mentlife niclas lindqvist - career in life sciences

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The job behind the title– Life Science careers explained

The Pharmaceutical-, Biotech- and Medical Deviceindustry and its positions

Medical Scientific Liaison, Sc.Advisor, Medical Advisor, Product Specialist Pharmacovigilance, RegulatoryOfficer, 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

Medical Scientific Liaison, Sc.Advisor, Medical Advisor, Pharmacovigilance, RegulatoryOfficer, Medical info, Medical writer, QA, Product Manager, Product Specialist and more…

”an exciting risky alternative?”

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

futureLack of

knowledge

OTHERMARKETING SALES MEDICAL

A ”company”

Keep an eye onRecommended

course

http://www.google.se/url?sa=i&rct=j&q=medical&source=images&cd=&cad=rja&docid=E271XQ8gZQaNFM&tbnid=wsH1YWLL3TuJUM:&ved=0CAUQjRw&url=http://www.seoclerks.com/imagedb/3349/Medical&ei=U2pmUYXEJ6ji4QS-s4GoDg&bvm=bv.45107431,d.bGE&psig=AFQjCNHGZCH4B92hh6uhQPqm9ZYU9Uh8cg&ust=1365752776406548

http://www.google.se/url?sa=i&rct=j&q=marknadsf%C3%B6ring&source=images&cd=&cad=rja&docid=Ch031aERDoiTUM&tbnid=f_U6Y94O4UR73M:&ved=0CAUQjRw&url=http://internetworld.idg.se/2.22603/&ei=i2pmUdDQCsqs4ATg1oDwAw&bvm=bv.45107431,d.bGE&psig=AFQjCNFmq_GNRrN44ED2xSuPBrZiE7gUvA&ust=1365752822232508

http://www.google.se/url?sa=i&rct=j&q=f%C3%B6rs%C3%A4ljning&source=images&cd=&cad=rja&docid=q7IH3edSFfBfzM&tbnid=5hAIabLaDkxT7M:&ved=0CAUQjRw&url=http://oriflamebloggen.blogspot.com/2012_03_01_archive.html&ei=IG9mUY2dFeaH4ASCqoCgBg&bvm=bv.45107431,d.bGE&psig=AFQjCNEW9y-ioWaQorKR5PM1npjuVFbyAw&ust=1365753987658259

http://www.google.se/url?sa=i&rct=j&q=advokat&source=images&cd=&cad=rja&docid=hq-E4VfZlwLDlM&tbnid=Bnn8qzYhPCfx1M:&ved=0CAUQjRw&url=http://www.floien.com/&ei=l29mUaurC4iw4QSXl4GQDA&bvm=bv.45107431,d.bGE&psig=AFQjCNFp5dbhaewiGczmyJVY25bp8ylEIQ&ust=1365754102059601

MARKETING SALES

Commercial Manager

Business Unit Director (BUD)


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/

MG

U

No

ne

LIF

Digital Marketeer

Project Leader(s)

GM

OTHER

Legal

Admin

HR

Sales Excellence

OBS: Med- LabTech

Communication

Nurse Advisor

Customer Serv. Mgr

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.

MARKETING SALES

Commercial Manager





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/

MG

U

No

ne

LIF

Digital Marketeer

Project Leader(s)

GM

OTHER

Legal

Admin

HR

Sales Excellence

OBS: Med- LabTech

Communication

Nurse Advisor

Customer Serv. Mgr

MGU

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 GRAGDP

GMP

GCP

LEAN

PRECLIN PHASE I PHASE II PHASE III PRESEN-TATION

PUBLICATION

INDICATIONREIMBURSE

MENTPATENT-exp

GENERICS

Sales window

PHASE IV PHASE IVNEW

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…

PRECLIN FAS I FAS II FAS III PRESEN-TATION

PUBLIC-ATION

INDICA-TION

REIMBURSEMENT

PATENT-Exp GENERICS

Sales window

FAS IV FAS IVNew

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

CRACRAProduct Mgr

KAM

PS

Project Leader(s)

CRA

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

Medical Scientific Liaison – Medical

Manager – Scientific Advisor –

Medical Advisor – Scientific Liaison

You are here

Offentlig/Privat

Sälj & MarknadKommun 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








• Health Economy





LIFs Etiska regelverkNiclas Lindqvist

Alkohol:

Måttfullhet gäller ej sprit,

INFORMATIONS-

GRANSKNINGSMANNEN

NBL

SEK > 60 000

INDUSTRY

PenaltiesINDUSTRY

Marketing mtrl

IMA at www.lakemedelsakademin.se

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:

Let´s have a look at some advertising…and decide: Good, Bad or Illegal?

Good, Bad or Illegal?

TREO: The pain killer


Conference location: OK or not?

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 – 6ARR = 2 %

RRR = (8 – 6) / 8RRR = 25 %

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 100ARR

http://www.sbu.se/sv/Evidensbaserad-vard/Ordlista/#riskreduktion

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

http://service.lif.se/etikfragor









• Health Economy




Critical Reviewing

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

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?

Archie Cochrane

(1909–1988)

1962

EBM

Evidence Based Medicine

http://www.google.se/imgres?imgurl=http://medvetenskap.files.wordpress.com/2008/10/cochrane-collaboration-johannesort.jpg&imgrefurl=http://medvetenskap.wordpress.com/category/alternativmedicin/&usg=__UYP2wYBXowPhBgrbt0GlrEmZtcY=&h=372&w=583&sz=187&hl=sv&start=16&tbnid=D4nD86i3fAUZyM:&tbnh=86&tbnw=134&prev=/images?q%3Dblindning%2Bbilder%26ndsp%3D18%26hl%3Dsv%26sa%3DN

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

OpenBlinded

Double BlindingTriple Blinding

Different clinical studies

Cohort-studiePatient not chosen at randomChosen due to exposure of a risk factor. E.g smoking and cardiovascular diseaseCase-controlPatients with certain illness vs. other patients or individuals from a population. To find

risk factor.Cross- sectionIndividuals (patients or healthy) are chosen. Data collection at a certain time -

RetrospectiveCase ReportReport 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

This is how it should look like: ”Head to Head”

Study designs

IT1 T2 T4T3

Tf

T1 T2 T4T3Tf

T1 T2 T4T3Tf

Observation

Parallell - Factorial?

Study designs

T1 T2 T4T3Tf

T1 T2 T4T3Tf

Cross over

T1 T2 T4T3Tf

T1 T2 T4T3Tf

Endpoint

Primary Secondary

Combined?

First trap

Where did all go?

Mat

ched

?

[email protected]

mentlife niclas lindqvist - career in life sciences

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