1. Aptuit INDiGO®
FACTSHEET
Accelerated, Integrated Drug Development:
Customized to Advance Your Molecule
®
APT/FACT/INDiGO/01/13/V003
Today’s Drug Development Challenges
The current pharmaceutical industry and business environment faces
multiple challenges.
There is the need to overcome Research & Development budget
constraints amidst fierce competition. Increasingly, the complexities of
drug development processes are requiring multiple expert disciplines
that need to be integrated through a proficient and efficient approach.
Multinational and large pharmaceutical companies are faced with
inefficiencies in the internal processes while the internal development
capabilities of biotechs are limited. When these businesses turn to
conventional outsourcing, they are challenged to manage multiple
vendors with inefficient handoff between groups. Additionally, there is
a lack of real time data interpretation that results in high resource input
and a non-integrated data package.
Clearly, a New Approach is Needed
By accelerating a novel compound into the clinic in a more cost effective
manner, drug developers can anticipate critical portfolio decisions and
save millions in cash resources and years in development time. Critical
factors for success include:
• Applying streamlined “fit for purpose” approaches, such as using
amorphous product, and utilizing quality-by-design strategies
throughout the development cycle;
• Early establishment of efficacy/safety profile with a rapid cycling of
information between preclinical and clinical studies, using effective
translational approaches;
• Clinical development show-stoppers, identified early by means of fusion
studies, adaptive design and experimental medicine approaches.
Aptuit INDiGO®
offers the opportunity for an accelerated route from Candidate Selection to First in Man/Proof-Of-Concept studies. The
program has been proven to reduce time and costs while achieving more robust results and an improved quality of the data package in key
development areas.
Importantly, each INDiGO®
program is custom designed for each molecule, maximizing the probability of success.
World class
preclinical
safety/DMPK
solid state
chemistry
Quality-by-
design
principles
applied in
earliest stages
Seamless data
and knowledge
integration
throughout
project
Regulatory
documentation
preparation
Clinical
Sciences
Reduced
service
provider
monitoring
26 wks
API to IND
52 wks
CS to IND
+30 wks FIM

2. Aptuit INDiGO®
FACTSHEET
®
APT/FACT/INDiGO/01/13/V003
As few as 26 weeks from API availability to Regulatory Submission
As few as 52 weeks from candidate selection to Regulatory Submission
Only 30 additional weeks from Regulatory Submission to FIM study report
The Aptuit INDiGO®
Solution to Development Challenges
* Industry average based on Tufts CSDD analysis: ~122 weeks (Compared with Aptuit INDiGO®
52 week package)
The graphic below outlines the optimized Aptuit INDiGO®
program
showing the approximate timeframes for parallel and fully
integrated development tracks. The process is divided according to
development areas: API Manufacture, Formulation Development and
Clinical Supply, Safety Assessment and DMPK/Bioanalysis Studies,
Regulatory Submission Documents Preparation, and Clinical Study
Design, Monitoring and Reporting. API manufacture is developed
in parallel with the preclinical program, which includes repeat dose
toxicity studies and ad-hoc tests required for a successful regulatory
submission. The clinical supply module includes method development
and a significant planning component, where the type of dosage
form for clinical supplies is determined based on the solubility of the
API. Clinical sciences provide CPK prediction, study design/protocol,
site selection, and human study monitoring and reporting. Regulatory
submission documentation is also generated in parallel and in real
time response to the data. All these services can be provided on either
a stand alone basis or a fully integrated manner.
Optimized timelines are achieved by using integrated, parallel development tracks:
Each project plan is customized for each molecule; Customized programs include a Guaranteed Price and Guaranteed Timeline
• Solutions are available for all therapeutic areas, small and large molecules, drug product changes and post-FIM IP extension
opportunities
• Services can be provided as stand alone or fully integrated

3. Aptuit INDiGO®
FACTSHEET
®
Why choose Aptuit INDiGO®
?
• Time and Cost Savings
- Timelines and costs are well defined for the agreed development
program, mitigating unexpected obstacles
• Integration and Project Management
- Seamless and efficient development with real time adjustments to
plan as required
- Integration of know-how and data across disciplines to maximize the
quality of the data package
- Experienced, dedicated Project Managers who are committed to
delivering your project on time in full and within budget
- Reduced burden/internal costs for the client due to low requirement
for monitoring
• Expertise and Experience
- Highly skilled recognized experts in all disciplines with a track record
of more than 60 successful INDiGO®
packages, including regulatory
submissions in multiple therapeutic areas
• Technologies and Quality
- State-of-the-art laboratories; cutting-edge technologies and quality
levels
• Communication
- Customized communication strategy and real time provision of data
with interpretation
• Customization
- World-class drug development professionals running tailored
development strategies designed specifically for the molecule,
therapeutic area and client needs
Uncommon expertise. Exceptional results.
Aptuit provides early to mid-phase drug development solutions by applying
scientific excellence, outstanding service and a team of some of the
foremost scientific professionals in the industry. These drug discovery and
development professionals offer proven experience in key therapeutic
areas. They share a legacy of success, having advanced a large number of
molecules efficiently, expeditiously and economically, from early discovery
through clinical development with low attrition rates.
It is our uncommon expertise that allows Aptuit to identify the unexpected,
mitigating risks and maximizing promising possibilities, ensuring
exceptional results through an open, transparent climate of trust that our
clients can count on.
Aptuit’s comprehensive drug development services include:
For information about Aptuit’s services, please contact us:
in Europe: +39 045 821 9333
in the US: 855-506-6360
email us at: expertise@aptuit.com
www.aptuit.com
APT/FACT/INDiGO/01/13/V003
• Drug Design Discovery
• Preclinical Biosciences
• API Development Manufacture
• Solid State Chemistry
• Sterile Fill Finish Formulation
Development
• Oral Dosage Form Development
Manufacture
• Clinical Sciences
• Consulting
• Aptuit INDiGO®
- fast track
to IND program
• Integrated Drug Discovery
Development