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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Keystone Healthcare Partners Establishes Partnership with Trinity Medical to Expand Emergency Medicine Footprint into Louisiana

Keystone Healthcare Partners | February 05, 2024

Keystone Healthcare Partners a leading provider of emergency medicine, hospital medicine, critical care medicine, and telehealth staffing and management services, as well as revenue cycle management, recently announced that it has formed a partnership with Trinity Medical in Ferriday, Louisiana. Keystone's delivery of emergency medicine services at Trinity Medical will commence on February 1, 2024. This contract represents an exciting expansion of Keystone's regional influence into Louisiana; the company has managed contracts in Mississippi for decades. Glenn Adams, Keystone's CEO & Co-founder, notes, "We are excited to kick off another partnership with a client where we see opportunity for real impact. We've hit the ground running to shore up areas of frustration for the client and bring value-add and innovative solutions, such as Keystone Connect AI technology to the emergency medicine program." While the healthcare landscape has been challenging for rural and critical access hospitals, the two entities share a patient-centered ethos that will be paramount to the partnership. The two entities share a community- and patient-focus that is embodied by Trinity's motto, "People you know, caring for people you love." "We are very excited to start our partnership with Keystone Healthcare," states Keisha Smith, CEO of Trinity. "My goal for Trinity Medical has always been to provide our patients with the best healthcare and customer service possible in the Miss-Lou area. We feel that Keystone shares the same goals that we have and will be a true asset to our hospital. Henry Ford stated, 'Coming together is a beginning, staying together is progress, and working together is success.' We are looking forward to a long lasting, successful partnership with Keystone Healthcare." Trinity Medical, a 23-bed licensed facility, continues to grow and upgrade their services and facilities in addition to recruiting physicians to meet the growing needs of their expanding community. About Keystone Healthcare Keystone Healthcare™ is a leading provider of Emergency Medicine, Hospital Medicine, Critical Care Medicine and Telehealth clinical management services and staffing solutions for hospitals. We efficiently deliver high-quality, patient-centered care through strong physician leadership and involved management that drive our innovative and integrated business model. About Trinity Medical Trinity Medical is operated by Concordia Parish Hospital Service District No. 1. Trinity Medical, formerly Riverland Medical Center, opened in 1964 as Concordia Parish Hospital and has continuously served the residents of the area for more than 55 years. In addition to emergency and acute care, Trinity Medical offers surgical services, diagnostic imaging, infusion center, cardio-respiratory care, gastroenterology, lab services, otolaryngology, urology, and an in-hospital rehabilitation service as well as an extensive range of out-patient services, both diagnostic and for treatment.

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Aya Healthcare Expands into UK with ID Medical Acquisition

Aya Healthcare | January 17, 2024

Aya Healthcare, the largest healthcare talent software and staffing company in the United States, today announced the acquisition of ID Medical, a leading workforce solutions provider in the United Kingdom (U.K.). ID Medical brings over 20 years of experience providing the National Health Service (NHS) and other healthcare organizations with innovative workforce solutions, including workforce management, international recruitment and temporary healthcare staffing. As part of the acquisition, ID Medical will make Aya Healthcare’s market-leading technology available to the NHS and U.K.-based clinicians. The companies plan to share best practices from each market with their respective clients. “We are excited about ID Medical joining the Aya family of brands. We believe that we will deliver enhanced value to our respective clients and clinicians through this cross-Atlantic collaboration,” said Alan Braynin, president and CEO of Aya Healthcare. ID Medical will continue to operate as its own brand in the U.K., supporting thousands of healthcare professionals and hundreds of healthcare organizations. “We are excited to join Aya in our shared mission to transform the healthcare industry worldwide,” said Deenu Patel, CEO of ID Medical. “With Aya’s support, we’ll have access to additional resources, technology and expertise to enhance our services and expand our impact.” About Aya Healthcare Aya Healthcare is the largest healthcare talent software and staffing company in the United States. Aya operates the world’s largest digital staffing platform delivering every component of healthcare-focused labor services, including travel nursing and allied health, per diem, permanent staff hiring, interim leadership, locum tenens and non-clinical professionals. Aya’s software suite, which includes vendor management, float pool technology, provider services and predictive analytics, provides hospital systems greater efficiencies, superior operating results and reduced labor costs. While technology drives efficiency and scale, Aya’s 7,000+ global employees power the company to deliver unparalleled accountability and exceptional experiences for clients and clinicians. Aya’s company culture is rooted in giving back and supports organizations around food security, education, healthcare, safe shelter and equity.

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