Case Study - Trial by Jury

Overview of Trial by Jury+

A jury trial (or trial by jury) is a legal proceeding in which a jury either makes a decision or makes findings of fact which are then applied by a judge. These "peers of the accused" are responsible for listening to a dispute, evaluating the evidence presented, deciding on the facts, and making a decision in accordance with the rules of law and instructions from the judge. Typically, the jury determines guilt or innocence and penalty is set by the judge.

Trial by Jury has many advantages over other decision making exercises, not the least of which is its centuries-old academic and practical history. We know what works and what doesn’t work with this decision mechanism. Of course it’s not perfect. But it’s far better than anything else anyone has been able to devise.

Below we list many of the advantages of this approach to decision making:

  • Pays more attention to false negatives: techniques to counteract the natural tendency of individuals to say no
  • Avoids deadline bias+: teams select their own court dates and there are serious consequences for missed dates. Teams are incented to claim their slot on the schedule early and not to miss their schedule.
  • Has a mechanisms (i.e., strong burdens and standards of proof) dedicated to falsifying the claims of the project team – to avoid false positives.
  • Includes mechanisms that provide independent scoring on the quality of evidence: admissibility and forensic techniques
  • Institutes a more careful selection process for individuals involved in the decision – based on their being bias-free and less on their technical skills or rank. This strengthens decision-making expertise across the R&D organization
  • Stresses the need for much longer timeframes for decision-making: move away from two weeks and a deck.1
  • Uses decision-making to drive improved understanding into the nature of scientific evidence: what constitutes the best evidence for approving a drug candidate
  • Allows regular evaluation of your decision-making process to see if it is leading to more project team satisfaction with the decisions – are there fewer skunkworks+?

Trial by Jury works well within an overall organizational form that allows it the time and the weight it requires. It would be difficult to maintain the discipline of the docket if R&D management felt the pressure to deliver a certain number of compounds by the 4th quarter. There would be great pressure to move up the court dates scheduled for next year, especially those we pushed back as a form of retribution.

To continue with a theme elaborated earlier, any decision mechanism must enforce consequences: the more serious the consequences the more trial by jury adds to improving the decisions and the evidence that goes into making those decisions.

Of course, in keeping with our theme of building fun and excitement into the work, these trials are keenly engaging and competitive for all who participate in them. Below we present snippets of discussions from a Trial by Jury to decide whether or not a new drug, FZR3452 for Alzheimer’s, should be graduated into full commercialization+. As the careful reader will note, there can be three verdicts: guilty, not guilty, or needs more study. Also, analogous to damages, the estimated market value of the drug candidate, is determined by the jury. Perhaps it’s not a blockbuster+ product and the jury can decide instead it’s a quite attractive sub-blockbuster candidate.

Trial Preparation

JUDGE:

Okay what’s the docket look like for the 2nd Quarter?

CLERK:

We have FZR3452 for Alzheimer’s, FZR3599 for Autism and FZR3090 for Incontinence. ‘90 is a continuance from 2nd Quarter of last year. ‘52 is apparently going for blockbuster status, ‘99 is back again. You remember the hung jury they had last year.

JUDGE:

Yes, I’m surprised those ’99 guys managed to keep it together after that decision. They must have other good drugs in the supply chest. Three court cases … that’s a pretty full calendar.

CLERK:

Oh, sorry, might’a missed one. Looks like we also have FZR3602 for Myeloma.

Also, this is apparently a request for continuance on ’99? That’s hard to believe.

JUDGE:

‘02 can’t come up again until next year … we had an agreement with the plaintiff. They had some problem with the forensic review of the evidence. Check with the plaintiff’s office to make sure nothing’s changed.

The ’99 team requested this current session immediately after last year’s hung jury thinking they could quickly fix their problems. Later they requested a continuance but the plaintiff refused to go along. When plaintiff threatened to push it back to next year ’99 decided they could make it in time for this court session. We’ll see.

Okay line up the preliminary hearings. Let’s see what kind of workload we’re really talking about here.

Dockets in the legal system are used to queue up trials. They take into account the time needed by both sides to prepare their cases.

Requests for slots on the docket will be driven by a teams’ urgency to meet deadlines before an annual assessment. If teams can’t show definitive progress as evidenced by a favorable verdict in court they may not survive the annual assessment. Inability to get on the court docket is no excuse for poor performance. Teams will sense the urgency of meeting the deadline of their slot on the docket. A missed court date may push back the project by as much as a year – the next open slot on the docket. The drug could be overtaken by competitors by then. The concept of the docket also avoids the hockey stick phenomena – everyone pushing delivery back to the 4th quarter. There will be a limited number of open slots in the 4th quarter docket.

Dockets are used to encourage settlements, especially in cases where the legal fee ‘clock is ticking.’ Dockets are a powerful tool for forcing concessions or agreement without the need to go to trial. This is important for teams requesting graduation+ on marginal drug candidates. The court might be willing to allow a hearing for sub-blockbuster graduation of these drug candidates – for certification of the drug candidate as having less than blockbuster market potential. Many of these ‘procedural maneuvers’ are key to keeping the court system functioning smoothly.

Statement of Charges

JUDGE:

Okay, let’s get down to the statement of charges. Today’s date is January 15th. Plaintiff has indicated you intend to request blockbuster status for your Alzheimer’s drug during our 2nd Quarter court session. Is this correct?

DEFENSE:

We have FZR3452 for Alzheimer’s as a ?-Secretase inhibitor. Based on preliminary clinical results we intend to show this drug will have blockbuster commercial potential in its single primary indication. We will show our product has a much higher tolerability and efficacy profile than any other therapy on the market. We will be ready for the court session.

JUDGE:

Plaintiff has offered to acknowledge the strength of FZR3452 for a sub-segment of the market, less than blockbuster status. They have offered a 1 quarter continuance to consider this offer. Otherwise the plaintiff intends to prove ’52 is worthless.

DEFENSE:

We have reviewed the offer and have decided to continue with our current schedule and intentions. We will show blockbuster status for FZR3452 in the 2nd quarter court session.

PLAINTIFF:

Therefore your honor we intend to prove FZR3452 is worthless and deserves no further project funding.

JUDGE:

How many witnesses do you intend to call?

DEFENSE:

We intend to call 15 witnesses your honor.

PLAINTIFF:

We also intend to call 15 witnesses your honor.

JUDGE:

Will you both be able to ready your cases by June 15th?

PLAINTIFF:

We have received and reviewed the evidence from the Defense. We have received their list of intended witnesses. Barring unforeseen events we will be ready.

DEFENSE:

Agreed. We see no obstacle to meeting that date.

JUDGE:

Okay then, trial date is set for June 15th

What is the defense trying to prove, blockbuster potential? This is the charge. A project team looking for a judgment that their drug has blockbuster potential will be measured against that potential. Less onerous would be a project team merely wishing to show their drug could achieve $300 million in sales per year. In this case the defense and plaintiff can possible reach agreement with less than a full jury trial.

The statement of charges is essentially the hurdle the drug intends to pass in order to reach Late R&D both from a scientific and commercial perspective. A verdict for the defense will mean the drug has surmounted the hurdle.

A lesser charge (i.e., lower award by the jury) may mean the drug hurdle has been lowered. For example, the jury decides that a drug does not have blockbuster potential, but it will agree that a drug should be able to achieve $300 million per year in sales.

Project Team (aka The Defense)

The project team is on the defense: they must prove their drug candidate is worthy of being graduated into Late R&D. They seek a verdict of Not Guilty.2

The project team needs to anticipate the plaintiff: what tactics will the plaintiff take to discredit our evidence? What new evidence (e.g., from outside studies or outside witnesses) might the plaintiff bring to the trial? The independent evaluator+ can be valuable in this preparation for the defense. Typically independent evaluators have broader and more frequent participation in a trial by jury and can play the role of expert advisors for the defense.

The project team must develop a convincing narrative for their evidence: they must look at the evidence in the same light as would a jury member. They must anticipate how the plaintiff will present its narrative and how to respond to the plaintiff’s narrative. Project teams can use techniques such as war gaming or mock trials to prepare for a trial by jury: 2 weeks and a deck no longer suffices.

Finally, any project member can derail a trial. Flaws in the evidence can be ‘leaked’ to the plaintiff. All project team ‘dissenters’ must be appeased or teams risk losing the trial.

DEFENSE LEAD:

Marsha, I need you to get me a life-size cut out Figure of a typical Alzheimer’s patient. Let’s make it look like a person a professional would be able to relate to. Most of our jurors will be higher income professionals.

John, I need you to do research on that list of witnesses we received from the plaintiff. They’re being called for a reason. See if you can dig up what their main arguments will be.

Sandra, pull together a mock plaintiff team. We’ll run a mock mini-trial this time next week. I want to be a spectator to see how well the human dimension of this evidence comes across.

Jerry, can you take those market projections and get them blown up into presentation tables. Also, see if you can simplify the projections a bit. There are too many variables for a jury to understand in a trial setting. Combine a few of them.

TEAM MEMBER:

Do you want to include our outside witnesses in the mock trial?

DEFENSE LEAD:

Yeah. Lisa see if you can get Dr. Ixis from the Alzheimer’s association at least on the phone. We need her to give an impassioned defense of those surrogate markers we used. She funded development of the markers, so we probably can’t do better. We should also have her practice her presentation of those latest clinical trials. She tends to be a bit preachy. Let’s see if we can humanize her testimony a bit.

Anything else?

TEAM MEMBER:

We’re investigating Dr. Ixis and the other witnesses to make sure they don’t have any conflicts of intersts.

Who’s going to pull together the outline of the overall strategy for questioning during the trial?

DEFENSE LEAD:

Mark and I are doing that right now. We’ll get it out to the team before the mock trial. And let’s make sure all the latest experimental and trial results are in the hands of the plaintiff. We wouldn’t want any of our evidence declared inadmissible. Lisa can you pull together the inventory? Thanks. Let’s go get ‘em.
Plaintiff’s Office

There is no plaintiff’s office in today’s pharmaceutical company, though certain ‘seasoned’ executives, those with enough seniority and success to be able to plainly say what they believe, take special delight in challenging the evidence of project teams. It has been likened to challenging someone’s religion, great fun for certain types of personalities.

The plaintiff’s office is looking for flaws in overall defense reasoning as well as poor experimental method for individual pieces of evidence. They also examine witness testamony for bias, contradictory prior statements, etc. Importantly the plaintiff will come up with a narrative to offset the defense narrative.

The plaintiff’s office can also ‘cut a deal’ with the project team up to and during the trial.

PLAINTIFF:

It’s always tough stepping into these projects near the end. We are at such a disadvantage in those devilish details. Luckily these teams can’t seem to learn how easily we can trip them up on their inability to summarize their own scientific reasoning.

Johnson I’ll need you to get with Dr. Wilson to go through the original research plan for this drug … what was their original hypothesis. We can be sure they didn’t build an ACH. Looks like they took the first hypothesis that popped into their heads and ran with it. Let’s build an ACH, get me the top 4-5 alternate hypotheses they haven’t investigated, and let’s see if it gives us some holes in their argument. I’d like to be able to show the clinical results they got are not due to the mechanism of action they’re proposing.

Livingston, go through the forensic documentation. I don’t think we’ll find a gaping hole in their evidence, but if we can kill one or two of the minor experiments using the inadmissibility rules it might just shake them up enough to get them to stumble.3 Also, I want you to build up the case they were not as diligent as they should have been in eliminating investigator or patient bias. Didn’t use any of the standard tricks – I guess they were relying on their randomized, double blind, placebo controlled stuff. Their independent evaluator must not be giving them very good expert advice. This stuff is 101.

Here’s a nugget. These guys just don’t seem to get it. They run these 30 person placebo controlled clinical trials and basically do our work for us. We can Simpsonize these guys without even breaking a sweat.4 As a matter of fact, let’s do a double-Simpson. Split this patient population twice and show in both cases we can make the placebo group better than the active group. Winston can you please do this? Try to stick to the categorizations in the demographic section of the protocol, but if you can’t then just make up a split with some reasonable differentiators for Alzheimer’s patients.

We’ve got to get our witnesses prepped so they don’t come off sounding like a bunch of academics. Let’s do a rehearsal next week. Lingley will take point on this.

We can’t get our alternate hypothesis together until Johnson and Wilson finish their work. We’ll need that ASAP. Let’s plan to go over it next Wednesday.

Is there anything else? I think this one will be a slam-dunk.

Jury Selection

The process used for the selection of the jury is critical to the perception of fairness of the trial. As in U.S. trials, both sides must generally agree on each juror.

Both defense and plaintiff are experienced in getting at the true motivations of the jurors. They will ask leading questions, trick questions, baiting questions, anything that is needed to better understand the thinking process of the juror, as well as merely to test the skills of the opposing counsel during juror questioning. The biases of individuals, whether emotional or rational, are specifically the topic of interest in Jury Selection.

The key selection criterion is the ability of the juror to empathize with the planned narrative. How does our current narrative evoke empathy from these now familiar members of the jury, and how should we now change the narrative to build upon that empathy? Defense is interested in jury members with a family member having a history of the disease, for example. The plaintiff is interested in jury members who have family members harmed by ethical pharmaceutical drugs, to take an extreme example.

Technical competence is not the overriding criteria for jury selection, as illustrated in many of the celebrated product liability trials in recent years. As shown by the recent product liability cases, having only 1 or 2 jurors with a working knowledge of the technical considerations behind the drug is many times enough. There is anecdotal evidence that less technically competent jurors are less prone to being duped by a convincing narrative or fancy technology to the detriment of the overall question of whether or not the drug is commercially viable.

JUDGE:

[Addressing potential jurors] You have all been pre-selected based on your freedom from preconceptions on the relative merits of either side of this case. Although we cannot sequester you as we might in a criminal trial, we rely on your professional standing that you will not do independent research on topics discussed during this trial. Your duty is to judge the results of this trial based solely on the merits of the arguments placed before you. I also instruct you to inform the court of any inappropriate discussions that take place between you and the defendant, the plaintiff or any of their staff.

You will not be selected based on any special technical skill, rather we expect you to exercise your best judgment based on your respect for fairness and considered reasoning. Please do not disappoint us.

With this opening statement, will defense begin questioning our first potential juror?

DEFENSE:

Thank you your honor. Good day Juror #1. Can we start off with a bit of a background about your understanding of the pharmaceutical industry? … So you understand the amount of work it takes to bring a drug to market? … Are you taking any prescription drugs? … Do you find them helpful? … Does anyone in your family have Alzheimer’s? … She does, it must be very difficult caring for them … Can you describe to me a time when you had to make a decision about something as complex as this case? … That must have been very time-consuming. What swayed you to go with the vendor you selected? … I see. That’s all. Thank you for your time.

PLAINTIFF:

You mentioned you had a sister-in-law you’re very close to with Alzheimer’s. Do you know if she’s taking any medications? … Yes that medication can be very difficult to tolerate. Despite the drawbacks do you think it’s helping? … I too have a relative with Alzheimer’s and found the same thing. It’s hard to tell if it’s the medicine or just periods of lucidity. Have you ever thought of giving up on the medications? … Yes, we have too. So if we were to go after a new medication what would be some of the things you would be looking for? … Of course we try very hard to keep down the side effects, but there will always be some … Yes that’s true too, so you should be looking to make sure this medication is really going to be helpful over the long term. That’s true. Switching a bit, you mentioned in your earlier example you selected a vendor based on selection criteria. I suspect though you wanted to know the operating system and coding software used? That’s right. No matter how good the software looks on the vendor’s machine, we’ll need assurances it will work on our machines. Thank you very much. No further questions your honor.
Witness Selection

Can we increase the value of a piece of evidence through its presentation by a compelling witness? On the other hand, can we trash the value of a piece of evidence through cross-examination of a key witness?

Witnesses do not have to be members of the project team nor of the parent company. As a matter of fact, the plaintiff will most likely use external expert witnesses to bring an industry or commercial perspective to the overall evidence. This, of course, forces the defense to take external evidence into account when developing its own case.

DEFENSE LEAD:

[Addressing defense team] Who’s going to present the results of the clinical trial? Dr. Winston was the lead investigator, should we use him? … Yes, he can be a bit of a put-off. But he does have the most in depth understanding of the individual patients. And he will probably stand up quite well to cross-examination – he can handle himself in an argument. Lisa? … Yes that’s right we will need to ‘get under the skin’ on our clinical trials. The raw numbers will put everyone to sleep. But Dr. Winston can bring these patients alive, especially if we use the full-sized cutout. George? … No we don’t need a detailed patient history on every participant, just a few illustrative cases. We should put in 1 or 2 that didn’t fare too well and give a convincing argument why they might not have responded. Fred? … No we won’t need to call up biostatistics. Dr. Winston can present a simplified version of the numbers. Anyone else? Okay, that’s a go. Dr. Winston will be our key witness.

PLAINTIFF:

[Addressing plaintiff team] Can you believe defense is going to call Dr. Winston for their key witness on the clinical trial results? I bet we can have him histrionic in less than 5 minutes. Johnson, get me the blood work-ups, before and after, on patients #24 and 27. They’re both RA sufferers and I bet their white blood cell counts are greatly elevated after taking ’52. Let’s watch ‘ole Winney wiggle out of that discussion.
Opening Statements

This is the first time we’re running a trial by jury process and we were lucky enough to get the Lindbergh Trial courtroom in Flemington, NJ. Well at least the courtroom where the trial would have been held if it weren’t such a media circus. The real Lindbergh Trial was held in the larger hotel across the street now converted into a restaurant.

It’s our first day in court. We’ve amassed a significant body of evidence+ as to why our proposed Alzheimer’s drug candidate should be graduated into Late R&D. We selected jurors who understand the urgency of our research – we even were able to seat a mother who had a sister-in-law with Alzheimer’s. Corporate commercial seems excited about our prospects. We have retained the best-known researcher in the field, Dr. Elliot Weisal. Defense is ready!

JUDGE:

All stand! The case of Fizer Corporation vs. Fizer- nACHr is now in session. Defense will proceed with opening statements.

PLAINTIFF:

Thank you your honor. Good afternoon ladies and gentlemen of the jury.

Association does not mean cause. Just because you find a fingerprint at the scene of the crime does not mean the defendant committed the crime … nor does it mean that biomarkers, in reality molecular fingerprints, point you to the cause of Alzheimer’s. Dr. Weisal is indeed an acknowledged expert in the treatment of Alzheimer’s and has performed a Herculean effort in gathering clinical data from many sources to build his database. It’s the best-known database in the field. It does not, unfortunately, give us any further insights as to the causes of the disease. There are two key problems. Merely knowing that individuals with Alzheimer’s exhibit elevated levels of these two molecular signals+ does not implicate the signals in the disease. As a matter of fact we only have a very rudimentary understanding of how often these signals show up in individuals with non-Alzheimer’s diseases, say those with ADD or arthritis. Second, we all know Avulsan™ received a black box+ warning after being implicated in several severe cases of arrhythmia. There is some evidence this may be due to its modulation of the same two molecular cascades …

I would like to remind the jurors that what we are looking for in this hearing is a large body of evidence showing the proposed intervention in these molecular cascades will indeed provide clinical benefits, either in Alzheimer’s or in the other named commercially attractive markets. If in the end you believe there is a large enough body of evidence then by all means fund this line of inquiry. The plaintiff unfortunately does not believe this will be the case.

JUDGE:

Thank you Counselor, and now the jury will hear from the defense.

DEFENSE:

Thank you your honor. If it pleases the jury today we will present an overview of our proposed research program. We have spent the last 6 months gathering evidence that shows our program can bring commercial results in as short as 12 months and has blockbuster potential across several disease areas. We will leverage the work of our retained specialist Dr. Elliot Weisal, an acknowledged expert in the field, who spent the last 20 years developing a unique understanding of this devastating disease. Dr. Weisal has almost single-handedly built a database containing over 80% of known Alzheimer’s cases in the U.S. He has developed algorithms that show an association between genetic, environmental and medical background that is highly predictive of disease progression. Importantly he has identified two unique biomarkers that contribute over 50% to the prediction of the disease progression. These biomarkers are based on molecular signals that we already know how to modulate using Fizer’s anticonvulsant Avulsan™ …

In conclusion, we have great expectations for a singular early commercial success in halting progression of Alzheimer’s in many cases, and a long-term scientific competitive advantage with the two key molecular cascades implicated in Alzheimer’s, ADD, certain childhood forms of arthritis, and in several types of bipolar disease. For the sake of the patients we urge you to fund this research by allowing our first drug coming out of this research to proceed to market.

Role of the Judiciary

A Trial by Jury may appear to industry veterans to give insufficient weight to the intrinsic merits or risks of a drug candidate. Many thoughtful individuals in the industry conclude that the decision about the merits of a drug should not be a matter of consensus, even if using a jury – a lone dissenter many times holds the correct answer. Several major pharmaceutical companies use a decision mechanism that is a combination of a peer review panel with a final decision belonging to a single senior executive.5 This brings us to a discussion about the role of the Judge in a Trial by Jury.

Similar to the U.S. criminal system the role of the judge is to act as a stopgap, and to counteract common biases, mistakes or limitations of the jury. We know that well-structured groupthink often outperforms the decision of a single individual even in trials requiring a highly technical background. But not always, though. For that we have the judge. The judge tells the jury about the burdens of proof for each side in the case.

The judge is the conductor of the trial, deciding who speaks and in what order and under what conditions. The judge gives instructions to the jury: what constitutes acceptable evidence, what is the role of the jury, how the jury can request additional information, etc. Also the judge arbitrates disputes during the course of the trial, admonishing both parties to keep arguments within the bounds of proper judicial procedure. Importantly the judge permits or disqualifies witnesses based on standards that have been developed for this purpose. Similarly the judge permits or qualifies specific bits of evidence using well-proven standards of evidence and burdens of proof.

The judge has no personal stake in the outcome of the trial, guilty or not guilty. Instead the judge’s overriding concern is that the trial be perceived as fair by both parties in the trial. But in the end, the judge does weigh the fairness of the deliberations of the jury, and does have the final pronouncement on the guilt or innocence of the drug candidate.

JUDGE:

I want to remind the jury of their obligation to only judge based on what is said in this courtroom. If you have prior opinions based on articles you have read or other work you have performed I ask you to park these at the door. Also, I remind the jury that we judge evidence in this court according to the Fizer Standards of Evidence. We are looking for evidence of diligent use of ACH, elimination of investigator bias+, and all the other standards of evidence explained to you in preparation for this trial. These will be posted in your deliberation room as a reminder.

For those of you who have been involved in a U.S. trial before, the rules in this trial are a bit different. You are allowed to ask questions of me, but only through the jury foreman. You are allowed to take notes, but only using court provided writing materials. For the statistical aspects of the clinical trial we will provide you with some tools to help you in your deliberations. On the other hand, we will be using many of the same elements from the U.S. trial rules that you may have already experienced. There will be no badgering of witnesses, no evidence introduced based on hearsay or unsubstantiated claims, and we will strictly observe the rule of order in this courtroom.

Again, you’ve heard the charges against the defendant. You will be asked to rule exactly on those charges. If you have any questions at all during the statement of charges you should ask them at the earliest possible moment, again using your jury foreman.

Admissibility of Evidence

Perhaps one of the most damaging outcomes that can happen to a party to a trial is to have valuable evidence declared inadmissible. Inadmissible evidence+ is at the discretion of the judge and may be due to the simple fact that the evidence was not made available to the plaintiff in a timely fashion. Note that this is similar to rules for experts: they too must meet minimum qualifications for their claimed ‘expertise’.

Inadmissibility also arises from lack of proper controls on the experimental method. Although the researcher may instinctively know that the change to the method was inconsequential, the plaintiff will not care. Valuable witness time will be spent justifying method rather than presenting compelling evidence. Scientific method, including timely record-keeping, becomes critical to the trial process.

The U.S. criminal justice system explicitly recognizes the ‘tyranny of models’ and does not allow models to be presented as evidence unless they are representative of a physical state of play on a smaller scale. For example, a diagram showing the relative positions of vehicles at an intersection would be admissible to clarify ‘who was where when’ claims. An animated model showing how individuals could have moved based on speed and distance calculations by a computer would not be admitted. There is no room for ‘causal relationships’ based on numercial modelling in the U.S. justice system, and there should be little room for these in the presentation of evidence for drug assessments.

JUDGE:

[addressing counselors aside from the jury] I want to remind you that we will not allow computer models of molecular docking onto cellular receptors unless they are merely supportive of hard evidence demonstrating the docking. The court will not admit molecular modeling based on covalence or ionic bond calculations in the absence of hard evidence that such modeling meets basic minimum standards of reliability. We need to know the compound is indeed docking at this receptor in our actual clinical patients and not that it can merely be modeled to do so.
Role of the Jury

The role of the jury is to make findings of fact, following instructions from the judge. The jury must limit its verdict to the instructions. Did the defendant prove their contention about the drug candidate? Then the drug candidate can graduate into Late R&D. However, the plaintiff also has a burden of proof. Did the plaintiff prove its contention about the drug candidate? Did the plaintiff proves its claim the drug candidate is useless?

JUDGE:

[Directed aside to Defending Attorney and the Plaintiff] Mr. Defendant, have you considered the Plaintiff’s renewed offer of a continuance in exchange for a sub blockbuster+ ruling?

DEFENSE:

We have your honor and we intend to place the future of FZR3452 into the hands of the jury.

JUDGE:

Okay, and then let’s begin our deliberations.

JUDGE:

I remind you of the Statement of Charges. Defense must have shown that FZR3452 can reach blockbuster status in accordance with the commercial schedule they presented in Exhibit 36. The plaintiff must have shown that FZR3452 will never reach NDA. That it is worthless. Your charge as jurors is to decide whether either or neither of these charges has been proved. I remind the jurors of our criteria for decision-making under uncertainty. Reminders of some of the rules-of-thumb for this type of decision-making are on display in the jury room, but I especially would like to remind the jurors to take advantage of the Bayesian net toolkit and facilitator we have made available should you need them during your deliberations.

Are there any questions? … Yes Mr. Foreman you will be able to direct further questions to me, the judge, in the course of your deliberations, but I would ask that you attempt to rely on the collective memory of your jury members and to keep questions to a minimum. …. Yes the exhibits will all be available to the jurors during the course of their deliberations. No further questions? Great, then please begin your deliberations. The schedule for deliberations is displayed on the wall in the deliberation room.

Trial Proceedings

[omitted for purposes of brevity]

Deliberation

Defense (and the plaintiff) are allowed to watch jury deliberations on a video monitor, to see how others viewed their evidence. Having the project team watch these deliberations will make any subsequent presentations to the FDA much better. Team members will be surprised at the importance attached to some of their minor comments, and how little importance gets attached to what they considered to be crucial evidence. The key to improved decision-making (i.e., large and small) throughout the corporation is experience in both making decisions and in watching others as they make decisions. There is not a better laboratory for this experience than in the deliberations of a jury.

It should be now evident how a trial by jury process will strengthen the Burden of Proof and Standards of Evidence used in R&D. The immense emotional value of stating all our work in terms of the patient becomes clear. Arrogance and conceit are seen by individuals as merely getting in the way: a certain level of humbleness (even if false) goes a long way towards reaching the hearts and minds of jurors. This jumps out when watching jury deliberations. The lessons of the trial will redound across all evidence gathering and decision-making in R&D.

Jury Delivers Their Verdict

JUDGE:

Mr. Foreman has the jury reached a decision?

JURY FOREMAN:

Yes, your honor, we have. We have found that neither the defense nor the plaintiff has demonstrated their case. FZR3452 has neither blockbuster potential nor is it worthless. We the jury believe it can be approved for usage in the those cases where patients show antimicroglia antibodies in their sera, which in accordance with Exhibits 36 and 53 can reach approximately $300 million in sales per annum. Additionally we do not believe that further work on this drug will achieve the endpoints the defense would like to achieve in other disease indications.

JUDGE:

Thank You, Mr. Foreman and ladies and gentlemen of the jury. We have our verdict. FZR3452 is certified for a sub-blockbuster status at about $300 million per annum commercial potential. The trial of FZR3452 is now concluded.

Home Page January 2011

  • 1. Comment made during the DIA  2006 DIA Pharmaceutical Industry Survey+ as to how much time decision makers are generally given prior to peer review session for today’s drug approval process.
  • 2. Merely for discussion purposes. The argument can be just as easily crafted with a verdict of ‘guilty’ needed to graduate a drug candidate into Late R&D. The direction taken in this book is consistent with all the legal literature, such as Best’s Evidence. You can read Evidence and by analogy all the legal precedents (Section 401, 502, etc.) apply. The direction in this book makes it easier to borrow learnings via analogy from the legal profession.
  • 3. In legal proceedings evidence has to conform to certain standards in order to be admissible.
  • 4. Recall we can completely reverse trial results for any comparative study with one arm in the study being less than 50% greater than the other, the Simpson’s Paradox+
  • 5. Personal communication from major pharmaceutical company. This has the advantage of giving the presenting (defense) team a consistent target for their presentations: they know how to present evidence to the key decision maker in the most effective manner.