Patient trials are receiving more focus in the early phase landscape. SGS strategy is to create robust and transparent capabilities to offer customized solutions for a wide range of patient trial requests. Enrollment potential, operational, excellence and completeness in control are the key concerns for sponsors in this field. Beyond our CPU capabilities, we employ a network of Phase I Patient Units. These units are located in hospitals both in Belgium and in the CEE region, where SGS own medical and support staff are present to ensure quality and professionalism in trial execution and SOPs are harmonized for full-scope transparency. Additional or alternative solutions involve our regular cooperation and partnership with carefully selected recruitment expert CROs in order to access highly challenging patient pools or unique geographical locations. Contact Us: clinicalresearch@sgs.com Visit our Website: http://www.sgs.com/cro Follow Us on LinkedIn: http://bit.ly/SGSLifeSciences

1. PATIENTS PHASE I CLINICAL TRIALS –
SECURED MULTI SITE MODEL FOR KEY
POPULATIONS RECRUITMENT
Dr. Istvan Udvaros
Medical and Project Director Oncology
SGS Life Science Services
SAFETY & EFFICACY CLINICAL TRIAL SOLUTIONS
SGS Life Science Services Biopharm Day Seminar – Antwerp, October 29, 2015

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
PHASE 1 TRIALS IN EU 2015 (OPEN,
INTERVENTIONAL) SOURCE WWW.CLINICALTRIALS.GOV
All With patients

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
PATIENT TRIAL PHASE I MARKET IN EU 2015
 Belgium (47)
 Oncology 72 %
 Organ impairment 4 %
 Reum/Immun 5 %
 Neurology 6 %
 France (114)
 Oncology 79 % !!!!
 Neurology 7 %
 UK (131)
 Oncology 58 %
 Cardiovascular 9 %
 Pulmonology 6 %
 Reum/Immun 6%
 Germany (99)
 Oncology 63 %
 Neurology 8 %
 Reum/Immun 8 %
 Metabolic 7%
 Poland/Hun (17)
 Oncology 50%
 Reum/Immun 29%
Key EP EU indications:
1. Oncology is TOP !!!
2. Immunology
3. Elderly population diseases

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
FROM LEAD COMPOUND TO PROOF OF
CONCEPT – THE SPONSOR PERSPECTIVE

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
THE CRO PERSPECTIVE
 Large number of request from stand alone to complete drug
development and service packages
 Wide range of therapeutical compounds
 large and small target molecules
 immune therapies, vaccines, vectors, adjuvants
 generics, biosimilars
 Various other compounds
 Supportive drugs: myelosuppression, anaemia, pain, cachexia, etc
 Others: diagnostics, devices, etc
 Complex or special study designs
 Strict inclusion/exclusion criterias, short timelines,
pressure on costs
 Competitive trials
 Demanding patient populations

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
SOLUTIONS TO HANDLE COMPLEXITY
 Professional environment dedicated to Early Phase trials
 Infrastructure
• Phase I Unit (CPU)
• Satellite Sites within high patient access institutions
• External sites
 Resources
• Clinical teams (medics, nurses, lab technicians)
• Site and study coordinators, project managers
• Feasibility, regulatory, functional services
 Proper experience both in development phase and therapeutic
indication (clinical and pharmacological)
 Adaptive, flexible, service oriented attitude to find optimal solutions
 Networking skills (KOLs, sites, referrals, patient groups)
 Strong vendor management
 Regulatory intelligence

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
PATIENT ACCESS SOLUTIONS
Large Academic
centers
Competitive
trials
Innovative value
expected to be
high
SMOs with Early
Phase
experience
Limited
selection
CPU internal
efforts
Efficiency
issues
External/satellite
sites in proximity
to CPU
Limitations in
recruitment
could still
happen
Inclusion of
additional
geographic
areas
Business
environment
(regulatory,
contracting,
etc..)
Quality and
logistical
aspects
Cost/benefit
estimations

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
SGS CLINICAL PHARMACOLOGY UNIT
IN PATIENT TRIALS
 Largest CPU in Belgium designed for HV and special
population trials
 Center of EP excellence
 Special infrastructure (pharmacy, viral challenge unit)
 88 beds, high number of subject visits on a daily basis
 Logistics and operations developed for mass workload
 Dedicated SMO group to support recruitment in PTs
 Database development
 Advertising campaigns
 Networking with referrals and patient associations
 Solid access to patients in common chronic medical conditions
 Renal impairment
 Chronic respiratory diseases (COPD, asthma) etc..

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
OUR SATELLITE /PATIENT SITE MODEL
 Cooperation with hospitals to create/facilitate Phase I patient
units
 MSA agreement
 Direct access to patient pools of selected indications via close
in-house cooperation with specialists
 Partnership and support
 Operational excellence and complete control over clinical
execution
 SGS SOP package for proper know-how and transparency
 SGS key medical staff to ensure quality in operation
 “Extension of CPU”
 Access to CPU capabilities, know-how, staff, services
 Pan European Model
 Belgium network (AZSM, Jesse)
 CEE network (Hungary, Poland, Czech)

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
SGS SATELLITE / PATIENT CENTERS
BELGIUM / HUNGARY
 In operation: AZ St Maarten, Mechelen, Belgium
 8 beds
 Access to pharmacy, lab, imaging, emergency, catering, ...
 Physicians collaborate as Sub-I or PI
 Study conducted by SGS staff
 Therapeutic areas
• Nephrology, Hepatology, GI, Immunology, Oncology, Pneumonology,
Endocrinology, Dermatology, Neurology, Neuro surgery, Vascular surgery
 CEE Pilot : National Central Military Hospital, Budapest, Hungary
 5 beds (linked to Department of Oncology)
 SGS employed medical team (CRP,SN) present, SGS SOPs
 Coordinating site in local networking (access to further sites)
 Transparent regulatory environment
 Developed business service background
 Therapeutic areas
• Oncology, Nephrology, Neurology, Rheumatology, Dermatology, etc…

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
SUBCONTRACTED PARTNER MODEL
 Select and subcontract recruitment expert external CROs
 As additional or alternative solution
 Flexibility to increase access to patients
 Added value: expertise in special indication or in geographic
location where recruitment potential is beneficial enough
 Proper proactive control is key in success
 Partnership type long term cooperation is preferred

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
TAKE HOME MESSAGES
 Patient trials in EP are significant and further short and middle
term increase is expected
 There is a very colorful palette of EP trials – even the best
single operational model will not be able to manage them
alone
 Flexible/adaptive and service orientated attitude is needed to
find optimal solutions
 Building up some models – like the satellite centre one in our
case – needs strategic thinking and significant investments but
can effectively fulfill sponsor demands

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ADDED VALUE IN CLINICAL TRIALS

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EXPERIENCE & THERAPEUTIC AREA

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FACILITIES

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PATIENTS RECRUITMENT

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SINT MARTEEN & SGS SUPPORTING PHYSICIANS

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
Life Science Services Istvan Udvaros MD MSc
Medical Director Clinical Research
Project Director Oncology
SGS Belgium NV Phone: + 32 (0)15 28 30 46
Generaal De Wittelaan 19A, Fax: + 32 (0)15 27 32 50
B-2800 E-mail : istvan.udvaros@sgs.com
Mechelen
Belgium Web : www.sgs.com/lifescience
THANK YOU FOR YOUR ATTENTION
+ 41 22 739 9548
+ 1 866 SGS 5003
+ 65 637 90 111
+ 33 1 53 78 18 79
+ 1 877 677 2667
+ 33 1 41 24 87 87

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
QUESTIONS ?

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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015