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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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Canon strengthens medical business with establishment of Canon Healthcare USA, INC.

Canon Medical Systems USA | November 28, 2022

Canon Inc. announced that the company has decided to establish a new subsidiary, to be named Canon Healthcare USA, INC. By strengthening its presence in the highly influential American medical market, Canon aims to accelerate the growth of its medical business. The Canon group is currently working towards a grand strategic transformation of its business portfolio in order to realize future growth. With the announcement of Phase VI, the latest in the company’s Excellent Global Corporation Plan series of 5-year management programs, Canon’s primary objective is to “thoroughly strengthen business competitiveness.” Under this slogan, Canon is striving to increase its competitiveness in various spheres of the medical industry, including diagnostics such as CT, MRI, diagnostic ultrasound systems, as well as medical component businesses such as X-ray tubes, X-ray detectors and key MRI components. In addition, the company is making strides in the field of healthcare IT and in vitro diagnostics. One of the most pressing challenges for Canon’s medical business has been the need to strengthen its presence in the American medical industry, which is extremely influential on the global market. Canon has decided to consider the greater Cleveland area, a key hub in the country’s medical industry as a candidate location for establishing Canon Healthcare USA, INC. in order to strengthen the company’s competitive presence in the global market. With the establishment of Canon Healthcare USA, INC., Canon will transfer a portion of its marketing operations, incubated at the Global Headquarters over Canon’s long history. These operations will transfer to the Global Marketing Center, to be established in January of 2023, in order to strengthen upstream marketing1. By establishing a network with medical institutions on the front lines of treatment and achieving a greater understanding of the market, Canon will develop and propose products and solutions that address the trends and needs of the medical market. Among such efforts is the commencement of joint research with American medical institutions on the practical application of X-ray CT systems utilizing photon counting detection modules, with the goal of capturing the No.1 share of the global CT market at an early stage. In addition, Canon Medical Systems USA the U.S. subsidiary of Canon Medical Systems Corporation will transfer a portion of its product sales and service operations to Canon Healthcare USA. This will integrate operations with downstream marketing2, thereby enabling the company to focus on increasing its share of medical diagnostic systems in the American market. The Cleveland area, one of the candidate locations, is home to the headquarters and factory of Quality Electrodynamics, LLC which develops and manufactures MRI key components and was welcomed into the Canon Group in 2019. By placing QED under the umbrella of Canon Healthcare USA, Canon will aim to increase coordination between its system and component businesses. Furthermore, Canon Medical will take over the advanced technology research activities that Canon has been conducting with Massachusetts General Hospital and Brigham Women’s Hospital at the Healthcare Optics Research Laboratory in Boston for 10 years, and will promote joint research aimed at commercialization in collaboration with the Global Marketing Center. In addition, Canon is considering the possibility of expanding U.S.-based development, manufacturing and other capabilities, with the goal of further strengthening its business in the country. The establishment of this new company and expansion of business operations is expected to require USD $300 million of investment capital. This investment will empower Canon’s medical business to grow by deepening its understanding of customer and market needs, as well as redouble its efforts in the American market, thereby contributing to the global medical industry.

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FUTURE OF HEALTHCARE

Medcase & NTT DATA Sign a Definitive Agreement to Enable Healthcare AI Developers a Holistic Solution to Access, Annotate

Medcase | November 29, 2022

Medcase, a leading solution provider for healthcare AI, and NTT DATA, a digital business and IT services leader, have signed a definitive agreement to enable data discovery and enrichment solutions for healthcare imaging. AI in healthcare is beginning to demonstrate an ability to improve productivity and outcomes in a competitive market space. Fulfilling data needs and enriching image data sets with annotation and labeling confronts an industry focused on critical development and release timelines. The new partnership between Medcase and NTT DATA addresses that inefficiency allowing AI developers and life sciences to focus on their training and data science. “Enabling access to rich medical datasets has become paramount to our customers focused on reducing the time from concept to algorithm production. Partnering with NTT DATA is exciting for us as we can now assist innovators with access to curated data, coupled with our enrichment solutions powered by Medcase’s global network of health care professionals and annotators from radiologists to gastroenterologists working side by side with AI developers.” Kyle Giddens, CEO and Co-Founder of Medcase The collaboration will enable innovators working with Medcase to access enriched patient studies, including medical imaging, through NTT DATA’s Advocate AI data cooperative network. Medcase’s curation services and AI annotation solutions leverage a global network of healthcare experts to identify, diagnose, and audit medical data according to annotation and labeling guidelines from research, all the way to FDA reader studies. “Data diversity across technology and patient populations is fundamental to ensuring strong analytics’ training and high conformance,” said Mitchell Goldburgh, Senior Director, Enterprise Imaging and Analytics, NTT DATA Services. “Confidence in AI grows by having a dynamic and broadly trained team of annotators complementing the data with their diversity in the art of annotation. We are pleased to have been chosen by Medcase as a go-to-market partner in advocating the adoption of AI.” “Advancing technology innovation in the digital and medical space is the best way to improve patient outcomes quickly,” said Giddens. “This is why we are excited to partner with NTT DATA to accelerate AI to the market with essential data annotation, labeling, and enablement that they need to innovate. Access to health care professionals should be as easy as spinning up a new cloud instance on Amazon, we make that easy with our platform and API’s.” About NTT DATA NTT DATA is a $30 billion trusted global innovator of IT and business services. We help clients transform through business and technology consulting, industry and digital solutions, applications development, and managed edge-to-cloud infrastructure services, BPO, systems integration, and global data centers. We are committed to our client's long-term success and combine global reach with local client service in over 80 countries. About Medcase Medcase is changing how businesses access medical expertise, knowledge, and data by building the largest global network of on-demand healthcare professionals working remotely to assist healthcare innovators and AI developers. By empowering leading industry leaders in medical devices, AI, and technology companies to pharmaceuticals and telemedicine, Medcase helps accelerate healthcare innovation and bring new medical technologies to market by connecting them to experts to enrich medical data, surveys, or interviews to assess go-to-market and regulation and even providing staffing for valuable telehealth or remote patient monitoring services.

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HEALTHTECH SECURITY

Intuit to Acquire Financial Health Startup SeedFi

Intuit | December 02, 2022

Intuit the global financial technology platform that makes TurboTax, Credit Karma, QuickBooks, and Mailchimp, announced it has entered into an agreement to acquire SeedFi, the partner behind Credit Karma’s Credit Builder1, which helps low, or no-credit borrowers build credit while saving money, all for free. Credit Builder offers a line of credit and a secured savings account enabling members to build their credit while building up savings. By combining SeedFi’s Credit Builder technology with Credit Karma’s long standing relationships with credit bureaus and others in the credit ecosystem, Intuit will be able to move with greater speed and scale to help Credit Karma members make financial progress. Late last year, Credit Karma entered into a partnership with SeedFi to offer Credit Builder to its members, enabling them to make regular payments, starting with as little as $20 per month or $10 per paycheck. By reporting these payments to the credit bureaus, members took steps toward improving their financial health. Through this partnership, members increased their score by an average of 21 points in as little as 30 to 45 days2 and built up over $10 million in savings. This acquisition will enable Credit Karma Money to continue to build on that momentum and help put more members on a path to financial security. “Credit Karma Money was built to change consumers’ relationship with money and help them develop responsible financial habits, like staying on top of their bills and spending within their means. With Credit Builder, we are able to differentiate ourselves as one of the best accounts for building credit. We have long standing relationships with credit bureaus and others in the credit ecosystem, and SeedFi has built great technology, so when combined, we will move even faster and build products to help more members, including those who need it the most.” Poulomi Damany, SVP and GM for Credit Karma Money and Tax A recent study from the Consumer Financial Protection Bureau showed that nearly three-quarters of Americans with no emergency savings have credit scores below 660. The correlation between low credit scores and lack of emergency savings persists over time, and SeedFi takes that problem head-on. Similar to Credit Karma, SeedFi’s mission is to break the cycle of debt and help Americans realize their financial potential. “We have already been working with the Credit Karma Money team for over a year to help members build their credit score and have been impressed with how Credit Karma’s mission comes through in everything the company does. SeedFi has a similar mission to help consumers become financially fit, so joining forces just makes sense,” said SeedFi co-founder and CEO Jim McGinley. “Together, leveraging Credit Karma’s resources and scale, we will be able to accelerate the momentum of Credit Builder and SeedFi’s technology capabilities to help more consumers improve their financial health.” The transaction between Intuit and McBurberod Financial, Inc. which does business as SeedFi, is subject to closing conditions, and is expected to close in the coming months. Upon close, SeedFi will become part of Intuit’s Credit Karma business. The transaction is not expected to have a material impact on Intuit’s operating results for the full fiscal year 2023. Terms of the transaction have not been disclosed. Intuit Ventures was an investor in SeedFi’s last financing round. About Intuit Intuit is the global financial technology platform that powers prosperity for the people and communities we serve. With more than 100 million customers worldwide using TurboTax, Credit Karma, QuickBooks, and Mailchimp, we believe that everyone should have the opportunity to prosper. We never stop working to find new, innovative ways to make that possible. Please visit us for the latest information about Intuit, our products and services, and find us on social. About Credit Karma Founded in 2007 by Ken Lin, Credit Karma, an Intuit company is a consumer technology company with nearly 130 million members in the United States, U.K. and Canada, including almost half of all U.S. millennials. While best known for pioneering free credit scores, the company’s members turn to Credit Karma for everything related to their financial goals, including identity monitoring, applying for credit cards, shopping for loans auto insurance, savings accounts and now checking accounts through our bank partner, MVB Bank, Inc., Member FDIC — all for free.

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