Q&A with Cecil Nick, Vice President at Parexel

Cecil Nick, Vice President (Biotechnology) at Parexel, is a biochemistry graduate and regulatory professional with over 30 years experience specializing in the clinical development of biological and biotech products. He has supported 7 biosimilar marketing approvals and has over 80 biosimilar Agency interactions in EU, US, Canada and RoW. He offers extensive expertise to clients with respect to biosimilars, comparabilty, clinical development, orphan drugs and training. He is a fellow of TOPRA and has been a guest lecture at Cardiff University for MSc in Clinical Research, and Greenwich University for MSc in Pharmaceutical Sciences, courses and Biotech Module leader for the TOPRA MSc course. He was on the editorial panel of SCRIP Clinical Research and has over 30 publications to his name.

It is important to set realistic expectations. For example, agree on timelines that can be met and align on the scope of the project and not make empty promises.



MEDIA 7: You are a proud author of 30 publications and have also been on the editorial panel for SCRIP Clinical Research. Can you please take us through your professional journey?
CECIL NICK:
After completing a postgraduate degree in biochemistry at the University of Cape Town, I started my career in regulatory affairs some four decades ago. In the course of my career, I've worked across all disciplines - quality, clinical & non-clinical, and in many therapeutic areas and product classes. In 1986, I joined Nordisk as their UK regulatory manager and continued in that role following the merger with Novo Nordisk. During this time, I built up extensive knowledge in the areas of diabetes, growth, and blood products as well as in the emerging area of biotechnology where my academic foundation in biochemistry and in particular my specialization in messenger RNA metabolism equipped me well to face the regulatory challenges emerging from this new technology. 
In my final years at Novo Nordisk, I became involved with Quality Management and Health Technology Assessments. Also, during this time, I took on the role of a visiting lecturer at Greenwich and Cardiff Universities, delivering courses on Biotechnology in the pharmaceutical industry. I also contributed to the TOPRA MSc. Biotech Module and later took on the role of the Module Leader. 

In 2001, I joined Parexel as a Senior Consultant progressing to my current role of Vice President, Technical. This was at the very beginning of the concept of biosimilars a topic in which I became extremely enthusiastic. I recognized the potential of biosimilars to expand access to the life-changing medicines that biotechnology was delivering and was keen to participate in unraveling the regulatory challenges faced by the concept of biosimilars. I became involved in delivering presentations on biosimilars at major international meetings as well as running many training courses. I also wrote extensively on the subject during this period and corresponded with EU regulators active in the biosimilar field. 

In helping clients develop biosimilars I have been involved in many spearheading projects including working extensively on one of the first biosimilars ever to be approved and the first monoclonal antibody biosimilar to be approved. When I started on the biosimilar road the prevailing view was that monoclonals were too complex to be approved as biosimilars and my challenging this perception was considered a radical position. I was therefore proud to be part of the team that brought the first monoclonal biosimilar to the market.
During my career at Parexel, I have been working in many other areas as well including many anti-infectives, flu vaccines, and anti-RSV monoclonal antibodies. In March 2020, I was drawn into the fight against COVID-19 and have worked on some ground-breaking ideas which hopefully will change the course of the pandemic.


I like to imagine myself in the clients’ position and understand how my role will contribute to their success; and the deliverable gets tailored accordingly.



M7: SCRIP Awards 2020 announced Parexel as the best contract research organization. What are some of the biggest challenges you have faced on this journey?
CN
: I am immensely proud to have contributed to the efforts that resulted in Parexel receiving the SCRIP Awards 2020 for the best contract research organization. Of course, my contribution was just a fragment of that effort. This recognition requires a strong positive corporate culture that recognizes the efforts of every one of the more than 17,000 employees. This award is a recognition of the efforts of all of my colleagues. The work that our consulting group does clearly differentiates Parexel. Successful drug development requires a fusion of input from different disciplines. We work as an integrated team to provide optimal solutions for our clients’ development programs. Our objective is to help our clients bring enhanced and life-changing treatments to the market rapidly and efficiently. This need has never been greater than during the current COVID-19 pandemic and Parexel employees take pride in the work we are doing to bring new treatments to market in a record-breaking time.


M7: How far have Clinical Developments progressed in the last 12 months? What are the latest advancements that have taken place in this field?
CN:
Clinical development is a complex process and I get involved in the trial design rather than delivery. From a design perspective, COVID-19 has placed focus on how trial designs can be streamlined and still achieve regulatory approval. This is not a change that has happened over 12 months or even 24 months. However, the past 18 months have provided a renewed focus on accelerating clinical development and applying techniques that have been discussed for years such as adaptive designs, seamless designs, platform trials, and the introduction of remote monitoring patients and trial conduct. On the regulatory front as well, there have been changes with the more widespread use of rolling reviews and greater interaction with sponsors. The extent to which these approaches will survive after the pandemic is debatable.


It is not just a question of doing what is asked but working in a collaborative way to provide new ideas and air any concerns before they escalate into major issues.



M7: What is your strategy to ensure the highest client satisfaction from your services at Parexel?
CN:
First and foremost is to listen to the client and understand their needs and offer them a solution that fits these needs. The second is to imagine myself in the clients’ position and understand how my role will contribute to their success; the deliverable will be tailored accordingly. Third, it is important to set realistic expectations. For example, agree on timelines that can be met and align on the scope of the project and not make empty promises.  My role is to work with the client to support the design of their clinical program and ultimately to gain regulatory approval of their product. It is not just a question of doing what is asked but working in a collaborative way to provide new ideas and air any concerns before they escalate into major issues. For example, if the client presents us with a draft synopsis, we will flag any issues that may impact recruitment, limit the probability of achieving the primary trial objective, or which may not align with a regulatory agency’s position. We consider ourselves an integral part of the client’s success and do all we can to ensure that success.


M7: What is your favorite part of working at Parexel?
CN:
My favorite part of working with Parexel is the opportunity to work with colleagues whose expertise I highly respect. Many of them are recognized experts in their field. Drug development requires an amalgamation of expertise across disciplines, and it is a privilege to be able to work with not only my highly experienced colleagues in the Regulatory Consulting Group but also statisticians, therapeutic area medical experts, trial feasibility experts, pharmacologists in the early phase team and health economists to name but a few. This allows me to provide my clients with a level of unparalleled service that I couldn't possibly achieve on my own. At Parexel I am constantly learning from my colleagues and clients and finding new and innovative ways to deliver on projects.

ABOUT PAREXEL

Parexel supports the development of innovative new medicines to improve the health of patients. We provide services to help life sciences and biopharmaceutical clients everywhere transform scientific discoveries into new treatments. From decentralized clinical trials to regulatory consulting services to leveraging real world insights, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. Parexel was named “Best Contract Research Organization” in December 2020 by an independent panel for Informa Pharma Intelligence.

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PureHealth Completes Acquisition of UK’s Largest Private Healthcare Group

PureHealth | January 16, 2024

PureHealth, the largest healthcare platform in the Middle East, has announced the successful completion of its strategic acquisition of Circle Health Group, UK’s largest independent operators of hospitals, marking a significant milestone in the company's global expansion strategy. The completion of this deal, which has achieved regulatory approvals in record time, signifies PureHealth’s exceptional operational capabilities and commitment to international growth. The completion of this transaction further strengthens PureHealth’s commitment to becoming a leading global player in healthcare. With a vision aligned with the UAE leadership to promote wellbeing and enhance healthcare services, PureHealth is dedicated to continuously improving patient experience and adopting the most advanced clinical practices. The company’s expansion into the UK healthcare market reflects its focus on advancing the science of longevity and unlocking time for humanity. Hamad Al Hammadi, Chairman of the Board of Directors of PureHealth, said: “We are pleased to complete the acquisition of Circle in record time. This remarkable achievement epitomises PureHealth's operational excellence and strategic adaptability in broadening its international impact. After investing in Ardent Health USA, this is PureHealth’s second international acquisition, and we look forward to building our portfolio internationally.” Farhan Malik, Founder and Managing Director of PureHealth, commented: “Completing the acquisition of Circle is a strategic leap forward for PureHealth. This acquisition is more than an expansion; it's a significant stride towards establishing PureHealth as a global healthcare platform. We are not just investing in the future of healthcare; we are shaping it to be more connected, innovative, and accessible on a global scale. This move aligns with our vision of pioneering a healthier future for all and underscores our commitment to elevating the global position of Abu Dhabi in the healthcare sector and revolutionising healthcare services globally. We look forward to fostering long term partnerships within the UK’s healthcare ecosystem.” Valued at c.USD 1.2 billion before debt, this acquisition marks a significant investment in the future of healthcare, positioning PureHealth at the forefront of international healthcare innovation and service provision. Building upon this significant momentum, PureHealth is advancing its expansion strategy in 2024. This strategic vision includes not only acquisitions in locally, but also international markets building a global healthcare platform. As PureHealth moves forward with its strategic global expansion, it remains committed to its mission of delivering unrivalled healthcare experiences through innovation, technology-driven solutions, and collaboration. This transaction not only enhances PureHealth's services and presence in the international healthcare landscape but also solidifies the company’s position as a leader in the healthcare industry, dedicated to improving lives and fostering healthier communities worldwide, and taking PureHealth from Abu Dhabi to the World. About PureHealth By advancing the Science of Longevity, PureHealth is introducing the healthcare of the future from the United Arab Emirates to the rest of the world. PureHealth is the largest healthcare platform in the Middle East with an ecosystem that challenges lifespans and reimagines health spans. With 25+ hospitals, 100+ clinics, multiple diagnostic centres, health insurance solutions, pharmacies, health tech, procurement, investments and more. With groundbreaking innovations at the forefront of healthcare, the company is on a mission to unlock time for humankind.

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Digital Healthcare

UCI Health Reaches Definitive Agreement to Acquire Four Southern California Hospitals From Tenet Healthcare Corporation

UCI Health | February 02, 2024

The Regents of the University of California, on behalf of the University of California, Irvine, has entered into a definitive agreement with Tenet Healthcare Corporation to acquire Tenet's Pacific Coast Network. The network will become part of UCI Health, the clinical enterprise of UC Irvine. "UC Irvine has deepened its healthcare commitment to the future of Orange County, our region and California," said UC Irvine Chancellor Howard Gillman. "This journey in healthcare is deeply intertwined with the University of California's dedication to bettering our communities, expanding access to premier healthcare, and pioneering the medical innovations of tomorrow, today. Our vision will bridge gaps in regional care and reinforce UCI's place among the nation's leading academic health systems while advancing solutions to challenges facing healthcare." Pending customary regulatory approvals, clearances, and closing conditions, the proposed acquisition would bring four medical centers in Lakewood, Los Alamitos, Fountain Valley and Placentia and associated outpatient locations into the UCI Health system. UCI Health currently delivers care at UCI Medical Center in Orange and a growing network of multispecialty care centers. "At UCI Health, we are excited to add these new care sites to the UCI Health network and extend the benefits of our compassionate, high-level care, clinical innovation, and scientific discovery," said Chad Lefteris, president and chief executive officer of UCI Health. "As Orange County's only academic health system, UCI Health is unique in its ability to offer the highest level of advanced care powered by the research and innovation of a world-class public research institution." UCI Health recognizes a unique opportunity to build on the quality care already being delivered in the communities served by Tenet Healthcare's Pacific Coast Network. "These four hospitals are well-regarded in their communities for providing high-quality, compassionate care," said Saum Sutaria, M.D., chairman and chief executive officer of Tenet Healthcare. "The local communities will benefit from the nationally recognized advancements, medical knowledge, research, and community focus that UCI Health brings as an innovative academic health system. UCI Health recognizes a unique opportunity to build on the quality care already being delivered in the communities served by the Pacific Coast Network." In a region with a population greater than that of two dozen states, UCI Health operates the only Level I trauma center, locally based National Cancer Institute-designated comprehensive cancer center, high-risk perinatal-neonatal service and is the largest regional burn center and leading provider of complex tertiary and quaternary care. The system's clinical excellence has consistently placed UCI Health in the top 10 for quality and safety among the nation's leading comprehensive academic health systems. The acquisition also means more patients will have access to advanced therapies in the region's largest and most diverse portfolio of clinical trials, ranging from cancer to neurosciences, digestive diseases, orthopedics and internal medicine specialties. UCI Health and Tenet Healthcare's Pacific Coast Network patients can continue receiving care at their local facilities as they normally would from the care teams they know and trust. The transaction is expected to be completed in spring 2024, subject to customary regulatory approvals, clearances, and closing conditions. "It is a privilege to provide world-class care to Californians and we are excited to welcome the clinicians and co-workers from these Tenet Healthcare sites to UCI Health as partners in improving the health of local communities," Lefteris said. About UCI Health UCI Health is the clinical enterprise of the University of California, Irvine, and the only academic health system in Orange County. Patients can access UCI Health at primary and specialty care offices across Orange County and at its main campus, UCI Medical Center in Orange, Calif. The 459-bed, acute care hospital, listed among America's Best Hospitals by U.S. News & World Report for 23 consecutive years, provides tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health and rehabilitation services. UCI Medical Center is home to Orange County's only National Cancer Institute-designated comprehensive cancer center, high-risk perinatal/neonatal program and American College of Surgeons-verified Level I adult and Level II pediatric trauma center, gold level 1 geriatric emergency department and regional burn center. About UC Irvine About the University of California, Irvine: Founded in 1965, UCI is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UCI has more than 37,000 students and offers 224 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide. About Tenet Healthcare Tenet Healthcare Corporation is a diversified healthcare services company headquartered in Dallas. Our care delivery network includes United Surgical Partners International, the largest ambulatory platform in the country, which operates or has ownership interests in more than 480 ambulatory surgery centers and surgical hospitals. We also operate 58 acute care and specialty hospitals, approximately 110 other outpatient facilities, a network of leading employed physicians and a global business center in Manila, Philippines. Our Conifer Health Solutions subsidiary provides revenue cycle management and value-based care services to hospitals, health systems, physician practices, employers, and other clients. Across the Tenet enterprise, we are united by our mission to deliver quality, compassionate care in the communities we serve.

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Health Technology

Rudolf Riester GmbH Announces Global Market Launch of Telemedicine Solution, Showcases ri-sonic® E-Stethoscope + eMurmur® AI Integration

Rudolf Riester GmbH | January 29, 2024

Rudolf Riester GmbH, a global leader in medical technology, proudly announces the full market launch of its comprehensive Telemedicine offering. Already in active use across Europe, the Middle East, and Africa, the solution from the trusted Riester brand delivers industry-leading quality and versatility through integration of a broad range of medical devices to meet the needs of diverse user scenarios. "Since its founding 75 years ago, Riester has been a pioneer in providing accurate and efficient diagnostic devices for front-line healthcare. We have brought this passion and expertise to the creation of our telemedicine solution," said Dr. Georgiana Gasquères, Global Business Unit Director, Telemedicine at Riester. "Now we empower healthcare providers worldwide with the tools they need to deliver accurate diagnosis and exceptional care to every patient, everywhere, and to do it more sustainably." Riester is demonstrating its Telemedicine Case and Cart offerings at the Arab Health show in Dubai, 29 January – 1 February 2024, at booth SA.E30. Traveling nurses with South African healthcare innovator EQiGate are already evaluating dozens of patients every week with the Riester Telemedicine Case. "EQiGate selected the Riester Telemedicine solution for its high quality, comprehensiveness, and versatile, Windows-based compatibility with our portfolio of operating applications," stated Braam Kruger, CEO at EQiGate. "The Riester solution integrates seamlessly with our Hospital at Home concept, enabling us to bring the hospital to the patient, a healthcare paradigm shift that yields significant cost and time savings for both the healthcare system and the patient." At Arab Health, Riester is showcasing the integration of their industry-leading ri-sonic® E-stethoscope with the eMurmur® AI platform. Digital auscultation with ri-sonic and eMurmur AI enables the early detection and analysis of heart murmurs, informing better, more timely decisions about treatment pathways. To demonstrate their commitment to raising heart health awareness and improving quality of life through accurate and efficient diagnosis, Riester is offering complimentary advisory heart checks to all exhibition attendees at their booth at Arab Health, conducted by a professional cardiologist. "Our participation at Arab Health reaches beyond showcasing our technological advancements; it is about educating and engaging with the public – including Arab Health attendees – and healthcare professionals," said Irina Zhdanova, CEO of Riester. "By providing free advisory heart checks, we emphasise the significance of regular cardiac health assessments and demonstrate how innovative technology can be a pivotal tool in advancing diagnostic cardiac care to improve health outcomes. This is a perfect way to honor Riester’s 75-year heritage and act on our vision and mission." About Rudolf Riester GmbH Since its founding in Germany in 1948, Rudolf Riester GmbH has been a pioneering force in improving quality of life through accurate and efficient diagnosis on the front-line of healthcare. By developing and manufacturing high-quality, market-leading medical diagnostic products, Riester has earned a global reputation for quality, reliability, and innovation in the healthcare sector, with a presence in over 150 countries. Specializing in diagnostic devices, Riester's product portfolio includes telemedicine solutions as well as stethoscopes, blood pressure monitors, otoscopes, ophthalmoscopes, and other medical equipment. Riester is part of the Halma plc group of companies.

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