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Kelly Zitlow, 847-858-5230
kelly.zitlow@waterstreet.com

Orgentec Appoints Gary Winer to President & CEO

Orgentec Diagnostika, a leading specialty diagnostics company, announced today that its board of directors has appointed Gary Winer to president and chief executive officer, effective immediately.  Mr. Winer will leverage his global healthcare leadership experience to further Orgentec’s long-term growth and position as one of the world’s premier providers of diagnostic assays specializing in autoimmune and infectious diseases.

Over the course of his more than 20-year career, Mr. Winer has held senior leadership positions on an international scale with numerous diagnostic and pharmaceutical businesses, including AbbVie, Inc., Abbott Laboratories and Pfizer.  He has spearheaded successful launches and growth of blockbuster product lines, namely Celebrex and Humira, in the United States, Latin America, Asia and Japan.  During his nearly 10 years with Abbott, Mr. Winer managed the company’s diagnostic business in the U.S., Canada and Latin America before being promoted to lead Abbott Japan, the company’s largest affiliate outside the U.S.  In addition to driving strong growth, Mr. Winer was instrumental in helping the business to achieve “Best Places to Work” recognition three years in a row.  He continued in this leadership role after planning and completing the separation of Abbott’s pharmaceutical business in Japan to form AbbVie.

“The combination of Gary’s diagnostic and global experience is the ideal match for Orgentec. We’re thrilled to gain the benefit of his years of industry expertise and insight as we build and enhance Orgentec’s global reach, sizeable installed instrument base, and unique menu of diagnostic tests to support health care providers around the world with identifying rare conditions and diseases,” said Scott Garrett, chairman, Orgentec.

Founded in 1988, Orgentec is an established leader in the specialty diagnostics market, serving hospitals and reference laboratories throughout Europe and the U.S., as well as the emerging markets of Asia, Latin America and the Middle East.  Since partnering in 2014 with strategic healthcare investor Water Street Healthcare Partners, Orgentec has expanded its global footprint and menu of more than 300 tests through a combination of organic initiatives and acquisitions.  Water Street worked with Orgentec’s leadership team to recruit Mr. Winer to continue the company’s strategic expansion.

"I’m delighted to join Orgentec at this important point in the company’s evolution to becoming a world-class specialty diagnostics provider.  I’d like to thank Water Street and the board for their confidence in me to build upon the successful foundation established by my predecessor, Jim Widergren,” said Mr. Winer.  “I look forward to working with the outstanding team of professionals across the company to continue to expand our product offerings, particularly for our Alegria product line with its proprietary autoimmune and infectious disease testing menu."

In addition to his appointment as president and CEO, Mr. Winer will serve as a member of Orgentec’s board of directors.  Jim Widergren will continue to lead Corgenix, Orgentec’s U.S. business subsidiary, and also will continue to serve as a member of Orgentec’s board.

About Orgentec

Headquartered in Mainz, Germany, ORGENTEC Diagnostika offers one of the industry’s most comprehensive portfolios in autoimmune diagnostics and cardiovascular diagnostics with additional strengths in infectious disease and organ function testing. Alegria®, the automated instrument for autoimmune and infectious disease serology enables labs to complete multiple assays and deliver faster results at minimum cost. With subsidiaries in Austria, Hungary, France, U.S. and China, as well as an established global network of distribution partners, ORGENTEC’s products are benefitting patients in over 100 countries around the world.  Orgentec is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry.  For more information, visit orgentec.com.

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Cato Research Appoints Life Sciences Leader & Innovator to Executive Chairman

Cato Research, LLC (CATO), a global provider of regulatory and clinical research services, announced today that its board of directors has appointed Mark Goldberg, M.D. to executive chairman, effective immediately.  Dr. Goldberg brings to CATO more than 25 years of leadership and innovation experience in building premier life sciences businesses.

Dr. Goldberg recently served as president and COO of PAREXEL International Corporation.  During his 21 years with the company, Dr. Goldberg leveraged his medical, technical and clinical research expertise to drive business results and build PAREXEL into one of the world’s leading biopharmaceutical service providers.  He joined PAREXEL to start the company’s Medical Imaging business and later helped to found its technology subsidiary, Perceptive Informatics (later renamed PAREXEL Informatics).  Dr. Goldberg began his career as a radiologist and clinical director of Teleradiology at Massachusetts General Hospital (MGH) after completing his postdoctoral training at Brigham & Women’s Hospital and MGH.  He also helped found a telehealth spin-off from MGH.  Dr. Goldberg currently serves on the board of Intensity Therapeutics, Inc., a clinical-stage biotechnology company.

“We’ve been searching for additional leadership talent to support our goal of building CATO into a leading clinical and regulatory services provider.  Mark is the perfect fit with his wealth of experience in our industry,” said Lynda Sutton, co-founder and president, Cato Research.  “I’m excited to have Mark on our team to help guide our growth and I look forward to working with him.”

Dr. Goldberg’s appointment follows CATO’s partnership in 2018 with strategic healthcare investors, Water Street Healthcare Partners and JLL Partners.  The firms worked with CATO’s leadership team to recruit Dr. Goldberg to continue CATO’s expansion and support their collective goal of building CATO into a leading clinical and regulatory services provider.

“I’m honored to have the opportunity to join Cato Research, which has built an exceptional reputation for regulatory expertise and clinical excellence over the past three decades.  This is a credit to the company’s leadership and employees.  I look forward to working together to drive growth and expand CATO’s capability set to continue to deliver outstanding service and results on behalf of our customers,” said Dr. Goldberg.

About Cato Research

Founded in 1988 by Dr. Allen Cato and Lynda Sutton and headquartered near Research Triangle Park, North Carolina, Cato Research is a full-service contract research and development organization providing strategic and tactical support for clients in the pharmaceutical, biotechnology, and medical device industries. Services range from design and management of preclinical and clinical studies to submission of regulatory documents required for marketing approval. With a staff of approximately 300 and offices located in the United States, Europe, Canada, Israel, and South Africa, the Cato Research team consistently demonstrates an unsurpassed level of responsiveness, flexibility, attention to detail, and passion for bringing their clients’ products to market with speed and cost-effectiveness.  For more information about Cato Research, visit cato.com.

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Discovery to Add the HudsonAlpha Genomic Services Laboratory to Expand Scientific Capabilities

Discovery Life Sciences (Discovery) announced today that it has entered into an agreement to add the Genomic Services Laboratory (GSL) of the HudsonAlpha Institute for Biotechnology, one of the world’s premier gene sequencing and bioinformatics laboratories, to form a new division: HudsonAlpha Discovery.

The new division, in combination with Discovery’s current global biospecimen and analytic services, will provide the highest quality of clinically and scientifically annotated biospecimens, gene sequencing, bioinformatics, and laboratory services to the global pharmaceutical, biotechnology, and diagnostics industries.

This agreement comes on the heels of Discovery’s recent European acquisitions and expansion which cemented the company’s position as the global leader in biospecimen analysis, procurement, processing, and distribution. Genetic sequencing and bioinformatics services are a natural extension of Discovery’s core capabilities. Its new HudsonAlpha Discovery division adds outstanding scientists, clinicians, analysts, and bioinformaticians to provide solutions to complex and sophisticated research challenges—for the first time through a single strategic global provider.

“The HudsonAlpha Institute for Biotechnology is a remarkable place. We embrace its vision of advancing science and education to improve health around the world,” said Discovery CEO Glenn Bilawsky. “We are so very proud that the Institute selected Discovery to be the stewards of the Genomic Services Laboratory going forward, and of their investment in the future of our company. The HudsonAlpha Discovery platform is one of the largest global installations of the newest Illumina NovaSeqä technology, which gives us the scale, speed, and quality to tackle the size and complexity of any sequencing project. With HudsonAlpha Discovery, Discovery Life Sciences is the largest and most capable company to satisfy global market demand for a single strategic partner to provide biospecimens, pathology, immunohistochemistry, flow cytometry, sequencing, and bioinformatics services to accelerate product development.”

The HudsonAlpha GSL was built at the Institute by renowned genomic scientist, Shawn Levy, PhD, establishing itself as one of the world’s largest academic genomics laboratories. It has supported thousands of research projects and processed hundreds of thousands of biospecimens for healthcare institutions, companies, and investigators around the world. Its scientists provide insights into the understanding of many complex disorders, including cancer, autism, ALS, bipolar disorder, schizophrenia, diabetes, and rare and undiagnosed diseases. HudsonAlpha Discovery is the Institute’s tenth research and technology transfer for commercialized use and the largest to date.

“We are taking two organizations with amazing proficiencies and joining them to achieve capabilities that neither could accomplish alone,” said Dr. Levy. “We have limitless opportunities as a specialized development partner. Together with the Discovery Partners' clinical network, we can offer high-density genomic data to provide insights to any project.”  Dr. Levy joins Discovery Life Science’s executive team as chief scientific officer, Genomics, and will continue as a faculty investigator with HudsonAlpha Institute.

About Discovery Life Sciences

Discovery Life Sciences is a global market leader in biospecimen analysis, procurement, and distribution for the pharmaceutical, biotechnology, and diagnostics industries. Driven by science, the Discovery team engages with customers in an innovative, consultative approach to overcoming obstacles and reaching a faster end result. We are Science at your Service! For more information, visit dls.com.

About HudsonAlpha Genomic Services Lab

The HudsonAlpha Genomic Services Laboratory (GSL) is a globally recognized service laboratory that leverages the most current genomic research technologies to comprehensively support discovery, translational, and clinical research. The GSL’s expertise focuses on high-throughput sequencing, workflow optimization, and developing cutting-edge analytical pipelines.

About HudsonAlpha Institute for Biotechnology

HudsonAlpha Institute for Biotechnology is a nonprofit institute dedicated to developing and applying scientific advances to health, agriculture, learning, and commercialization on one campus. Opened in 2008, HudsonAlpha’s vision is to leverage the synergy between discovery, education, medicine, and economic development in genomic sciences to improve the human condition around the globe. To learn more, visit hudsonalpha.org.

 

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Water Street’s Development Partnership Achieves Another FDA Approval

Water Street announced today that its development partnership with a leading medical products company has resulted in the U.S. Food and Drug Administration (FDA) approval and launch of the ready-to-use cardiovascular medication, eptifibatide.  It is the first and only presentation of eptifibatide in a flexible container.

The approval of eptifibatide marks the seventh drug product successfully developed by Water Street’s company, Celerity Pharmaceuticals, LLC. Celerity both funded and led the development and approval of eptifibatide through its strategic partnership with the medical products company. Following FDA approval of eptifibatide, Celerity transferred ownership to its partner, which is commercially launching the new product in the United States.

“We are honored that our partner entrusted us to develop this new presentation of eptifibatide – the first of its kind available in a flexible container,” said Dan Robins, Ph.D., president, Celerity.  “We’re pleased that our work together has advanced our partner’s goal of engaging its innovative technologies with medicines that will benefit both patients and clinicians.”

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Water Street Announces New Investment

Water Street announced today that it has completed a new investment in Irvine, Calif.-based diagnostic solutions company, Pathnostics.  Water Street’s team, which has years of experience in the diagnostic and laboratory services sector, will partner with the fast-growing company to invest in and expand its innovative technology and portfolio of products.

Founded in 2014, Pathnostics specializes in diagnostic tests and services across a range of therapeutic areas, including urology, women’s health, gastroenterology and cancer.  The company has grown rapidly in recent years as increasing numbers of urologists have adopted its Guidance UTI test, which simultaneously diagnoses and guides antibiotic treatment for complex, recurring urinary tract infections.  This test utilizes proprietary technology featuring combined phenotypic sensitivity and genotypic resistance to conquer unresolved infections and rapidly provide therapeutic guidance to physicians. Studies show that Pathnostics’ patented technology has strong potential to reduce hospitalizations and improve patient satisfaction – a significant need and priority across the health care industry.

“Pathnostics’ one-of-a-kind technology is a breakthrough. Its proven ability to swiftly deliver highly accurate therapeutic guidance enables physicians to immediately treat complex and chronic infections.  We have a significant opportunity to leverage this unique technology across medical specialties to substantially improve patient care and reduce the cost of problematic infections.  We’re excited to be Pathnostics’ partner as they develop new tests and expand their product portfolio into new therapeutic areas, and continue their impressive growth,” said Scott Garrett, senior operating partner with Water Street and former chairman and CEO of Beckman Coulter.

Dave Pauluzzi, co-founder of Pathnostics, will continue to lead the company as CEO. Mr. Pauluzzi previously collaborated with Water Street when he was president and CEO of PLUS Diagnostics to grow the company into a national anatomic pathology leader.

“I’m thrilled to be working again with the Water Street team,” said Mr. Pauluzzi.  “Their industry expertise and network of resources will give us the ‘lift’ we need to take Pathnostics to the next level to benefit our customers and achieve our long-term vision of building Pathnostics into a diagnostic solutions leader.”

Pathnostics marks Water Street’s fifth investment in the diagnostics sector and first new investment of 2019.  Since its founding in 2005, the health care firm has completed more than 100 strategic transactions to build 30 market-leading companies in key sectors of health care.  Water Street targets investments ranging from $50 million to $500 million in four health care sectors: specialty distribution, medical and diagnostic products, health care services and pharmaceutical products and services.

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Discovery Launches European Expansion

Discovery Life Sciences™ (Discovery) announced a major expansion into Europe today, acquiring Sofia Bio and its extensive network of human biospecimen collection sites in Bulgaria, Romania, Poland, and the Czech Republic. Discovery also has entered into an agreement to become the exclusive industry distributor of East West Biopharma, which maintains the largest biocollection network in Ukraine.

These initiatives cement Discovery’s position as the global leader in biospecimen analysis, procurement, and distribution for the pharmaceutical, biotechnology, and diagnostics industries, and create the largest venture of its kind in Europe.

Discovery’s expansion will enhance the company’s ability to provide excellent service, capacity, and specificity of biospecimens to researchers across Europe, within 24 hours of collection.  Globally, Discovery’s clinical network will grow by more than 100 sites, to nearly 280; researchers will benefit from Discovery’s added capabilities of rapid sourcing, processing, and analysis of rare and high-demand biospecimens from Eastern Europe that have the potential to advance the diagnosis and treatment of life-threatening and chronic diseases.

“Sofia and East West Bio are highly regarded suppliers in the region and have been long-standing Discovery partners; they provide timely and high-quality services in compliance with all consent and industry regulations,” Discovery’s CEO Glenn Bilawsky said.  “As we knit this territory together, we will streamline logistics and further invest in providing outstanding processing and analytic services to the global medical research community.”

Leveraging its partnership with Water Street Healthcare Partners, Discovery’s continued expansion comes on the heels of its recent merger of four complementary bioanalytic and biospecimen businesses: Conversant Bio, Folio Bio, Discovery Life Sciences, and Phylogeny. This created a global leader in biospecimen analysis and procurement, offering the world’s largest repository of biospecimens.

The European expansion addresses the acute need for discovery, research, and development support services across the continent. “Eastern Europe’s clinical, academic, and research communities are seeking expanded opportunities to participate in the rapid growth of research and development of new diagnostics and therapies.” Bilawsky said. “Discovery’s expansion will answer that need.

About Discovery Life Sciences

Discovery Life Sciences is a global market leader in biospecimen analysis and procurement for the pharmaceutical, biotechnology, and diagnostics industries.

Driven by science, the Discovery team engages with customers in an innovative, consultative approach to overcoming obstacles and reaching a faster end result. We are Science at your Service™! For more information, visit dls.com.

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Cato Research Partners with Water Street

Cato Research, LLC (CATO), a global provider of regulatory and clinical research services, announced today that it has formed a strategic partnership with Water Street and JLL Partners to continue its growth and expansion.

Water Street will invest its pharmaceutical experience and network of resources to further develop and build CATO into a leading clinical and regulatory services provider. Founded in 1988, CATO has grown to offer pharmaceutical and biotechnology companies a range of regulatory and clinical services encompassing regulatory submissions, strategy and representation, nonclinical oversight, CMC management, pharmacokinetics, project management, medical writing, biostatistics, data management, pharmacovigilance, quality assurance, and trial conduct and management.

“Water Street and JLL stood out to our leadership team as the best partners to support the continued growth of our business and expand our offering into a broader suite of regulatory and clinical services,” said Lynda Sutton, co-founder and president, CATO.  “Working together, we will invest in CATO’s technical expertise and operations, as well as complete acquisitions that will enhance our ability to support our sponsors in today’s increasingly complex and regulated environment.”

CATO will continue to operate under the Cato Research brand with Lynda Sutton and the leadership team spearheading CATO’s day-to-day operations.  Cato BioVentures will continue to operate as a separate entity offering innovative investment approaches as a privately held family office fund.

“When we founded CATO, it was with the belief that we could make a difference in helping biopharmaceutical companies design and execute successful development strategies.  I’m excited to begin this next chapter toward achieving our goal of building CATO into a premier global clinical and regulatory services provider,” added Ms. Sutton.

CATO marks the fourth collaboration in five years between Water Street and JLL Partners. The healthcare firms have achieved one of the most accomplished track records of investing in and growing companies in the pharmaceutical products and services sector.  Collectively, they have completed nearly 40 strategic acquisitions in the past decade to invest in and build 13 market-leading companies in this space.

Terms of Water Street and JLL’s strategic investment in CATO are not being disclosed.

About Cato Research

Founded in 1988 by Dr. Allen Cato and Lynda Sutton and headquartered near Research Triangle Park, North Carolina, Cato Research is a full-service contract research and development organization providing strategic and tactical support for clients in the pharmaceutical, biotechnology, and medical device industries. Services range from design and management of preclinical and clinical studies to submission of regulatory documents required for marketing approval. With a staff of approximately 300 and offices located in the United States, Europe, Canada, Israel, and South Africa, the Cato Research team consistently demonstrates an unsurpassed level of responsiveness, flexibility, attention to detail, and passion for bringing their clients’ products to market with speed and cost-effectiveness.  For more information about Cato Research, visit cato.com.

 

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Perrigo Announces New Product Developed in Partnership with Water Street Company

Perrigo Company plc (NYSE; TASE: PRGO) today announced it has launched its AB rated abbreviated new drug application referencing Solaraze® Gel, 3% (diclofenac sodium gel, 3%).

Solaraze® Gel, 3% is indicated for the topical treatment of actinic keratoses. Annual market sales for Solaraze® Gel, 3% for the 12 months ending September 2018 were approximately $31 million as measured by IQVIATM.

Perrigo Executive Vice President and President Rx Pharmaceuticals Sharon Kochan stated, “Bringing this new product to market is another illustration of the Rx team’s commitment to providing high quality, affordable, Rx products that benefit patients in this important extended topical category.”

Diclofenac sodium gel, 3% was developed through a pharmaceutical development partnership with Capstone Development Solutions, a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry.  The product is manufactured by Perrigo and shipping to customers has commenced.

About Perrigo

Perrigo Company plc, a leading global healthcare company, delivers value to its customers and consumers by providing Quality Affordable Healthcare Products®. Founded in 1887 as a packager of home remedies, Perrigo has built a unique business model that is best described as the convergence of a fast-moving consumer goods company, a high-quality pharmaceutical manufacturing organization and a world-class supply chain network. Perrigo is one of the world's largest manufacturers of over-the-counter (“OTC”) healthcare products and suppliers of infant formulas for the store brand market. The Company also is a leading provider of branded OTC products throughout Europe and the U.S., as well as a leading producer of “extended topical” prescription drugs. Perrigo, headquartered in Ireland, sells its products primarily in North America and Europe, as well as in other markets, including Australia, Israel and China. Visit Perrigo online at (http://www.perrigo.com).

 

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Merger Creates Global Leader in Biospecimen Solutions

Conversant Bio, Folio Bio, Discovery Life Sciences and Phylogeny announced today that they have merged under the name Discovery Life Sciences™ (Discovery) to create a global market leader in biospecimen analysis and procurement for the pharmaceutical, biotechnology and diagnostics industries.

The new company will leverage deep scientific expertise and consultative services, combined with the largest repository of more than 10 million research-quality biospecimens—all available and processed for analysis—to accelerate the discovery, research, and development of novel biomarkers, drug candidates, and diagnostics.

Water Street Healthcare Partners, a strategic investor focused exclusively on the healthcare industry, facilitated the merger and invested in the company.

Glenn Bilawsky, a longtime executive in the pharmaceutical and contract research industries, is Discovery‘s CEO. “We’ve created an organization to provide researchers with significant added value through our consultative ‘SmartSourcing™’ model, which creates intelligent partnerships to overcome research problems and accelerate progress, saving both time and money,” he said. “We retain the world’s most diverse base of high-quality biospecimens and the global logistical systems to acquire, process, biostore, and ship them most efficiently, with adherence to all local and international laws.”

With a particular emphasis in oncology; cardiology; neurology; and infectious, inflammatory, and autoimmune diseases, the newly combined company’s catalog includes normal, suspect, and disease-state specimens comprising rare diseases and racially and ethnically diverse exemplars. Discovery obtains these biosamples through its Discovery Partners™, a global, integrated network of more than 165 clinical sources, in 25 countries on six continents. Due to these clinical partners, Discovery is unmatched in its ability to recruit the most diverse patient populations and obtain the highest quality of ethically obtained clinical research specimens.

Discovery can study specimens on all research and diagnostic platforms. It is committed to quality and integrity as an ISO 9001-certified company with CLIA-certified labs, stringent IRB and Ethics Committee compliance, and all required EU approvals and certifications. Navigating the new personal data protection regulations (both US and internationally) is a core competency.

About Discovery Life Sciences

Discovery Life Sciences is a global market leader in biospecimen analysis and procurement for the pharmaceutical, biotechnology, and diagnostics industries.  Driven by science, the Discovery team engages with customers in an innovative, consultative approach to overcoming obstacles and reaching a faster end result. We are Science at your Service™! For more information, visit dls.com.

 

 

 

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EVERSANA Announces Acquisition

EVERSANA, the leading independent provider of global services to the life science industry, today announced the addition of Seeker Health® to its platform.

Headquartered in Palo Alto, Calif., Seeker Health offers breakthrough digital patient identification technology to accelerate drug development and commercialization for biopharmaceutical companies. The company excels at identifying and engaging patients with complex diseases for clinical trials and patient databases. Now powered by EVERSANA, Seeker Health technology will be applied throughout the full product lifecycle, helping clients create stronger patient relationships through continued engagement.

“We face a pivotal shift in healthcare as medicines become increasingly more precise, serving smaller and harder-to-find patient populations.  Our technology has already helped biopharmaceutical companies accelerate clinical trial enrollment, launch therapies faster and reach the patients who need them. Now, we can have an even greater impact by engaging patients throughout the entire lifecycle of a medicine,” shared Sandra Shpilberg, founder & president, Seeker Health. “It’s been an honor to see our idea grow into technology that has such a profound impact on patients and drug development.”

Seeker Health complements EVERSANA’s suite of patient-focused capabilities, which include service and support HUB models, specialty pharmacy distribution, and The Patient Experience Project, a full-service, patient-centric communications firm serving the healthcare industry. The Seeker PortalTM, a proprietary patient-lead management system that is pending patent, and PEPTrials, a patient-centered model for clinical trial recruitment and enrollment, will immediately work together to advance recruitment for current trials and assist clients in developing more patient-focused clinical research programs.

“As people use technology in their daily lives, our industry has a tremendous opportunity to leverage technology to treat rare disease,” added Jim Lang, chief executive officer, EVERSANA. “From patient databases and research panels to ongoing therapy adherence, EVERSANA is well-positioned to help our clients create value for all stakeholders, and most importantly, for their patients.”

Seeker Health will continue to operate from Palo Alto with Shpilberg leading the team and operations. EVERSANA, which unveiled its brand earlier this week, encompasses seven premier service providers including Dohmen Life Science Services, The Access Group, Alliance Life Sciences, Health Strategies Group, Triplefin, Patient Experience Project, and Seeker Health. Together as EVERSANA, the organization delivers a fully-integrated service portfolio to help life science leaders create value for key constituents across the product lifecycle.

About EVERSANA™

EVERSANA is the leading independent provider of global services to the life science industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product lifecycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies to advance life science services for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.

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