10 Most Efficient Drug Delivery Solution Providers in 2023V2_compressed.pdf

March
Issue 12
2023
Transforming IV to SQ Biologic Therapies to
Improve Patients’ Quality of Life
Ca
Life Sciences
Harnessing Technology
for Be er Health
Medica on Management
in the Digital Age
Jeﬀrey Hackman
Chairman and CEO
Comera Life Sciences
Medica on Compliance
Overcoming Barriers
to Adherence

Good N
Nutr ion
utr ion
Good Nutr ion
can be the Savior
of Your Life
Your Life
of Your Life

n the ever-evolving healthcare landscape, drug delivery
Isolution providers are vital in advancing medical
treatments and patient outcomes. These innovative
companies specialize in developing technologies and
systems that ensure the safe, efficient and targeted delivery
of therapeutic drugs. With their expertise, they bridge the
gap between pharmaceuticals and patients, revolutionizing
the way medicines are administered.
One of the key challenges in healthcare has always been
optimizing drug delivery to maximize the benefits of
medications while minimizing side effects. Drug delivery
solution providers address this challenge through a range of
cutting-edge technologies. These providers are at the
forefront of innovation, from advanced drug delivery
devices such as auto-injectors, inhalers and transdermal
patches, to novel formulations and controlled-release
systems.
The significance of drug delivery solution providers
becomes particularly evident when considering the growing
field of personalized medicine. Tailoring treatments to
individual patients' needs requires precise drug delivery
mechanisms. These providers develop customized solutions
that can deliver medications at the right time, in the right
dosage, and to the specific site of action within the body.
This level of precision is instrumental in improving
therapeutic outcomes and reducing adverse effects.
Furthermore, drug delivery solution providers contribute to
the accessibility and convenience of medications. For
patients with chronic diseases, self-administration of
medications is often a part of their daily routine. These
providers develop user-friendly devices and technologies
that empower patients to manage their treatments
effectively at home, promoting independence and
improving their quality of life.
In addition to their impact on patients, drug delivery
solution providers also collaborate closely with
pharmaceutical companies and healthcare professionals. By
working in tandem, they optimize drug formulations,
enhance drug stability, and ensure compliance with
regulatory standards. This collaborative effort streamlines
the drug development process, expediting the availability of
new and improved therapies.
Insights Care's latest edition, 10 Most Efficient Drug
Delivery Solution Providers in 2023, navigates you to the
rapidly changing healthcare landscape. The role of drug
delivery solution providers is increasingly pivotal for their
relentless pursuit of innovation and commitment to patient-
centric care. By harnessing the power of technology, these
providers empower patients, advance medical treatments
and ultimately, shape the future of healthcare delivery.
Hope you have an exciting read!
Drug Delivery
Revolutionizing
for Better Health
-Pooja Shah
Pja Sh

Articles
16
Crossject
Saving Lives in Emergency Situations
through Needle-free Injectables
24
PolyPid Ltd
Eliminating Surgical Site
Infections (SSIs) through Controlled
Delivery of Medications
32
Ziccum
Expanding the Potentials for
Next-Gen Vaccines and Biologics
Medication Management in
the Digital Age
Harnessing Technology
for Better Health
20
Overcoming Barriers to
Adherence
28
Medication
Compliance

Comera Life
Sciences
Transforming IV to SQ Biologic
Therapies to Improve Patients'
Quality of Life
Cover
Story
08
Contents

Editor-in-Chief
Chidiebere Moses Ogbodo
Visualiser
David King
Art & Design Head
Mrunalinee Deshmukh
Co-designer
Paul Belin
Art & Picture Editor
Deepanjali Jena
Business Development
Manager
Emily Jones
Marketing Manager
Bill Thompson
Business Development
Executives
Anna Smith, Jack Miller
Sales Executives
Mike, Carl, John
Technical Head
Jacob Smile
Assistant Technical Head
Prashanth Hiremath
Technical Consultants
David, Robert
Digital Marketing
Manager
Alina Sege
Assistant Digital
Marketing Manager
Sagar Lahigade
SME-SMO Executives
Gemson
Research Analyst
Eric Smith
Circulation Manager
Tanaji Fartade
Managing Editor
Pooja Shah
Executive Editor
Saloni Agarwal
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March, 2023
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Description
Featuring
Person
Company Name
ADOCIA
adocia.com
Gérard Soula
CEO
Adocia is a clinical-stage biotech company
specialized in the development of best-in-class
medicine relying on innovative formulations of
already-approved therapeutic proteins.
Crossject
crossject.com
Patrick Alexandre
Founder &
President of its
Executive Board
Crossject is revolutionizing the administration of
well-established, clinically-proven treatments
and bringing unprecedented advantages to
patients with its innovative, needle-free auto-
injector ZENEO®.
Comera
Life Sciences
comeralifesciences.com
Jeffrey Hackman
Chairman & CEO
Comera Life Sciences is committed to
transforming the formulation of biotherapeutics
for the ultimate benefit of patients
ICONOVO AB
iconovo.se
Johan Wäborg
CEO
ICONOVO AB is developing proprietary
inhalation products for licensing.
Matrivax Research
and Development
Corporation
matrivax.com
Enda Moran
CEO
Matrivax Research and Development
Corporation is applying breakthrough science
to develop life-saving vaccines for people in
need around the globe.
PolyPid
polypid.com
Dikla Czaczkes
Akselbrad
CEO
PolyPid is a global clinical-stage bio-
pharmaceutical company focused on developing,
manufacturing and commercializing novel, locally
administered therapies to improve surgical
outcomes.
TransCode
Therapeutics, Inc.
transcodetherapeutics.com
Michael Dudley
Co-Founder and
CEO
TransCode Therapeutics, Inc., an RNA oncology
company, has developed a modular, iron oxide
nanoparticle–based nanocarrier system for the
delivery of RNA therapeutics to tumors.
Topas Therapeutics
GmbH
Klaus Martin
CEO
Topas Therapeutics GmbH is a clinical-stage
biotechnology company with a mission to
deliver novel, disease-modifying treatments for
autoimmune and inflammatory diseases.
Xylome
xylome.com
Dr. Thomas Kelleher
CEO
Dr. Thomas Jeffries
President & Founder
Xylome is a synthetic biology company with a
deep understanding and proprietary genomic
tools for the manipulation of non-conventional
yeasts.
Ziccum AB
ziccum.com
Ann Gidner
CEO
Ziccum AB's ambient drying technology
LaminarPace opens up unique thermostable
formulation possibilities for next-generation
biomolecules - from vaccines to protein
therapeutics.
10 Most Efficient Drug Delivery Solu on Providers in 2023

Jeﬀrey Hackman
Chairman and CEO
Comera Life Sciences

Transforming IV to SQ Biologic Therapies to
Improve Patients’ Quality of Life
In contrast to IV delivery, SQ
delivery involves a single brief
injec on through a smaller syringe
designed to cause less pain and
discomfort. According to the
majority of physicians that Comera
has surveyed, SQ dosing is strongly
preferred over IV, if available.

A Brief on Comera Life Sciences
Comera Life Sciences aims to give patients the freedom to
self-administer life-saving products at home, a mission that
is important to Jeff on a personal level. His wife, who
passed away from breast cancer, had to endure various
intravenous (IV) therapeutics during her ten-year treatment
journey.
Millions of patients needing IV drugs must spend hours at a
hospital or infusion center with a large needle in their arm.
It’s painful, time-consuming and costly. Intending to change
this reality for people like his wife, Jeff joined the
successful team at Comera as the CEO in 2021.
Journey to Inception
The company was founded in 2014 as ReForm Biologics
and recently rebranded as Comera Life Sciences to
reflect the vision of bringing about a compassionate new
era in medicine. Comera is built on the belief that true
medical advances are inspired by compassion. Its team of
innovators sees itself in patients and their families and is
working to make meaningful changes to how people take
medicines.
From the outset, Comera’s goal has been to develop novel
excipients—substances added to a biologic drug to aid in
manufacturing, delivery and stability—that can transform
biologics from IV infusions to subcutaneous (SQ) injections
that can be easier for patients to use. Since Jeff joined
Comera, the company has expanded its focus to go beyond
formulation science, and it is now reimagining the impact
that its science could have on healthcare and the patient
experience.
Jeff and the team at Comera, together, are working with
industry partners to accelerate the development of SQ
formulations of monoclonal antibodies (mABs) that can
substantially impact millions of patients while also
developing their pipeline of candidates. This ambitious
mission led them to take the company public in May 2022.
Comera’s focus is to help patients who depend on IV
biologics for treating significant diseases. That’s why the
company has set out to maximize the true potential of life-
changing biologics by empowering patients to administer
their own medicine via a single, simple injection wherever
they feel most comfortable.
Biologic therapies have gained a lot of attention in
Bthe last two decades for their role in treating
diseases for which no treatments previously
existed. For many patients, however, intravenous (IV)
delivery is currently the only option for taking these
lifesaving medicines but this often involves the use of IV
needles to administer liquid medications into the veins of
patients. Infusions are performed in an in-patient setting of
either a hospital or an infusion center. That process comes
at the expense of time and comfort as the treatment can take
multiple hours to administer and can be a painful
experience.
This process naturally raises questions such as, “How are
these treatments impacting the quality of patients’ lives?”
IV delivery of biologics can be time-consuming and also
painful and costly. This makes it challenging for everyone
involved.
Comera Life Sciences is a life sciences company that
leverages the power of high precision science and
engineering to support patients in gaining back their
freedom. Through its investigational self-injectable
innovative subcutaneous (SQ) biologics, patients may have
access to an alternative therapeutic delivery option in the
future that can potentially aid in improving their quality of
life.
In contrast to IV delivery, SQ delivery involves a single
brief injection through a smaller syringe designed to cause
less pain and discomfort. It enables self-administration at
home, sparing patients from traveling to frequent
appointments and reducing healthcare costs for supplies,
storage and staffing. Moreover, an SQ injection has lower
healthcare delivery costs and can be administered within the
comfort of patients’ homes. According to the majority of
physicians that Comera has surveyed, SQ dosing is strongly
preferred over IV, if available.
Jeff Hackman, the Chairman and CEO of Comera Life
Sciences, is leading the company as it advances a promising
clinical pipeline aimed to improve patient experience,
potentially increase patient adherence and reduce the
overall cost of care during their course of treatment.
Let’s learn more about the innovative work Comera is doing
to advance SQ therapeutics and how it has the potential to
improve patients’lives.

Comera is working to transform IV
biologics into SQ versions that can be
administered by syringe in a single
dose, poten ally increasing pa ent
compliance and quality of life.

The SQore™ Technology Approach to Transform
Medicines
Comera is not the only one studying excipient technology,
but its team is one of the first to pursue this science for
antibody reformulation and potential patient care at home.
Foundational to the company’s approach is its SQore™
technology, a proprietary excipient formulation platform
that aims to transform medicines from IV to SQ form.
A longstanding challenge to developing viable SQ biologics
is viscosity. A lower volume of medicine in an SQ
formulation requires increasing the drug concentration,
often to the extent that biological molecules aggregate or
stick together so that they can no longer be delivered
through a syringe. To date, few companies have been able
to develop effective excipients to reduce the viscosity of
antibodies for SQ delivery. However, the SQore platform
potentially solves this dilemma through proprietary
techniques using excipients to decrease the viscosity of IV
drugs so that they can be delivered subcutaneously while
maintaining their stability and efficacy.
Unlike other excipient approaches that have been
unsuccessfully applied for decades, SQore technology does
not alter the structure or form of antibodies in solution,
reducing drug product development uncertainty, time and
expense. Comera is working to transform IV biologics into
SQ versions that can be administered by syringe in a single
dose, potentially increasing patient compliance and quality
of life.
Unique Products and SQ Solutions at Comera
The biologics market is estimated to grow to $422 billion in
2025, and patients worldwide rely on IV drugs for various
conditions. In fact, seven of the top ten global medicines are
biologics and most are administered intravenously, so
there’s an opportunity to improve how these patients
receive their medicines significantly.
Comera has over 200 excipients that it is using to
reformulate marketed IV biologics for SQ administration. It
has a number of novel and proprietary excipients, and its
lead excipient is caffeine. In its SEQURUS-1 and
SEQURUS-2 preclinical studies, Comera’s team has
demonstrated that a caffeine excipient can reduce the
viscosity of the mAB ipilimumab without affecting its
bioactivity.
The biologics market
is es mated to grow
to $422 billion in
2025, and pa ents
worldwide rely on IV
drugs for various
condi ons. In fact,
seven of the top ten
global medicines are
biologics, and most
are administered
intravenously, so
there’s an
opportunity to
improve how these
pa ents receive their
medicines
significantly.

The company also has a pipeline of three wholly owned
candidates: CLS-001, an SQ formulation of the mAB
vedolizumab in preclinical development for inﬂammatory
bowel syndrome; CLS-002, a SQ formulation of an
unannounced mAB in preclinical development for immuno-
oncology; and CLS-003, a candidate in the research stage
for an unannounced indication. CLS-001 and CLS-002 are
currently in IND-enabling studies, with ﬁlings anticipated
in 2024.
SQ delivery, when available, is generally preferred by
patients and healthcare providers and can result in reduced
drug delivery-related healthcare costs and resource use.
Advancement of Therapeutic Pipeline
In addition to its internal pipeline, Comera is advancing a
pipeline of therapeutic reformulations through partnerships.
Comera has three ongoing partnerships with other
companies to develop SQ drug formulations using its
innovative proprietary SQore formulation platform.
Comera has a research collaboration with Regeneron, a
leading U.S. biotechnology company, with high-priority
assets in development. Recently, Comera extended and
broadened this collaboration, which includes a right to
negotiate a license after further technical evaluation is
complete. A second partnership is with an undisclosed top
10 global pharmaceutical company for a drug that is
commercialized globally, and grants Comera the options to
license after further technical evaluation is complete.
Through its collaborations with pharmaceutical and
biotechnology companies, Comera is leveraging the SQore
platform to enhance both commercial biologics and those in
the early development stages. Its proprietary platform
supports others in the industry to address formulation
challenges and make biologics more easily administered
subcutaneously. All these initiatives aim to bring this
important therapeutic modality closer to the patients who
need it.
Wrapping Up
Looking ahead, Comera will continue its two-pronged
approach of growth through its internal pipeline and
partnerships, complemented by a sizable patent portfolio
protecting its technology.
Representing a massively growing market, biologics are at
the vanguard of cutting-edge biomedical technology and
driving the next generation of treatments for patients. For
this reason, the company will continue to focus on high-
value collaborations with near-term milestone potential.
Comera currently has three ongoing partnerships all of
which include options to license after the technical
evaluation of the asset is complete.
The goal will be to get an SQ-based biologic into clinical
trials. Comera’s team is headed in that direction with IND-
enabling studies ongoing in 2023. Their approach to
reformulating known biologics demonstrates the potential
for a faster development timeline and lower development
costs.
Represen ng a massively
growing market, biologics are
at the vanguard of cu ng-edge
biomedical technology and
driving the next genera on of
treatments for pa ents.

Crossject
Saving Lives in Emergency Situations through
Needle-free Injectables
he drug delivery industry is often on a constant
Tlookout for innovative ways to improve how drugs
are delivered to patients who are suffering from a
specific illness. Syringes or needles are one of the first
preferred resources when the drug is required to be
delivered directly into the patient's body, passing through
the skin. This is true in the case of medical
emergencies—where quick action is required to ward off
the risk of severities, a long-term consequence, or to
manage a situation of stress or crisis.
However, in emergencies like an epileptic seizure,
anaphylactic shock, or suffering an overdose—where
patients are the victims—do needles and syringes guarantee
to be an immediate therapeutic solution?
Crossject is a leading company that is revolutionizing the
administration of well-established treatments in emergency
situations by developing innovative life-saving solutions.
®
ZENEO is its injective approach which provides an
alternative to using needles and syringes. Patients no longer
have to fear needles as this product is a needle-free self-
administration innovation designed to support patients in
emergencies and life-threatening situations.
In an interview with Insights Care—Patrick Alexandre,
the Founder of Crossject and President of its Executive
®
Board—shares how his company's innovation, ZENEO , is
dedicated to fulfilling the mission of saving the lives of
patients across the world.
Below are the highlights of the interview:
Kindly brief us about the company. What led to its
inception?
Crossject is a French speciality pharmaceutical company
based in Dijon and spun off from Fournier Labs. The
company has been listed on Euronext Growth in Paris since
2014. It receives funding from the United States BARDA
(Biomedical Advanced Research and Development
Authority) under contract n° 75A50122C00031 and from
Bpifrance (French Government investment bank).
Crossject is developing and will soon commercialize a
portfolio of treatments for emergencies, including epileptic
seizures, adrenal insufficiency, anaphylactic shock, and
opioid overdose, all based on its unique needle-free auto-
®
injection platform, ZENEO .
®
ZENEO finds its origins in the combination and
miniaturization of cutting-edge technologies used in the
automotive, pharmaceutical and aerospace sectors. Our
technology relies on a specifically formed, siliconized,
depyrogenated, pharmaceutical glass tube (unique
technique worldwide) that can support up to 1,200 bars of
pressure, in conjunction with a polycarbonate nozzle with
submillimeter conduit that directs the injection thru clothing
and into the skin/muscle in a precise minute stream to the
desired depth of injection.
This unique delivery system is coupled to a state-of-the-art
energy material-based gas generator with an actuator
culminating in a simple-to-use, safe and efficient injection
system.
Shed some light on your journey as the guiding light of
the company. How does your presence play an
important role in the growth of the company?
With its patented, needle-free auto-injection system,
Crossject aims to become the world leader in self-
administered emergency treatments.
In 1997, I began directing the conceptualization and
development of needleless injection technology at
16
March 2023 www.insightscare.com

®
ZENEO needle-free
auto-injector is a device
that has been designed
with patients for patients. It
enables a very easy injection
in only two steps, "Open and
push" onto the injection site. With
this device, Crossject brings to the
patient and caregivers the molecules
that they would have received in the
hospital before arrival. It is a unique
technology for the needle-free injection of
medicines.
The preﬁlled, single-use device propels the
treatment through the skin in less than a tenth
of a second. ZENEO® is factory-set as a
function of the viscosity of the medicine, its
dosage, and injection route (subcutaneous or
intramuscular).
Its reliance has been reﬂected in the last
Human Factors study conducted by Crossject
in 2022, which showed a 99.6% success rate
on the use scenario assessed.
Patrick Alexandre
Founder and President of
its Executive Board
Crossject
About ZENEO®, a Needle
Free Auto-Injector
17

Laboratoires Fournier, now Abbvie. In 2001, I built upon
®
that acquired expertise to launch Crossject and ZENEO ,
which has now proven to be a world-premiere technology
to inject a drug without a needle, even through clothing.
I graduated from Supélec, a top engineering school in
France, and was an R&D manager in the steel industry for
10 years before joining the pharmaceutical industry, where I
worked for 15 years.
Can you elaborate upon the core values, mission and
vision on which the company is built?
Dare
From the solid foundation of its unmatched technology,
Crossject aims to become the world's leading
pharmaceutical laboratory for emergency needle-free auto-
injectables.
Persevere
Crossject's incomparable technology is the fruit of no less
than 20 years of R&D. Thanks to its continuous R&D
efforts dating back to 1997, Crossject has created a high-
performance auto-injection system protected by 400 patents
®
worldwide until 2036. ZENEO is the world's first clinically
proven prefilled needle-free auto-injector capable of
delivering treatments intramuscularly or subcutaneously.
Innovate
Crossject developed a needle-free injection technology,
unique worldwide, capable of delivering treatments in less
than a tenth of a second. To always move forward,
Crossject has united a vanguard team of specialists from a
range of industries and thus gathered the expertise it needs
to empower each step of its evolution.
To save lives simply
The purpose of the revolutionary, needle-free auto-injection
®
system ZENEO is nothing less than to save lives in
emergencies.
Brief us on the scientific process of drug delivery to the
company's target population.
ZENEO® uses miniaturized automotive industry
technology from airbags and pre-tensioning seat belt
systems to deliver drug products into the muscle without
the use of a needle.
As soon as the device is pressed against the skin, the spring-
loaded striker is released. It hits a gas generator located at
the top of the device, and high pressure is released by the
expansion of powders (slow and fast). This high pressure
pushes down the liquid into a canal with a diameter of
0.4mm, and a thin jet of pharmaceutical product hits the
skin at 200m/s and reaches the muscle.
Depending on the volume or viscosity of a drug, the device
pressure profile can be modified to reach the targeted
injection depth.
How does your company offer personalized treatment to
the patient's concerns?
®
ZENEO address many issues that patients are facing with
current solutions. One of the biggest fears regarding
injectable drugs is the needle. Crossject goes beyond the
needle and changes the injection paradigm for many people,
as 20% of us fear the needle, and 10% are completely
needle phobic.
®
ZENEO has been developed to be very easy to use to make
sure that even naïve users can inject a drug quickly and
th
safely in less than 1/10 a second; it is particularly
interesting for an emergency situation such as epileptic
seizure where it is rather challenging for a non-professional
caregiver to give an Intramuscular injection of Midazolam
with a needle-based solution on a convulsing patient.
What diagnostic tools does Crossject find to be essential
in conducting its operations?
Understanding patient needs, the different scenarios, and
the environment has been at the centre of Crossject needle-
18

free drug/device combinations products. The company has
designed its unique solution with and for the patient and
tested it through numerous Human Factors studies that
assessed that the device was used properly and safely in
different use environments.
What endeavours is Crossject currently pursuing to
improve its measures for patients?
Crossject is constantly discussing with health authorities
and patients to ensure its device meets crucial medical
requirements. The company has been developing a portfolio
of seven drugs, mostly for emergency use to bring to
patients or their entourage solutions that can be safely used
outside the hospital.
What advice would you like to give to budding
entrepreneurs and enthusiasts who desire to venture
into drug delivery?
Maintain your enthusiasm, expand your knowledge base,
and push for perfection in a rapid, sustainable methodology.
Fail often, fail quickly, learn from your failures and move
on towards success!
How do you envision scaling your organization's
services and operations in 2023 and beyond?
Through our partnerships with international pharmaceutical
companies and government agencies, we intend to become
the world's foremost supplier of rapid, safe, easy-to-use
needle-free auto-injectors for personal emergency use.
2022 has been an important year for Crossject as it has
signed an agreement with BARDA for the late-stage
development, regulatory approval and procurement of its
lead compound ZENEO Midazolam. This program has also
shown positive outcomes through a bioequivalence study.
This study demonstrated bioequivalence in an intra-
®
muscular injection with ZENEO Midazolam compared to
an injection of midazolam with a syringe and 30-mm
needle. It also demonstrated that clothing had zero impact
®
concerning injection with ZENEO .
2023 will be a crucial year for Crossject as it will file its
first marketing authorization, a drug-device combination,
ZENEO® Midazolam, as well as pursue other
developments such as ZENEO Hydrocortisone for which
the company has signed a licensing agreement with ETON
pharmaceuticals.
What are some of the testimonials or recognition that
accurately highlight your organization's position in the
market?
Many patient advocacy groups within the epilepsy, food
allergy and adrenal crisis world have expressed serious
desires for a rapid, safe, easy-to-use emergency auto-
® ®
injector. ZENEO , Midazolam, ZENEO Epinephrine and
®
ZENEO Hydrocortisone bring this desire to reality for
these patients and their caregivers.
Crossject developed a
needle-free injection technology
®
ZENEO , unique worldwide, is capable
of delivering treatments in less than
a tenth of a second. With this patented,
needle-free auto-injection system,
the company aims to become the
world leader in self-administered
emergency treatments, saving
patients' lives worldwide.
19

Digital
Digital
Digital
Every industry, including healthcare and medicine, in
the modern age incorporates digital tools and
various technologies to enhance operations. When
it comes to implementing digitalization, technology is not a
driver, but it is critical to make the process happen.
According to Anita Goel, MD, PhD, the next generation of
healthcare will be decentralized, mobilized, and
personalized. Instead of the past's blunt instruments, we
will give patients more precise medications and therapies.
The most vital part of healthcare is medicine; without it,
therapeutic processes will be hampered. As telemedicine,
virtual reality (VR), robotics and Artiﬁcial Intelligence (AI)
are changing the healthcare landscape, taking the help of
these tools, the management of medicine can be done
appropriately. Medication management is a strategy that
involves managing medicine stocks, prescriptions, and
administration to patients. In general, the process consists
of the brown bag method, and with its help of it, patients
and caregivers are engaged in creating a list of complete,
accurate medicine. It is also known as the 'Medication
Management Pathway'.
Let’s understand in detail the key role of digitalization in
managing medication!
Why is digitalization in Medication Management
important?
Adherence to personalized medicine and management is the
best solution for the suboptimal use of medicines. Hospitals
and small clinics primarily face medication management
issues and adverse outcomes due to prescribing errors,
medication contradictions, over and under-prescriptions,
patients' responses, etc., as patients are vulnerable between
the process of getting primary care and a specialist opinion.
Hence, it is the responsibility of hospitals and healthcare
systems to undertake the obligation of medication
management.
20

21

Additionally, old systems were manual and non-digitalized.
Also, the visibility of medicine stock was low and medical
data was vague, as well as the lack of digitalization made
the systems prone to errors. The OECD group has to pay
millions for such errors to stabilize the healthcare system.
Moreover, the whole process is suspected of having non-
adherence to medicine management. There is always
mismanagement in catching the statistics of actual pill
intake, misunderstanding, patients' biased responses, etc.
One of the important drawbacks of traditional methods of
handling medicine management is patients are not exposed
to appropriate tools. As a result, they cannot facilitate the
management of their medicines. Moreover, daily hospital
stays are becoming short, and therapies/counselling are also
provided; however, patients often do not remember the
instructions provided during their medical visits due to
multiple health problems. In such a scenario, fast digital
methods must be applied for better and smooth medication
management.
Digitalized Healthcare
Due to the inception of digital methods, the healthcare
sector has been modified. For example, telehealth,
electronic, mobile, telemedicine, etc, have become popular
and recognized as powerful tools that make the processes
easy. According to a review in 2017, four primary digital
strategies that enabled medication adherence in patients are
interactive voice recording systems, Short Message Service
(SMS), telemonitoring, and web-based software.
Interactive voice recording systems: While handling
medicines, problems such as medication side effects, costs,
and forgetting about the intake of medicines can hamper the
decision and health of patients. In this case, interactive
voice recording systems remind individuals to take or refill
their medications. The system provides personalized and
medication-specific reminders and communication with
voice recognition.
Short Message Service (SMS): For medicine adherence,
SMS services are used often. A study shows that text
message interventions have improved the adherence rate in
patients. It also shows that those patients were recovering
from chronic physical and mental diseases such as HIV,
asthma, diabetes, schizophrenia, etc.
Telemonitoring: Remote patient monitoring during and
after the pandemic has become a norm, spreading
awareness among patients to take their medication
schedules seriously. Healthcare professionals help patients
with any help without interrupting their comfort at home
and patients having difficulties reaching the medical care
centres. For example, wearable sensors used in this method
can help professionals track their patients' health conditions
from a distance.
Web-based Software: This software solution improves
medical management, especially after hospital discharge. It
included pill identification, patient-friendly reminder
leaflets, interaction checkers, adherence monitoring
checkers, weekly medication schedules, and daily pill
reminders.
Electronic Medication Management (EMM)
With the help of EMM, errors in prescribing medicines and
dispensing them can be avoided. These systems enhance the
accuracy and legibility of medical information for clear and
transparent processes for patients, hospitals and
professionals. Rather than searching for information and big
files of patients in paper format, clinicians and professionals
can directly access it through digital services.
The system is developed to digitally manage medical
prescriptions, reviews, dispensing, medications,
administration, etc., in their electronic files. Moreover,
EMM protects patients' data and provides them with safety.
EMM adopts the technology and security protocols that
enable safe mode. Also, if, in any case, any electronic
device having an EMM system gets lost, admins can wipe
the data electronically.
In conclusion, digitalization in Medication Management is
vital for enhancing healthcare operations. By adopting
digital tools and technologies, hospitals and healthcare
systems can address medication management issues,
improve patient adherence and minimize errors. Digital
strategies like interactive voice recording systems, SMS
interventions, telemonitoring and web-based software
enable personalized and effective medication management,
leading to better patient outcomes. Electronic Medication
Management further enhances accuracy, accessibility, and
data security in healthcare processes.
- Saloni Agarwal
22

Surgical Site Infections, the most
common hospital-acquired infections in
the US, can result in additional seven to
eleven days of hospitalization and cost
the US healthcare system as much as
$10 Bn each year. Our main product,
D-PLEX is designed to release antibiotics
100
over a period of thirty days to prevent
post-surgical wound infections or SSIs.
Dikla Czaczkes
Akselbrad
CEO
PolyPid Ltd.
24

Eliminating Surgical Site Infections (SSIs) through Controlled Delivery of Medications
PolyPid Ltd
ost-surgical complications hinder the patient's return
Pto their preoperative health status. Health care
acquired infections, in particular surgical site
infections (SSI), unfortunately remain amongst the most
common potentially preventable complications. Those who
develop infections not only face a risk to their health but
may also have to delay other import treatment (i.e.,
oncologic care). From a health care system perspective,
surgical site infections risk increased hospital stays,
escalated expenses, and higher readmission rates and thus,
infections have become a clinical and economic burden for
patients and hospitals.
One way to reduce the threat posed by SSI is to improve the
prophylactic measures taken perioperatively, such as timely
and controlled administration of medications at the surgical
incision site. PolyPid Ltd, a global clinical-stage
biopharmaceutical company targets this core aspect. Its
product candidates allow surgeons to deliver medications
locally to the body for days and months, in a controlled and
continuous manner.
In an interview with Dikla Czaczkes Akselbrad, PolyPid's
CEO, she highlights the core products developed at the
company to improve patient outcomes in localized medical
conditions such as infection, pain, inflammation and cancer.
Below are the highlights of the interview.
inception?
PolyPid is an Israel-based, public company, traded on
NASDAQ. Our PLEX (Polymer-Lipid Encapsulation
matriX) platform was developed by our founder, Dr. Noam
Emanuel, in response to a clear need from physicians,
specifically dentists who were looking for a solution that
can treat severe gum infections over a prolonged period.
Over the years, PolyPid has demonstrated the capabilities of
its PLEX platform to encapsulate and locally deliver several
types of Active Pharmaceutical Ingredients (API), including
antibodies, proteins, peptides and small molecules.
PolyPid's proprietary PLEX technology pairs with APIs,
enabling precise delivery of drugs at optimal release rates
over durations ranging from several days to months.
PolyPid's lead product candidate D-PLEX is in Phase 3
100
clinical trials to prevent abdominal surgical site infections.
In addition, we are currently in the preclinical stages to test
the efficacy of OncoPLEX for the treatment of solid tumors,
beginning with glioblastoma.
I joined PolyPid in 2014, and in my position as Chief
Financial Officer, I successfully raised over $200 million
for the company. I led the company through its initial public
offering in June 2020, right in the midst of the chaos of the
early days of the Covid-19 pandemic. As part of PolyPid's
executive management team, I helped the company
maintain high patient recruitment numbers, recruiting close
to 1,000 patients across 60 centers, despite the patient
recruitment decline that most pharmaceutical companies
faced during the pandemic.
This past July, I assumed the role of Chief Executive
Officer of the company. One of my first actions as CEO was
to guide the company through an exclusive licensing
agreement with Advanz Pharma for the commercialization
of the company's lead product candidate, D-PLEX , for the
100
prevention of surgical site infections. This deal, which was
signed even before the results of the company's Phase 3
clinical trial were released, included upfront and milestone
payments, as well as royalties on net sales. It is now my
role to expand the breadth of PolyPid's pipeline while
transitioning the company from a clinical stage company to
a commercial-focused one.
Can you elaborate upon the core values, mission and
While the standards of care have advanced, physicians'
ability to optimize surgical care remains limited. From
surgical infection prevention to effective local delivery of
medications, PolyPid is on a mission to improve surgical
outcomes, arming surgeons with its proprietary local drug
25

delivery platform that integrates with existing hospital/ and
operating room protocols.
With controlled and continuous local delivery of medication
using PolyPid's PLEX technology, physicians can
incorporate this solution into various surgical procedures –
distributing medication directly at the surgery site with
optimal release rates to maximize the success of the
procedure.
PolyPid's PLEX platform circumvents a big challenge
manufacturers encounter when developing new drugs, how
to deliver drugs to their target in high enough concentration
to be effective without any risk of significant systemic drug
exposure, dramatically increasing the safety margin of a
given medication. Whether by enhancing the delivery of
already approved drugs or by creating new approaches to
innovative molecules, we believe our PLEX platform can
improve efficacy, reduce systemic side effects, and generate
better patient outcomes.
What are the core products and services that your
company has to offer? In what way do they serve the
target population? How are these different from other
forms of care that patients receive or do not receive in
general?
PolyPid has developed its own proprietary drug delivery
platform that can encapsulate almost any API and deliver it
locally over a prolonged, pre-determined period. Our main
product, DPLEX is designed to release antibiotics over
100
thirty days to prevent post-surgical wound infections or
SSIs. SSIs, the most common hospital-acquired infections
in the US, can result in an additional seven to eleven days
of hospitalization and cost the US healthcare system as
much as $10 Bn each year.
DPLEX has shown in a large phase three trial a reduction
100
of 54% in infections in complex, large incision colorectal
surgeries (>20cm), compared to the current standard of
care. Our second product, OncoPLEX, currently in pre-
clinical studies, combines our PLEX platform with
approved chemotherapy to serve as local intra-tumoral
adjuvant treatment for solid tumors. OncoPLEX provides a
high, local concentration of chemotherapy directly to the
tumor resection bed for a period of up to 3 weeks, limiting
the risk of typical side effects of traditional systemic
chemotherapy delivery.
What advice would you like to give to budding
entrepreneurs and enthusiasts who desire to venture
into the process of drug delivery?
I would advise young entrepreneurs to prepare for a
marathon. Drug development in general and drug
development based on novel drug delivery platforms is a
long journey, it has ups and downs, highs and lows, and
there are surprises at every corner, on the science side,
talent, and financing. A leader in this area should remain
focused on the end goal while adjusting to the changing
circumstances.
We have recently completed a 977-patient phase three trial,
the largest clinical trial in the prevention of infection in
colorectal surgery in over a decade. Our next step will be to
discuss with the FDA the path for approval of the drug.
Once we have a clear path for approval, we will scale up
our manufacturing capabilities and start developing
commercial capabilities to be able to bring the product as
fast as possible, post-approval, to the hands of surgeons. A
big part of this scale-up will be done in collaboration with
partners. We already have a commercial partner for D-
PLEX in Europe and are in advanced discussions with
100
other potential partners for other territories, such as India,
China and Latin America.
In terms of pipeline, our current focus is on pairing PLEX
with chemotherapy. We are constantly evaluating our future
program to identify new areas where we can add value on
our own or with other biotech companies pairing PLEX
with novel antibodies. We have shown in the past that the
PLEX platform works well with small molecules as well as
large molecules, peptides, and siRNA.
The PLEX platform is ideal when local administration is
preferred to systemic administration to avoid toxicity while
addressing localized disease and the associated difficulties
of achieving sustainable therapeutic drug levels at the site.
We are looking to collaborate with companies interested in
the life-cycle management of already approved molecules
and for new innovative ones where effective local disease
eradication is the major clinical goal.
market.
We are proud for our company to have achieved Corporate
Live Wire Global Awards Winner 2022/ 2023 - Bio-
Pharmaceutical Company of the Year.
26

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Barriers
Overcoming
to Adherence
Aroutine might be boring; however, it saves time,
and it is important for patients who are suffering
from chronic diseases like diabetes, HIV, blood
pressure, etc. Such patients can also enjoy a good quality of
life if they maintain a regular intake of their medicines.
Poor clinical outcomes are generally not caused due to
treatment and medical issues but because of irregularity in
the intake of medicine.
Though patients really care about their health, the state of
ignorance, 'Medication non-adherence state arises due to a
variety of reasons, including affordability issues, less
knowledge and understanding of the importance of taking
medicines, and most importantly, hazardous side effects of
these medicines, especially in chronic diseases.
Let's understand in detail the compliance to follow in
overcoming barriers!
Medication Adherence: Types
The World Health Organization defines medication
adherence as "The degree to which the person's behavior
corresponds with the agreed recommendations from a
health care provider." In general, healthcare professionals
use terms such as adherence and compliance
simultaneously. However, in practice, these terms differ in a
small context. Compliance implies how the patient is
obedient to the physician's prescriptions and authority.
Adherence believes in a combination of the physician's
advice and the patient's lifestyle.
If anything from prescribing medicine to the
completion of treatment goes wrong, then one of
the primary reasons must be non-adherence to
medicines. Among several reasons, two main
reasons are indisputable and degree of overlap. In
the first one, clinical professionals provide
prescriptions, but the medicine never gets initiated. This is
also known as 'non-fulfillment adherence'. The second type
involves a condition wherein patients stop taking medicines
after starting and continuing them for a while without
consulting their doctors. This is also known as 'non-
persistence' behaviour.
28

Medication Compliance
29

- Saloni Agarwal
Reasons behind Medication Non-adherence
Why does non-adherence to medicine continue to be an
issue for most patients? Patients always want to get better in
no time and still, they fail to follow the routine. Some of the
reasons are mentioned below:
Ÿ Inadequate Education: Patients are unaware of the
advantages of therapy or the potential negative effects of
non-adherence. For that reason, they may refuse to take
their medicines. Also, they might have concerns about
negative effects or gradually lose interest.
Ÿ Complexity in Medicines: Simply put, patients may
find it difficult to recall what their doctor told them.
They might require more assistance to remember the
schedule and which medicine should be taken at what
time.
Ÿ Finance Problems: Sometimes, money becomes the
biggest barrier in the journey of curing patients. Patients
who can't afford a medication may stop taking it.
Medicines can be highly expensive and hence patients
are in denial of taking them for a long time.
Ÿ Logistics Problems: Patients may find it challenging to
stay on schedule due to issues with transportation. They
might not pick the medicines up if frequent trips to the
pharmacy are necessary, particularly if the patient has
several drugs that are renewed on various schedules.
Moreover, if the patient is not capable of reaching drug
stores due to health conditions, their medical supply is
likely to be delayed.
How can we improve medication adherence with
medical compliance?
With better communication and automated outreach via
mobiles, many of the recognised obstacles to medication
adherence can be removed. Text messaging has been found
to be a useful strategy for encouraging adherence. In
practice, carrying out medical compliance is very crucial as
various aspects affect the process. For successful
medication adherence, the 100 percent involvement of
patients, clinicians and healthcare systems plays a vital role.
In order to carry out it effectively, there must be a variety of
ways and different adherence approaches in conjunction
used for patients. A blend of numerous methods is
recommended instead of suggesting a single method.
Some of the methods are mentioned below:
Ÿ Proper Education and Communication with Patients:
By providing patients with timely information and
detailed instructions, healthcare professionals can help
them overcome obstacles to medication adherence. They
should be informed about prescribed medication, the
benefits of following their care plan, and resources to
minimise side effects. Help patients to merge their
medication and care plan into their daily routine.
Ÿ Motivation is necessary: Patients must be encouraged
to follow their treatment plan and reminded of its
importance in addition to receiving education about the
same. This ensures patients' adherence to their
prescriptions. Moreover, if a patient achieves any
milestone in his journey of medication adherence, this
should be acknowledged and appreciated timely.
Ÿ Identify and address Barriers: To increase medication
adherence, patient participation in decision-making is
very essential. To choose the best treatment technique,
healthcare professionals must first discover the
underlying causes of patient non-adherence. Moreover,
applying technology and digital means to the treatment
can benefit the patients. Patients must be kept on track
by proactively responding to queries, offering
encouragement, and disseminating information, etc.
In conclusion,
In conclusion, we might answer the common question
among patients—why am I not getting cured? To get cured
and come back to normal life, patients must know the
importance of medication adherence and its benefits. Not
impossible with good communication, digital ways to
reminders, and medical help this can be achieved.
30

Ann Gidner
CEO
Ziccum
32

Ziccum
Biologics are often composed of living organisms
and molecular weights that make them vulnerable
to change in the environment. Traditionally, in the
healthcare sector, these biologics are delivered in liquid
form. However, their liquid formulations pose chemical and
physical stability concerns as they can be negatively
affected by moisture, temperature, oxygen, or prolonged
storage.
In recent years, drug-delivery operators have been looking
to eliminate this formulation gap. Thus, they are slowly
opting for alternative biologics that are rather formulated as
a dry powder and freeze-dried products that are more
promising with regard to their stability and longer shelf life.
To address the market's needs, Ziccum is developing
LaminarPaceTM, a unique ambient drying method for
pharmaceuticals and vaccines. Unlike other pharmaceutical
drying systems, it uses the science of mass transfer rather
than heat transfer to the active ingredient, thus enabling
thermostable dry powder pharmaceuticals.
In an interview with Insights Care, Ann Gidner, the CEO,
talks about Ziccum's innovative technology that enables it
to stand out in the drug delivery market.
Below are the highlights of the interview.
inception?
Ziccum was established in April 2017 as a spinout from its
parent company, Inhalation Sciences AB (ISAB). It was set
up to develop and commercialize ISAB's laminar drying
system, LaminarPace.
LaminarPace was originally invented by Per Gerde (Assoc.
Prof of Inhalation Toxicology at the Institute of
Environmental Medicine in Karolinska Institutet,
Stockholm) to generate small amounts of micronized
particle powder for aerosolization, including biologics. As
there was (and remains) a significant unmet need for a
system that can dry biologics with no heat damage, the
potential of LaminarPace ambient drying was immediately
clear.
I became the new CEO of Ziccum on May 9th and hit the
ground running with an ambitious raft of new strategies.
These included a new Business Model, targeting key
vaccine platforms, streamlining the company's project
pipeline and strengthening its focus on industrial partnering.
I have decades of senior strategic pharma experience and an
extensive international and national network. I also have
significant experience in building up and turning around life
science startups and designing and implementing new
business models to achieve steep, sustainable
growth—which is of particular value to Ziccum.
During my role, I've led Ziccum firmly toward an action-
based approach, restructuring the company and firmly
targeting pharma and biopharma companies (the company's
earlier focus was on NGOs and IGOs.) Since the time I
started working there, we have enlarged our business
development pipeline very significantly, with a wide range
of new dialogues established. We have also closed 2022,
receiving funding for an advanced, cutting-edge project
developing digital 3D Modelling and a Digital Twin of
LaminarPace. This will be very valuable in helping partners
implement the technology seamlessly into their vaccine and
biopharma manufacturing lines.
Expanding the Potentials for Next-Gen
Vaccines and Biologics
33

Can you elaborate upon the core values, mission, and
Ziccum's vision is to enable new biological treatments for
patient needs globally. Our unique contribution towards this
is by making drug formulation, biopharmaceutical
processing, product transport and patient administration
more efficient – with our unique ambient technology for
drying next-generation vaccines and biotherapeutics.
LaminarPace can dry delicate biomolecules, with no heat
stress or degradation, from nebulized droplets into dry, fast-
dissolving particles that are thermostable and also well-
suited to inhaled and novel administration routes.
We are passionate about driving forward innovation in
biopharmaceutical formulation. The innovation we're seeing
around new biologics and vaccines today is fantastic – from
cancer vaccines to personalized vaccines to mRNA. We
want to match that innovation in development with
innovation in formulation too. And there is a big need for
this.
Take the year, 2022. The world's three best-selling drugs
were all Biologics. From Pfizer's mRNA Covid-19 vaccine
to AbbVie's monoclonal antibody treatment for rheumatoid
arthritis to Merck's humanized antibody cancer
immunotherapy. They're all inspiring, ingenious therapies
derived from living, protein-based biological materials –
and they have all transformed the treatment landscape of
their indications.
But they all require refrigeration or ultra-cold freezing to be
stored and transported. One of them, for example, can only
be stored and transported at an ultra-low temperature (ULT)
of -60ºC to -86ºC which is a big challenge if you are a
healthcare provider in a Low to Middle-Income country that
does not have that kind of infrastructure.
So, we see a great opportunity here for ambient drying to
help formulate a new generation of thermostable
biopharmaceuticals that could also be administered using a
range of different routes beyond only injectables.
We emphasize sustainability too. We believe that
thermostable vaccines and biologics can help reduce the
impact of the global cold chain for those therapies—helping
reduce the currently large carbon footprint of today's
pharmaceutical manufacturing and supply chains.
What are the core products and services that your
company has to offer? In what way do they serve the
target population?
Our core product is LaminarPace, our unique ambient
drying method for biopharmaceuticals and vaccines based
on mass transfer, not heat transfer. The technology is
offered by licensing to vaccine and biologics developers
and manufacturers in the global pharmaceutical industry.
By reducing drying stress to the active ingredient,
LaminarPace uniquely enables particle-engineered,
thermostable dry powder biopharmaceuticals which can be
easily handled and transported and also are highly suitable
for novel administration routes. The technology has been
successfully applied to mRNA, peptides, proteins,
antibodies, lipids, and enzymes as well as excipients and
adjuvants, and is well suited for industrial application.
LaminarPace dries next-generation vaccines and biologics
as thermostable, particle-engineered powders that require
no cold chain and are highly suited for novel administration
routes.
34

Unlike other legacy methods for drying pharmaceuticals
(spray drying and freeze-drying, for example), LaminarPace
operates by mass transfer rather than heat transfer,
eliminating extreme temperatures and heat stress. Both
vaccines and biologics are vulnerable to degradation from
heat stress. Retaining API activity at the temperatures used
in today's legacy drying technologies remains a challenge
for drug developers and formulation specialists.
LaminarPace meets that need.
It is also a high-yield, low-waste drying technology. The
increasing cost of biopharmaceutical raw materials offers
important benefits. With spray drying, for example, a
typical process yield is around 40% to 70% (leaving 60% to
30% waste). LaminarPace drying delivers a comparatively
high process yield of around 80%, meaning typically, only
20% of the raw materials are wasted in the drying process.
How does your company offer personalized treatment to
the patient's concerns?
LaminarPace offers vaccine and biologics developers to
deliver unique capabilities and competitive advantages in
formulating their compounds for novel administration
routes. We are currently evaluating LaminarPace drying for
personalized cancer treatments. The technology is applied
not primarily for thermostability purposes but for very
convenient, gentle and convenient drying of individual
doses.
We are currently carrying out an advanced 3D Digital
modelling/Digital Twin project that is optimizing
LaminarPace for integration into the pharmaceutical
manufacturing process. (This is in partnership with the ICP
Institute of Computational Physics team at the Zurich
University of Applied Sciences' School of Engineering
(ZHAW). The project is accelerating LaminarPace's
industrial development and scale out as a unique unit of
pharmaceutical production.
3D modelling will be used to optimize LaminarPace design,
exploring optimal capacity loads and increasing the
repeatability of outcomes. It will be a valuable enabler of
tech transfer and integration into existing pharmaceutical
production chains. A cloud-enabled Digital Twin, the
ultimate stage of the project, will enable real-time
modelling and optimization.
market?
We recently received funding from the Eurostars funding
body towards our 3D Digital Twin project. International
competition for funding was intense. It is an important
validation of our business plan and technology (and the
impact it could have in vaccine and biologics
manufacture)—that our proposal was chosen among so
many competitors.
Take the year, 2022. The world's three best-
selling drugs were all Biologics. From Pfizer's
mRNA Covid-19 vaccine to AbbVie's monoclonal
antibody treatment for rheumatoid arthritis to
Merck's humanized antibody cancer
immunotherapy. They're all inspiring, ingenious
therapies derived from living, protein-based
biological materials – and they have all
transformed the treatment landscape of their
indications.
But they all require refrigeration or ultra-cold
freezing to be stored and transported, which is a
big challenge if you are a healthcare provider in
a Low to Middle-Income country that does not
have that kind of infrastructure.
So we see a great opportunity here for ambient
drying to help formulate a new generation of
thermostable biopharmaceuticals that could
also be administered using a range of different
routes beyond only injectables.
35

10 Most Efficient Drug Delivery Solution Providers in 2023V2_compressed.pdf

10 Most Efficient Drug Delivery Solution Providers in 2023V2_compressed.pdf

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