© Onorach Clinical 2015

onorach[onoir + -ach] a.Scots Gaelic word meaning honest, honourable and plain-dealing

Onorach is a member of the CCRA & EU CRA

Onorach’s headquarters at Prospect House, Dundee Technology Park, Dundee

What we doOnorach® Clinical manage Phase I to IV clinical research studies for drug products (including biologicals (stem cells)) and medical devices using a tailored partnership approach that provides an effective and efficient route for clients and patients to benefit from the potential of their products.

Onorach® provide pharma companies (from emerging, virtual and SMEs to large-scale multinationals) with a responsive and flexible development service.

Locations

• Onorach Clinical founded in 2009• Onorach Innovations founded in 2015• Both headquartered in Dundee, Scotland UK• Onorach Baltics, based in Riga Latvia founded in 2015• Onorach group capable of managing Clinical Trials in over

26 countries

Riga

Dundee(Headquarters)

UnitedKingdom Latvia

What sets us apart

“Onorach® have developed a range of transformational services that completely change the success rate of patient recruitment and retention in clinical trials.

Stephen Leiper, CEO

What sets us apartOnorach was created following research conducted into CROs performance in the industry.The research identified 5 areas where clients felt CROs under-delivered.Onorach has developed a philosophy of eDIB (electronically doing it better) which is a suite of electronic solutions that together improve the quality of data in Clinical Trials:

What sets us apart

Client time/resourcesrequired to manage project

Current industry model

What sets us apart

Client time/resourcesrequired to manage project

Onorach® innovative model

What sets us apart• Onorach’s business model has been designed directly in response to client

requests for a holistic approach to delivery of clinical trial services. Existing and potential partners are very attracted to this concept, and Onorach is able to select high quality partners based on their expertise and ability to add value in delivering a cost effective solution on time and within budget.

• Onorach® work with companies of any scale from virtual to multi-national. The Company has developed niche markets in dentistry, health and well-being and investigator led (non-commercially funded) clinical trials.

• Onorach® is led by Professor Christene Leiper who’s 30 year’s hands-on experience within the health industry is unusual. It is a huge benefit for a CRO to have a managing director with these credentials. Professor Leiper has a global reputation in a variety of therapeutic areas, which is greatly appreciated by potential clients, as she fully understands their opportunities and challenges.

Service areas:

GCP compliant Clinical Trial Management:• Clinical research which is bespoke i.e. “turn-key” or special requirements• Communication, planning & development• Gap Analysis & Risk Management• Clinical Operations Management • Protocol design in collaboration with clients• Site set-up, site initiation, patient recruitment• PI selection• Monitoring• Medical Report Writing• Data capture, storage, management and statistical analysis• Regulatory and Quality management• Site Close-out• Stability & Palatability Studies• Clinical Trial Supplies

Therapeutic areas:

• Central Nervous System

• Diabetes

• Respiratory

• Oncology

• Hepatology/Gastroenterology

• Stem Cells

• Paediatrics/Neonatal Intensive Care

• Vaccines

• Renal Impairment

• Medical Devices

• Haemophilia

• Cardiology

• Other

Cardiovascular capabilities in CVDExpertise:•Noninvasive imaging including nuclear perfusion studies,  cardiac computed tomography(CT), Cardiac Magnetic resonance imaging(CMRI), Cardiac Positron Emission Tomography(PET) and Echocardiography-either in Dundee or Latvia•GradCed exercise testing•Flow mediated dilation•Platelet Aggregation•Ambulatory blood pressure monitoring•ECG studies demonstrates thorough understanding of dosing requirements, study design, conduct and study-group sizes•Full suite of service offerings including protocol development, clinic conduct, ECG analysis, data management, fully integrated statistical analysis, study reports, regulatory submission support and ECG

These integrated services ensure production of the highest-quality data, turn-key operations and process efficiencies, which result in cost savings

Paediatrics/Neonatal Intensive CareExpertise:

• Extensive paediatric clinical diagnostic and research experience including

paediatric imaging in Nuclear Medicine

• Knowledge of clinical trials examining various drugs used in paediatrics

• Active member of NeoCirc clinical trial phase III study on the use of dobutamine

with neonates

Capabilities:• Onorach® have access to some of the best NIC and Paediatric research units

internationally

• We have strong links to international experts in paediatric/neonatal intensive care

(including key authorities for PIP & PUMA guidelines)

HaemophiliaExpertise:

• Post-marketing safety study following the treatment of subjects suffering with

severe haemophilia A involving the collection of safety data in an EU country

including inhibitor development, unexpected adverse drug reactions and serious

adverse drug reactions.

• Onorach team has experience in haemophilia and aphoresis treatments.

Capabilities:• We can manage haemophilia studies at UK and international hospitals and have

access to industry experts. (eg. a QP specialising blood bank experience)

Hepatology/GastroenterologyExpertise:

• Acted as UK Medical Liaison for a German hepatology company and conducted

CTs with several London hospitals

• Clinical trials included HIV co-infection and IgG4-associated Cholangitis, Acute on

Chronic liver failure and various gastroenterology studies

Capabilities:• We can manage hepatology/gastroenterology studies in the UK and

internationally and have access to relevant diagnostic equipment

• We have access to both leading UK experts in hepatology as well as

other international opinion leaders

• Strong relationship with the editors of ‘GUTS Journal’ for gastroenterologists

OncologyExpertise:

• Clinical and research experience, including project management for end-of-life

patients and telemedicine for remote areas

• Various research experience across chemotherapy, solid tumors, retrospective

studies and patient’s ‘quality of life’ studies

Capabilities:• We can manage oncology research projects at key UK & international sites

(including haematalogical cancers) and have access to diagnostic medical

imaging, ultrasound and biomarker technologies.

• Onorach are building a specialist Oncology Clinical Trials unit in Latvia

• We have access to key opinion leaders internationally across 26 countries

DiabetesExpertise:

• Experience of diagnostic & clinical research. Worked on medications for diabetes

mellitus types I & II.

• Research into peripheral neuropathy, glucose testing medical devices, retinal

detachment and sliding scale insulin studies

• Experience of blood glucose monitoring devices

Capabilities:• There are strong diabetes research networks across both Scotland and England

• Global coverage for diabetes studies & diagnostic medical imaging

• Glucose clamp technique (quantifying insulin secretion & resistance)

• We have access to key opinion leaders at Aberdeen Royal Infirmary, Ninewells

Dundee & Edinburgh Royal Infirmary (amongst others)

Central Nervous SystemExpertise:

• Written 1st Scottish standards for stroke admissions & rapid treatment

• Experience of CT for Alzheimer’s, Parkinson’s, Huntingdon’s, Multiple Sclerosis &

various neurological tumours

• Experience of CNS studies

Capabilities:• Global coverage for CNS studies

• Access medical imaging for CNS diagnostic/research studies

• We have access to key opinion leaders at Aberdeen Royal Infirmary & Edinburgh

Royal Infirmary (amongst others)

Respiratory Expertise:

• PhD in respiratory medicine (specialising in pulmonary embolism, COPD & chronic

lung infections). Performed many clinical trials on respiratory diseases including

NSAIDS, bronchiolitis, COPD, cystic fibrosis etc.

• Published author 2011, Respiratory – Positive Ventilation Delivery Systems.

• Experience of research into COPD

Capabilities:• We can manage respiratory research projects across 26 countries and have access

to diagnostic medical imaging

• We have access to key opinion leaders across UK and internationally

VaccinesExpertise:

• Experience of clinical trials with flu vaccines including Hib – bacteria causing

pneumonia and meningitis, H. influenzae disease – the main cause of meningitis,

Haemophilus Influenzae - Gram Negative coccobacillus causing serious invasive

disease in paediatrics & adults and non encapsulated ncHi – (non-typeable)

causes respiratory tract infections.

Capabilities:• We have access to private isolation rooms in early phase clinical trial units

• Onorach China facility (proposed) will have specific vaccine study rooms

• We have good relationships with key opinion leaders and links with local and

Australian vaccine researchers

Renal ImpairmentExpertise:

• Experience in clinical diagnostics, medical imaging and clinical research

• Involved in studies relating to continuous and intermittent dialysis for ARF and

use of dopamine in patients with renal dysfunction.

• Knowledge of peritoneal dialysis

Capabilities:• Onorach have access to key opinion leaders UK and internationally

• We have access to haemodialysis and peritoneal dialysis patients for clinical trials

• Dundee has a large Renal unit and are very active in research studies

Medical DevicesExpertise:

• Involved for many years in a large range of medical device studies

• Theatre instruments, glucometers, filters for haemodialysis and plasmaphoresis,

sutures, wound-care products, ultrasound machines etc.

• Co-developed positive ventilation delivery system for lung scanning intensive care

patients

• Experience of medical device clinical trials in the US and UK

Capabilities:• Onorach have access to a range of hospitals in the UK and internationally who

can participate in medical device clinical trials

Stem CellsExpertise:

• Sits on the Scottish Stem Cell Special Interest Group and SRMIC who influence

Government policy & bid for stem cell research funding

• Acted as UK Medical Liaison for a German stem cell company and conducted

CTs with hospitals in the UK and Germany

• Experienced in setting up stem cell studies

• Member of the EUSTM (European Society for Translational Medicine)

• Senior CRA with 10 years experience including stem cell studies

Capabilities:• We can offer specialist regulatory consultancy and stem cell study sites

in the UK

• We have access to both leading Scottish experts in stem cell studies as well as

other international research specialists

Other

We also have expertise across other areas including:

•Cardiac metabolic studies

•MS studies

•Rare diseases

•Orphan drugs

•Biomarker studies

•Vascular flow studies

•Opthalmics

•Dentistry

•Psychiatry

•Demographic studies

•Stability studies

Ethical & Regulatory TimelinesM

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Benefits to clients

• Improved clinical trials design using innovative services

• Internalizing of knowledge of how to meet FDA and other regulatory requirements

• Higher degree of confidence in preparation for GxP audits

• Accelerated patient/subject recruitment

• More effective conduct of clinical research studies

• Delivery of clinically relevant results

• Achieve faster completion of clinical trials than in-house CROs

• Better management of risk (clinical development & financial)

• More highly informed position regarding ‘go/no go’ for CT projects

Who we are (Onorach Management Team)Managing DirectorProfessor Christene Leiper

Founding member of Onorach®

•Currently holds the position of Managing Director and is a major shareholder•Professor in Medicine and Health Sciences at Bond University, Queensland, Australia •Holds a PhD for research in Nuclear Medicine, awarded by the University of Melbourne, Australia•30-year career in the health industry, holding a variety of senior positions in contract and clinical research organisations including GM Clinical, Glasgow; The University of Edinburgh; Vita Medical, Australia•Worked at Ninewells Hospital in Drug Development Solutions and played a key role (at Scottish Government level) in Quality Assurance for the first Scottish National Stroke Services Audit•Senior Associate of the Royal Society of Medicine• Member of the EUSTM (European Society for Translational Medicine)

Who we areChief Executive OfficerStephen Leiper, B.Sc.

Co-founder of Onorach®

•Currently CEO and Director and a major shareholder•Bachelor of Science degree from the University of Sydney, majoring in histology•Senior Associate of the Royal Society of Medicine•Proven track record of over 30 years success in sales and marketing to life sciences organisations•Areas of expertise include specialist sales of medical devices to surgeons in cardiac operating theatres; enterprise level IT solutions for life science companies; cutting edge molecular biology and tissue culture products•Prior to setting up Onorach, Stephen was global business development manager for GM Clinical, Glasgow

Who we areSenior Projects ManagerMandy Peden

Mandy Peden is a Pharmacist with 25 years’ experience in the pharmaceutical/biotech industry and holds a Dip Clin Sci from Cardiff University, a postgraduate qualification specifically for clinical research.

Mandy has extensive clinical monitoring experience, from Principal, Lead and Senior Clinical Research Associate roles with skills in management and co-ordination of clinical trials with both International Pharma and CRO companies.

Mandy has experience in training, protocol development, site management, data monitoring, electronic data capture, auditing and reporting as well as being accustomed to working and managing projects in highly regulated and fast-paced environments.

Who we areGlobal Marketing ManagerMartin E. Hunt, BSc (Hons)

Directing the branding, marketing and promotion of Onorach® and it’s subsidiaries world-wide.

•Career spanning 20 years, involving Quality Management, Organisational Development and International Marketing disciplines.•Worked in organisations from SMEs of less than 10 employees up to multi-national blue-chip global entities.•Diverse background in industries including Academia, Oil & Gas, Electronics, Pharmaceutical Manufacturing, Clinical Trial Manufacturing and CRO.•Experienced in the creation and management of new business start-up for a top 10 Pharmaceutical CMO.•High degree of experience working in high-value, regulated industrial sectors.•Other areas of expertise include quality auditing and employee performance system design.

Onorach® Clinical Prospect Business CentreDundee Technology ParkDundee DD2 1TY United Kingdom Tel: +44 (0)1382 561048 Email: info@onorach.com

www.onorach.com

By taking over the management of the entire (or elements of the) clinical development programme, Onorach shoulders the burden of responsibility, liability and risk.

It enables clients to leverage the knowledge, resources and skills of Onorach® to successfully deliver clinical development outcomes.

Onorach’s services are especially valuable to clients who lack theinternal resources or know-how to manage their clinicaldevelopment process in-house.

Thank you

© Onorach Clinical 2015