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Group Forms to Amp Up Research Major drug companies and nonprofit research group

ID: 356441 • Letter: G

Question

Group Forms to Amp Up Research Major drug companies and nonprofit research groups would never put aside fierce competition and conflicting agendas just to crack some of the world’s most challenging diseases, would they? Except they did. In early 2014, the National Institutes of Health (NIH) an- nounced the creation of the Accelerating Medicines Part- nership (AMP) to target some of the most challenging diseases. And to accelerate potential cures, they all agreed to share “scientists, tissue and blood samples, and data, in a five-year collaborative effort.”91

Competition through Cooperation This deal, put together by the NIH, creates wins for all par- ticipants. “By pooling their brightest minds and best lab discoveries,” The Wall Street Journal reports, “they hope to put together a research system that can decipher the diseases in ways each hasn’t been able to on its own.”92 The Journal notes that the costs to the participants are much lower than they would be when working on their own. In fact, the total budget for the partnership is $213 million, split roughly between the NIH at $118.9 million and industry at $110.6 million. These amounts are dramatically lower than the $350 million average cost for the discovery and development of a single drug. Beyond reducing the financial costs, this collaboration also spreads the risk, as 95% of experimental medicines fail to be both effective and safe.93 Not Just Cost Savings The NIH identifies benefits beyond cutting research costs: shorter development time, improved prospects for success, and increased range of therapies. “Under- standing the biological pathways underlying disease and the specific biological targets that can alter disease will lead to more rational drug design and better tailored therapies,”94 the NIH says. The agency predicts that the projects will enable more robust clinical trials and re- duce the number of failures in Phase II and Phase III clin- ical trials.

Early Stage and Open Source One reason why the coalition works is because the com- petitors are collaborating on the earliest stage of the re- search. The NIH says that the project shouldn’t face antitrust concerns because it consists of early research and will make all results freely available to the public.

Three Projects Scientists from the NIH and its industry partners selected three focal diseases: • Alzheimer’sdisease. • Type 2 diabetes. • The auto-immune diseases of rheumatoid arthritis and lupus. Egos at the Door? The project is unique. “We are getting together in a way that has not happened before,” Dr. Francis S. Collins, direc- tor of the National Institutes of Health, told The New York Times. “We are bringing scientists from different perspec- tives into the same room. They will leave their egos at the door, leave their affiliations at the door.”95 The Times reports that such a collaboration would have been impossible five years ago, quoting Dr. Mikael Dolsten, president of worldwide research and develop- ment at Pfizer. “It was a different time,” Dr. Dolsten said. “Companies had the view that going alone would be sufficient.”96 Who’s Who Industry participants include household names. The ten commercial partners are AbbVie, Biogen Idec, Bristol- Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Lilly, Merck, Pfizer, Sanofi, and Takeda. Nonprofit partners are the Alzheimer’s Association, the American Diabetes Asso- ciation, the Arthritis Foundation, the Lupus Foundation of America, the Lupus Research Institute/Alliance for Lupus Research, the Foundation for the NIH, the Geoffrey Beene Foundation, PhRMA, the Rheumatology Research Founda- tion, and USAgainstAlzheimer’s.9

QUESTION 1:

Apply the 3-Stop Problem-Solving Approach to OB Referring to Figure 8.4 and your notes, apply the knowl- edge of OB presented in this chapter to the above case. Applying this knowledge should enable you to recommend realistic and effective solutions. Stop 1: What is the problem? • Identify the outcomes that are important in this case. • Which of these outcomes are not being achieved in the case? • Based on considering the above two questions, what is the most important problem in this case?

QUESTION 2:

Stop 2: Use the material in this chapter to help you understand the problem in this case. • What person factors are most relevant? • What environmental characteristics are most important to consider? • Do you need to consider any processes? Which ones? • What concepts or tools discussed in this chapter are most relevant for solving the key problem in this case? LEGAL/ETHICAL CHALLENGE

QUESTION 3:

Stop 3: What are your recommendations for solving the problem? • Review the material in the chapter that most pertains to your proposed solution and look for practical recommendations. • Use any past OB knowledge or experience to generate recommendations. • Outline your plan for solving the problem in this case.

I need answers for Question 1, 2, and 3. Not sure how to answer Question 2 in particular. Need specific answers to use to build an essay. I know it is a lot but ANY help would be GREATLY appreciated! Thanks!

Explanation / Answer

Apply the 3-Stop Problem- Solving Approach to OB Stop1: What is the problem?

Identify the outcomes that are important in this case.

Below are the outcomes from the above case.

Which of these outcomes are not being achieved in the case?

Based on considering the above two questions, what is the most important problem in this case?

Use the material in this chapter to help you understand the problem in this case.

What person factors are most relevant?

Dr. Francis S. Collins, Director of the National Institutes factors is most relevant.

‘We are bringing scientists from different perspectives into the same room. They will leave their egos at the door; leave their affiliations at the door.”

Because the National Institutes of Health, 10 biopharmaceutical companies and several nonprofit organizations to transform the current model for identifying and validating the most promising biological targets of disease for new diagnostics and drug development.

What environmental characteristics are most important to consider?

Do you need to consider any processes? Which ones? What concepts or tools discussed in this chapter are most relevant for solving the key problem in this case? LEGAL/ETHICAL CHALLENGE

By optimizing the process for identifying and validating clinically relevant disease targets for drug design, AMP aims to:

What are your recommendations for solving the problem?

Review the material in the chapter that most pertains to your proposed solution and look for practical recommendations. Use any past OB knowledge or experience to generate recommendations. Outline your plan for solving the problem in this case.