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The 10 Most Innovative Pharma and Biotech Solution Providers, 2020 September 2020
1. FRONTAGE
LABORATORIES
Solving the Most Complex Drug Discovery Challenges
The 10
Most Innovative
Pharma
Biotech
Solution Providers,
2020
&
VOL 09 | ISSUE 08 | 2020
2.
3.
4. Pioneers of Pharma
and Biotech
s the novel coronavirus continues to spread,
Ascientists and researchers are working day and
night to identify diagnostics, therapeutics and
vaccines to help protect individuals and communities across
the globe. Leaders within the biopharmaceutical industry
are stepping ahead across the world to insure the safety of
people and promising help is on the way.
In the present condition of our society, bioanalytical tools
and technologies are playing a crucial role to make it
functional effectively. But there are few technologies which
are becoming trend and reducing spread of corona while
helping business to stay open. These technologies are
making society more resilient in the time of pandemic and
may have a long-term impact beyond COVID-19.
In its upcoming edition “The 10 Most Innovative Pharma
and Biotech Solution Providers, 2020” Insights Success is
bringing a list of pioneer/leading companies which vision to
make the world a healthy & happy place to live by
enhancing the quality of pharmaceutical & biotechnology
products.
The cover features Frontage Laboratories, is a value-added
partner with a focus on solving its customers’most significant
and complex drug discovery and development challenges.
The organization’s scientific knowledge base, technical
expertise and reputation for high quality services have been
integral to its ability to enter into strong long-term strategic
relationshipsandpartnershipswithitskeycustomers.
Frontage is closely monitoring the outbreak of COVID19 and
Editor’s Desk
Protecting the world
in times of crisis
5. following guidance from the Centers for Disease Control
and Prevention (CDC), the World Health Organization
(WHO) and other public health and government
agencies. “We are committed to ensuring the health,
welfare and safety of our employees and to the best of our
ability continues to the delivery of our services,” says the
company.
The edition features Metrendalytics as company of the
month. Metrendalytics is a Pharmaceutical consulting
services and software development company focused on
helping pharma/biotech clinical operations and CRO’s
laboratory operations centralize operational data for
real-time use. The company utilizes cloud-based,
scalable, modular, rapid development, and low-cost
platforms which are analytics and visualization enabled.
The key to success is its software combines existing
internal and external data into a single platform allowing
customers to gain efficiencies and make faster, more
informed decisions. As a result, the firm helps transition
a business from a process that is reactive to one that is
moreproactive.
Also, while flipping the pages, don’t forget to go through
the articles and CXOs written by our in-house editorial
teamandindustryexpertsrespectively.
6. FRONTAGE
LABORATORIES
Solving the Most Complex
Drug Discovery Challenges
08
METRENDALYTICS
Combining Knowledge
and Technology to Bring
Efficiency in Business
Company of The Month
18 3Scan
Digitizing Tissue
in 3D
ClinCapture
A Sweeping Wave of Big
Data Innovation in the
Pharmaceutical Industry
26
22
7. C
O
N
T
E
N
T
S
CMIC Inc.
30
Golden Helix
34
Leading Treasure in
Healthcare Industry
Especially in
Pharmaceutical
Sector
®
Helping Researchers and
Clinicians Understand the
Role of CNVs in Human
Health and Disease
Peachtree
BioResearch
Solutions
40
Janrain
38
Triox Nano
44
Pioneering Digital
Identity Solutions
for the Healthcare
Industry
Determined to Deliver
Flexible, Reliable and Scalable
Clinical Development Services
Pioneers in point of care
programmable medicine!
presenting the next
healthcare revolution!
Pros & Cons
Article
28
Mobile Healthcare
Applications: Treating
People Anytime,
Anywhere.
11. FRONTAGE
LABORATORIES
Solving the Most Complex Drug
Discovery Challenges
“
“Our commitment to investing in highly
trained and experienced scientists, state-
of-the-art facilities and instrumentations,
and a strong commitment to operational
excellence will allow us to deliver results
that meet or exceed our customers' needs.”
- Song Li
12. rontage Laboratories, is a value-added partner with a
Ffocus on solving its customers' most significant and
complex drug discovery and development challenges. The
organization's scientific knowledge base, technical expertise and
reputation for high quality services have been integral to its ability
to enter into strong long-term strategic relationships and
partnerships with its key customers.
The company immensely gets benefited from having operations in
both the United States and China (the two largest markets for CRO
services in the world) and are well placed to capture growth
opportunities in both markets. Frontage's “Two Countries, One
System” approach is integral to its commitment to high quality
standards. This approach assures the company's customers the
same quality standards, operating procedures and systems in both
China and the United States, whilst also providing its customers
with a detailed and highly experienced understanding of the
regulations and requirements for drug discovery and development
in both countries. This approach enables Frontage Laboratories to
be a partner of choice for companies with multinational
requirements or companies that need support for parallel
submissions with the US FDA and China FDA.
In an Interview with Insights Success, Frontage Laboratories'
spokesperson has shared many details, which has made the
organization a true global leader.
Below are the highlights of the interview;
What led to the inception of Frontage Laboratories, Inc?
Our origins date back to 2001 when our founder, Dr Song Li, set
up a testing laboratory in Thorofare, New Jersey with an ambition
to build a customer-focused organization to help pharmaceutical
companies overcome their complex drug development challenges
through an outsourced solution. Over the past 19 years Frontage
Laboratories, Inc, has grown to one of the leading CRO's with over
850 employees in both North America and China.
Describe Frontage Laboratories, Inc. and its cutting-edge
services which address all the needs of its customers.
Frontage Laboratories, Inc. is a CRO that provides integrated,
science-driven, product development services throughout the drug
discovery and development process to enable pharmaceutical and
biotechnology companies to achieve their development goals.
Comprehensive services include drug metabolism and
pharmacokinetics, analytical testing and formulation development,
preclinical and clinical trial material manufacturing, bioanalysis,
preclinical safety and toxicology assessment and early phase
clinical studies.
13. Drug Metabolism and Pharmacokinetics (“DMPK”)
We offer standard and customized in vivo and in vitro
DMPK services. This includes pharmacokinetic (“PK”)
and pharmacodynamics (“PD”) studies throughout the
development process. We also offer ADME studies. For
the discovery phase, we also offer PK screening and
characterization to enable structure optimization. We
also offer metabolite identification in different animal
species, Metabolites in Safety Testing (“MIST”), drug-
drug interaction, and radiolabeling studies.
Safety and toxicology
We offer clients and extensive range of safety and toxicology
services, including large animal testing, to our customers for
the first time. These services include non-GLP and GLP
toxicology studies to support regulatory submissions such as
INDs. Additional toxicological assessments include
pathology, ophthalmology and cardiovascular studies. We
also offer chronic toxicity and investigative toxicology
studies, carcinogenicity studies and support for additional
indications. We also assist with the development of safety
and toxicology testing plans, mainly for the pre-clinical stage,
with the goal of identifying the pharmacological and
toxicological effects of drug candidates.
Bioanalytical
Our bioanalytical services include non-GLP research
based and GLP assays (both in vivo and in vitro) for small
and large molecule drugs and biomarkers throughout the
drug development process as well as immunogenicity and
neutralizing antibody assessments. These assays support
first-in-human dose justifications and Investigational
New Drug (“IND”) packages for pharmaceutical
therapeutics. We provide method development and
validation services in addition to sample analysis services
to assess pharmacokinetics, immunogenicity and
pharmacodynamics effect.
COVERSTORY
14. Chemistry, manufacturing and controls (CMC)
Our portfolio of CMC services spans drug discovery to
the post approval phase, including lead compound
quantification and analytical testing for the discovery
phase, formulation development, GLP toxicology batch
studies, release and product testing, stability testing,
CTM and Good Manufacturing Practice (“GMP”)
manufacturing, extractability and leachability studies
and commercial product release following approval of an
application.
Clinical Services
With over 20 years' experience in the execution of
comprehensive Phase I-IIa studies, the Frontage Clinical
team collaborates closely with our clients to develop a
unique approach to overcome the challenges of each study,
while maximizing efficiency and mitigating risk. We leverage
our best practices in study design and execution to advance
investigative compounds to drug candidates. Located near
NYC, we have access to one of the most diverse study
populations and acclaimed medical professionals and
facilities to help support each study.
Bioequivalence
We provide bioequivalence (“BE”) and related services (such
as medical writing and regulatory support) in China.
Bioequivalence is the term used to assess the expected in vivo
biological equivalence of two preparations of a drug.
Bioequivalence is generally defined as the absence of a
significant difference in the rate and extent of which the active
ingredient or active moiety in pharmaceutical equivalents or
pharmaceutical alternatives becomes available at the site of
drug action when administrated at the same molar dose under
similar conditions in an appropriately designed study. These
services are currently provided by us in China from our facility
in Zhengzhou, Henan, and 17 clinical research centers in our
collaborating hospitals in China. Focus on product
development on clients' needs then the services are one stop
shop – list services in product development
15. Give a detailed description of the featured person's
influence over Frontage Laboratories, Inc. and the
industry.
Dr. Song Li founded Frontage Laboratories in 2001 with
the ambition of building a client-focused organization to
help solve the most complex drug development
challenges. Prior to Frontage, Dr. Li held management
positions at Great Valley Pharmaceuticals and Wyeth.
During this time, he led numerous projects related to the
development of pharmaceutical products.
Dr. Li has authored more than 15 scientific publications
spanning a wide range of topics, including chiral
separations, drug-protein interactions, pharmacokinetics,
and analytical chemistry.
Importantly, Dr. Li has been the recipient of numerous
awards, most recently Healthcare CEO award from
Philadelphia Alliance for Capital and Technologies,
Ernst & Young Entrepreneur of the Year Award, the
“Realizing the American Dream” award from the
Pennsylvania Welcoming Society, and the Outstanding
50 Asian Americans in Business Award from the
AABDC.
Dr. Li earned a Doctor of Philosophy degree in analytical
chemistry from McGill University and a Bachelor of
Science degree in chemistry from Zhengzhou University
in China.
What measures are you taking to prevent the
outbreak of COVID-19, amongst your workforce?
Frontage is closely monitoring the outbreak of COVID-
19 and following guidance from the Centers for Disease
Control and Prevention (CDC), the World Health
Organization (WHO) and other public health and
government agencies. We are committed to ensuring the
health, welfare and safety of our employees and to the
best of our ability continue to the delivery of our
services.
Given the rapid spread of COVID-19 and its proximity
to our communities, we have implemented the following
measures, in which we believe are in the best interest of
our workforce and operations, to minimize, as best as we
can, the risk of our employees' exposure to COVID-19,
and the likelihood of its spread to the members of our
community while striving to maintain the continuity of
our business operations.
Ÿ We have established an internal situation
management committee and dedicated resources to
help our organization to navigate through the
immediate challenges presented by the evolving
COVID-19 outbreak.
Ÿ We have continuity plans in place to prepare for
events as they occur and to meet the needs of
employees and clients.
Ÿ We have instituted business travel restrictions that
apply to our employees, contractors, suppliers and
vendors.
Ÿ We have worked with our facilities teams to employ
additional disinfecting and cleaning procedures in all
facilities.
Ÿ Frontage has donated RMB 1M to Wuhan through
Red Cross Society of Shanghai in order to support the
prevention and control of novel coronavirus
epidemic. This donation helped to purchase urgent
medical supplies such as protective clothing,
respirators, goggles and disinfectants, as well as
supporting the construction of hospitals that used for
the treatment of patients infected by novel
coronavirus pneumonia in Wuhan and surrounding
areas
To enable our delivery of services during this dynamic
situation, we emphasize the need for open lines of
communication about potential challenges as a result of
the current COVID-19 outbreak. We encourage you to
regularly connect with your respective contacts at
Frontage.
Is it possible to find a cure of COVID-19 virus by the
end of the year?
Many of our leading Pharmaceutical partners are
committed to proactively developing anti-COVID-19
virus products. Frontage is honorably supporting several
of these programs and clinical trials. We have seen
extraordinary commitment from the industry as a whole
and as a result we believe it is very possible to have new
therapeutics available by the end of the year.
As a leading laboratory and agrochemical services
provider, what contribution has been made by you?
We are a value-add partner with a focus on solving our
customers' most significant and complex drug discovery
and development challenges. Our scientific knowledge
base, technical expertise and reputation for high quality
services have been integral to our ability to enter into
strong long-term strategic relationships and partnerships
with our key customers.
COVERSTORY
16. Over the years, Frontage has enabled many
biotechnology companies and leading pharmaceutical
companies of varying sizes to advance a myriad of
molecules through development and file regulatory
submissions globally.
Describe in detail about the work culture and the
values that drive Frontage Laboratories, Inc.
Our Purpose: To improve quality of life
Our Vision: To be the preferred partner of life science
leaders in product development Our Core Values
Quality: We are committed to excellence in the results
we achieve, and how we achieve them.
Integrity: We believe in honesty, reliability and
accountability in our words and behavior.
Innovation: We employ new scientific approaches,
technologies and processes to provide innovative
solutions to challenging problems.
“
“We believe this
approach—where we are
positioned as a value-add
partner—differs from
standard CROs, who focus
on offering a variable-cost
alternative to their
customers' internal product
development functions and
support their customers on
their routine work.”
- Song Li
What are the future aspirations of Frontage
Laboratories, Inc.? What strategies are you
undertaking to achieve those goals?
Frontage Laboratories will continue to grow its capacity
and capabilities both organically and through mergers
and acquisitions as appropriate. In just the last six
months, the company has expanded its footprint in both
North America and China, acquiring a majority share
position of a CMC group in China and setting up new
labs in both China and North America to accommodate
growth in the CMC and Bioanalytical areas. Along the
same lines, Frontage Laboratories will continue to look
for opportunities that will enhance its end-to-end
discovery and drug development services.
What is your idea of Corporate Social Responsibility?
Frontage engages in local community activities in order
to promote its community commitment and value to the
community. Our strategy is to establish partnerships with
local non-profit organizations (Autism, Breast cancer,
any other significant charity).
17. How are you solving your customers' complex drug
discovery challenges?
Integrated CRO operating in a large and growing
market and well positioned to capitalize on strong
industry growth drivers, especially in China
We provide integrated, scientifically-driven research,
analytical and development services in the United States
and China - the two largest pharmaceutical markets in
the world. Our “Two Countries, One System” approach
enables us to be a partner of choice for pharmaceutical
companies with multinational requirements, which we
believe could uniquely position us for the outsourcing
demands from foreign companies entering China as well
as Chinese pharmaceutical companies expanding into the
United States.
Proven ability to deliver value-add technical expertise
because of our deep pool of talented scientists and
world-class facilities and equipment
We believe that we deliver high quality services through
our focus on technical excellence, which enables us to
understand and solve complex scientific challenges (such
as challenges in drug formulation, data interpretation and
bioanalysis).
Our facilities and equipment enable us to deliver results
that meet our customers' needs. Each of our facilities is
equipped with state-of-the-art equipment, which includes
over 80 mass spectrometers across our facilities and
high-performance chromatography systems. We aim for
our facilities and equipment to remain at the forefront of
the global pharmaceutical research, analytical and
development standards.
Effective quality management systems and strong track
record of regulatory inspections
We have a strong track record of successful regulatory
inspections. Our facilities have successfully undergone
inspections by the US FDA, NMPA and Health Canada
on numerous occasions. In addition, our facilities have
also been inspected by the US EPA, the US Drug
Enforcement Agency (“DEA”), the World Health
Organization (“WHO”) and the US Nuclear Regulatory
Commission (“NRC”). None of these inspections have
resulted in any materially adverse issues being identified.
Highly experienced and professional management team
Our highly skilled and experienced management team
possesses extensive knowledge of the markets in which
we operate. Most of our senior management team have
experience with leading global pharmaceutical
companies and an in-depth understanding of our markets
and the requirements of our customers. Almost all
members of our senior management team possess a
scientific background with a PhD and/or MD in their
relevant field. They also regularly contribute to peer-
reviewed industry publications and journals as well as
present at national and international scientific
conferences.
Our deep pool of talented and highly qualified scientists
is integral to our business. The majority of our scientists
held advanced degrees, including PhDs, MDs or Master's
degrees. In addition to being highly qualified, our
scientists are regularly trained on new scientific and
regulatory developments and frequently participate in
academic activities. A number of our scientists have
expertise across a range of disciplines, that enables them
to perform and manage a wide variety of tasks across our
various business units.
This helps us provide flexibility in allocating resources
to our customers and maximizes our productivity. We
believe that the depth of our scientific knowledge base is
a key strength and the foundation of our reputation and
competitive position in our markets.
COVERSTORY
18.
19.
20. Pharmaceutical services
consulting and software
development company,
focused on helping both
pharma and CRO's
centralize operational
data for real-time use.
‘‘ Jan Miotto
President
Metrendalytics
18 | September 2020 www.insightssuccess.com
21. etrendalytics was founded by scientists, for
Mscientists. Our goal is to provide integrated
solutions which provide a consolidated view of
all of one's operational data—whatever the source—on one
shared platform for faster interactive collaboration and
client service with reduced risk.
Metrendalytics recognizes that companies need a platform
to create comprehensive efficiencies across project planning
and execution with built-in analytic tools that are easy to
implement, are highly customizable, and cost-effective. To
enable this transformation journey to optimize “running the
laboratory business” with technology requires innovative
business solutions uniquely designed and customized
around a company's specific business model and processes.
Metrendalytics works to understand and build systems to
meet the unique process needs of each company. Then we
enhance the resultant process efficiency with corresponding
operational dashboard views with automated data
integration, aggregation, and signal detection in interactive
visualizations, which allows for centralized views and
remote monitoring of project performance in real-time.
Reviewers are able to zero in on signals and trends that
could affect operational performance and make smarter
decisions sooner about how to deploy resources. This
eliminates error prone, redundant entry and information
update lag time associated with typical business
management via various spreadsheets used for tracking of
these activities which are a basis of vast inefficiencies. As a
result, companies are essentially road blocked in the ability
to unleash the power buried in their operational data.
Metrendalytics' solutions have been presented at multiple
pharma/biotech meetings and conferences over the years.
Many of these presentations were from its customers. Most
recently, it was featured in a Bioanalysis Zone article on
how Metrendalytics' remote access solutions helped
businesses continue and thrive through the Covid-19
pandemic.
Extensive Service Offerings
Metrendalytics is a Pharmaceutical consulting services and
software development company focused on helping
pharma/biotech clinical operations and CRO's laboratory
operations centralize operational data for real-time use. The
company utilizes cloud-based, scalable, modular, rapid
development, and low-cost platforms which are analytics
and visualization enabled. The key to success is its software
combines existing internal and external data into a single
platform allowing customers to gain efficiencies and make
faster, more informed decisions. As a result, the firm helps
transition a business from a process that is reactive to one
that is more proactive.
The laboratory tools and technologies in the bioanalytical
laboratory have evolved and changed. However, leveraging
real-time business data to make more informed decisions
has seen limited progress. Further, additional time is
required to manually create plots and metric reports to be
used for analytics and process improvement initiatives. As a
result, less time is available for analyzing data to improve
business outcomes, customer service, and risk reduction.
Metrendalytics' software integrates the information from
existing software like Salesforce, Watson, NetSuite, etc and
incorporates these into a suite of applications to centralize
from proposal creation, award, and management of
milestones and deliverables through QC, QA, and reporting.
This provides a “one-stop-shop” for all critical business
functions and data so that each stakeholder has what they
need to efficiently complete their part. This means
laboratory and management personnel can spend more time
doing science and serving customers instead of chasing data
and re-entering information.
Passion and Expertise
Jan Miotto, President of Metrendalytics, had a successful
career in the drug development industry because of her
ethics of hard work and wanting to make things better for
the industry. This, along with a lifelong passion to learn and
apply new technologies is what drives the success of
Metrendalytics. She has assembled a group of like-minded
successful individuals who work together with the goal of
making customers successful.
METRENDALYTICS
Combining Knowledge and Technology to Bring Efficiency in Business
Company of The Month
19
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www.insightssuccess.com
22. Jan focuses on being authentic and bringing
value every day and trying her best not to
keep a fixed mindset in order to be able to
explore new opportunities. Jan says, “If you
wait for things to be perfect, you can miss
opportunities.” She brings a mindset to
never stop adapting. For Metrendalytics,
experimentation has helped them reach a
product-market fit.
Driving Improvement by Knowing Your
Customer
Metrendalytics' culture is to really partner
with its clients to help take them to the next
level. “We work with our customers to
understand their business, their pain points,
and where they want to be in the future,”
says Jan. Being knowledgeable in the
industry allows the company to understand
each client's specific situation and allowing
it to be flexible to design the tools they need
to be successful. The goal is to add value
and transparency to all levels of the
organization.
Metrendalytics aims to improve the “life of
the scientist in the laboratory” by providing
tools to leverage already existing
information. It helps mid-level managers
drive improvement gains through
automated capture of metrics and trends. It
also provides senior-level executives up to
the minute visibility to their entire portfolio
to understand the current status of their
projects and where action is needed to keep
programs on track. By being more efficient
with information, the company helps all
levels of the organization perform better to
help take time and cost out of the drug
development process.
Current Crisis and Future Opportunities
Metrendalytics has always been at the
forefront when it comes to how it uses the
information to improve business results. It
will continue to do so in the future. The
recent Covid-19 pandemic has accelerated
the adoption of cloud-based and remotely
accessed information systems. The
company will build on its past success in
this area to develop new and expanded
capabilities to meet the full-service needs of
20 | September 2020 www.insightssuccess.com
23. its customers. The company asserts “Our low cost, rapid
development model also makes replacing some of the
disconnected and more expensive “point solution” systems
possible.”
Metrendalytics continues to build a network of experienced,
results-oriented subject matter experts in the laboratory,
drug metabolism, and chemistry manufacturing and
controls. This expanded knowledge base provides access to
new markets and the opportunity to leverage its technology
to benefit these areas.
Socially Responsible
Metrendalytics is active in Corporate Social Responsibility
including philanthropy, environment conservation, diversity
and labor practices, and volunteerism. As a company,
Metrendalytics is diverse and designated as a female-
owned, minority business and some of its partners are also
minority-based.
It has donated time and resources to start-up groups and
technology companies that share the same passion for data
and using that data to build the next-generation laboratory
or improving upon existing technology to help the day-to-
day work life of the scientist.
On Drug Development Challenges
Drug development is a long and costly process typically
requiring approximately 10 years and hundreds of millions
of dollars. By developing solutions that reduce this time and
cost, Metrendalytics not only saves money for customers
but also helps get products to market faster. As a result, the
public has access to potentially life-saving medications
sooner. This in turn provides a revenue stream for the
pharma company to reinvest in future drug development.
For CROs, where the name of the game is efficiency and
value, here again, Metrendalytics helps to improve both of
these. The more efficient the resources are in a CRO, the
more projects can be completed, which accelerates drug
development as noted above. It also means better
profitability and stability for the CRO.
For both CROs and pharma biotech companies, the time
saved translates to more focus on the actual work of drug
development instead of time wasted collecting and
managing information. That time saved can then channelled
into value-added activities like quality control, assessment
and impact analysis or actions or innovations to improve
the outcome.
Testimonials from Clients
“Jan and her team at Metrendalytics collaborated with our
team at Alturas Analytics to create a total customized
information management system that organizes and
manages client information, data and resource
management. The system has improved productivity,
efficiency and compliance in our bioanalytical CRO. Thank
you Metrendalytics!”
-Shane Needham, Co-Founder and Chief Scientific
Officer at Alturas Analytics, Inc.
“Immunologix Labs is accelerating our bioanalytical
service delivery to the technology forefront with the
Metrendalytics initiative. The platform will be our primary
driver for industry-leading efficiency, organization and
client experience. It will provide the architecture to
seamlessly ensure consistent, high-quality, on-time
performance for our clients. We are very enthusiastic about
our partnership with Jahanara (Jan) Miotto and the team at
Metrendalytics"
-Michael Anderson, President and Chief Executive
Officer at Immunologix Laboratories
“We are on an exciting journey with Metrendalytics in
moving from a paper heavy lab to a paper-lite lab to a
paperless lab, which will enhance the efficiency of the
entire laboratory process, leading to a dramatic overall
cost reduction in operations and a better way to work for
everyone. Many thanks to Metrendalytics in bringing our
vision into reality”
-Luca C Matassa, VP and Head of Bioanalytical at QPS
Laboratoriese operational data for real-time use”
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24. 3Scan
Digitizing Tissue in 3D
Todd Hu man
CEO & Co-founder
Medical science has made incredible advances in
modern times. However, the field of anatomic
pathology has remained largely static since the
19th century. It is regarded as an artisanal practice – manual
and qualitative with little attention given to automation or
computation.
In recent decades, though, pathology has shown immense
growth potential, not only in its methods, but also in its role
in the understanding, development, and diagnosis of
disease.
Diseases faced today are more complex and therapeutics
potentially more precise, requiring more nuanced
investigations and even better platform to explain the
issues. Platforms developed in recent years through
technological advancements have empowered the
healthcare sector. 3Scan is amongst the prime examples of
companies leading this push.
The company’s 3D tissue imaging platform improves the
comprehensiveness of investigations in the same way gene
sequencing revolutionized genetics. The company believes
that every biopsy, sample, or specimen should provide
broad, spatially-indexed information to further medical
innovation and improve clinical outcomes.
It envisions a transformation of how scientists and doctors
understand anatomy. 3Scan supports both translational
medical research, and the biotechnology industry in its
quest to create new diagnostics and novel therapies.
Detailed Representation of Anatomical Structures
A San Francisco-based startup, 3Scan uses revolutionary
technology that digitizes entire tissue samples through
serial sectioning and simultaneous high-resolution image
capture. The procedure enables them to compute metrics
and apply mathematical models with a high degree of
precision.
This computer-aided technique further maps related micro-
environment structures and produces detailed 3D
representations of anatomical structures, and supports the
emerging field of computational pathology throughout the
procedure.
The Pursuit of Biotechnological Innovation
Todd Huffman is the CEO and Co-Founder of 3Scan.
Prior to joining the company, he worked for DARPA
(Defense Advanced Research Projects Agency) on
advanced technology development in post-disaster
stabilization.
Todd’s background is in complex technology innovation,
particularly in the domains of collection and organization of
data. He has a deep interest in mapping the human brain.
His scientific bent has driven the unceasing innovation
efforts at 3Scan. Todd hopes to help digitize tissue samples
in support of scientific discovery and the progress of
biotechnology.
22 | September 2020 www.insightssuccess.com
25. We digitize whole
tissue samples,
through serial
sectioning and
simultaneous high-
resolution image
capture, enabling
us to compute
metrics and apply
mathematical
models.
A Revolutionary but Complex Idea
Timing is the most essential factor
when introducing a new product or an
innovative idea. As a concept, 3Scan
was specially designed for the
pharmaceutical industry five years
before the company was officially
established. The time delay was to
allow for the IT industry to lower
prices on compute, transport, and
storage technologies, as 3Scan’s
techniques push the limits of what’s
possible on data creation. The 3Scan
robots can collect up to 50 terabytes
per robot per day, so the trends in
performance on processors,
networking, and hard drives have only
recently made 3Scan’s approach
viable.
The company has been developing its
products in translational research and
drug development scenarios. The
pharmaceutical industry implements
cutting edge technologies before the
clinical markets due to lower
regulatory barriers and more
technology progressive workflow
philosophies. Thus its focus is on being
patient and thoughtful with product
design to fit the evolution of
underlying technology, application
requirements, and market maturity.
Automating and Digitizing
Pathology
Anatomic pathology is an antiquated
discipline, filled with highly manual,
time-intensive processes.
3Scan is automating the process of
slicing and imaging; by removing the
human hand, it speeds up tissue
analysis 100-fold. The idea is to look at
these tissue slides in the context of an
entire organ. A 3D view of, for
example, the microvasculature of a
tumor helps in observing the effects
and efficacy of drugs. This process
takes days and while it can show the
microanatomy of a cell, very little can
be discovered about how that cell fits
within the greater tissue structure.
3Scan, by contrast, is working on
automating and digitizing the cross-
section of tissue in its original
structure, without the human factor to
slow things down or introduce errors.
The idea is to look at these tissue slices
in the context of an entire organ. 3Scan
is automating the process of slicing and
imaging; by removing the human hand,
it speeds up tissue analysis 100-fold.
Many diseases manifest at the tissue
and organ scale, so a conventional slide
on a microscope may not provide the
same insights that a full tissue analysis
would. A 3D view of, for example, the
microvasculature of a tumor helps in
observing the effects and efficacy of
drugs.
Increasing the Predictive Value of
Preclinical Studies
3Scan is a company that gives
pathologists a cutting edge
technological tool that focuses on
increasing the predictive value of
preclinical studies for clinical trials. In
addition to this, 3Scan is removing
sampling bias from the pathology
workflow by automating the sectioning
and imaging process using a robotic
microscope.
This ensures that every tissue sample is
comprehensively digitized with its
structural alignment intact. Moreover,
3Scan uses its proprietary software to
interpret the image stack in three
dimensions, providing spatial
information that rivals radiology with
light microscopy resolution.
These features are unsurpassed and
have elevated 3Scan to the status of an
industry leader with its real-time
solutions. Since its inception, the
company has delivered end-to-end
solutions with multiple experts from a
diverse range of disciplines who are
dedicated to empowering each piece of
the value chain.
Modernizing Pathology Workflows
3Scan is focused on tackling diseases
that cannot be cured using
conventional pathology workflows.
The company is working to expand
their assays into wider range of
disorders and find more effective cures
for disease.
3D reconstruction
of Murine brain
vasculature modeled from
1,200 serial sections
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26.
27.
28. ClinCapture
A Sweeping Wave of Big
Data Innovation in the
Pharmaceutical Industry
Todd Hu man
CEO & Co-founder
A
Few years ago, Mckinsey Global Institute
estimated that the application of big-data
strategies to improve decision making was capable
of generating over $100 billion in value annually across the
US health-care systems. This advanced decision making
made possible by cloud technology, improved analytical
methods was the next horizon of innovation on the block.
Today, this change is sweeping across the healthcare
landscape creating value and opening new territories for
innovation.
However, in order to benefit from this innovation it is
important for companies to optimize this innovation and
improve the efficacy of their current research methods and
trials simultaneously. This innovation opens up a
personalized array of solutions for patients supported by a
wide array of tools for physicians, consumers, insurers and
regulators.
A large part of this innovation is the role of Big data and it
is an opportunity unlike anything we have witnessed before.
Earlier the data generated from clinical trials under
controlled environment could be well documented.
However, with the advent of cloud solutions, pharma
companies can store data from various sources including
patient care, retail stores and caregivers as well. Of course,
all of this data must be HIPAA compliant. Applying this
data effectively will allow pharmaceutical companies to get
an insight into the industry to predict the rise of new patient
needs and develop effective drugs to reach new patients and
reach greater heights.
ClinCapture provides a powerful eClinical platform that
enables sponsors and CROs to rapidly build and deploy
studies, lower clinical trials costs, and streamline data
capture processes. Offering a host of private cloud
solutions, ClinCapture’s technologies help advance the
evaluation and development of drugs, biologics, and
devices that demonstrate promise for the diagnosis and/or
treatment of a wide range of diseases or medical conditions.
By bringing greater efficiency and accuracy into clinical
trials, ClinCapture serves the mantra, “Software that saves
lives!”
A vision - the Turning Point
CEO Scott Weidley joined the ClinCapture team at a pivotal
time in the company’s history. The company had recently
built Electronic Data Capture (EDC) software, but was also a
Scott Weidley
President & CEO
26 | September 2020 www.insightssuccess.com
29. professional services business. Weidley
saw the value of technology in the
clinical trials space, and felt that
customers were seeking solutions – not
services. From this vision, the Captivate
eClinical platform was born.
“Scott is the Marc Benioff of EDC,”
Ale Gicqueau, ClinCapture founder,
was quoted as saying at the time.
History seems to be proving him right,
as ClinCapture is now a leading
provider of eClinical software
solutions.
A Leading Innovator
From the beginning, ClinCapture has
set out to be different than what the
industry is used to. Its competitive and
technologically-advanced product is
setting new EDC industry standards,
giving customers a higher quality,
more affordable EDC alternative to
established industry leaders. For
example, Electronic Data Capture
(EDC) with Medical Coding integrates
a user-friendly interface that was built
on the same modern framework as
Facebook, Instagram, and Netflix and
includes a free build tool, and free
training and support. Additionally, it is
HIPAA, CFR 21 Part 11, and GDPR
compliant and the platform includes
Electronic Clinical Outcomes
Assessments (eCOA) / Patient
Reported Outcomes (ePRO) as well as
Randomization options for customers.
The company has pushed the limits
with both the brand and the product
alike. It believes in providing
innovative and high-quality Electronic
Data Capture (EDC) product at a
fraction of the cost of its leading
competitors. Its eClinical solutions
help advance the evaluation and
development of drugs, biologics, and
devices by bringing increased
efficiency and accuracy into the
clinical trials process, thereby allowing
pharmaceutical, biotechnology, and
diagnostic companies to bring products
to the market faster and at a lower cost.
Ultimately, these products may be life-
saving; this is the story behind the
mantra of the company, “Software that
saves lives!” ClinCapture’s customers
are creating medical advancements,
some of which may have life-saving
applications.
An Upcoming Bright Future
There are two or three big companies
in the eClinical space and ClinCapture
is committed to being on top in terms
of quality with these companies. It has
stayed true to its brand and its high-
quality product, which is increasingly
gaining popularity with clinical data
managers in the industry. When asked
about the future prospects of the
company, Scott said, “From big 3 EDC
to the gold standard in EDC? We are
on our way!”
He also added, “ClinCapture is
growing at a high velocity as we
continuously introduce new products.
Our primary goal is to continue to
provide our customers with the
highest-quality eClinical solutions at
the lowest price.” His statement
highlights a rapid advancement in the
industry.
According to the Mckinsey Global
Institute study, there are various
segments in the pharmaceutical
industry which are experiencing a
rapid growth. One such segment is
biopharmaceuticals. According to the
study, the rates of growth for
biopharmaceuticals is near 8%
annually and it is almost double that of
conventional pharmaceutical solutions.
In order to tap the growing potential
and demand in the pharmaceutical
industry, ClinCapture adopts a simple
approach to innovation. To summarize
it, Scott said, “Data is what makes it
work. We love our customers. We love
data managers!”
Our primary goal
is to continue
to provide
our customers
with the
highest-quality
eClinical solutions
at the
lowest price.
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30. Mobile Healthcare
Applications
Treating People Anytime, Anywhere.
whether it is an emergency or not. People do not have to
wait in long lines or take prior appointments for getting
themselves checked.
Illness is never an expected thing. So to be prepared to face
the worst is all a man can do.
Even people who do not have any health conditions can use
these apps to monitor their health and prevent any
unexpected health hazards. There are several advantages of
these mobile healthcare applications and are discussed
below.
Convenience and Control
With smartphones and mobile apps, monitoring health
ealthcare is of prime importance to any and every
Hindividual. With pandemic times like these,
monitoring the health has become necessary. Even
though people take care of themselves with a set routine
that they follow, they need to be reminded of it every now
and then. This need of continuous healthcare has led to the
invention of mobile healthcare applications.
Every individual from 10 years of age has their own smart
phone or any other smart device. This is the only thing that
is always around and with people. It is easy with mobile
healthcare apps to take care of one's health. There are
applications that are free or paid depending on the
requirement of the individual. Mobile healthcare makes it
very convenient for people to get access to a doctor,
28 | September 2020 www.insightssuccess.com
31. Pros and Cons
progress has become convenient and efficient. The patients
do not need to go to doctors to understand and maintain
their health. There are thousands of apps to choose from.
Fewer Visits to Clinics
A combined advantage to the medical practitioners as well
as the patients is that the visits to the clinics are reduced. It
helps the patients who cannot leave their homes to visit the
doctors and also the hospitals can get rid of the crowded
lines. There are numerous types of apps that people can use
for different conditions. There are medical reference apps
that provide information on health conditions and help
prevent diseases. There are telemedicine apps that provide
remote health options. This type of app is in the booming
stage.
24/7 Patient Monitoring
Keeping patients under observation continuously is a
challenge, especially for those who do not stay at the
hospital. The wearables and mobile apps that serve the
purpose of wearables are usually helpful in such situations.
They keep a check on the patient vitals, blood pressure,
heart rate, sleep quantity and quality, etc. Doctors can keep
track of the patients' health and give immediate help in case
of emergency or whenever needed. It is easy for the patient
and the doctor to communicate through chats in these apps.
Easy Access in Emergency Situations
In most countries, emergency services are lagging the
ability to immediately locate the victim. Considering the
fact that every individual has a smart device with them
these days, it is bad that victims cannot be located on time.
There are mobile phone towers and GPS technology, which
can help locate the victims at the earliest. These mobile
health apps allow easy access to the location of the injured.
The emergency apps also provide widgets that can be
placed on the home screen of the phones. Clicking on the
widget, the victim can call an emergency service or their
family member also.
Reduced Healthcare Costs
When the patients are properly educated of their health
conditions and are in continuous communication with their
doctor, they tend to take good care of themselves. There are
also patients who cannot afford expensive OPD for small
health issues. Such people can use the medical health apps.
Studies even show that these apps reduce the cost of overall
healthcare.
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32. CMIC Inc.
Leading Treasure in Healthcare Industry
Especially in Pharmaceutical Sector
harmaceutical sector is blooming at subsequently than ever being imagined.
PAnd only few companies proved themselves worthy of it. Meet, a CMIC, Inc.
leading CRO (Contract Research Organization) and a provider specialized in
bioanalytical services, whose cutting-edge capabilities and sophisticated expertise in
various aspects helped it achieve a greater stature in the business. Its bioanalytical
services are in support of TK/PK/PD Biomarker studies for pre-clinical and clinical
developments. It firmly focuses and holds expertise in bioanalytical method
development, method validation/qualification and study sample analysis for small,
large molecules and Oligonucleotide. The “CMIC” name originally stood for
“Current Medical Information Center”, and the company remains committed to the
advancement of medicines and healthcare revolution. As a strategic drug
development partner, CMIC helps sponsors to overcome challenges in bioanalysis
with expertise, rapid data turn-around-time, and high-quality customer services.
The company states its core values intercepted through, W & 3C;
Ÿ WELLBEING: Fully Live Every Moment
Ÿ Challenge: Liberate opportunity by changing our vantage point
Ÿ Change: Transform without seeking refuge in conventional wisdom
Ÿ Communication: Proactively reach out to sponsors, people and society
The Story behind CMIC
CMIC Inc. originated from CMIC Group, which is the very first and largest Contract
Research Organization (CRO) in Japan. Contract research organizations (CROs) have
become an integral part of drug discovery and development to support sponsors
research needs, expedite timelines and provide an extension of technical and
scientific support. CMIC has worked with the top 10 global pharma companies and
has been involved in and supported more than 80% of new drug development in
Japan.
CMIC, Inc. was established as a strategic cornerstone for CMIC Group’s North
America growth. It has the vision to provide a solution service as “Pharmaceutical
Value Creator” (PVC) that encompasses an entire value-chain of pharmaceutical
companies. The company has been the top bioanalysis CRO in oligonucleotide
therapeutics (Oligo) development for nearly a decade with strong proven expertise. It
also offers 30+ years of experience in conventional & small molecule and are also
significantly expanding its capabilities in large molecule and biomarker Bioanalysis.
On account being different from other companies, it is leading bioanalysis CRO in
oligonucleotide therapeutics (Oligo) as well as very flexible and agile with quick
turn-around time on all services offered, which is not possible by large CROs. In
addition, CMIC, Inc. together with the rest of CMIC Group has significant scientific
publications and whitepapers and had been the integrated players f supporting various
drug development efforts.
30 | September 2020 www.insightssuccess.com
35. A Glimpse into Jenny’s Life
Jenny Lin, Chief Operating Officer and Board Member. She holds
26 years of executive/lab management experience in bioanalytical
and analytical laboratory operations in support of drug discovery,
pre-clinical and clinical drug development. Moreover, she is
proficient in GLP, GMP, GCP, OECD, ICH and 21 CFR part 11
regulations and in business strategic planning and execution. Her
expertise includes building organizational quality system, staff
training, bioanalytical/analytical method development/validation,
bioanalytical sample analysis, analytical development for CMC
submission, chromatography purification, stability studies,
reference standard certification, QC support for GMP manufacture.
She has been also a selected member for Global Bioanalysis
Consortium (GBC) making recommendations for global
Bioanalysis harmonization. She serves as editorial board member
for peer reviewed journal and chair for international conferences.
Besides, she is an author and co-author for approximately 40
publications, white papers and presentations and is the inventor of
7 issued US patents. Jenny earned her BS in Analytical Chemistry
at Peking University and her MS in Medicinal Chemistry at
University of Connecticut. She is a member of the American
Society of Mass Spectrometry (ASMS), American Association of
Pharmaceutical Scientists (AAPS), American Chemical Society
(ACS), National Association of Professional Woman (NAPW) and
Global CRO Council (GCC).
Future of CMIC
CMIC and the CREED as corporate philosophy, consists of
Wellbeing, Challenge, and Communication (W&3Cs). The
company has been applying these items to continuously evolve
itself in line with market changes, and will do so in the future.
Moreover, by further expanding from the current “Pharmaceutical
Value Creator” (PVC) business model, the company has 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.
“Our vision is to advance the
innovation of products and solutions
that will empower people worldwide
to achieve greater health and
well-being.”
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36. F
®
ounded in 1998, Golden Helix is a global
bioinformatics firm. Since foundation, the
organization has accumulated a significant customer
base and is currently working with more than 350
organizations—with thousands of users leveraging the
organizations’ various analytics products. From its early
days till the present-day, GlaxoSmithKline has been the
®
largest outside investor of Golden Helix. Till date the
organizations’ software has been referenced in more than
®
1000 publications. The customers of Golden Helix fall into
five primary categories: testing labs, hospitals,
pharmaceutical companies, major research organizations
and government organizations.
A Well-known Leader
Back in 2013 with the objective of leading the business into
genetic testing market, Andreas Scherer joined Golden
®
Helix as the President and CEO. While working for
organizations like Netscape and AOL as a Global Vice
President, Andreas gained much needed valuable insights in
running world-wide businesses which require functional
know-how in sales, marketing, product development,
services and operations.
His educational background is centered around Computer
Science in which he holds a PhD from the University of
Hagen, Germany. Andreas has so far published more than
twenty peer reviewed articles, authored books on Neural
Networks, Intranets and Project Management. His latest
book, “Be Fast Or Be Gone” was a prizewinner in 2012
Eric Hoffer Awards competition.
In his private time, Andreas enjoys weightlifting throughout
the year. In the winters, he likes to spend his times by skiing
the mountains of Montana and in the summer, anyone can
find him on the golf course.
Empowering End Users to Perform High-End Analytics
Work
®
Golden Helix’s main goals is to empower their end users to
perform high end analytics work. This is achieved by
producing software which gives the power of analysis to
researchers, supporting them through their analysis, and by
providing them with genomic services when the need
arises.
®
Golden Helix takes pride in itself for creating software
tools that are integrated and robust, but more importantly
user-friendly and intuitive. The tools are specifically created
in order to empower biologists, clinicians and other
researchers to easily perform complex analyses and
visualizations, eliminating the need to rely exclusively on
bioinformatics experts or cobble together difficult to use,
incompatible freeware. This way researchers can
completely focus on their research instead of learning to be
a programmer or waiting in line for bioinformaticians.
The organizations’ support team is motivated by one
mission—to make sure that the customers have a great
experience with its software tools. From helping to import
data, to bug detection, to finding technical resources,
®
Golden Helix is fully committed to provide its customers
with the resources they need in order to complete their
analysis in a world class manner and at a lightning fast
pace.
However, the organization doesn’t stop only at support, it
also offers comprehensive and personalized training
sessions to help researchers jumpstart their research.
®
Golden Helix s’ Field Application Scientists and Engineers
help researchers by taking them through workflows that are
relevant to their specific research.
Ground Breaking Products
®
Golden Helix has developed a powerful technology stack
that supports a number of products in the genomics space,
including the following:
Ÿ VarSeq®: VarSeq is an intuitive, integrated software
solution for tertiary analysis. With VarSeq you can
automate your workflows and analyze variants for gene
panels, exomes and whole genomes.
Ÿ VS-CNV: Directly calls CNVs in target regions and
avoids the cost and turn-around time of additional CMA
®
Golden Helix
Helping Researchers and Clinicians Understand
the Role of CNVs in Human Health and Disease
34 | September 2020 www.insightssuccess.com
37. or MLPA testing.
Ÿ VSPipeline: Repeatable clinical workflows essential for
CLIA and CAP certified analysis, creation of high
throughput pipelines and access to curated annotation
sources that are updated regularly.
Ÿ VSReports: With VSReports, you can easily convert the
output of your tertiary analysis into a customized
clinical report. After you’ve filtered down your imported
variants, simply select variants to include in the report.
Ÿ VSWarehouse: A scalable, multi-project warehouse for
NGS variant call sets, clinical reports and catalogs of
variant assessments.
Ÿ SNP & Variation Suite™ (SVS): SNP & Variation Suite
is a powerful analytic tool created specifically to
empower biologists and other researchers to easily
perform complex analyses and visualizations on
genomic and phenotypic data.
Ÿ GenomeBrowse®: A powerful tool that delivers
stunning visualizations of your genomic data that gives
you the power to see what is occurring at each base pair
in your samples.
A Different Organization
When it comes to client handling and providing support,
®
Golden Helix is a completely different organization from
its competitors mainly due to:
Pervasiveness: The company has a strong competence
building on-premises solutions for the life science space. To
date, many labs, hospitals and government organizations
prefer to control the IT environment over cloud solutions.
However, as the clinical testing space goes mainstream,
cloud deployment models are attractive for certain market
Andreas Scherer
President & CEO
We provide a complete
end-to-end solution for
clinical labs and hospitals to
analyze Next-Generation
Sequencing data
‘‘
‘‘
®
segments. Golden Helixs’ future development plans
®
include a strategy to deploy the Golden Helix stack in a
way that customers can pick and choose their preferred
deployment model:
Ÿ On Premises: Currently, the main deployment mode for
Golden Helix. This continues to be a highly desirable
approach as hospitals and testing labs are concerned
about hosting patient data outside their premises.
Ÿ Cloud: Certain segments of the market have accepted
cloud solutions as viable. The company is extending out
technology stack in this direction.
Ÿ Mix Deployment: For certain deployment scenarios a
mixed approach is preferable. For example, in certain
scenarios it could make sense to run the analysis and
clinical reports pipeline on premises and store all the
resulting data in a cloud hosted data warehouse.
Ÿ Internationalization: The US has been a strong market
for clinical testing and research analytics products and
services. However, selected markets in Europe, Asia and
Latin America, as well as Australia and the Middle East
®
are increasingly important. Golden Helixs’ mid-term
strategy is to increase its local presence in these markets
either through partners or directly.
®
Ÿ Preservation: Golden Helix has a strong customer
base with a high renewal rate. Its high rate of customer
satisfaction and the stickiness of its solution is one of
the reasons why Golden Helix has been highly capital
efficient. The organization continues to focus on a high-
quality customer experience to encourage future
renewals.
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38.
39.
40. Janrain
Pioneering Digital Identity
Solutions for the
Healthcare Industry
Todd Hu man
CEO & Co-founder
Founded in 2002, Janrain pioneered Customer
Identity and Access Management (CIAM) and is
widely recognized by industry analysts as a global
CIAM leader. Janrain is the first choice of global enterprises
for mission-critical CIAM, and the largest brands in the
world trust Janrain to manage their most valuable assets:
customer identities.
The company’s identity capabilities include social and
traditional login and registration, which includes single
sign-on (SSO), customer profile data storage, and
management, customer segments, customer insights and
engagement solutions. Janrain reaches over 1.5 billion
digital identities with over 3,400 commercial deployments,
including Pfizer, Merck, Samsung, Whole Foods, Philips,
McDonald’s and Dr Pepper.
The Leader’s Perspective
Jim Kaskade is the CEO of Janrain and leads the
company’s strategy, worldwide operations and vision. He
has helped enable the digital transformation of the
healthcare industry to improve patient experience and data
security.
Jim is a seasoned entrepreneur with more than 31 years’
experience in complex enterprise technology. For 10 years,
he worked as a startup CEO, leading companies from
founding to acquisition. Jim has built multiple technology
businesses in cloud computing, enterprise software,
software as a service (SaaS), online and mobile digital
media, online and mobile advertising, and semiconductors.
Distinctive Services
Janrain Identity Cloudis a CIAM solution that balances
security, privacy, and compliance while providing the
seamless, frictionless experience healthcare providers,
patients and partners’ demand. It is also the first choice in
leading healthcare, biopharma and life sciences
organizations. The platform enables the secure exchange of
verified, third-party credential information and authorized
access, to restricted information and assets. It also makes it
easy for organizations to manage patients’ information and
Jim Kaskade
CEO
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41. health care provider identities in
compliance with regulatory
requirements.
With Janrain Identity Cloud, your
organization and your users will benefit
from the peace of mind that comes
from knowing that the right people
have access to the right content – all in
a secure, friction-free, patient-focused
environment. In addition, healthcare
companies can leverage omnichannel
access and robust data collection to
create more engaging customer
journeys that ensure these individuals
remain satisfied and continue to build
relationships with the company.
Digital Transformation of
Healthcare
Pharmaceutical companies are working
hard to keep pace with the disruptions
brought about by digital technology
and a shifting health care landscape. To
overcome these challenges, companies
must develop digital identity strategies
for creating seamless, safe and
compliant customer journeys.
In 2010, Janrain began investing in the
pharmaceutical category and now
serves a majority of the top pharma
companies globally, including Pfizer
and Merck. Janrain is the only identity
management provider to be
HIPAA/HITECH certified. Its
technology allows healthcare
professionals and life science firms to
gain actionable customer insights in a
secure manner and streamline their
customer interactions for improved
patient experience.
Industry Involvement
Janrain is a member of Align
Biopharma™, an industry technology
standards group that includes 23
leading pharmaceutical companies and
technology and service providers
dedicated to making it faster and easier
for healthcare professionals to connect
with the life sciences industry. Align
Biopharma has defined an
identification and authentication
standard that enables single sign-on for
HCPs to access online
content—including websites, portals,
virtual events or webinars—directly
from the life sciences companies. It is
also defining the standards for consent
and preference management so that
there is consistency in how HCPs
specify communication preferences
with each company—an essential
component for companies that do
business in the EU and must comply
with the General Data Protection
Regulation (GDPR).
When Janrain announced its joining
with Align Biopharma, Jim, expressed,
“Our excitement around Align
Biopharma is first rooted in our
passion to innovate in digital identity,
but then also in our passion to
collaborate and share those
innovations with the identity industry.
Janrain’s commitment to open
standards began when we helped form
the OpenID foundation. We’re very
eager to contribute our pharma
learning’s from over the past seven
years and to help advance not only the
HCP’s experiences but patients’
experiences and our client
organizations’experiences.”
Aiming towards Future Goals
Janrain envisions a future where
patients and healthcare providers will
move seamlessly and safely between
their in-person visits, web and mobile
properties and connected digital
healthcare devices. The process
combines security, privacy, marketing,
data infrastructure, and application
technologies to create simple and safe
experiences that improve healthcare
outcomes.
Our vision is to
be the largest
digital identity
network in the
world.
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42. Peachtree
BioResearch
Solutions
Determined to Deliver Flexible,
Reliable and Scalable Clinical
Development Services
The challenges in the pharma industry continue to
rise. Declining R&D productivity coupled with the
need for increasingly complex head-to-head clinical
trials to prove superiority have resulted in a significant
increase in clinical development expenditures. Pricing
pressures have impacted return on investment.
The pressure on clinical research departments has never
been so high. Timely completion and cost-efficiency are
paramount to the projected return on investment. With
limited internal resources, the reliance on contract research
organizations (CRO) continues to grow. In 2008, the
founders of Peachtree recognized this trend, but with a
twist. Peachtree would invest in highly-experienced clinical
research professionals with the requisite expertise in
planning and executing clinical trials. Additionally,
focusing on emerging to mid-sized companies, the founders
believed the organization fit well in an underserved market
needing attention and solutions.
Peachtree is a full-service Clinical Research Organization
(CRO) that specializes in providing clinical development
services for emerging to mid-sized biotechnology,
pharmaceutical and medical device companies. Peachtree
was formed to ensure the balance between the level of
attention the companies required and the experience of the
operational teams provided were neither contingent on the
size of a company’s pipeline nor the dollar amount of the
services needed. It ensures that every company it works
with receives flexible, reliable, and scalable solutions
coupled with undivided attention, thus, ensuring both
program and overall company success.
Delivering Superior Clinical Trial Support Services with
Remarkable Agility
Peachtree is dedicated to delivering superior and
customized clinical development services that enable its
clients to complete their clinical projects in an efficient and
cost-effective manner. Peachtree aims to build long-term
relationships with its clients based on mutual trust, respect
and integrity. Peachtree’s CEO, Kristy Nichols, mentions
“Our goal? To be most admired for the commitment to our
people, partnerships and performance.”
Identifying the customer needs, the company provides a
wide range of solutions .Peachtree’s core services include -
study and clinical site feasibility, clinical project
management, clinical monitoring and site management,
medical monitoring, clinical data management, biostatistics,
Sharon Hilton
COO
Kristy Nichols
CEO
40 | September 2020 www.insightssuccess.com
43. clinical quality assurance, and medical
writing.
Dynamic Pillars
Kristy Nichols, CEO, and Sharon
Hilton, COO are the dynamic pillars
of Peachtree. These astute individuals
had a vision to create a company to
support emerging to mid-sized sponsor
companies that were underserved by
existing CRO models. True to their
passion, Peachtree was founded in the
same year.
Kristy has relevant experience of more
than fifteen years in both medical
device and pharmaceutical clinical
development. Prior to creating
Peachtree, Kristy served as a Global
Director within Clinical Development
for UCB, a Belgium based
biopharmaceutical company focused
on severe diseases in CNS and
Immunology.
Sharon is a consummate, seasoned
professional motivated by challenge
and rewarded through the seamless
implementation of key corporate
initiatives that aid profitability,
productivity and quality. She has been
acknowledged for vigorously
managing multifaceted projects,
applying stringent standards and
rallying cross-functional team
participation that serves to elevate
marketplace status.
Both with over 20 years of Sponsor
and CRO-side experience had
empirical knowledge of what the ideal
CRO should be and set out to fill this
void.
Ahead of the Curve
Peachtree is big enough to matter, but
flexible, scalable, and reliable enough
to execute a complex clinical program
without the multiple layers of
bureaucracy, commonplace with larger
vendors. The company recognizes that
its people are its most valuable asset.
Peachtree continues to evaluate and
implement superior technologies in
clinical study management and data
management. Its experienced and
highly capable clinical operations staff
has been instrumental in performing
every task and applying this experience
to run clinical studies efficiently, cost-
effectively, and without sacrificing
quality.
Peachtree’s Clinical Operations senior
management leaders individually have
over 25 years of clinical development
experience including the management
of multiple global programs in
numerous therapeutic areas. These
leaders are empowered, allowing
straight-forwardness, responsiveness
and flexibility in decision making.
COO, Sharon Hilton states, “Providing
solutions, not problems to our clients is
paramount. Supporting our clinical
operations teams, the company utilizes
best-in-class study management, data
management, and analysis tools.”
Tackling Challenges with
Determination, Achieving
Sustainability with Excellence
With global sponsor-side experience,
Peachtree’s founders witnessed the
frustrations of working with CROs that
assigned personnel with limited
experience, and were unable to provide
solutions to study challenges as they
arose. The opportunity was identified
to build a solutions-oriented CRO that
required experienced clinical
operations professionals to
successfully implement their clinical
programs.
Peachtree was fortunate to start with a
highly-experienced staff assuming
responsibility for over 25 ongoing
clinical studies. This enabled the
company to generate revenue from
Day 1, and invest to improve in its
processes and systems. Recognizing
the need for sustainability and long-
term growth, expansion of its client
base was initially accomplished
through networking and established
industry contacts. It also recognized
that each client has unique challenges
and issues, and thus could not take a
cookie-cutter approach to the business.
Now, entering its 10th year of
operation in 2018, Peachtree is
experiencing phenomenal growth and
expecting this to continue. The
company believes that its reputation as
‘solution’ providers with a highly-
experienced staff, and continued
success in managing clinical programs
is the key to sustainability.
We are the
CRO that
thinks and
acts like
a Sponsor.
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44.
45.
46. Triox Na
Pioneers in point of care programmable medicine! presenting th
n an interview with Insights Success, Triox Nano's
Imanagement describes its impeccable journey to
become the first biotech company to develop a
modular programmed drug delivery platform. The
company's revolutionary technology, termed S.M.A.R.T, an
acronym for Stimuli Multi Adjusted Responsive
Technology, or simply put “Programmable medicine” is
based on combinations of DNA coding, DNA molecular
machines and mesoporous nanoparticles. SMART offers the
potential to add programming to almost any approved
medicine that may in turn increase its efficacy
exponentially.
Prominent opinion leaders and investors had been funding
TrioxNano's development to date including the European
commission through the prestigious H2020 Horizon
program. Competing with over 1500 companies
TrioxNano's technology won a non diluting grant of
roughly $2.5 million USD. TrioxNano's all inclusive patents
are granted around the world . Many believe this
breakthrough technology may lead the way to the next
healthcare revolution!
To create S.M.A.R.T Triox Nano had to first invent the
modular hardware that will allow incorporation of many
different medications, the software language which is based
on DNA coding and the actual codes that will control the
nano particle. The technology is expected to create a
paradigm shift and highly impact human lives around
the globe, transforming medicine from its current primitive
analog state to a programmable digital modern era.
S.M.A.R.T creates a vast field of programmable
nanoparticles that can deliver their payload to target tissues
based on the software code that is uploaded to them. The
final commercialized product is expected to be supplied
with a list of common software codes. The treating
physician will decide which codes to use and will easily
upload them to the modular nanoparticle that incorporates
the relevant medication. The doctor will have the option to
upload a mixture of several codes into the same treatment
based on the patient's clinical and pathologic profile.
Under the supervision of Joseph Farfara, Triox Nano's
CEO, the company has progressed robustly in the last 3
years, broadening the type of medications that can be
loaded into the platform, improving the capping
characteristics and securing its IP with patents granted
around the world.
Below are the highlights of the interview:
Can you explain to our readers what so exciting about
Triox Nano work?
Joseph Farfara, Triox Nano's CEO “By the year 2020,
thousands of APIs (Active Pharmaceutical Ingredients) had
been developed to treat different diseases, yet not even one
efficient modular technology was developed to deliver them
accurately to their target! The most efficient way to do this
is use programming abilities so that each API can have tens
of programs to direct it to different targets upon request. If
you compare this to the car industry its like everyone has
been developing thousands of types of engines without
finding a way to connect them to the wheels yet. Current
delivery methods, such as Injections or tablets deliver only
a small percentage of their original doses to the tissues
requiring treatment, and instead, most of the dose arrives to
healthy tissue causing severe toxicity.
Examples for our programing abilities include the TXN770
family of nanoparticles intended for the treatment of TNBC
(Triple Negative Breast Cancer). TXN770 combines
between a modular unit loaded with the chemotherapy
doxorubicin, that is already approved for the treatment of
TNBC and the ability to be programmed by a combination
of different software codes that control its release according
to common traits found in the patient's specific tumor such
as high levels of Magnesium and high levels of ATP. Other
programing options we are developing include high levels
44 | September 2020 www.insightssuccess.com
47. ano
he next healthcare revolution!
Roy Farfara, MD
Founder & CTO
of PD1, PARP and Nucleolin found to be high in subgroups
of TNBC patients. This allows us to use the same modular
particle that includes Doxorubicin and program it to react to
different cancer traits. In parallel we have created other
modular particle loaded with the chemotherapies
Mitoxantrone and Docetaxel (that is approved already for
TNBC) that can use the same software codes described
above (Mg, ATP, PD1, PARP, Nucleolin).
We are focusing on TNBC Triple Negative Breast Cancer to
prove our technology's benefits but expect it to be relevant
for many other indications. We offer specific licenses to
the use of our S.M.A.R.T platform loaded with the
client's APIs (active pharmaceutical ingredient). This is
relevant for many types of companies, those who have a
medication that is effective but proven to be too toxic to be
used, or for medications that require high doses to be
effective, or in cases patent cliff issues have to be avoided.
Our standard license agreements includes milestone
payments and royalties fees, we offer our services for a fee
to develop the asset until completion of the of In Vitro
phase, expecting the companies to complete the In Vivo Tox
and clinical trials.
What led to the inception of Triox Nano?
Answer Dr. Roy Farfara CTO and founder of
TrioxNano
The inception of TrioxNano was at 2 AM after a long
operation of a young kidney cancer patient. Our department
was regularly accepting patients that other surgeons had
given up on operating them due to the technical difficulties.
We had the best techniques and technologies in Israel at the
time (biologic glues, mannitol, hypothermia) we were
taking out carefully tumor after tumor in the renal. We
finished the surgery exhausted though we knew we did the
best that can possibly be done. The patient kidney was not
resected, we managed to take out all tumors and substantial
bleeding avoided. Yet we understood that the patient ended
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48. up having less than %20 of the original kidney parenchyma
meaning he would most probably need dialysis in the near
future. My grandfather Simon Farfara RIP who was an
artisan taught me when I was a child that "The first step in
every challenge is to find the best tools to complete it".
Understanding that it is not possible that in the year 2013
we are trying to resect micron (one millionths of a meter)
size cancer cells with centimeter size knifes while on the
other hand treating with chemotherapy that is not specific
enough thus causing substantial side effects. Being aware of
the limitation of surgery (trying to resect micro meter size
cancer cells with inch size knifes) and the limitations of non
specific chemotherapies causing substantial toxicity made
me understand at that moment that we are totally not using
the right tools to achieve this goal, and set me out on this
journey”
Describe Triox Nano and its cutting-edge technology.
Answer Dr. Ehud Saas head of biologic programming
Interestingly computers have been incorporated into
everyaspect of our lives except medicine. 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. These amazing
machines are made from single-stranded DNA and RNA
and allow us to program a modular particle with almost
infinite possibilities. Once completed, the technology will
enable the treating physician to upload the relevant DNA
module per individual patient and precise the administered
treatment based on his specific cancer traits. It is estimated
that more than 1000 approved medication can be delivered
by this programmable system and at least 500 unique
programmed modules can be uploaded to them. This adds
up to about half a million different options of unique
treatments (in the case that only one code is uploaded per
particle), in the case a combination of three codes is loaded
and estimated 125 billion treatment options are created.
As a leading pharma and biotech solution providers, what
contribution has been made by you?
Answer by Dr. Ofer Nusbaum head of chemistry biology
interface.
TrioxNano is trying to create a paradigm shift in the way
we treat disease. Programming is urgently need to enhance
the treatment of patients. In the case of Cancer as an
example, cancer cells develop different mutations in
different organs of the same patient. On the other hand
different cancer type share common pathways. For example
the PD1 pathway is relevant for a small percentage of
TNBC patients and larger percentage in many other cancer
types, many are being treated with PD1 inhibitors. This
translate into a need for modular programmed platform that
can relate to common traits in different tumors and different
mutation in the same patient. We believe we will be able to
offer the world the first modular programmable nano
delivery platform where the physician will be able to
program the medicine he gives his patient, he will choose
from a list of software codes that we will offer commercialy
and upload it to an armantarium of medication he can
choose from. Later on we plan to offer specific
programming to less common cases that require specific
softwares. Of note is that all the different chemotherapies
are packed in the same modular nanoparticle.
Describe in brief about the work culture and the values
that drive Triox Nano.
Joseph Farfara, Triox Nano's CEO
TrioxNano is driven by a team of highly intelligent hard
working open minded scientist. All our staff have hands on
experience of years in the industry. We are roughly divided
to chemists and biologists that are integrators able to bridge
the gap between these two worlds. As an Israeli company
we try to think out the box and “cut to chase” as much as
possible basing our decision on sound science.
What are the future aspirations of Triox Nano? What
strategies are you undertaking to achieve those goals?
Answer Dr. Roy Farfara CTO and founder of
TrioxNano
TrioxNano aspires to be the next Microsoft and IBM, on
one hand creating "the operating system for computerized
drug delivery" and on the other developing the hardware
required to run the operation system and the code. We want
to revolutionize the way patients are treated! To achieve this
“Triox Nano’s technology offers a paradigm shift that will highly impact
human lives, transforming medicine from an analog state to an
exciting programmable digital modern era”
46 | September 2020 www.insightssuccess.com
49. “It is estimated that more than 1000 approved medication can be delivered by this
programmable system and at least 500 unique programs can be uploaded to them.
This adds up to about half a million different options of unique treatments (in the
case that only one code is uploaded per particle), in the case a combination of three
codes is loaded and estimated 125 billion treatment options are created."
goal our strategies include a hybrid business model where
we develop our own drug candidate TXN770 (as a proof of
concept) for the treatment of TNBC but are actively
persuing to cooperate with others to incorporate their APIs
(Active Pharmaceutical Ingredients) into our modular
computerized platform.
How are you solving your customers' complex drug
discovery challenges?
Answer Dr. Roy Farfara CTO and founder of
TrioxNano
By incorporating their APIs into TrioxNano's S.M.A.R.T
platform, our partners may be able to increase efficacy
while using smaller doses, creating decreased toxicity, new
IP and an exponential increase in value. This cooperation
will importantly benefit humanity as thousands of
medications can be improved which translate into
improving human lifes!
What is your idea of Corporate Social Responsibility?
Joseph Farfara, Triox Nano's CEO
The hebrew saying "KOL HAMEZIL NEFESH ACHAT
KEILU HEZIL OLAM U MELO'O," meaning he who
saves one life is considered to save the world entire.
www.Smartriox.com
Joseph@TrioxNano.com
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