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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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Avail Reaches Significant Network Expansion Milestone with the Signing of its 50th MedTech Contract

Avail Medsystems | August 05, 2022

Avail, the digital hub of the operating room enabling the medical technology and healthcare industries to work smarter to advance patient care, announced the addition of a 50th MedTech organization to its telepresence network. With the signing of this contract, the Avail platform is poised to enable hundreds of thousands of people to collaborate, educate, and share surgical and MedTech expertise between operating rooms and remote locations in real time. "The Avail platform was built to connect the MedTech industry more frequently, efficiently and seamlessly to surgeons and interventionalists, enabling them to work together more closely to advance medicine. With this exciting milestone, the digital evolution of MedTech is well underway. Many of our MedTech partners are integrating Avail into their daily processes to expand the productivity and reach of their commercial teams, thus helping representatives to better engage with customers and support their success." Daniel Hawkins, CEO of Avail For some of the world's largest and most respected MedTech companies specializing in devices for neurosurgery, interventional cardiology, interventional radiology, vascular surgery, and orthopedic surgery, among others — Avail has positively changed business practices in myriad ways. These include enabling faster product training and expanded reach for field teams, dramatically increasing the time they have available to sell products and support live procedures. In addition, MedTech companies and surgeons have realized the mutual benefits of using Avail to collaborate during unplanned cases when field representatives are unable to reach remote locations to join in person. With skyrocketing travel costs and staff shortages, Avail's approach to collaboration has allowed physician education and product launch programs not only to continue, but to operate more efficiently and rapidly. Other uses include enabling the acceleration of product innovation by allowing engineering and R&D teams to better connect with providers. "As far as technology goes, the Avail experience has completely raised the bar for our Professional Education Programs — Avail makes us look good," stated John Vogrin, Senior Manager, Surgical Care Services for Cochlear Americas. "But more importantly, using Avail has allowed Cochlear to reduce travel for members of our sales team and give them back countless hours of their personal lives while improving the training experience and shortening the time it takes to complete. It's a win-win-win-win for our company, employees, customers, and their patients." Avail's footprint of consistent, purpose-built hardware in procedure rooms, along with integrated software created for that hardware, serves as the foundation of the company's surgical telepresence platform. The mobile Avail console includes edge-based computing and a large display monitor and is connected securely to the cloud to stream high-quality audio, video, and surgical imaging to remote participants in a HIPAA-HITECH protected environment. "Future-forward MedTech companies and healthcare systems not only need better, faster means of collaboration, but they want a way to share their own software capabilities to and from the OR," stated James Domine, CTO of Avail. "Avail's consistent hardware footprint provides eyes and ears into the operating room and will also enable the sharing of applicable third-party software capabilities, including AI and machine learning, which can be displayed on the large Avail console monitor to further elevate the collaborative experience. This can help improve processes and speed the adoption of new products that better meet the changing healthcare environment." News of the 50th MedTech contract follows Avail's recent announcements of another company expansion and a partnership with the Stroke Thrombectomy and Aneurysm Registry (STAR), which enables participating neurosurgeons to collaborate and share expertise, regardless of their locations. About Avail Medsystems Avail enables the MedTech industry and healthcare providers to work together more often and more efficiently, harnessing expertise and technology in and out of the OR to accelerate the innovation, adoption, and reach of tools and techniques to improve patient care. Avail does this by placing a consistent, mobile, hardware platform with integrated software into operating rooms, audibly and visually connecting remote participants and serving as the hub for advanced digital capabilities including AI and machine learning, in a secure cloud-based digital telepresence network. Today, 50 MedTech organizations have contracted with Avail to rethink commercial models, reduce inefficiencies, and enhance the reach and timeliness of collaboration. Avail was founded in 2017 by MedTech veterans with a vision to leverage Silicon Valley technology expertise to evolve the industry and enable MedTech and healthcare to deliver the best care possible. Avail.io

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HEALTH TECHNOLOGY

Leading ACOs are Choosing Innovaccer’s ACO REACH Solution Suite to Improve Population Health and Advance Health Equity

Innovaccer Inc., | August 05, 2022

Innovaccer Inc., the Health Cloud company, announced the expansion of its Solution Suite for ACO REACH participants. With its ACO REACH Solution Suite, Innovaccer has taken its entire portfolio of solutions that several leading ACOs across the country use, to help New Entrant ACOs and High Needs Population ACOs accelerate their transformation and advance health equity. Since the initial launch of the ACO REACH Solution Suite in April, Innovaccer has rapidly expanded its client base to include new entrants such as UpStream, Florence Health, and many more organizations that are accelerating their transformation to value-based care. These organizations are leveraging Innovaccer’s end-to-end technology platform to build a unified data foundation, develop population health management strategies, and better engage physicians and patients. For example, UpStream chose Innovaccer as their technology partner to get a 360-degree patient view that provides actionable insights at the point of care to help improve outcomes, employ advanced analytics to assess and predict health risks to help keep patients out of the hospital, and use clinically contextual patient engagement throughout the care continuum to help improve chronic care management and the overall patient experience. “Traditionally, many practices don’t have the experience or resources to take on the financial risks associated with value-based care models, especially for older, higher-risk populations,” said Lucas Sahm, chief information officer at UpStream. “UpStream is deeply rooted in data, which makes partnering with Innovaccer a logical step for us because we speak the same language and have the same goal: to connect, curate, and make better use of healthcare data to improve patient outcomes, improve the patient experience, while also improving financial outcomes for providers.” Innovaccer’s ACO REACH Solution Suite brings technology and services together to help providers jump-start and excel at this new value-based model: the Innovaccer Health Cloud’s Data Activation Platform, Innovaccer’s industry-leading population health management solution, Innovaccer’s world-class population health analytics; and Innovaccer’s comprehensive SDoH solution for identifying, understanding, and mitigating social determinants—an absolute essential for supporting health equity, access to care, and community health. “Through ACO REACH, the CMS is paving the way for provider organizations to advance health equity through value-based care. To succeed with this new program, they need the right people, processes, and technologies to help develop, implement, and optimize their shared savings strategies. As a technology-enabled service, our enhanced ACO REACH Solutions Suite enables providers to identify and address SDoH factors, reach vulnerable populations with remote patient monitoring, identify relevant care gaps and utilization trends, predict obstacles, and assist providers and patients in optimizing outcomes. We’ve strived to include everything a provider could need in a technology-enabled solution to succeed as a REACH ACO.” Abhinav Shashank, cofounder and CEO at Innovaccer Innovaccer has a proven history of helping health organizations succeed under risk-bearing, value-based care models. Reach out to an Innovaccer representative today to get a demo of the Innovaccer® Health Cloud’s Data Activation Platform or to find out how we are helping provider partners like you with the tools they need to reach underserved patients, identify and address SDoH, and progress in the movement toward health equity. For more information, please visit https://innovaccer.com/accelerators/aco-reach. About Innovaccer Innovaccer Inc., the Health Cloud company, is dedicated to accelerating innovation in healthcare. The Innovaccer® Health Cloud unifies patient data across systems and care settings, and empowers healthcare organizations to develop scalable, modern applications that improve clinical, financial, and operational outcomes. Innovaccer’s solutions have been deployed across more than 1,600 care settings in the U.S., enabling more than 96,000 providers to transform care delivery and work collaboratively with payers and life sciences companies. Innovaccer has helped its customers unify health records for more than 39 million people and generate over $1B in cumulative cost savings. Innovaccer is the #1 rated Data and Analytics Platform by KLAS, and the #1 rated population health technology platform by Black Book.

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HEALTH TECHNOLOGY

TELUS and LifeWorks receive court approval and key regulatory approvals for proposed acquisition

TELUS Corporation | August 12, 2022

TELUS Corporation and LifeWorks Inc. announced that the Ontario Superior Court of Justice has granted its final order approving the plan of arrangement in respect of the acquisition by TELUS of LifeWorks previously announced on June 16, 2022. TELUS and LifeWorks also announced that the Competition Bureau of Canada has issued a no action letter in respect of the Arrangement. Accordingly, Competition Act Approval, as defined and as required by the Arrangement Agreement previously entered into between LifeWorks and TELUS, has been obtained. In addition, the applicable waiting period in relation to the Arrangement under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, has expired with the result that the acquisition is clear to proceed in the United States as well as Canada. The Court Approval, the Competition Act Approval and the HSR Approval are significant milestones toward closing TELUS’ acquisition of LifeWorks and follows LifeWorks’ shareholder approval, which was obtained at a special meeting of LifeWorks’ shareholders on August 4, 2022. Pending receipt of regulatory approvals in the United Kingdom and Australia, and the satisfaction of customary closing conditions, the Arrangement is expected to proceed to closing which is anticipated to be on or about the fourth quarter of 2022. “We are pleased to have reached this significant milestone, with clearance to proceed with the TELUS – LifeWorks transaction in Canada and the United States. Importantly, we have seen overwhelming support from LifeWorks’ team members, customers and shareholders, and I am confident that the potent combination of the respective skills and capabilities of LifeWorks and TELUS Health will create a world-leading, end-to-end, digital-first employee primary and preventative healthcare, mental health and wellness platform, covering more than 50 million lives, and growing, on a global basis. We look forward to welcoming LifeWorks employees into our TELUS family so that, together, we can help even more people around the world lead their healthiest and most productive professional and personal lives.” Darren Entwistle, President and CEO of TELUS “This is an exciting new chapter for LifeWorks and together with TELUS we will be able to accelerate our shared vision of empowering individuals to take a more proactive role in the management of their health by unifying the continuum of care through digital-first innovations, as well as our unmatched in-person care,” said Stephen Liptrap, President and CEO of LifeWorks. “Our two organizations are aligned as leading purpose-driven companies that are committed to improving the lives of people around the world.” About TELUS Corporation TELUS is a dynamic, world-leading communications technology company with $17 billion in annual revenue and 17 million customer connections spanning wireless, data, IP, voice, television, entertainment, video, and security. Our social purpose is to leverage our global-leading technology and compassion to drive social change and enable remarkable human outcomes. Our longstanding commitment to putting our customers first fuels every aspect of our business, making us a distinct leader in customer service excellence and loyalty. The numerous, sustained accolades TELUS has earned over the years from independent, industry-leading network insight firms showcase the strength and speed of TELUS’ global-leading networks, reinforcing our commitment to provide Canadians with access to superior technology that connects us to the people, resources and information that make our lives better. TELUS Health is Canada’s leader in digital health technology, improving access to health and wellness services and revolutionizing the flow of health information across the continuum of care. TELUS Agriculture & Consumer Goods is a global technology provider of innovative data insights and digital solutions, creating a unified, trusted and sustainable value chain. TELUS International is a leading digital customer experience innovator that designs, builds, and delivers next-generation solutions, including AI and content moderation, for global and disruptive brands across high-growth industry verticals, including tech and games, communications and media and ecommerce and FinTech. TELUS and TELUS International operate in 28 countries around the world. Driven by our determination and vision to connect all citizens for good, our deeply meaningful and enduring philosophy to give where we live has inspired TELUS, our team members and retirees to contribute more than $900 million, in cash, in-kind contributions, time and programs, and 1.8 million days of service since 2000. This unprecedented generosity and unparalleled volunteerism have made TELUS the most giving company in the world. Together, let’s make the future friendly. About LifeWorks LifeWorks is a world leader in providing digital and in-person solutions that support the total wellbeing of individuals – mental, physical, financial and social. As the trusted leader in mental health and wellbeing, LifeWorks delivers a personalized continuum of care that helps our clients improve the lives of their people and by doing so, improve their business. Guided by our purpose to improve lives and improve business, we help our clients improve the wellbeing of their people, we help them improve workforce engagement and productivity, thereby improving the performance of our clients’ organizations. LifeWorks is a publicly traded company on the Toronto Stock Exchange (TSX: LWRK). LifeWorks has approximately 7,000 employees, 25,000 clients, and serves 36 million individuals and their families in more than 160 countries.

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HEALTH TECHNOLOGY

Avail Reaches Significant Network Expansion Milestone with the Signing of its 50th MedTech Contract

Avail Medsystems | August 05, 2022

Avail, the digital hub of the operating room enabling the medical technology and healthcare industries to work smarter to advance patient care, announced the addition of a 50th MedTech organization to its telepresence network. With the signing of this contract, the Avail platform is poised to enable hundreds of thousands of people to collaborate, educate, and share surgical and MedTech expertise between operating rooms and remote locations in real time. "The Avail platform was built to connect the MedTech industry more frequently, efficiently and seamlessly to surgeons and interventionalists, enabling them to work together more closely to advance medicine. With this exciting milestone, the digital evolution of MedTech is well underway. Many of our MedTech partners are integrating Avail into their daily processes to expand the productivity and reach of their commercial teams, thus helping representatives to better engage with customers and support their success." Daniel Hawkins, CEO of Avail For some of the world's largest and most respected MedTech companies specializing in devices for neurosurgery, interventional cardiology, interventional radiology, vascular surgery, and orthopedic surgery, among others — Avail has positively changed business practices in myriad ways. These include enabling faster product training and expanded reach for field teams, dramatically increasing the time they have available to sell products and support live procedures. In addition, MedTech companies and surgeons have realized the mutual benefits of using Avail to collaborate during unplanned cases when field representatives are unable to reach remote locations to join in person. With skyrocketing travel costs and staff shortages, Avail's approach to collaboration has allowed physician education and product launch programs not only to continue, but to operate more efficiently and rapidly. Other uses include enabling the acceleration of product innovation by allowing engineering and R&D teams to better connect with providers. "As far as technology goes, the Avail experience has completely raised the bar for our Professional Education Programs — Avail makes us look good," stated John Vogrin, Senior Manager, Surgical Care Services for Cochlear Americas. "But more importantly, using Avail has allowed Cochlear to reduce travel for members of our sales team and give them back countless hours of their personal lives while improving the training experience and shortening the time it takes to complete. It's a win-win-win-win for our company, employees, customers, and their patients." Avail's footprint of consistent, purpose-built hardware in procedure rooms, along with integrated software created for that hardware, serves as the foundation of the company's surgical telepresence platform. The mobile Avail console includes edge-based computing and a large display monitor and is connected securely to the cloud to stream high-quality audio, video, and surgical imaging to remote participants in a HIPAA-HITECH protected environment. "Future-forward MedTech companies and healthcare systems not only need better, faster means of collaboration, but they want a way to share their own software capabilities to and from the OR," stated James Domine, CTO of Avail. "Avail's consistent hardware footprint provides eyes and ears into the operating room and will also enable the sharing of applicable third-party software capabilities, including AI and machine learning, which can be displayed on the large Avail console monitor to further elevate the collaborative experience. This can help improve processes and speed the adoption of new products that better meet the changing healthcare environment." News of the 50th MedTech contract follows Avail's recent announcements of another company expansion and a partnership with the Stroke Thrombectomy and Aneurysm Registry (STAR), which enables participating neurosurgeons to collaborate and share expertise, regardless of their locations. About Avail Medsystems Avail enables the MedTech industry and healthcare providers to work together more often and more efficiently, harnessing expertise and technology in and out of the OR to accelerate the innovation, adoption, and reach of tools and techniques to improve patient care. Avail does this by placing a consistent, mobile, hardware platform with integrated software into operating rooms, audibly and visually connecting remote participants and serving as the hub for advanced digital capabilities including AI and machine learning, in a secure cloud-based digital telepresence network. Today, 50 MedTech organizations have contracted with Avail to rethink commercial models, reduce inefficiencies, and enhance the reach and timeliness of collaboration. Avail was founded in 2017 by MedTech veterans with a vision to leverage Silicon Valley technology expertise to evolve the industry and enable MedTech and healthcare to deliver the best care possible. Avail.io

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