The 10 Most Eminent Leaders in Pharmaceutical Industry, 2021

VOL 07 I ISSUE 07 I 2021

1 E

TH

MOST EMINENT LEADERS IN

PHARMACEUTICAL INDUSTRY, 2021

Quality Life Helping People to Live Longer and Healthier Lives

A Positive Slant Steppingstone of Healthy Life

JOHN THERO Letting Results Speak Louder than Ambitions

Editor’s Desk The Best of Pharmaceutical Leaders

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e have witnessed the discovery of the scientific industry throughout the ages that has led humans to invent and achieve any feat, including the development of the medical and research industry that provides a strong foundation for healthcare resources. Today, some medicines can delay the spread of cancer with gel technology, which is a massive testament to the pharmaceutical industry. Companies working in the pharmaceutical niche are constantly developing innovative methods to acquire and better people's lives. Their comprehensive services range from biotechnology, drug testing, manufacturing of medicines, bioanalysis that go through clinical trials before being deployed for public usage.

Although technology offers optimization to the pharmaceutical industry, having a visionary leader throughout the pharmaceutical process is vital. Therefore, serving in such an inventive field, pharmaceutical leaders do their best to analyze the complete pharmaceutical process. With their diverse experience and studies, these leaders offer us safety in the pre-clinical and post-clinical operations. They identify the good and bad effects of the newer medication dedicating their lives to the betterment of the process.

They are surrounded by risks and challenges and work closely with the team to solve all the challenges. Being a professional in the field, they handle all the situations of the pharmaceutical process. Their high-quality services, knowledge-base, and technical expertise make solving the customers' issues and building strategic relationships with the clients an integral part of their work.

With new scientific discoveries, technologies, and innovative solutions, pharmaceutical niche leaders readily face every challenging problem situation and challenge.

They are committed to improving the quality of life and displaying their excellence in the development of the pharmaceutical industry.

As of today, unfortunate conditions have prevailed due to the pandemic. Many pharmaceutical leaders are working together to curb the risk of this deadly virus. With visionary pharmaceutical leaders around us, we can soon see the eradication of the pandemic with their scientific knowledge. As the vaccines are already available to the people and the results show optimistic hopes, putting an end to the pandemic.

The contribution of such leaders is undoubtedly worthwhile. Their impact on the foundation of the pharmaceutical industry makes a big difference in the lives of the people.

Focusing on such pharmaceutical leaders, Insights Success brings its new edition - The 10 Most Eminent Leaders in Pharmaceutical Industry, 2021. We appreciate the efforts and portray the success journey of the pharmaceutical leaders through this edition. At the cover of this edition is the inspiring journey of one such pharmaceutical leader - John Thero. He is the CEO of Amarin Corporation - a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to improve cardiovascular health cost-effectively.

You will also discover the business journeys of other pharmaceutical leaders in this edition, along with CxO standpoints by the industry experts and the ingenious articles written by the in-house editorial team.

Step in!

Sourabh More sourabh@insightssuccess.com

Cover Story

08

John Thero

Letting Results Speak Louder than Ambitions

Articles

22

38

Quality Life

A Positive Slant

Helping People to Live Longer and Healthier Lives

Steppingstone of Healthy Life

30

Leader's Viewpoint Technologies Which are Disrupting

Future of Pharma Industry

16

Dr. Song Li

An Ardent Leader Solving the Most Complex Drug Discovery Challenges

24

Greg Savino

Changing the Future of Patient Service Programs

34

Jenny Lin

A Leader Building Quality Organizational Systems

C O N T E N T S

Editor-in-Chief Hitesh Dhamani Managing Editor Anish Miller

Executive Editor Sourabh More

Assistant Editors Jenny Fernandes

Visualizer

Art & Design Director

Associate Designer

Co-designer

David King

Priyanka Rajage

Kartik Balapurkar

Shubham Dali

Senior Sales Manager

Business Development Manager

Kshitij S

Peter Collins

Marketing Manager

Sales Executives

John Matthew

David, Martin, Irfan

Technical Head

Business Development Executives

Jacob Smile

Steve, Joe, Saurabh

Technical Specialist Aditya

Digital Marketing Manager Marry D'Souza

SME-SMO Executive Amol Wadekar

Research Analyst Frank Adams

Database Management Stella Andrew

Circulation Manager Robert Brown

Technology Consultant David Stokes

sales@insightssuccess.com July, 2021

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Featured Person

Company Name

Brief

Adar Poonawalla CEO

Serum Institute of India seruminstitute.com

Serum Institute of India was founded with the aim of manufacturing life-saving immuno-biologicals.

Annette Säfholm CEO

Gedea Biotech gedeabiotech.com

Gedea Biotech is working to reflect the progress being made in healthcare towards a more sustainable future.

Dr. Song Li Founder & CEO

Frontage Laboratories frontagelab.com

Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services.

Greg Savino Founder

Baybridge Pharmacy baybridgepharmacy.com

Baybridge Pharmacy addresses the rising cost of medication and the changing landscape of pharmaceutical services.

John Thero CEO

Amarin Corporation amarincorp.com

Amarin Corporation is focused on developing and commercializing therapeutics to cost-effectively improve patient health.

Joseph Kim President, CEO, Director

INOVIO Pharmaceuticals inovio.com

INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines.

Jenny Lin Chief Operating Officer & Board Member

CMIC Inc. cmicgroup.com

CMIC’s skilled researchers provide cutting-edge expertise in small and large molecule bioanalysis to optimize drug development.

Michael Zahigian SVP, CIO

Amgen amgen.com

Amgen has grown to be one of the world's leading independent biotechnology companies and has reached millions of patients around the world.

Nazli Azimi CEO and Founder

Bioniz Therapeutics bioniz.com

Bioniz is a clinical-stage therapeutics company transforming drug development for immune-driven diseases.

Sarah Howell CEO

Arecor arecor.com

Arecor is a biopharmaceutical company transforming patient care by bringing innovative medicines to market.

C O V E R S T O R Y

John Thero CEO

Amarin Corpora on

John Thero Letting Results Speak Louder than Ambitions

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Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of icosapent ethyl to help address persistent cardiovascular risk.

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I

mpactful leadership begins with a strategy that is clear, compelling, supported by thoughtful analysis and designed to deliver competitive advantages, and is followed by an unwavering focus on execution. Strong execution relies on finding the right people and creating the right environment for them to succeed. Great leaders believe that it is pivotal to the company’s success to place confidence in their team, empower them and let experts in relevant fields be out in front on critical initiatives or in conversations with stakeholders to solve problems.

cardiovascular health. Amarin’s roots trace back to 1993, with most of its early work in Ireland and the United Kingdom. The company’s initial focus was on rare neurological conditions, but that was in the process of changing when John joined the company in 2009. Later that year Amarin started two clinical studies as part of a multistep strategy to develop the company’s lead investigational asset for cardiovascular risk reduction.

Focusing on Improving Cardiovascular Health

After clinical study successes in its initial steps to proving the ability to lower cardiovascular risk, as a small company with limited resources, Amarin had to make choices. The company could go ‘all in’ and move as quickly as possible toward becoming a commercial-stage company, but with more limited potential; or it could remain predominantly an R&D company and stay tightly focused on demonstrating that its lead product significantly reduces cardiovascular events in at-risk patients – a need that had not been addressed by prior patient treatment options from any company. Amarin chose the latter path, and that has proven to be successful.

Amarin Corporation is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve

Amarin Corporation’s early emphasis was on demonstrating impact in reducing triglyceride levels primarily to prevent pancreatitis. High triglyceride levels were also an identifier

Inspiring leaders often work hard and let success be their voice. They lead by example and results. John Thero, CEO of Amarin Corporation, is one such exemplary leader. John and his team at Amarin Corporation look for people who have “can do” attitudes, who are smart, and have successful track records. They focus on outputs more than inputs. They create environments where people have room to be creative, solve problems and flourish.

of increased cardiovascular risk. The effects of Amarin’s lead product went beyond triglyceride lowering. These and other scientific insights motivated Amarin to continue on decade-long journey, which in turn led to approval of its lead drug, icosapent ethyl (VASCEPA®), for cardiovascular risk reduction indications in the U.S., Canada and Europe.

Along the way, 17 leading international professional societies have recommended icosapent ethyl or incorporated its use for risk reduction into their guidelines – in a number of cases even before the product was approved for use in their region.

Letting Vision Become a Reality When John first arrived at Amarin in 2009, the U.S. was in the midst of a major recession. It wasn’t the best time for a company to seek funding and a foothold in a new therapeutic area.

Amarin did, however, have some very encouraging science, and a dozen or so dedicated, talented, and experienced professionals who believed in its vision and potential to help people avoid the devastating impacts of heart attacks, stroke, and other serious cardiovascular conditions.

John was recruited to be part of a newly constructed management team, in part because of his experience in the cardiovascular category and in turnaround situations like this one. Having worked further “downstream” in the space – in the recovery of patients after major cardiovascular complications -- and with a history of heart disease in his own family, John was eager to have an impact in preventative cardiovascular care. Then, as is true today, in the industrialized world, CV disease was the most deadly and expensive condition in healthcare, which was another motivating factor for him.

Amarin Corporation finished 2020 with revenue growth of 43% to more than $600 million. It now has more than 1,000

employees, and its vision is becoming a reality. It has come a long way since those early days, and John couldn’t be prouder of what Amarin has accomplished.

Treating At-risk Patients with Pragmatic Innovation Most importantly, Amarin’s drug, in addition to being clinically effective and safe, is affordable. It lowers the significant risk that remains for many people even though they’re on conventional therapies for cholesterol management. It is currently approved by multiple regulatory authorities, including in Canada, Europe, and the United States and is poised for approval in other countries.

The data on its product has been broadly published in leading peer-reviewed medical journals and is out there for any clinician, or patient, to see. And they can take comfort in knowing that, based on that data, the product’s clinical results have been broadly reviewed and recommended.

While there is no other cardiovascular drug approved for the same indication as Amarin’s, of all branded cardiovascular drugs in the United States with positive outcomes study results, the list price of its product is the lowest. Amarin wants its product to be accessible to as many at-risk patients as possible.

Beginning with the Patient Experience in Mind Surveys of patients and health care professionals emphasize the importance of medical therapy which is preventative (helps avoid major negative health consequences), outcomes-based (proven to work in many patients over extended study), cost-effective, readily available and easily administered. Technologies that are supportive of preventative approaches, and are accessible and useful to patients in helping to track and enhance outcomes can be helpful -- especially if and when they’re integrated with the

dedicated, “family-like” culture which emphasizes teamwork, quality, integrity and results. As Amarin has grown, proactive steps have been taken to ensure that the most positive elements of its culture are retained. As a result, Amarin has built a team of people and a culture that has allowed John Thero to pursue his plans to retire in 2021 with knowledge and confidence that what he has helped get underway will continue to be advanced.

Having a Remarkably Focused Team

right clinical interventions alongside approaches designed to consistently engage patients in risk-modifying behaviors.

One of the complications of preventing heart attacks and strokes is that risk factors are often unnoticeable. Over time, technology may be developed to better identify and help to address cardiovascular risk from a behavioral perspective. Amarin has pursued a pragmatic path to help patients by: a.) identifying those patients needing cardiovascular risk reduction based on elevated triglyceride levels, a measure which is common in standard (widely accessible) lipid blood tests, and b.) making a clinically effective therapy available to them that is easily administered, accessible, and has been shown to work across a broad population of patients with similar risks.

People and Data Drive Solutions Four keys to innovation are people, data, resources and time. Time is a valuable but limited commodity for innovators and, while it never expands as needs grow, it can be made more productive with a collaborative and talented team. Resources, in turn, are always available for good ideas, steered by compelling data, and with the right people behind them.

At Amarin, our people found compelling insights in data on a particular compound, which led to an idea, and ultimately a mission to lower cardiovascular risk in a category where many others have failed to demonstrate impact. The idea alone was not enough. Developing this idea required years of hard work and focus from talented people driven to innovate and to help improve patient care.

The path to get there wasn’t easy, or straightforward, and John expresses that Amarin would not have been able to overcome many of its challenges if it were not for a

John believes that focus and accountability are the most important qualities to have as a CEO. He says, “When you’re trying to improve healthcare, and there are so many unmet needs, it’s tempting to try and do everything you can rather than doing the most important things really well.

Without adequate focus, much less gets accomplished.”

Amarin is fortunate to have a great team that believes in what it is doing and is remarkably focused on its end goals, despite the many challenges and disruptions the company has had to overcome along the way.

Expanding Accessibility of Services In the near future, Amarin’s priorities are to continue to grow its business in the U.S., successfully introduce its lead product in Europe, and directly, or with the help of commercial partners, expand globally, including securing regulatory approval for the drug in China.

Amarin has some incredible opportunities in front of the organization– not only with the recent approval of its drug in Europe and potential approval in China, but also through other assets it may develop or bring into the organization in the years ahead. It has built an incredible commercial organization in the U.S. and is creating a similarly strong commercial team in Europe. The company’s outreach to leading cardiologists, GPs and other healthcare professionals gives it a strong foundation to continue to

grow based on its lead product while considering opportunities for diversification into other therapeutic areas and indications.

Rejecting the Herd Mentality The pharma industry today tends to prioritize innovation around specialized condition areas like rare diseases. Such innovation is certainly needed and worthwhile.

Unfortunately, other conditions that are prevalent and costly in our society are consequently getting less attention.

Chronic conditions such as cardiovascular and pulmonary disorders are especially neglected given lengthy time frames needed to develop therapies and limitations on patent protection, which combine to disincentivize drug development. These circumstances can also lead to higher prices and costs associated with products and procedures for acute medical conditions (rather than lower costs and reduced suffering when the focus is on earlier interventions and preventive approaches).

Many of the large companies which were pioneers in developing cardiovascular solutions decades ago today have very limited or no focus on cardiovascular disease. When Amarin entered the cardiovascular disease market a little over a decade ago, relatively few companies were continuing to invest -- and fewer still like Amarin were focused exclusively on the problem of heart disease.

Amarin saw this growing void as an opportunity for major impact.

We believed in the science, we stayed true to our strategy, and now have a strong foundation for global growth – while also being a leader in addressing risks associated with one of the world’s most costly and deadly diseases. With smart people and using scientific data as a guide and improving patient care as motivation, Amarin elected to not follow the herd and, to paraphrase Robert Frost, following the path less traveled has made all the difference.

Dr. Song Li Founder and CEO

Frontage Laboratories

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The 10 Most Eminent Leaders in Pharmaceu cal Industry, 2021

Dr. Song Li An Ardent Leader Solving the Most Complex Drug Discovery Challenges

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ith an ambition to build a customer-focused organization to help pharmaceutical companies overcome their complex drug development challenges through an outsourced solution, Dr. Song Li formed Frontage Laboratories, Inc. Today, Frontage Laboratories has grown to one of the leading CRO’s with over 850 employees in both North America and China.

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. Besides, 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, he 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. 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.

In our endeavor to find “The 10 Most Eminent Leaders in Pharmaceutical Industry, 2021” we crossed our paths with Dr. Li to know more about his leadership journey and how Frontage Laboratories is addressing the most significant and complex drug discovery and development challenges of pharmaceutical companies. www.insightssuccess.com

Below are the highlights of the interview: Describe Frontage Laboratories, Inc. and its cuttingedge services which address all the needs of its customers.

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.

Drug Metabolism and Pharmacokinetics (“DMPK”) We offer standard and customized in vivo and in vitro DMPK services. This includes pharmacokinetic (“PK”) and pharmacodynamics (“PD”) studies throughout the development process. We also offer ADME studies. For the discovery phase, we also offer PK screening and characterization to enable structure optimization. We also offer metabolite identification in different animal species, Metabolites in Safety Testing (“MIST”), drug-drug interaction, and radiolabeling studies.

Safety and toxicology We offer clients and extensive range of safety and toxicology services, including large animal testing, to our customers for the first time. These services include nonGLP and GLP toxicology studies to support regulatory July 2021

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Bioanalytical Our bioanalytical services include non-GLP research based and GLP assays (both in vivo and in vitro) for small and large molecule drugs and biomarkers throughout the drug development process as well as immunogenicity and neutralizing antibody assessments. These assays support first-in-human dose justifications and Investigational New Drug (“IND”) packages for pharmaceutical therapeutics.

We provide method development and validation services in addition to sample analysis services to assess pharmacokinetics, immunogenicity and pharmacodynamics effect.

Chemistry, manufacturing and controls (CMC) Our portfolio of CMC services spans drug discovery to the post approval phase, including lead compound quantification and analytical testing for the discovery phase, formulation development, GLP toxicology batch studies, release and product testing, stability testing, CTM and Good Manufacturing Practice (“GMP”) manufacturing, extractability and leachability studies and commercial product release following approval of an application.

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Our commitment to investing in highly trained and experienced scientists, state-of-theart facilities and instrumentations, and a strong commitment to operational excellence will allow us to deliver results that meet or exceed our customers' needs.

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submissions such as INDs. Additional toxicological assessments include pathology, ophthalmology and cardiovascular studies. We also offer chronic toxicity and investigative toxicology studies, carcinogenicity studies and support for additional indications. We also assist with the development of safety and toxicology testing plans, mainly for the pre-clinical stage, with the goal of identifying the pharmacological and toxicological effects of drug candidates.

Clinical Services With over 20 years’ experience in the execution of comprehensive Phase I-IIa studies, the Frontage Clinical team collaborates closely with our clients to develop a unique approach to overcome the challenges of each study, while maximizing efficiency and mitigating risk. We leverage our best practices in study design and execution to advance investigative compounds to drug candidates.

Located near NYC, we have access to one of the most diverse study populations and acclaimed medical professionals and facilities to help support each study.

Bioequivalence We provide bioequivalence (“BE”) and related services (such as medical writing and regulatory support) in China.

Bioequivalence is the term used to assess the expected in vivo biological equivalence of two preparations of a drug.

Bioequivalence is generally defined as the absence of a significant difference in the rate and extent of which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes

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available at the site of drug action when administrated at the same molar dose under similar conditions in an appropriately designed study. These services are currently provided by us in China from our facility in Zhengzhou, Henan, and 17 clinical research centers in our collaborating hospitals in China. Focus on product development on clients’ needs then the services are one stop shop – list services in product development

Our Core Values Quality: We are committed to excellence in the results we achieve, and how we achieve them.

Integrity: We believe in honesty, reliability and accountability in our words and behavior.

Innovation: We employ new scientific approaches, technologies and processes to provide innovative solutions to challenging problems.

As a leading laboratory and agrochemical services provider, what contribution has been made by you?

What are the future aspirations of Frontage Laboratories, Inc.? What strategies are you undertaking to achieve those goals?

We are a value-add partner with a focus on solving our customers’ most significant and complex drug discovery and development challenges. Our scientific knowledge base, technical expertise and reputation for high quality services have been integral to our ability to enter into strong long-term strategic relationships and partnerships with our key customers.

Over the years, 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 globally.

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.

Describe in detail about the work culture and the values that drive Frontage Laboratories, Inc. Our Purpose: To improve quality of life Our Vision: To be the preferred partner of life science leaders in product development

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Quality Life

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HELPING People to

LIVE LONGER and

HEALTHIER LIVES he role of the pharmaceutical industry is huge in the lives of all people in the world for their better health and well-being. Good health and well-being is one of the most important sustainable development goals by the United Nations. The leaders in the pharmaceutical industry have great responsibility to ensure the good health and well-being of people worldwide. The greater the leaders in the pharmaceutical industry, the greater solutions can be found to resolve all the issues in this sector and ensure people's good health and well-being sustainably.

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enough. Especially pandemic has highlighted the importance of leaders in the pharmaceutical industry to a great extent. The pharmaceutical industry comes up with unprecedented solutions in unprecedented times, and pandemic is one such example. Under the expert leadership of pharmaceutical leaders, the pharmaceutical industry strives its best to eradicate the diseases and illnesses in society with its advanced medications and treatments. Many pharmaceutical leaders come with solutions that play a huge role in relieving patients from pain and suffering.

The quest to live healthy for a longer period of time is forever in human beings. The leaders in the pharmaceutical industry continuously strive to come up with innovative treatments and medications that help people improve their overall health and well-being. Under the leadership of a competent pharmaceutical leader, pharmaceutical companies develop, manufacture, market, and distribute the advanced therapies that can benefit people in maintaining their overall health.

The leaders in the pharmaceutical industry minimize the anxiety and depression of people to a great extent with the solutions they provide through their organizations. These leaders provide quality treatments to give adequate comfort to patients and help them fight the illness they go through.

Such leaders improve the quality of life of people and facilitate them the freedom to live healthy and fulfilling lives. These leaders utilize all the resources they have to deliver efficient services through their pharmaceutical organization.

Pharmaceutical leaders contribute greatly to increasing the life expectancy for people all over the world. If we see the statistics, we can understand the life expectancy of people has certainly increased with innovations in the pharmaceutical sector. Advancements in medicines not only help people live for a longer period of time but also live efficiently and function with the highest productivity for a longer period of time in their lives.

The role of pharmaceutical leaders in helping people battling with different diseases cannot be appreciated

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The business leaders in the pharmaceutical industry do justice to all the stakeholders involved in their business and the industry. These leaders drive medical progress by researching, bringing, and developing new medicines that improve health as well as the quality of life for people all over the world with their innovative solutions. All the developments in the medical field by leaders in the pharmaceutical industry also contribute significantly to the world's economic growth and leads to the stable and balanced life of the people.

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Greg Savino Co-founder and Board Member

InfinityRx

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The 10 Most Eminent Leaders in Pharmaceu cal Industry, 2021

Greg Savino Changing the Future of Patient Service Programs

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or the past few years, the pharmaceutical industry has witnessed drastic transformations. It is due to the significant contributions of leaders who are poised to navigate changing the face of the pharmaceutical industry. One such leader we at Insights Success, came across is Greg Savino, the Co-Founder & Board Member of InfinityRx and Founder of Baybridge Pharmacy.

With his 15+ years of pharmacy experience, Greg spent six of those years building Baybridge Pharmacy 2015 – 2020.

Developing a business model in a specific therapeutic class exposed him to the many challenges patients encounter after being prescribed medication. He expresses that patient adherence and compliance were part of the problem, while initiation of therapy carried its own challenges and is secondary to various factors; cost of medication, availability of medication, coverage limitations and restrictions, etc. Even after those obstacles are overcome, patients may experience side effects or need consultation throughout their medication journey, especially with more complex specialty medications. These areas of healthcare are being inadequately addressed, and the patients are the ones suffering.

Growing Baybridge from a team of two to what it is today was a task that required constant nurturing. Leading by example and being involved in every aspect of the business, from hiring, product acquisition, patient care, and even cleaning up at night, is integral in producing culture for success. Taking time to learn about each employee and discover their strengths and ambitions empowers them to develop new skills and occasionally enter areas of discomfort, often producing growth. Building a team of highly skilled operatives provided Greg the opportunity to continue business development, leading to exponential year-over-year increases in revenue and profit, all while ensuring the patient was at the forefront of his company’s efforts. With this growth came recognition. For two consecutive years, Baybridge landed a spot on the INC 5000 list, being the #46 fastest growing healthcare company in the country in 2019. Despite that, the pace at which Greg was growing professionally outweighed the ability of his

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own business to keep up. He had to transition the business into another owner’s hands in order for him to take the next steps at a greater objective with a broader reach.

Upon the sale of Baybridge Pharmacy in 2020 to a private equity firm, along with its branding and marketing arm, Sparta Rx Programs, Greg now had the time and opportunity to form a new company with a clear vision and broad reach. Thus, InfinityRx was founded in 2021 by him, acting as a Board Member and another industry leader, Yuriy Davydov.

Making Medication Affordable and Accessible InfinityRx is a Patient Service Programs provider for pharmaceutical manufacturers with a mission to make medications more affordable and accessible for patients by simplifying the process for all parties involved in the dispensing of medication; including physicians, manufacturers, pharmacies, and patients. The company delivers progressive, efficient, and cost-effective patient service programs and advanced technology solutions to healthcare organizations that enable them to empower prescribers and drug service providers to furnish valueadded services to their patients.

Greg asserts, “Creating an all-encompassing, end-to-end solution for the life cycle of medication was a priority for us at InfinityRx.” He explains further, “We begin our relationship with manufacturers during late-stage clinical trials to gain market access, which is essentially formulary coverage on various insurance plans. Simultaneously, we develop an affordability program (aka coupon program) for their medication, allowing patients to obtain the product at a lower cost. Next, we assist physician specialists with the triage of prescription orders through our white-glove service hub, a facility designed to increase speed to therapy and increase patient compliance/adherence.”

If desired by a manufacturer and appropriate for the patient circumstance, InfinityRx’s own non-commercial pharmacy,

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eScript360, can deliver medication nationwide at no cost to the patient. During the dispensing process at eScript360, patients can have full visibility into the status of their prescription through the company’s patient portal, available on the desktop or through its mobile application. With an interactive interface and appealing design, patients can track exactly at what stage in eScript360 their medication is. Despite the value these solutions have in and of themselves, the data collection and reporting process is extremely critical for pharmaceutical manufacturers, and InfinityRx always provides real-time access to information.

Best of all, each Patient Service Program is unique and custom-designed for its clients.

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A Take on Technology It's no secret that technology is the way ahead. InfinityRx dove deep into software development, creating something new, its own proprietary claims processing system that is far more advanced and user intuitive vs the competition.

“Giving our clients (pharmaceutical manufacturers) the ability to make changes to their affordability programs on the front end/user side was a great accomplishment and a step ahead of industry standards.” Compared to other vendors, InfinityRx’s system can make changes in realtime, taking only minutes to accomplish, where it would take another vendor weeks, if not months. Giving its customers this type of access and control puts them in the driver seat of their own affordability program, a naïve and

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empowering position for them. Additionally, InfinityRx provides remittance and reimbursement solutions for all sites of care.

An Elite Team Greg believes that InfinityRx’s vision can not become a reality without the outstanding people behind the mission.

Its team of disruptors and innovators is led by its CEO, Nicholas Opalich, a 30+ year industry veteran and no stranger to success. Nick has built multi-million and multihundred-million dollar companies, including an infusion pharmacy, specialty pharmacy, mail-order pharmacy, and pharmacy benefit manager. His experience and expertise are second to none. Abbey Chakalis is InfinityRx’s CIO and she brings a wealth of diversity to the team. She is also an active member of NCPDP and NASP, where she continues to address the importance of affordable healthcare services.

InfinityRx’s Co-founder and Chairman of the Board, Yuriy Davydov, founded DermSource, dermatology’s first online group purchasing organization (GPO), now with over 800 independent pharmacy members. Greg and Yuriy also operate as business development partners in a private equity firm’s national specialty pharmacy chain. Its third member of the board is Arthur Gukasyan, a Nurse Practitioner by profession and an experienced business growth expert.

Arthur also co-founded a non-profit organization that enables underprivileged high school students to obtain a college degree.

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We are passionate about inspiring pharmaceutical companies, healthcare service providers, and all others who share our commitment to join us in changing the future.

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Being Vendor of Choice InfinityRx has gained a number of pharmaceutical manufacturer clients and has been the topic of many discussions in the short time since its formation. Greg says, “As we continue to progress our technology and perfect our services, InfinityRx will be the vendor of choice across the spectrum. Ensuring that we create the right solutions, it’s important to discuss the problems, something that many in the industry brush under the rug.” InfinityRx is not here to comply; it’s here to defy and do so in a way that promotes patient access to medications and therapy, driven by technology and ease across the continuum of care.

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Jahanara Miotto President Metrendalytics

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Jenny Lin Chief Opera ng Officer and Board Member

CMIC Inc.

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The 10 Most Eminent Leaders in Pharmaceu cal Industry, 2021

Jenny Lin A Leader Building Quality Organizational Systems

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enny Lin, the Chief Operating Officer and Board Member of CMIC Inc., holds 27 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.

Moreover, 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).

A Pioneer in the CRO Business CMIC, Inc., is a subsidiary of CMIC Group and a leading CRO (Contract Research Organization) specialized in bioanalytical services, whose cutting-edge capabilities and

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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 preclinical 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. CMIC Group was founded in 1992 as Japan’s first CRO. The “CMIC” name stood for “Current Medical Information Center”, and the company remains committed to the advancement of medicines and healthcare revolution.

CMIC Inc., as one of the CMIC Group’s subsidiaries in US, helps sponsors overcome challenges in bioanalysis with expertise, rapid data turn-around-time, and high-quality customer services.

CMIC Group’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., a CMIC Group’s non-clinical service subsidiary in Chicago, Illinois is a global CRO with over 30 years’ experience. The laboratory offers bioanalysis for nonclinical 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

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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.

Current large molecule capabilities include analysis of oligo, peptide, or antibody therapeutics using standard ELISA or MSD-ECL ligand-binding platforms. A variety of formats are 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 assay, CMIC Inc. brings a wealth of experience with capture and detection probe-based assays for quantitation of antisense or siRNA based therapies.

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

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Our vision is to advance the innovation of products and solutions that will empower people worldwide to achieve greater health and well-being. 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.

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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 reversetranscriptase 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.

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CMIC Inc. plans to add droplet digital PCR and cell-based assays 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.

Future of CMIC Group CMIC Group’s CREED as a corporate philosophy, consists of Wellbeing, Challenge, Change and Communication (W&3Cs). The company has been applying this 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 address the up-coming personalized medicine movement and individual patient quality of life.

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A Positive Slant

Steppingstone of Healthy Life W

hat makes the healthcare industry biologically safe, treating all diseases and making us all healthy? It is the pharmaceutical industry – the mediator between the people and the healthcare industry. If it were not because of their clinical studies, research, biotechnology, and findings to cure the diseases, people would have struggled for their lives. From the bubonic plague that struck in Europe and Asia in the mid-1300s to the very recent COVID-19 pandemic, the efforts of the entire pharmaceutical industry are worth appreciating.

The research required to cure all these deadly diseases is where the existence and contribution of pharmaceutical companies come into the picture. Continuous research studies, findings, new scientific discoveries, manufacturing medicines, and many such contributions are always appreciated in making this world fit and healthy. Because of their scientific discoveries, humans can follow their passion and live a long and healthy life. But it has faced many challenges lately.

Looking at the risk that humankind is at today, the world needs the pharmaceutical industry more than anything today.

When the pandemic was at its peak, we lost enormous lives, and everyone was praying for a cure – vaccine. The healthcare workers saved many lives, and the pharmaceutical industry provided us with the vaccine. We could finally, if not put an end but could control the spread of this havoc. This pandemic not only made us realize the importance of health in our lives but also had someone who can act quickly to control such situations in the future.

We were already aware of their contribution to the world.

However, these new deadly diseases like the Zika virus, or covid variants, have pharmaceuticals around us that have

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become crucial in these weird times. The pharmaceutical industry's new discoveries and expertise have become an intrinsic part of the world. Today, with their excellence, we can be ready to face any such virus or plague and continue to put smiles on the face of people.

We are moving towards a significant transformation with the advancements of innovation and technology, and we would prefer to go things smoothly, but the future cannot be predicted. Thankfully, we have smart pharmaceutical companies always ready to our rescue. They have displayed their outstanding results in the past and will continue their efforts in the future, avoiding outbursts keeping us all healthy.

The use of pharmaceuticals is so extensive that it has an impact on the entire industry. Pharmaceutical companies are the ones whom we look at as a bigger picture. So, we have to support the things that favor them and follow an ecofriendly path to living a healthy lifestyle. That's what we expect on the individual level.

On the global level, nations need to come together to develop more ground-breaking pharmaceutical discoveries.

It holds an enormous strength and can provide incredible opportunities for all of us. Unfortunately, governments neglect science in some nations, and getting less attention to new inventions and discoveries means no protection from diseases. We should come forward to support such countries; after all, that is what makes us humans. It will help to live longer and eradicate even the deadliest disease like Cancer.

Everyone should believe in science and support the pharmaceutical environment around us; if it weren't for the pharmaceutical industry, we humans would not have made our mark on the world.

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