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PATIENTS PHASE I CLINICAL TRIALS –
SECURED MULTI SITE MODEL FOR KEY
POPULATIONS RECRUITMENT
Dr. Istvan Udvaros
Medical and...
2
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
PHASE 1 TRIALS IN EU 2015 (OPEN,
INTERVENTIONAL) SOURCE WWW.C...
3
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
PATIENT TRIAL PHASE I MARKET IN EU 2015
 Belgium (47)
 Onco...
4
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
FROM LEAD COMPOUND TO PROOF OF
CONCEPT – THE SPONSOR PERSPECT...
5
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
THE CRO PERSPECTIVE
 Large number of request from stand alon...
6
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
SOLUTIONS TO HANDLE COMPLEXITY
 Professional environment ded...
7
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
PATIENT ACCESS SOLUTIONS
Large Academic
centers
Competitive
t...
8
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
SGS CLINICAL PHARMACOLOGY UNIT
IN PATIENT TRIALS
 Largest CP...
9
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
OUR SATELLITE /PATIENT SITE MODEL
 Cooperation with hospital...
10
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
SGS SATELLITE / PATIENT CENTERS
BELGIUM / HUNGARY
 In opera...
11
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
SUBCONTRACTED PARTNER MODEL
 Select and subcontract recruit...
12
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
TAKE HOME MESSAGES
 Patient trials in EP are significant an...
14
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
ADDED VALUE IN CLINICAL TRIALS
15
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
EXPERIENCE & THERAPEUTIC AREA
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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
FACILITIES
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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
PATIENTS RECRUITMENT
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SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
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...
20
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
QUESTIONS ?
21
SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015
Patients Phase I Clinical Trials – Secured Multi Site Model for Key Populations Recruitment
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Patients Phase I Clinical Trials – Secured Multi Site Model for Key Populations Recruitment

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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

Published in: Health & Medicine
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Patients Phase I Clinical Trials – Secured Multi Site Model for Key Populations Recruitment

  1. 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
  2. 2. 2 SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015 PHASE 1 TRIALS IN EU 2015 (OPEN, INTERVENTIONAL) SOURCE WWW.CLINICALTRIALS.GOV All With patients
  3. 3. 3 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
  4. 4. 4 SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015 FROM LEAD COMPOUND TO PROOF OF CONCEPT – THE SPONSOR PERSPECTIVE
  5. 5. 5 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
  6. 6. 6 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
  7. 7. 7 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
  8. 8. 8 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..
  9. 9. 9 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)
  10. 10. 10 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…
  11. 11. 11 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
  12. 12. 12 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
  13. 13. 14 SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015 ADDED VALUE IN CLINICAL TRIALS
  14. 14. 15 SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015 EXPERIENCE & THERAPEUTIC AREA
  15. 15. 16 SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015 FACILITIES
  16. 16. 17 SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015 PATIENTS RECRUITMENT
  17. 17. 18 SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015 SINT MARTEEN & SGS SUPPORTING PHYSICIANS
  18. 18. 19 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
  19. 19. 20 SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015 QUESTIONS ?
  20. 20. 21 SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015

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