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Mentlife Niclas lindqvist - Career in Life sciences

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Mentlife Niclas lindqvist - Career in Life sciences

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Mentlife Niclas lindqvist - Career in Life sciences

  1. 1. Impress in Impress in 3,9 seconds
  2. 2. 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, Product Specialist Pharmacovigilance, Regulatory Officer, Medical info, Medical writer, QA and more… • What do they do? • 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 the 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
  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. ”an exciting risky alternative?”
  5. 5. 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
  6. 6. OTHERMARKETING SALES MEDICAL A ”company” Keep an eye on Recommended course
  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) GM OTHER Legal Admin HR Sales Excellence OBS: Med- LabTech Communication Nurse Advisor Customer Serv. Mgr
  8. 8. 2.5 Undantag från prov i Medicinsk grundutbildning Undantag från kravet om medicinsk grundutbildning gäller för person som har läkarexamen, tandläkarexamen, apotekarexamen, sjuksköterska/barnmorskeexamen, receptarieexamen, biomedicinarexamen. För övriga utbildningar hänvisas till flödeschemat nedan, observera dock att grundkravet är en utbildning på 180 hp.
  9. 9. 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) GM OTHER Legal Admin HR Sales Excellence OBS: Med- LabTech Communication Nurse Advisor Customer Serv. Mgr MGU
  10. 10. 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 IMA GPV GRA GDP GMP GCP LEAN
  11. 11. 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…
  12. 12. 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
  13. 13. R & D - Positions 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/ GCP GMP
  14. 14. Medical Scientific Liaison – Medical Manager – Scientific Advisor – Medical Advisor – Scientific Liaison
  15. 15. You are here Offentlig/Privat Sälj & Marknad Kommun Produktion/forskningLandstingStat • Miljö • Provtagningar • Avfall • Energi • Vatten • Markpåverkan • LMV (MPA) • Livsmedelsverket • FOI Försvaret • SMI Smittskydd • FHI Folkhälsoinstitut • SoS • Naturvårdsverket • SLU • Kemikalieinspektionen’ • ECDC Disease prev. • SBU Med. utvärdering • NEPI Läkemedelsepi. • TLV Förmånsnämnden • Cytolog • Patolog • Mikrobio • Kemlab • Servicetekniker • Producerande företag (ex vis Mejeri etc) • Egenvård • BioTech, Läkemedel • Kemist läkemedel • Projektledare • Konsultbolag Lab-Tech Bio-Tech Med- Tech OTC Säljare, produktspecialist, KAM, MSL, PC, Advisor, Projektledare, Medical writer, Medical info, Affärsutvecklare, Prövningar, PV, QA, Reg Läkemedel * * Folkhälsomyndigheten Akademin
  16. 16. 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, Product Specialist Pharmacovigilance, Regulatory Officer, Medical info, Medical writer, QA and more… • What do they do? • 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 the 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
  17. 17. LIFs Etiska regelverk Niclas Lindqvist
  18. 18. Alkohol: Måttfullhet gäller ej sprit,
  19. 19. INFORMATIONS- GRANSKNINGSMANNEN NBL SEK > 60 000 INDUSTRY Penalties INDUSTRY Marketing mtrl
  20. 20. IMA at www.lakemedelsakademin.se
  21. 21. 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:
  22. 22. Let´s have a look at some advertising …and decide: Good, Bad or Illegal?
  23. 23. Good, Bad or Illegal?
  24. 24. TREO: The pain killer Good, Bad or Illegal?
  25. 25. Good, Bad or Illegal?
  26. 26. Good, Bad or Illegal?
  27. 27. Conference location: OK or not?
  28. 28. 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 %
  29. 29. 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
  30. 30. Blood pressure • NNT=280 • 5 years Smoking cessation • NNT=14-28 • 3 months • ~ 40 different diseases 200-4000 x more effective to treat smoking instead of hypertension Källa: Per Åke Lagerberg samt SBU
  31. 31. http://service.lif.se/etikfragor
  32. 32. 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, Product Specialist Pharmacovigilance, Regulatory Officer, Medical info, Medical writer, QA and more… • What do they do? • 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 • Critical reviewing of the scientific article • Health Economy 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
  33. 33. Critical Reviewing
  34. 34. PubMed Facts 2016 • 5 600 journals in 40 languages •  22 million articles • Up to 4 000 articles per day Source: MEDLINE Fact Sheet 2016. The U.S. National Library of Medicine. Maryland, 2016. Less than 15 % fullfills the lowest acceptable standard
  35. 35. Ship Doctor James Lind: Frigate Salisbury • n=6 patients with scurvy • Alternatives: cider, vitriol drops, vinegar, sea water, orange juice/lemons and nutmeg. • Treatment duration: 2 weeks • Result: ”oranges and lemon were the most effectual remedies for this distemper at sea” Treaties on Scurvy 1753 How did it all start?
  36. 36. Archie Cochrane (1909–1988) 1962 EBM Evidence Based Medicine
  37. 37. Questions we have to ask: • Publication Bias / Selective Reporting / Duplicate Publication • Positive studies? • WHO has sponsored and WHY? • Peer reviewed? • Reference list? • Prospective – Retrospective • Design: - Observational - Randomized - Meta analysis • Explorative or hypothesis – driven? • How did they recruit the patients … and where? • …more
  38. 38. Open Blinded Double Blinding Triple Blinding
  39. 39. Different clinical studies Cohort-studie Patient not chosen at random Chosen due to exposure of a risk factor. E.g smoking and cardiovascular disease Case-control Patients with certain illness vs. other patients or individuals from a population. To find risk factor. Cross- section Individuals (patients or healthy) are chosen. Data collection at a certain time - Retrospective Case Report Report from one (or a few) patient(s) - Randomized controlled trial with a ”large” number of patients - Randomized controlled trial with ”small” number of patients - Non randomized trial with contemporary control-patients - Non randomized trial with non contemporary control-patients
  40. 40. This is how it should look like: ”Head to Head”
  41. 41. Study designs I T1 T2 T4T3 Tf T1 T2 T4T3 Tf T1 T2 T4T3 Tf Observation Parallell - Factorial?
  42. 42. Study designs T1 T2 T4T3 Tf T1 T2 T4T3 Tf Cross over
  43. 43. T1 T2 T4T3 Tf T1 T2 T4T3 Tf Endpoint Primary Secondary Combined?
  44. 44. First trap
  45. 45. Where did all go?
  46. 46. Matched?
  47. 47. niclas@svenskmedicin.se

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