1. Aizant Drug Research Solutions
Integrated Drug Development Solutions
7/3/2012 Confidential 1
2. Flow of presentation
• Introduction
• Business verticals
– CDO Capabilities
– CRO Capabilities
• Support functions
• Advantage
• Contacts
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3. Milestones
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2005 • Aizant incorporated
2008 • Formulation R&D and clinical operations started
2009 • cGMP facility commissioned
Aug
2009
• R&D centre recognized by Dept. of Science and Industrial Research, GoI
Apr
2010
• Clinical facility audited by US FDA with NO 483s
May
2010
• Diagnostics laboratory accredited by NABL
Aug
2010
• Clinical facility was approved by Brazilian ANVISA
Oct
2011
• Clinical facility approved by WHO
Dec
2011
• Clinical facility approved by Turkey MoH
4. Vision & Mission
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• To be a global leader for science based integrated drug
developmentsolutionsVISION
• Pursuit of excellence through science and technology
• Agile team with open communication and honoring
deliverables
• Environmentally and socially responsible research
MISSION
• Innovation
• People
• Learning
• Quality
VALUES
5. Quality
• Quality is by design and not an after thought
• QbD is fundamental to our operations
– Targetthe product profile (TPP)
– Determine the critical quality attributes (CQAs)
– Link input material attributes and process parameters to CQAs and perform
risk assessment
– Develop a design space
– Designand implement a control strategy
– Manageproduct lifecycle, including continual improvement
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6. Flow of presentation
• Introduction
• Business verticals
– CDO Capabilities
– CRO Capabilities
• Support functions
• Advantage
• Contacts
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7. Business Verticals
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CDO
Contract
development
NCEs and LCMs
Specialtyproducts
Preclinicaltox
formulations
Enablingformulations
First in human
formulations
Late stage clinical
formulations
Generics etc.
cGMP
Manufacturing
Clinical trial
material
Commercial
manufacturing of
low volume
products
CRO
Clinical studies
BA/BE studies
Bioanalytical
Patient studies
(Oncology)
ExpansionPlans:
PhaseI to III clinical
trials & data
management
8. CDO – Infrastructure
• State of the art pharmaceutical development laboratories spread over 40,000
sqfeet
• Modern equipments and instruments in formulation and analytical
laboratories in tune with latest technology
• ~ 80,000 sq ft open space for scaling up any operations within short time
• Developmentcapabilities for:
– Oral dosage forms (solid/ liquid)
– Novel Drug Delivery Systems
• Controlledrelease/ sustainedrelease/ extended/ modified release dosage forms
• Multiparticulate systems
• Gastro-retentive system
– Topical dosage forms
– Parenteraldosageforms
– Ophthalmicdosage forms
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9. CDO - Services
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Preformulation
• Reverse
engineering
• Thermal analysis
• Dynamic vapor
sorption
• Particlesize
analyser
• Viscosity
measurements
• Solubility studies
• Dissolution
studies
• XRPD, SEM, Hot
stage
microscopy*
Formulation
Development
• Dry blending
• High shear
granulation
• Fluid bed
granulation
• Roller compaction
• Extrusion
spheronisation
• Wurstercoating
• Spraydrying
• Micronization
• PanCoating
• Encapsulation
Analytical
Development
• Method
development
• Method
validation
• Method
qualification
• Methodtransfers
• Stabilitystudies
• Chiral analysis
• Microscopy
Other Services
• Scale-upand
technology
transfer
• Standalone
stabilitystudies
• Product
registrationand
regulatory
support
• Clinical support
• Upcomingfacility
forpotent
substances
10. cGMP – Infrastructure
• About 10,000 sq. feet cGMP area for scale up and clinical batch
manufacturing
• Designed to meet US FDA/ MHRA standards
• DedicatedAHUs
• Flexibility of manufacturing batches from 0.05kg to 80kgs
• Power back to ensure smooth operations
• EnsuresOSHA compliance and other industry legislations
• Process train for solid orals:
– Up to 15 kg
– Up to 100 kg
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11. cGMP - Services
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Scale up
• Scaleup of
formulation
development
products
• Manufacturing
batchesfor
regulatory
submissions
• Commercial
manufactureof
low volume
products
• Allkinds of
packaging
Clinical trial
material
• Investigational
drug product
• Placebo
• Encapsulationof
tablets,
multiparticulate,
capsulesand
other solid
dosage forms
• Comparator
manufacturing
• Clinical
packaging,
blinding,
randomization
Analytics
• Testingand
release of
finishedgoods
• Cleaning
validation/
process
validation
• Microbiology
• Standalone
stabilitytesting
Other Services
• Regulatory
support
15. CRO – Infrastructure
• 80 bed (2 clinics) facility spread over 28,000 sq feet
• IP based cameras to virtually monitor projects
• Dedicated registration area
• Independent ethics committee
• In-house NABL accredited clinical diagnostics laboratory
• In-house kitchen
• Bioanalytical laboratories equipped with 7 LCMS/MS including API 5500
• Offsite storage of data for disaster recovery and business continuity
• Volunteer database
• Male: 4000+
• Female: 600+
• Access to post menopausal women database
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16. CRO - Services
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Clinical
Pharmacology
• Clinical studies for
males, females
and special
population
• BA/BE studies for
global submissions
• Proof of concept
studies
Bioanalytics
• Method
development and
validation
• Method transfer
of drugs in
biological matrix
• LCMS-MS and
HPLC analysis of
drugs and
metabolites in
biological matrix
from clinical trial
PK
&Biostatistics
• Study design
• CRF review
• Randomization
schedule
• Statistical analysis
& reporting (SAS
9.2 and WinNonlin
5.2 software)
• Well trained staff
Diagnostics
•Hematology
•Biochemistry
•Immunology
•Urine analysis
•X-ray
17. CRO - Regulatory approvals
• US FDA audited facility with NO 483s
• ANVISA inspection successfullycompleted (No major or critical
observations)
• NABL accreditation for clinical diagnostics
• DCGI inspected and approved
• WHO approved
• Turkey MoH approved
• Working on EMEA inspection
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20. Flow of presentation
• Introduction
• Business verticals
– CDO Capabilities
– CRO Capabilities
• Support functions
• Advantage
• Contacts
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21. Project management
• Cross functional project teams from formulation, analytical,
quality and regulatory departments
• All projects teams are monitored on MS projects by an
experienced project manager
• Metrics based project planning and execution
• Well defined communicationsystems as decided at beginning of
project
• Good track record of completing projects on time
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22. Informationtechnology
• Data-centrewith backup and recovery facility
• Offsitedata storage for disaster recovery
• IP Cameras for remote virtual monitoring of projects
• Biometrics for cross-check and validation
• Well defined IT policy for security and access control
• Metrics based reporting
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23. Key Management Team & Scientists
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S.No. Name Designation Qualification Years of
experience
Patents and
publications
Area of specialization
1 Varma Rudraraju Chairman and
Managing Director
MS (Pharmaceutics), University
of Mississippi, USA
Ph.D. (Pharmaceutics),
University of Mississippi, USA
20 21
publications
Preformulation to
commercial
manufacturing including
clinical
Business strategy
2 Ashok Illpakurthy DirectorProduct
Development
MS (Pharmaceutics), University
of Mississippi, USA
Ph.D. (Pharmaceutics),
University of Mississippi, USA
14 7 publications Formulation
development
QbD, DoE
Certified “Chemical
Design for Six Sigma”
(CDFSS) black belt
3 Narasimhan K Associate Director
Analytical
Development
MS (Physical Chemistry),
Bombay University, Mumbai
MS (Analytical Chemistry), SIU,
Carbondale, IL, USA
Ph.D., (Analytical Chemistry),
Purdue University, IN, USA
11 17
Publications;
Oral
presentations
Analytical development
and validations;
Bioanalytical;
Solid state chemistry
Process development;
QbD, DoE;
Stability studies
Totalteam of 300 + people between Product development,clinical
developmentandGMP business verticals
24. Key Management Team & Scientists
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S.No. Name Designation Qualification Years of
experience
Patents and
publications
Area of specialization
4 Tathagata Dutta Deputy Director-
Formulation
Development
M. Pharm, Dr. Hari Singh Gour
University, Sagar;
Ph.D., Dr. Hari Singh Gour
University, Sagar;
Post Doc., University of
Queensland, Brisbane, Australia
8 23
Publications;
2 Book
Chapters,
Invited
Lectures and
Oral
Presentations
in International
Conferences
Formulation
Development;
Novel Drug Delivery
Systems;
Dendrimers;
Nanotechnology;
Drug and Gene Delivery;
Development of RNAi
therapeutics
5 Suneela Prodduturi Associate Director,
Formulation
Development
Ph.D., Pharmaceutics, Post
Doctoral fellowship in Drug
Delivery
11 14 publications
and 25
presentations
(International)
Solubility enhancement
using solid dispersions
and melt extrusion
technology; Transdermal
and Transmucosal Drug
Delivery
6 Karan Singh Deputy Director
Analytical
Development
M.Sc (Chemistry) from
Rohilkhand University, Bareilly
(UP) India.
Ph.D. (Chemistry) from
Rohilkhand University, Bareilly
(UP) India
15 5 Publications Method Development,
Validation & Stability
studies of all kind of
Finished dosage forms.
25. Key Management Team & Scientists
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S.No. Name Designation Qualification Years of
experience
Patents and
publications
Area of specialization
7 Rajan Kombu
Subramanian
Senior Manger,
Bioanalytical
Department
M.Pharm, Gujrat University;
Ph.D., Kakatiya University;
MS, Case Western Reserve
University, USA
9 Patent-1;
Publications-
21;
Book Chapters-
1
Bioanalytical method
development and
validation using GC-MS
and LC-MS/MS
8 Ramesh Mattupalli DirectorQuality
Assurance
M.Pharm, (Pharmacognosy)
Banglore University
12 None Quality assurance
9 Anand Bhogu Vice President-
Clinical
Development
MSc (Biotech),
MPhil (National Chemical
Laboratory, CSIR, Pune, India)
14 None Project Management BA
BE studies (healthy and
patient based PK studies),
Discovery, Phase I, Phase
II- III,
Business Development
26. Flow of presentation
• Introduction
• Business verticals
– CDO Capabilities
– CRO Capabilities
• Support functions
• Advantage
• Contacts
7/3/2012 Confidential 26
27. Experience
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Projects
Handled over 150
developmentand
200 + clinical
projects since
inception
development
projects include:
Simple IR , complex IR,
Simple MR, complex MR,
Combination products,
LCMs, NCEs
Geography
Rich experience of
working in various
regulatory
environment
USA, EU, LatAm,
Worldwide, RoW
Clients
Versatileinworking
with various
partners
Big Pharma,
Specialty,
Generics, Indian
Generics
28. ExpansionPlans
• Adding potent development suite (completedevelopment under
isolators) for handling highly potent molecules
• Adding another 40 bed clinic for handing BA/BE studies
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