Q&A with Cecil Nick, Vice President at Parexel

Media 7 | August 2, 2021

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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CommonSpirit Health Sets Up National Value-Based Care Organization

CommonSpirit Health | September 22, 2023

Population Health Services Organization strives to enhance access to equitable healthcare, elevate quality, reduce costs, and benefit millions of patients. Half of CommonSpirit's value-based providers are external, paving the way for PHSO's network expansion. PHSO leverages CommonSpirit's value-based healthcare expertise, including successful risk-bearing organizations and ten accountable care organizations covering over 2.6 million lives. CommonSpirit Health has unveiled a nationwide value-based services platform named Population Health Services Organization (PHSO). This initiative primarily aims to enhance access to equitable healthcare, elevate care quality and outcomes, and reduce the overall cost of healthcare delivery. PHSO will deliver various services, including advanced population health analytics, network administration, care coordination, data management and analytics, technological infrastructure support, reporting, and additional support to empower healthcare providers and provider networks to excel in value-based care. Wright Lassiter III, CEO of CommonSpirit Health, stated, The PHSO is a natural extension of our mission and longstanding commitment to providing high-quality, equitable care and addressing social determinants of health. [Source – Business Wire] He added that by harnessing CommonSpirit's national scale and expertise in value-based care, the company's goal is to elevate the standard of healthcare in the United States and assist providers in succeeding in value-based care within diverse community-based health system environments. CommonSpirit Health extends its services to urban and rural communities across 24 states, establishing itself as one of the United States' most prominent providers of Medicare and Medicaid services. Consequently, its PHSO will cater to an even more diverse payer portfolio. Thomas McGinn, MD, MPH, Executive Vice President, Physician Enterprise at CommonSpirit Health, highlighted the organization's unique advantage in serving diverse communities encompassing Medicaid, Medicare, and commercial insurance, making their data more representative of the American population compared to models primarily focused on commercial insurance. He added that CommonSpirit's presence in 24 states provides them with the data, tools, and access to a broad patient demographic, allowing them to tackle crucial national health challenges that require their size, scale, and expertise. For example, they can utilize data insights to understand testing, referral, and treatment patterns, enabling interventions that reduce viral infections like Hepatitis C, disproportionately affecting vulnerable populations. Value-based care emphasizes the quality of healthcare over its quantity, promoting comprehensive and coordinated care to enhance health outcomes, quality, and equity. This model relies on contractual incentives for providers to achieve superior results, improve quality, enhance patient experiences, and curb healthcare expenses. Notably, the demand for such agreements is rising, exemplified by the company's goal to transition most Medicaid and all Medicare beneficiaries into value-based care relationships by 2030.

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GE HealthCare Releases Sustainability Report, Shares Future Goals

GE HealthCare | September 25, 2023

First Sustainability Report since January 2023 showcases the company’s commitment to creating a world with no healthcare limits Report shows reduced operational Scope 1 and 2 greenhouse gas emissions by 27% since 2019 Strong leadership focus on sustainability efforts and ESG with a cross-functional ESP GE HealthCare has released its inaugural Sustainability Report, marking its commitment to environmental, social, and governance (ESG) practices since becoming an independent company in January 2023. The report highlights the reduction of operational Scope 1 and 2 greenhouse gas emissions by 27% since 2019 and outlines the company's dedication to ESG principles and sustainability. GE HealthCare recognizes the importance of sustainability and corporate responsibility in the healthcare industry. The report reflects the company's dedication to creating a world where healthcare knows no limits and its commitment to environmental and social impact. ESG Program Leader at GE HealthCare, Kelvin Sanborn, stated, GE HealthCare recognizes the global significance of fulfilling our purpose and delivering on our objectives and is pleased to have reduced our operational GHG emissions by 27% versus our 2019 baseline. With our broad ESG strategy and priorities in mind, we are carrying out a climate risk assessment that will inform our climate transition plan, and developing a net zero roadmap for Scope 1, 2, and 3 GHG emissions. [Source: Business Wire] Key Highlights from the Company's Inaugural Sustainability Report: Environmental Impact Since 2019, reduced GHG emissions by 27% with goals of 50% reduction by 2030 and net zero by 2050 Registered with Science Based Targets Initiative Committed to decarbonizing the healthcare sector Social Impact Established cultural operating principles Planned GE Healthcare Foundation for philanthropy Appointed chief diversity, equity, and inclusion officer Governance and Accountability Strong corporate governance as a stand-alone public company Relaunched Code of Conduct with high employee engagement Joined UN Global Compact to support sustainable development goals GE HealthCare conducted an ESG materiality assessment, defining five key focus areas for its sustainability strategy. These include expanding healthcare access, fostering diversity and inclusion, reducing greenhouse gas emissions, promoting the circular economy, and enhancing patient data cybersecurity. The report outlines the company's long-term ESG objectives and progress toward previous goals. It is preparing to release an updated task force on climate-related financial disclosures (TCFD) report once its climate risk assessment is finalized. Furthermore, the company has scheduled a materiality assessment update for 2024. In parallel, GE HealthCare is exploring the expansion of Reporting Standards for its ESG disclosures and evaluating how its objectives align with the United Nations Sustainable Development Goals (UN SDGs). After conducting an ESG materiality assessment before its spin-off, the company has pinpointed five vital areas for its sustainability strategy. These priorities, underscored by the company's core innovation, product quality, and integrity principles, encompass the following: Expanding global healthcare access by ensuring underserved populations have better healthcare opportunities; promoting a culture of inclusion and diversity; mitigating its climate impact through concerted efforts; facilitating equipment and prioritizing patient data security and cybersecurity by adhering to standardized data privacy and security practices based on global regulations such as the EU GDPR.

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