Company Presentation Edition February 2015

We are the first digital CLO (Contract Life sciences Organization)

that provides technological solutions

& value-added services for :

Clinical Research (drug development)

Personalized Health ( genomics )

We are a transformational life science solutions company converging

innovative digital and mobile technologies and “omics sciences”

to transcend the traditional inefficiencies and limitations of today’s

clinical research operations and patients’ healthcare.

Founders’ History

They have taken risks, encouraged creativity and transformed

ideas into innovations to tackle big Life Sciences and Pharma challenges, starting with the way new drugs and devices are developed.

They are committed to introduce a value-based approach in clinical research and to drive change in the way physicians, patients and other sector stakeholders interact.

Luigi Visani , MD CEO Medical Degree, University School of Medicine, Bologna, Italy. Post-garduate degree in Cardiology at the same University. Medical Director of the Italian Operative Unit at Boheringer Ingelheim Italy .Major shareholder and CEO of Hyperphar Group SpA , a leading Italian CRO . Shareholder and CEO of Pierrel spa , a CMO and CRO company, listed on the Milano stock exchange market. During his leadership the company , has been granted with both the FDA approval of its manufacturing plant in Capua (NA) for the production in sterile conditions of “small volume for parenteral injection” as well the FDA marketing authorization of a novel dental anesthetic (Orabloc) . Co-founder and CEO of Genes Holding AG, a consumer genetic company based in Lausanne (Switzerland)

Marco Romano, MD

President & COO

Medical degree at the University of Genova, Italy, where he went on to post-graduate studies in hygiene, epidemiology, and public health, followed by another post-graduate degree in clinical pharmacology at the University of Milan, Italy. He has been working for 25 years as Clinical Project Leader , Managing Director and Chief Medical Officer , in pharmaceutical and international clinical research: Parexel, ClinTrials Research,Inveresk, Charles River, Kendle and Chiltern International. He is co-author of several scientific papers on the topics of mutagenesis and cancerogenesis, pharmacokinetics and pharmacodynamics of chemical compounds and glutathione metabolism

Augusto Zaninelli, MD, FAHA, FESO Chief Healthcare Services

Medical degree at the University of Milano, Italy, where he went on to post-graduate degree in Internal Medicine and Cardiology. General Practitioner and Associate Professor of General Practice at the School of Medicine, University of Florence. Founder and President of The Italian Stroke Organization and of The Italian Society of Medical Simulation. Affiliate to many International Scientific Societies. Promoter and coordinator of many clinical research projects. Author of more than 250 scientific papers .

Peter Minich, Master of Science Chief Technology Officer Master's program in Information Systems and Diploma’s program in Medical Documentation and Computer Science at the University of Applied Science Ulm. Freelancer in Computer Science at the Institute of Human Genetics. Research Associate at the University of Applied Science Ulm, Institute of Computer Science. Associated Director of Clinical Trials Technology Pierrel Research Europe GmbH. Director of Clinical Trials Technology at Genes SA.

Milena Crespi, CCA, Master HR Executive Director Diploma in Accounting & Business Administration in Commercial Institute in Monza , Italy. Professional experience in drug price negotiation at Pharma company. Head of General Services at Hyperphar Group, a leading Italian CRO, dealing with HR, Talents Acquisition, Procurement , Legal and IT services . Executive Director and Board Member at Pierrel Research Italy and Pierrel Research IMP.

Corporate Office in Milano - Italy

Value-Added Digital CRO Services

We introduces a new vision into the inherent complexity of clinical trials by combining the expertise across medical, regulatory and operational functions with the ultimate Clinical Trial Technology solutions and “multi-omics “ sciences, to generate valuable and quality information about drug responses, drug resistance, diagnostic markers, and fundamental disease/toxicity pathways

Our unique model of embedding Technology and Science early in the planning process is proven to accelerate drug development , mitigate study risks, support data quality and to lead to significant advances in Stratified and Precision medicine

Mission

Navigating and accelerating the value-based transformation of clinical drug development through disruptive technology and multi-omics sciences.

Our 3C Vision

Sponsors Centric Our unique credo is to serve our Sponsors with passion, integrity, transparency, caring and innovation.

Investigators Centric We are committed to improve and facilitate the duties of investigators, through the introduction of mobile and cutting edge technological solutions.

Patients Centric We provide the assessment of molecular biomarkers to stratify patients for study drug efficacy and safety.

Our innovative digital CRO model is based on the digital platform – Genius Suite™,

that enables integration and collaboration among functions across the spectrum of clinical trials operations :

Randomization & Supplies Handling

Sites Monitoring & Management

Data and Documents collection & Management

Project Management,

eTMF

Risk-Based Management

ePRO

PHV

Patients’ Recruitment

Genius SUITE™ Developed in partnership with major leading technological partners , for the conduction of

Digital, Cloud, Mobile & Global Clinical Trials

Genius SUITE™

Genius CTMS™ centralized management of all clinical trial activities

Genius LINGO™ unique mobile Voice Interactive EDC System

Genius RIBAM™ risk based adaptive management and monitoring

Genius VIGILANCE™ drug safety and Pharmaco Vigilance

Genius IMP™ drug supply , randomization , accountability and compliance

Genius PRO™ patient ‘s mobile diary and study assistant

Genius TMF™ study document collection, management and analysis

Genius ENROLL™ expedites patient recruitment and increases retention

Value-added digital CRO

We are the first CRO that has been successfull in integrating in one single platform (Genius SUITE™) the most innovative and sophisticated digital and clouding solutions for the entire clinical trial operations

We combines the comphrensive CTT solutions of the big organizations, with the benefits of being a value-added boutique CRO, constantly focused on clients’ expectations and individual trial specificities

Exom Research, is Innovation, Passion and Excellence

Genius CTMS™

Genius CTMS™

Streamlines the clinical trial process by consolidating tracking and management of all clinical trial activities and information in a secure web-based system that is easily accessible across multiple sites, studies and teams

Reduces administrative costs and improve resource allocation and collaboration

Increases productivity by using a single source for maintaining critical study data and documents, reducing the need for internal staff to input data

Improves teamwork using collaboration portals that provide secure remote access

Views all subject visit data in one place across all protocols

Stays current and eliminate forgotten or overlooked tasks with staff and visit calendars

Reduces time spent looking for information and documents

Enhances the planning and effectiveness of monitoring visits

Genius Lingo™

Genius Lingo™

Functionalities

Unique worldwide mobile CRF that allows both the traditional manual «Touch» and the innovative dual-ways interactive «Speech» data entry

Time and resources-saving solution for filling out mCRF forms by simply speaking The spoken responses are automatically converted to text and inserted in the appropriate form fields Each Form combines recorded verbal responses with keypad choice selections Voice responses include a link to play the original audio recording, if necessary Once a form is completed, investigators are able to review, make edits and corrections if necessary,

sign and submit it to the study central application server and links to voice message files

Genius Lingo™

Competitive Advantages

Optional voice messages transcripted in mail messages delivered to study CRAs or PMs

Increased accuracy of data collections

Improved investigators’ compliance

High quality and reliability speech-to-text and text-to-speech technologies

Compatibility with most of the smart mobile devices

Genius RIBAM™ Risk Based Quality & Performance Management

The Traditional On-Site Monitoring approach

The on-site visits are generally conducted based on a set visit window schedule, such as every four to six

weeks and all data are source verified 100%, regardless of the type of study, safety risks, phase of the study,

stage of the study, or experience of the individuals conducting the study.

Visit objectives:

• Identify missing data in source records and data entry errors in CRFs

• Assess compliance with protocol and IMP accountability

• Evaluate Investigator supervision

• Review essential documents

Genius RIBAM™ Risk Based Quality & Performance Management

Why Should the Traditional Monitoring approach be changed ?

The endorsement of a change in monitoring by key regulatory authorities

(FDA & EMA) serves as a rationale for looking at monitoring in a different way.

These regulatory authorities are communicating that monitoring can and

should be designed and customized to meet the specific needs of the study.

Genius RIBAM™ Risk Based Quality & Performance Management

Industry stakeholders have recognized that although current on-site monitoring

practices do provide a level of control, advances in risk-based approaches and

technology provide an opportunity for a more holistic and proactive approach.

This philosophical shift in monitoring processes employs Centralized and Off-site

mechanisms to monitor important study parameters holistically and uses

Adaptive Onsite Monitoring to further support site processes, subject safety, and

data quality.

Genius RIBAM™ Risk Based Quality & Performance Management

What is Risk-Based Monitoring (RIBAM) ?

An adaptive approach to clinical trial monitoring that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality.

RIBAM provides sponsors with an ability to evaluate and plan for risks before a study starts and continuously adapt monitoring activities to areas that have the most potential to impact patient safety and data quality.

Genius RIBAM™ Risk Based Quality & Performance Management

How does RIBAM differ from “Traditional” monitoring ?

RIBAM customizes approach and/or schedule as needed based on trial related risk assessment to identify potential issues.

Leverages technology to allow the supervision of study conduct without having to be at the site location.

Shares monitoring responsibilities across many functional area

Relies more heavily on central and off-site monitoring

Genius RIBAM™ Risk Based Quality & Performance Management

Common Principles Underlying RIBAM

Early and ongoing risk assessment

Building Quality by Design (QbD) into the study

Identifying and tracking critical processes and critical data

Use of risk indicators and thresholds

Partial source data verification

Use of centralized, off-site, and adaptive monitoring while the study is underway

Genius RIBAM™ Risk Based Quality & Performance Management

Deploys predictive modeling techniques to assess levels of site risk, and allocate resources to areas of need

Improves the traditional site management approach

Determines the most results-oriented management strategy

Supports quantitative project risk analysis

Guarantees and documents in real time, continuous study quality

Helps sites to meet agreed-upon performace standards

Allows Sponsors to continuously follow study progress and data quality

Optimizes and adapts resources utilizations

Reduces global study costs

Genius eTMF™

What is Genius eTMF ?

It’s our digital and validated solution for the filing of clinical trial documents

It provides a single, secure Type II certified internet data centers for all clinical

players for sharing any study document, in a standardized and fully reportable

system.

Genius eTMF™

The benefits of eTMF

Brings all study stakeholders , CRO, Sponsors, and Investigator sites together in the regulated cloud. Sponsors get complete document visibility with real-time dashboards and actionable reports.

Tracks outstanding content and automatically places documents into the right section of the eTMF. The result is complete visibility, faster study start-up, and an inspection ready eTMF.

Supports the DIA TMF Reference Model, submission-ready rendering, auditor review support and API-based integration with Genius CTMS™.

Renders all documents in submissions-ready format (module 5 of an eCTD), already prepared for use in an HA submission. This feature eliminates significant downstream processing and removes unnecessary time and expense.

Genius ENROLL™ Patient Recruitment & Retention

Accelerates Clinical Trials

Robust Technology Global Digital Marketing Know-How Global Clinical and Regulatory Expertise Global Reach 42 countries, 28 languages

10 Year Track Record

800+ trials in six continents Used by 8 of top 10 Pharma Companies

Genius ENROLL™ Patient Recruitment & Retention

ClinLife® statistics 2014 36+ million visitors

Thousands of investigational sites working with ClinLife® 900,000+ registered patients in ClinLife® database

The Omics Sciences

The Omics Sciences

Omics based bio-markers will identify the more suitable patients for the specific investigational drug and will increase the chances for getting positive efficacy and safety data.

The integration of data-dense information from the different omics platforms at the individual levels is an essential step to develop drugs that make the personalized medicine

The Omics Sciences

Exom Research has selected qualified Disease Specific Centres of clinical excellence

and has established partnerships with international omics experts, molecular biology

and bio-computational centres to provide the following multi-omics services :

whole genome whole exome, transcriptomics metagenomics, epigenomics proteomics validation single cell sequencing methods

Therapeutic Areas Expertise

Oncology & Hematology

Cardiovascular & Metabolic Diseases

Central Nervous System (CNS)

Disorders

Rare Diseases

Respiratory

Infectious Diseases

Urology

Gastroenterology

Critical care

Immunology

Services 1

Coverage of every aspect of clinical research, from First-In-Human through Proof-of-Concept up to complete Phase III- IV international clinical development programs and post-approval projects

Intelligence Support with a

complete International Regulatory Strategy & Management for Product Development Programms

Dynamic digital study

management through the integrated, complete and mobile Genius Suite®

Recruitment and assessment of clinical studies results based on patients' genetics, and other omics and bio-markers

Services 2

Innovative solutions for

delivering rapid patient enrollment in more than 40 countries and 28 languages

Medical Imaging analysis Enhance post-marketing

surveillance and real world outcome studies with genetic data

Determine Market Access

requirements and develop strategy in the early phase

Full Pharmaco-Vigilance

pre and post marketing management services

New models for population-based research studies

Staff & Structure

Geographic Coverage

Our subsidiaries, field-based staff and partner CROs, provide an established infrastructure through which we are active across the whole of Europe, USA and the Asia-Pacific region.

Organization at a Glance

Exom Research

European Organizations &

International Partnerships

International Certified CRAs

Network

Patient Recruitment

Service

Medical Imaging Analysis Center

MIAC Basel

Clinical Research

Technology

Multi - Omics Labs

Early Phase Units

International CTA Regulatory & PHV

Competitive Advantages

Medical experts who design and monitor studies from beginning to end Strong Clinical Project Teams for superior and quality execution Global regulatory experts who can provide local knowledge support across about 90 countries Strong investigative sites and key opinion leader relationships Ultimate CTT mobile technology solutions for integrated study and data management

Digital, Cloud & Mobile Clinical Trial Technology

The Omics Sciences

The Value-Added CRO Services

We look forward to hearing from You

www.exomgroup.com