ja.1 Being a Medical Statistician in the Pharmaceutical Industry

ja.2 Topics What is the Pharmaceutical/Pharma Industry?What is the Pharmaceutical/Pharma Industry? How do we develop drugs?How do we develop drugs? An example of how statisticians get involvedAn example of how statisticians get involved Opportunities, qualifications, my experienceOpportunities, qualifications, my experience SummarySummary

ja.3 What is the Pharmaceutical Industry? Develops medicinesDevelops medicines Successful and growing industrySuccessful and growing industry

ja.4 A few examples…

ja.5 Drug Development Process - Overview Aim: to gather enough evidence to prove that a drug is safe and effective for a particular disease.Aim: to gather enough evidence to prove that a drug is safe and effective for a particular disease. Developing a new medicine costs over $500 million and takes over 12 years.Developing a new medicine costs over $500 million and takes over 12 years.

ja.6 Drug Development Process DrugDiscovery Pre-clinical Clinical trials (people) Authorisation Sales & Marketing Manufacturing

7 Why is medical statistics is important – are doctors enough? "Smoking cigarettes causes lung cancer“ Since the first research showed that smoking was bad for you 60 years ago we have:  Flu jab, pace makers, kidney transplants, inhalers, polio/measles/mumps/ meningitis/rubella/ small pox vaccines  Test tube babies, cloning  Many many others…

8 Example of problem a statistician has to solve – Trial Design You have 2 drugs (Drug A and Drug B) and a placebo Which drug is better A or B? A B

9 Trial design options (9 patients) Option 1 No patients Visit 1Visit 2Visit 3 9Drug APlaceboDrug B No PatientsVisit 1 3Drug A 3Drug B 3Placebo Option 2

10 Trial design options (9 patients) No Patients Visit 1Visit 2Visit 3 3Drug ADrug BPlacebo 3 Drug ADrug B 3 PlaceboDrug A Option 3 Perfect! (multiple solutions of course)

ja.11 Key Skills for a Statistician Good communication and presentation skillsGood communication and presentation skills Can work well in a team and independentlyCan work well in a team and independently An eye for detailAn eye for detail Well organisedWell organised Logical thinkerLogical thinker

ja.12 How did I get here? A Levels – Maths and Stats, English and Music.A Levels – Maths and Stats, English and Music. BSc Maths and Stats - SouthamptonBSc Maths and Stats - Southampton MSc Statistics with Applications in Medicine – Southampton (only 6-7 course in UK)MSc Statistics with Applications in Medicine – Southampton (only 6-7 course in UK) Been working for 3-4 yearsBeen working for 3-4 years Worked across many areas including cancer, depression, optometry, MRI, schizophreniaWorked across many areas including cancer, depression, optometry, MRI, schizophrenia

ja.13 Why is it a great job? You are the expert, the specialist, the teacher.You are the expert, the specialist, the teacher. You work with top doctors, scientists, experts in fields, sales, academiaYou work with top doctors, scientists, experts in fields, sales, academia Always part of a teamAlways part of a team Never stop learningNever stop learning Massive varietyMassive variety Generous benefits and competitive salariesGenerous benefits and competitive salaries Opportunities for travelOpportunities for travel You make a real differenceYou make a real difference

ja.14 To Summarise... Applying your education to help improve health and save livesApplying your education to help improve health and save lives Growth industryGrowth industry Good career prospectsGood career prospects Make a differenceMake a difference

ja.15 BACK UP SLIDES

ja.16 Discovery/Pre-clinical Creating moleculeCreating molecule Testing in test tubes (on blood etc)Testing in test tubes (on blood etc) Animal testingAnimal testing Is it safe?Is it safe? Is it ready for humans?Is it ready for humans?

ja.17 In the Clinic - Phase I Small sample of healthy volunteers Volunteers are closely monitored How much should you take? How often should you take it? Do you take it with food? Can you take it with other drugs? Safety Safety Safety

ja.18 In the Clinic - Phase II and III First time drug is given to patientsFirst time drug is given to patients Aim to show the drug works - Does it do what it says on the tin?Aim to show the drug works - Does it do what it says on the tin? Usually larger than Phase I studiesUsually larger than Phase I studies Usually longer duration than Phase I studiesUsually longer duration than Phase I studies Licence applicationLicence application SafetySafety

ja.19 In the Clinic - Phase IV After the drug has been licensed for prescription by doctorsAfter the drug has been licensed for prescription by doctors To provide supporting data for further investigationsTo provide supporting data for further investigations MarketingMarketing