Pharmaceutical Best Practices: R&D Strategic Partnerships

Nintai Partners Copyright © All Rights Reserved 2012

Strategic Partnerships & Communication: A Report Card

Thomas Macpherson

June 5th, 2012


Agenda For Today

I.  Opening Remarks and Agenda

II.  The Main Issues Facing Pharmaceuticals Today A. Increased IRR/Productivity in Research & Development B. Creating Agile Systems Utilizing Increased Availability of Informatics C. Creating New Risk/Reward Models with CRO Partners

II.  Communication in CRO/Pharmaceutical Strategic Partnerships A. It Isn’t Just About Data or Communications….But About Communicating Data 1. Client Comments B. Knowledge is Power…Therefore Data Communicators are Power Brokers 1. Client Comments C. Data/Informatics Help In Cuts…But Are Even More Important For Growth 1. Client Comments

III.  Report Card: Strategic Partnerships and Communications

IV.  Questions and Comments


The Big Three Imponderables: A (Very) High Fly Over

No industry has survived by con2nually cu4ng their way to survival. The ul2mate long term health of the industry will be driven by sustainable and profitable growth. To

achieve this, R&D will need to increase produc2vity & IRR.

New rela2onships will need to be created – with incen2ves for both cost savings and corporate growth. These rela2onships will require more flexible

and integrated business models.

The industry has never been a leader in the use of informatics, technology, and integrated data platforms. The increasing digitization of data at all levels (EDC, EMRs, eCTD) is going to fundamentally change the way we make decisions.


Some Context: Major Strategic Issues Facing Life Sciences

We Can’t Cut Our Way Out Of This Managements recognize it isn’t about just cost cutting anymore. Internal research teams are stretched to the maximum and budgets have been pared to their lowest possible levels. The future success of drug discovery is no longer about outsourcing and slashing fixed costs. Management is demanding leaner organizations, more efficiency, and greater productivity from its R&D teams. In short….it’s about drug discovery again. “Our teams have been downsized, streamlined, and outsourced as much as possible. We have removed assets from the balance sheet, costs from the income statement, and reduced burn rates from the cash flow statement. In the final analysis, we will be saved by increased productivity, innovative research, and outstanding use of informatics. My performance will be ultimately measured by how much I grew the company, not how much I outsourced or divested”.

- C-Level Manager, Merck “When I look out our organization, there really isn’t any more “fat” to cut. Regardless of what Wall Street analysts say, mergers and acquisitions, finding synergies and reducing redundancies and outsourcing fixed costs will not get the company many new molecules to market. The bottom line is we need to create organizations that find innovative ways to increase productivity, IRR in research & development, and quicker/better informed decision making. Then and ONLY then will we start to turn this thing around”. - Board Member, AstraZeneca


Risk Mitigation Through Innovative Partnerships Many of the management we have gotten to know frequently talk about mitigating or reducing risk. In drug discovery and development outsourcing, this generally means creating contracts that reduce the risk of project failure or with penalty clauses for poor performance. We have found the most powerful relationships are where CROs and their sponsors are incentivized through out the process. An example of this is creating incentives to not only prevent failure, but to also to mitigate the risk of lost opportunity. “I want my CRO to be a real partner – someone who is paid to bring value in everything they do. This includes incentives for not just producing good data, but producing good decision making, good data evaluation processes, and outcomes produced by both. I want our CRO to be equally happy for helping me kill an unsuccessful project quickly as they are for moving one forward slowly. I want our CRO to to reduce the risk of a bad research outcome, but I also want them to make sure we reduce the risk of missed opportunities. While these seem the same, they are actually quite unique with very different audiences”.

- GSK “So far we’ve used our CROs to cut costs. I’d like to see incentives for creating real growth. Our team recognizes that traditional outsourcing is no longer a valid policy or budget option. Our Board wants to know how we intend to ally ourselves with organizations finding innovative ways to discover and launch new products. While novel for us, I think it’s only a matter of time until we in-source back some functionality and utilize third party vendors as growth drivers”.

- BI




Agile Informatics Are Changing The Research & Development Field Life sciences has rarely done a great job with technology, and now the explosion in clinical informatics has forced it to evaluate its entire business model – from office-based reps to outsourced clinical development. The winners of this new model will be pharmaceuticals with the vision and strategy to make informatics as the predominant tool in research. “Some of our CRO partners understand the power of a fully integrated clinical research informatics platform. Everything from assays to personalized medicine are going to directly – and totally – changed by this. The ability to think quickly and act decisively will one of the most important attributes of a senior manager. The challenge will be creating a system that can sort through all this data and provide warning signs and decision making tools in a nearly real-time environment”.

- Baxter “The development of clinical informatics has been a double edged sword. On one side is the ability to see data from across the clinical spectrum, the integration of enormous sums into an accessible format, and the ability to frame decisions with data support we could not have imagined 20 years ago. Conversely, it has created an explosion of data that – without real controls – can lead many a manager down a garden path of enormous cost with absolutely no chance of success. The ultimate success of this movement will be measured in drug development, product launches, and diseases treated”.

- Hoffman


Communication, Data, and Strategic Partnerships

A Report Card


Main Themes

It Isn’t Just About Data or Communication….But About Communicating Data One thing we have learned over time is that good data is never reported, but communicated. Good data should tell a story, both to the person collecting it and to the person analyzing it. Far to many organizations have a remarkable amount of data that is reported, but that in reality communicates nothing. If Knowledge is Power…Then Data Facilitators are Power Brokers Far too often the role of data or informatics is seen as an information technology issue – something to be sliced, diced, and spit out with little or no forethought. We couldn’t disagree more. Informatics is the life blood of clinical research and should be treated as such. For those of you sitting here today as data facilitators, the world has never looked so good. Data/Informatics Help In Cuts…But Is Even More Important For Growth You can go about the process of achieving operational efficiencies, cost cutting, and budget reductions without good data. But you will NEVER achieve reasonable sustained growth without quality data and informatics. A Japanese proverb once said that a man with his eyes closed can cut any person’s arm off, but it takes the most enlightened and wide open eyes to sew it back on.


Data Performance: It Really Does Matter

Data Performance – Right Person, Right Data, Right Time The ability to make timely decisions is based on the collection, distribution, and presentation of the relevant data. Ultimately, this should increase the possibility of meeting deadline goals, reduce project costs, and speed up the ultimate go/no go decision process. Many of our clients have no way to identify, measure, and fix this process.

As companies moved to a more integrated data reporting system, satisfaction increased dramatically as well as confidence in the decision making process. This was reflected in an average 17% reduction in change orders and 7% reduction in sponsor project oversight hours – a saving estimated at roughly $2.3 million per project or 2.8% of the total project budget.

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Right Person

Right Data

Right Time

19%

5%

41%

62%

24%

82%

Top 10%

Lowest 10%


Data Performance: It Really Does Matter

“Communicating data is one of the more important things our CRO partners do. If we don’t get the right data to the right person at the right time we put our entire research program at risk. Important as this may be, we have found our (CRO) partners have actually done a relatively poor job creating a process to achieve better results”. - AstraZeneca

“One particular failure of our partner has been in communicating data back to our internal teams. This isn’t necessarily all their fault – for instance we have NEVER done a very good job using data to make decisions. Most of the time data is an excuse to put off decisions. But part of the failure of our partner has been the inability to take into account our issues and designing a reporting system to meet that. There really isn’t a cookie cutter solution to this”. - Pfizer

“We have been working at this for probably over a decade now. We struggle with the fact that too much data has a tendency to distract us or paralyze us into not making ANY decision. When I first met with our partner, I tried to discuss this but I think it fell on deaf ears. My company’s needs are different than our competitor and they need to create a customized way to deal with that”. - Takeda


Date Performance: Timely Decision Making

Decision Turn Around Time – Was It Timely? In a clear majority of our clients, strategic partnerships led to a significant drop in the ability to make timely decisions. The inability to do this can lead to significant costs downstream as timelines slip, management makes hasty (and poorly researched) decisions, and the project critical path is put at risk.

$0

$20

$40

$60

$80

$100

$120

$140

$160

$180

Delay: <2 Days Delay: >2 Days <5

Days Delay >5 Days <10 Days Delay > 10 Days

$23 $23

$23 $23

$28 $32

$77

$169

Ini2al Es2mate

Final Cost

It is clear poor communication delays projects and impacts budgets. What became very clear is overrun costs due to decision making delays grows exponentially – from 23% in the beginning to over 600% when delays go on more than 10 days.


Date Performance: Timely Decision Making


Data and Decision Making: Getting It Right

Accuracy in Decision Making – Did It Help Us Get It Right? Making timely decisions is only part of the solution. A quick decision with bad data is just as bad – if not worse - than no decision at all. Communicating data in the format necessary for an informed evaluation is critical to success. Yet all too often we see reports and data delivered in such ways to be wholly useless to the sponsor. If the data cannot assist in making a decision, it in likelihood should never have been delivered.

0%

20%

40%

60%

80%

Data Was Adequate Data Was

Inadequate

68%

32%

3% 11%

12%

62%

12%

Data Is Unreadable (Format)

Data Is Off Topic

Incorrect (Bad) Data

Insufficient Data

Too Much Data

A total of 17 companies participated in the survey which took place in January, 2012. 84 individuals participated in the survey with internal clinical, IS, informatics, data management, and senior management making up the major areas of practice.


“When we design our informatic reporting system, the first thing I tell our partners is “if the information cannot help me make a determined and educated decision, then don’t send it”. Yet even after all this I will frequently still see data which arrives in forms or structure that provide little or no value to me as a sponsor”. - Biogen Idec

“I’m not sure anybody outside of our business would believe the amount of information that can flow across my desk over the course of a work week. The challenge for anyone in my position is finding the data that can assist me in making what can be sometimes very difficult decisions. I just wish sometimes our CRO partners could sit in my shoes and try to make decisions after they’ve sent me this 10 gig folder of data”. - sanofi

“I need every advantage I can get when I have to review my budget with the higher ups. I tell my CROs that this is as important to them as it is for me”. - Novartis

Data and Decision Making: Getting It Right


Strategic Partnerships and Communication: A Report Card

Communicating Data: The Right Person, The Right Data, The Right Time

Communicating Data: Timely Decision Making

Communicating Data: Getting The Decision Right

Clear Communication: Integrating Platforms

Clear Communication: Managing Up and Down

Clear Communication: Mapping To Objectives/Goals

A total of 18 pharmaceutical and biotechnology companies were interviewed. A total of 84 individuals completed the survey over the period of January – February, 2012.

B-‐

B+

C

D+

D

B+

Grade Trend

Pharmaceutical Best Practices: R&D Strategic Partnerships

Healthcare

Transcript of Pharmaceutical Best Practices: R&D Strategic Partnerships