Presentation to Company X

May 2009

Veeda Clinical Research

• Veeda is a global CRO focussed on the early phase of clinical development (phase I/IIa)

• Veeda Locations:– India: Ahmedabad, Mumbai

– UK: Plymouth, Oxford

– Europe: Brussels, Paris

– US: Columbus, OH

Veeda Services

Pre-clinical Phase I Phase II

Veeda Clinical Research

Veeda Oncology

Biometrics

Bioanalytical & Biomarker Labs

Advinus

Phase III/IV

The Veeda advantage

• Unique blend of Eastern and Western facilities and expertise

• Privately owned company• Small enough to be responsive and

flexible• Large enough to offer global capabilities

covering everything from preclinical through to patient studies

• Most experienced Phase I CRO in India

Europe India Joint Services

Common Training for all StaffCommon Training for all StaffCommon SOPs for all staffCommon SOPs for all staff

Common Equipment for all unitsCommon Equipment for all unitsDivision of Laboratory tasks Division of Laboratory tasks withinwithin Group Group

The Veeda ModelGlobal Phase I Clinical Pharmacology

The Veeda model in action

• Veeda was asked to perform a programme of studies for a novel anti-diabetic drug

• Programme included First in Human, multiple dose and QTc as well as other studies

• Client priorities – save time, save cost, maintain quality• Programme split across Veeda UK and India:

– UK – FIH, drug interactions– India – Multiple dose, QTc

• All bioanalysis of drug and metabolites at Veeda India Labs• Joint project management from UK and India, joint team meetings

for all studies• Result - Entire programme was completed by Veeda with significant

time (ca 8-10 weeks) and cost savings (ca 40%)

Veeda UK - Plymouth

Plymouth

Advantages of Plymouth location

• Veeda is the only CRO in this region – closest competitor is 150 miles away by road

• Extensive volunteer access – around 5 million people live in the South West

• Stable volunteer population

• Good links with major regional hospitals, GPs and Consultants

Veeda India

Ahmedabad

Mumbai

Nadiad

Veeda India – facts and figures

• India – country of ca 1.1 billion people• Ahmedabad and Nadiad units in Gujarat State,

state population 15 million• Ahmedabad is India’s 7th largest city, population

of 5 million• Centre of academic excellence• Capital of CRO industry in India• Location of many Indian Pharma companies

Veeda Accreditations

India

no 483’s – 3 complete inspections

no critical findings

ANVISA approved

WHO approved

“Partner of Choice” for phase I studies 2007

UK

Oxford November 2007, awarded GLP/GCP accreditation

Plymouth awaiting Phase I accreditation

Veeda’s clients

• Veeda works with clients from across the globe, large and small

• Currently working with 10 of the top 15 Global Pharmaceutical companies

• Clients include:– Global pharma companies

– Mid-size pharma from UK, US, India, Japan

– Small/virtual companies from Australia, UK, India, US and others

Veeda’s experience

Female Health

Diabetes

CNS

Cardiovascular

Respiratory

GI

Dermatology

Pain

Urology

Other

Over 500 studies performed globally

Special Populations at Veeda

• Veeda has worked with the following special populations:– Elderly– Renal impaired– Hepatic impaired– Diabetes– BPH– Psoriasis– Females (sterile, non-sterilised, post-meno)– Many others!

Veeda’s UK Unit

• Established 22 years ago

• 61 beds, 21 monitored

• 100 staff

• On site pathology Lab

• Specialists in technically

complex studies, elderly

and female studies

Veeda’s India unit

Ahmedabad

• 116 beds, 12 monitored

• 250 staff

• >100 studies submitted to FDA

for approval

• Expertise in BA / BE studies

• Most experienced Phase I unit

in India

Veeda’s Indian unit (cont.)

Nadiad Renal Unit• 6 Bed unit in specialist

renal & urology hospital• Staffed by Veeda

personnel• Studies in mild, moderate

and severe renal impairment patients

• Access to hospital database of over 5,000 renal patients

India Facilities – Phase I

India facilities – BA/BE studies

Why Veeda UK?

• Experience: 21 years in Phase 1• Volunteers: Extensive database, stable

population• Special populations: Elderly, Female, Diabetic• Patients: GP network gives access to over

50,000 patients• Reliable recruitment: Proven track record in

recruiting patients and special populations

Why Veeda India?

• Quality: High quality, Western style Unit, run to Western standards

• Expertise: Staff trained to Western standards, very low staff turnover

• Access to patients: Good links with consultants and speciality hospitals across India

• Specialists: Purpose built units in renal and diabetes hospitals

Veeda Laboratory Facilities

• Oxford, UK• Biomarkers• Large molecule PK• Immunogenicity

• Ahmedabad, India• Small molecule PK• LC-MS/MS• UPLC• HPLC

Veeda Laboratory - India

• Equipment: 12 LC/MS-MS; UPLC, HPLC, Tomtec, Watson LIMS

• Method development, validation and sample analysis for NCEs and generic compounds

• Led by experienced UK scientist with experience in major Pharma and CROs

• Over 150 methods validated in 3 years • True 24/7 operation allows rapid turnaround of data

Veeda Laboratory - UK

• Large Molecule Bioanalysis (Oxford)– Immunochemistry, PK &

Immunogenicity• Bespoke Biomarker Laboratory (Oxford)

– Immunochemistry, Flow Cytometry, Multiplexing

• Many different platforms available• Central Clinical Laboratory (Plymouth)

Biomarkers at Veeda

• Biomarkers can be a useful addition to clinical drug development. They can offer:– Early indications of efficacy– Confirmation of mechanism of action– Aid in dose range finding– Early indications of toxicity or side effects

• Veeda can develop, validate and analyse samples for existing or new biomarkers

• Veeda has globally recognised expertise in this field, notably in “fit for purpose” validation

Fit for Purpose Biomarker assay development

Biomarkers at Veeda

Veeda Biometrics

• Veeda offers a full Data Management & Statistics service

• Data entry, data management, medical coding, pharmacovigilance, statistical analysis

• Located in Brussels and Mumbai• More than 20 years experience of all phases of

clinical development from Phase I through to Phase III/IV

• ClinTrial system installed and validated• All systems fully CFR 11 Part 21 compliant

Veeda Regulatory Services

• In house consultancy– Advice on study design

– Advice on regulatory requirements

– Wealth of experience in Europe and in India

• Regulatory consultancy– CTA preparation, legal representative for

EU

Regulatory in India

• For new drug substances discovered in India: Trials may be carried out in India right from FIM and required data needs to be submitted.

• For new drug substances discovered in countries other than India: FIM data must be generated outside India, permission may be granted to repeat phase 1. All Phases after FIM approved

• Administrative/Logistic Protocols and usual documentation submitted to DCGI and EC simultaneously

Study Timeframes India & UK

UK• MHRA Approval• Ethics Approval• Parallel application• Approval = 5 weeks

India• DCGI Approval• Ethics approval• Parallel application• Approval = 8-12 weeks

BUT…. Recruitment, screening and clinical phases much faster in India

Veeda – The Gateway to India

• Veeda offers an efficient, rapid and cost effective route to take a compound from FIH to POC

• Veeda can provide a full service from program and protocol development through to final reporting

• Veeda is focussed on the early phase of clinical development so understands the challenges at this crucial stage

• Veeda understand the needs and objectives of both large pharma and SMEs and can provide advice and support through all stages of the development process