including neurology, dermatology, psychiatry, infectious disease, oncology, genetics, and more. As experts worldwide continue to develop COVID-19 vaccines and therapeutic compounds, ACM stands ready to support and optimize these trials. An instance that portrays the company’s value proposition is when ACM recently partnered with industry leaders to develop a vaccine candidate, which is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe. Leading the charge with a suite of central laboratory services, ACM successfully supported the vaccine through Phase 3, thanks to a flexible and consultative approach. Over the years, ACM has built a strong reputation in the industry by delivering clinical trials and support on-time and with the highest level of quality. In the future, ACM will continue to explore and implement new ways of providing the highest levels of quality and service to clients. “Our investments will remain focused on equipping our business with the right people, processes, systems, and technology, to responsibly scale our operations so that we can continue to provide health, hope, and healing around the world,” concludes Wright. We offer all of the global logistics services that one might expect from a large central laboratory, including multiple carrier options, real-time sample tracking, access to a comprehensive shipping manifest, and various service option levels Brian Wright, PresidentNext >