Bridging the GAP
Global Access Programs
Bridging the GAP
For unmet medical needs
Bridging the GAP
“How can pharmaceutical and
biotechnology companies manage
patient requests for treatment, which,
if communication is not properly
channeled, can result in negative
publicity? How can they fulfill their
obligation to provide ethical access,
while remaining compliant? Caligor
provides the answers to these
questions effectively filling the
I NT E R NAT IONA L R EG U L AT ION S
Providing physicians with access to medicines not
available for use in their countries can save or have a
significant impact on patients’ lives. Caligor bridges
the gap between medicines and those that need them
by finding appropriate and regulatory compliant solutions for drug access through our innovative Global
Access Programs (GAP).
GAP is Caligor’s term for programs which are
sometimes referred to as “named patient,” “expanded
access,” “early access”, or “compassionate use”.
Through GAP, Caligor partners with pharmaceutical
and biotechnology companies around the world to
provide controlled and ethical access on a per-country
basis to medicines at every stage in their life cycle.
GAP opportunities across product life cycle
Working alongside your team, we provide strategies
to allow access throughout the product life cycle.
Planning for, and establishing a GAP with Caligor
early in the product development cycle offers
manufacturers the ability to anticipate and meet early
demand, gain valuable insight on “real world” use, and
provide access to products throughout their life cycle.
• Early Access - allows your medicine to be available
to patients when it is still globally unlicensed.
• Pre and Post Commercialization - includes
programs in lieu of open label extension studies,
as well as access during a phased commercial
medicine launch until each country has reached
authorization and reimbursement agreement.
• Mature and Supply Challenges - includes continuing access during and after a marketing authorization
withdrawal, as well as controlled access when a
commercial supply chain issue is encountered.
For pharmaceutical and biotechnology companies,
GAP provides a solution for effectively meeting patient
demand in markets around the world.
GAP solutions are not clinical trials, but rather targeted and controlled programs specifically intended for
patients who have exhausted their treatment options
and for whom appropriate therapies exist outside standard commercial channels. A GAP can be established
for an individual patient or for a group of patients.
Demand for medicines
Demand for medicines has never been greater, yet
the path to market is uncertain and it takes years to
get new therapies licensed and available to patients.
Today, requests for access to medicines often begins
well before therapies are commercially available.
Access to information on possible treatments is easily
available via the web, which enables patients and their
families to research possible treatments, keeping them
up-to-date on any new therapies in development.
Patients who have exhausted all other avenues of
treatment and who do not qualify for participation/
continued participation in clinical trials are seeking
access to these promising therapies — and often
cannot afford to wait.
Global Access Programs
Through GAP, Caligor can help your organization make a
positive impact on the lives of patients, while expanding
your market footprint on a global scale
“Our team understands the critical
importance of strong and effective
relationships serving as the
foundation for success. Our
authenticity and honest approach
can be seen and felt across all areas
of our business.”
An expert team to manage critical programs
Caligor has the experience, the means and the tools
to develop and implement global programs that bridge
the gap between innovation and commercial availability for life-saving and life-changing medicines. By
choosing Caligor as your access partner, you achieve
ethical access in a compliant, controlled, and legal
way while removing the resource burden of managing
these programs from your team.
Once your program is established with Caligor, we
will be the point of contact for patient and physician requests, ensuring adherence to all program
specifications, continuously monitoring the regulatory
landscape, and proactively working with you should
any changes in regulations have an impact on your
program. We will handle all day-to-day operations,
and provide you with the detailed reporting that you,
as the GAP sponsor, require and expect.
A collaborative partner for strategic
development, implementation and
management of your GAP
Caligor will work with you to provide individual access
solutions to meet patient needs. We offer:
• Regulatory expertise - Our in-depth regulatory
knowledge enables us to navigate the complexities
of compassionate use/ethical access laws and
regulations that are specific to each country to
ensure program compliance.
• Global reach - Our international distribution and
logistics capabilities allow us to reliably meet patient
demands throughout the Americas, Europe, and
Asia, extending your market reach.
• Personalized attention—As a Caligor GAP partner,
you enjoy highly attentive service at every step
— from planning your access strategy, to comprehensive program development utilizing our GAP
Compass, to implementation and day-to-day operations and logistics. We handle all the details to make
providing ethical access easy and cost-effective for
• Peace of mind - Our team is committed to managing your program with a keen focus on quality, honesty, integrity, and strict adherence to all regulatory
and legal requirements.
• A relationship-focused approach – Our team
understands the critical importance of strong and
effective relationships serving as the foundation for
success. This is reflected in how we represent you
through our relationships with your treating physicians, and all internal/external stakeholders for the
program. Our authenticity and honest approach can
be seen and felt across all areas of our business.
To learn how a GAP partnership could benefit you, please contact us today.
Caligor Rx Inc.
Caligor Rx Ltd.
801 Penhorn Avenue
Secaucus, NJ 07094
Unit 23 Schooner Park
Crossways Business Park
+44 (0) 1322 311 134