World’s Most Trust Worthy Bioanalysis Companies | CIOLook by ciolookmagazine

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March 2020

T o p

World’s Most Trust Worthy

Bioanalysis Companies In

2020

“Our goal is to be your top tier Bioanalysis solution provider for drug discovery, development through commercialization.”

Industry Insights Innovation Management An Integral Part of the Business

Jenny Lin

Chief Operating O cer and Board Member

CMIC Inc. Leading Treasure in Healthcare Industry Especially in Pharmaceutical Sector

EDITOR’S NOTE The Un-Ending Race to Save the Smartest Species

ARS-COV-2 is the most idiotic thing that can ever happen to the entire mankind. Schools around the world are shut, organizations are shut, businesses are not closed, the world economy is down to its knees. And you know what the worst part is? We might face an economic recession, worst than the great depression and millions of people will lose their jobs.

This strain of Corona virus emerged in late 2019. According to reports, it started infecting people from November 2019. However, China reported the ﬁrst case in December 2019 and since then it has been reported to spread through person to person contact mainly via respiratory droplets or via contaminated surfaces. The virus’s virulence is so high, that it could been transmitted, even before the viruspositive shows up any symptoms. Although Coronaviruses are quite common in different species of animals and people can be infected occasionally. Whereas the SARS-COV-2 is a betacoronavirus and it is thought to be emerged from bats. Although, the complete clinical picture is yet to be known. However, it is already known that, COVID-19’s symptom can range from mild to severe for elderly people, especially those with underlying health conditions like diabetes, high blood pressure, lung, heart and kidney disease are at risk. So, with more than a million people affected around the world, various companies are turning towards developing a treatment for SARS-COV-2 in a war footing. According to WHO, currently there are more than 20 vaccines are in works, with several therapeutic trials. With each passing

“Things could be better, but things could always be worse”. day scientists are sharing their research and insights in order to ﬁnd the cure for the virus. Recently the World Health Organization has shared multiple documents in order to provide the much-needed guidance to all the laboratories and stakeholders, who are involved in various laboratory testing of COVID-19. Also, scientists are developing molecular assays just to detect SARS-COV-2, while some assays detecting other strains including SARS-CoV, which is genetically similar. So, in this issue of CIO Look magazine, we have shortlisted “Top 10 World’s Most Trust Worthy Bioanalysis Companies in 2020”, who are working round the clock to keep the entire mankind safe. In this issue we have CMIC, Inc. as our Cover Story. CMIC, Inc., is 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.

Kaustav Roy

CONTENTS

Cover Story

CMIC Inc. Leading Treasure in Healthcare Industry Especially in Pharmaceutical Sector

ARTICLE 22

Industry Insights Innovation Management An Integral Part of the Business

Amy Heymans Innovative Design Inspired by Empathy

ANDREA BLOOM

Arlen Meyers, MD, MBA

Empowering People to Live a Healthy Life

Transforming Healthcare by Entrepreneurship

36 Frontage Laboratories A Drug Development Partner, Turning Services into Solutions

42 DR JOANNE M. HACKETT Enabling a Better Quality of Life for Everyone

38 Golden Helix, Inc. Empowering Health-care Organizations with Industry-Leading NextGeneration Sequencing Analysis Software

46 Nexelis The Next Generation Advanced Testing Lab

K. Roy Editor-in-Chief

CONTENT

Senior Editor Alan Swann Managing Editor Bhushan Ghate Executive Editors Sourabh More

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March, 2020

Jenny Lin Chief Opera ng Oï¬ƒcer and Board Member

CMIC Inc.

Cover Story

Leading Treasure in Healthcare Industry Especially in Pharmaceu cal Sector

â€œOur vision is to advance the innova on of products and solu ons that will empower people worldwide to achieve greater health and well-being.â€?

Cover Story

harmaceutical sector is blooming at subsequently than ever being imagined. And only few companies proved 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. The company states it’s core values intercepted through, W & 3C; Ÿ WELLBEING: Fully Live Every Moment Ÿ Challenge: Liberate opportunity by changing our vantage point Ÿ Change: Transform without seeking refuge in conventional wisdom Ÿ Communication: Proactively reach out to people and society The Story behind CMIC CMIC Inc. originated from CMIC Group, which is the very first and largest Contract Research Organization (CRO) in Japan. Contract research organizations (CROs) have become an integral part of drug discovery and development to support sponsors research needs, expedite timelines and provide an extension of technical and scientific support. CMIC has worked with the top 10 global

pharma companies and has been involved in more than 80% of new drug development in Japan.

“Our goal is to be your top er Bioanalysis solu on provider for drug discovery, development through commercializa on.”

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 encompass an entire value-chain of pharmaceutical companies. The company has been the top bioanalysis CRO in oligonucleotide therapeutics (Oligo) development for nearly a decade with strong proven expertise. It also offers 30+ years of experience in conventional & small molecule and are also significantly expanding its capabilities in large molecule and biomarker Bioanalysis. On account being different from other companies, it is leading bioanalysis CRO in oligonucleotide therapeutics (Oligo) as well as very flexible and agile with quick turn-around time on all services offered, which is not possible by large CROs. In addition, CMIC, Inc. together with the rest of CMIC Group has, significant scientific publications and whitepapers and had been the integrated players supporting various drug development efforts. 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

Cover Story

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 and the CREED as corporate philosophy, consists of Wellbeing, Challenge, Change and Communication (W&3Cs). The company has been

applying these 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 â€œPersonal Healthcare Value Creatorâ€? (PHVC) to contribute for and to address to the up-coming personalized medicine and individual patient quality of life.

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Amy Heymans Founder & Chief Experience OfďŹ cer Mad*Pow

| March 2020 |

Mad*Pow

“

It’s an exciting time to be in design – our work has the potential to improve so many people’s lives.

AMY Heymans

Innovative Design Inspired by Empathy

he ‘care’ in ‘healthcare’ symbolizes the significance of ‘care and empathy’ in the ever-evolving healthcare sector. The inclusion of “care” as part of our health process has become an essential element of the changing healthcare ecosystem. Meet Amy Heymans, Founder & Chief Experience Officer at Mad*Pow. Because of her background in design, Amy understands the importance of empathy in the design process. She believes that design, along with bit of care, can help improve the human condition. Under her guidance, Mad*Pow has achieved many milestones in helping improve the healthcare ecosystem. Below is her story: Amy pursued a career in design because it requires a keen eye to look at things from a different perspective and find new ways to solve problems. Her expertise in web design, experience design and research helped her identify people’s needs and then use design to meet those needs. After working as a freelancer, Amy teamed up in 2000 with business partner Will Powley to start Mad*Pow. The company focused on making digital solutions more useful, usable, and desirable. Eventually, Mad*Pow extended its focus into innovation, service design, and behavior change design, which Amy believes is the next frontier in design. As Mad*Pow grew its client base, Amy developed a passion for using design to improve health experiences and had a desire to build a community around that passion. Amy’s passion motivated her to start the Health Experience Design (HXD) conference 10 years ago, then create the Center for Health Experience Design (CHXD) three years ago. Both the HXD conference and the Center draw participants from industries across the health ecosystem to share resources and collaborate on patient experience problems. Recently, Mad*Pow was

| March 2020 |

“

acquired by Tech Mahindra, boosting the company’s ability to not just envision amazing experiences, but also bring them to life in a completely holistic way for its clients. Amy was inspired to pursue a career in design because she knew she could help improve lives on a large scale. Under her guidance, Mad*Pow worked across a variety of industries, but some experiences with early clients inspired Amy to put a larger focus on health and health care. As a result, Amy established a health practice, working with organizations across the ecosystem–from health tech, pharma, nonprofits, government agencies, retail, providers, and payers. “The community in health is so rich and diverse,” Amy says. She is inspired by the amount of empathy in this industry, and the shared purpose of driving toward better health and improved quality of life. Mad*Pow leverages strategic design and positive motivation to create innovative experiences and digital solutions that are good for people as well as for business. The company aligns business strategy with experience strategy by creating a path that puts empathy and the understanding of human behavior at the core of its clients’ operations. Human-centered design activities help the Mad*Pow team identify what motivates people, what they desire, and what should happen next as they interact with clients, their customers and other organizations. These insights fuel creative approaches that allow Mad*Pow to collectively envision new and exciting experiences. It leverages an in-depth understanding of behavior science to create products and services that help people achieve greater health and wellness. Mad*Pow identifies target behaviors for change, uncovers their underlying modifiable determinants, and draws on techniques best suited to shift behaviors into new patterns. It also designs and builds scalable, usable, and accessible digital solutions that deliver seamless and compelling experiences while producing measurable business results for clients. Mad*Pow brought empathy and patient centricity into the health care industry ethos before it was in the limelight. Now, 10 years later, empathy and patient centric-solutions are well known and embraced by the design and health communities. Amy founded the Health Experience Design (HXD) conference 10 years ago because there was an unmet need to bring the health and design communities together to share experiences and collaborate on solutions. The success of the HXD conferences spawned the Center for Health Experience Design (CHXD), a free online community where users can share information, continue learning and foster collaboration year-round. Amy has been able to create multistakeholder collaborations among organizations that are serving the same types of patients. For example, CHXD was able to connect government and non-profit organization with companies that want to collaborate on better solutions to address tough challenges. Amy believes, through empathy and collaboration, one can easily prevail in the intensely competitive health care sector. In business, and when it comes to delivering care, experiencing the same pain point again and again can feel defeating, like the problem is unsolvable. Amy’s goal as a leader is to see a problem from all sides, to inspire empathy in others, and to paint a picture of what is possible.

| March 2020 |

Amy believes that business leaders need to involve all stakeholders who will be affected by a solution in the process of creating it. Businesses need to consider personal perspectives – the patient, doctors, caregivers, and families. Companies should not assume they know what’s valuable to the end-user, even if they are or were a practicing doctor or patient. In fact, that’s a handicap because they will automatically assume that their target audience thinks as they do. When business leaders engage with doctors and patients on a continuous basis, the solutions will become clear. They will come to understand what motivates people, how the solution fits in their ecosystem, how it can connect with existing resources, how data should flow in and out, and with which entities they need to cooperate. As volatile changes in technology can be witnessed daily, Amy prefers to set goals and keep pursuing them. She knows that reaching these goals is going to take time. Her stubbornness can be a positive thing, because it makes her diligent and helps her persevere to meet her goals; it drives her success. She reminds herself to consider, what does she really need? What does she want? She works hard to keep learning about herself and the business by reading and staying current on industry trends and standards. She is not afraid to create the resources she needs to succeed, even when they don’t exist yet, e.g., the CHXD, Mad*Pow’s Financial Experience Design (FXD) or HXD conferences. Amy states that the next evolution of health care is blending behavior science, motivational psychology, and public health frameworks with human-centered design, data science, and technology. And the beauty of human-centered design is that it’s interdisciplinary. Mad*Pow will continue exploring new frameworks to pull all the parts together in a way that will create the most impact for its clients. Yet, Amy still believes that Mad*Pow has some work to do to push things forward. Partnership with UC Berkeley School of Public Health Amy is proud, under Mad*Pow’s banner, to stimulate innovation industry wide by bringing together multi-stakeholder collaborations to address important challenges. For example, in 2018, Commonwealth wanted to better support lower-income employees who enroll in a high-deductible health plan (HDHP), so they set out to run a design and innovation challenge in partnership with Mad*Pow’s CHXD to grow awareness of this problem space and crowdsource novel solutions. A team of students from U.C. Berkeley’s Center for Health Technology won the top prize for their app called the “Plan Picker.” Plan Picker lets employees complete a questionnaire about medical use, financial assets, and risk tolerance; this information directs employees to the plan that best fits their health and financial needs, and even screens users for Medicaid eligibility. Post-enrollment support features within the app include educational videos, a deductible calculator, a prescription drug price checker, and a doctor visit copay estimator. “This kind of collaboration is the future of the health industry, and Mad*Pow takes pride in facilitating that collaboration,” says Amy.

| March 2020 |

Industry Insights

Innovation Management An Integral Part of the Business

nnovation Management plays a crucial role in businesses, as it assist an organization to strengthen its roots and, flourish promptly in the markets. It mainly involves managing processes regarding an organization’s innovation procedures, from initial ideation to execution. It’s a cyclic loop structure starting with ideation followed by the auditing, prototype testing and full implementation. Either it may be decision making or a drafting innovation strategy, this type of system manages all. It bestows some fruitful benefits to organization and allows its employees to bring forward their ideologies, which can be filtered depending on the errors while execution. This significantly increases the quantity and quality of input ideas empowering specific organization’s objectives and goals. Moreover, many innovation management tools enable employees to initiate a germ of an idea, and share it for gaining varied perceptions from every aspect of the enterprise. Through such systems, accumulating ideas from each and every unit of the organization becomes quite easier. And the source of idea collection is not just left inhibited with R&D and marketing but to every sector. These ideas could be stored in a shared repository, allowing respective employees to gain more transparency within various business processes.

into the repository, which increases the participation of employees in the innovation campaigns. Moreover, theses database-driven tools assist in analyzing the effect of an implemented idea for the benefit of an organization. In an attempt to admire employee contribution, a company can also present rewards to the winning ideas. Idea Management systems a.k.a. Innovation Management systems basically help companies to share best practices further capitalizing them efficiently. It narrows down the bridges between the different locations of shared ideas and brings them together under the best practices. Known for the quick processing analogies, innovation management systems delivers cost-effective practices that multiply the bottom-line benefits of the company. One of the best practices is to implement a cloudoriented idea management system, which will allow access to the database from any region breaking the geographical and organizational barriers. Even though the system is self-efficient, it does require some manual input to carry out repetitive changes in its complex programming. This carries out the identification and evaluation of potential ideas from the pile of innovative ideas. Outlook on Achieving Innovation Management

By maintaining transparency, a business person can look through the outcomes of all the ideas submitted

It is quite necessary for a company to install and

| March 2020 |

support innovation culture so that, employees can put forth their participation in generating quality ideas. Also, making employees feel valued boost up their enthusiasm and conﬁdence in order to take part in the idea campaigns. Digitalization is the rolling stone in the market which is single-handedly creating a change in the traditional method of business practices. Integrating one such subcategory—social networking, with idea campaigns also helps in gaining customer-oriented perspective of the idea and product. This feedback through social media platforms, generate a steady stream of ideas within and outside the organization.

staffs, collecting and allocating resources, acquiring and implementing intelligence, creating and maintaining relationships, identifying and nurturing talent, and comprehending the demands of a disruption. The way of performing tasks varies from one manager to other. Every individual work on their own terms and managerial ethics, and thus reinvents the methodologies of organization. Processes such as capital auditing, hiring and promotion, project management, internal communications, strategic drafting and knowledge management are the foundation on which the management is taken into practice. Such managers mainly focus on implementing operational inventive ideas for the business processes such as logistics, consumer’s requirement, and procurement.

As described earlier, an organization must follow a cyclic approach for comprehending and processing innovation management systems. Ideation stands ﬁrst in this cyclic structure, which encourages the generation of unique ideas. Followed to the ideation, comes the well-managed innovation process in order to identify and differentiate the viable and authentic ideas from others. In the end, it is essential to evaluate the results and come to a conclusion for its successful implementation.

Implicating innovation management for one’s business could be an issue at an early stage. But with a complete knowledge and an adequate guidance, one can easily overcome the issues and establish an efﬁcient innovation management system. Either an organization could reach out and outsource their innovation management to a promising company or it could in-house the management on their own. Both ways facilitate with same reimbursements and determine a unique future approach for the company.

In addition, engaging with C-suite in discussion over innovation management will help an organization to ensure that the shortlisted ideas are as per the business goals and norms. Organizations must hire innovation managers with a keen knowledge and skills to drive innovation and monitor on over-all management process. Managerial work includes setting goals and deploying plans, motivating other

| March 2020 |

ANDREA BLOOM

Empowering People to Live a Healthy Life

native of Bay Area, Andrea Bloom the Founder and CEO of ConnectWell started the company with the intention to help people live better lives through empowering them to improve their health and well-being. The organization's public-private partnership with the UC Berkeley School of Public Health guarantees access to a vast library of health and wellness content that is continually reviewed and updated to include the latest standard of care guidelines and scientiďŹ c ďŹ ndings on health, wellness, and disease management. Andrea was a 2020 task force member of the American Heart Association in order to engage and inform the greater Bay Area community when it comes to improving cardiovascular health by 2020. She founded a co-ed adult softball team to reengage team members with a sport they enjoyed during their youth. With her husband and three children, Andrea enjoys hiking throughout the Bay Area, skiing and snow shoeing in Tahoe, and traveling. She received a Bachelor of Arts in Economics from University of California, Berkeley with departmental honors, high distinction in general

| March 2020 |

ConnectWell

Andrea Bloom ConnectWell

John Swartzberg

UC Berkeley

| March 2020 |

scholarship, and Phi Beta Kappa and a Master in Business Administration from Harvard Business School.

ability to scale health information for easy access, anytime and anywhere.

Developing a Deep Skill Set in an Industry from the Ground Up As a child of a physician, Andrea's exposure to the ﬁeld of healthcare from a very early age became a springboard for her career and passion for helping people achieve well-being. After receiving her MBA from Harvard Business School, Andrea started her career in healthcare at Johnson and Johnson's diabetes division in Silicon Valley in product marketing. On the product side of the business, she participated in researching the unmet needs of the market and in bringing new medical devices to people with diabetes to meet those needs. On the marketing side, Andrea became an expert in understanding the underlying causes of diabetes and the stakeholders that help people manage their disease: doctors, diabetes educators, pharmacists, and the patient.

Assembling a Team with the Expertise for Success Given that the San Francisco Bay Area is an epicenter for health and wellness thought leadership, Andrea assembled a Scientiﬁc Advisory Board made up of subject matter experts in different areas of wellness. She built a team of talented, experienced individuals with diverse backgrounds who could hit the ground running and work in an entrepreneurial and collaborative environment. Together they created and deployed consumer-oriented wellness programming in the areas of healthy eating, physical activity, stress management, sleep, and maternal health.

information through their health and wellness publications. Andrea was introduced to Dr. John Swartzberg, who oversees the development of the school's health and wellness publications and their large editorial board consisting of faculty and physicians from both UC Berkeley and UC San Francisco Medical School. Dr. Swartzberg and Andrea formulated a strategy in order to form a public-private partnership to digitize and consumerize the school's vast collection of health and wellness publications. Both of them further expanded their team to include a Chief Medical Ofﬁcer, Lead Health Writer, and Technical and User Experience Expert so that they could build an offering that would enable people to unlock their potential of reaching a higher level of health and well-being.

Forming a Partnership with a Leading Academic Institution Next, it was the need of the hour to partner with a leading academic institution that had deep experience in consumer-oriented health publications covering a wide range of health conditions. She found that partner in her undergraduate alma mater, UC Berkeley. For 35 years, the UC Berkeley School of Public Health has been a pioneer in providing evidence-based wellness

Developing an Offering that Appeals to the Target Customer and their Users According to Andrea, she and her team have achieved their vision of transforming the industry's most trusted health and wellness information into an engaging digital health content offering and making it available to their partners. ConnectWell works with a broad array of healthcare providers, health engagement platforms, beneﬁt

Identifying Trends and Acting on Them According to Andrea, the demands on the healthcare system have dramatically shifted from acute care to chronic care given the steep rise in the prevalence of chronic disease. Because chronic conditions are long-term health issues, people must get involved in managing their care in order to maintain their health. Observing these trends, Andrea eventually decided to found ConnectWell. She shifted her focus from disease management to wellness — empowering people to live well and incorporate healthy lifestyle habits into daily living. To empower people in their health and well-being, they need to have access to engaging, accurate, up-to-date, and expertly vetted health information. Andrea could see the digital revolution unfolding and that it would eventually hit the healthcare system — enabling the

| March 2020 |

The Content Suite has 3 areas that are complementary in supporting total health and well-being: Health & Wellness Digital Library: Extensive coverage of health, wellness, and disease topics from A to Z Ÿ Wellness Initiatives: Wellness education with strategies and tools to help in the adoption of healthy lifestyle practices Ÿ Healthy Recipe Collection: Healthy recipes that are tasty, easy to make, and made from whole foods and healthy ingredients Ÿ

Staying Current with Tech Trends Being located in the heart of the tech community has given Andrea and her team the much needed advantage of tapping tech talent and incorporating the ever-evolving technical trends. The underlying architecture of ConnectWell's content offering makes it visually oriented and easy to navigate, while providing seamless integration into the portals of their customers. ConnectWell's content is tagged for easy topic search, so it can be directed to end users based on their individual health and wellness needs, tapping into their partners' AI capabilities through ConnectWell's API. Building Interest in ConnectWell's Services Andrea believes digital health services are rapidly expanding, and innovative companies are highly interested in integrating the ConnectWell offering as a part of their services to advance their value proposition. The challenges Andrea

“

My approach to business leadership is: “Develop deep and broad expertise in a ﬁeld, stay abreast of trends, assemble a high-performing team, partner with leading organizations, and collaborate with your customers.”

“

providers, and employers that license ConnectWell's content for integration into their platforms to engage their patients, members, and employees in their health. These companies can now deliver on the promise of improving the health of those they serve by integrating the ConnectWell Content Suite as part of their services.

and her team face are breaking into the more traditional healthcare companies which are large bureaucracies that are slow to adopt new services. As a leader in healthcare, it is incumbent on her to help the healthcare system incorporate new services that advance and enable cost-effective patient education and engagement to improve health outcomes and well-being. Helping to break down old paradigms and providing insights to other industry leaders so they can envision how they can thrive in this ever-changing healthcare landscape is a role she embraces. Andrea works to create dynamic partnerships so that traditional healthcare companies can ensure their future and not be left behind due to the rapid changes that digital health is bringing to the healthcare industry. Future of Healthcare When it comes to the future, Andrea believes that the future of the healthcare industry will be one where the patient is at the center, having the knowledge and skills to be a committed and vested partner in their care. ConnectWell and the UC Berkeley School of Public Health

plan to be a big part of this future as their suite of health and wellness content provides the means to educate and empower these patients. About ConnectWell: ConnectWell is a mission-based company that is a leading-edge provider of digital health and wellness content that is academically sourced and designed for a consumer audience to engage people in their total health and wellbeing. ConnectWell's partnership with the UC Berkeley School of Public Health ensures a continuous ﬂow of up-to-date, expertly vetted health information. This partnership enables ConnectWell to serve large communities and cross socioeconomic and geographic boundaries through distribution over a wide range of digital health platforms, ensuring access to the most trusted source of health and wellness content.

| March 2020 |

ARL Arlen Meyers MD, MBA President & CEO

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Society of Physician Entrepreneurs

LEN MEYERS,

MD, MBA

hose who lead health service organizations need to evolve from technicians to managers to leaders to entrepreneurs to leaderpreneurs in order to thrive. Some call it practicing at the top of one’s license. In addition, ﬁlling the Csuite with more physician managers just makes it harder to innovate and adds further clutter to the organization. Leaderpreneurs lead innovators; they don’t just manage innovation systems. After 40 years as a professor of otolaryngology (ear, nose and throat surgery) at the University of Colorado School of Medicine, Dr. Arlen Meyers, President and CEO of the Society of Physician Entrepreneurs, transitioned from teaching, practicing and researching the art of medicine to teaching, practicing and researching the business of medicine, innovation and entrepreneurship.

Transforming Healthcare by Entrepreneurship

Arlen teaches innovation and entrepreneurship at the University of Colorado Denver Anschutz medical campus and the business school at the downtown campus. Also he is a physician in residence at the Jabs Center for Entrepreneurship. In addition, he also consults to several healthcare companies which are creating drugs, devices, diagnostics, digital health products, care delivery

| March 2020 |

entrepreneurship personal but don’t “ Make take it personally. Connect to what drives you

“

but don’t take the inevitable failures personally. Instead, learn from them

models and medical education platforms. The mission of Society of Physician Entrepreneurs (SoPE) a non-proﬁt, global open biomedical and clinical innovation and entrepreneurship network is helping members get their ideas to patients.

mentors, experience, peer to peer support and career and professional development training. The most important trait, however, is an entrepreneurial and growth mindset. Innovation starts with mindset. Nowadays, leaders are charged with winning the 4th industrial revolution that is powered by cyber intelligence. That involves creating, scaling and sustaining a culture of innovation and leading an ambidextrous resilient organization with a workforce that has an entrepreneurial mindset. Overcoming those barriers require an innovative structure, process and culture that is supportive and determines the success by measuring the results of outcomes, not process or engagement. In addition Arlen said “Be sure you clearly deﬁne entrepreneurship, innovation and value and paint a picture of success so followers know the goal.”

Arlen does not believe sick care, i.e. a system that predominantly takes care of sick patients instead of keeping them healthy, can be ﬁxed from inside. That is the reason his non-proﬁt, the SoPE (Society of Physician Entrepreneurs ) is a global open innovation network that includes many different stakeholders, not just doctors ,but also other health professionals such as investors, service providers, technologists, patients, academics and many more. Each member segment wants SoPE to do a different job for them and, therefore, the company emphasizes different value propositions to each segment. The overall mission, however, remains the same; helping members get their ideas to patients or help someone who is.

To get updated with technological trends, and to boost personal and company’s growth, Arlen practices entrepreneurial habits and has created an encore career portfolio. He reads articles and books outside of sick care, writes almost every day, and accepts assignments where he has limited experience. He believes that he is

According to Arlen, physician entrepreneurs and leaderpreneurs need education, resources, networks,

| March 2020 |

learning from failure to ﬁll his blind spots. He actively mentors, consults and advises start-ups developing new technologies. Teaching, speaking, connecting people and building robust internal and external networks, consulting with mentors and a personal advisory board and attending non-sick care technology events and conferences all are helping him to achieve consistency and growth.

resources to do it, so he decided to do something to change that. Arlen is attempting, with the help of others, to lead change with the goals of transforming sick care to health care, reforming medical education and training, restoring the joy of medicine, and improving the disparity in global health outcomes through the deployment of innovation. He is building an international innovation and entrepreneurship network and helping, educating students to win the 4th industrial revolution. He is aiming to reduce sick care quality cost, access and experience inequities, and reconcile the conﬂicts between the ethics of business with the ethics of medicine with these he is changing the rules for the common good and creating sustainability.

Midway in Arlen’s academic career, with his colleagues, he invented a device to optically detect oral cancer. The team attempted to transfer the technology to commercial markets but never made it over the ﬁnish line. It was the ﬁrst of many of his entrepreneurial failures. The experience taught him three important lessons including; 1) everyone thinks they have a good idea 2) they don’t know what to do with their ideas, and 3) they won’t be taught what to do with their ideas in formal training.

Arlen is scaling the Society of Physician Entrepreneurs around the world in an effort to close global health outcome disparities through the deployment of biomedical and clinical innovation and entrepreneurship.

Arlen thinks it is cruel and unusual punishment to expect people to innovate and create value and pay them for value without giving them the education, training and

| March 2020 |

“Our commitment to investing in highly trained and experienced scientists, stateof-the-art facilities and instrumentations, and a strong commitment to operational excellence will allow us to deliver results that meet or exceed our customers’ needs.” — Song Li

Song Li, PhD

Frontage Laboratories, Inc

Frontage Laboratories A Drug Development Partner, Turning Services into Solutions

CRO (Contract Research Organization) is an essential partner for the biotech, pharmaceutical and MedTech companies in order to support their customers' attempt of developing, testing, reﬁning and marketing the improvised medical and pharmaceutical related products.

Below are the highlights of the interview conducted between Dr. Song Li and CIOLOOK: Give a brief overview of your company, its uniqueness and its vision. Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment, and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and ﬁle regulatory submissions in the United States, China and other countries.

In order to enhance the full-service capabilities of organizations, CRO marketplace has become quite competitive. Though markets are ﬁlled with many such CROs yet merely few have experienced the taste of success. Among various such CROs, Exton, Pennsylvania-based organization, Frontage Laboratories stands tall in this ever-evolving sector. It is a unique platform which provides its comprehensive services for the development of the relative industry. In an interview with CIO Look, Dr. Song Li, the Founder of Frontage Laboratories has shed a light on the interesting facts about the platform, and also provided a detailed information about the cutting-edge solutions which the company offers.

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Frontage Laboratories, Inc Describe your company's cutting edge solutions, which address all the needs of your customers. We beneﬁt greatly from having operations in both the United States and China (the two largest markets for CRO services in the world), and are well placed to capture growth opportunities in both markets. Our "Two Countries, One System" approach is integral to our commitment to maintain high quality standards. This approach assures our customers the same quality standards, operating procedures and systems in both China and the United States, whilst also providing our customers with a detailed and highly experienced understanding of the regulations and requirements for drug discovery and development in both countries. This approach enables us to be a partner of choice for companies with multinational requirements or companies that need support for parallel submissions with the US FDA and China FDA.

wide array of pharma projects, they are technically challenging. In order to successfully take on these drug development projects, CROs require a broad array of highly-trained specialized scientists and new technologies and instrumentation. What technologies are you leveraging to make your solutions resourceful and bringing advancement in the industry? Leveraging its strong scientific and management expertise, the company is committed to provide the highest quality for each project. Over 70 percent of the company's scientific staff have advanced degrees. The team provides the required knowledge on utilizing novel pharma tools in the most creative way to its clients in order to help companies deal with complex challenges such as issues in drug formulation, bioanalysis and data interpretation. The company's focus on technical and scientific excellence helps them to form strong, long-term relationships and partnerships with the customers.

Give a detailed description of the featured person's inﬂuence over the company and the industry. Dr. Song Li founded Frontage Laboratories in 2001 with the ambition of building a client-focused organization to help solve the most complex drug development challenges. Prior to Frontage, Dr. Li held management positions at Great Valley Pharmaceuticals and Wyeth. During this time, he led numerous projects related to the development of pharmaceutical products. Dr. Li has authored more than 15 scientiﬁc publications spanning a wide range of topics, including chiral separations, drug-protein interactions, pharmacokinetics, and analytical chemistry. Importantly, Dr. Li has been the recipient of numerous awards, most recently Healthcare CEO award from Philadelphia Alliance for Capital and Technologies, Ernst & Young Entrepreneur of the Year Award, the 'Realizing the American Dream' award from the Pennsylvania Welcoming Society, and the Outstanding 50 Asian Americans in Business Award from the AABDC.

Describe the experiences, achievements or lessons learned that have shaped the journey of the company. Frontage Laboratories' varied services include Discovery services such as Drug Metabolism and Pharmacokinetics (DMPK), PK/PD and Lead Characterization, Safety and Toxicology Assessment, Bioanalytical Services, Pharmaceutical Development Services such as Chemistry, Manufacturing, and Controls (CMC), and Clinical Phase 1 studies. Frontage applies the same rigorous quality system across its business units in North America and China to ensure consistency in quality standards, operating procedures, setup, and systems. What are your company's future aspirations? What strategies are you undertaking to achieve those goals? Frontage Laboratories will continue to grow its capacity and capabilities both organically and through mergers and acquisitions as appropriate. In just the last six months, the company has expanded its footprint in both North America and China, acquiring a majority share position of a CMC group in China and setting up new labs in both China and North America to accommodate growth in the CMC and Bioanalytical areas. Along the same lines, Frontage Laboratories will continue to look for opportunities that will enhance its end-to-end discovery and drug development services.

Dr. Li earned a Doctor of Philosophy degree in analytical chemistry from McGill University and a Bachelor of Science degree in chemistry from Zhengzhou University in China. How does your services differ from the other companies' offerings? New developments in immunotherapies, gene and cell therapies, and antibody-drug conjugates are continuously contributing toward the growth of biologics. With the ever-expanding biologics market, CROs not only need to support standard pharma and biotech drug platforms for projects like small molecule and therapeutic monoclonal antibodies, but also novel therapies using novel platforms for gene and cell therapy as well. While these novel platforms support a

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Empowering Healthcare Organizations with Industry- Leading Next-Generation Sequencing Analysis Software

Golden Helix, Inc.

iotech is one of the fastest growing sectors in the world as data continues to drive the development of biotechnology solutions to advance the healthcare system. With the aim to bring advancements in genomic data and Next-Generation Sequencing (NGS), Golden Helix enables clinicians and researchers to conduct advanced analytics on genomic data with full scalability, workﬂow automation and the ability to capture and query a lab's entire output. The Montanabased biotech ﬁrm has been in business for over 20 years supporting and streamlining the clinical decision-making process for NGS clients in over 400 organizations with 1,000s of users worldwide.

integration of their CNV capabilities into their clinical interpretation and reporting workﬂows.

Anyone in the industry is familiar with the term "pay-per-sample" and knows how quickly that adds up. Golden Helix stands as a key player in the industry with their unique business model. Golden Helix's clinical decision-making platform is licensed annually, meaning one, predictable cost with zero additional fees.

Secondary Analysis

The company is solely focused on enabling precision medicine with powerful software tools that allow their users to derive meaning from the rapidly increasing amounts of data the industry is currently experiencing. Being the constantly evolving industry that it is, Golden Helix is expected to keep up with these changes and will continue to strengthen their capabilities for interpreting cancer-related diseases. Additionally, they will be strengthening their Copy Number Variant (CNV) analytics capabilities. Their industry-leading CNV algorithm is a high focus for the company and deepening the

Comprehensive Clinical Solution Golden Helix's clinical suite is an end-to-end solution for the rapid analysis of genomic data from the raw sequencer output to clinical report. Their software supports the thorough analysis of the sample data coming from NGS machines and takes the analysis to the endproduct of the clinical test: the genetic test report. Finally, it stores all the intermediate and ﬁnal data in a repository integrating with laboratory and hospital record systems through standard protocols and APIs.

Golden Helix provides the unique ability to analyze genomic data in regards to Single Nucleotide Variations and Structural Variations. Via their partnership with Sentieon, they can provide a highly performant secondary pipeline that includes alignment and variant calling on par with GATK and MuTect2 at much-improved speed levels. Golden Helix's product VSCNV is capable of detecting CNV events starting at the exon level all the way to aberrations of an entire chromosome. Tertiary Analysis VarSeq and VSClinical cover all clinically relevant workflows for the filtering and annotating of genomic data. For example, it supports gene panels, trios, single exome, and whole genome workflows. With a single click, users can generate a clinical report that integrates the specific findings with annotation | March 2020 |

Andreas Scherer, Ph.D President & CEO Golden Helix, Inc.

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sources. VSClinical provides specialized workﬂows to answer the variant scoring criteria of the ACMG and AMP guidelines or the interpretation of germline and somatic variants, respectively. Reports can be customized to meet the requirements of each clinical test, while the interpretations of variants are stored in a laboratory knowledge base that reduces the work done on each new sample.

Extensive Offering at an Affordable Price Today, most of the businesses have adopted a persample model which becomes complex when the customer starts using it. The per-sample charges continually add up, leading to higher, unpredictable costs; affordable solutions for labs performing NGS are essential in the precision medicine industry. Thus, Golden Helix has instilled simplicity in its business model. Their products are affordable and come with a yearly license fee without any additional intermittent charges. Additionally, the yearly fee includes all training and support required by the user, and any software updates as well. The company continuously strives to shrink price points and make its solutions available to users in a convenient, affordable way.

Data Warehousing VSWarehouse captures the artifacts of the bioinformatics pipeline. Via powerful APIs, the product connects to other lab and hospital systems such as EPIC or Cerner's Millennium. It allows users to version the clinical analysis conducted by lab work, including the annotation sources that have been used during the tertiary analysis. This is a key capability during discovery should a lab or hospital be involved in legal disputes.

Stepping Towards Never-Ending Success Last year, Golden Helix received a Phase II SBIR Grant from the NIH to further improve and reﬁne proprietary algorithms for detecting CNVs and other structural variants from NGS data in the clinical context. Golden Helix's President & CEO, Dr. Andreas Scherer, said, "In the last three years, Golden Helix has launched numerous products and will continue to do so. Likewise, we are on an expedition to embed AI capabilities to strengthen our capabilities for AI-supported solutions further while enabling customers to be in control of the diagnostic process." Therefore, as one of the most experienced leaders in the biotech industry, Golden Helix is building a golden path toward a sustainable future with new products and features at an affordable cost.

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A Healthcare Proﬁcient

In business for 20 years and cited in 1,300+ publications, we are proud to support over 20,000 users in more than 400 institutions worldwide.

Andreas Scherer, Ph.D, prior to joining Golden Helix as President & CEO, took on management roles at AOL/Netscape, as well as at a number of private software companies. He has also worked on improving research and development activities within pharmaceutical companies, life science organizations, and medical research companies.

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DR JOANNE M. HACKETT Enabling a Better Quality of Life for Everyone

oanne M. Hackett, the CCO of Genomics England, is an accomplished entrepreneur, scientist and strategist with experience in the execution and management of complex business transactions. She has extensive management experience in health and pharma industry which enables her to ensure the commercial success of the organization. Joanne possesses multidisciplinary knowledge and she is highly skilled in team management, setting external investment strategies and the identiﬁcation and evaluation of targets. Joanne has spent many years in business management which is reﬂecting on her strengths and weaknesses and she is trying to surround herself with people who complements her. She believes “True leadership is about empowering those around you to be successful.” Joanne also believes that she has been very fortunate to have people around her who are excellent leaders and whom she could learn from. She has also witnessed behaviors that she did not want to emulate. Joanne has always tried to lead by example and listen twice as much as she speaks. Genomics England has a very unique offering: the team at the company work very closely with the National Healthcare Service in order to provide clinical and genomic data for individuals with suspected rare diseases and cancer. This linked clinical and genomic data is crucial for advancing research and development, which in turn will positively impact healthcare. It is incredibly important for

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Genomics England

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I was once told that if my dreams did not scare me they were not big enough research (be it academic or industrial) to be carried out on this data. As such, the team has designed a secure Research Environment that grants access to the qualified researchers. The hope is that the undiagnosed participants will one day get a proper diagnosis – which will be the result of the data being accessed. The linked clinical and genomic data is very useful for repurposing drugs, stratifying for clinical trials and for real world data and evidence to be generated. It is necessary to know the audience, what the market has to offer and what changes are required to advance the industry. It is also incredibly useful to be aligned with major strategic initiatives. Don’t try to ‘own’ everything – it is much better to contribute to a larger ambition and move things forward faster. For Joanne “leadership is about defining a goal and getting those around you to support and strive to achieve it.” The leaders who see themselves as a part of something greater are the ones who are more confident and can take others with them. Leaders need to listen, be objective, be fair and empower those around them. Leaders also need to be reflective and seek feedback. No one has all the answers, and there is never just one opinion. It is very rare that leaders actually have the authority to make decisions in isolation. Consultation is the key. This goes back to knowing the audience – it is much better to have many leaders pushing forward the same

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agenda and inďŹ‚uencing a wider network collaboratively. Joanne has a genetic disease and she has always wanted to advance healthcare to enable others to have a better quality of life. She believes that good health is the best thing anyone could hope for and with her approaches; she wants to touch as many lives as possible. Joanne spends a lot of time reading, attending conferences, events and showcases, and is implementing pilot projects to determine if it is feasible for full implementation. She also observes t h e w ay s e n i o r l e a d e r s c o n d u c t themselves and try to understand if any of the behaviours and strategies would be useful for her to adopt. she learns something new everyday. Joanne has relentlessly pushed forward health partnerships between the A, B, Câ€™s: Academia, Business and the Clinical community. She was instrumental in reconďŹ guring stroke services, merging three cardiovascular hospitals to their streamline services; implement a Genomic Medicine Service into the healthcare system. She was designing and implementing a Research Environment that houses clinical and genomic data. Joanne has also been instrumental in getting the Clinical Entrepreneurs Programme launched as well as the NHS Innovation Accelerator and the DigitalHealth and London Acelerator successfully running. Joanne spends most of her time mentoring, advising and investing in healthcare SMEs. She wants to continue to revolutionize healthcare. The deep personal satisfaction she receives from changing the way healthcare is delivered is enough to keep her committed and dedicated, regardless how frustrating it can be. For now, she will continue to change the world one genome at a time.

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The Next Generation Advanced Testing Lab

ith people's health at heart, Nexelis contributes to saving lives by supporting pharmaceutical and biotech companies in the development of vaccines and large molecules. The company's dedicated team of scientists and versatile technology platforms have been instrumental in the development, qualification and validation of assays supporting FDA filing of blockbuster biologics, such as vaccines and complex large molecules. Nexelis has established a strong reputation among the biotech industry and regulatory bodies. With its deep scientific expertise, high-tech platforms and a broad range of instrumentation and automated systems, Nexelis can provide robust and innovative assays for fast and reliable preclinical and clinical immunological sample analysis. In an interview with CIO Look, Dr. Benoit Bouche, Ph.D. AMP, President and Chief Executive Officer of Nexelis have shared few of the key pointers regarding the unique balance of world class standards and human scale collaboration.

versatile team of scientists, working with our advanced technology platforms, was instrumental in the development, qualification, validation, and largescale sample testing of assays that supported the FDA filing of more than 100 new molecular entities, including blockbuster vaccines and anti-viral drugs. Describe your company's cutting-edge solutions, which address all the needs of your customers. Nexelis services consist in: R&D whose aim is to develop, qualify, and validate biomarkers and bioanalytical assays to study desired or undesired immunogenicity; High-throughput testing: immunochemistry, functional and cell-based assays (killing and neutralization assays); Contract preclinical and clinical research support services. Give a detailed description of the featured person's influence over the company and the industry. Dr. Bouche, as a serial entrepreneur in the outsourcing field, came on board with the strong conviction that the concentration in the Contract Research Organization (CRO) market left broad open incredible opportunities to companies capable of showing superior agility than multinational CRO giants whose size and overheads are a handicap, and not a competitive advantage for turnaround time optimization purposes.

Below are the highlights of the interview: Give a brief overview of your company, its uniqueness and its vision. Nexelis is a global immunology centric specialty contract service provider with 200 people and 3 operating sites in North America (East and West Coast) and Europe. Spun-off from GSK vaccines in 2015, the company has grown exponentially through organic and inorganic initiatives, positioning it as a reference service provider in a number of segments including infectious vaccines, immunotherapies and cell or gene therapies targeting cancer and metabolic diseases. Our

How do your services differ from the other companies' offerings? Nexelis excels by combining robust protocols with scientiﬁc discipline, human agility and client partnership in order to answer the most demanding mission requirements.

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By supporting the top 10 biotechnology and pharma companies with global phase 2 and phase 3 studies, we have established a market leader position in infectious vaccines, immunotherapies and metabolic diseases testing. Dr. Benoit Bouche Ph.D. AMP, President & Chief Executive Ofcer Nexelis

What technologies are you leveraging to make your solutions resourceful and bringing advancement in the industry? Nexelis in vitro state-of-the-art analytical platforms include immunochemistry, cellular immunology, viral and bacterial functional assays, ﬂow cytometry and PCR/qPCR. Those laboratory tests are supported by in silico and in vivo teams (in house (BSL2) and preclinical facilities) and a protein sciences group.

as potential preferred vendors by the pharmaceutical company. We believe to be one among a handful of mid-size organizations in a position to build a world class champion providing highly specialized services. Nexelis results from the merger between entities with prestigious roots spun off from the pharmaceutical industry (GSK vaccines) or the academic world and have a leading position in areas such as infectious vaccines and immunotherapies .

Describe the experiences, achievements or lessons learned that have shaped the journey of the company. In 2020, two large CROs, although not pure players, will generate revenues of $10B USD, and eight CROs will contribute to another $1B USD. The market share of the top 10 players is increasing year over year and the M&A market is still quite dynamic. In short, size does matter in our business based on risk mitigation policies by the pharmaceutical industry. No doubt that these giant CROs are well positioned to capture mainstream clinical opportunities where global coverage and logistic capabilities only really matter. Some birds are not meant to be caged, however. Niche segments such as specialty laboratory testing is a totally different world requiring organizations centered around senior scientiﬁc leaders aiming at favoring versatility and ingenuity. This segment is extremely fragmented with hundreds of academic groups and transactional CROs with less than 100 people, who don't have the resources, credentials, or equipment to be considered

What are your company's future aspirations? What strategies are you undertaking to achieve those goals? Nexelis management aims at bringing the company to the next level and further expands its scope of services to become a one stop shop from the early development stage to the late clinical stage for companies to whom desired or undesired immunogenicity is a core topic. Our future resides in our capacity to maintain the venture entrepreneurial mindset, focusing on leveraging the skills of the best scientists in town and invest massively in the innovative technologies required to stay the reference CRO in the specialty lab services segment.

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