BioMedical Strategy - Regulatory Presentation

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Regulatory Affairs:
A Multi-Task Approach

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  • 1. ‫ודיאגנוסטיקה:‬‫מכשור רפואי ודיאגנוסטיקה:‬ ‫תקינה‬ ‫אנליזה וניתוח חברות ‪Health Care‬‬
  • 2. Regulatory Affairs: R l t Aff iA Multi-Task Approach Orna Oz, PhD BioMedical Strategy (2004) LtdRegulatory & Clinical Affairs Group Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 3. Regulation Key Role in Due Diligence and d Market propositionStepwise Increase in Company Valuation Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 4. BioMedical Strategy (2004) Ltd Clinical & Regulatory Affairs GroupFounded by:Gal Ehrlich Ami Eyal & Orna Oz Ehrlich,The Team:Scientists experts inClinical & Regulatory Affairs Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 5. ‫01/6/9‬ ‫• אולטרה שייפ קיבלה חיזוק: הטיימס שלח כתב עד ליוקנעם, המניה‬ ‫מזנקת %05 .‬ ‫בכתבה מגדיר הכתב את החברה כ"עמק הסיליקון של היופי הטכנולוגי ."המנכ"ל אסף‬‫איל ל" :‪-Bizportal‬החדשות הגדולות של החברה הגיעו אתמול, כאשר ה ‪-FDA‬הודיע על‬ ‫אישור הליך המזורז‬ ‫01/01/81‬ ‫• אולטרה שייפ זינקה ב-%82; עד תחילת נובמבר צפויה להגיע‬ ‫תשובת ה-‪ FDA‬למוצר ההרזייה‬ ‫ל‬ ‫01/01/13‬ ‫• אולטרה שייפ צללה: ה ‪-FDA‬לא העניק אישור למכשיר ההרזייה של‬ ‫החברה‬ ‫אכזבה למשקיעי אולטרה שייפ לאחר המתנה של שלושה חודשים, אתמול הודיע מנהל‬ ‫המזון והתרופות בארה"ב כי הוא דורש הבהרות ונתונים נוספים בטרם אישור מכשיר‬ ‫ההרזייה, הקונטור 1‬ ‫אנליזה וניתוח חברות ‪Health Care‬‬ ‫0102 ‪January‬‬
  • 6. How does it start? Technology T h l Medical M di l need dScientifically Clinical use of based core rationales technology & Use of Benefits of clinical use and expected p valid t l lid tools clinical outcome Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 7. Medical Product Project Assessment• Medical need• Technological solution• Market Analysis• Patentability• Feasible markets and competitors• Survey on scientific evidence S e o cie tific e ide ce• Regulatory and Reimbursement• Funding F di Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 8. Medical Device Definition D fi i i• an instrument apparatus … implant in instrument, apparatus, implant, vitro reagent, or other similar or related article, article including a component part or part, accessory• Used for the diagnosis treatment or prevention of diagnosis, disease or condition and that• Affects the structure or function of the body• Does not achieve its function through chemical action• Is not metabolized to achieve effect Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 9. Medical Device Examples E l Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 10. Main Target Markets gEU USA Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 11. US MarketFood DF d & Drug Ad i i t ti Administration Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 12. FDA is part of the Public HealthService (PHS) within the Department ofHealth and Human Services (HHS).FDA is headed by a commissionerappointed by the President with Senateconsent.consent Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 13. Food & Drug Administration Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 14. FDA/CDRH FOCUS(Center for Devices and Radiological Health) Ensuring that medical devices are “reasonably” safe and effective reasonably Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 15. Types of FDA Regulated Products P d t• Medical Devices (including IVD) & Radiation Emitting Products - Center for Devices & Radiological Health CDRH• Drugs- Center for Drugs Evaluation & Research• Biologics- Center for Biologics Evaluation & Research• Combination Products- Office of Combination Products• Food and Cosmetics- Center for Food Safety & Applied Nutrition• Animal feed and Drugs- Center for Veterinary Medicine Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 16. Premarket Life Cycle y US market as an example Quality Assurance Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 17. Project Milestones• Claim – Intended Use & Indications• Project Initiation –Requirements Proof of Concept• Regulatory Strategy• Product Specification and Risk Analysis p y• R&D Plan (development and V&V)• Ongoing Development g g p •Quality System• Design Freeze •Manufacturing• Pre clinical Verification &Validation• Premarket Clinical Investigation• Submission for market clearance/approval• Post-market activities (clinical study/ies) Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 18. Regulatory Strategy • Regulatory Classification and existing similar marketed devices • P Pre-clinical Testing li i l T i • Clinical Strategy (pre and post market) • Discussion and recommendations•Re-assess intended use and/or indications for use•Re-assess technological (engineering) approach and R&D plan•Re-assess business plan – designated product, timelines and budget Alternative approaches Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 19. Claim / Intended UseIntended Use: What is being done Sometimes where it is being done Sometimes why it is being done Indications: Diseases Patients P ti t Subsets Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 20. ClaimIntended Use & Indications For UseDesign Specifications Test Plan to Verify andRegulatory & Clinical Validate Claim V lid t Cl istrategies (including targetmarkets)) 1. Bench T ti 1 B h Testing 2. Animal Testing 3. Clinical Data Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 21. Regulatory Implications of Claim SPECIFICITY LEVEL1. Identification of function Tool Claim2. Identification of tissue type an organ system or (higher clinical Identification of a specific evidence)) organ3. Identification of a particular disease or target population4. Identification of an effect on clinical outcome Clinical Claim Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 22. Regulatory Implications of Claim SPECIFICITY LEVEL Tool vs. Clinical – Cardiac Pacing DevicesTool:The Frontier Biventricular Cardiac Pacing System isindicated for maintaining synchrony of the left andright ventricles in patients who…….Clinical:Cli i lThe InSync model 8040 pulse generator is indicated forthe reduction of the symptoms of moderate to severeheart failure (NYHA Functional III or IV) in thosepatients who……. Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 23. Claim / Intended Use GENERAL VS. SPECIFIC INTENDED USEThe claim(s) for a device can be general or specific.When deciding the claims for the device it is gimportant to consider not only the marketing goalsbut also the regulatory process.Examples of General vs. Specific Use: Skin resurfacing vs. Wrinkle removal vs Evaluation of soft tissue vs. Aid in differentiation of benign from malignant breast lesions g g Cut/coagulate soft tissue vs. Photorefractive keratectomy (PRK) for myopia Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 24. Claim / Intended UseGENERAL VS. SPECIFIC INTENDED USE Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 25. Classification – Risk Based User/Pt g MitigationEnvironment RISK Generic type Circumstances Claim Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 26. ClassificationClass I (Low Risk) ~45%Examination gloves, Sunglasses, Instruments forgeneral use (scalpels), Diagnostic Stethoscope trol Level of ContClass II (Med. Risk) ~47%Vital signs monitors, Ventilators, Infusion pumps, oIncubators, MRI, US LClass III (High Risk) ~8Coronary Stents, Heart Valves, Pacemakers, Implantable Lenses,new and untested technologies, life-supporting or sustaining…. Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 27. Regulatory Pathway g y yThe class to which the device is assigned determines (amongother things) the type of the required regulatory pathwayand premarketing application:ExemptE Class I Cl510(k) ( ) Class I or II (Non exempt) ( p) Class III preamendments device (on the market prior to 1976, or substantially equivalent to such a device) and PMAs have i l h d i ) d PMA h not been called forPMA Class III Cl Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 28. CDRH’s Risk Based Paradigm gClass I Class II Class III Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 29. Regulatory Pathway g y yDe Novo 510(k) (after re-evaluation of an automatic ( )(class III designation) – NSE & Lower Risk device orthat contemplates “Similar Technologies” and riskprofile.HDE “medical device intended to benefit patients in medicalthe treatment or diagnosis of a disease or conditionthat affects or is manifested in fewer than 4,000 ,individuals in the United States per year.” Similar toa premarket approval (PMA) application, but exemptfrom the effectiveness requirementsf h ff i i Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 30. Regulatory Implications of Claim DIAGNOSIS VS. MONITORING BLADDER CANCER KIT THE UROVYSION BLADDER CANCER KIT (UROVYSION KIT) IS DESIGNED TO DETECT ANEUPLOIDY FOR CHROMOSOMES 3, 7, 17 AND LOSS OF THE 9P21 LOCUS VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN URINE SPECIMENS FROM PERSONS WITH HEMATURIA PMA SUSPECTED OF HAVING BLADDER CANCER RESULTS SUSPECTED OF HAVING BLADDER CANCER. FROM THE UROVYSION KIT ARE INTENDED FOR USE, IN CONJUNCTION WITH AND NOT IN LIEU OF CURRENT STANDARD DIAGNOSTIC PROCEDURES, AS AN AID FORUroVysion Kit AS AN AID FOR INITIAL DIAGNOSIS INITIAL DIAGNOSIS OF BLADDER CARCINOMA IN PATIENTS WITH HEMATURIA AND SUBSEQUENT MONITORING FOR TUMOR RECURRENCE IN PATIENTS PREVIOUSLY DIAGNOSED WITH BLADDER CANCER. 510(K) THE UROVYSION BLADDER CANCER RECURRENCE KIT (UROVYSION KIT) IS DESIGNED TO DETECT ANEUPLOIDY FOR CHROMOSOMES 3, 7, 17, AND LOSS OF THE 9P2L LOCUS VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN URINE SPECIMENS FROM SUBJECTS WITH TRANSITIONAL CELL CARCINOMA OF THE BLADDER. RESULTS FROM THE UROVYSION KIT ARE INTENDED FOR USE AS A NONINVASIVE METHOD FOR MONITORING FOR TUMOR RECURRENCE IN CONJUNCTION WITH CYSTOSCOPY IN PATIENTS PREVIOUSLY DIAGNOSED WITH BLADDER CANCER. Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 31. Regulatory Implications of Claim DIAGNOSIS VS. MONITORING THE UROVYSION BLADDER CANCER KIT (UROVYSION KIT) IS DESIGNED TO DETECT ANEUPLOIDY FOR CHROMOSOMES 3, 7, 17 AND LOSS OF THE 9P21 LOCUS VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN PMA URINE SPECIMENS FROM PERSONS WITH HEMATURIA SUSPECTED OF HAVING BLADDER CANCER. RESULTS FROM THE UROVYSION KIT ARE INTENDED FOR USE, IN CONJUNCTION WITH AND NOT IN LIEU OF CURRENT STANDARD DIAGNOSTIC PROCEDURES, AS AN AID FORUroVysion Kit INITIAL DIAGNOSIS OF BLADDER CARCINOMA IN PATIENTS WITH HEMATURIA AND SUBSEQUENT MONITORING FOR TUMOR RECURRENCE IN PATIENTS PREVIOUSLY DIAGNOSED WITH BLADDER CANCER. 510(K) ( ) THE UROVYSIONBLADDER CANCER RECURRENCE BLADDER CANCER KIT (UROVYSION KIT) IS DESIGNED TO DETECT ANEUPLOIDY FOR CHROMOSOMES 3, 7, 17, AND LOSS OF THE 9P2L LOCUS VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN URINE SPECIMENS FROM SUBJECTS WITH TRANSITIONAL CELL CARCINOMA SUBJECTS WITH TRANSITIONAL CELL CARCINOMA OF THE BLADDER. OF THE BLADDER. RESULTS FROM THE UROVYSION KIT ARE INTENDED FOR USE AS A NONINVASIVE MONITORING FOR TUMOR RECURRENCE METHOD FOR MONITORING FOR TUMOR RECURRENCE IN CONJUNCTION WITH CYSTOSCOPY IN PATIENTS PREVIOUSLY DIAGNOSED WITH BLADDER CANCER. Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 32. 510(k) Determination of SEDemonstration that a new device is substantially yequivalent to a legally marketed device (i.e., marketedbefore May 28, 1976 or marketed after that date andwas f found substantially equivalent through the d b i ll i l h h h510(k) process). Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 33. 510(k) SE DeterminationA device is substantially equivalent if, in comparisonto a legally marketed device it:has the same intended use; ANDhas the same technological characteristics as the legallymarketed device, ORhas different technological characteristics, andsubmitted information does not raise new questions of qsafety and effectiveness, and it demonstrates that thedevice is as safe and as effective as the legally marketedd idevice. Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 34. 510(k) SE D t Determination i tiRef: 2010 RAPS Annual Conference, Christy Foreman, Acting Director, Office of Device Evaluation, FDA Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 35. 510(k) SE D Determination i iRef: 2010 RAPS Annual Conference, Christy Foreman, Acting Director, Office of Device Evaluation, FDA Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 36. 510(k) SE D t Determination i tiRef: 2010 RAPS Annual Conference, Christy Foreman, Acting Director, Office of Device Evaluation, FDA Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 37. 510(k) SE D t Determination i tiRef: 2010 RAPS Annual Conference, Christy Foreman, Acting Director, Office of Device Evaluation, FDA Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 38. PMA (Premarket Approval)Class III devices which require an approved PMAapplication to be marketed include: High Risk devices which by regulation require a PMA New devices for which substantial equivalency cannot be determined Could undergo a down classification (de Novo 510(k)) – risk based decision Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 39. Marketing Submissions While 510(k) devices must only demonstrate that there are as safe and as effective as a similar device already marketed PMA devices must demonstrate, on their own merit, safety and effectiveness through valid scientific evidence. Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 40. De Novo 510(k) ( )If FDA determines the device is not substantiallyequivalent (NSE), the applicant may: resubmit another 510(k) with new data, file a petition to reclassify the device (i.e., request review under section 207 of the FDAMA) OR FDAMA), submit a PMA application. Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 41. SR vs. NSR Devices• For the purpose of clinical investigationSignificant Risk (SR) – …presents a potential forserious risk to the health safety, or welfare of a subject… safety subjectIs for a use of substantial importance in diagnosing, curing,mitigating, or treating disease……NonN SR (NSR) – d not pose a significant risk t the do t i ifi t i k to thhuman subjects.• SR devices undergo FDA approval (IDE) prior to initiating clinical investigations in the US• Relevant to 510(k) and PMA classified devices Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 42. Marketing Submissions g DEVICE USER FEE FOR FY 2011 Type of Application Standard Small Fee Business* B i * PMA $236,298 $236 298 $59,075 $59 075 180-Day Supplement $35,445 $8,861 Real Time Supplement $16,541 $4,135 510(k)’s 510(k)’ $4,348 $2,174*S*Small Business: (≤$100 million i annual sales) ll B i illi in l l ) Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 43. Device Approval in Europe CE M ki Marking Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 44. Device Approval in Europe Relevant Authorities R l A h i i• Member State of the European Union is any one of the 27 sovereign states that have acceded to the European Union (EU)• Competent Authority has the authority to act on behalf of the government of the Member State to ensure that the requirements of the Medical Device Directives are transposed into National Law and are applied• The Notified Body (NB) is a private, commercial testing laboratory or certification organization approved by the y g pp y Competent Authority in the Member State in which they have their head-office to carry out some or all of the Conformity Assessment procedures in the medical device directives. Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 45. Device Approval in Europe EC Di Directives i• Medical Devices are regulated by the EC Directives: – the Active Implantable Medical Device (AIMD) Directive - 90/385/EEC – the Medical Device Directive (MDD) 93/42/EEC – the In Vitro Diagnostic Device Directive (IVD) - 98/79/EC. h I Vi Di i D i Di i / /EC – AIMD and MDD are now governed b the Amended Directive 2007/47/EC• Medical devices may be classified (risk based) as Class I, Class IIa, IIb and III• MEDDEV guidance documents Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 46. Device Approval in Europe• Within the scope of which Directive?• Classification (The classification rules are based on different criteria such as the duration of contact with the patient, the degree of invasiveness and the part of the body affected by the use of the device).• Conformity Assessment Route (design and manufacturing inspections, manufacturing ONLY, etc.) t )• Technical File (Contains all the relevant information to demonstrate that the product meets the Essential Requirements of the Directive) Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 47. Device Approval in Europe Declaration of C f D l i f Conformity iWe hereby declare that the distributed CE marked products,specified in the annexed product list, are covered by the "CEMarking of Conformity Certificate", reference g ynumber:.....CE.., issued on (date) and delivered by [NAMEOF NB], and conform to the required technicaldocumentation, in accordance with Annex ___of the "EC-DirectiveDirective", the Council Directive 93/42/EEC of 14 June 1993amended in September 2007, concerning medical devices.In addition we ensure and declare that the distributed CE addition,marked products, as mentioned and falling within Class XX,meet the provisions of the EC-Directive which apply to them. ………………………… . Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 48. Meeting the Regulatory Authorities A th iti Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 49. Meetings with FDA• P IDE: Pre IDE – Regulatory strategy: regulatory classification, test plan ( p (bench test methodologies animal g studies), clinical strategy – Prior to expanding clinical trials from feasibility to pivotal phase• Pre-PMA• Day 100 PMA meetings• Post-deficiency letter for 510(k) or PMA• Appeal a final decision on a PMA or 510(k) or an A l fi l d i i IDE disapproval• Agreement or determination meeting g g Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 50. In SummaryRegulatory Aff i i about claimingR g l t Affairs is b t l i i g and brandingIt is the umbrella that covers the Companyactivities from early development through y p gproduction and up to post-marketing activities. Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 51. Clinical Evidence Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 52. The Key to Market Penetration yA breakthrough technology is great but does notensureens re market s ccess successRegulatory approvals are meaningful milestones •In creating value for strategic agreements and funding •In entrance to the marketClinical evidence (data) is the leading forceto successful market penetration andpositioning Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 53. Clinical Strategy gy Post-market Post market. . .Study # 3Study #2 FIM Investigational/pre-market Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 54. Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 55. Key Players in Strategic Pl St t gi Planning i gA Multidisciplinary team from: Management Medical practice (SAB) Clinical Regulatory g y Biostatistical Marketing and Reimbursement R&D Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 56. Clinical StrategyNeed for premarket clinical data?• Yes - for a PMA route• No and Yes – for a 510(k) route No – all aspects of safety and effectiveness are covered by SE rationale and pre clinical performance tests Yes – There are still safety and efficacy aspects not proven by SE and pre clinical tests b d li i l Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 57. Clinical StrategyNeed for valid postmarket clinical data? Yes! For Postmarket surveillance (mainly for PMAs) For i F scientific publications ifi bli i For market penetration For reimbursement For F a revised intended use i di t d d Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 58. Hierarchy of Medical Scientific E id S i tifi Evidence Randomized Controlled Trial T i l Observational Trial Case-control Case control Cohort Descriptive study p y Physiologic study Case series Expert opinionRef: 2010 ICI Meeting, Andrew Farb MD Interventional Cardiology Devices Branch, Office of Device Evaluation Meeting Farb, MD, Branch Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 59. Clinical Strategy gy Premarket Phase• Pilot Pivotal OR One study• US and OUS sites/ investigators/data d it / i ti t /d t• Type of medical institute/s yp If hospitals – referral centers or others• Type of investigators Opinion leader, Experienced practitioner, Regular practitioner Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 60. Clinical Strategy gy Postmarket Phase• Postmarket surveillance (PMA) and long-term observations• First In Man (510(k)) - confirmatory/field• Market penetration• S i tifi publications Scientific bli ti• Reimbursement Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 61. Clinical Study Design Critical El C iti l Elements t• Type of study Single arm or randomized Equivalency (as good as) or Superiority (better than)• Study objectives and endpoints Safety, Safety Performance and/or Efficacy, Efficacy Usability, Quality of Life• Target population (Eligibility Criteria) Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 62. Critical Decisions in Study Management Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 63. Investigator SelectionOpinion Leader Availability Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 64. Site Selection IP Laws of CountryCosts Scientific PublicationsLocation /Market AvailabilityPersonnel &Facilities Regulatory Expected subjects eligibility subjects- Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 65. Financial AspectsCosts of clinical study are mainly based on: 1. Sample size (No of subjects) 2. The experimented procedure 3. Requested clinical assessments (i 3 R d li i l (imaging, l b i lab. tests, etc.) & medications 4. 4 Number of follow-up visits 5. Required site participating personnel 6. Requested presence of sponsor personnel q p p p (technical, clinical) 7. Costs for ethical committee 8. Hospital overhead 8 H it l h d 9. Monitoring, data management and analysis Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 66. Some Common Pitfalls• Bad study design• Inappropriate selection of sites and/or investigators• Incomplete and/or inappropriate study management tools (procedures, logs CRFs…)• Using under-qualified clinical research personnel ( p (sponsor and/or site) )• Poor compliance with GCP– not only necessary for regulatory reasons b also to reduce the company’s l but l d h ’ risk from potential adverse publicity and lawsuits Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 67. Study Management Monitoring Inadequate monitoring continues to be the top deficiency cited in FDA i d fi i i di inspections of sponsors i fR f B ildi g Q lit i t D i T il P t 2 – MRef: Building Quality into Device Trails, Part Marcarelli M Et l 2006 lli M. Etal, Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 68. Study Management Investigator Compliance The regulations require sponsors to bring noncompliant investigators into complianceR f B ildi g Q lit i t D i T il P t 2 – MRef: Building Quality into Device Trails, Part Marcarelli M Et l 2006 lli M. Etal, Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 69. To Sum UpValid Cli i l D t iV lid Clinical Data is a Composite Result of: C it R lt f(1) Team Work(2) Pre Pl P Planned Global Clinical Strategy d Gl b l Cli i l S(3) Well Designed St d /i W ll D i d Study/ies(4) Closely controlled implementation Health Care ‫אנליזה וניתוח חברות‬ January 2010
  • 70. Thank You!!!Moshe Aviv Tower, 34th, Floor7 Jabotinsky Street, Ramat GanE-mail: biomedical@ebms.co.ilTel: 03-6123281 Health Care ‫אנליזה וניתוח חברות‬ January 2010