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10 Most Efficient Drug Delivery Solution Providers in 2023

Insights Careu2019s latest edition, 10 Most Efficient Drug Delivery Solution Providers in 2023, navigates you to the rapidly changing healthcare landscape.

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10 Most Efficient Drug Delivery Solution Providers in 2023

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  1. March Issue 12 2023 Jeffrey Hackman Chairman and CEO Comera Life Sciences Harnessing Technology for Be?er Health Medica?on Management in the Digital Age Ca Life Sciences Medica?on Compliance Overcoming Barriers to Adherence Transforming IV to SQ Biologic Therapies to Improve Patients’ Quality of Life

  2. Good N of Your Life Good N Your Life N utr?ion utr?ion utr?ion can be the Savior of Your Life

  3. Ed tor’ s Note

  4. Revolutionizing Drug Delivery for Better Health I Furthermore, drug delivery solution providers contribute to the accessibility and convenience of medications. For patients with chronic diseases, self-administration of medications is often a part of their daily routine. These providers develop user-friendly devices and technologies that empower patients to manage their treatments effectively at home, promoting independence and improving their quality of life. n the ever-evolving healthcare landscape, drug delivery solution providers are vital in advancing medical treatments and patient outcomes. These innovative companies specialize in developing technologies and systems that ensure the safe, efficient and targeted delivery of therapeutic drugs. With their expertise, they bridge the gap between pharmaceuticals and patients, revolutionizing the way medicines are administered. In addition to their impact on patients, drug delivery solution providers also collaborate closely with pharmaceutical companies and healthcare professionals. By working in tandem, they optimize drug formulations, enhance drug stability, and ensure compliance with regulatory standards. This collaborative effort streamlines the drug development process, expediting the availability of new and improved therapies. One of the key challenges in healthcare has always been optimizing drug delivery to maximize the benefits of medications while minimizing side effects. Drug delivery solution providers address this challenge through a range of cutting-edge technologies. These providers are at the forefront of innovation, from advanced drug delivery devices such as auto-injectors, inhalers and transdermal patches, to novel formulations and controlled-release systems. Insights Care's latest edition, 10 Most Efficient Drug Delivery Solution Providers in 2023, navigates you to the rapidly changing healthcare landscape. The role of drug delivery solution providers is increasingly pivotal for their relentless pursuit of innovation and commitment to patient- centric care. By harnessing the power of technology, these providers empower patients, advance medical treatments and ultimately, shape the future of healthcare delivery. The significance of drug delivery solution providers becomes particularly evident when considering the growing field of personalized medicine. Tailoring treatments to individual patients' needs requires precise drug delivery mechanisms. These providers develop customized solutions that can deliver medications at the right time, in the right dosage, and to the specific site of action within the body. This level of precision is instrumental in improving therapeutic outcomes and reducing adverse effects. Hope you have an exciting read! -Pooja Shah Pja Sh

  5. 16 Crossject Saving Lives in Emergency Situations through Needle-free Injectables 24 PolyPid Ltd Infections (SSIs) through Controlled Delivery of Medications Eliminating Surgical Site 32 Ziccum Expanding the Potentials for Next-Gen Vaccines and Biologics 20 Harnessing Technology for Better Health Medication Management in the Digital Age Articles 28 Medication Compliance Overcoming Barriers to Adherence

  6. 08 Cover Story Comera Life Transforming IV to SQ Biologic Therapies to Improve Patients' Quality of Life Sciences Contents

  7. Editor-in-Chief Chidiebere Moses Ogbodo Executive Editor Saloni Agarwal Managing Editor Pooja Shah Visualiser David King Art & Design Head Mrunalinee Deshmukh Co-designer Paul Belin Art & Picture Editor Deepanjali Jena Business Development Manager Emily Jones Marketing Manager Bill Thompson Business Development Executives Anna Smith, Jack Miller Sales Executives Mike, Carl, John Technical Consultants David, Robert Assistant Technical Head Prashanth Hiremath Technical Head Jacob Smile Digital Marketing Manager Alina Sege Assistant Digital Marketing Manager Sagar Lahigade SME-SMO Executives Gemson Research Analyst Eric Smith Circulation Manager Tanaji Fartade sales@insightscare.com March, 2023 Contact Us: Insights Success Media Tech LLC 555 Metro Place North, Suite 100, Dublin, OH 43017, United States Phone - +1614-602-4132 Email: info@insightscare.com For Subscription: www.insightscare.com Insights Success Media and Technology Pvt. Ltd. Survey No.133/134, Brand Square, Office No. 512, Kunjir Chowk, Pimple Saudagar, Pune, Maharashtra 411027. Phone - India: 7410033802, 8956487823 Email: info@insightscare.com For Subscription: www.insightscare.com https://twitter.com/Insightscare Follow us on : www.facebook.com/InsightsCare/ We are also available on : Copyright © 2023 Insights Success Media and Technology Pvt. Ltd., All rights reserved. The content and images used in this magazine should not be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from Insights success. Reprint rights remain solely with Insights Success Media and Technology Pvt. Ltd. Insights Care is powered by Insights Success Media and Technology Pvt. Ltd.

  8. 10 Most Efficient Drug Delivery Solu?on Providers in 2023 Featuring Person Company Name Description Adocia is a clinical-stage biotech company specialized in the development of best-in-class medicine relying on innovative formulations of already-approved therapeutic proteins. ADOCIA adocia.com Gérard Soula CEO Comera Life Sciences is committed to transforming the formulation of biotherapeutics for the ultimate benefit of patients Comera Life Sciences comeralifesciences.com Jeffrey Hackman Chairman & CEO Crossject is revolutionizing the administration of well-established, clinically-proven treatments and bringing unprecedented advantages to patients with its innovative, needle-free auto- injector ZENEO®. Patrick Alexandre Founder & President of its Executive Board Crossject crossject.com ICONOVO AB is developing proprietary inhalation products for licensing. ICONOVO AB iconovo.se Johan Wäborg CEO Matrivax Research and Development Corporation is applying breakthrough science to develop life-saving vaccines for people in need around the globe. Matrivax Research and Development Corporation matrivax.com Enda Moran CEO PolyPid is a global clinical-stage bio- pharmaceutical company focused on developing, manufacturing and commercializing novel, locally administered therapies to improve surgical outcomes. Topas Therapeutics GmbH is a clinical-stage biotechnology company with a mission to deliver novel, disease-modifying treatments for autoimmune and inflammatory diseases. Dikla Czaczkes Akselbrad CEO PolyPid polypid.com Klaus Martin CEO Topas Therapeutics GmbH TransCode Therapeutics, Inc., an RNA oncology company, has developed a modular, iron oxide nanoparticle–based nanocarrier system for the delivery of RNA therapeutics to tumors. Michael Dudley Co-Founder and CEO TransCode Therapeutics, Inc. transcodetherapeutics.com Xylome is a synthetic biology company with a deep understanding and proprietary genomic tools for the manipulation of non-conventional yeasts. Dr. Thomas Kelleher CEO Dr. Thomas Jeffries President & Founder Xylome xylome.com Ziccum AB's ambient drying technology LaminarPace opens up unique thermostable formulation possibilities for next-generation biomolecules - from vaccines to protein therapeutics. Ann Gidner CEO Ziccum AB ziccum.com

  9. Jeffrey Hackman Chairman and CEO Comera Life Sciences

  10. 10 Most Efficient Drug Delivery Solu?on Providers in 2023 Transforming IV to SQ Biologic Therapies to Improve Patients’ Quality of Life In contrast to IV delivery, SQ delivery involves a single brief injec?on through a smaller syringe designed to cause less pain and discomfort. According to the majority of physicians that Comera has surveyed, SQ dosing is strongly preferred over IV, if available.

  11. B needles to administer liquid medications into the veins of patients. Infusions are performed in an in-patient setting of either a hospital or an infusion center. That process comes at the expense of time and comfort as the treatment can take multiple hours to administer and can be a painful experience. B A Brief on Comera Life Sciences iologic therapies have gained a lot of attention in the last two decades for their role in treating diseases for which no treatments previously existed. For many patients, however, intravenous (IV) delivery is currently the only option for taking these lifesaving medicines but this often involves the use of IV Comera Life Sciences aims to give patients the freedom to self-administer life-saving products at home, a mission that is important to Jeff on a personal level. His wife, who passed away from breast cancer, had to endure various intravenous (IV) therapeutics during her ten-year treatment journey. Millions of patients needing IV drugs must spend hours at a hospital or infusion center with a large needle in their arm. It’s painful, time-consuming and costly. Intending to change this reality for people like his wife, Jeff joined the successful team at Comera as the CEO in 2021. This process naturally raises questions such as, “How are these treatments impacting the quality of patients’ lives?” IV delivery of biologics can be time-consuming and also painful and costly. This makes it challenging for everyone involved. Journey to Inception The company was founded in 2014 as ReForm Biologics and recently rebranded as Comera Life Sciences to reflect the vision of bringing about a compassionate new era in medicine. Comera is built on the belief that true medical advances are inspired by compassion. Its team of innovators sees itself in patients and their families and is working to make meaningful changes to how people take medicines. Comera Life Sciences is a life sciences company that leverages the power of high precision science and engineering to support patients in gaining back their freedom. Through its investigational self-injectable innovative subcutaneous (SQ) biologics, patients may have access to an alternative therapeutic delivery option in the future that can potentially aid in improving their quality of life. From the outset, Comera’s goal has been to develop novel excipients—substances added to a biologic drug to aid in manufacturing, delivery and stability—that can transform biologics from IV infusions to subcutaneous (SQ) injections that can be easier for patients to use. Since Jeff joined Comera, the company has expanded its focus to go beyond formulation science, and it is now reimagining the impact that its science could have on healthcare and the patient experience. In contrast to IV delivery, SQ delivery involves a single brief injection through a smaller syringe designed to cause less pain and discomfort. It enables self-administration at home, sparing patients from traveling to frequent appointments and reducing healthcare costs for supplies, storage and staffing. Moreover, an SQ injection has lower healthcare delivery costs and can be administered within the comfort of patients’ homes. According to the majority of physicians that Comera has surveyed, SQ dosing is strongly preferred over IV, if available. Jeff and the team at Comera, together, are working with industry partners to accelerate the development of SQ formulations of monoclonal antibodies (mABs) that can substantially impact millions of patients while also developing their pipeline of candidates. This ambitious mission led them to take the company public in May 2022. Jeff Hackman, the Chairman and CEO of Comera Life Sciences, is leading the company as it advances a promising clinical pipeline aimed to improve patient experience, potentially increase patient adherence and reduce the overall cost of care during their course of treatment. Comera’s focus is to help patients who depend on IV biologics for treating significant diseases. That’s why the company has set out to maximize the true potential of life- changing biologics by empowering patients to administer their own medicine via a single, simple injection wherever they feel most comfortable. Let’s learn more about the innovative work Comera is doing to advance SQ therapeutics and how it has the potential to improve patients’ lives.

  12. Comera is working to transform IV biologics into SQ versions that can be administered by syringe in a single dose, poten?ally increasing pa?ent compliance and quality of life.

  13. The SQore™ Technology Approach to Transform Medicines Comera is not the only one studying excipient technology, but its team is one of the first to pursue this science for antibody reformulation and potential patient care at home. Foundational to the company’s approach is its SQore™ technology, a proprietary excipient formulation platform that aims to transform medicines from IV to SQ form. A longstanding challenge to developing viable SQ biologics is viscosity. A lower volume of medicine in an SQ formulation requires increasing the drug concentration, often to the extent that biological molecules aggregate or stick together so that they can no longer be delivered through a syringe. To date, few companies have been able to develop effective excipients to reduce the viscosity of antibodies for SQ delivery. However, the SQore platform potentially solves this dilemma through proprietary techniques using excipients to decrease the viscosity of IV drugs so that they can be delivered subcutaneously while maintaining their stability and efficacy. The biologics market is es?mated to grow to $422 billion in 2025, and pa?ents worldwide rely on IV drugs for various condi?ons. In fact, seven of the top ten global medicines are biologics, and most are administered intravenously, so there’s an opportunity to improve how these pa?ents receive their medicines significantly. Unlike other excipient approaches that have been unsuccessfully applied for decades, SQore technology does not alter the structure or form of antibodies in solution, reducing drug product development uncertainty, time and expense. Comera is working to transform IV biologics into SQ versions that can be administered by syringe in a single dose, potentially increasing patient compliance and quality of life. Unique Products and SQ Solutions at Comera The biologics market is estimated to grow to $422 billion in 2025, and patients worldwide rely on IV drugs for various conditions. In fact, seven of the top ten global medicines are biologics and most are administered intravenously, so there’s an opportunity to improve how these patients receive their medicines significantly. Comera has over 200 excipients that it is using to reformulate marketed IV biologics for SQ administration. It has a number of novel and proprietary excipients, and its lead excipient is caffeine. In its SEQURUS-1 and SEQURUS-2 preclinical studies, Comera’s team has demonstrated that a caffeine excipient can reduce the viscosity of the mAB ipilimumab without affecting its bioactivity.

  14. Represen?ng a massively growing market, biologics are at the vanguard of cu?ng-edge biomedical technology and driving the next genera?on of treatments for pa?ents. The company also has a pipeline of three wholly owned candidates: CLS-001, an SQ formulation of the mAB vedolizumab in preclinical development for inflammatory bowel syndrome; CLS-002, a SQ formulation of an unannounced mAB in preclinical development for immuno- oncology; and CLS-003, a candidate in the research stage for an unannounced indication. CLS-001 and CLS-002 are currently in IND-enabling studies, with filings anticipated in 2024. platform to enhance both commercial biologics and those in the early development stages. Its proprietary platform supports others in the industry to address formulation challenges and make biologics more easily administered subcutaneously. All these initiatives aim to bring this important therapeutic modality closer to the patients who need it. Wrapping Up SQ delivery, when available, is generally preferred by patients and healthcare providers and can result in reduced drug delivery-related healthcare costs and resource use. Looking ahead, Comera will continue its two-pronged approach of growth through its internal pipeline and partnerships, complemented by a sizable patent portfolio protecting its technology. Advancement of Therapeutic Pipeline Representing a massively growing market, biologics are at the vanguard of cutting-edge biomedical technology and driving the next generation of treatments for patients. For this reason, the company will continue to focus on high- value collaborations with near-term milestone potential. Comera currently has three ongoing partnerships all of which include options to license after the technical evaluation of the asset is complete. In addition to its internal pipeline, Comera is advancing a pipeline of therapeutic reformulations through partnerships. Comera has three ongoing partnerships with other companies to develop SQ drug formulations using its innovative proprietary SQore formulation platform. Comera has a research collaboration with Regeneron, a leading U.S. biotechnology company, with high-priority assets in development. Recently, Comera extended and broadened this collaboration, which includes a right to negotiate a license after further technical evaluation is complete. A second partnership is with an undisclosed top 10 global pharmaceutical company for a drug that is commercialized globally, and grants Comera the options to license after further technical evaluation is complete. The goal will be to get an SQ-based biologic into clinical trials. Comera’s team is headed in that direction with IND- enabling studies ongoing in 2023. Their approach to reformulating known biologics demonstrates the potential for a faster development timeline and lower development costs. Through its collaborations with pharmaceutical and biotechnology companies, Comera is leveraging the SQore

  15. Crossject Saving Lives in Emergency Situations through Needle-free Injectables T he drug delivery industry is often on a constant lookout for innovative ways to improve how drugs are delivered to patients who are suffering from a specific illness. Syringes or needles are one of the first preferred resources when the drug is required to be delivered directly into the patient's body, passing through the skin. This is true in the case of medical emergencies—where quick action is required to ward off the risk of severities, a long-term consequence, or to manage a situation of stress or crisis. company has been listed on Euronext Growth in Paris since 2014. It receives funding from the United States BARDA (Biomedical Advanced Research and Development Authority) under contract n° 75A50122C00031 and from Bpifrance (French Government investment bank). Crossject is developing and will soon commercialize a portfolio of treatments for emergencies, including epileptic seizures, adrenal insufficiency, anaphylactic shock, and opioid overdose, all based on its unique needle-free auto- ® injection platform, ZENEO . However, in emergencies like an epileptic seizure, anaphylactic shock, or suffering an overdose—where patients are the victims—do needles and syringes guarantee to be an immediate therapeutic solution? ZENEO finds its origins in the combination and miniaturization of cutting-edge technologies used in the automotive, pharmaceutical and aerospace sectors. Our technology relies on a specifically formed, siliconized, depyrogenated, pharmaceutical glass tube (unique technique worldwide) that can support up to 1,200 bars of pressure, in conjunction with a polycarbonate nozzle with submillimeter conduit that directs the injection thru clothing and into the skin/muscle in a precise minute stream to the desired depth of injection. ® Crossject is a leading company that is revolutionizing the administration of well-established treatments in emergency situations by developing innovative life-saving solutions. ® ZENEO is its injective approach which provides an alternative to using needles and syringes. Patients no longer have to fear needles as this product is a needle-free self- administration innovation designed to support patients in emergencies and life-threatening situations. This unique delivery system is coupled to a state-of-the-art energy material-based gas generator with an actuator culminating in a simple-to-use, safe and efficient injection system. In an interview with Insights Care—Patrick Alexandre, the Founder of Crossject and President of its Executive Board—shares how his company's innovation, ZENEO , is dedicated to fulfilling the mission of saving the lives of patients across the world. ® Shed some light on your journey as the guiding light of the company. How does your presence play an important role in the growth of the company? Below are the highlights of the interview: With its patented, needle-free auto-injection system, Crossject aims to become the world leader in self- administered emergency treatments. Kindly brief us about the company. What led to its inception? Crossject is a French speciality pharmaceutical company based in Dijon and spun off from Fournier Labs. The In 1997, I began directing the conceptualization and development of needleless injection technology at 16 March 2023 www.insightscare.com

  16. 10 Most Efficient Drug Delivery Solu?on Providers in 2023 About ZENEO®, a Needle Free Auto-Injector ZENEO needle-free auto-injector is a device that has been designed with patients for patients. It enables a very easy injection in only two steps, "Open and push" onto the injection site. With this device, Crossject brings to the patient and caregivers the molecules that they would have received in the hospital before arrival. It is a unique technology for the needle-free injection of medicines. ® The prefilled, single-use device propels the treatment through the skin in less than a tenth of a second. ZENEO® is factory-set as a function of the viscosity of the medicine, its dosage, and injection route (subcutaneous or intramuscular). Patrick Alexandre Founder and President of its Executive Board Crossject Its reliance has been reflected in the last Human Factors study conducted by Crossject in 2022, which showed a 99.6% success rate on the use scenario assessed. 17 March 2023 www.insightscare.com

  17. Laboratoires Fournier, now Abbvie. In 2001, I built upon that acquired expertise to launch Crossject and ZENEO , which has now proven to be a world-premiere technology to inject a drug without a needle, even through clothing. the top of the device, and high pressure is released by the expansion of powders (slow and fast). This high pressure pushes down the liquid into a canal with a diameter of 0.4mm, and a thin jet of pharmaceutical product hits the skin at 200m/s and reaches the muscle. ® I graduated from Supélec, a top engineering school in France, and was an R&D manager in the steel industry for 10 years before joining the pharmaceutical industry, where I worked for 15 years. Depending on the volume or viscosity of a drug, the device pressure profile can be modified to reach the targeted injection depth. Can you elaborate upon the core values, mission and vision on which the company is built? How does your company offer personalized treatment to the patient's concerns? Dare From the solid foundation of its unmatched technology, Crossject aims to become the world's leading pharmaceutical laboratory for emergency needle-free auto- injectables. ZENEO address many issues that patients are facing with current solutions. One of the biggest fears regarding injectable drugs is the needle. Crossject goes beyond the needle and changes the injection paradigm for many people, as 20% of us fear the needle, and 10% are completely needle phobic. ® Persevere Crossject's incomparable technology is the fruit of no less than 20 years of R&D. Thanks to its continuous R&D efforts dating back to 1997, Crossject has created a high- performance auto-injection system protected by 400 patents worldwide until 2036. ZENEO is the world's first clinically proven prefilled needle-free auto-injector capable of delivering treatments intramuscularly or subcutaneously. ZENEO has been developed to be very easy to use to make sure that even naïve users can inject a drug quickly and th safely in less than 1/10 a second; it is particularly interesting for an emergency situation such as epileptic seizure where it is rather challenging for a non-professional caregiver to give an Intramuscular injection of Midazolam with a needle-based solution on a convulsing patient. ® ® Innovate Crossject developed a needle-free injection technology, unique worldwide, capable of delivering treatments in less than a tenth of a second. To always move forward, Crossject has united a vanguard team of specialists from a range of industries and thus gathered the expertise it needs to empower each step of its evolution. What diagnostic tools does Crossject find to be essential in conducting its operations? Understanding patient needs, the different scenarios, and the environment has been at the centre of Crossject needle- To save lives simply The purpose of the revolutionary, needle-free auto-injection ® system ZENEO is nothing less than to save lives in emergencies. Brief us on the scientific process of drug delivery to the company's target population. ZENEO® uses miniaturized automotive industry technology from airbags and pre-tensioning seat belt systems to deliver drug products into the muscle without the use of a needle. As soon as the device is pressed against the skin, the spring- loaded striker is released. It hits a gas generator located at 18 March 2023 www.insightscare.com

  18. free drug/device combinations products. The company has designed its unique solution with and for the patient and tested it through numerous Human Factors studies that assessed that the device was used properly and safely in different use environments. Crossject developed a needle-free injection technology ® ZENEO , unique worldwide, is capable of delivering treatments in less than a tenth of a second. With this patented, needle-free auto-injection system, the company aims to become the world leader in self-administered emergency treatments, saving patients' lives worldwide. What endeavours is Crossject currently pursuing to improve its measures for patients? Crossject is constantly discussing with health authorities and patients to ensure its device meets crucial medical requirements. The company has been developing a portfolio of seven drugs, mostly for emergency use to bring to patients or their entourage solutions that can be safely used outside the hospital. What advice would you like to give to budding entrepreneurs and enthusiasts who desire to venture into drug delivery? Maintain your enthusiasm, expand your knowledge base, and push for perfection in a rapid, sustainable methodology. Fail often, fail quickly, learn from your failures and move on towards success! 2022 has been an important year for Crossject as it has signed an agreement with BARDA for the late-stage development, regulatory approval and procurement of its lead compound ZENEO Midazolam. This program has also shown positive outcomes through a bioequivalence study. This study demonstrated bioequivalence in an intra- muscular injection with ZENEO Midazolam compared to an injection of midazolam with a syringe and 30-mm needle. It also demonstrated that clothing had zero impact concerning injection with ZENEO . How do you envision scaling your organization's services and operations in 2023 and beyond? Through our partnerships with international pharmaceutical companies and government agencies, we intend to become the world's foremost supplier of rapid, safe, easy-to-use needle-free auto-injectors for personal emergency use. ® ® 2023 will be a crucial year for Crossject as it will file its first marketing authorization, a drug-device combination, ZENEO® Midazolam, as well as pursue other developments such as ZENEO Hydrocortisone for which the company has signed a licensing agreement with ETON pharmaceuticals. What are some of the testimonials or recognition that accurately highlight your organization's position in the market? Many patient advocacy groups within the epilepsy, food allergy and adrenal crisis world have expressed serious desires for a rapid, safe, easy-to-use emergency auto- ® injector. ZENEO , Midazolam, ZENEO Epinephrine and ® ZENEO Hydrocortisone bring this desire to reality for these patients and their caregivers. ® 19 March 2023 www.insightscare.com

  19. Digital very industry, including healthcare and medicine, in the modern age incorporates digital tools and various technologies to enhance operations. When it comes to implementing digitalization, technology is not a driver, but it is critical to make the process happen. According to Anita Goel, MD, PhD, the next generation of healthcare will be decentralized, mobilized, and personalized. Instead of the past's blunt instruments, we will give patients more precise medications and therapies. Digital Digital E Let’s understand in detail the key role of digitalization in managing medication! Why is digitalization in Medication Management important? Adherence to personalized medicine and management is the best solution for the suboptimal use of medicines. Hospitals and small clinics primarily face medication management issues and adverse outcomes due to prescribing errors, medication contradictions, over and under-prescriptions, patients' responses, etc., as patients are vulnerable between the process of getting primary care and a specialist opinion. Hence, it is the responsibility of hospitals and healthcare systems to undertake the obligation of medication management. The most vital part of healthcare is medicine; without it, therapeutic processes will be hampered. As telemedicine, virtual reality (VR), robotics and Artificial Intelligence (AI) are changing the healthcare landscape, taking the help of these tools, the management of medicine can be done appropriately. Medication management is a strategy that involves managing medicine stocks, prescriptions, and administration to patients. In general, the process consists of the brown bag method, and with its help of it, patients and caregivers are engaged in creating a list of complete, accurate medicine. It is also known as the 'Medication Management Pathway'. 20 March 2023 www.insightscare.com

  20. 21 March 2023 www.insightscare.com

  21. Telemonitoring: Remote patient monitoring during and after the pandemic has become a norm, spreading awareness among patients to take their medication schedules seriously. Healthcare professionals help patients with any help without interrupting their comfort at home and patients having difficulties reaching the medical care centres. For example, wearable sensors used in this method can help professionals track their patients' health conditions from a distance. Additionally, old systems were manual and non-digitalized. Also, the visibility of medicine stock was low and medical data was vague, as well as the lack of digitalization made the systems prone to errors. The OECD group has to pay millions for such errors to stabilize the healthcare system. Moreover, the whole process is suspected of having non- adherence to medicine management. There is always mismanagement in catching the statistics of actual pill intake, misunderstanding, patients' biased responses, etc. Web-based Software: This software solution improves medical management, especially after hospital discharge. It included pill identification, patient-friendly reminder leaflets, interaction checkers, adherence monitoring checkers, weekly medication schedules, and daily pill reminders. One of the important drawbacks of traditional methods of handling medicine management is patients are not exposed to appropriate tools. As a result, they cannot facilitate the management of their medicines. Moreover, daily hospital stays are becoming short, and therapies/counselling are also provided; however, patients often do not remember the instructions provided during their medical visits due to multiple health problems. In such a scenario, fast digital methods must be applied for better and smooth medication management. Electronic Medication Management (EMM) With the help of EMM, errors in prescribing medicines and dispensing them can be avoided. These systems enhance the accuracy and legibility of medical information for clear and transparent processes for patients, hospitals and professionals. Rather than searching for information and big files of patients in paper format, clinicians and professionals can directly access it through digital services. Digitalized Healthcare Due to the inception of digital methods, the healthcare sector has been modified. For example, telehealth, electronic, mobile, telemedicine, etc, have become popular and recognized as powerful tools that make the processes easy. According to a review in 2017, four primary digital strategies that enabled medication adherence in patients are interactive voice recording systems, Short Message Service (SMS), telemonitoring, and web-based software. The system is developed to digitally manage medical prescriptions, reviews, dispensing, medications, administration, etc., in their electronic files. Moreover, EMM protects patients' data and provides them with safety. EMM adopts the technology and security protocols that enable safe mode. Also, if, in any case, any electronic device having an EMM system gets lost, admins can wipe the data electronically. Interactive voice recording systems: While handling medicines, problems such as medication side effects, costs, and forgetting about the intake of medicines can hamper the decision and health of patients. In this case, interactive voice recording systems remind individuals to take or refill their medications. The system provides personalized and medication-specific reminders and communication with voice recognition. In conclusion, digitalization in Medication Management is vital for enhancing healthcare operations. By adopting digital tools and technologies, hospitals and healthcare systems can address medication management issues, improve patient adherence and minimize errors. Digital strategies like interactive voice recording systems, SMS interventions, telemonitoring and web-based software enable personalized and effective medication management, leading to better patient outcomes. Electronic Medication Management further enhances accuracy, accessibility, and data security in healthcare processes. Short Message Service (SMS):For medicine adherence, SMS services are used often. A study shows that text message interventions have improved the adherence rate in patients. It also shows that those patients were recovering from chronic physical and mental diseases such as HIV, asthma, diabetes, schizophrenia, etc. - Saloni Agarwal 22 March 2023 www.insightscare.com

  22. Dikla Czaczkes Akselbrad CEO PolyPid Ltd. Surgical Site Infections, the most common hospital-acquired infections in the US, can result in additional seven to eleven days of hospitalization and cost the US healthcare system as much as $10 Bn each year. Our main product, D-PLEX is designed to release antibiotics 100 over a period of thirty days to prevent post-surgical wound infections or SSIs. 24 March 2023 www.insightscare.com

  23. 10 Most Efficient Drug Delivery Solu?on Providers in 2023 PolyPid Ltd acquired infections, in particular surgical site infections (SSI), unfortunately remain amongst the most common potentially preventable complications. Those who develop infections not only face a risk to their health but may also have to delay other import treatment (i.e., oncologic care). From a health care system perspective, surgical site infections risk increased hospital stays, escalated expenses, and higher readmission rates and thus, infections have become a clinical and economic burden for patients and hospitals. Eliminating Surgical Site Infections (SSIs) through Controlled Delivery of Medications ost-surgical complications hinder the patient's return P enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. to their preoperative health status. Health care PolyPid's lead product candidate D-PLEX is in Phase 3 clinical trials to prevent abdominal surgical site infections. In addition, we are currently in the preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma. 100 Shed some light on your journey as the guiding light of the company. How does your presence play an important role in the growth of the company? I joined PolyPid in 2014, and in my position as Chief Financial Officer, I successfully raised over $200 million for the company. I led the company through its initial public offering in June 2020, right in the midst of the chaos of the early days of the Covid-19 pandemic. As part of PolyPid's executive management team, I helped the company maintain high patient recruitment numbers, recruiting close to 1,000 patients across 60 centers, despite the patient recruitment decline that most pharmaceutical companies faced during the pandemic. One way to reduce the threat posed by SSI is to improve the prophylactic measures taken perioperatively, such as timely and controlled administration of medications at the surgical incision site. PolyPid Ltd, a global clinical-stage biopharmaceutical company targets this core aspect. Its product candidates allow surgeons to deliver medications locally to the body for days and months, in a controlled and continuous manner. In an interview with Dikla Czaczkes Akselbrad, PolyPid's CEO, she highlights the core products developed at the company to improve patient outcomes in localized medical conditions such as infection, pain, inflammation and cancer. This past July, I assumed the role of Chief Executive Officer of the company. One of my first actions as CEO was to guide the company through an exclusive licensing agreement with Advanz Pharma for the commercialization of the company's lead product candidate, D-PLEX , for the prevention of surgical site infections. This deal, which was signed even before the results of the company's Phase 3 clinical trial were released, included upfront and milestone payments, as well as royalties on net sales. It is now my role to expand the breadth of PolyPid's pipeline while transitioning the company from a clinical stage company to a commercial-focused one. Below are the highlights of the interview. 100 Kindly brief us about the company. What led to its inception? PolyPid is an Israel-based, public company, traded on NASDAQ. Our PLEX (Polymer-Lipid Encapsulation matriX) platform was developed by our founder, Dr. Noam Emanuel, in response to a clear need from physicians, specifically dentists who were looking for a solution that can treat severe gum infections over a prolonged period. Over the years, PolyPid has demonstrated the capabilities of its PLEX platform to encapsulate and locally deliver several types of Active Pharmaceutical Ingredients (API), including antibodies, proteins, peptides and small molecules. PolyPid's proprietary PLEX technology pairs with APIs, Can you elaborate upon the core values, mission and vision on which the company is built? While the standards of care have advanced, physicians' ability to optimize surgical care remains limited. From surgical infection prevention to effective local delivery of medications, PolyPid is on a mission to improve surgical outcomes, arming surgeons with its proprietary local drug 25 March 2023 www.insightscare.com

  24. delivery platform that integrates with existing hospital/ and operating room protocols. development based on novel drug delivery platforms is a long journey, it has ups and downs, highs and lows, and there are surprises at every corner, on the science side, talent, and financing. A leader in this area should remain focused on the end goal while adjusting to the changing circumstances. With controlled and continuous local delivery of medication using PolyPid's PLEX technology, physicians can incorporate this solution into various surgical procedures – distributing medication directly at the surgery site with optimal release rates to maximize the success of the procedure. How do you envision scaling your organization's services and operations in 2023 and beyond? PolyPid's PLEX platform circumvents a big challenge manufacturers encounter when developing new drugs, how to deliver drugs to their target in high enough concentration to be effective without any risk of significant systemic drug exposure, dramatically increasing the safety margin of a given medication. Whether by enhancing the delivery of already approved drugs or by creating new approaches to innovative molecules, we believe our PLEX platform can improve efficacy, reduce systemic side effects, and generate better patient outcomes. We have recently completed a 977-patient phase three trial, the largest clinical trial in the prevention of infection in colorectal surgery in over a decade. Our next step will be to discuss with the FDA the path for approval of the drug. Once we have a clear path for approval, we will scale up our manufacturing capabilities and start developing commercial capabilities to be able to bring the product as fast as possible, post-approval, to the hands of surgeons. A big part of this scale-up will be done in collaboration with partners. We already have a commercial partner for D- PLEX in Europe and are in advanced discussions with 100 other potential partners for other territories, such as India, China and Latin America. What are the core products and services that your company has to offer? In what way do they serve the target population? How are these different from other forms of care that patients receive or do not receive in general? In terms of pipeline, our current focus is on pairing PLEX with chemotherapy. We are constantly evaluating our future program to identify new areas where we can add value on our own or with other biotech companies pairing PLEX with novel antibodies. We have shown in the past that the PLEX platform works well with small molecules as well as large molecules, peptides, and siRNA. PolyPid has developed its own proprietary drug delivery platform that can encapsulate almost any API and deliver it locally over a prolonged, pre-determined period. Our main product, DPLEX is designed to release antibiotics over 100 thirty days to prevent post-surgical wound infections or SSIs. SSIs, the most common hospital-acquired infections in the US, can result in an additional seven to eleven days of hospitalization and cost the US healthcare system as much as $10 Bn each year. The PLEX platform is ideal when local administration is preferred to systemic administration to avoid toxicity while addressing localized disease and the associated difficulties of achieving sustainable therapeutic drug levels at the site. We are looking to collaborate with companies interested in the life-cycle management of already approved molecules and for new innovative ones where effective local disease eradication is the major clinical goal. DPLEX has shown in a large phase three trial a reduction 100 of 54% in infections in complex, large incision colorectal surgeries (>20cm), compared to the current standard of care. Our second product, OncoPLEX, currently in pre- clinical studies, combines our PLEX platform with approved chemotherapy to serve as local intra-tumoral adjuvant treatment for solid tumors. OncoPLEX provides a high, local concentration of chemotherapy directly to the tumor resection bed for a period of up to 3 weeks, limiting the risk of typical side effects of traditional systemic chemotherapy delivery. What are some of the testimonials or recognition that accurately highlight your organization's position in the market. We are proud for our company to have achieved Corporate Live Wire Global Awards Winner 2022/ 2023 - Bio- Pharmaceutical Company of the Year. What advice would you like to give to budding entrepreneurs and enthusiasts who desire to venture into the process of drug delivery? I would advise young entrepreneurs to prepare for a marathon. Drug development in general and drug 26 March 2023 www.insightscare.com

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  26. Overcoming Barriers to Adherence A pressure, etc. Such patients can also enjoy a good quality of life if they maintain a regular intake of their medicines. Poor clinical outcomes are generally not caused due to treatment and medical issues but because of irregularity in the intake of medicine. routine might be boring; however, it saves time, and it is important for patients who are suffering from chronic diseases like diabetes, HIV, blood corresponds with the agreed recommendations from a health care provider." In general, healthcare professionals use terms such as adherence and compliance simultaneously. However, in practice, these terms differ in a small context. Compliance implies how the patient is obedient to the physician's prescriptions and authority. Adherence believes in a combination of the physician's advice and the patient's lifestyle. Though patients really care about their health, the state of ignorance, 'Medication non-adherence state arises due to a variety of reasons, including affordability issues, less knowledge and understanding of the importance of taking medicines, and most importantly, hazardous side effects of these medicines, especially in chronic diseases. If anything from prescribing medicine to the completion of treatment goes wrong, then one of the primary reasons must be non-adherence to medicines. Among several reasons, two main reasons are indisputable and degree of overlap. In the first one, clinical professionals provide prescriptions, but the medicine never gets initiated. This is also known as 'non-fulfillment adherence'. The second type involves a condition wherein patients stop taking medicines after starting and continuing them for a while without consulting their doctors. This is also known as 'non- persistence' behaviour. Let's understand in detail the compliance to follow in overcoming barriers! Medication Adherence: Types The World Health Organization defines medication adherence as "The degree to which the person's behavior 28 March 2023 www.insightscare.com

  27. Medication Compliance 29 March 2023 www.insightscare.com

  28. Reasons behind Medication Non-adherence patients, clinicians and healthcare systems plays a vital role. In order to carry out it effectively, there must be a variety of ways and different adherence approaches in conjunction used for patients. A blend of numerous methods is recommended instead of suggesting a single method. Why does non-adherence to medicine continue to be an issue for most patients? Patients always want to get better in no time and still, they fail to follow the routine. Some of the reasons are mentioned below: Some of the methods are mentioned below: Inadequate Education: Patients are unaware of the advantages of therapy or the potential negative effects of non-adherence. For that reason, they may refuse to take their medicines. Also, they might have concerns about negative effects or gradually lose interest. Ÿ Proper Education and Communication with Patients: By providing patients with timely information and detailed instructions, healthcare professionals can help them overcome obstacles to medication adherence. They should be informed about prescribed medication, the benefits of following their care plan, and resources to minimise side effects. Help patients to merge their medication and care plan into their daily routine. Ÿ Complexity in Medicines: Simply put, patients may find it difficult to recall what their doctor told them. They might require more assistance to remember the schedule and which medicine should be taken at what time. Ÿ Motivation is necessary: Patients must be encouraged to follow their treatment plan and reminded of its importance in addition to receiving education about the same. This ensures patients' adherence to their prescriptions. Moreover, if a patient achieves any milestone in his journey of medication adherence, this should be acknowledged and appreciated timely. Ÿ Finance Problems: Sometimes, money becomes the biggest barrier in the journey of curing patients. Patients who can't afford a medication may stop taking it. Medicines can be highly expensive and hence patients are in denial of taking them for a long time. Ÿ Logistics Problems: Patients may find it challenging to stay on schedule due to issues with transportation. They might not pick the medicines up if frequent trips to the pharmacy are necessary, particularly if the patient has several drugs that are renewed on various schedules. Moreover, if the patient is not capable of reaching drug stores due to health conditions, their medical supply is likely to be delayed. Identify and address Barriers: To increase medication adherence, patient participation in decision-making is very essential. To choose the best treatment technique, healthcare professionals must first discover the underlying causes of patient non-adherence. Moreover, applying technology and digital means to the treatment can benefit the patients. Patients must be kept on track by proactively responding to queries, offering encouragement, and disseminating information, etc. Ÿ Ÿ How can we improve medication adherence with medical compliance? In conclusion, With better communication and automated outreach via mobiles, many of the recognised obstacles to medication adherence can be removed. Text messaging has been found to be a useful strategy for encouraging adherence. In practice, carrying out medical compliance is very crucial as various aspects affect the process. For successful medication adherence, the 100 percent involvement of In conclusion, we might answer the common question among patients—why am I not getting cured? To get cured and come back to normal life, patients must know the importance of medication adherence and its benefits. Not impossible with good communication, digital ways to reminders, and medical help this can be achieved. - Saloni Agarwal 30 March 2023 www.insightscare.com

  29. Ann Gidner CEO Ziccum 32 March 2023 www.insightscare.com

  30. 10 Most Efficient Drug Delivery Solu?on Providers in 2023 Ziccum Expanding the Potentials for Next-Gen Vaccines and Biologics B healthcare sector, these biologics are delivered in liquid form. However, their liquid formulations pose chemical and physical stability concerns as they can be negatively affected by moisture, temperature, oxygen, or prolonged storage. iologics are often composed of living organisms and molecular weights that make them vulnerable to change in the environment. Traditionally, in the Environmental Medicine in Karolinska Institutet, Stockholm) to generate small amounts of micronized particle powder for aerosolization, including biologics. As there was (and remains) a significant unmet need for a system that can dry biologics with no heat damage, the potential of LaminarPace ambient drying was immediately clear. Shed some light on your journey as the guiding light of the company. How does your presence play an important role in the growth of the company? In recent years, drug-delivery operators have been looking to eliminate this formulation gap. Thus, they are slowly opting for alternative biologics that are rather formulated as a dry powder and freeze-dried products that are more promising with regard to their stability and longer shelf life. I became the new CEO of Ziccum on May 9th and hit the ground running with an ambitious raft of new strategies. These included a new Business Model, targeting key vaccine platforms, streamlining the company's project pipeline and strengthening its focus on industrial partnering. To address the market's needs, Ziccum is developing LaminarPaceTM, a unique ambient drying method for pharmaceuticals and vaccines. Unlike other pharmaceutical drying systems, it uses the science of mass transfer rather than heat transfer to the active ingredient, thus enabling thermostable dry powder pharmaceuticals. I have decades of senior strategic pharma experience and an extensive international and national network. I also have significant experience in building up and turning around life science startups and designing and implementing new business models to achieve steep, sustainable growth—which is of particular value to Ziccum. In an interview with Insights Care, Ann Gidner, the CEO, talks about Ziccum's innovative technology that enables it to stand out in the drug delivery market. During my role, I've led Ziccum firmly toward an action- based approach, restructuring the company and firmly targeting pharma and biopharma companies (the company's earlier focus was on NGOs and IGOs.) Since the time I started working there, we have enlarged our business development pipeline very significantly, with a wide range of new dialogues established. We have also closed 2022, receiving funding for an advanced, cutting-edge project developing digital 3D Modelling and a Digital Twin of LaminarPace. This will be very valuable in helping partners implement the technology seamlessly into their vaccine and biopharma manufacturing lines. Below are the highlights of the interview. Kindly brief us about the company. What led to its inception? Ziccum was established in April 2017 as a spinout from its parent company, Inhalation Sciences AB (ISAB). It was set up to develop and commercialize ISAB's laminar drying system, LaminarPace. LaminarPace was originally invented by Per Gerde (Assoc. Prof of Inhalation Toxicology at the Institute of 33 March 2023 www.insightscare.com

  31. Can you elaborate upon the core values, mission, and vision on which the company is built? Ziccum's vision is to enable new biological treatments for patient needs globally. Our unique contribution towards this is by making drug formulation, biopharmaceutical processing, product transport and patient administration more efficient – with our unique ambient technology for drying next-generation vaccines and biotherapeutics. healthcare provider in a Low to Middle-Income country that does not have that kind of infrastructure. So, we see a great opportunity here for ambient drying to help formulate a new generation of thermostable biopharmaceuticals that could also be administered using a range of different routes beyond only injectables. We emphasize sustainability too. We believe that thermostable vaccines and biologics can help reduce the impact of the global cold chain for those therapies—helping reduce the currently large carbon footprint of today's pharmaceutical manufacturing and supply chains. LaminarPace can dry delicate biomolecules, with no heat stress or degradation, from nebulized droplets into dry, fast- dissolving particles that are thermostable and also well- suited to inhaled and novel administration routes. What are the core products and services that your company has to offer? In what way do they serve the target population? We are passionate about driving forward innovation in biopharmaceutical formulation. The innovation we're seeing around new biologics and vaccines today is fantastic – from cancer vaccines to personalized vaccines to mRNA. We want to match that innovation in development with innovation in formulation too. And there is a big need for this. Our core product is LaminarPace, our unique ambient drying method for biopharmaceuticals and vaccines based on mass transfer, not heat transfer. The technology is offered by licensing to vaccine and biologics developers and manufacturers in the global pharmaceutical industry. By reducing drying stress to the active ingredient, LaminarPace uniquely enables particle-engineered, thermostable dry powder biopharmaceuticals which can be easily handled and transported and also are highly suitable for novel administration routes. The technology has been successfully applied to mRNA, peptides, proteins, antibodies, lipids, and enzymes as well as excipients and adjuvants, and is well suited for industrial application. Take the year, 2022. The world's three best-selling drugs were all Biologics. From Pfizer's mRNA Covid-19 vaccine to AbbVie's monoclonal antibody treatment for rheumatoid arthritis to Merck's humanized antibody cancer immunotherapy. They're all inspiring, ingenious therapies derived from living, protein-based biological materials – and they have all transformed the treatment landscape of their indications. But they all require refrigeration or ultra-cold freezing to be stored and transported. One of them, for example, can only be stored and transported at an ultra-low temperature (ULT) of -60ºC to -86ºC which is a big challenge if you are a LaminarPace dries next-generation vaccines and biologics as thermostable, particle-engineered powders that require no cold chain and are highly suited for novel administration routes. 34 March 2023 www.insightscare.com

  32. Take the year, 2022. The world's three best- selling drugs were all Biologics. From Pfizer's mRNA Covid-19 vaccine to AbbVie's monoclonal antibody treatment for rheumatoid arthritis to Merck's humanized antibody cancer immunotherapy. They're all inspiring, ingenious therapies derived from living, protein-based biological materials – and they have all transformed the treatment landscape of their indications. How does your company offer personalized treatment to the patient's concerns? LaminarPace offers vaccine and biologics developers to deliver unique capabilities and competitive advantages in formulating their compounds for novel administration routes. We are currently evaluating LaminarPace drying for personalized cancer treatments. The technology is applied not primarily for thermostability purposes but for very convenient, gentle and convenient drying of individual doses. But they all require refrigeration or ultra-cold freezing to be stored and transported, which is a big challenge if you are a healthcare provider in a Low to Middle-Income country that does not have that kind of infrastructure. How do you envision scaling your organization's services and operations in 2023 and beyond? We are currently carrying out an advanced 3D Digital modelling/Digital Twin project that is optimizing LaminarPace for integration into the pharmaceutical manufacturing process. (This is in partnership with the ICP Institute of Computational Physics team at the Zurich University of Applied Sciences' School of Engineering (ZHAW). The project is accelerating LaminarPace's industrial development and scale out as a unique unit of pharmaceutical production. So we see a great opportunity here for ambient drying to help formulate a new generation of thermostable biopharmaceuticals that could also be administered using a range of different routes beyond only injectables. 3D modelling will be used to optimize LaminarPace design, exploring optimal capacity loads and increasing the repeatability of outcomes. It will be a valuable enabler of tech transfer and integration into existing pharmaceutical production chains. A cloud-enabled Digital Twin, the ultimate stage of the project, will enable real-time modelling and optimization. Unlike other legacy methods for drying pharmaceuticals (spray drying and freeze-drying, for example), LaminarPace operates by mass transfer rather than heat transfer, eliminating extreme temperatures and heat stress. Both vaccines and biologics are vulnerable to degradation from heat stress. Retaining API activity at the temperatures used in today's legacy drying technologies remains a challenge for drug developers and formulation specialists. LaminarPace meets that need. What are some of the testimonials or recognition that accurately highlight your organization's position in the market? We recently received funding from the Eurostars funding body towards our 3D Digital Twin project. International competition for funding was intense. It is an important validation of our business plan and technology (and the impact it could have in vaccine and biologics manufacture)—that our proposal was chosen among so many competitors. It is also a high-yield, low-waste drying technology. The increasing cost of biopharmaceutical raw materials offers important benefits. With spray drying, for example, a typical process yield is around 40% to 70% (leaving 60% to 30% waste). LaminarPace drying delivers a comparatively high process yield of around 80%, meaning typically, only 20% of the raw materials are wasted in the drying process. 35 March 2023 www.insightscare.com

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