The 10 Most Innovative Pharma and Biotech Solution Providers, 2023 January2023

VOL-01 | ISSUE-09 | 2023 The Most Innovative Pharma and Biotech Solution Providers, 2023 Laurence Birch Chief Executive Officer Anju Software Anju Software Delivering Compreh ensive Solutions www.iosightssuccess.com

he pharmaceutical and biotech industries have seen and reduce costs. Some of the innovative companies in the Hire a significant increase in innovation and niche are utilizing these trends and benchmarking T T T technological advancements in recent years. excellence with core innovation. Spotlighting these Precision medicine is an innovative approach to patient care gemstones of the pharma and biotech niche, Insights that involves tailoring treatments to individual patients Success showcases “The 10 Most Innovative Pharma and based on their genetic makeup, environment, and lifestyle. Biotech Solution Providers, 2023.” character. This approach allows for more targeted and personalized treatments, which can lead to better outcomes and reduced Flip through the pages and indulge in the odyssey of side effects. prolonged brilliance. Have a delightful read! AI and ML are being used to revolutionize drug discovery and development by analyzing large datasets and identifying potential drug candidates faster and more efficiently than traditional methods. Moreover, Gene Train skill. therapy is an emerging field that involves using genetically engineered viruses to deliver therapeutic genes to patients. This approach has the potential to cure genetic diseases by replacing or repairing faulty genes. Digital health solutions, such as mobile apps and wearables, are being developed to help patients manage their health conditions and provide healthcare providers with real-time data to make informed decisions. Leading the 3D printing technology is being used to create personalized medical devices and implants, such as prosthetics and Way in dental implants, which can improve patient outcomes and reduce costs. Blockchain technology is being explored as a way to improve the efficiency and security of drug supply Abhishek Joshi chains, clinical trials, and medical records. Overall, these innovations are driving significant advances Biotech Abhishek Joshi in the pharmaceutical and biotech industries, with the potential to improve patient outcomes, increase efficiency, Innovation

The Most Editor-in-Chief Innovative Merry D'Souza Pharma and Deputy Editor Executive Editor Assistant Editor Abhishek Joshi Jenny Fernandes Anish Miller Biotech Solution Providers, 2023 Art & Design Director Associate Designer Visualizer David King Ankita P. Revati B. Company Name Featured Person Brief Anju Software is a customer-first organization providing Anju Software Laurence Birch Senior Sales Managers Business Development Manager adaptable life science solutions for clinical research, medical anjusoftware.com Chief Executive Officer affairs, and data science. Sihanee M., Rouniyar A. Peter Collins, Prathamesh Tate Bristol Myers Squibb a global biopharmaceutical company Marketing Manager Sales Executives Bristol Myers Squibb Giovanni Caforio whose mission is to discover, develop and deliver innovative bms.com CEO John Matthew Ryan, Andrew medicines that help patients prevail over serious diseases. ClinCapture provides a powerful eClinical platform that Technical Head Business Development Executives ClinCapture enables sponsors and CROs to rapidly build and deploy studies, Scott Weidley Jacob Smile Steve, Joe, Ram, Rohit clincapture.com lower clinical trial costs, and streamline data capture processes. President & CEO CMIC Inc. CMIC is an innovative and unique provider of high-quality Technical Specialist Digital Marketing Manager Jenny Lin cmicgroup.com solutions for the healthcare industry. Chief Operating Officer & Dominique T. Prachi M. Board Member Mr. Kaskade is a visionary leader within both large as well as Jim Kaskade Janrain small company environments with over 30 years of experience Research Analyst SME-SMO Executive lJanrain.com CEO in complex enterprise technology. Frank Adams Sagar L. Metrendalytics Consulting, focused on helping companies Metrendalytics Jan Miotto develop highly customized and flexible business intelligence Metrendalytics.com President solutions. Database Management Technology Consultant Circulation Manager Stella Andrew David Stokes Peachtree BioResearch Robert Brown Peachtree BioResearch Solutions is a full-service Clinical Kristy Nichols Solutions Research Organization based in the United States. CEO premier-research.com sales@insightssuccess.com From sleep apnea to respiratory conditions including COPD, January, 2023 ResMed Michael Farrell ResMed has innovative solutions to help people live a healthier resmed.com CEO life. PCPM will disrupt medicine! it will allow the doctor/pharmacist to program the patient's treatment in real- Follow us on : www.facebook.com/insightssuccess/ www.twitter.com/insightssuccess TrioxNano Roy Farfara time by uploading infinite program codes to control its programedicine.com We are also available on : MD Founder & CTO functions in order to improve its therapeutic window Copyright © 2023 Insights Success, All rights reserved. The content and images used in this magazine should not be reproduced or transmitted in any (efficacy/toxicity). form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from Insights Success. Reprint rights remain solely with Insights Success. Werfen is a worldwide leader in specialized diagnostics, Jose Manent Werfen focused on Hemostasis, Acute Care, Autoimmunity and OEM CEO werfen.com products and services.

The The The of today of today of today Science Science Science is the is the is the Technology Technology Technology of of Tomorrow Tomorrow of Tomorrow

C C O O V V E E Anju R R S S T T O O Software Delivering Compreh ensive Solutions R R Y Y Anju’s Medical Affairs Suite pro vides adaptive, connected, and patient-centric solutions that offer comprehensive, purpose-built capabilities which together unify and enhance capabilities of medi cal affairs organizations. Laurence Birch Chief Executive Officer Anju Software

The 10 Most Innovative Pharma and Biotech Solution Providers, 2023 nju Software, a leading provider of software enabling faster decision-making, and driving impactful solutions to the life sciences industry, links with its results. A customers' existing tools, enabling them to expand on their existing platform and deliver a custom software Anju provides best value solutions that span the lifecycle of experience that ideally suits their requirements. clinical development through medical affairs and into commercialization to support post-market activities. Anju Anju provides an integrated platform spanning clinical delivers the exceptional customer experience of smaller operations, medical affairs, and commercial divisions, vendors and the feature-rich product offering of larger including integrated data intelligence. It has combined deep competitors at a fair price across three distinct service industry and software domain expertise to build a next- areas: eClinical, Medical Affairs, and Data Sciences. generation platform for the life sciences sector that can scale to provide solutions that meet customers’ needs. Mr. Birch, please tell us about yourself and please highlight some of your healthcare sector experience. In an interview with Insights Success, CEO of Anju, Laurence (Larry) Birch, let us explore the parameters that I have more than three decades of life sciences, software, led to the success of Anju. and global management experience. I joined Anju because it can be built into one of the leaders in the life sciences Below are the highlights of the interview: technology space. My goal is to empower our customers to help patients by applying our software in eClinical, Medical Please enlighten our readers about Anju Software, Affairs, and Data Sciences, as well as other technology- highlighting its significance in the modern healthcare based services. sector. My strong track record in healthcare, life sciences, and Anju is built on a strong “customer-first” culture focused on software technology enables me to drive innovation and the delivery of feature-rich, adaptable life science solutions, achieve success for Anju’s clients and partners. I have been on both sides of clinical research and data management, technologies that reduce the complexity of clinical research starting my career at Baxter, Inc. and the commercialization of drugs and devices. I enjoy being a part of an industry that helps people live TrialMaster is the flagship product in Anju’s eClinical Suite, longer and better lives—we must never forget our important which is the most adaptable clinical solution for life role in this process. sciences, incorporating best-of-breed applications for all Phases and complexities of clinical trials that can be Tell us about the services and solutions that Anju seamlessly incorporated into our clients’ existing infrastruc- Software provides to its clients. ture. Traditional technology providers offer platform solutions Anju’s eClinical Suite orchestrates the most intuitive that force customers to adopt their technology their way. At assembly of integrated cross-Phase clinical software. Their Anju, our technology can be integrated into our customer’s eClinical solutions conduct and optimize the functions of current tools, allowing them to add complementary class-leading electronic data capture (EDC), clinical trial solutions to their existing environment and create a tailored management system (CTMS), randomization and trial software experience that perfectly meets their needs. supply management (RTSM / IRT), and, when needed, early-phase data collection (EPS). Anju has deep expertise in three distinct service lines: clinical trials, medical affairs, and data sciences. Anju Anju’s Medical Affairs Suite provides adaptive, connected, provides a leading suite of solutions that leverage data- and patient-centric solutions that offer comprehensive, driven analytics to provide a breadth of services to many of purpose-built capabilities which together unify and enhance the worldwide pharmaceuticals, biotech, and contract the capabilities of medical affairs organizations. Anju’s research Life Sciences customers & partners. Medical Affairs suite utilizes a robust platform to elevate medical information, medical communications, and KOL Anju’s eClinical Suite, Data Science Suite, and Medical Management to enhance performance, prove value and Affairs Suite provide comprehensive services and

optimize experiences and outcomes. These platforms include IRMS MAX, iCare MAX, and PubStrat Max. Anju’s Data Science Suite, TA Scan and TA Scan CRM, delivers comprehensive clinical and commercial intelligence to support Clinical Operations and Medical Affairs Anju provides a leading teams to make more informed, data-driven decisions around suite of solutions that clinical trial design, feasibility, site identification, and KOL leverage data-driven identification and management. Our seamless data analytics to provide a integration and analytics save research time, spark actionable insights, shorten trial timelines, and accelerate go-to- breadth of services to market strategies. many of the worldwide pharmaceutical, biotech, What were the initial challenges that Anju Software had and contract research to overcome, and what are the challenges now? Life Sciences, customers Clinical development and life sciences data management & partners. are undergoing a great transformation. Catalyzed by a global pandemic, technology-driven changes are revolutionizing EDC and data deployment. Anju’s leadership experience in terms of volume over years and types of trials is unparalleled. continues transforming the life science industry. As vital as our customer-first mission, Anju strives to deliver the best Anju’s eClinical Suite, Data Science Suite, and Medical value. Affairs Suite provide comprehensive services and technologies that reduce internal oversight, simplify vendor What are the necessary factors and aspects in clinical management, and reallocate internal personnel resources to trials and medical affairs? How does Anju Software higher-priority tasks. And all these services are delivered stand out as one of the leading companies in this niche? within a fair and competitive pricing structure. Traditional technology providers offer platform solutions Under your staunch leadership, what is the vision and that force customers to adopt their technology their way. At mission of Anju Software in the ever-evolving healthcare Anju, the strength of our offerings focuses on delivering industry? solutions specifically for the client’s needs. Anju’s solutions At Anju, we strive to put our customers first. Our goal is to allow customers Anju’s solutions allow customers to add complementary provide an exceptional customer experience while deliver- to add comple technologies to their existing environment and create a ing scalable technology solutions at a fair price. We want to mentary tech tailored software experience that perfectly meets their be the long-term partner helping our customers evolve with nologies to their needs. This differentiating service utilizes Anju’s propri- industry needs. existing envi etary integration technology. ronment and These technologies can be complex and require close create a tailored Anju’s IRMS MAX delivers a new Medical Affairs customer support. We are building a leadership position on software expe experience with best-in-class solutions built on the the delivery of the best customer experience of anyone else rience that industry’s most robust platform to elevate medical informa- in the industry. We are committed to building support teams perfectly meets tion, medical communications, and KOL Management to that are available to answer complex and simple questions their needs. enhance performance, prove value and optimize experi- and provide constant support to maximize the value of our ences and outcomes. technology. Anju delivers best-in-class information tools for medical I believe that the health tech revolution has only just begun, affairs professionals in the form of its IRMS MAX, iCare and I want to do my part to drive and adopt the changes in MAX, and Pubstrat MAX. digitalization and artificial and machine learning as it

Anju’s Data Science Suite, including TA Scan, delivers Share your opinions on how advanced automated comprehensive clinical and commercial intelligence to technology is reshaping the modern healthcare industry support Clinical Operations and Medical Affairs teams to and how Anju Software is leveraging these emerging make more informed, data-driven decisions around clinical technologies to enhance its services and operations. trial design, feasibility, site identification, and KOL identification and management. Our seamless data The increased number of clinical trial endpoints has integration and analytics save research time, spark action- significantly contributed to the complexity of designing, able insights, shorten trial timelines, and accelerate go-to- launching, and completing clinical trials. And, while trial market strategies. complexity has increased, the demand for faster and cheaper trials, with fewer failures, has also increased. At Can you provide any testimonials of your cli- Anju, all our services are designed to improve trial success ents/customers that accurately highlights your organiza- by making data easier to share, understand, and use. tion’s position as a prominent company in the sector. For example, Anju’s TrialMaster EDC is the most intuitive Anju serves 29 of the top 50 pharmaceutical companies and Electronic Data Capture (EDC) Suite on the market. 15 of the top 20 contract research organizations (CROs). TrialMaster EDC features superior usability and flexibility Gustave-Roussy, one of the largest oncology research and is an ideal solution for Phase I-IV clinical trials. centers in Europe, is ranked #1 outside the U.S. and is TrialMaster improves efficiencies and reduces workflow ranked #5 globally. With hundreds of oncology clinical impact while enhancing your data quality, resulting in faster trials, Gustave Roussy requires software that can manage study submission times. the ever-expanding demands of data management. Anju’s TrialMaster allows site researchers, patients, and sponsor Equally important is Anju’s advanced automated technolo- sta ffto access the platform from any device (desktop, gies that are providing extreme value in the Medical Affairs laptop, tablet, or smartphone). TrialMaster provides business as well as the Data Sciences business. Gustave Roussy researchers with flexible query management as well as sophisticated reporting and data visualiza- As mentioned, Anju’s IRMS MAX delivers a new Medical tion, enabling actionable insights that facilitate better trial Affairs experience with best-in-class solutions built on the oversight across a clinical organization. industry’s most robust platform to elevate medical information, medical communications, and KOL Management to enhance performance, prove value, and optimize experiences and outcomes.

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Rising Up Embracing Dital Tsfmi for M Me ed dT Te e  S So ollu ut tii s s ompanies in the medical device business (also known as MedTech), which is under increasing C price pressure from healthcare providers and contending with declining returns from mature technologies, must now look for novel methods to boost their bottom lines. For medical equipment to continue to be cost-competitive in the future, supply chains must be digitalized. The healthcare sector used digital solutions in several sectors before the pandemic. However, it was either a piecemeal strategy or a technology paradigm that worked for everyone. To manage electronic health record (EHR) systems and create apps that suited business models, it used technology. But technology offers more than that. To provide room for creativity and business objectives that can adapt to the future, corporations are now going a step further and embracing new technologies like cloud computing, artificial intelligence (AI), the internet of things (IoT), big data, quantum computing, and analytics. They are ready to have a major positive impact on the sector. By offering scalable microservices and adaptable strategies, the proper cloud partner may assist you in accumulating technological riches. The objective of digital transformation is to integrate digital technologies to lower costs, enhance processes, and boost productivity. It is not a straightforward pipeline process, but rather a nuanced scheme with the primary goal of substituting cutting-edge technologies for antiquated ones. January 2023 | 18 | www.insightssuccess.com January 2023 | 19 | www.insightssuccess.com

The adoption of digital innovation and the accelerated Addressing Challenges improvement of service quality are essential for the healthcare sector. Complexity can be managed by When embarking on the route of digital transformation, organizations employing cutting-edge analytical techniques some obstacles must be surmounted, just like with any and quick choices. Building an agile system that combines change in the company. These difficulties include gaining web and mobile applications, enhances the patient support for the switch to cloud computing technologies, experience, and provides real-time decision-making is the data integrity, cybersecurity, integrating legacy systems heart of digital transformation. with other platforms and tools, changing organizational attitudes, funding, etc. Read through to learn about how digital transformation could the next solution for MedTech. But with a strategy that acknowledges the significance of digital transformation, appreciates the advantages, and Benefits of Digital Transformation accepts that this is the direction the sector is going, all these difficulties can be addressed. Some of the benefits that digital transformation brings for MedTech solutions are as follows: To design the necessary solutions and put the necessary mechanisms in place, one must also need the appropriate Ÿ It Saves lives and raises the standard of living for people partner. all around the world. This is accomplished by digital transformation in several ways, including by lowering Recommendations manufacturing costs, raising quality, efficiently controlling output to meet demand, comprehending To prepare for the disruption of today, the following tactics user/patient/customer wants, and more. could be considered: Ÿ Strengthens connections with users, partners, consumers, and patients. 1. Adopting a humanized mentality reset across the Ÿ Increases productivity across the board for your advertising of products. Invest in new, insight-driven company, but especially in the production lines. talent, enable customer centricity at scale, and embrace Improving the distribution chain can also result in partnerships and M&A with a focus on customer significant efficiency gains. outcomes. Ÿ Achieves huge efficiency savings, not the least by 2. Updating your technology environment. More than ever, automating laborious operations. technology is the foundation for future corporate Ÿ Gives decision-makers greater, more accurate, and more expansion and operational performance. To upgrade current information on which to base their judgments, legacy apps, think about developing, purchasing, or which improves company supervision. collaborating. Ÿ Satisfies regulatory standards more effectively and 3. Taking data insights and releasing them. Create a solid efficiently. data foundation for the entire organization. The use of Ÿ Reduces human mistakes by utilizing more automation curated data sets can open up new channels and markets Ÿ Reduces hazards in a variety of areas for your company. by enabling tailored marketing and pricing optimization. As an illustration, consider enhancing product quality to lower the risks to finances and reputation brought on by A fragmented or half-hearted strategy won't guarantee a recall scenario. economic success. MedTech organizations must Ÿ Decreases the time it takes to launch new products. purposefully alter to compete with disruptors. To achieve Ÿ Enhances workplace health and safety, especially in this, they must embrace new connectivity and emphasize manufacturing and distribution. humanization, technology, and data & analytics. Ÿ Improves the transmission of knowledge within an organization. This is a huge advantage given the problem of a skills shortage that many in the sector are dealing with. January 2023 | 20 | www.insightssuccess.com

Industry Insights disorders, and certain types of cancer. As our understanding gene therapy. This technology allows scientists to edit DNA of genetics continues to advance, we can expect to see sequences with incredible precision, making it possible to Emerging Trends many more gene therapies coming to market in the years correct genetic mutations that cause disease. ahead. CRISPR/Cas9 has already been used to treat a number of CRISPR/Cas9 conditions in preclinical studies, including Duchenne in Pharma muscular dystrophy and sickle cell anemia. As this CRISPR/Cas9 is a powerful gene editing tool that is technology continues to advance, we can expect to see Biotech Sect revolutionizing the way we approach genetic research and many more applications in the years ahead. and Conclusion The pharma and biotech sector is in a period of rapid he pharma and biotech sector is a fast-growing and Digital Health change, with new technologies and innovations emerging highly competitive industry that is constantly all the time. Personalized medicine, digital health, artificial T evolving. The pharma and biotech sector is Digital health is another trend that is rapidly gaining ground intelligence, gene therapy, and CRISPR/Cas9 are just a few constantly evolving, with new technologies and innovations in the pharma and biotech sector. This encompasses a wide of the trends that are shaping the industry today. As our emerging all the time. The pharma and biotech sector is range of technologies, including wearables, mobile apps, understanding of genetics and disease continues to advance, dominated by a few major players, including Pfizer, Roche, and remote monitoring. These technologies can be used to we can expect to see many more exciting developments in Johnson & Johnson, Novartis, and Merck & Co. track patient health data in real-time, allowing doctors to the years ahead. detect potential health problems before they become These companies have large research and development serious. budgets and are responsible for many of the industry's most significant breakthroughs. Here are some of the key trends Digital health technologies can also help patients manage that are shaping the industry today: their own health more effectively. For example, patients can use mobile apps to track their medication schedules, Personalized Medicine monitor their diet and exercise, and communicate with their healthcare providers. One of the biggest trends in the pharma and biotech sector is personalized medicine. This approach involves tailoring Artificial Intelligence treatments to an individual's genetic makeup, lifestyle, and medical history. Advances in genomics and bioinformatics Artificial intelligence (AI) is another technology that is have made it possible to identify genetic biomarkers that starting to play a major role in the pharma and biotech can help predict which patients will respond best to sector. AI can be used to analyze large volumes of medical particular treatments. data, helping to identify new drug targets and predict which patients will respond best to particular treatments. Personalized medicine has the potential to increase treatment efficacy and reduce side effects. By tailoring AI can also be used to automate certain aspects of drug treatments to an individual's unique needs, doctors can development, such as identifying promising drug candidates ensure that patients receive the most appropriate treatment and designing clinical trials. This can help to speed up the for their condition. drug development process and reduce costs. The pharma and biotech sector is highly regulated, Gene Therapy with strict standards in place to ensure the safety and efficacy of drugs and therapies. In the US, the Food and Gene therapy is a rapidly growing field that holds great Drug Administration (FDA) is responsible for approving promise for treating a wide range of genetic disorders. This new drugs and therapies, while in Europe, the European approach involves introducing new genes into a patient's Medicines Agency (EMA) plays a similar role. cells in order to correct genetic mutations that cause disease. Regulatory approval is a critical milestone for pharma and biotech companies, as it allows them to bring their products Gene therapy has already been used to treat a number of to market and start generating revenue. conditions, including inherited blindness, immune January 2023 | 22 | www.insightssuccess.com January 2023 | 23 | www.insightssuccess.com

Making Regulatory Strategies Navigating the Evolving Regulatory Landscape in the Pharmaceutical Industry he pharmaceutical industry is one of the most regulated industries in the world. The regulations T are put in place to ensure that the products are safe, effective, and of high quality. However, the regulatory landscape in the pharmaceutical industry is constantly evolving, making it challenging for companies to keep up. In this article, we will discuss the evolving regulatory landscape in the pharmaceutical industry and provide some tips on how to navigate it. The Changing Regulatory Landscape The regulatory landscape in the pharmaceutical industry has been evolving over the years, driven by several factors. One of the main factors is the increasing demand for new and innovative therapies to address unmet medical needs. This has led to the development of new drugs and biologics, which require new and more complex regulatory frameworks. Another factor driving the evolving regulatory landscape is the increasing focus on patient safety. Regulatory bodies are placing more emphasis on ensuring that drugs are safe and effective and that the benefits of the drugs outweigh the risks. This has led to stricter regulations and increased scrutiny of clinical trial data. The rise of digital technologies is also impacting the regulatory landscape. The use of digital health technologies, such as wearables and mobile apps, is transforming the way healthcare is delivered. This has led to the development of new regulations and guidance to ensure the safety and effectiveness of these technologies. January 2023 | 24 | www.insightssuccess.com January 2023 | 25 | www.insightssuccess.com

Navigating the Evolving Regulatory Landscape Navigating the evolving regulatory landscape in the pharmaceutical industry requires a proactive and strategic approach. Here are some tips to help companies stay ahead of the curve: Stay informed: Keep up to date with the latest regulatory developments and changes in guidelines. Regulatory bodies such as the FDA and EMA publish guidance documents and updates regularly, so it's important to monitor these and stay informed. Build strong relationships with regulatory authorities: Developing strong relationships with regulatory authorities can help companies navigate the regulatory landscape more effectively. This can include attending meetings and conferences, engaging in open dialogue with regulators, and seeking feedback on product development. Embrace new technologies: Digital health technologies are transforming the healthcare industry, and companies that embrace these technologies will be better positioned to navigate the evolving regulatory landscape. This can include using digital tools to streamline regulatory compliance, such as electronic submission systems. Conclusion Implement a robust quality management system: A robust The regulatory landscape in the pharmaceutical industry is quality management system is essential for navigating the constantly evolving, driven by factors such as the demand evolving regulatory landscape. This includes implementing for new therapies, patient safety concerns, and the rise of quality control measures, conducting regular audits, and digital technologies. ensuring compliance with regulations. Navigating this landscape requires a proactive and strategic Collaborate with stakeholders: Collaborating with approach, including staying informed, building strong stakeholders, including patient groups, healthcare providers, relationships with regulators, embracing new technologies, and regulators, can help companies navigate the evolving implementing a robust quality management system, and regulatory landscape. This can include engaging in public collaborating with stakeholders. By following these tips, consultations, partnering with academic institutions, and companies can stay ahead of the curve and navigate the participating in industry associations. evolving regulatory landscape more effectively. January 2023 | 26 | www.insightssuccess.com

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The 10 Most Innovative Pharma and Biotech Solution Providers, 2023 January2023

The 10 Most Innovative Pharma and Biotech Solution Providers, 2023 January2023

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