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Career in life sciences - Feb 9th, 2016

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Career in life sciences - Feb 9th, 2016

  1. 1. The job behind the title – Life Science careers explained The Pharmaceutical-, Biotech- and Medical Device industry and its positions Medical Scientific Liaison, Sc.Advisor, Medical Advisor, Pharmacovigilance, Regulatory Officer, Medical info, Medical writer, QA and more… • What do they do? • Is it fun? • How do you prepare a career in Life science? The seminar will also focus on three important areas for a career within Life Science: • Ethical Regulations • Health Economy • Critical reviewing of scientific article Niclas Lindqvist Molecular Biologist, >20 years as Brand Leader, Global Product Manager, Business Unit Director (Medhouse, More Medical) within recruitment and staffing in LifeScience sector. Certified coach and lecturer for Trygghetsstiftelsen, Trygghetsrådet, Omställningsfonden, Certified in OPQ. Owner of Svensk Medicin AB
  2. 2. Impress in Impress in 3,9 seconds
  3. 3. Medical Scientific Liaison, Sc.Advisor, Medical Advisor, Pharmacovigilance, Regulatory Officer, Medical info, Medical writer, QA, Product Manager, Product Specialist and more…
  4. 4. Why do not more people have interest in working in the LifeScience industry? n=173 worked >5 years in LifeScience 48 % 21 % 21 % Bad reputation Unsecure future Lack of knowledge
  5. 5. Do you like working in LifeScience industry? Very much Much Neither or Don´t like Definitely not like n=173 worked >5 years in LifeScience
  6. 6. OTHERMARKETING SALES MEDICAL A ”company” Keep an eye on
  7. 7. MARKETING SALES Commercial Manager Business Unit Director (BUD) Business Unit Director (BUD) Business Unit Manager (BUM) Business Unit Manager (BUM) Product Manager (OTC)Product Manager Sales Mgr KAM KAMKAM KAM PSPS PS PS Reg. Sales Mgr Reg. Sales Mgr Reg. Sales Mgr Business Developer Tender Manager Patient Advocacy Market Access Pharmacy Manager Health Economist Compliance officer LIF/MGU NoneLIF Digital Marketeer Project Leader(s) MD OTHER Legal Admin HR Sales Excellence OBS: Med- LabTech Communication Nurse Advisor Customer Serv. Mgr
  8. 8. MEDICAL Med. Dir Med. Affairs Manager Med. Advisor Medical Scientific Liaison Med. Info Labelling Med. AdvisorMed. Advisor Medical Scientific Liaison Medical Scientific Liaison Pharmacovigilance Regulatory Services Quality Med. Writer Research Dir CRA CRA CRO
  9. 9. R & D Biology: cell-, enzym-, micro-, genetics, biochem, tox, immuno, biochem, imaging, animaltech Chemistry: physical-, analytical-, medicinal-, process-, Clinical: CRA, CRO, CRS, CS, Clinical project managers http://www.hornonline.com/book s/life_science_sweden/ http://www.swedishlifesciences.se/
  10. 10. PRECLIN PHASE I PHASE II PHASE III PRESEN- TATION PUBLICATION INDICATION REIMBURSE MENT PATENT-exp GENERICS Sales window PHASE IV PHASE IV NEW INDICATION PARALLELIMPORT TENDER 4-5 yrs Weeks - yrs 1 day < 1 yrs < 1 yrs 10  13 years 15 1Number of molecules En produkts godkännandeprocess Revenue Costs Launching…
  11. 11. PRECLIN FAS I FAS II FAS III PRESEN- TATION PUBLIC- ATION INDICA- TION REIMBURSE MENT PATENT-Exp GENERICS Sales window FAS IV FAS IV New indication PARALLELIMPORT TENDER 4-5 år Veckor - 8 år 1 dag < 1 år < 1 år 10  13 år Med. Info Med. Advisor Medical Scientific Liaison Pharmacovigilance Regulatory Services Quality Med. Writer CRACRA Product Mgr KAM PS Project Leader(s) CRA
  12. 12. 
 Oncology ”Metabolic syndrome” Neurologic indications Antibiotics Vaccines Geriatric indications ? Primary prevention Diagnostics Asthma/COPD Autoimmune Cardiovascular GastroAuthoroties QA,PV, Reg
  13. 13. Health Economy
  14. 14. LIFs Etiska regelverk Niclas Lindqvist
  15. 15. INFORMATIONS- GRANSKNINGSMANNEN NBL SEK > 60 000 INDUSTRY Penalites INDUSTRY Marketing mtrl
  16. 16. Novartis: 790´ Grand Hotel Stockholm. Off label recommendation, 3 course dinner with wine ”an unfortunate avec with the coffee…due to lack of information from the hotel” Boehringer Ingelheim: 460´ Pre-launch Sifrol ”Soon Sifrol will be available…” AstraZeneca: 120´ ”Wow! How exciting. I have never kissed anyone with mononucleosis before” Let´s have a look at some cases:
  17. 17. Let´s have a look at some advertising …and decide: Good, Bad or Illegal?
  18. 18. TREO: The pain killer Good, Bad or Illegal?
  19. 19. Good, Bad or Illegal?
  20. 20. ARR & RRR (Eng. relative risk), detsamma som riskkvot (eng. risk ratio), RR. Risk (R) definieras som sannolikheten för att någon händelse sker under viss tid, . RR kan då vara kvoten (R i studiegruppen)/(R i kontrollgruppen), dvs. R(s)/R(k). Relativ riskminskning (RRR)=[R(k)-R(s)]/R(k) och absolut riskminskning (ARR) = R(s)-R(k). I epidemiologiska termer får man ersätta minskning med skillnad, men då talar man inte om RRR utan bara RR (och OR). a b 8 % 6 % a b 8 % 6 % ARR = 8 – 6 ARR = 2 % RRR = (8 – 6) / 8 RRR = 25 %
  21. 21. number needed to treat, antal personer som behöver behandlas för att, under viss angiven tid, en av dem sannolikt ska dra nytta av behandlingens gynnsamma effekt. Exempel: antalet personer som haft blodpropp och som behöver behandlas med ett visst blodproppshämmande medel för att en av dem ska undgå att åter få blodpropp. NNT är inverterade värdet av den absoluta riskreduktionen (se »riskreduktion). Exempel: Behandlingen under ett års tid minskar risken från 10 procent till 8 procent är den absoluta riskreduktionen 2 procent och NNT därmed 50. NNT a b 10 % 8 % eller 100 ARR
  22. 22. http://service.lif.se/etikfragor
  23. 23. Hälsoekonomi Beslutsfattare
  24. 24. Health Economy “The science of allocating limited resources to improve health”
  25. 25. Why do we need Health Economy? Consumption of medical care for the corresponding age
  26. 26. What have we won from new treatments? No new treatments since 1992 Actual
  27. 27. Why is health economy so difficult?
  28. 28. Best Care for the least amount of money…. Alternative 1 Alternative 2 Alternative 3 Alternative 4 How to use limited resources?
  29. 29. Två typer av studier: 1. Cost of illness - Tittar på kostnader för sjukdom. Ej alternativa kostnader 2. Hälsoekonomiska utvärderingar - Undersöker kostnadseffektivitet. Jämför olika alternativ avseende såväl kostnader som effektivitet Within trial…
  30. 30. More expensive and less efficacy Cheaper and less efficacy Cheaper and more effective More expensive and more effective COSTS EFFECTS TREATMENT A TREATMENT B COST 150 000 35 000 HOSPITAL COSTS 40 000 80 000 PRIMARY CARE COSTS 15 000 25 000 TOTAL 205 000 140 000 SURVIVAL 1,8 yrs 1,2 yrs Is that cost effective?
  31. 31. KOSTNADER - Direkta - In direkta EFFEKTER - Kliniska effektmått - Händelser - Överlevnad - QALY´s EFFEKT + LIVSKVALITÈ QUALITY ADJUSTED LIFE YEARS
  32. 32. Vi måste alltså veta patienternas livskvalité 1 0 Perfekt hälsa Värsta tänkbara hälsa QALYs = Vinsten i år x livskvalitén Exempel: Man lever i 20 år med stabil angina med en livskvalité på 0,8 20 x 0,8 = 16 QALYs
  33. 33. TREATMENT A TREATMENT B COST 150 000 35 000 HOSPITAL COSTS 40 000 80 000 PRIMARY CARE COSTS 15 000 25 000 TOTAL 205 000 140 000 SURVIVAL 1,8 yrs 1,2 yrs COST A – COST B EFFECT B – EFFECT A Is that cost effective?
  34. 34. Socialstyrelsen has the answer for us
  35. 35. Livskvalitet Svårt men viktig att mäta • + Mäter både positiva och negativa effekter • - Dåligt med standardiserade tester • - Risk för massignifikans pga. stort antal frågor • - Svårt med generalisering tvärs länder/kulturer
  36. 36. Critical Reviewing
  37. 37. The documentation behind a registration: 8 tonnes of paper
  38. 38. Questions we have to ask: • Duplicate publications / Selective reporting? • ”Referee journal” ? • WHO has sponsored and WHY?
  39. 39. This is how it should look like: ”Head to Head”
  40. 40. Where did all go?
  41. 41. Matched?
  42. 42. niclas@svenskmedicin.se

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