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www.themrn.co.uk

COMPANY OVERVIEW


MEDICAL RESEARCH NETWORK

37 COUNTRY COVERAGE

>600 HOME VISITS COMPLETED EACH MONTH ON AVERAGE

>99% HOME VISITS COMPLETED SUCCESSFULLY

MRN specializes in the conduct of clinical trial visits in the patients’ homes and supporting clinical trial sites with nursing resources. Our nursing services are designed to ease these burdens, therefore accelerating patient recruitment and retention and maximizing the impact of the trial for the pharmaceutical sponsor. MRN aims to create services to provide a platform for mainstream implementation of community-based clinical trials by 2020, which are designed to speed up clinical trials and make them efficient, bringing drugs to the market quicker for our customers and patients who volunteer to take part in the trials we support.

We want to accelerate patient recruitment and increase patient retention through the most patient-centric approach possible Graham Wylie

Chief Executive Officer 2


Patient and site-centric clinical trial solutions Patient recruitment and retention is arguably one of the biggest challenges in the clinical trials industry today. 30% of investigator sites under enroll, with 15% failing to recruit a single subject. On average, clinical trials last 30% longer than planned. At MRN, we understand the complexities of today’s clinical trial environment and the burden this places on both patients and sites.

Our Services – your solutions Home Trial Support is the conduct of clinical trial

visits in the patient’s home, replacing a number of protocol defined visits which would normally take place onsite, reducing the burden of the trial on the patient and significantly boosting patient recruitment and maximizing patient retention.

Site Nurse Support places experienced

research nurses into sites to manage trials; this enables each site to focus on patient identification and selection, as well as facilitating performance of all procedures in a timely manner. Placements can be made at single sites, or nursing teams can be pulled together to support sites across whole countries or trials.

PROVEN RESULTS Clinical trials conducted using our services experience:

95% PATIENT RETENTION RATE

60% patient recruitment IncreasE

MEDICAL RESEARCH NETWORK

3


OVER 45 CLINICAL TRIALS SUPPORTED ACROSS NORTH AMERICA

geographic coverage

OVER 75 CLINICAL TRIALS SUPPORTED ACROSS EUROPE

OVER 35 CLINICAL tRIALS SUPPORTED ACROSS REST OF WORLD

We’re currently operating in over 37 countries through our broad vendor network. Our Vendor Contracts and Management (VCM) Team are constantly exploring and investigating new regions to enable our sponsors to reach their patient populations. Our VCM Team assess and approve all our nurse vendors in each of the countries they work in to ensure we are able to provide a comprehensive and high quality service.

MRN offer the largest geographic coverage in our sector, driven by our unique global Vendor & Contract Management Team Elaine Wylie

executive director, vendor contracts & management Team 4


global CLINICAL TRIALS Countries where we currently offer nursing solutions: Argentina Australia Austria Belgium Bulgaria Canada Costa Rica Croatia Czech Republic � Denmark � Estonia � France

� � � � � � � � �

� Germany � Greece � Guatemala � Hungary � Ireland � Israel � Italy � Latvia � Lithuania � Mexico � Netherlands � New Zealand � Poland

� � � � � � � � � � �

Portugal Romania Russia Serbia South Africa Spain Thailand Turkey UK Ukraine USA

Countries where we are currently investigating nursing solutions: � Brazil � Chile � Columbia � Finland

� India � Japan � Malaysia � Norway

� Phillipines � Singapore � Sweden � Switzerland

Coverage

Map Key Countries where we currently offer nursing solutions Countries where we are currently investigating nursing solutions

MAP KEY Countries where we currently offer nursing solutions

Countries where we are currently investigating nursing solutions geographic coverage

5


>20 Pediatric Clinical Trials Supported

home trial support

>50 global Trials Supported

>40 Imp administration Trials Supported >40 rare disease clinical Trials Supported

We’ve supported over 100 clinical trials, ensuring that we understand your challenges. Home Trial Support takes the clinical trial to the patient by conducting visits in the home. Using Home Trial Support reduces the number of visits to site and significantly lessens the burden on patients and their families. Performing a number of visits in the home also lessens the resource burden on clinical sites, allowing them to enter more patients or run more trials. This ease of participation directly increases patient recruitment by 60% or more and typically maintains retention at over 95%.

Home Trial Support gives patients better access to new therapies, through reducing the burden of trial participation Helena Baker

Vice President of global nursing 6


TRADITIONAL PROCESS THETHE TRADITIONAL PROCESS

MRN PROCESS THETHE MRN PROCESS

LAB LAB

LAB LAB

PHARMACY PHARMACY

PHARMACY PHARMACY

CRA CRA

PATIENTS PATIENTS

SITE SITE

HOMECARE HOMECARE NURSE NURSE

CRA CRA NURSE NURSE

PATIENTS PATIENTS

SITE SITE

WHAT CAN BE DONE IN THE HOME? Our service enables a range of protocol procedures to be conducted in the patient’s home, from simple blooddraws to complex IMP administration. As a rule of thumb, if a visit doesn’t need a physician to be present and the equipment required is portable, then the visit can be done by a nurse in the home. As studies are initiated, the visit schedule is set up in MRN-SMART – MRN’s unique scheduling, managing and reporting tool - which enables capture and transmission of digital images of the data within the patients’ homes.

MRN can set up pharmacy services globally to support IMP administration; this includes central pharmacy services where possible, and local pharmacy solutions. IMP can be simply stored and shipped to the home where there is no manipulation requirement or compounded/reconstituted as required. We are also able to provide secure IMP storage in patients’ homes.

PROCEDURES There are a number of procedures that can be performed in the patients’ home, including: � � � � �

Blood sampling � Safety blood sampling � PK/PD blood sampling Pharmacodynamic sample collection Vital signs ECGs Quality of Life questionnaires

� IMP administration � Oral (for compliance studies) � Injections, including sub-cutaneous � Intravenous infusions � IMP administration training for parents/carers/patients

� � �

Adverse event monitoring Cognitive testing Lung function tests

HOME TRIAL SUPPORT

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IMP Logistics Working in partnership with World Courier and its sister companies, we provide an integrated supply chain that improves quality and accountability in the transportation and storage of IMP, as well as blood and other samples.

Secure in-home IMP storage CUBIXXCT is an RFID-enabled product storage system for direct-to-patient visits. Its advantages include: � � � � �

Small, personal RFID controlled refrigerator units allowing healthcare facilities to be provided for patients’ in-home storage of life-saving medications Exclusive treatment reporting capabilities deliver real-time data to stakeholders Network and radio frequency technologies monitor real-time product use Web portal access provides stakeholders total visibility of actionable data Technology to help improve treatment compliance, healthcare reporting and product accounting

SPONSOR/OUTSOURCER

MARKET-LEADING HOME HEALTHCARE �

Larger potential patient pool

� Faster recruiting (includes recruitment services) �

Greater retention

Faster completion/ time to market

Integrated GXP Supply Chain

PROTOCOL

BULK IMP

PHARMACY

Recruitment, Site Support, Scheduling, Protocol Training

HOME TRIAL SUPPORT

Fully integrated, high quality supply chain

� Reduced wastage due to central pharmacy � Improved drug accountability

NURSE & TOOLS

DISPENSED IMP

CUBIXXCT 8

Enhanced economics of DTP trial


The Right tools & processes How do our services support complex clinical trials? Through our unique mix of proprietary processes, latest technology and expertise.

MRN TEC

Our unique, web based training portal, customized per project, to ensure rapid and certified training to global nursing teams. All training is conducted in local language, at the nurse’s convenience, and covers both study specific procedures and ICH GCP.

MRN Smart

Our custom-built patient scheduling and project management system, offering real time tracking of patient visits globally. All patient data acquired in the home is recorded via electronic pen technology, ensuring rapid transfer of data back to site and immediate date/time stamping of visit completion.

mRn comply

Quality and compliance are high priorities at MRN. Our Quality Management System ensures clinical governance and regulatory compliance.

COMPLEX CLINICAL TRIALS MRN specializes in COMPLEX clinical trials. From studies in oncology, pediatrics or rare diseases, to IMP administration in the patients’ homes and global trials, our solutions are designed to make complex clinical trials simple to conduct.

RaRe Diseases Trials for orphan and rare drug indications are notoriously difficult to recruit into. However, Home Healthcare is widely deployed for commercial orphan disease products, drastically improving the quality of life for the patients. Offering the same level of service to the patients in trials significantly improves recruitment by making them accessible to patients who may otherwise have to give up a homecare service and travel huge distances to the sites.

IMP Administration IMPs are carefully assessed by our medical and nursing team, through review of the Investigator Brochure and discussion with the sponsor. We assess the condition of the patients expected from the protocol design, as well as overall patient exposure and side effect rates in initial doses and then recommend which visits can be conducted in the home and which at site.

Global Studies Home healthcare reduces the impact of the trial on the patient’s life - a totally patient centric approach that allows them to consent to participate in trials more easily. Delivering these services for large multinational trials is one of MRN’s specialities. MRN uses unique bespoke IT systems - MRN TEC and MRN SMART to allow us to startup and train large teams of nurses quickly and efficiently, tracking all their visits remotely in real time.

Pediatric Trials Enrolling children into clinical trials is one of the most pressing, but also the most difficult tasks facing therapeutic R&D teams. Children, perhaps more than any other group, need medical care to cause as little disruption as possible to their education and everyday life, and to instil a sense of security.

HOME TRIAL SUPPORT

9


BENEFITS OF HOME TRIAL SUPPORT Impact of Greater Reach

Home Trial Support allows recruitment of patients living further from the site.

D

E

PRE-SCREENING CONSENT SCREENING

C

HOME TRIAL SUPPORT

SITE NURSE SUPPORT & HOME TRIAL SUPPORT

33

59

59

10

17.9

35.8

COMPLEX

SIMPLE

COMPLEX

SIMPLE

COMPLEX

3.9

3.9

7.0

7.0

13.9

13.9

COMPLEX

SIMPLE

COMPLEX

SIMPLE

COMPLEX

1.6

1.1

4.2

3.5

8.4

7.0

SIMPLE

COMPLEX

SIMPLE

COMPLEX

SIMPLE

COMPLEX

1.0

0.7

2.6

2.2

5.2

4.4

0.8

0.5

2.5

2.1

4.9

3.7

SIMPLE

COMPLEX

SIMPLE

COMPLEX

SIMPLE

COMPLEX

SIMPLE

Implementing Home Trial Support allows sites to recruit patients from a wider geographical area and therefore reach a larger patient pool, as well as increase their consenting and retention rates. Implementing Site Nurse Support in parallel ensures sites have a dedicated resource to identify and screen patients from the increased patient pool effectively.

SIMPLE

SIMPLE

Patient Recruitment & Retention

The combined impact of these services can result in up to a 600% increase in completed patients per site.

RECRUITMENT RATES

ONGOING

B

COMPLETED

A

APPROACHED

PATIENT POOL

TRADITIONAL

SIMPLE: Blood draws and data collection

COMPLEX: IMP administration, blood draws and data collection

HTS & SNS

A

Studies suggest 70% of eligible patients are never approached by the site to enroll.

B

Pre-screening leads to 61% of patient pool being eliminated in all models.

C

Consent rates in traditional models of 40% to 28% improve to 60% to 50% when HTS is offered.

10

HOME TRIAL SUPPORT

HTS

TRADITIONAL

D

Screen failure of 62% in all models.

E

Retention rates of 80% in a traditional model improve to 95% when HTS is offered.


Case study home trial support global

Indication: Neurology Countries: 12 countries Sites: 88 sites in total / 84 used homecare Number of Patients: 972 / 797 used Home Trial Support Total Number of Visits Conducted: Approximately 4,000

Situation:

MRN was brought in to support a large international project spanning 12 countries, with a total of 88 sites and 972 patients randomized. The patients were on the study for 12-18 months in total, with homecare offered for alternating monthly visits. In total, 82% of the patients were referred to homecare from 94% of the sites who utilized the service.

Results: � �

Patient recruitment at the sites utilizing the homecare option was 16% better MRN consistently completed over 300 homecare visits per month

� �

Patient recruitment was originally planned for 9 months, but completed in less than 6 months, 33% faster than planned Patient retention was maintained at 96%

Patient Recruitment: 1200 1000 800 600 400 No. of Patients Randomised

200

No. Patients on Homecare Predicted Recruitment 13

M

th

12

M

th

11 th

10

M

th M

9 th M

8 th M

6

7 th M

th M

5 th M

4 th M

3 th M

2 th M

M

th

1

0

HOME TRIAL SUPPORT

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Case study Recruitment

Indication: Oncology Country: United Kingdom Sites: 6 sites in total / 5 used homecare Number of Patients: 63 Total Number of Visits Conducted: Over 3,200 across 2 years

Situation:

MRN’s Home Trial Support service was commissioned to support a complex oncology study requiring routine blood sampling for 63 patients across 6 sites in the UK including London, Midlands, Yorkshire and Scotland, every two weeks for 2 years with visits alternating between hospital, outpatient and home. 5 out of 6 sites utilized homecare. MRN trained 25 nurses to provide continual cover, including weekends and bank holidays.

Results: � �

� The center that did not use home care recruited 7 patients over the same time period, demonstrating in this case a 63% improvement in recruitment rates with homecare

Sites that adopted Home Trial Support achieved an average recruitment of 11 patients per site over an 18-month recruitment period One patient dropped out due to pregnancy

patient recruitment: 12 10 8 6 4 Average/Site without HTS

2

Average/Site with HTS

12

HOME TRIAL SUPPORT

7 th M

6 th M

5 th M

4 th M

3 th M

2 th M

M

th

1

0


community based trials A traditional site-focused clinical trial model significantly reduces the numbers of patients available to participate in trials as their physician is not taking part, whereas MRN’s community based model makes trials easier for patients to participate. Our experience demonstrates that when clinical trials are conducted using the traditional method, involving a high number of visits to the clinical site, a large burden is placed on the patient, often resulting in low recruitment. The complete virtual model, where there is little or no human-contact, experiences similar recruitment challenges, especially in populations that do not have access to technology. Our Community-Based Trial Model aims to optimize the amount of patient contact and use technology to ensure high-quality, real-time data and efficiency. Such a model has challenges. MRN is dedicated to providing services that meet these challenges as the desire to run trials in patients’ homes grows. Allowing a number of trial visits to be conducted in the patient’s home makes the trial considerably less onerous

for the patient and can have a significant impact on recruitment and retention rates. With many trial sites being under resourced and unable to apply the time required to their studies, placing a dedicated research nurse or coordinator into the site makes sure your trial is getting the focus it needs. Technology will play a key role in community based trials, as it allows many of the assessments to be centralized even with the patient still sitting in their own living room – radiology read by central reading sites, central labs testing all the samples, tests run on portable equipment with central validation and calibration, easy communication between physician and nurses and patients, wearable bio sensors and more that we have not yet even imagined. Community based trials will increasingly use the Internet to identify patients and other tools to open up trials to huge populations and explore recruitment whilst increasing retention, all the time maintaining standardized methods of assessments and measurement, while massively reducing costs. It is already possible to do so much of this – and the MRN is playing a key part.

SWEET SPOT FOR

Recruitment and Retention Performance

RECRUITMENT

Decreasing patient workload

Traditional model High degree of medical supervision

Increasing human contact

Increasing access to patients 6%

60%

Virtual model High degree of disintermediation community based trials

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site nurse support Our Site Nurse Support service places experienced and trained research nurses and study site coordinators (SSCs) into sites to overcome resource constraints. Placements can be made at single sites or nursing and project teams can be created to support multiple sites globally across a clinical trial.Â

Our Site Nurse Support service offers flexible dedicated resource solutions to improve site performance Paul Bodfish

Vice president of corporate services 14


benefits of site nurse support For the patients, their families and carers: � � �

Increased likelihood of being considered for a trial More site staff time for screening procedures and questions Better standard of care during visits

For clinical research site staff, Sponsors and CRO: � Dedicated resource for your clinical trial at the Investigative site � Faster patient identification and patient recruitment � Help with high throughput of patients � Clarity of site recruiting potential � Potential higher patient enrollment per site � Clearer view on where to focus efforts of Clinical Research Associates (CRA) � More choice in site selection

What can MRN’s on-site nurses and study site coordinators do? Our staff can cover all the roles and responsibilities expected of a research nurse or trial coordinator, including but not limited to: �

Database review and patient identification

Pre-screening and screening activities

Manage patient schedules and clinics

Patient assessment – safety and efficacy

IXRS access and entry

Investigator liaison, Pharmacy liaison

(e)CRF completion and query management

Drug management and administration

Site file management, site paperwork and general administration

Site Nurse Support projects are varied and can range from full time nurses working on single sites to international teams of nurses working across many sites. Services offered range from patient identification, dosing and ongoing trial support to CRF completion and Investigator site file maintenance.

Experienced & Trained Research Nurses and Study Site Co-ordinators

SITE NURSE SUPPORT

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Case STUDY GLOBAL SNS project Indication: Neurology (Parkinson’s Disease) Countries: 9 Countries (United Kingdom, Belgium, Netherlands, Poland, Germany, Thailand, Spain, Australia and Portugal) Sites: 20 MRN provided a team of multi lingual neurology specialist nurses across 9 countries. Nurses were required to visit sites with 24 hours’ notice. Patients were titrated via a complex system over 10 days for a Parkinson’s trial. The nurses conducted hourly neurological observations for each patient over 16 hours per day and also trained the site staff & patients on appropriate use of specific equipment. Service commenced in 2008 and is still ongoing.

nurse locations:

United Kingdom Belgium Portugal

Netherlands Poland Germany Spain

Thailand

Australia

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SITE NURSE SUPPORT


Case STUDY Patient Identification Indication: Cardiology Country: United Kingdom Sites: 10 sites

The cardiology study was failing to recruit due to: � �

Complex inclusion and exclusion criteria Limited on site staff to conduct database searches. MRN provided a team of 5 research nurses to conduct database searches across 10 sites, over a 12 month period. Sites had identified approximately 2,100 patients in the initial 24 months prior to the sponsor requesting MRN Site Nurse Support services.

Result: �

MRN’s Site Nurse Support Team increased pre- screened patient identification by over 2,200 patients (over 100% increase) across a 12-month period.

patient identification comparison:

6000

4000

2000

Site Work MRN Site Support

0 10

20

30

40

SITE NURSE SUPPORT

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Management team Dr Graham Wylie

Chief Executive Officer (CEO) Graham has more than 25 years’ experience in the pharmaceutical industry working for Pfizer, Parexel and Healthcare at Home. He was also named as one of the most influential leaders in the pharmaceutical industry by PharmaVOICE 100 in 2014. Graham joined Healthcare at Home in 2005 to set up their trial division and led the management buy out to create MRN in 2006.

Helena Baker

Vice President of GLOBAL Nursing

Paul Bodfish

Vice President of Corporate Services

Helena has over 22 years’ experience in nursing and healthcare. She previously worked at the Royal London Hospital in Whitechapel, Ferring Pharmaceuticals Ltd and St Bartholomew’s Hospital as well as acting as a healthcare analyst to the pharmaceutical industry.

With a BSc in Applied Biology and a diploma in Industrial Science, Paul has held senior roles at Proctor & Gamble, the Imperial Cancer Research Fund and Parexel. Paul joined MRN (formally Healthcare at Home) in 2006 to support the setup of the clinical trials division.

Stuart Redding

Simon Mouncer

Vice President of Global Business Development & Marketing

Vice President of Finance, Technology and HR

Stuart has over 20 years’ experience in the pharmaceutical industry, beginning his career at American Cyanamid before taking positions at Novo Nordisk, MDS Harris and Chiltern, before joining MRN as one of the founders in 2006.

A Chartered Management Accountant (ACMA), Simon has wide commercial and financial experience gained working for much of his career at Marks & Spencer. He has operated in many diverse business areas including procurement, logistics, operations, IT, audit, change programmes and overseas operations.

DR ELAINE wylie

todd mcgrath

A qualified physician, Elaine worked in hospital based medical and surgical roles for five years and then as a family practitioner, becoming a fully qualified General Practitioner in 1994. Elaine established MRN’s Vendor Contracts and Management Team working across both MRN’s HQ in the UK and the North America office.

Todd has over 12 years’ experience in the clinical trial and life science industry; beginning his career in pharmaceutical and biotec consulting and then holding operational positions at Parexel managing teams and projects.

Executive Director, Vendor Contracts & Management Team

18

Management team

Executive Director, US Operations


Complex clinical trials

Hematology � � � � �

Paroxysmal Nocturnal Haemoglobinuria (PNH)* Anaemia, Chemotherapy-Induced Anti-thrombin III Deficiency Hemophilia A* Hemophilia B*

Cancer

� Gastro-Intestinal Cancer (Bowel Cancer) � Multiple Myeloma � Breast Cancer � Non-Small Cell Lung Cancer (NSCLC)

Cardiovascular � �

Pulmonary Hypertension Congestive Heart Failure

Rare Disease

� Gaucher’s Disease* � Fabry Disease* � Morquio Syndrome* � Wolman’s Disease* � Duchenne Muscular Dystrophy* � Prader-Willi Syndrome* � Hypophosphatemic Rickets* � Amyotrophic Lateral Sclerosis (ALS)

Infectious Disease � � � � �

MRSA Infections Hepatitis C RSV Infections Hepatitis B* Cytomegalovirus Infections

Immunology � � �

Multiple Sclerosis (MS) Wegener’s Granulomatosis Hereditary Angioedema*

Other

� Rheumatoid Arthritis � Achondroplasia � Alzheimer’s Disease � Pelvic Inflammatory Disease (PID)* � Emphysema � Idiopathic Pulmonary Fibrosis � Wet Macular Degeneration � Psoriasis � Acute Kidney Injury � Nocturia � Polycystic Kidney Disease * Clinical trials involving pediatric patient populations complex clinical trials

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UK ADDRESS Medical Research Network Ltd Talon House Presley Way Milton Keynes Buckinghamshire MK8 0ES Tel: +44 (0)1908 261 153 Email: enquiries@themrn.co.uk NORTH AMERICA ADDRESS Medical Research Network Inc. 8001 N Lincoln Ave Skokie IL 60077 USA Tel: +1 (847) 983 3640 Email: enquiries@themrn.co.uk

Follow Us @MedResNet Medical Research Network www.themrn.co.uk

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