The 10 Successful Magnetic Leaders Revamping The Healthcare

VOL 12 | ISSUE 01 | 2020 The 10 Most Successful MAGNETIC LEADERS Revamping the Healthcare 2020 MAGNETIC LEADERS MAGNETIC LEADERS MAGNETIC LEADERS NETWORKING AND BUSINESS A CONNECTED WORLD GROUND REALITY THE IMPACTS OF PANDEMIC IN PHARMA AND BIOTECH LABORATORY CMIC.Inc Leading Treasure in Healthcare Industry Especially in Pharmaceutical Sector

Editor’s Desk T he outbreak and the effect of Covid-19 took everyone by surprise. This is a unique challenge. We have to adapt to the “new normal” of working remotely in our daily operations. It has forced us to prioritize health and to focus on critical matters in both business and life. The pandemic has its challenges and opportunities. Although it has a lot of thought to it. We have to see things from a positive angle and find new opportunities in the current situation. Leaders are involved in online leadership and scientific courses to refresh the knowledge on the situation and connect with other executives. Leadership styles have become contextual. A great leader is someone who can recognize the awareness of such a situation by interaction and adjust to the actual reality. It is although empathy, fairness, positivity, and leading by example that will build credibility and engage people. Leadership is not for everyone. If leaders decide to embark on one such entrepreneurial venture, they should not expect things to go according to the initial plan. They will always face disbelievers. All you have to do is, trust your gut feeling and channelize criticism as a motivation & driving force, and celebrate every little win. A leader is defined as a risk-taker. The Leader will know when it is time to abort or cash-in, any business model. Every leader should be able to listen, respect all points of view, make decisions for all, and not be afraid to make those decisions. Just believe in what you do! Stay motivated, persistent, and never give up. Ultimately, it is important to remember that not trying is worse than failing! A Golden Opportunity to Win and Shine

The world of healthcare has changed exceptionally over the last few months. Today, paramedical and pharmaceutical leaders have become the focus of healthcare where the aim is patient-centric. With an intent to acknowledge and admire these passionate leaders in healthcare, CIO Look has enlisted “The 10 Most Successful Magnetic Leaders Revamping the Healthcare 2020” - Jenny Lin is one such healthcare leader, COO & Board Member at CMIC, Inc. She holds 26 years of executive/lab management experience in bioanalytical and analytical laboratory operations in support of drug discovery, pre-clinical, and clinical drug development. Moreover, she is proficient in GLP, GMP, GCP, OECD, ICH, and 21 CFR part 11 regulations and business strategic planning & execution. Rohit Chaturvedi Let’s unveil more alike and motivating stories of such healthcare leaders in this special edition and spread the word about their contribution in making this world a better place. These leaders with their healthcare- educational skills, business competencies, and technical know-how, are taking healthcare to the next level. Finally, while flipping the pages, don’t forget to go through the articles and CXOs written by our in-house editorial team and industry experts respectively. Let’s begin...!

08 CMIC Inc. Leading Treasure in Healthcare Industry Especially in Pharmaceutical Sector Cover Story 22 Tech Insight Haseeb Awan 38 Ground Reality The Impacts of Pandemic in Pharma and Biotech Laboratory Article Networking and Business A Connected World 26

Contents Elaine M. Wallace Elevating Standards of Education in Healthcare 14 Elias Chabtini Becoming a Trendsetter in Cosmetic Industry 18 Karim Smaira 30 Committed to the Rare Disease Community Katrin Keller 34 A Leading Name in the Health-Tech Space METRENDALYTICS Efficiency in Business 42 Combining Knowledge and Technology to Bring Triox Nano Pioneers in point of care programmable medicine! presenting the next healthcare revolution! 48

Editor-in-Chief Sumita Sarkar Executive Editor Rohit Chaturvedi Assistant Editors Jenny Fernandes Managing Editor Anish Miller Co-designer Visualizer David King Art & Design Director Asha Bange Associate Designer Sanket Zirpe Kushagra Gupta Senior Sales Manager Business Development Manager Peter Collins Kshitij S Sales Executives David, Martin, Maneesh Marketing Manager John Matthew Business Development Executives Technical Head Jacob Smile Steve, Joe, Aidan, Prathamesh Digital Marketing Manager Marry D'Souza Technical Specialist Aditya Research Analyst Frank Adams SME-SMO Executive Amol Wadekar Database Management Stella Andrew Technology Consultant David Stokes Circulation Manager Robert Brown sales@insightssuccess.com December, 2020 Follow us on : www.facebook.com/insightssuccess/ We are also available on : www.twitter.com/insightssuccess Copyright © 2020 Insights Success, 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.

Management Company Name Brief CMIC, Inc. was established as a strategic cornerstone for CMIC Group’s North America growth. It has the vision to provide a solution service as “Pharmaceutical Value Creator” (PVC) that encompasses an entire value-chain of pharmaceutical companies. Jenny Lin Chief Operating Officer/Board Director CMIC, Inc cmicgroup.com Genpharm is managed by senior pharma executives with vast regional experience having held senior management roles in multinational pharmaceutical organizations. GENPHARM genpharmservices.com Karim Smaira Founder and CEO Medica Trading LLC is a leading Dubai-based medical trading company, committed to providing aesthetics, dermatology, and dental machines and products in the UAE and operating countries which meet the expectations of the interested parties. Medica Trading LLC medicagroup.com Elias Chabtini CEO Metrendalytics was founded by scientists, for scientists. The goal is to provide integrated solutions which provide a consolidated view of all of one’s operational data—whatever the source on one shared platform for faster interactive collaboration and client service with reduced risk. Metrendalytics metrendalytics.com Jan Miotto President Nova Southeastern University nova.edu Elaine M. Wallace, an Osteopathic Physician, certified in Family Medicine, Sports Medicine and Neuromusculoskeletal Medicine. Elaine Wallace Dean Professor Samedi GmbH founded in 2008 with the goal to solving communication problems beyond the boundaries of the individual medical practice wall and clinic wall for the benefit of the patient. Katrin Keller Manager samedi GmbH samedi.de TrioxNano’s revolutionary technology, termed S.M.A.R.T, an acronym for Stimuli Multi Adjusted Responsive Technology, or simply put “Programmable medicine” is based on combinations of DNA coding, DNA molecular machines and mesoporous nanoparticles. TrioxNano trioxnano.com Roy Farfara MD Founder & CTO

‘ ‘ ‘ ‘ Cover Story Leading Treasure in Healthcare Industry Especially in Pharmaceutical Sector Our vision is to advance the innovation of products and solutions that will empower people worldwide to achieve greater health and well-being.

‘ ‘ ‘ ‘ Jenny Lin Chief Operating Officer & Board Member CMIC, Inc.

‘ ‘ P themselves worthy of it. Meet CMIC, Inc., a leading CRO (Contract Research Organization) and a provider specialized in bioanalytical services, whose cutting-edge capabilities and sophisticated expertise in various aspects helped it achieve a greater stature in the business. Its bioanalytical services are in support of TK/PK/PD Biomarker studies for pre-clinical and clinical developments. It firmly focuses and holds expertise in bioanalytical method development, method validation/qualification and study sample analysis for small, large molecules and Oligonucleotide. The “CMIC” name originally stood for “Current Medical Information Center”, and the company remains committed to the advancement of medicines and healthcare revolution. As a strategic drug development partner, CMIC helps sponsors to overcome challenges in bioanalysis with expertise, rapid data turn-around-time, and high-quality customer services. harmaceutical sector is blooming at subsequently than ever being imagined. And only few companies proved ‘ ‘ The company states its core values intercepted through, W & 3C; • • WELLBEING: Fully Live Every Moment Challenge: Liberate opportunity by changing our vantage point Change: Transform without seeking refuge in conventional wisdom Communication: Proactively reach out to people and society • • The Story behind CMIC CMIC Inc., CMIC’s Chicago, Illinois location is a global CRO with over 30 years’ experience, the laboratory offers bioanalysis for non-clinical and clinical projects, both GLP and non-GLP within a state-of-the-art facility that has the capacity to accommodate quick turnaround for high-volume projects. CMIC’s skilled researchers provide deep expertise in small and large molecule bioanalysis, biomarker services and oligonucleotide bioanalysis expertise. Purpose built in 2010, CMIC Inc.’s contract bioanalytical and biomarker laboratory is located nearby Chicago O’Hare International Airport and is one of four global contract laboratories in the CMIC Holdings group. Our goal is to be your top tier Bioanalysis solution provider for drug discovery, development through commercialization. Current large molecule capabilities include detection of oligo, peptide, or antibody therapeutics using standard ELISA or MSD-ECL ligand-binding platforms. A variety of formats are

The 10 Successful Magnetic Leaders Revamping the Healthcare, 2020 available including but not limited to direct, indirect, sandwich, competitive, and multiplex which can be performed with off-the-shelf assays or developed in-house. For oligonucleotide detection by hybridization, CMIC Inc. brings a wealth of experience with capture and detection probe-based assays for quantitation of antisense or siRNA based therapies. CMIC Inc. plans to add droplet digital PCR and cell-based assays in 2021 to augment current GLP capabilities for bioanalytical support of gene therapy programs. While industry and regulatory contemporaries are building out a knowledge base for new and updated assays, CMIC Inc. will be well positioned to support large molecule biologics ranging from monoclonal antibodies, biosimilars, anti- cancer compounds, peptide-based therapies, gene therapy, and vaccines. CMIC Inc.’s flow cytometer has the ability to detect up to 13 colors, and is equipped with a 96-well plate loader to handle high-throughput applications. The software is 21 CFR Part 11 compliant, and displays easily viewed data. Immuno-phenotyping on whole blood, PBMC, or bone marrow can be performed with a general panel to determine the percentage of T- and B-cells, Natural Killer, and monocyte/macrophage lineage within the leukocyte population. Alternatively, specialized panels such as regulatory T-cells (Treg cells) can be characterized. Treg cells play a role in regulating or suppressing other cells in the immune system, and can be defined by the cellular markers CD25, FoxP3, and CTLA4, and the intracellular cytokines IL4 and TGFβ. Another specialized type of T- cell (one that is important for battling foreign invaders) is the CD4+ memory T-cell, which can be identified by staining CD45RA and CCR7 to determine the percentage of naïve, central memory, and effector memory T-cells within the overall T-cell population. Other flow cytometry applications include confirmation of gene expression in order to establish potency of gene therapy, or the efficacy of a treatment regimen. Real-time qPCR has emerged as a powerful tool for bioanalysis, and offers the ability to explore mRNA gene expression. RNA can be isolated from whole blood, PBMC, bone marrow, solid tissue, or matrices such as urine, saliva, or cerebrospinal fluid and then added to a reverse-transcriptase quantitative PCR to accurately quantify mRNA levels. Alternatively, DNA can be isolated and added to a qPCR to identify single nucleotide polymorphisms, for detection of known mutations, or to determine individual copy number variation. One of the more powerful applications of qPCR is the ability to multiplex, which is the detection of many targets within the same reaction. This can be leveraged for biomarker screening to determine which genes are differentially regulated in response to therapeutic treatment. CMIC Inc.’s qPCR instruments are compatible with a variety of flourophores and are fully supported by the vendor, providing for seamless design of specialized panels, thereby saving precious time and cost. Yet another application for qPCR is detection of viral nucleic acids in order to determine the remaining levels of a vaccine or gene therapy vector in order to establish washout and allow further optimization of a dosing regimen. A Glimpse into Jenny’s Life Jenny Lin, Chief Operating Officer and Board Member. She holds 26 years of executive/lab management experience in bio-analytical and analytical laboratory operations in support of drug discovery, pre-clinical and clinical drug development. Moreover, she is proficient in GLP, GMP, GCP, OECD, ICH and 21 CFR part 11 regulations and in business strategic planning and execution. Her expertise includes building organizational quality system, staff training, bioanalytical/analytical method development/validation, bioanalytical sample analysis, analytical development for CMC submission, chromatography purification, stability studies, reference standard certification, QC support for GMP manufacture. She has been also a selected member for Global Bioanalysis Consortium (GBC) making recommendations for global Bioanalysis harmonization. She serves as editorial board member for peer reviewed journal and chair for international conferences. Besides, she is an author and co-author for approximately 40 publications, white papers and presentations and is the inventor of 7 issued US patents. Jenny earned her BS in Analytical Chemistry at Peking University and her MS in Medicinal Chemistry at University of Connecticut. She is a member of the American Society of Mass Spectrometry (ASMS), American Association of Pharmaceutical Scientists (AAPS), American Chemical Society (ACS), National Association of Professional Woman (NAPW) and Global CRO Council (GCC). Future of CMIC CMIC CREED as corporate philosophy, consists of Wellbeing, Challenge, Change and Communication (W&3Cs). The company has been applying these philosophy to continuously evolve itself in line with market changes, and will do so in the future. Moreover, by further expanding from the current “Pharmaceutical Value Creator” (PVC) business model, the company has an aspiration to become a “Personal Healthcare Value Creator” (PHVC) to contribute for and to address to the up-coming personalized medicine and individual patient quality of life.

Top 10 Successful Magnetic Leaders Revamping the Healthcare -2020 Elaine M. Wallace Elevating Standards of Education in Healthcare T solutions are becoming patient-centric. In its upcoming edition “Top 10 Successful Magnetic Leaders Revamping the Healthcare” Insights Success is praising those leaders who are making remarkable progress in the sector with their advanced solutions and efficient services. One such healthcare leader is Elaine M. Wallace, anOsteopathic Physician, certified in Family Medicine, Sports Medicine and Neuromusculoskeletal Medicine. A Proficient Educator One of the most wonderful things about Elaine’s job is that she oversees 6 Bachelors programs, 6 masters programs, two PhD programs and a professional program in Osteopathic Medicine – the largest medical school within the state of Florida. Four of the bachelor’s programs are “track programs” into the DO medicine program. This means that the students take their bachelor’s training at NSU and are offered interviews with the DO program upon successful completion. This has allowed the college to admit a diversity of applicants from non-traditional fields including Public Health, Health and Wellness Coaching, Nutrition, and soon, Biomedical Informatics. This allows changes the composition of a typical medical school class and fosters a depth within the class that many other medical schools do not enjoy. he world of healthcare has changed remarkably over the last few years. Today, the patient has become the focus of the healthcare where the About Elaine Elainebegan her career in private practice in Kansas City Missouri, where her practice was a true family practice; she did her own D&C’s and tonsillectomies; she delivered one to two babies per week; she took care of geriatric and pediatric patients; established and was the director of a rape crisis center at Lakeside Hospital in Kansas City Mo. She loved family medicine, but during the mid-80’s, she made a transition to the Kansas City College of Osteopathic Medicine where she became the Chair of the Department of Osteopathic Principles and Practice. Shortly thereafter (1990), Elaine became the Assistant Dean of Clinical Education and has spent the remainder of her career in Medical Education. According to Elaine, Physicians are often not educators, so with her new role as a dean she went back to school at University of Kansas and received a degree in Higher Education Leadership and Administration. This has been followed by two other master’s degrees in education from NSU, one in Brain Based Learning as well as one in Curriculum Development. She also has a master’s degree in criminal justice with attention to forensic psychology and is currently in NSU Law School in the Education Law program. Current Challenges and Effects “COVID 19 offers challenges and opportunities,” says Elaine. She further adds, the biggest challenge has been the interruption of the third- and fourth-year clinical rotations at affiliated hospitals, which are not able to accommodate the students due to being overwhelmed with COVID 19 patients. This has caused the college to look with greater depth into online training and simulation training. Many of these materials were foreign, but they do offer education in a new modality that many of the students relate to. Learning through Reading, Travelling and Understanding People Elaine is an avid reader. She read one book per week. She asserts “I have read every novel written by Joyce Carol Oates. Having followed her career through her life and my life, I have grown to see the nuances in people, 14 | DECEMBER 2020 www.insightssuccess.com

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the absurdities of life and understandings of the vicissitudes of society.” Travelling world is also important to Elaine. She has been in 110 countries and on all 7 continents. She has also studied the great religions of the world in their origin countries and has learned that people the world over, are much the same – wanting what is best for their families and in their lives. Advising From Experience Elaine opines “Every leader should be able to listen; to respect all points of view; should demonstrate kindness; should make decisions for all; should not be afraid to make those decisions; should have a great sense of humor and should not take themselves too seriously.” On advising upcoming leaders, Elaine says “I would recommend listening in the quiet and finding the resonance of your passion and your mission. Then, never sway from that.” Combining Leadership and Team Work Elaine believes, she is supported by wonderful teams of people. She governs, not in a top down management, but with two management teams, one that is administrative with 5 members and one that is academic with 7 members. The team discusses all issues together; with multiple people having the “30 thousand-foot view” we are able to critique one another, guide one another and help one another from our diverse experiences. She also is guided by a vision of “how we get things done”, not “can I get things done”. Elaine is not afraid, if the front door is closed, to go through the back door or through the window to get to where she needs to go. She also laughs a lot. This is the key to much in life. “Find your passion; identify your mission; keep your eye on your end goal; be sure you can sleep with yourself with a clear conscious every night; and laugh heartily every day.” A Leader also A Mother Elaine maintains a balance of personal and professional due to the fact that she is raising three young children: twin 8-year-old boys and a 12-year-old daughter. They keep one’s sense of reality and reminds me every day of the value of love and kindness over all else. She says “I have also lived my life and my career knowing that my values come first and at any given moment, I could walk away and still be a happy person.” 16 | DECEMBER 2020 www.insightssuccess.com

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Haseeb Awan T classification of these threats would fall into four categories: 1. Application-based threats; 2. Web-based threats; 3. Physical threats; 4. Network-based threats he days are long gone where the security threat surrounded our computer only. Modern problems have expanded to our personal devices. The broad Physical threats: This occurs when you lose your mobile phone or if it has been stolen. This is a strong case for hackers to loop into your personal information via your device (as they have direct access to the hardware where all your personal information is resting). Network-based threats: This is where cybercriminals are actively looking to encrypt your data with the use of public Wi-Fi networks. Application-based threats: Privacy, information security, and data security are inseparable, dependent on each other, as well as, complimentary. The advanced mobile threats comprises of: a. Phishing attacks; b. Data leakage; c. Unsecure Wi-Fi (particularly public Wi-Fi) connection; d. Sim Swap Web-application threats occur when the application resembles an authentic application, but it is a disguise and has the ability to skim your precious information. Phishing attacks: A phishing attack is an online theft attack that gains your personal information such as username, password, and even your financial information. Phishing education is mandatory to mitigate the risk of this threat to an acceptable level. It is incumbent to learn that phishing is different from conventional scams. The thwarting ways would differ depending on the level of fraud committed and who is the victim (corporation or individuals). The prime examples include malware and spyware where your personal information is at stake. Web-based threats: As subtle in nature, these web-based threats remain unnoticed because visitors visit malicious websites that are better from their front-end but in reality, they are skimming your information by downloading malicious content on your device. 22 | DECEMBER 2020 www.insightssuccess.com

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Sim Swap: A fraudster beautifully impersonates you and manages to get victims Sim deactivated. There is a replacement activation without the knowledge of the victim (Marimuthu, V., 2019). For corporations it would be: 1. Design policies in place and the communication should be strong, 2. There should be a control designed to ensure the legitimacy of an email and it should be communicated to loyal customers (as well as others), 3. Scan the internet for likely phishing sites, 4. Implement a quality anti-virus, anti-spam, and content filtering at the gateway. This is a surplus for hackers where they can reset victims' online accounts. EFANI was designed to mitigate such happenings with a 100% money-back guarantee for 60- days. For individuals it is simple: 1. Block malicious or fraudulent email promptly, 2. Detect and delete malicious software immediately, 3. Block the sensitive information delivery to third parties automatically, 4. Apply skepticism wherever necessary. Safeguards – Ÿ 1. Beware of phishing - as it penetrates sim swapping incidents. These sketchy emails and bogus logins can get the hacker the required information and these key data can spawn a sim swap occurrence. 2. People should rely less on online space, they should reduce the personal information to be stored online. Social engineering is an initial sim swapping stage, where the hacker collects as much information as they want. Keep compromising information low-key such as your digits, date of birth, mailing address off your account. 3. Protect your accounts or crypto space using Yubikey, frequently changing the PIN, multi-factor authentication. Please do not trust SMS-based 2FA. Data Leakage: Data leakage occurs where there is a compromise in the (information) confidentiality breach. This refers to an unauthorized leakage or possible data transmission within an organization to a third party. The lost data is either private, sensitive, or confidential in nature. The data could be lost due to a system crash or even a deliberate deletion. Safeguards- Ÿ 1. Quarantine your outgoing information (which is private, sensitive, or either confidential in nature) from your organization network. 2. Archive suspicious files. 3. Quarantine sensitive files to be copied into USB or smartphones. 4. Block print jobs that contain private information. 5. Discover confidential information that is stored on databases, organizational laptops, and workstations. Unsecured Public Wi-Fi: Public Wi-Fi networks offer potential privacy risks and invite security issues. People are tempted to pursue public WiFi which is controlled by a hacker. It invigorates the MITM attack. Safeguards – Ÿ 1. The network should be verified. Hackers are smart but users are smarter, it is better to play smart. 2. Using a VPN (Virtual Private Network) which is the most secure surfing option on public networks. 3. Use Antivirus and keep the Firewall Enabled. 24 | DECEMBER 2020 www.insightssuccess.com

A Connected World 26 | DECEMBER 2020 www.insightssuccess.com

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rom speedy access to the F almost anyone anywhere in the world by dialling just a few digits, the contemporary technology-oriented world has changed the way we connect and communicate. With smart devices, people have also become smarter. efficiency and excellence in their operations. seamlessly deliver services proving that physical distances can’t dampen the innovative spirits. Digital experiences supported by Cloud have found new takers during the pandemic and the technology is poised for steady growth. internet to the ability to instantly get in touch with Even though enterprises have under- stood the importance of network infrastructure, choosing the right networking services partner is another challenge. Businesses are in search of partners with integrated networking solutions and a team that possesses the required skill-set and industry rich expertise. They are on the lookout for a solution provider which they can trust and rely on. With so much dependence on networks, it is bound to grow complex. To reduce and manage its complexity and shift creation of network rules and its maintenance, Intent-based networking is one solution to look-out for. The idea is to put a network control- ler(deploying AI/ML) that can regularly monitor the network, suggest best paths and continuously adjust the network performance for maximum output. Though the processes of connecting have become simpler, there is a need for effective communication and service between users, applications, services, devices and so forth. This is where network infrastructure comes into the picture. Taking this need into consideration, many networking solution providers have come forward with cutting edge solutions and are ensuring the smooth running of the enterprises without any performance issue. The changes start with migration to 5G technology. It is built to increase the network speed and reduce latency. It will assist in the mobilization of employees allowing them to work from any part of the world. Let’s consider the current situation. COVID-19 has compelled IT businesses to close their workplace and made their employees work remotely. As employees working from a different location on enterprise networks consists of traffic and thus, centralizing traffic could have been a challenge for business. To address this challenge, there arises a need for a suitable network infrastructure. And while we are at it, how can we not mention Internet of Things(IoT). From empowering manufacturing, providing enhanced tracking to logistics, to helping the healthcare sector in remote monitoring and more, IoT is redefining the way industries work and behave. As connectivity grows, so does IoT’s application. Next up is harnessing the prowess of Artificial Intelligence(AI) and Machine Learning(ML) in solving business problems in real-time. Right from hiring the most suitable candidate to process transformation and enriching customer experience, AI and ML can deliver solutions to help business flourish. Along with the employee's performance and excellent equipment, the agility and productivity of organizations also depend on the robust and secured network infrastructure. In today’s digital age, businesses cannot afford to have poor user experience and security issues that can impact employee productivity and thus, are realizing the importance of adopting comprehensive network infrastructure. With sound networking solutions, businesses can ensure optimum Networking is evolving and with each new step that it takes, it presents a new opportunity for businesses to digitally transform and scale their services. Cloud Solutions are seen as the way forward to maintain business continu- ity and resilience and are being proven effective in today’s crisis. It has helped teams stay connected over work and 28 | DECEMBER 2020 www.insightssuccess.com

Top 10 Successful Magnetic Leaders Revamping the Healthcare -2020 W marketing and management functions. Karim’s entire career has been focused on international operations and emerging markets. He left the corporate world and co-founded Genpharm in 2012. Since then he has been serving as its CEO. “ e strongly feel that we have a responsibility towards rare and genetic disease patients and their families in the Middle East region,” says Karim Smaira. He is the Co-founder and CEO of Genpharm and has worked in several geographies and served in different sales, In an interview with Insights Success, Karim shares his experiences, challenges, and advises emerging business leaders to become more resilient, motivated and focused. Below are the highlights of the interview: How do you diversify your organization’s healthcare offerings to entice the target audience? We are a very focused organization with a clear vision and an aspirational purpose. We strongly feel that we have a responsibility towards rare and genetic disease patients and their families in the Middle East region. Access to Orphan drugs has always been complicated due to lack of overall awareness for many of these diseases, diagnostic challenges and reimbursement issues due to the high costs of drugs in this sector. We have built our vision on tackling these challenges through “Bringing Cures to MENA Patients”. We diversify our offering by trying to overcome them by bringing breakthrough treatments and innovative solutions to as many of these rare diseases as we can. We always try to walk the talk and we are currently the first and only company that has launched gene therapy treatments in the region. As a director and business leader, describe the challenges you are having during the pandemic COVID-19 and what initiatives are you taking to mitigate them. The proportion of the outbreak and the impact of Covid-19 took everyone by surprise. This is a unique challenge. We had to adjust quickly to integrate the “new normal” of working remotely into our daily operations. Like for many, it accelerated our adoption of digitalization. We have for example conducted Karim Smaira Karim Smaira Karim Smaira Committed to the Rare Disease Community 30 | DECEMBER 2020 www.insightssuccess.com

actions, are learnt during these early years. Your life experiences just add onto these building blocks. I have lived in 5 different countries, learning languages and adopting cultures along the way. This has been one of the most determining factors for me and has taught me the ability to work and communicate globally. I am a passionate reader of geopolitics, history, biographies, management and leadership books. My inspiration has come as much from visionary business leaders, philanthropists, professional athletes and ordinary people that have taken inspiring initiatives. It would be extremely difficult and unjust to list a couple of book titles or names. As a keynote business leader, what are some of the vital attributes that every leader should possess? Leadership and leadership styles are really contextual. A great leader is someone who can recognise the specificity of each situation or interaction and adjust to the actual context. I do believe though that empathy, fairness, positivity and leading by example are attributes that build credibility and engages people. many webinars and on-line CME conferences, reaching in fact significantly more physicians than we would have in a physical conference, and we will continue to do so. We are a regional organisation with staff in many geographies. Our agility and lean structure allowed us to adapt swiftly, to be in sync with measures taken by different governments. We also introduced safety measures to ensure the safety of our employees working in the office. Like with every crisis, regular communication to and with employees in both a group and/or in individual setting is critical and we have on many occasions as we can reassured and engaged with them. We are very proud to be one of the few companies that have neither reduced salaries nor let go employees; in fact we have hired 3 additional colleagues during this crisis. How do you maintain balance between your professional & personal life? As an entrepreneur this balance is mostly fictional, particularly in the first 3 years of the venture. As the business is proven sustainable as well as successful and trust is built with employees that balance becomes attainable. I have now become better at making time for a family trip, exercising regularly and satisfying some hobbies and recently earning a boating license. What people, what books, what life factors have influenced and impacted you? I have been fortunate enough to cross paths with many inspiring people and leaders throughout the years. Nevertheless, I believe the childhood years and the civic values embedded during your upbringing, tend to guide you throughout your life. At the risk of sounding cliché, I am convinced that traits like honesty, respect, compassion, standing for your principles and owning your How do you sustain your creative leadership spirit in this crucial time? 32 | DECEMBER 2020 www.insightssuccess.com

“You never have to apologise for doing the right thing.” My priority is to continue expanding and growing the business both geographically and organically. We have established ourselves as the rare disease and gene therapy experts. We need to leverage and build on this to make sure that patients in the Middle East are not left out of the scientific and therapeutic benefits provided by these innovations. We expect several breakthroughs in the near future and we want to be positioned as the natural partner in the region. What advice would you like to give to the emerging business leaders/entrepreneurs? Entrepreneurship is not for everyone. If you decide to embark on an entrepreneurial venture don’t expect things to go according to your initial plan. You will always have doubters. More people will be cheering for you to fail than to succeed. Stick to your gut feeling and use criticism as a motivation and a driving force. Make sure you celebrate every little win! Nevertheless, know when it is time to pull the plug on your idea or business model. An entrepreneur is by definition a risk-taker. It is important to remember that not trying is worse than failing! The current crisis has brought a lot of reflection. It forced me to do a prioritization exercise and to focus on critical matters in both business and life. I have enrolled in a couple of online leadership and scientific courses to refresh some of the knowledge and connect with other executives. What are your future endeavours/objectives and where do you see yourself in the near future? DECEMBER 2020 | 33 www.insightssuccess.com

Ground Reality The Impacts of Pandemic in Pharma and Biotech Laboratory T positive note, it was an accelerant of technology and has forced companies to innovate. Companies that can do it better, faster, cheaper, more efficient, and have more creative approaches to problem solving will leapfrog to the forefront of the industry. We will see more of a focus to develop and implement technology that can deliver transparent, secure, and reliable data sharing remotely. he Coronavirus disease 2019 (COVID-19) was and is a world-changing event that has touched the lives of everyone on the planet, but on a As a laboratory solution developer for the Pharma and Biotech industry, it's important to highlight this background as an important framework which provides a basis for the direct impact of the COVID-19 era on the bioanalytical business today as well as providing insight of what the lab of the future needs to become. For example, direct impact for the laboratory when pharma companies moving toward more efficient SMART clinical trial adaptive designs, which allows for the continual modification of the trial based on interim data, is that in in addition to help in shortening development time, such designs may reduce the total sample size needed thereby reducing the number of samples that would need to be analyzed by the laboratory. So, in a business very much driven by the number of samples to be analyzed, when trials are delayed or producing much less samples, labs have to pivot more towards a focus on other activities such as the emerging market for biomarkers in order to fill the void from lost sample count to analysis types that would generate the same revenue. When COVID-19 was declared a pandemic, the industry rapidly responded with efforts put into place to effectively protect patient safety in their trials. Across the world, clinical trials answering important healthcare questions were stopped, or temporarily paused to possibly restart later, some with important modifications. Pharmaceutical companies and clinical research organizations greatly felt the effects of the COVID-19 outbreak on the clinical trial life cycle and began to incorporate remote ways of working to mitigate disruption. Over the last decade, regulators have been advocating for greater use of technology, virtual trials, and SMART trial designs. In the era of COVID-19, ongoing studies were now faced with new challenges like site closures, quarantines and limited access to study documents. As a result, clinical study teams are now relying heavily on remote monitoring and a more secure means of document sharing in order to meet clinical study timelines. In addition to evaluating different business strategies, labs need to be able to have access to information technology to be able to manage operations more efficiently including managing all processes remotely. In order to be effective, everyone needs to be well versed and comfortable using this technology. Use of disconnected spreadsheets or non-database sources are DECEMBER 2020 | 39 www.insightssuccess.com

no longer a viable option because they are problematic for real time sharing of information. Despite the significant investment that pharma has made in technology, the #1 problem still facing the scientist today is “Finding data when I need it”. Historically, technology has focused on just replacing the existing paper process with electronic counterpart. We must ask ourselves, are we going to continue to build tools to support existing business models and existing ways of working or should we begin to think about tools to reinvent the way we do business? from home, how can we reduce the need for “essential” lab staff to work on site? Is the lab of the future one which places much less burden on needing so many scientists to be on site and instead leverages integrated operational robotics, machine learning and remote control of these laboratory systems? Tools that enable a flexible business model, are cost effective, and allow for remote access will be in high demand moving forward and will allow us to get beyond just managing data more efficiently. This allows us the opportunity to start doing interesting things with that data. Technologies that facilitated the ability to do this have been brought to the forefront in lieu of the more typical investments of continually just adding more people and more instruments. As virtual and remote working prove to be sustainable methods of laboratory operations, it is unlikely early adopters will revert back to the more laborious and time- consuming methods involved in the previous, high- contact model. Consequently, companies will require comprehensive platforms that address their changing unmet needs and evolve their expectations of what an integrated ecosystem can provide. Having a good understanding of how much work is taking place digitally will accelerate the technology enabled remote work. At Metrendalytics, we have always recognized the value of online work situation and had the infrastructure in place to do so, therefore our operations did not skip a beat during these pandemic times. Labs have now learned that they can and must work remotely for many tasks without significant impact on performance. Roles relating to project management particularly fit this new paradigm very well but only if the tools to do so are in place and folks are comfortable with using them. The upside is improved quality of life for staff who can significantly reduce commute time, stress and costs. Time gained can be re-invested into actual work for clients and conducting more science. For the laboratory operations staff who are typically required to be on-site as “essential” lab personnel, in addition to adhering to typical lab safety requirements, new pandemic related items such as spatial distancing, masks etc have been included. Lab space available was the key driver to ensure this was achieved. But what we have learned is labs can actually reallocate space previously used by project management and other remote staff and even reduce their fixed costs on building office space etc needed by giving folks who can work remotely the tools and training to do so. Acting on both these learnings will only become more important depending on how long this pandemic lasts, and also as proactive preparedness for the next one. Perhaps we should already be building for this next phase? If non-essential folks can mostly work While the new normal is still unfolding, it is becoming increasing clear that the future will be anything but normal. We will begin to see more decentralization, technology, and the need to make important decisions not at the office. It is always important to remember that during these times of disruption, uncertainty and challenge, those who can reinvent themselves and move forward will open a gateway to an abundance of opportunities. 40 | DECEMBER 2020 www.insightssuccess.com

Pharmaceutical services ‘‘ Jan Miotto President Metrendalytics consulting and software development company, focused on helping both pharma and CRO's centralize operational data for real-time use. 42 | DECEMBER 2020 www.insightssuccess.com

The 10 Successful Magnetic Leaders Revamping the Healthcare, 2020 METRENDALYTICS Combining Knowledge and Technology to Bring Efficiency in Business etrendalytics was founded by scientists, for M all of one's operational data—whatever the source—on one shared platform for faster interactive collaboration and client service with reduced risk. Metrendalytics is a Pharmaceutical consulting services and software development company focused on helping pharma/biotech clinical operations and CRO's laboratory operations centralize operational data for real-time use. The company utilizes cloud-based, scalable, modular, rapid development, and low-cost platforms which are analytics and visualization enabled. The key to success is its software combines existing internal and external data into a single platform allowing customers to gain efficiencies and make faster, more informed decisions. As a result, the firm helps transition a business from a process that is reactive to one that is more proactive. scientists. Our goal is to provide integrated solutions which provide a consolidated view of Metrendalytics recognizes that companies need a platform to create comprehensive efficiencies across project planning and execution with built-in analytic tools that are easy to implement, are highly customizable, and cost-effective. To enable this transformation journey to optimize “running the laboratory business” with technology requires innovative business solutions uniquely designed and customized around a company's specific business model and processes. The laboratory tools and technologies in the bioanalytical laboratory have evolved and changed. However, leveraging real-time business data to make more informed decisions has seen limited progress. Further, additional time is required to manually create plots and metric reports to be used for analytics and process improvement initiatives. As a result, less time is available for analyzing data to improve business outcomes, customer service, and risk reduction. Metrendalytics' software integrates the information from existing software like Salesforce, Watson, NetSuite, etc and incorporates these into a suite of applications to centralize from proposal creation, award, and management of milestones and deliverables through QC, QA, and reporting. This provides a “one-stop-shop” for all critical business functions and data so that each stakeholder has what they need to efficiently complete their part. This means laboratory and management personnel can spend more time doing science and serving customers instead of chasing data and re-entering information. Metrendalytics works to understand and build systems to meet the unique process needs of each company. Then we enhance the resultant process efficiency with corresponding operational dashboard views with automated data integration, aggregation, and signal detection in interactive visualizations, which allows for centralized views and remote monitoring of project performance in real-time. Reviewers are able to zero in on signals and trends that could affect operational performance and make smarter decisions sooner about how to deploy resources. This eliminates error prone, redundant entry and information update lag time associated with typical business management via various spreadsheets used for tracking of these activities which are a basis of vast inefficiencies. As a result, companies are essentially road blocked in the ability to unleash the power buried in their operational data. Metrendalytics' solutions have been presented at multiple pharma/biotech meetings and conferences over the years. Many of these presentations were from its customers. Most recently, it was featured in a Bioanalysis Zone article on how Metrendalytics' remote access solutions helped businesses continue and thrive through the Covid-19 pandemic. Passion and Expertise Jan Miotto, President of Metrendalytics, had a successful career in the drug development industry because of her ethics of hard work and wanting to make things better for the industry. This, along with a lifelong passion to learn and apply new technologies is what drives the success of Metrendalytics. She has assembled a group of like-minded successful individuals who work together with the goal of making customers successful. Extensive Service Offerings DECEMBER 2020 | 43 www.insightssuccess.com

Jan focuses on being authentic and bringing value every day and trying her best not to keep a fixed mindset in order to be able to explore new opportunities. Jan says, “If you wait for things to be perfect, you can miss opportunities.” She brings a mindset to never stop adapting. For Metrendalytics, experimentation has helped them reach a product-market fit. Driving Improvement by Knowing Your Customer Metrendalytics' culture is to really partner with its clients to help take them to the next level. “We work with our customers to understand their business, their pain points, and where they want to be in the future,” says Jan. Being knowledgeable in the industry allows the company to understand each client's specific situation and allowing it to be flexible to design the tools they need to be successful. The goal is to add value and transparency to all levels of the organization. Metrendalytics aims to improve the “life of the scientist in the laboratory” by providing tools to leverage already existing information. It helps mid-level managers drive improvement gains through automated capture of metrics and trends. It also provides senior-level executives up to the minute visibility to their entire portfolio to understand the current status of their projects and where action is needed to keep programs on track. By being more efficient with information, the company helps all levels of the organization perform better to help take time and cost out of the drug development process. Current Crisis and Future Opportunities Metrendalytics has always been at the forefront when it comes to how it uses the information to improve business results. It will continue to do so in the future. The recent Covid-19 pandemic has accelerated the adoption of cloud-based and remotely accessed information systems. The company will build on its past success in this area to develop new and expanded 44 | DECEMBER 2020 www.insightssuccess.com

capabilities to meet the full-service needs of its customers. The company asserts “Our low cost, rapid development model also makes replacing some of the disconnected and more expensive “point solution” systems possible.” Metrendalytics continues to build a network of experienced, results-oriented subject matter experts in the laboratory, drug metabolism, and chemistry manufacturing and controls. This expanded knowledge base provides access to new markets and the opportunity to leverage its technology to benefit these areas. Socially Responsible Metrendalytics is active in Corporate Social Responsibility including philanthropy, environment conservation, diversity and labor practices, and volunteerism. As a company, Metrendalytics is diverse and designated as a female- owned, minority business and some of its partners are also minority-based. It has donated time and resources to start-up groups and technology companies that share the same passion for data and using that data to build the next-generation laboratory or improving upon existing technology to help the day-today work life of the scientist. team at Alturas Analytics to create a total customized information management system that organizes and manages client information, data and resource management. The system has improved productivity, efficiency and compliance in our bioanalytical CRO. Thank you Metrendalytics!” -Shane Needham, Co-Founder and Chief Scientific Officer at Alturas Analytics, Inc. On Drug Development Challenges Drug development is a long and costly process typically requiring approximately 10 years and hundreds of millions of dollars. By developing solutions that reduce this time and cost, Metrendalytics not only saves money for customers but also helps get products to market faster. As a result, the public has access to potentially life-saving medications sooner. This in turn provides a revenue stream for the pharma company to reinvest in future drug development. “Immunologix Labs is accelerating our bioanalytical service delivery to the technology forefront with the Metrendalytics initiative. The platform will be our primary driver for industry-leading efficiency, organization and client experience. It will provide the architecture to seamlessly ensure consistent, high-quality, on-time performance for our clients. We are very enthusiastic about our partnership with Jahanara (Jan) Miotto and the team at Metrendalytics" -Michael Anderson, President and Chief Executive Officer at Immunologix Laboratories For CROs, where the name of the game is efficiency and value, here again, Metrendalytics helps to improve both of these. The more efficient the resources are in a CRO, the more projects can be completed, which accelerates drug development as noted above. It also means better profitability and stability for the CRO. “We are on an exciting journey with Metrendalytics in moving from a paper heavy lab to a paper-lite lab to a paperless lab, which will enhance the efficiency of the entire laboratory process, leading to a dramatic overall cost reduction in operations and a better way to work for everyone. Many thanks to Metrendalytics in bringing our vision into reality” -Luca C Matassa, VP and Head of Bioanalytical at QPS Laboratoriese operational data for real-time use” For both CROs and pharma biotech companies, the time saved translates to more focus on the actual work of drug development instead of time wasted collecting and managing information. That time saved can then channelled into value-added activities like quality control, assessment and impact analysis or actions or innovations to improve the outcome. Testimonials from Clients “Jan and her team at Metrendalytics collaborated with our DECEMBER 2020 | 45 www.insightssuccess.com

The 10 Successful Magnetic Leaders Revamping the Healthcare, 2020 Triox Pioneers in point of care programmable medicine! presenting the next healthcare revolution! Nano I n an interview with Insights Success, Triox Nano's management describes its impeccable journey to become the first biotech company to develop a modularprogrammeddrug delivery platform. The company's revolutionary technology, termed S.M.A.R.T, an acronym for Stimuli Multi Adjusted Responsive Technology, or simply put “Programmable medicine” is based on combinations of DNA coding, DNA molecular machines and mesoporous nanoparticles. SMART offers the potential to add programming to almost any approved medicine that may in turn increase its efficacy exponentially. upload a mixture of several codes into the same treatment based on the patient's clinical and pathologic profile. Under the supervision of Joseph Farfara, Triox Nano's CEO, the company has progressed robustly in the last 3 years, broadening the type of medications that can be loaded into the platform, improving the capping characteristics and securing its IP with patents granted around the world. Below are the highlights of the interview: Can you explain to our readers what so exciting about Triox Nano work? Prominent opinion leaders and investors had been funding TrioxNano's development to date including the European commission through the prestigious H2020 Horizon program. Competing with over 1500 companies TrioxNano's technology won a non diluting grant of roughly $2.5 million USD. TrioxNano's all inclusive patents are granted around the world . Many believe this breakthrough technology may lead the way to the next healthcare revolution! Joseph Farfara, Triox Nano's CEO “By the year 2020, thousands of APIs (Active Pharmaceutical Ingredients) had been developed to treat different diseases, yet not even one efficient modular technology was developed to deliver them accurately to their target! The most efficient way to do this is use programming abilities so that each API can have tens of programs to direct it to different targets upon request. If you compare this to the car industry its like everyone has been developing thousands of types of engines without finding a way to connect them to the wheels yet. Current delivery methods, such as Injections or tablets deliver only a small percentage of their original doses to the tissues requiring treatment, and instead, most of the dose arrives to healthy tissue causing severe toxicity. To create S.M.A.R.T Triox Nano had to first invent the modular hardware that will allow incorporation of many different medications, the software language which is based on DNA coding and the actual codes that will control the nano particle. The technology is expected to create a paradigm shift and highly impact human lives around the globe, transforming medicine from its current primitive analog state to a programmable digital modern era. Examples for our programing abilities include the TXN770 family of nanoparticles intended for the treatment of TNBC (Triple Negative Breast Cancer). TXN770 combines between a modular unit loaded with the chemotherapy doxorubicin, that is already approved for the treatment of TNBC and the ability to be programmed by a combination of different software codes that control its release according to common traits found in the patient's specific tumor such as high levels of Magnesium and high levels of ATP. Other programing options we are developing include high levels S.M.A.R.T creates a vast field of programmable nanoparticles that can deliver their payload to target tissues based on the software code that is uploaded to them. The final commercialized product is expected to be supplied with a list of common software codes. The treating physician will decide which codes to use and will easily upload them to the modular nanoparticle that incorporates the relevant medication. The doctor will have the option to 48 | DECEMBER 2020 www.insightssuccess.com

The 10 Successful Magnetic Leaders Revamping The Healthcare