EXODON Overview

Our Company

Exodon offers a novel combination of CRO services. Over the past several years we have provided intelligent and creative solutions for accelerating the clinical trial process by identifying and selecting investigator sites using a proprietary internationally based site and patient recruitment database model.

We also have been meeting the needs of pharmaceutical and nutraceutical clients with smaller Phase I and II projects, bioequivalent, comparative effectiveness and post-marketing clinical research projects offering a timelier, cost-effective and comprehensive CRO solutions. We conduct the majority of these studies in our own clinical research units located in the USA, India, the Philippines and Argentina. This approach allows for far more control over the project which reduces both errors and cost, allowing for faster completion of the clinical research project.

Therapeutic Expertise

• Oncology

• Cardiovascular Diseases

• CNS

• Infectious Disease

• Rheumatology

• Endocrinology

• Nutrition

History of Work

PRODUCTS AND SERVICES

Patient Recruitment

Site Selection and Management

Comprehensive Product R & D CRO services for Phase I, II, PK/Bio-equivalence and IITs

Outsourced Central and Field Medical Sales Representatives

Exodon’s Patient Services Center™ offers: Healthcare/Lifescience Central Support Services

PRODUCT RESEARCH AND DEVELOPMENT DEPARTMENT

Product R & D Department

From Concept to Closeout

Pre-clinical Studies

Nutraceutical Division

Phase I and II Division

Bioequivalence/PK Division

Investigator Initiated Trials Division

Outsourced Sale Representatives for approved products

Product R & D Department

State of the Art Clinical Research Units (CRUs)

India

The Philippines

USA

Argentina

We offer a timelier, more cost-effective and comprehensive CRO solutionfor our clients. We conduct the majority of these studies in our own clinicalresearch units with our in-house team of experts in pharmaceutical andnutraceutical product development, pre-clinical and clinical research trials.

This approach allows for far more control over the projectwhich reduces both errors and cost, allowing for fastercompletion of the clinical research project.

Many companies who make these products would love to test the safety and efficacy of their products. But without adequate R & D funding, which can often exceed several hundred thousand dollars to test their products, these manufacturers have been unable to clinically test their products - until now.

Product R & D Department

Pharmaceutical, Nutraceutical, Medical Food and Biotech Companies

Exodon, in its ongoing efforts to transform clinical research, has developed a cost effective way to test these dietary supplement, functional food, pharmaceutical and nutraceutical products and those that pass safety and efficacy testing, we design, develop, implement and mange the necessary clinical trial to test the efficacy of the product in humans. You just supply the product to be tested.

Product R & D Department

Phase I-II Studies

Drug Design and Consultation

Multinational Regulatory Affairs Filing

Phase I-II Clinical Trials Management

Drug Safety and Pharmacovigilance

Medical Monitoring

Data Capture and Management

Statistical Analysis and Medical Writing

We offer you the opportunity to have your products undergopharmacokinetic studies - the study of the mechanisms of absorptionand distribution of an administered drug, the rate at which a drug actionbegins and the duration of the effect, the chemical changes of thesubstance in the body, and the effects and routes of excretion of themetabolites of the drug.

Product R & D Department

Bioequivalence Studies

Investigator Initiated Trials (IITs) are challenging as sponsors have to strike a delicate balance between providing oversight while maintaining a “hands-off” approach.

Product R & D Department

Investigator – Initiated Trials

Exodon and ERA Clinical can offer the following: • Study design, protocol creation, CRF development and e-data mgt. • Regulatory document preparation and IRB Submission• Identification, selection, qualification and training of investigators• Contract negotiation and management• Monitor subject enrolment, and source document verification• Write the FSR and assist investigator with publications, posters & presentations

VALIDATE System® and VALtrack™ Site Selection

VALIDATE System® Site Database

VALIDATE System® site database- this system identifies clinical trial sites with the necessary experience in the needed therapeutic area that likely has the necessary patient population for the study. The patient data from these sites can be searched by the study I/E criteria. Additionally we have various site metrics on these sites such as PI experience, on-site staffing, equipment at site or available, etc. Confirmation of patient population will be performed prior to site submission to the sponsor.

VALtrack™ site database

VALtrack™ site database – is an international database of physicians per therapeutic area that we screen. All VT sites will be contacted, screened and validated by our medical liaison and study start up specialist teams to as part of the site feasibility process. Those sites that pass the screening for this study are moved into our VS site database, their patient data pre-screened and selected sites forwarded to the sponsor.

Exodon VALIDATE System® and VALtrack™ Patient Recruitment Programs

Exodon’s VALIDATE System® Patient Recruitment Database

Database includes searchable de-identified medical records of patients from multiple global regions that have pre-consented for participation in upcoming clinical research trials

The patients in our VS database have authorized us and their treating doctors to find new diagnostic and treatment options relevant to their condition(s) by signing a HIPAA Authorization and pre-consent form. The pre-consent form is an Informed Consent without naming a specific trial.

Exodon VALtrack™Direct Patient Recruitment Database

Contains Approximately 42 million Patients

Is a much larger database of approximately 40 million patients, some who have opted in to participate in clinical trials.

The patients in the database are not yet pre-consented or if they opted to participate in clinical trials we do not have access to their full medical records.

We have various levels of diagnostic and clinical related information on our VT patients and the ability to pre-screen and pre-consent those who meet criteria for our clients’ trials. Those patients who meet criteria and want to participate in the trial are referred to the already enrolled study site.

Some Patient Recruitment Vignettes

Pediatric Bipolar Disorder Phase III Trial Recruited 6 VS sites during site-selection with an average of 6 pre-consented

Pts per site; 32 of these patients were successfully enrolled into this study shortly

after their SIV. 4 pre-qualified patients per month were referred to sponsor sites

throughout the length of this contract.

PFO Migraine Phase III Trial Referred an average of 14 pre-consented and pre-qualified migraine patients

each month to be screened at sponsor sites for a period of approx. 1 year.

Hepatitis B Phase II Trial Successfully recruited 5 sites in Eastern Europe with approximately 50-60 pre-

consented patients and 3 sites in the US with 16 pre-qualified pts. Their patient

enrollment was completed before the trial started.

Some Patient Recruitment Vignettes

Cancer Pain Study

2 network sites participated. Ranked the highest enrolling site in the

multisite international trial.

Chemotherapy induce nausea study

3 network sites participated in the study. Ranked the highest enrolling site in the

multisite international trial.

Breast Cancer Study

Joined the study in the late stages, but still had 14 out of 57 screened patients

enrolled into the study.

Ovarian Cancer Study

1 network site participated – enrolled 4 patients

Enrolled 3 patients from a database approach for Patient Recruitment for other study

sites

Screening Centers

• Point of care centers that have the patient population needed for the trial , but not participating in clinical trials.

• Patients are pre-screened against the Inclusion/Exclusion criteria, and qualified candidates are referred to the nearest study site for final screening.

Referral Centers and Site BasedPatient Recruitment

Patient Support Groups and Community Outreach Programs

Exodon has established relationships with patient support and advocacy groups worldwide who refer patients matching their medical profiles to different clinical trials opportunities.

Site-based

Using the searching software built into our VALIDATE System we have developed a quick and effective method to help study sites reach out within minutes to all their patients with the study diagnosis. Either the site or Exodon’s doctors then screen these patients for eligibility into the trial. This approach is coupled with proven trial promotional strategies at the site level.

Public Relations and Media-basedPatient Recruitment

PR, TV, Radio, and the Internet

The director of this division has 20 years experience in promoting clinical trials and new healthcare options thru strategic PR campaigns and broad based media. This division nicely supplements our database-driven patient recruitment solutions.

Patient Recruitment Performance-based Pricing

VS and VT products

Set-up and performance

Screening Centers

Set-up and monthly fee

Referral Centers

Per Active Center

Media-based

Budget driven

Site-selection

Screening fees

Selection fee optional

We use a shared-risk partnership model with our clients based on performance

Site Selection Metrics

We use our Top 30 Model per Medical Discipline

Model is expandable based on needs of client

World Wide Study Center Options

Asia and Asia-Pacific Region

India

Latin America

Eastern and Western Europe

US and Canada

Sites are selected based on experience, ability to meet the study requirements and the number of pre-consented patients meeting the protocol’s requirements at each site

Site Selection Features & Benefits

Systematic, comprehensive and objective method of identifying potential sites from Exodon’s Worldwide Network of Clinical Investigators.

Potential Clinical Investigators are experienced in their field of medical specialization and can implement studies immediately.

Complete investigator’s information on their medical practice, patients, study history, site facility, etc.

Established professional and working relations for smooth coordination.

Targets your precise therapeutic areas of interests/topics

Patient Services Center™ and Medical Sales Representatives

Our 1,000 seat clinically staff Patient Services Center™specializes in pre-screening patients for clinical trials, conducting healthcare assessment, medical triage and support services. All clinicians are supervised by doctoral-level supervisors

Outsourced central and field sales representative to detail and sell client products globally to a wide network of healthcare practitioners

CRO Sales Outsourcing

Exodon’s central and regional medical and nutraceutical sales representatives can educate, detail and sell your products to our global and international network of healthcare practitioners.

We offer full as well as shared marketing and sales programs to help you launch or revive your product line.

R International Network of Healthcare providers

R Scientifically-trained sales and medical representatives!

R Experienced professionals across multiple specialities

RAffordable and flexible purchasing options

R Licensing agreements available

Looking forward to working with you!

ExodonUS Headquarters111 Howard BlvdMt. Arlington, NJ 07856Contact No: 973-398-2900www.exodon.com