Drug-the Game Part III

D

As you have seen the pecha kuca from Prof G

I present mine in a much more low tech way. Drug-Game Part I, Drug-Game Part II

Why Does it take So Long to Develop a Drug For MSers

Find Out! Play…….Drug

So you all know the Rules, How much is it Going to Cost?

Alot



Whats on the Cards?




Financial Zone (FZ)

Charity Funding
Grant Funded-Role Dice For Amount
Grant Needs Rewriting-Try Again Next Turn

Grant Rejected
-Miss a Turn and Try Again
Grant Rejected-Return to Start
Not Enough Funds-Miss a Turn

Project funded byPhilantropists-Role Dice For Amount

Project funded byVenture Capitalist-Role Dice For Amount

Charity changes Priorities- Return to Start


Company Funding
(a)

Project Funded-Role Dice For Amount
Company Change Priorities. Drug Project Dropped. Go back to Charity Route

Company Merged. Drug Project Dropped. Go back to Charity Route

Company Merged. Drug Project Fast-Tracked: Role Dice for amount + Gain £2,000,000

Funded by Bad Profits Forcast-Role the Dice For Amount and Half-it.




Chemistry (Chem) Results

Drug has not Detectable Issues that Prevent Development--Proceed to Toxicology

Drug causes Degradation of Other Drugs-Drug Fails.Back to Start

Drug causes Degradation of Other Drugs-Need More Chemistry-Go Back to Microscope

Drug causes Mutations in cells.Drug Fails.Back to Start

Drug causes Mutations in cells-Need More Chemistry-Go Back to Microscope

Drug doesn’t work in EAE.Drug Fails.Back to Start

Drug doesn’t work in EAE.Need More Chemistry-Go Back to Microscope

Drug may cause tumour growth-Drug Fails.Back to Start

Drug may cause heart problem-Drug Fails.Back to Start

Drug may cause heart problem-Need More Chemistry-Go Back to Microscope

Drug can not be delivered using a Pill,-Use Injectable-Miss a turn & Proceed to Toxicology

Drug can not be delivered using a Pill, Drug Fails-Go Back to Start

Drug can not be delivered using a Pill, Need More Chemistry-Go Back to Microscope

Drug is rapidly Degraded. Drug Fails-Go Back to Start

Drug is rapidly Degraded. Need More Chemistry-Go Back to Microscope

Drug is rapidly Degraded. Need More Chemistry and EAE study-Go Back to Microscope/Mouse

Drug can’t get into Brain. Drug Fails-Go Back to Start

Drug can’t get into Brain. Need More Chemistry-Go Back to Microscope

Lawyers Did Not File Patent at Start. Competitor has Patent.Project Fails-Go Back to Start

Lawyers Did Not File Patent at Start. Now Filed. Extra £20 million at Completion

Patent Validity is Challenged. Win case Lose £100,000 and Proceed to Toxicology

Patent Validity is Challenged. Lose £100,000 and Go back to Start

Pharmaceutical company buys the drug-Use Company FZ

Pharmaceutical company buys the drug-Get £1,000,000 & Use Company FZ

Pharmaceutical company buys the drug-Get £3,000,000 & Use Company FZ

Toxicology (Tox) Results

Before being used in humans currrently drugs must be tested on animals (one small mammal species and one large animal species) for the length of time that human trials will take

Animals All Healthy-Proceed to Ethics


Problem with Large Animal Study, Repeat-Back to Rabbit.

Animal Death, Maybe Technical reason, Repeat-Back to Rat.

Animals Death, Project Fails-Go back Start

Animals Death, Repeat Chemistry of Drug-Go back to Microscope

Damage in Tissues, Maybe Technical reason, Repeat-Back to Rat.

Damage in Tissues, Project Fails-Go back Start

Damage in Tissues, Repeat Chemistry of Drug-Go back to Microscope

Animals All Healthy, but need to check higher Drug Dose-Back to Rat

Pharmaceutical company buys the drug-Use Company FZ

Pharmaceutical company buys the drug-Get £2,000,000 & Use Company FZ

Pharmaceutical company buys the drug to stop development. Miss 4 turns + loose £100,000

Lawyers Did Not File Patent at Start. Competitor has Patent.Project Fails-Back to Start

Lawyers Did Not File Patent at Start. Now Filed. Extra £50 million at Completion-Go to Ethics

Patent Validity is Challenged. Win case Lose £100,000 and Proceed to Toxicology

Patent Validity is Challenged. Lose £100,000 and Go back to Start



Ethical (E) Review

All procedures in humans must be approved by an Independent Ethical Review board. People on trial must give informed consent such that they agree to participate and understand the risks of doing so.

Ethically Sound-Proceed to Phase I


Paperwork Not in Order,Resubmit-Miss a turn

Ethical Case Not Made,Resubmit- Miss a turn




Phase I Results

No Adverse Effects-Proceed to Phase II

Drug gets broken down quickly-Reformulate-Go back to chemistry.

Drug induced side-effect. Start again at Chemistry

Drug induced Side-Effect. Start again.

Pharmaceutical company buys the drug-Use Company FZ. Proceed

Pharmaceutical company buys the drug-Get £2,000,000 & Use Company FZ

Pharmaceutical company buys the drug to stop development. Miss 4 turns + loose £100,000

Phase II Interim Analysis (IA)

A independent panel of Doctors ass the the results half way through the study to check if there are safety issues that warrant stopping the trial.

No Health Issues Identified. Continue Trial

Health Issue Identified. Trial Stopped. Go back to Start

Drug is Working So Well. Not Ethical to Continue with Placebo Group. Trial Stopped-Go to Phase III

Placebo Group not Progressing so Positive Results Not Possible. Repeat Trial. Go back to Phase II



Phase II Results (IIR)

No Adverse Effects-Proceed to Phase II

No Adverse Effects and seems to be working-Proceed to Phase II

Drug induced side-effect. Start again at Chemistry

Drug induced Side-Effect. Start again.

Drug causes Cancer. Start again.

Drug causes Infection. Decide How to Mnitor and Treat. Miss Two Turns

Pharmaceutical company buys the drug-Use Company FZ. Proceed



Phase III Results (IIR)

You have to state what the main outcome will be before the trial starts. If that main effect is not found, its a failure even if it has an affect on a other outcomes.

No Adverse Effects and Treats MS-Proceed to Regulatory Approval

No Adverse Effects but Does No. Return to Start

Drug fails to Change One symptom, but treats other symptoms. Repeat Trial

Drug induced side-effect. Start again at Chemistry

Drug induced Side-Effect. Start again.

Drug causes Cancer. Start again.

Drug causes Infection. Decide How to Mnitor and Treat. Miss Two Turns

Pharmaceutical company buys the drug-Use Company FZ. Proceed



Regulatory Approval (FDA/EMA)

To market/sell a drug comes approval is needed from the FDA (Food and Drug Administration, USA) and EMA (European Medicines Ageny, Europe).


Drug Appoved-Throw a Six to Cross Finishing Line and Start Selling the Drug

Paperwork Not in Order-Miss Two Turns and Try Again

Regulators want more Safety Data-Repeat Phase III Trial

Regulators want more Safety Data-Company Pull Out. Back to Start

Regulators want more Safety Data-Company Pull Out, Repeat Phase III Trial with Charity

Regulators want more Efficacy Data-Repeat Phase III Trial

Regulators want more Efficacy Data-Repeat Phase III Trial. Back to Start

Regulators want more Efficacy Data-Company Pull Out Repeat Phase III Trial with Charity

I think you can seee that it is not easy to win and it may take along time to get round the board

Do you have Suggestions…Constructive Please……..

Could we make this into an Actual Game?

To be continued

.













About the author

MouseDoctor

3 comments

  • It all seems so hopeless. Almost feel like I now know why so many MS'ers are lobbying for the right to die.

  • Re: "Who'll play a game you can almost never win?"

    It takes $800 million and at least 15 years to develop a new drug for MS. A part from the Pharma Industry nobody else has deep enough pockets and the time. There are winners a lot of you on DMTs that have got through the pipeline.

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