The 10 Most Trusted Vaccine Solution Providers, December2020

DECEMBER 2020

Tech Outlook The Age of DNA Nanotechnology Leaders Viewpoint Caring for the elderly amid covid-19 New Horizons Evolving Future Of The Biopharmaceutical Industry

The

10

Most Trusted

Vaccine Solution Providers,

2020

NEXELIS An Agile Approach to Bioanalysis

EDITOR’S NOTE A Light of Hope

H

ealth and medical scholars have defined vaccination as one of the best ten achievements of public health in the 20th century. Vaccines work by imitating an infective agent also called viruses, bacteria or other microorganisms that can cause a sickness. It prepares the immune system to rapidly and effectively counter against the disease.

Usually, vaccines have done this by presenting a weakened form of an infectious agent that allows the immune system to build a memory of it. This way, the immune system can quickly recognize and fight it before it makes body ill. That’s how some existing COVID-19 vaccine candidates are being designed.

A vaccine for COVID-19 will be a critical instrument to bring pandemic under control by using combined and effective testing and existing prevention measures.

There are several promising vaccine candidates in the pipeline, some of them are under review for approval and the Pfizer/BioNTech and Moderna vaccines are already approved for use. The race for providing a safe and effective vaccine has entered into a new phase.

According to a report, the world class association like UNICEF is sharing its knowledge as the largest single vaccine buyer in the world by cooperating with the PAHO Revolving Fund and the COVID-19 Vaccine Global Access Facility (COVAX Facility).

But it’s important to remember that the journey from developing a vaccine to licensing it, producing it at scale and using it widely is a long one. Once a vaccine receives the required approval, it will then be critical

The

10

Most Trusted

Vaccine Solution Providers,

2020

that it is made accessible, in a timely and equitable manner, to reach those that need it most. That’s where UNICEF and its partners come in.

So, in this edition, ‘The 10 Most Trusted Vaccine Solution Providers, 2020’ CIO Look has shortlisted various healthcare organizations which are playing important role towards global healthcare system.

The cover featured Nexelis which has deep expertise in the disciplined field of vaccines, large molecules, immunotherapies and biomarkers, with a strong reputation for accelerated results, enabled by state-of-the-art platforms. The company excels by combining robust protocols with scientific discipline, human agility and client partnership in order to answer the most demanding mission requirements.

Also, while flipping the pages, don’t forget to go through the articles and CXOs written by our in-house editorial team and industry experts respectively.

Happy Reading!

Abhishaj Sajeev abhishaj@ciolook.com

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COVER STORY

NEXELIS

An Agile Approach to Bioanalysis

C O N T E N T S

ARTICLE

52 New Horizons Evolving Future Of The Biopharmaceutical Industry

36 Leaders Viewpoint Caring for the elderly amid covid-19

44

Healthcare Viewpoint

56

The Impacts of Pandemic in Pharma and Biotch Laboratory

Tech Outlook The Age of DNA Nanotechnology

40

BSV Setting benchmarks in

32

patient outcomes

Celerion Translating Scientific Ideas into Potential Medicines

CMIC, Inc. Ascending Zeniths of Global Success

48

Abhishaj Sajeev Editor-in-Chief

CONTENT

Senior Editor Alan Swann Executive Editors Rohit Chaturvedi Alex Spellman

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December, 2020

Company Name

Featuring Person

Brief

2A Pharma AB 2apharma.comon

Preben Bruun-Nyzell CEO

2A Pharma is a clinical stage Swedish/Danish biopharmaceutical company focused on discovering, developing and commercialising novel, cost effective prophylactic and therapeutic vaccines based on its patented AAVLP platform.

Bharat Serums and Vaccines Ltd bharatserums.com

SANJIV NAVANGUL Managing Director and CEO

Bharat Serums And Vaccines Limited is one of the fastest growing bio pharmaceutical companies in India.

Blue Water Vaccines, Inc bluewatervaccines.com

Joseph Hernandez CEO

Blue Water Vaccines, a Greater Cincinnati startup, has received $7 million in financing to commercialize a single vaccine that could offer protection against all types of flu.

Celerion celerion.com

Zori Cheshmedzhieva Vice President Global Clinical Development

Celerion’s commitment to swift, exceptional research through translational medicine.

CMIC, Inc cmicgroup,com

HRBoostLLC hrboost.com

HRBoost is Shared Services HR firm specializing in building HR from scratch and implementing practices that add value.

Maroba Aged Care maroba.com.au

Viv Allanson CEO

Maroba is a caring community for self-care, semi-independent and full residential care for the aged. Visitors call it “exceptional” and “amazing”.

Metrendalytics Consultants metrendalytics.com

Jahanara Miotto President

The company specializes in the development of a variety of cost-efficient and scalable cloud-based applications for the centralization, aggregation, and standardization of data for real time analytics.

MEVAC me-vac.com

Magdy Elsayed CEO

MEVAC is the first and largest private factory for manufacturing vaccines in Egypt, the Middle East and Africa with International Accreditations.

Nexelis nexelis.com

Benoit Bouche CEO

Nexelis is a leading provider of assay development and advanced laboratory testing services in the infectious diseases, metabolic diseases, and oncology fields.

Triox Nano smartriox.com

Dr. Roy Farfara Founder

TrioxNano has developed and patented a programmable nano delivery platform that can carry different medications, including chemotherapies, to their target tissue. The technology uses nanoparticles based on DNA machinery.

An Agile Approa

NEX

ach to Bioanalysis

XELIS

COVER STORY

Key milestones of Nexe

Cover Story

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here is a unique strength in numbers. We understand more and more easily together, and the ongoing pandemic underlines the crucial position of international cooperation on science and technical frontiers. In recent months, our doctors, clinicians, scientists, and medical experts from all walks of life have collaborated relentlessly to tackle the pandemic of coronavirus in a spirit of cooperation that is beyond precedent.

The necessity for both simultaneous attempts to generate several prospective candidates and the need for fast, large-scale production and global delivery are crucial to the evaluation of vaccinations for every type

of disease. And that's what our edition The 10 Most Trusted Vaccine Solution Providers, 2020 is all about. We are on an adventure to extract out all the companies making revolutionary developments in the industry.

And we can't be more pleased to commence this issue with Nexelis, a preferred partner of choice for companies working on the vaccine development.

Despite being a relatively young Contract Research Organization (CRO) firm, Nexelis has become the preferred partner in vaccine development in no time.

With its roots deep in vaccine research, with many of its experts originating in GSK vaccines, Nexelis is a

elis story

organizations funding the development of vaccines targeting emerging countries, which use the CRO's services to help develop lifesaving innovations.

The Inception Saga The company came into existence as a meeting of minds, when NEOMED-LABS was spun-off from GSK Vaccines in 2015, partnered with Ampersand Capital in 2018, acquired Pacific Biomarkers the same year and PairImmune in 2019.This group combines over 10 years of bioanalysis, 20 years of vaccine and 25 years of biomarker experience. Through new strategic acquisitions, Nexelis continues to grow and bring in important areas of expertise, solidifying its leadership position in the immunology field.

Earlier this year, Belgian specialty immunogenicity and immuno-oncology testing ImmunXperts and Indianapolis based bioanalytical ligand binding and mass spectrometry laboratories joined the group, further extending its portfolio of services. These acquisitions also provide Nexelis a global presence with 3 sites in North America: Laval, QC; Indianapolis, IN; Seattle; WA and 2 sites in Europe: Gosselies, Belgium and Porton Down, the UK (through a partnership with PHE, Public Health England). We understand that the company will add a third site in Europe in the months to come through another acquisition to be announced before the end of the year.

A passionate leadership team

dynamic and motivated company dedicated to apply its knowledge, agility and drive to further support vaccine efforts against diseases like COVID-19, as well as servicing other areas in immunology where new therapies are urgently needed to save lives.

The CRO firm brings its unrivalled expertise in immunology to the industry. With assay development and advanced laboratory testing, the company provides services to companies seeking solutions in the infectious diseases, metabolic diseases, and oncology arenas. Nexelis has become a testing lab of choice for top 10 global pharmaceutical, innovative biotechnology companies, and governmental or non-governmental

Benoit Bouche, the CEO of Nexelis, has spent over 30 years growing in healthcare business. His dual professional background in both science and business has provided him with an in-depth knowledge of all aspects of a healthcare venture stage company. As an entrepreneur, investor, advisor, and board member, he has honed his expertise in dealing with the challenges that arise when a company experiences a growth spurt.

It is his experience that has proven invaluable for the meteoric rise of Nexelis.

Bouche joined NEOMED-LABS in 2017. His assignment was to transform a 55-person vaccine R&D unit, into a global services provider for immuno-centric advanced lab testing. With an MBO backed by Ampersand Capital in July 2018, and a number of organic and inorganic

COVER STORY

“

“The COVID-19 has placed our labs at the heart of multiple R&D initiatives with an incredible number of projects initiated in a short period of time. This, while we have continued to work on our preexisting projects. Agility and speed have been absolutely key.” initiatives, the company more than sextupled its size in two years and a half.

He says, “At Nexelis, we offer a distinctive approach centered on this openness to creativity and innovation which allows us to be very flexible in our pursuits. This approach, in turn, generates enthusiasm from our scientists, collaborators and clients. Personally, I view politics and lack of transparency as the main roadblocks to efficiency in a corporation. That is why I have always tried to promote this culture, whereby we encourage our specialists to exchange freely with colleagues and partner with clients in a spirit of collaboration and transparency. As a result, there's no overlong process or heavy hierarchy at Nexelis. We get things done!”

Luc Gagnon, VP Vaccine Sciences Armed with over 20 years of experience, Luc Gagnon is in charge of scientific operations at Nexelis in the vaccines field. He is responsible for developing assays supporting vaccines and biologics through the various phases of the clinical trials. Since its very beginnings, Luc has worked as VP of Vaccine Sciences, making the transition from the pharmaceuticals to a CRO following GSK 's 2015 spin-off.

GSK exchanged the oncology business in 2015 with the business of Novartis vaccines. As a result, GSK had to abandon the Laval facility in Canada for so many R&D sites worldwide. However, the pharmaceutical industry was conscious of the tremendous potential of the Laval experts and sponsored their conversion into a single CRO. Luc says, “At the Laval GSK site, we almost had the full chain of vaccine testing available, from early discovery of new antigens up to the pre-GMP production, and even a

clinical site where human samples were tested to assess immune responses. We were able to take all that expertise and convert it into a new CRO venture.”

In the first three years Nexelis-initially called NEOMED-LABS-has begun to travel and was given the buildings and all the instruments and $25 million in financing. 55 workers entered the newly established organization in terms of professionals, all of them with more than 15 years of vaccine evaluation experience.

“As I always say to potential partners: we're a young CRO with an old soul, thanks to our very experienced staff. The core team was highly versed in analyzing samples generated in phase I up to phase IV clinical trials.

Furthermore, we have access to the best equipment. We have fully automated systems that can tackle large series of clinical samples while maintaining both the integrity and quality of the testing being performed,” he adds.

He further continues with “In terms of quality, we also stay true to our pharma roots. The first time we were audited to obtain our GCLP certification, we were told we were overly engineered. Usually companies need to take action to reach a certain line, but we were already way above the line! So, we have the whole package, combining our eye for quality with the scientific expertise and the instruments. This makes us one of the best players for vaccines and immunology specialty labs in the market.”

Nexelis has complete assay packages that allows collaborators to produce all data required to submit for new vaccines. Their collective strategy is one of the keys for Nexelis growth. They follow the approach of a collaborator instead of a customer support provider during projects.

Luc asserts, “In every project, we strive to be an extension of our partner's lab. We're not a CRO where it's 'our way or

Benoit Bouche President & CEO

COVER STORY

the highway'. We're always willing to further improve on the science, process, or performance of the assay. Working as partners also means that we can openly discuss things without being afraid to challenge each other on important decisions. We are confident that our opinions matter and that our input is beneficial to our partners, as our scientists are so experienced. This collaborative relationship lets us achieve the best possible outcome without the risk of any caveat or grey zone. We're not only executing; we're also providing advice based on our experience in the vaccine field.”

The SARS-CoV-2 soon began to disperse across the world at the beginning of 2020. This challenge has been recognized by the Nexelis team early and committed collaborators have begun to search into solutions. In battling this deadly pandemic, the organization has played a leading role.

“We were able to very quickly develop new assays that measure the extent to which candidate vaccines elicit an immune response to SARS-CoV-2. Because we already had a general approach to developing such assays, we were able to fast-track the development. This is something we are capable of doing for any new health threat that arises unexpectedly. It's an important lesson we've learned from this crisis: we all need to develop more generic approaches and stay vigilant for potential new pandemics, so we can start developing tools in time like we managed to do for the COVID pandemic. Our assays are now becoming the gold standard, used around the world. I'm also proud to say that we initially funded this work internally and obtained the support of the Bill and Melinda Gates foundation in this initiative, out of a desire to quickly help tackle this pandemic issue,” cites Luc. The Nexelis SARS-CoV-2 research forced several businesses and industries to invest in COVID-19 vaccinations and therapies at the front and center of the market.

The business has grown steadily since its creation in 2015 by integrating internal innovations and external acquisitions. The Nexelis team has quadrupled in scale in 18 month and will have sextupled in two years and a half at the end of the year 2020. Additional Nexelis locations, based on biomarker studies in Seattle, and Belgium with experience in early in vitro and in vivo preclinical development are situated in addition to the Laval location in Canada where vaccine research is carried out. Nexlis often collaborates with Public Health England – Porton Down following entering into strategic relationship in July 2019. Nexelis has become an immunocentric CRO with a robust reach.

He comments, “We are also supporting CEPI (the Coalition for Epidemic Preparedness Innovation), a global partnership launched in 2017 to develop vaccines to stop future epidemics. CEPI is now also sponsoring initiatives to accelerate the development of COVID-19 vaccines. Our assays, to determine immunogenicity of candidate vaccines, will be transferred to six other labs around the world, which we will be managing at distance in terms of quality.”

“Despite the boom in COVID-19 vaccine research, the vaccine field remains limited to a few key players, particularly when compared to larger domains such as immuno-oncology or cell and gene therapy. With our strong background in vaccines, we have quickly become the number one partner for this field. Now, with the growing demand of other growing immunology fields, we are working hard to extend our services in other domains. The

aim is, of course, to become the partner of choice for these larger fields as well. To do so, we have been investing heavily in our capability to perform next-generation sequencing and qPCR, and measure gene and biomarker expression using flow cytometry or cellular immunology. In addition to this internal growth, we're purchasing companies that allow us to build new capabilities rapidly and incorporate further expertise in our scientific team,” he asserts.

Adding further to the sustainable future, he says, “For our vaccine business, international growth is a key focus.

We're working on setting up centralized labs in Europe and Asia, reducing the costs of shipping samples around the world. This saves not only money, but also reduces both the time and environmental impact. Our new site in Belgium already gives us a footprint in Europe, but the goal is to expand further geographically. In that aspect, we will be not only growing horizontally with different pillars, but also vertically to have a broader presence around the world. All of this growth will bring new benefits to our partners, and further cement our position as the top CRO for advanced

laboratory testing services.”

Greg Kulnis, Senior Director of Customer Solutions Greg Kulnis is the first in line for sponsors in the vaccines field as a Senior Director of Customer Solutions at Nexelis. Combining a research background with many years of business development experience, he is the perfect fit to connect the operational and commercial departments within Nexelis. Kulnis expresses some of his favorite facets of Nexelis work and his confidence in the vaccinations and medicines the organization aims to produce.

The team of Customer Service aims at supplying Nexelis consumers with the greatest consumer experience. A core component of this step is to identify what prospective customers need and link them to the right research tools inside the organization.

Greg says, “We have a number of experts in different fields, meaning we can always find a good fit for new partners. For

COVER STORY

Greg Kulnis Senior Director of Customer Solutions

“ “We have the whole package, combining our eye for quality with the scientific expertise and the instruments. This makes us one of the best players for vaccines and immunology specialty labs in the market example, we have Luc Gagnon, our VP of Vaccine Sciences for all vaccine related projects. For preclinical development, we can rely on Danielle Poirier, who leads our preclinical team in Laval, or Bassam Hallis of Public Health England.

For early in silico or in vitro immunogenicity assessment, we leverage the insights of Sofie Pattijn from our newly acquired division in Belgium.”

“I worked in the lab for a number of years prior to moving to the commercial side, and I've always appreciated being able to establish a conversation between two well-aligned experts. For a new client, it's important that we are confident in all of the business areas, but what really instills trust in our organization is connecting the experts and allowing them to engage in those in-depth exchanges. It helps demonstrate our competence and instils confidence in our ability to deliver the project in exactly the right way and according to the desired timelines.”

Nexelis is set up to foster cohesive cooperation across the globe. The organization is built so that each of the sites has their own specialty without significant overlap in expertise.

“Our biomarker experts in Seattle remain our biomarker experts. If we have a vaccine-based project that's looking to assess a biomarker, we don't rely on the resources in Laval, but instead reach out to the team in Seattle where that is their true core expertise. The same applies for mass spectrometry which is the core expertise of the Indianapolis team led by Shelby Anderson. This way we ensure that our clients are accessing the top experts at all times, no matter the area and geographical location,” says Greg.

Like a sharp blade, Nexelis uses its limited scale and professional scientists to perform the utmost. The company's emphasis on immunologic tests, usually for large molecular molecules, has been improved over the

years. The business has taken on a strong leadership role in this region due to its long-standing expertise.

The reduced scale of the organization often helps the team to handle consumer initiatives much more flexibly than the bureaucracy-laden activities of the bigger, broader CRO. He says, “Since we are rather specialized in what we do, and we don't try to cover a large number of other disease areas, we are able to house all services under one roof and still be very nimble in our approach to client studies. We are not bogged down by the corporate machinery of larger companies, where the requirement to conform to standard processes causes delays for clients. We're adaptable and very flexible in serving the needs of our clients. As a company grows, you need to make more of a concerted effort to maintain that agility, which has definitely been the case with the Nexelis leadership team.”

The strengths of Nexelis include the firm's contribution to rigorous research and performance. The preservation of these expectations ensures that the finest research minds are drawn, a challenge for which the Nexelis team has a variety of cards up its sleeve.

Greg asserts, “One of the key opportunities we offer researchers who join our team is being able to interact directly with the top scientific minds in the companies we work with. For instance, if we're talking to a large pharmaceutical company, a Nexelis researcher would likely be working with a principal scientist in their immunology group, and when we're working with smaller partners, our researchers are often personally engaging with their CSO. This opportunity, to liaise and exchange ideas directly with the world's top experts, is a real plus of working at Nexelis as it is not usually possible for most researchers at larger CROs.”

COVER STORY

Vaccine credentials Respiratory Seasonal & Pandemic Influenza Haemophilus influenzae Respiratory Syncytial virus, Neisseria meningitidis Streptococcus pneumoniae Bordetella pertussis Corynebacterium diphtheriae Rhinovirus

Enteric Escherichia coli Shigella spp.

Clostridium difficile Rotavirus Salmonella typhimurium

Vector/Zoonotic Chikungunya Zika Dengue Malaria Yellow Fever “The diversity of the projects that our researchers get to work on is also a real motivator. When I started my career at Merck, I worked on the rotavirus vaccine for 5 years, without any variation. Whereas within the span of 5 days, a scientist developing new assays at Nexelis could be working on a meningococcal, pneumococcal, rabies and a chikungunya vaccine, just to name a few. This diversity of assays leads them to really have a deeper understanding of different infectious disease agents, and not be pigeonholed within a particular assay. They are able to build a tremendously broad expertise and translate that into projects that are geared towards saving lives.”

Nexelis operates in a large variety of bacterial and viral disease environments, where people require successful

Sexually Transmitted Cytomegalovirus Herpes Hepatitis B

Other Infectious Diseases Human papilloma virus Adenovirus Adeno-associated virus (AAV) Measles Mumps Rubella Varicella Zoster Tetanus Staphylococcus aureus Streptococcus agalactiae (GBS) Lymphocytic choriomeningitis mammarenavirus (LCMV) Vaccinia

vaccinations urgently. The organisation also built a toolbox for the wide spectrum of pathogens that is appropriate for the differing needs of multiple researchers.

He cites, “Right now, some of the biggest areas that we are focusing on are bacterial targets like pneumococcal and meningococcal vaccines. However, we have also been working on viral diseases for a number of years, like RSV for example. All of these diseases are severe issues that urgently need vaccines to protect the vulnerable. RSV is particularly pressing, as the disease is literally the second most common cause of death for children under the age of one, only beaten by malaria.”

While Nexelis' disease foci are typically client-driven, some developments are funded by the company itself.

“Our chikungunya efforts were actually self-funded, a development that we then offered to different commercial partners. We chose to fund this particular project upfront as chikungunya is a neglected tropical disease, primarily affecting people in the world's poorer regions, spread by mosquitos in Africa, Asia, and India. Because for us it is not just about serving client needs; it is also about making a positive difference to people,” says Greg.

This ability to adjust their assays to address widely varying diseases is a real strength of Nexelis'.

He adds, “Having the flexibility to shift team members between projects and possessing a core expertise in different methodologies is significantly beneficial to both Nexelis and our clients. One of the great things about the infectious disease model and the assessments that we perform is that they are pathogen agnostic, so they can be used for a range of different diseases. Whether it's E. coli or Shigella, they do remarkably similar things at the immunological level. Naturally, with a bacterium you are going to be measuring some different things than you would with a virus, but that's why we have our specialized teams in place to make sure we're addressing what's needed in each case. Transferring the assays from one bacterium to another also takes some work, but you're not trying to completely understand the biology of the different pathogens every time; you're just trying to measure the body's immune response to it, which is usually a welldefined process by the time you get to a vaccine candidate.”

Having a full portfolio of services in-house enables Nexelis to respond rapidly to emerging health threats.

The ongoing SARS-CoV-2 pandemic has proved to be an excellent example of the company's capabilities.

Greg asserts, “We quickly recognized SARS-CoV-2 as a major event that we needed to act on. Together with Benoit, Luc, and the support of our Board of Directors, we decided to self-fund the efforts to develop assays to determine if vaccine candidates could elicit an immune response. We rapidly got these up and running and offered them commercially to the various sponsors. Thanks to that quick decision making, our assays are very advanced compared to others and have been adopted by the global community. The choice to self-fund their development was

however more of a humanitarian decision than a commercial one. Getting these candidate vaccines to market faster will be a great benefit to everybody.”

“In developing the SARS-CoV-2 assays, we were able to benefit from the breadth of our own services. For example, in the early stages of the outbreak, it was exceedingly difficult to obtain a commercial source of the different SARS-CoV-2 antigens that we needed. They are critical for the assays and, thanks to our protein engineering team, we were able to develop all those materials in-house. This allowed us to act faster than when having to wait on a commercial supplier. Producing the antigens in-house also prevented the risk of supply chain breakdown, which would have slowed down the process. We were just able to walk it down the hall, turn it over to our immunochemistry team and say: “Here you go, please start developing your ELISA.” “Another key factor in our success was a lot of sacrifice, hard work and long hours by the team. Because the team has worked together for almost 20 years now, we could really leverage our best practices, allowing us to push these assays forward in an extremely accelerated timeframe without jeopardizing the quality. It was really through the dedication of the team, that these assays were made possible.”

Therapeutic Focus Infectious diseases Vaccines Antiviral drugs

Oncology Immunotherapies Gene and cell therapies

Metabolic diseases Metabolic syndrom, diabetes and dyslipemia Inherited metabolic disorders

COVER STORY

“ “An inspiring mission is the most powerful motivator there is. And at Nexelis, we are part of overcoming some of the world's most difficult healthcare challenges.”

Kulnis says the pandemic has also changed the nature of some client projects.

“Because of the urgency of the pandemic, we're getting involved in COVID-19 projects at a much earlier stage than we typically would. Sometimes the companies don't even have their antigen selected yet, or they don't know what their formulation is going to look like. Even so, they already want to start talking about the assays, to understand what our capabilities are and make sure that we are the best partner for their clinical development program. It's a testament to our team's agility that it is able to rapidly recalibrate to work in such a different way. And I think it is evidence of Nexelis' reputation for excellence that these companies are reaching out to us so early, trusting that our experts will be able to meet their needs.”

Kulnis believes that the global response to the widespread health threat of COVID-19 has triggered a drastic change in how companies conduct their work. It remains to be seen if these changes are temporary, or the dawn of a new era of increased cooperation.

He says, “In the past, companies went at it on their own, trying to 'win the race' for a new drug or vaccine out of a desire to be the first on the market. However, with the urgency of this pandemic, everyone is inclined to work together on collaborative projects. The focus seems to be less on profits, and more on saving lives. It's understandable: everyone has been affected by this disease in some way, meaning that we are all have a personal incentive for trying to fight it.

Companies like Sanofi-Pasteur and GSK, Pfizer and BioNTech, and Medicago and GSK are working together in their response to the ongoing pandemic. It has been an interesting situation, because the level of secrecy and

ownership of various aspects of the development process have been stripped away. A lot of people have understood that, in order to accelerate the timelines, they need to be more collaborative. There has been more willingness to share information, from general knowledge to technology.

Furthermore, the speed at which licensing agreements have been processed has been absolutely amazing! We've also seen an increase in the sharing of materials needed to benchmark how your product is performing compared to others.

Philanthropic agencies like CEPI and the Bill and Melinda Gates Foundation are also providing further incentives for cooperation by funding collaborative projects. I think this general spirit of increased collaboration will be a lasting improvement, even if companies will likely revert a little bit when it comes to certain proprietary information. At Nexelis, we definitely see this as a really positive change in the industry, in line with our own mission of making a difference to patients.”

People's Health at Core People's health is at the heart of the Nexelis' mission, with the company contributing to lifesaving efforts by supporting pharmaceutical and biotech companies in the development of vaccines and large molecules. With a firm grasp of the needs of both sides of the client/CRO relationship, Nexelis has been instrumental in the development, qualification, validation and largescale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines and soluble large molecules.

Nexelis' versatile team of scientists, using advanced technology platforms, supports work ranging from preclinical to clinical Phase I – IV, meeting the ever-

Luc Gagnon VP Vaccine Sciences

COVER STORY

Facilities America

Laval, Canada BSL2/BSL2+ laboratories and animal facilities. Focus Infectious diseases and Immuno-oncology.

20 years legacy in vaccines R&D and protein sciences In vivo / in vitro preclinical High-throughput GCLP preclinical and clinical testing

Seattle, USA State-of-the-art laboratories.

Focus on metabolic diseases and oncologic diseases. BSL2 lab extension plan focusing on infectious disease to be implemented Commercial kits validation CAP/CLIA & NYDOH (biomarkers) GLP/GCP standards (bioanalytical)

AIT Biosciences Indianapolis, USA Paperless FDA inspected state-ofthe-art 19,000 sq. ft laboratories with LBA and LC-MS/MS platforms R&D Bioanalytical and Mass Spectrophotometry Preclinical and clinical testing GLP/GCP standards (Bioanalytical)

Facilities Europe

ImmunXperts Gosselies, Belgium BSL2/BSL2+ laboratories dedicated to early stage projects and R&D Early stage in silico and in vitro BSL2/BSL2+ laboratories Biobanking license (PBMC)

Public Health England Porton Down, UK BSL2/BSL3/BSL4 laboratories and animal facilities under the leadership of world class KOLs Academic and commercial R&D GLP testing small scale BSL2/BSL3/BSL4 animal facility

growing demand for techniques to assess humoral, innate and cell-mediated immunity induced by candidate vaccines and immunotherapies.

By adhering to a strong focus on rigorous scientific discipline and robust protocols, supported by cuttingedge technological platforms, the firm addresses even the most demanding client requirements. Unlike huge generalized CROs who focus on global coverage and logistic capabilities, the scientific leaders at Nexelis focus on versatility and ingenuity, enabling the company to provide highly specialized laboratory testing services.

At Nexelis, all projects are run in a collaborative clientcentric way, and the agility of Nexelis' team means that urgent projects can be tailored to meet expedited timelines. By avoiding overlong processes or heavy hierarchy, Nexelis' specialists exchange ideas with colleagues and partner with clients in a collaborative and transparent manner.

Consequently, the company is recognized for its scalable operational model, resulting in optimal flexibility for its clients and high throughput capabilities for supporting large, global studies.

Turning Challenges into Opportunities Nexelis' flexibility and work ethic has been put to the ultimate test during the COVID-19 pandemic. The company has been supporting the massive R&D efforts within the international community and has demonstrated its leadership in the infectious diseases field through multiple collaborations. Nexelis is cooperating with almost all multinational sponsors and innovative biotechnology companies combatting the SARS-CoV-2 virus.

Furthermore, the company has been selected by the Bill and Melinda Gates Foundation as the referral laboratory for all their COVID-19 grantees, representing hundreds of millions of dollars in research funding.

In an extraordinarily short amount of time, Nexelis has dedicated more than 40 scientists to new SARS-CoV-2 developments. This was achieved without pausing any other strategic vaccine development programs in fields such as meningitis, flu (seasonal and universal), Chikungunya, RSV, and malaria.

“ “In every project, we strive to be an extension of our partner's lab. We're not a CRO where it's 'our way or the highway'.”

The company responded rapidly to emerging health threats thanks to the agility of its scientists and cause of its portfolio of services in-house. For vaccines and therapies for COVID-19, as for a large range of other challenging diseases, Nexelis is proud to partner with companies looking for patient solutions.

As a state-of-the-art CRO, scientific discipline is at the heart of every project, supported by the advanced facilities and cutting-edge technology. At Nexelis, a truly translational scope of services answers the many scientific questions that arise from the lead selection stage through to phase III clinical trials.

The Differentiating Factor

Nexelis' in vitro analytical platforms include immunochemistry, cellular immunology, viral and bacterial functional assays, as well as flow cytometry, ELISpot, and PCR/qPCR platforms. The in vitro laboratory tests are further supported by the in silico and in vivo teams (in house BSL2 and preclinical facilities) and a protein sciences group.

One of the key advantages in favor of Nexelis is agility, where an abundance of critical thinking from open minds compress time and achieve rapid results. There's no doubt about other CRO companies being positioned to address the mainstream clinical opportunities, however, advanced laboratory testing is all on another level where companies need collaboration with companies like Nexelis.

Nexelis excels by combining robust protocols and scientific discipline with human resourcefulness to quickly tackle even the most demanding of challenges in the collaborative client partnerships. This combination of scientific, technological, and human strengths is what makes Nexelis special.

A Culture that Harbors Innovation The team at Nexelis offers a distinctive approach centered on this openness to creativity and innovation which has rendered the company to be very flexible in its pursuits. Mr. Bouche has always tried to promote a culture that encourages specialists to collaborate freely with colleagues and partners with clients in a spirit of collaboration and transparency. As a result, there's no overlong process or heavy hierarchy.

Every year, the firm invests millions in new systems and platforms ensuring that the labs are up to date with the latest technological advancements.

A More Collaborative Future In the past few years, Nexelis has developed into a world-class organization. It has partnered up with the global top 10 pharmaceutical companies. And for the forthcoming years, the foundations are already in place for the organization.

With deep unyielding roots in GSK, Nexelis has already become the #1 CRO for vaccinology, and now visions to becoming the choice of partner in other areas as well. It also wants to expand the scope of services to become a one-stop shop for companies working on anything from early development to late clinical stage.

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BSV Setting benchmarks in patient outcomes

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Chairman of AMCHAM Pharma committee (American Chamber of Commerce) from 2016 to 2019 and Chairman, Medical and Regulatory Committee from 2016 to 2019. He has been on the Academic Board of NMMIS Pharma management, IES Management school and IIHMR, Jaipur.

He is also a management committee member of the wellknown Victoria Memorial School for the Blind, Mumbai.

“I’ve known BSV since I started my practice in 1992. It is a leading biopharma company with unique, innovative products with no compromise on quality and efficacy. I've met people that have worked for long with them and it speaks volumes about the company's culture. It also promotes educational activities in the field of obstetrics and gynaecology. BSV really lives up to its logo tagline Bringing Life to Life” - Dr. Mugdha M Raut, Dr. Raut's Women's Hospital, Mumbai.

"BSV really lives up to its logo tagline - Bringing Life to Life" -Dr. Mugdha M Raut

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Zori Cheshmedzhieva Vice President, Global Clinical Development

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The need for multi-site Phase I studies is driven by a trend towards hybrid studies exploring drug effects in patients 40

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Translating Scientific Ideas into Potential Medicines

C

elerion is a premier global provider of early clinical drug development services to the pharmaceutical industry, and its track record spans both preventive and therapeutic vaccines, subunit, and conjugates, as well as antiviral agents and (passive) antibody therapies across all phases I-IV in more than 20 countries, 300 study centers and over 5000 subjects.

Zori Cheshmedzhieva is the Vice President, Global Clinical Development at Celerion. She is leading Celerion Global Clinical Development services across Europe and North America with direct line management of Operational team including Project management, Budgeting and Proposal preparation, Feasibility and start-up, Site management.

When was Celerion founded and what is its current market position like?

This year, Celerion is celebrating its 10th anniversary. When founded in 2010, the name Celerion was derived from the Latin word celeritas, meaning swiftness and speed, to reflect the high quality, speed, and efficiency of services that we provide. Our early clinical development and bio-analytical divisions are built upon the legacy of

MDS Pharma Services and Harris Laboratories, and, thus, we can rely on more than 40 years of experience in this field. Today, Celerion is the leader in accelerating drug development for Phase I–IIb. As one of the world's leading CROs in early clinical development, we offer clinical services ranging from First-in-Human studies to Proof-ofConcept and larger Phase II studies.

These are exactly the stages of drug development during which our clients need to make critical go-nogo decisions on their investigational products. Any further investments in the candidate drugs are strongly driven by early signals of drug efficacy, in addition to favorable safety profiles. Celerion has a unique combination of competencies allowing it to extend exploration of drug effects from healthy volunteer studies to patient populations. We recruit healthy subjects in our internal clinics and through our network of external sites – but we also execute studies in patients at our in-house or partnering clinics.

What measures have you taken to stay one step ahead of your competition?

Well, irrespective of COVID-19, we have always been able to innovate

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our services over the years and optimally adapt to the needs of ours clients. But 2020 is the year that COVID-19 changed the world, including the way trials can and should be conducted. So perhaps the way we adapted our services illustrates our ability to adapt our operations swiftly and remain a leading provider of early clinical research services.

In response to the pandemic, we immediately drew up Risk Mitigation Plans and incorporated novel working procedures and facility changes to accommodate COVID-19 concerns, all in line with regulatory guidelines and local public health regulations. We also implemented a broad package of protective measures for the safety of both study participants and staff and created more bed and lab space.

Altogether, these measures enabled us to re-open our clinics and resume trial activities in May of this year.

Our bioanalytical labs, which have a long standing experience with vaccine-related analyses, have developed various assays in the context of COVID-19, ranging from PCR tests for SARS-CoV-2 to specific antibody assessments for IgG, IgM e.g. against the Spike protein – not only to enable in-

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house screening for infection, but in particular to support the development of vaccines and anti-viral drugs targeting COVID-19.

global operations, expand the site networks and add efficiencies to the setup and conduct of trials. In particular, my expertise has been extremely useful in the seamless integration of in-house operations and external site management. With regard to trials evaluating vaccines and antiviral drugs, for instance, this is key when extending early studies in healthy volunteers to larger or special populations, such as elderly and health care workers.

Moreover, due to the impact of COVID-19 clinical trial conduct, a rapid expansion of virtual clinical trials was made. These trials take full advantage of virtual technologies (apps, monitoring devices, etc.) and online social engagement platforms to conduct aspects of each stage of the clinical trial from the comfort of the patients' home. This includes recruitment, informed consent, patient counselling, as well as measurements of clinical endpoints through deployment of wearables, ePRO and other tools/devices. We assist our clients in determining the most appropriate approach for their study, ranging from fully virtual to traditional trial execution.

One of our key approaches towards building relationships with potential clients is to showcase our scientific expertise and operational experience with the setup and conduct of exploratory Phase I and II trials.

Although a personal interaction is our preferred way to connect with new customers, presentation of case studies at conferences often helps trigger the interest of its clients. With conferences going virtual because of the pandemic, we contributed to various discussions over the past months.

How did the landscape of clinical trials change and how relevant was that for your role?

Celerion has always focused on the earlier stages of clinical drug development, in addition to bio-analytical services.

Being the world's leading provider of early clinical trial services, what makes Celerion so unique?

Over the years, our Phase I bed capacity has grown to the largest in the world, which in combination with complex methodologies, trial site networks, ECG Core Lab and bio-analytical lab services enables us to provide drug development services that accelerate the translation of scientific ideas into potential medicines.

In the 10 years of its existence, the need for multi-site, exploratory studies has steadily increased. On the one hand, this reflects a trend towards hybrid studies, combining conventional safety and tolerability studies with early exploration of drug effects in patients.

Achieving clinical Proof-of-Concept is a critical milestone for drug candidates, and we help clients define what a successful clinical proof-of-concept study should entail. When a sponsor demonstrates that a drug works in humans as anticipated from preclinical data, their drug acquires real value.

On the other hand, vaccine trials do not necessarily need the highly specialized clinical research unit environment that many Phase I trials demand and may also recruit faster if multiple sites enroll participants.

With my solid background in clinical trial management organizations, I have been able to strengthen Celerion's

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For many drugs, such as antiviral agents, after initial evaluation in healthy subjects, Phase Ib and hybrid studies are conducted. These studies usually enroll patient cohorts to measure biomarkers that represent pathophysiological pathways that a drug is targeting.

Thus, value is added by providing early signals of drug effects in the target population in the earliest stage of drug development.

For the development of prophylactic vaccines, Celerion has established innovative methods, for example to determine the percentage of functional antibody capable of producing a therapeutic effect, neutralizing a virus or toxin, or eliciting a specific immune cell response to enable, which can be applied to establish Proof of Concept in healthy volunteers.

Our innovative solutions set Celerion apart as a leading early-phase CRO, but we realize that ongoing advances are required to maintain that leadership position. Much of our strategy will focus on accelerating drug development up to Proof-of-Concept, by integrating early patient studies and biomarker development. The latter will encompass identification of biomarkers for new drug targets and method development featuring bio-analytical technologies like ELISpot and flow cytometry. Implementation of new technologies will contribute to virtual data management processes as well as to sophisticated sampling and detection methods to accelerate clinical conduct.

new technologies. For instance, we were at the forefront of highly automated electrocardiogram overread, and Celerion's laboratories were the first to move completely to electronic lab notebooks.

For Celerion, the implementation of virtual technologies have diminished the burden of in-house operations, especially during the COVID-19 pandemic requiring social distancing and stringent infection prevention measures, and have also facilitated the conduct of trials across multiple sites and geographies.

As a result, we have been able to stabilise our in-house trial operations and grow our external trial capacity.

By using our expertise in biomarkers and clinical study design and conduct, we also believe that Celerion has an important role to play towards future modalities for curing diseases rather than treating symptoms, such as cell-based therapies and 3D-printed tissues or organs.

We take pride in many of our clients referencing Celerion when presenting their clinical trial data at scientific conferences or when publishing in peerreviewed journals.

Apart from the shift to virtual trial conduct, at Celerion we have implemented the Veeva platform to achieve an interconnected and fully automated virtual environment for data management, with direct live access to study status and monitoring of data, trial files and documentation (eTMF) and direct access to sites data. This platform for instance allows straightforward tracking of study milestones and software integration enabling remote Source Data Verification and monitoring, thereby increasing efficiencies and data quality capture in any type of clinical trial – virtual, hybrid or traditional.

With the volatile technological changes, what measures is the company taking to boost its growth?

It's absolutely true that technological advancements are a key driver of innovation in clinical trial conduct and in fact Celerion has always been an early adopter of

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Healthcare Viewpoint

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Mike Suga President & CEO CMIC, Inc.

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CMIC, Inc. Ascending Zeniths of Global Success “Without laboratories, men of science are soldiers without arms!”

So said Louis Pasteur, Chemist and Microbiologist par-excellence on the subject of laboratories.

So important are laboratories in the creation and development of drugs worldwide that today the likes of CMIC, Inc, a global contract laboratory aren't taken to be an outsourced entity but are treated as an integral element in the working of pharmaceutical companies worldwide. With the pandemic having driven humanity to cower behind closed doors and high walls, and every conceivable lab trying to churn out a vaccine, CMIC Inc's activities have an added significance of finding decisive and long-term succour for humanity.

validation, cross-validation and sample analysis. Due to the range of services under Bioanalysis, it remains a critical element to drug development in the pharma industry.

With over 30 years of expertise as a leading Contract Research Organization (CRO) and a provider of specialized bioanalytical services to research CMIC Inc. provides cutting-edge expertise to pharmaceutical companies in their small and large molecule bioanalysis in order to optimize the latter's drug development activity. To this end, CMIC, Inc provides bioanalysis for nonclinical and clinical projects, both GLP and non-GLP, to meet critical drug development milestones. Its GLP compliant state-of-the-art facility can accommodate quick turn around and high-volume projects.

Speaking of activities and services to the pharmaceutical industry, CMIC's most significant offering happens to be in the area of Bioanalysis that finds application in clinical and other pharmaceutical related studies, and includes method development, method transfer, method qualification, method

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Those in the know attribute the reason for CMIC Inc's high efficiency and incisiveness to its origins. A significant off-shoot of Japan's formidable first and largest Contract Research Organization (CRO) and also the top bioanalysis lab, the CMIC Group, the former was established as a strategic cornerstone for CMIC Group's growth prospects in the North American pharma sector.

CMIC Inc was established with a vision to provide the "Pharmaceutical Value Creator" (PVC) service encompassing the entire value-chain of pharmaceutical companies to include not just CRO, but also manufacturing, sales, and marketing services. In doing so, they remain the leading bioanalysis CRO in oligonucleotide therapeutics (Oligo) for several years now who remain extremely flexible and agility with quick turn-around times- a forte not found in most large CROs. Their 3 plus decades of experience in the field has earned them a name in conventional small molecule research and they are in the process of significantly expanding their capabilities in large molecule and biomarker. Marking their presence in the field as also getting them their clients' attention are several scientific publications and whitepapers and several webinars either already implemented or planned by CMIC, Ind together with the rest of CMIC Group.

If there is anything that mirrors CMIC. Inc's growth story, it is that of its President and CEO Mike Suga.

With 3+ decades in the industry that matches that of the group, he came into the CMIC fold in the year 2015.

With significant and commendable experiences across fields including biotechnology, pharmaceuticals, life sciences and medical devices, he is more than a known figure in the industry.

With a Bachelor and then a Master's degrees in agricultural biosciences from the University of Tokyo, Mike started his 30-year's professional career as tissue culture and genomics scientists at JT genetic engineering lab and later spent 5 years in New York and San Francisco as JT's recombinant DNA business development manager. He was also the Deputy General Manager of GE's Healthcare's CT/MRI contrast media in vivo diagnostics and PET/SPECT radiopharmaceuticals division in Japan and was responsible for establishing a new pharmaceutical operation reporting into GE Healthcare's U.K Headquarters.

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Complementing Mike's efforts is the leadership team at CMIC. With experience ranging from 15 to 25+ years, they are helping the company grow and address the bioanalysis CRO needs of mid-to-small/bio ventures who were never the target clientele pf larger CROs. Together the current leadership team has also competed the strategic facility investment in 2017, leveraged by CMIC's new U.S. client base expansion after business integration. At CMIC, Inc., we will accelerate our growth of services in North America and most importantly better aligns with our overall vision to bring value with each client interaction," so says a charged Mike Suga. Based in Chicago, Mike also serves as the Senior Vice President of CMIC HOLDINGS Co., Ltd., reporting directly to CMIC Group's Tokyo Headquarters. “

“ “We have an aspiration to become a “Personal Healthcare Value Creator” (PHVC) to contribute for and to address to the up-coming personalized medicine and individual patient quality of life.”

Despite Mike's initiatives and CMIC, Inc's formidable presence and activities, the industry remains a volatile place with newer technologies and methodologies making their presence at regular intervals. To address these and evolve themselves to address customer needs has been CMIC's "CREED", a corporate philosophy that is about considering the Wellbeing, Challenge, Change and Communication (W&3Cs) any opportunity might bring. Mike and his team apply the philosophy with marked seriousness to evolve themselves in line with market changes and the voices of customers.

every situation. To this end CMIC, Inc and Mike's team plan to expand their scope from the current "Pharmaceutical Value Creator" (PVC) business model to an aspirational "Personal Healthcare Value Creator" (PHVC) which would see them contribute to and address the up-coming personalized medicine and individual quality of life among patients. A great decision given that the ultimate aim of any pharmaceutical initiative, including of those of their subsidiary entities, is to be of use to individual patients.

If there is one word which best describes the future, it is volatility which as a phenomenon affects everyone in

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New Horizons

O

ver the coming years, we expect pharmaceutical industry models to be reshaped by some forces both from within and outside of the industry - that will demand present organizations to recognize shifting markets and figure out how they will compete in the changing market.

parameters and create personalized insights into the health of the patients. The availability of streamlined data and personalized AI can enable much precise well-being and actually real-time micro-interventions that will allow us to get ahead of illness and far ahead of catastrophic or chronic disease. By 2040, health is much more likely to revolve around preventing some illnesses from happening and curing others. Fewer people might have long-term conditions or chronic disabilities with a continued need for medicines to treat symptoms.

Biopharmaceutical companies will continue to evolve in new ways to treat and cure a variety of diseases. However, in the future actionable health insights, driven by artificial intelligence and big data analytics, can help doctors and patients to identify illness much quicker than the time we require today. In the first place, the newly invented vaccines and other early interventions due to technological advancements could prevent a greater number of illnesses from developing.

Other diseases can be also prevented. Changes in how diseases are recognized, prevented, diagnosed, treated, or cured might lead to basically different business models for traditional pharmaceutical companies.

The few factors that may be the most important component of shaping the future of pharmaceutical industry can be prevention or recognition and early detection, streamlined or customized treatments, curative therapies, digital therapeutics, and precision intervention.

Prevention and early detection: Vaccine and general improvements in wellness could help prevent illnesses, making treatment for some illnesses no longer essential. Progress in early detection will more likely enable interventions that halt diseases in the beginning stages before they progress to become more serious or chronic conditions.

The future of health that we will witness in the upcoming years will be much different from what we have now. Based on evolving technologies, we can be sure that digital transformation driven by big data analytics, artificial intelligence, and through such secure platforms will be key in leading this change. Unlike today, we can expect that care will be streamlined around the patients, rather than around the institutions that drive our current health care system.

Customized treatments: Personalised services in medicine driven by data-powered insights can effectively match patients with customized drug medicines or design therapies that will work for just a few people or even a specific person. More customized treatments will be the most important part of the pharmaceutical industry in the future.

In the next few years, streams of healthcare data, combined with data from a variety of other relevant resources will probably merge to create a multifaceted and highly personalized picture of the well-being of every patient. Many digital health organizations have already started to incorporate biosensors and software into devices that can create, gather, and integrate data.

Advanced cognitive intensive technologies can be developed to analyze a precisely large set of

Curative therapies: As with prevention, treatments that cure the illnesses can decrease or eliminate the demand for some prescription medicines. Developing, marketing, and costing of these curative treatments may require the pharmaceutical sector to adopt new capabilities and strategies.

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EVOLVING FUTURE OF THE

BIOPHARMACEUTICAL INDUSTRY

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Tech Outlook

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