References

Chapter 1

  1. 1. Evens R, Kaitin K. “The Evolution of Biotechnology and Its Impact on Health Care.” Health Affairs. 2015;34(2):210–219.
  2. 2. Jinek M, Chylinski K, Fonfara I, Hauer M, Doudna JA, Charpentier E. “A Programmable Dual-RNA-Guided DNA Endonuclease in Adaptive Bacterial Immunity.” Science. 2012;337(6096):816–821. See also Platt RJ, Chen S, Zhou Y, et al. “CRISPR-Cas9 Knockin Mice for Genome Editing and Cancer Modeling.” Cell. 2014;159(2):440–455. See also Ruby T, Singh N. “Realizing the Potential of CRISPR: Three Healthcare Executives Share Industry Perspectives on the Future of Genome Editing.” McKinsey, January 2017.
  3. 3. Paine J, Shipton CA, Chaggar S, et al. “Improving the Nutritional Value of Golden Rice through Increased Pro-vitamin A Content.” Nature Biotechnology. 2005;23(4):482–487. See also Simon F, Kotler P. Building Global Biobrands: Taking Biotechnology to Market. New York: Free Press; 2003; p. 4.
  4. 4. Greenwood J. “Unleashing the Promise of Biotechnology to Help Heal, Fuel and Feed the World.” In: Shimasaki C, ed. Biotechnology Entrepreneurship: Starting, Managing and Leading Biotech Companies. Waltham, MA: Elsevier; 2004: 3–13. See also Friedman Y. Building Biotechnology. Washington, DC: Logos Press; 2014.
  5. 5. Clark D, Strumpf D. “Tech Stalwarts Soar to New Highs.” Wall Street Journal. October 24, 2015; Eisen B, Dieterich C, “Apple Market Cap Tops $800 Billion”. Wall Street Journal. May 10, 2017; market cap for Johnson & Johnson, Capital IQ, May 2017.
  6. 6. World Health Organization. MHealth: New Horizons for Health through Mobile Technologies. Global Observatory for eHealth Series, volume 3, 2011; cited in IMS Health Research Institute, Patient Adoption of mHealth, September 2015.
  7. 7. PWC Health Research Institute. Health Wearables: The Early Days. 2014.
  8. 8. Dormehl L. “Why the Anthem Security Breach Was Such a Wake-Up Call for the Health Industry.” Fast Company. February 6, 2015.
  9. 9. Steinberg D, Horwitz G, Zohar D. “Building a Business Model in Digital Medicine.” Nature Biotechnology. 2015;33(9):910–920.
  10. 10. Forrester Research. The State of Consumers and Technology: Benchmark 2015, US.
  11. 11. IMS Institute for Healthcare Informatics. Patient Adoption of mHealth, September 2015.
  12. 12. Steinberg D, Horwitz G, Zohar D. “Building a Business Model in Digital Medicine.” Nature Biotechnology. 2015;33(9):910–920.
  13. 13. Miller R. “Proteus Seeks Pharma Partnerships for Ingestible Sensors.” The Gray Sheet. July 15, 2015.
  14. 14. Neil R. “The Digital Healthcare Revolution Picks Up Speed.” MedTech Insight. July 14, 2015.
  15. 15. Etherington D. “Apple Boasts over 3500 Apple Watch Apps Already Available.” TechCrunch Website. https://techcrunch.com/2015/04/27/apple-boasts-over-3500-apple-watch-apps-already-available/. Published April 27, 2015. Accessed April 18, 2017. Cited in Husson T. “Beyond the Apple Watch Hype–Early Lesson for B2C Marketers.” June 22, 2015.
  16. 16. Michael O'Reilly, VP Medical Technology, Apple, interview by Françoise Simon and Ellen Licking, October 20, 2015.
  17. 17. O'Reilly interview, ibid. See also Apple. “Apple Announces New ResearchKit Studies for Autism, Epilepsy and Melanoma.” https://www.apple.com/pr/library/2015/10/15Apple-Announces-New-ResearchKit-Studies-for-Autism-Epilepsy-Melanoma.html. Published October 15, 2015. Accessed April 18, 2017; for CareKit, see Genes N, “The First CareKit Apps Are Out. What's Next?”, Telemedicine Magazine, March 7, 2017.
  18. 18. Jack Young, former leader of dRx Capital at Qualcomm, interview by Françoise Simon, September 16, 2015. Don Jones, Chief Digital Officer, Scripps Translational Research Institute, interview by Françoise Simon, October 2, 2015; see also dRX Capital website, http://www.dRxcapital.com.
  19. 19. Simon F, Kotler P. Building Global Biobrands: Taking Biotechnology to Market, Free Press, New York, 2003; p. 35.
  20. 20. Paul Grundy, IBM Global Director of Healthcare Transformation, interview by Françoise Simon, October 22, 2015.
  21. 21. IBM Annual Report/SEC Form 10 K, February 24, 2015; see also IBM Annual Report 2016.
  22. 22. Apple. “Japan Post Group, IBM and Apple Deliver iPads and Custom Apps to Connect Elderly in Japan to Services, Family and Community.” https://www.apple.com/pr/library/2015/04/30Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Community.html. Published April 30, 2015. Accessed April 18, 2017.
  23. 23. Medtronic. “IBM and Medtronic Partner to Improve Diabetes Care.” http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2034597. Published April 13, 2015. Accessed April 18, 2017.
  24. 24. Rubenfire A. “IBM's Watson Targets Cancer and Enlists Prominent Providers in the Fight.” Modern Healthcare. May 5, 2015.
  25. 25. Lohr S. “Google to End Health Records Service after It Fails to Attract Users.” New York Times. June 24, 2011. Available at http://www.nytimes.com/2011/06/25/technology/25health.html?_r=1. Accessed April 18, 2017.
  26. 26. Verel D. “Google to Reshape How It Provides Health Information, Mayo Clinic Joins as Partner,” MedCity News. http://medcitynews.com/2015/02/google-seeks-bring-accuracy-online-health-information/. Published February 10, 2015. Accessed April 18, 2017.
  27. 27. Ginsberg J, Mohebbi M, Patel R, Braumer L, Smolinski M, Brilliant L. “Detecting Influenza Epidemics Using Search Engine Query Data.” Nature 2009;457(7232):1012–1014. Available at http://www.nature.com/nature/journal/v457/n7232/full/nature07634.html. Accessed April 18, 2017. See also Lazer D, Kennedy R, King G, Vespignani A. “The Parable of Google Flu Traps in Big Data Analysis.” Science. March 14, 2014;343: 1203–1205. Available at https://gking.harvard.edu/files/gking/files/0314policyforumff.pdf. Accessed April 18, 2017. Cited in Hopkins B. “Google Flu Trends–A Big Data Fail? Not Exactly.” Forrester Research. https://www.forrester.com/Google+Flu+Trends+A+Big+Data+Fail+Not+Exactly/fulltext/-/E-RES116507. Published June 20, 2014. Accessed April 18, 2017.
  28. 28. Sanofi. “Sanofi to Collaborate with Google Life Sciences to Improve Diabetes Health Outcomes.” http://www.news.sanofi.us/2015-08-31-Sanofi-to-Collaborate-with-Google-Life-Sciences-to-Improve-Diabetes-Health-Outcomes. Published August 31, 2015. Accessed April 18, 2017; see also Roland D, Landauro I, “Companies Join to Fight Diabetes”, Wall Street Journal, September 13, 2016.
  29. 29. Comstock J. “DexCom Taps Google for Smaller, Cheaper Diabetes Devices.” MobiHealthNews. http://mobihealthnews.com/46008/dexcom-taps-google-for-smaller-cheaper-diabetes-devices/. Published August 11, 2015. Accessed April 18, 2017.
  30. 30. Winslow R. “Google Joins Heart Research Effort.” Wall Street Journal. November 9, 2015: B5. See also “Google to Collect Data to Define Healthy Human.” Wall Street Journal. July 24, 2014. Available at http://online.wsj.com/articles/google-to-collect-data-to-define-healthy-human-1406246214. Accessed April 18, 2017. See also “Johnson & Johnson Announces Formation of Verb Surgical Inc, in Collaboration with Verily”, press release December 10, 2015. Available at https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-formation-of-verb-surgical-inc-in-collaboration-with-verily. Accessed July 8, 2017.
  31. 31. GSK. “GSK and Verily to Establish Galvani Bioelectronics–A New Company Dedicated to the Development of Bioelectronic Medicines.” http://us.gsk.com/en-us/media/press-releases/2016/gsk-and-verily-to-establish-galvani-bioelectronics-a-new-company-dedicated-to-the-development-of-bioelectronic-medicines. Published August 1, 2016. Accessed April 18, 2017.
  32. 32. Calico. “AbbVie and Calico Announce a Novel Collaboration to Accelerate the Discovery, Development and Commercialization of New Therapies.” http://www.calicolabs.com/news/2014/09/03/. Published September 3, 2014. Accessed April 18, 2017.
  33. 33. GV Portfolio (https://www.gv.com/portfolio/) and Google Capital company data (https://www.capitalg.com).
  34. 34. Macmillan D. “Google Backs Health Insurance Start-Up.” Wall Street Journal. September 7, 2015: B1, B8.
  35. 35. Caradigm.“Caradigm Partners with Eliza Corporation to Improve Patient Outcomes Care Efficiency.” https://www.caradigm.com/en-us/news-and-events/caradigm-partners-with-eliza-corporation-to-improve-patient-outcomes-care-efficiency/. Published April 13, 2015. Accessed April 18, 2017.
  36. 36. Robinson M. “Johns Hopkins Joins Forces with Microsoft to Improve Critical Care.” http://www.microsoft.com/en-us/health/blogs/johns-hopkins-joins-forces-with-microsoft-to-improve-critical-care/default.aspx#fbid=QY6nldkv8EJ. Published October 19, 2015. Accessed April 18, 2017. See also Chase D. “Microsoft Ends Another Vertical Market Dalliance—This Time in Healthcare.” TechCrunch. http://techcrunch.com/2011/12/10/microsoft-ends-dalliance-healthcare/. Published December 10, 2011. Accessed April 18, 2017.
  37. 37. Tan T, “Big Pharma Helps Pour $900 Million Into Grail,” MedTech Insight, March 1, 2017. Available at https://medtech.pharmamedtechbi.com/MT104520/Big-Pharma-Helps-Pour-$900m-Into-Grail. Accessed July 8, 2017.
  38. 38. Friend S. “App-Enabled Trial Participation: Tectonic Shift or Tepid Rumble?” Science Translational Medicine. 2015;7(297):297ed10.

Chapter 2

  1. 1. Hay M, Thomas D, Craighead J, Economides C, Rosenthal J. “Clinical Development Success Rates for Investigational Drugs.” Nature Biotechnology. 2014;32(1):40–51.
  2. 2. Mathers E. “If You Build It, Will It Matter?” Beyond Borders: Matters of Evidence. EY Biotechnology Annual Report. 2013: 5. Available at http://www.ey.com/Publication/vwLUAssets/Beyond_borders/$FILE/Beyond_borders.pdf. Accessed April 19, 2017.
  3. 3. Pharmaceutical Research and Manufacturers of America (PhRMA). Medicines in Development: Biologics 2013 Report. Washington, DC: PhRMA 2013; 6. Available at http://phrma.org/sites/default/files/pdf/biologicsoverview2013.pdf. Accessed April 19, 2017.
  4. 4. Tufts Center for the Study of Drug Development. How the Tufts Center for the Study of Drug Development Pegged the Cost of a New Drug at $2.6 Billion. Boston: Tufts University; 2014. Available at http://csdd.tufts.edu/files/uploads/cost_study_backgrounder.pdf. Accessed April 19, 2017.
  5. 5. Data derived from the respective companies' financial statements, available at US Securities and Exchange Commission Website, EDGAR Company Search. http://www.sec.gov/edgar/searchedgar/companysearch.html. Accessed April 19, 2017.
  6. 6. Bosley K.“Life of a Start-up CEO: Priorities and Preparation.” In: EY, Beyond Borders: Reaching New Heights. Biotechnology Industry Report 2015. Available at http://www.ey.com/Publication/vwLUAssets/EY-beyond-borders-2015/$FILE/EY-beyond-borders-2015.pdf. Accessed April 19, 2017.
  7. 7. EY analysis based on data from Capital IQ and VentureSource databases.
  8. 8. Bosley K. “Life of a Start-up CEO: Priorities and Preparation.” In: EY, Beyond Borders: Reaching New Heights. Biotechnology Industry Report 2015. Available at http://www.ey.com/Publication/vwLUAssets/EY-beyond-borders-2015/$FILE/EY-beyond-borders-2015.pdf. Accessed April 19, 2017.
  9. 9. Mass Medical Angels MA2 Website. http://www.massmedangels.com/. Accessed April 19, 2017. See also Life Sciences Angels Website. http://lifescienceangels.com/about/. Accessed April 19, 2017.
  10. 10. Sohl J. “The Angel Investor Market in Q1Q2 2015: Modest Changes in Deals and Dollars.” Center for Venture Research. https://paulcollege.unh.edu/sites/paulcollege.unh.edu/files/webform/Q1Q2%202015%20Analysis%20Report%20FINAL.pdf. Published January 15, 2016. Accessed April 19, 2017.
  11. 11. Timmerman L. “Crowdfunding Is Coming to Biotech, so Get Ready for a Wild Ride.” Xconomy. http://www.xconomy.com/national/2013/01/28/crowdfunding-is-coming-to-biotech-so-get-ready-for-a-wild-ride/. Published January 28, 2013. Accessed April 19, 2017.
  12. 12. Bancroft D.“Biotech Crowdfunding in Europe: Trendy but Only 0.2% of Total VC Money Raised since 2010.” Labiotech. European Biotech News Website. http://labiotech.eu/biotech-crowdfunding-in-europe-trendy-but-only-0-2-of-total-vc-money-raised-since-2010/. Published July 9, 2015. Accessed April 19, 2017. See also Kelly E.“Life Science Start-Ups Turning to Crowdfunding,” Science Business News Website. http://www.sciencebusiness.net/news/77188/Life-science-start-ups-turning-to-crowdfunding. Published September 10, 2015. Accessed April 19, 2017.
  13. 13. EY analysis based on various primary data sources, including review of the financial statements included in the relevant IPO documents and Capital IQ and VentureSource databases.
  14. 14. Booth B.“Debunking Corporate Venture Capital in Biotech.” Life Sci VC Website. https://lifescivc.com/2011/09/debunking-corporate-venture-capital-in-biotech/. Published September 15, 2011. Accessed April 19, 2017.
  15. 15. Google Ventures (GV) Life Sciences Portfolio Investments Website. https://www.gv.com/portfolio/#life. Accessed June 2016.
  16. 16. WebMD. “Cystic Fibrosis—Topic Overview.” http://www.webmd.com/children/tc/cystic-fibrosis-topic-overview. Accessed April 19, 2017.
  17. 17. Cystic Fibrosis Foundation Website. “CF Foundation Venture Philanthropy.” https://www.cff.org/Our-Research/Our-Research-Approach/Venture-Philanthropy/. Accessed April 19, 2017.
  18. 18. Aurora Biosciences Corporation Form 10-K for Year ended December 31, 1999. http://www.sec.gov/Archives/edgar/data/1010919/000091205700011002/0000912057-00-011002.txt. Accessed April 19, 2017.
  19. 19. Pollack A. “Deal by Cystic Fibrosis Foundation Raises Cash and Some Concern.” New York Times. November 19, 2014. Available at https://www.nytimes.com/2014/11/19/business/for-cystic-fibrosis-foundation-venture-yields-windfall-in-hope-and-cash.html?_r=0. Accessed April 19, 2017.
  20. 20. Walker J, Rockoff J. “Cystic Fibrosis Foundation Sells Drug's Rights for $3.3 Billion: The Biggest Royalty Purchase Ever Reflects Group's Share of Kalydeco Sales.” Wall Street Journal. November 19, 2014. Available at http://www.wsj.com/articles/cystic-fibrosis-foundation-sells-drugs-rights-for-3-3-billion-1416414300?alg=y. Accessed April 19, 2017.

Chapter 3

  1. 1. Czerpak EA, Ryser S. “Drug Approvals and Failures: Implications for Alliances.” Nature Reviews Drug Discovery. 2008;7: 197–198.
  2. 2. Booth B. “Transformational Late Stage Drugs Delivered through Deal-Making,” Life Sci VC Website. http://lifescivc.com/2014/03/transformational-late-stage-drugs-delivered-through-deal-making/. Published March 21, 2014. Accessed April 20, 2017.
  3. 3. Berkrot B. “Success Rates for Experimental Drugs Falls: Study.” Reuters Health News Website. http://www.reuters.com/article/us-pharmaceuticals-success-idUSTRE71D2U920110214. Published February 14, 2011. Accessed April 20, 2017.
  4. 4. Lo A, Pisano G. “Lessons from Hollywood: A New Approach to Funding R&D.” MIT Sloan Management Review. 2015;57 (2). Bernal L. “Why Pharma Must Go Hollywood.” The Scientist. 2017;21 (2):42–45.
  5. 5. Morgan Stanley Research. “Pharmaceuticals: Exit Research and Create Value.” January 20, 2010.
  6. 6. Bluestein A. “Will Johnson & Johnson's New Innovation Centers Point the Way Toward Its Future?” Fast Company. http://www.fastcompany.com/3025556/keeping-up-with-the-johnsons. Published January 20, 2010. Accessed April 20, 2017. Senior M. “J&J Courts Biotech in Clusters.” Nature Biotechnology. 2013;31; 769–770.
  7. 7. Index Ventures. “Index Ventures Launches New €150 Million Life Sciences Fund.” https://indexventures.com/news-room/news/index-ventures-launches-new-%E2%82%AC150m-life-sciences-fund. Published March 21, 2012. Accessed April 20, 2017.
  8. 8. Jarvis J. “Pfizer's Academic Experiment.” Chemical & Engineering News. 2012;90 (40):28–32. http://cen.acs.org/articles/90/i40/Pfizers-Academic-Experiment.html. Accessed April 20, 2017.
  9. 9. UCB Pharma. “UCB Leads Epilepsy Hackathon to Support Patient Needs through Digital Tools and Services.” http://www.cureepilepsy.org/downloads/articles/UCB-hackathon.pdf. Published February 18, 2015. Accessed April 20, 2017.
  10. 10. EY. “Firepower Index and Growth Gap Report 2016.” http://www.ey.com/GL/en/Industries/Life-Sciences/EY-vital-signs-firepower-index-and-growth-gap-report-2016. Accessed April 20, 2017.
  11. 11. For example, the page on Merck's website that describes licensing, available at http://www.merck.com/licensing/home_licensing.html. Accessed April 20, 2017.
  12. 12. Carroll J.“Novartis Options Proteon Therapeutics for $550 M.” FierceBiotech Website. http://www.fiercebiotech.com/story/novartis-options-proteon-therapeutics-550m/2009-03-05. Published March 5, 2009. Accessed April 20, 2017.
  13. 13. Carroll J.“Constellation Inks $95 M Discovery Deal, Buyout Option with Genentech.” FierceBiotech Website. http://www.fiercebiotech.com/story/constellation-inks-95m-discovery-deal-buyout-option-genentech/2012-01-16. Published January 16, 2012. Accessed April 20, 2017. Fidler B.“Constellation Pharma Plots IPO Run as Genentech Passes on Buyout Deal.” Xconomy Website. http://www.xconomy.com/boston/2015/08/24/constellation-pharma-plots-ipo-run-as-genentech-passes-on-buyout-deal/. Published August 24, 2015. Accessed April 20, 2017.
  14. 14. McBride R.“Updated: Fueled by Sanofi, Warp Drive Bio Takes off with $125 M Deal.” FierceBiotech Website. http://www.fiercebiotech.com/story/fueled-sanofi-warp-drive-bio-takes-125m-deal/2012-01-10. Published January 10, 2012. Accessed April 20, 2017.
  15. 15. Genentech. “Genentech and Roche Holding Ltd. Form Pioneering Relationship; Roche to Own 60 Percent of an Independent Genentech.” http://www.gene.com/media/press-releases/4305/1990-02-02/genentech-and-roche-holding-ltd-form-pio. Published February 2, 1990. Accessed April 20, 2017.
  16. 16. Genentech. “Genentech Stockholders Approve Roche's Extended Buyout Option.” http://www.gene.com/media/press-releases/4728/1995-10-25/genentech-stockholders-approve-roches-ex. Published October 25, 1995. Accessed April 20, 2017.
  17. 17. Infinity Pharmaceuticals. “Infinity Announces Global Strategic Alliance with Purdue Pharma and Mundipharma Encompassing Infinity's Early Clinical and Discover Programs.” Nasdaq GlobalNewswire Website. https://globenewswire.com/news-release/2008/11/20/388767/155108/en/Infinity-Announces-Global-Strategic-Alliance-With-Purdue-Pharma-and-Mundipharma-Encompassing-Infinity-s-Early-Clinical-and-Discovery-Programs.html. Published November 20, 2008. Accessed April 20, 2017.
  18. 18. Pierson R. “Sanofi to Buy 12 Percent of Alnylam, Expands Rare-Disease Drug Deal.” Reuters Website. http://www.reuters.com/article/us-sanofi-alnylam-idUSBREA0C07K20140113. Published January 13, 2014. Accessed April 20, 2017.
  19. 19. Roche. “Roche Enters a Broad Strategic Collaboration with Foundation Medicine in the Field of Molecular Information in Oncology.” http://www.roche.com/media/store/releases/med-cor-2015-01-12.htm. Published January 12, 2015. Accessed April 20, 2017.
  20. 20. Menzel G, Xanthopoulos K. “Securing a Partner Is Only the Beginning—You then Have to Put Substantial Effort and Resources into Keeping the Collaboration Functioning and Productive.” Bioentrepreneur (Nature Biotechnology) Website. http://www.nature.com/bioent/2012/120201/full/bioe.2012.2.html. Published February 23, 2012. Accessed April 20, 2017.

Chapter 4

  1. 1. Personalized Medicine Coalition. The Case for Personalized Medicine. 4th ed. Washington, DC: Personalized Medicine Coalition; 2014. Available at http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/pmc_the_case_for_personalized_medicine.pdf. Accessed April 21, 2017.
  2. 2. Biotechnology Industry Organization, Biomedtracker, Amplion. Clinical Development Success Rates: 2006–2015. Report, June 2016. Available at https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf. Accessed April 21, 2017.
  3. 3. About the Precision Medicine Initiative Cohort Program, National Institutes of Health webpage (https://www.nih.gov/precision-medicine-initiative-cohort-program).
  4. 4. Naylor S. “What's in a Name? The Emergence of P-Medicine.” The Journal of Precision Medicine. October/November 2015; 15–29. Available at http://www.thejournalofprecisionmedicine.com/wp-content/uploads/2015/10/NAYLOR.pdf. Accessed April 21, 2017.
  5. 5. Mara Aspinall, Executive Chairman of GenePeeks and CA Therapeutics and cofounder of the School of Biomedical Diagnostics, personal correspondence, February 2016.
  6. 6. Tozzi J. “Drugs Could Soon Come with a Money-Back Guarantee.” Bloomberg Businessweek, October 8, 2015. Available at http://www.bloomberg.com/news/articles/2015-10-08/drugs-could-soon-come-with-a-money-back-guarantee. Accessed April 21, 2017.
  7. 7. Senior M. “How Patients Are Transforming Pharma R&D.” In Vivo Website. Published May 9, 2016. https://invivo.pharmamedtechbi.com/IV004513/How-Patients-Are-Transforming-Pharma-RampD. Accessed April 21, 2017.
  8. 8. National Institute for Health and Care Excellence. Technology Appraisal Guidance, 2014. https://www.nice.org.uk/process/pmg19/chapter/1-acknowledgements.
  9. 9. Kolata G, “F.D.A. Approves Repatha, a Second Drug for Cholesterol in a Potent New Class.” New York Times. August 27, 2015. Available at http://www.nytimes.com/2015/08/28/health/fda-approves-another-in-a-new-class-of-cholesterol-drugs.html?_r=0. Accessed April 21, 2017.
  10. 10. Hirschler B, “New Heart Drugs Struggle to Win Sales as Doctors Hold Back.” Reuters Health News Website. http://www.reuters.com/article/us-health-heart-drug-idUSKCN0XI0T6. Published April 21, 2016. Accessed April 21, 2017.
  11. 11. Lincoln Nadauld, Director, Cancer Genomics at InterMountain Healthcare, personal correspondence, February 2016.
  12. 12. Nadauld L, Van Norman SB, Fulde G, et al. “Precision Medicine to Improve Survival Without Increasing Costs in Advanced Cancer Patients.” Journal of Clinical Oncology. 2015; 33. (suppl; abstr e17641). Available at http://meetinglibrary.asco.org/content/152750-156. Accessed April 21, 2017.
  13. 13. Kaiser Permanente.“Connectivity: Comprehensive Health Information at Your Fingertips.” https://share.kaiserpermanente.org/total-health/connectivity/. Accessed April 21, 2017.
  14. 14. Minor L. “We Don't Just Need Precision Medicine, We Need Precision Health.” Forbes. http://www.forbes.com/sites/valleyvoices/2016/01/06/we-dont-just-need-precision-medicine-we-need-precision-health/#60f6ddb6415e. Published January 6, 2016. Accessed April 21, 2017.
  15. 15. US Food and Drug Administration. “FDA Approves New Pill to Treat Certain Patients with Non-Small Cell Lung Cancer.” http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm472525.htm. Published November 13, 2015. Accessed April 21, 2017.
  16. 16. Boggs J. “AstraZeneca Concedes NSCLC Drug Iressa in U.S. Withdrawal.” BioWorld Website. http://www.bioworld.com/content/astrazeneca-concedes-nsclc-drug-iressa-us-withdrawal. Published May 29, 2012. Accessed April 21, 2017.
  17. 17. Dennis B, Bernstein L. “Cancer Trials Are Changing. That Could Mean Faster Access to Better Drugs.” The Washington Post. June 1, 2015. Available at https://www.washingtonpost.com/national/health-science/paradigm-change-in-the-development-of-cancer-drugs/2015/06/01/09fcb4c4-086e-11e5-95fd-d580f1c5d44e_story.html. Accessed April 21, 2017.
  18. 18. “The Top 15 Best-Selling Drugs of 2016,” Genetic Engineering News, March 6, 2017. Available at http://www.genengnews.com/the-lists/the-top-15-best-selling-drugs-of-2016/77900868.
  19. 19. US Food and Drug Administration. “FDA Approves First Companion Diagnostic to Detect Gene Mutation Associated with a Type of Lung Cancer.” May 13, 2014.
  20. 20. Staton T. “BMS' Opdivo Gets a Jump on Keytruda with Another Early FDA Approval.” FiercePharma Website. http://www.fiercepharma.com/regulatory/bms-opdivo-gets-a-jump-on-keytruda-another-early-fda-approval. Published October 12, 2015. Accessed April 21, 2017.
  21. 21. Loftus P, Rockoff J, Steele A. “Bristol Myers: Opdivo Failed to Meet Endpoint in Key Lung-Cancer Study.” Wall Street Journal. August 5, 2016. Available at http://www.wsj.com/articles/bristol-myers-opdivo-failed-to-meet-endpoint-in-key-lung-cancer-study-1470400926. Accessed April 21, 2017. See also U.S. Food & Drug Administration. “FDA Approves First Cancer Treatment for Any Solid Tumor with a Specific Genetic Feature.” U.S. Department of Health and Human Services website. Published May 23, 2017. Available at: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm560167.htm. Accessed July 17, 2017.
  22. 22. Rockoff J, Loftus P. “Bristol-Myers Bucks Trend Toward Precision Medicine.” Wall Street Journal. March 13, 2016. Available at http://www.wsj.com/articles/bristol-bucks-trend-toward-precision-medicine-1457912801. Accessed April 21, 2017.
  23. 23. Armour A, Watkins C. “The Challenge of Targeting EGFR: Experience with Gefitinib in Non-Small Cell Lung Cancer.” European Respiratory Review. 2010;19: 186–196. Available at http://err.ersjournals.com/content/19/117/186. Accessed April 21, 2017.
  24. 24. De Bock A.“Iressa (gefitinib): The Journey.” A presentation by AstraZeneca Portfolio Leader Oncology/Infection Anne De Bock, May 2011. Available at https://ec.europa.eu/research/health/pdf/event06/12052011/anne-debock_en.pdf. Accessed April 21, 2017.
  25. 25. Schattner E. “Companion Diagnostics? For Cancer Care, We Need Better Ones.” Forbes. http://www.forbes.com/sites/elaineschattner/2015/11/19/companion-diagnostics-why-we-need-more-and-better-ones-to-optimize-cancer-care/#5b2ce2996003. Published November 19, 2015. Accessed April 21, 2017.
  26. 26. Relling M, Evans W. “Pharmacogenomics in the Clinic.” Nature. 2015;526:343–350. Available at http://www.nature.com/nature/journal/v526/n7573/full/nature15817.html. Accessed April 21, 2017.
  27. 27. Audette J. “Biomarker Trends: 73% Growth in the Use of Companion Diagnostic Biomarkers.” Amplion Website. http://www.amplion.com/biomarker-trends/73-growth-in-use-of-companion-diagnostic-biomarkers/. Published October 19, 2015. Accessed April 21, 2017.
  28. 28. Getz K, Stergiopoulos, Kim JY. “The Adoption and Impact of Adaptive Trial Designs.” R&D Senior Leadership Brief. Boston, MA: Tufts Center for the Study of Drug Development, February 13, 2013. Available at https://www.iconplc.com/icon-files/docs/thought-leadership/premium/TuftsCSDD_Adaptive-Design-Trials-Sr-Mgmt-Brief_May2013.pdf. Accessed April 21, 2017. See also Woodcock J, Lavange L. “Master Protocols To Study Multiple Therapies, Multiple Diseases, Or Both.” New England Journal Of Medicine 2017; 377:62-70. Accessed July 17, 2017.
  29. 29. Schork N. “Personalized Medicine: Time for One-Person Trials.” Nature. 2015;520: 609–611. Available at http://www.nature.com/news/personalized-medicine-time-for-one-person-trials-1.17411. Accessed April 21, 2017. See also Demeyin W, Frost J, Ukoumunne O, Briscoe S, Britten N. “N of 1 Trials and the Optimal Individualisation of Drug Treatments: A Systematic Review.” Systematic Reviews 2017 6:90. Accessed July 17, 2017.
  30. 30. Hayes D, et al. “Breaking a Vicious Cycle.” Science Translational Medicine. 2013;5, 196cm6.
  31. 31. Schork N. “Personalized Medicine: Time for One-Person Trials.” Nature. 2015;520: 609–611. Available at http://www.nature.com/news/personalized-medicine-time-for-one-person-trials-1.17411. Accessed April 21, 2017.
  32. 32. Food & Drug Administration. In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff. Rockville, MD: US Department of Health and Human Services, August 6, 2014. Available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM262327.pdf. Accessed April 21, 2017.
  33. 33. Pothier K, Gustavsen G. “Combating Complexity: Partnerships in Personalized Medicine.” Personalized Medicine. 2013;10(4):387–396.
  34. 34. Hayes D, et al. “Breaking a Vicious Cycle.” Science Translational Medicine. 2013;5, 196cm6.
  35. 35. National Institute of Health and Care Excellence. “EGFR-TK Mutation Testing in Adults with Locally Advanced or Metastatic Non-Small-Cell Lung Cancer.” NICE Diagnostics Guidance. https://www.nice.org.uk/guidance/dg9/chapter/3-Clinical-need-and-practice. Published August 2013. Accessed April 21, 2017.
  36. 36. Domchek SM, Bradbury A, Garber JE, Offit K, Robson ME. “Multiplex Genetic Testing for Cancer Susceptibility: Out on the High Wire Without a Net?” Journal of Clinical Oncology. 2013;31(10):1267–1270.
  37. 37. Thermo Fisher Scientific. “Thermo Fisher Scientific Signs Development Agreement for Next-Generation Sequencing-Based Companion Diagnostic.” http://news.thermofisher.com/press-release/life-technologies/thermo-fisher-scientific-signs-development-agreement-next-generation. Published November 18, 2015. Accessed April 21, 2017.
  38. 38. Global Genomics Group. “Global Genomics Group (G3) Partners with Sanofi to Identify New Signaling Pathways in Atherosclerotic Cardiovascular Diseases.” PR Newswire Website. http://www.prnewswire.com/news-releases/global-genomics-group-g3-partners-with-sanofi-to-identify-new-signaling-pathways-in-atherosclerotic-cardiovascular-diseases-300195426.html. Published January 5, 2016. Accessed April 21, 2017.
  39. 39. Human Longevity, Inc. “Human Longevity, Inc. Announces 10 Year Deal with AstraZeneca to Sequence and Analyze Patient Samples from AstraZeneca Clinical Trials.” http://www.humanlongevity.com/human-longevity-inc-announces-10-year-deal-with-astrazeneca-to-sequence- and-analyze-patient-samples-from-astrazeneca-clinical-trials/. Published April 21, 2016. Accessed April 21, 2017. See also Mack H. “Verily, Stanford, and Duke Kick Off Project Baseline Study to Develop Broad Reference to Human Health.” Mobihealth News, April 20, 2017. Available at: http://www.mobihealthnews.com/content/verily-stanford-and-duke-kick-project-baseline-study-develop-broad-reference-human-health. Accessed July 17, 2017.
  40. 40. Lung-MAP Clinical Trial. http://www.lung-map.org. Accessed April 21, 2017.
  41. 41. US Food & Drug Administration Biomarker Qualification Program. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/BiomarkerQualification Program/default.htm. Accessed April 21, 2017.
  42. 42. About PrecisionFDA. https://precision.fda.gov/about. Accessed April 21, 2017.
  43. 43. Mike Capone, COO, Medidata, personal correspondence, March 7, 2016.
  44. 44. Molteni M. “Medicine Is Going Digital. The FDA Is Racing to Catch Up.” Wired. Published May 22, 2017. https://www.wired.com/2017/05/medicine-going-digital-fda-racing-catch. Accessed July 17, 2017. See also European Medicines Agency. “Work Programme 2016. London: European Medicines Agency. July 5, 2016. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Work_programme/2016/03/WC500202857.pdf. Accessed April 21, 2017.
  45. 45. Foundation Medicine. “IMS Health and Foundation Medicine Announce Collaboration to Optimize Targeting of Precision Therapies in Oncology.” http://investors.foundationmedicine.com/releasedetail.cfm?releaseid=918859Published June 22, 2105. Accessed April 24, 2017.
  46. 46. Oracle. “Oracle Powers Precision Medicine Delivery with New Solution Connecting Research, Pathology and Clinical Care.” https://www.oracle.com/corporate/press/oracle-precision-medicine-012516.html. Published January 25, 2016. Accessed April 24, 2017.
  47. 47. National Academies of Sciences, Engineering, Medicine. “Roundtable on Genomics and Precision Health.” http://www.nationalacademies.org/hmd/Activities/Research/GenomicBasedResearch.aspx. Accessed April 24, 2017.
  48. 48. Independence Blue Cross. “Independence Blue Cross Becomes First Major Insurer to Cover Next-Generation Whole Genome Sequencing for a Variety of Cancers.” http://news.ibx.com/independence-blue-cross-becomes-first-major-insurer-to-cover-next-generation-whole-genome-sequencing-for-a-variety-of-cancers/.) Published January 11, 2016. Accessed April 24, 2017.
  49. 49. Buzyn A. “How INCa Is Supporting the Development of Personalized Medicine.” Presented at WIN2013, July 10–12, 2013. Available at http://www.winsymposium.org/wp-content/uploads/2013/07/WIN2013_Agnes-Buzyn-REVISED.190713.pdf. Accessed April 24, 2017.
  50. 50. Personalized Medicine Coalition. “The Case for Personalized Medicine.” 4th ed. Washington, DC: Personalized Medicine Coalition; 2014. Available at http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/pmc_the_case_for_personalized_medicine.pdf. Accessed April 24, 2017.
  51. 51. Qiagen. “QIAGEN and Lilly Collaborate to Co-Develop Companion Diagnostics for Simultaneous Analysis of DNA and RNA Biomarkers in Common Cancers.” PR Newswire Website. http://www.prnewswire.com/news-releases/qiagen-and-lilly-collaborate-to-co-develop-companion-diagnostics- for-simultaneous-analysis-of-dna-and-rna-biomarkers-in-common-cancers-261199831.html. Published May 30, 2014. Accessed April 24, 2017.
  52. 52. Adaptive Biotechnologies Corporation. “Adaptive Announces a Biomarker Discovery Agreement with Johnson & Johnson Innovation.” PR Newswire Website. http://www.prnewswire.com/news-releases/adaptive-announces-a-biomarker-discovery-agreement-with-johnson--johnson-innovation- 239926921.html. January 13, 2014. Accessed April 24, 2017.
  53. 53. Senior M. “How Patients Are Transforming Pharma R&D.” In Vivo Website. Published May 9, 2016. https://invivo.pharmamedtechbi.com/IV004513/How-Patients-Are-Transforming-Pharma-RampD. Accessed April 21, 2017.
  54. 54. Tom Miller, cofounder and managing partner, GreyBird Ventures, personal correspondence, February 8, 2016.
  55. 55. Mara Aspinall, executive chairman of GenePeeks and CA Therapeutics and cofounder of the School of Biomedical Diagnostics, personal correspondence, February 2016.
  56. 56. Chen C. “Google's Huber to Lead Illumina Cancer-Detecting Startup Grail.” Bloomberg Technology. http://www.bloomberg.com/news/articles/2016-02-10/google-s-huber-to-lead-illumina-cancer-detecting- startup-grail. Published February 10, 2016. Accessed April 24, 2017.

Chapter 5

  1. 1. Loftus P. “US Drug Spending Climbs.” Wall Street Journal. April 14, 2016; B3; see also Aitken M, “Medicines Use and Spending in the US,” Quintiles IMS Institute, May 2017.
  2. 2. Aitken M, Outlook for Global Medicines Through 2021, Quintiles IMS Institute, December 2016.
  3. 3. Birth A.“Whether Prescribed or Over-The-Counter, Americans Prefer Generics.” Harris Poll. December 2, 2015.
  4. 4. IMS Institute for Healthcare Informatics. “Medicines Use and Spending in the US: A Review of 2015 and Outlook to 2020.” IMS Health Website. http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports/medicines-use-and-spending-in-the-us-a-review-of-2015-and-outlook-to-2020. Accessed April 26, 2017; see also Aitken M, “Medicines Use and Spending in the US,” op. cit.
  5. 5. Experts in Chronic Myeloid Leukemia, Abboud C, Berman E, et al. “The Price of Drugs for Chronic Myeloid Leukemia (CML) Is a Reflection of the Unsustainable Prices of Cancer Drugs: From the Perspective of a Large Group of CML Experts.” Blood. 2013;121(22):4439–4442.
  6. 6. Bennette C, Richards C, Sullivan S, et al. “Steady Increases in Prices for Oral Anticancer Drugs after Market Launch Suggest a Lack of Competitive Pressures.” Health Affairs. 2016;35 (5):805–812.
  7. 7. Knutsen RM.“Rare Disease Drugs Facing Questions Over Prices, Incentives.” Medical Marketing and Media website. http://www.mmm-online.com/rare-disease-drugs-facing-questions-over-prices-incentives/printarticle/478088/. February 22, 2016. Accessed April 26, 2017. For drug sales, see “The Top 15 Best-Selling Drugs of 2016,” Genetic Engineering News, March 6, 2017. Available at http://www.genengnews.com/the-lists/the-top-15-best-selling-drugs-of-2016/77900868.
  8. 8. Kaplan H.“Preparing for the Zero Moment of Truth: Managing Early Awareness in Rare Disease Drug Commercialization.” In Vivo. April 13, 2016.
  9. 9. “Patient Engagement and Patient Use of Evidence.” Health Affairs. 2016; 35(4):744.
  10. 10. Wenzel M, Hall C.“Opposites Attract: Pairing R&D and Commercial Teams.” Pharmaceutical Executive. May 5, 2015. Available at http://www.pharmexec.com/opposites-attract-pairing-rd-and-commercial-teams. Accessed April 26, 2017. See also Bailey CJ. “Why Is Exubera Being Withdrawn?” British Medical Journal. 2007; 335(7630):1156.
  11. 11. Wenzel M, Hall C, ibid.
  12. 12. Magids S, Zorfas A, Leemon D.“The New Science of Customer Emotions.” Harvard Business Review. 2015. (November): 68–76. Available at https://hbr.org/2015/11/the-new-science-of-customer-emotions. Accessed April 26, 2017.
  13. 13. Edelman D.“Branding in the Digital Age: You're Spending Your Money in All the Wrong Places.” Harvard Business Review. 2010; (December): 2–8. Available at https://hbr.org/2010/12/branding-in-the-digital-age-youre-spending-your-money-in-all-the-wrong-places. Accessed April 26, 2017.
  14. 14. Fox B, Hofmann C, Paley A.“How Pharma Companies Can Better Understand Patients.” McKinsey & Company Website. http://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/how-pharma-companies-can-better-understand-patients. Published May 2016. Accessed April 26, 2017. See also Bell D, Fox B, Olohan R. Pharma3D: Rewriting the Script for Marketing in the Digital Age. Google, McKinsey & Company, 2016.
  15. 15. Simon F, Kotler P. Building Global Biobrands: Taking Biotechnology to Market. New York: Free Press; 2003: 109–110.
  16. 16. Simon F, Kotler P, op. cit., 118–120.
  17. 17. “The Top 15 Best-Selling Drugs of 2016,” Genetic Engineering News, March 6, 2017. Available at http://www.genengnews.com/the-lists/the-top-15-best-selling-drugs-of-2016/77900868.
  18. 18. Simon F, Kotler P, op. cit, 142–143. See also Merrill J.“Among New Drug Launches, Oncology Scores Big While CV Lags.” Pink Sheet. March 28, 2016. Sutter S.“Pitting Crestor Against Lipitor Misses the Mark.” Pink Sheet. September 5, 2011. For Crestor sales, see Pharmacompass, “Top Drugs by Sales Revenue in 2015, Who Sold the Biggest Blockbuster Drugs,” March 10, 2016. Available at https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-revenue-in-2015-who-sold-the-biggest-blockbuster-drugs. Accessed April 26, 2017.
  19. 19. The Top 15 Best-Selling Drugs of 2016, op. cit.
  20. 20. Longman R.“The Shrinking Value of Best-in-Class and First-in-Class Drugs,” In Vivo. July 20, 2015. Available at https://www.pharmamedtechbi.com/publications/in-vivo/33/7/the-shrinking-value-of-bestinclass-and-firstinclass-drugs. Accessed April 26, 2017.
  21. 21. Dysart J.“Diagnostic Companions.” Medical Marketing and Media. June 2014; 26–30; for Xalkori sales, see Datamonitor/Decision Resources Group database, 2016.
  22. 22. Crow D, “Lung Cancer Drug Failure in Trials Deals $23bn Blow to Bristol-Myers Squibb”, Financial Times, August 6/7, 2016; see also “FDA Approves First Cancer Treatment For Any Solid Tumor with a Specific Genetic Feature”, FDA news release, May 23, 2017 (https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm560167.htm); Helfand C, “In Unexpected Blow, Merck Halts Keytruda Myeloma Trial Enrollment to Probe Patient Deaths”, Fierce Pharma, June 13, 2017 (http://www.fiercepharma.com/pharma/merck-halts-keytruda-myeloma-study-enrollment-to-gather-info-trial-deaths); Helfand C, “With Asco Data Tallied, Bristol-Myers Loses Ground to Merck in I-O Field, Fierce Pharma, June 7, 2017 (http://www.fiercepharma.com/pharma/asco-data-tallied-bristol-myers-falls-farther-behind-merck-i-o-field); “Phase III Study Evaluating The Safety and Efficacy of Adjuvant Opdivo in Resected High-Risk Melanoma Patients Meets Primary Endpoint”, Bristol-Myers press release, July 5, 2017.
  23. 23. Schnipper L, Abel G. “Direct-to-Consumer Drug Advertising in Oncology Is Not Beneficial to Patients or Public Health.” JAMA Oncology. 2016; 2(11):1397–1398.
  24. 24. Simon F, Kotler P, op. cit, 114–116.
  25. 25. Simon F, Kotler P, op. cit, 149–151.
  26. 26. Dobrow L.“Community Clash.” Medical Marketing and Media. April 2017; 31–39.
  27. 27. Vranica S. “Catch Me If You Can.” Wall Street Journal. June 22, 2016; R1; Sharma A. “Big Media Needs to Embrace Digital Shift – Not Fight It.” Wall Street Journal. June 22, 2016; R1, R2.
  28. 28. American Medical Association.“AMA Calls for Ban on Direct to Consumer Advertising of Prescription Drugs and Medical Devices.” https://www.ama-assn.org/content/ama-calls-ban-direct-consumer-advertising-prescription-drugs-and-medical-devices. Published November 17, 2015. Accessed April 26, 2017.
  29. 29. Dobrow L, “Gut Check,” Medical Marketing and Media, April 2016, 27–33.
  30. 30. Mahoney S.“How to Seize Your Omnichannel Moment.” Medical Marketing and Media. March 15, 2016. Available at http://www.mmm-online.com/features/how-to-seize-your-omnichannel-moment/article/481839/. Accessed April 26, 2017.
  31. 31. Darling P. “Commercial Models for a New Healthcare Ecosystem.” PharmExec.com website. http://www.pharmexec.com/commercial-models-new-healthcare-ecosystem. Published January 28, 2016. Accessed April 26, 2017.
  32. 32. Vranica S, op. cit., R1, R2.
  33. 33. Mayo Clinic Staff. “Type 2 Diabetes.” Mayo Clinic website. http://www.mayoclinic.org/diseases-conditions/type-2-diabetes/diagnosis-treatment/treatment/txc-20169988. Accessed June 24, 2016.
  34. 34. Merck Manuals Online. https://www.merckmanuals.com/. Accessed June 24, 2016. Porter RS. The Merck Manual. 19th Ed. West Point, PA: Merck & Co., 2011.
  35. 35. Greenwood T.“Sales and Marketing: Reaching the Unreachables.” Modern Marketing Concepts website. http://www.mmcweb.com/sales-marketing-reaching-the-unreachables/. Published January 16, 2016. Accessed April 26, 2017.
  36. 36. Groebel R.“Cloud Marketing: Faces in the Cloud.” Medical Marketing and Media website. http://www.mmm-online.com/cloud-marketing-faces-in-the-cloud/printarticle/440390. Published September 25, 2015. Accessed April 26, 2017.
  37. 37. Edmunds R, Danner S, Padilla N. “Tomorrow's Selling Strategies: Invest and Test.” Pharmaceutical Executive. 2015;35(3). Available at http://www.pharmexec.com/tomorrow-s-selling-strategies-invest-test. Accessed April 26, 2017.
  38. 38. Cohen J.“Biosimilars: Improving Patient Access to Biologics While Bending the Cost Curve.” In Vivo Pharma Intelligence website. https://invivo.pharmamedtechbi.com/IV004385/Biosimilars-Improving-Patient-Access-To-Biologics-While-Bending-The-Cost-Curve. Published June 8, 2015. Accessed April 26, 2017.
  39. 39. Celia F.“Brand Development Strategies: Golden Oldies.” Medical Marketing and Media website. http://www.mmm-online.com/features/brand-development-strategies-golden-oldies/article/433923/. Published August 26, 2015. Accessed April 26, 2017.
  40. 40. Subramanian R, Baqri R.“Branding: When One Is Not Enough.” Pharmaceutical Executive website. http://www.pharmexec.com/branding-when-one-not-enough. Published February 3, 2016. Accessed April 26, 2017.
  41. 41. Laffler MJ.“Roche: Slow and Steady Wins the Race.” Pink Sheet. April 19, 2016.
  42. 42. Simon F, Kotler P. Building Global Biobrands, op. cit., 164.
  43. 43. Scala S, Miner K, Issi L, et al. “Pharmaceutical Industry Pulse.” Cowen Equity Research Report, March 2016; 212–221.
  44. 44. Buck Luce, C, Jaggi G. Progressions: Building Pharma 3.0. Report, EY; 2011: 46–47.
  45. 45. Simon F, Kotler P, op. cit., 186–187, 195, 199–200.
  46. 46. Cohen J., op. cit.
  47. 47. Zhan P, Bolger T, Renjen V.“The Birth of an Orphan Biosimilar Market.” In Vivo Pharma Intelligence website. https://invivo.pharmamedtechbi.com/IV004469/The-Birth-Of-An-Orphan-Biosimilar-Market. Published February 17, 2016. Accessed April 26, 2017.

Chapter 6

  1. 1. Coulter A. “Patient Engagement—What Works?” Journal of Ambulatory Care Management. 2012;35(2):80–89; see also Coulter A, Ellins J. “Effectiveness of Strategies for Informing, Educating and Involving Patients. ” British Medical Journal. 2007;335(7609):24–27.
  2. 2. Senior M.“Outcomes-Focused Payers, New Technologies and Empowered Consumers Are Pushing Pharma Towards Patient-Centric Drug Development and Commercialization.” Datamonitor Healthcare Trends Report, 2016.
  3. 3. Perlin J, Baker D, Brailer D, Fridsma D, Frisse M, Halamka J, et al. “Information Technology Interoperability and Use for Better Care and Evidence.” National Academy of Medicine discussion paper, September 19, 2016. Available at https://nam.edu/information-technology-interoperability-and-use-for-better-care-and-evidence-a-vital-direction-for-health-and-health-care/. Accessed May 1, 2017.
  4. 4. Parsons S, Starling B, Mullan-Jensen C, Tham SG, Warner K, Wever K. “What the Public Knows and Wants to Know About Medicines Research and Development: A Survey of the General Public in Six European Countries.” British Medical Journal Open. 2015;5: e006420. (doi: 10.1136/bmjopen-2014-006420); see also European Patients Academy website https://www.eupati.eu/.
  5. 5. Janssen. “Janssen Launches Three New Research Platforms Focused on Redefining Healthcare.” https://www.jnj.com/media-center/press-releases/janssen-launches-three-new-research-platforms-focused-on-redefining-healthcare. Published February 12, 2015. Accessed May 1, 2017.
  6. 6. Insel R, Dunne J, Atkinson M, Chiang J, Dabelea D, Gottlieb P, et al. “Staging Presymptomatic Type 1 Diabetes: A Scientific Statement of JDRF, the Endocrine Society and the American Diabetes Association.” Diabetes Care. 2015;38: 1964–1974.
  7. 7. Janssen E.“UCB Wins Award for ‘Hack Epilepsy’ Initiative.” UCB website. http://www.ucb.com/patients/magazine/article/UCB-wins-award-for-%E2%80%98Hack-Epilepsy%E2%80%99-initiative. Published March 22, 2016. Accessed May 1, 2017; see also UCB. “UCB Leads Epilepsy Hackathon to Support Patient Needs through Digital Tools and Services.” UCB website. http://www.ucb.com/stories-media/press-releases/article/UCB-leads-epilepsy-hackathon-to-support-patient-needs-through-digital-tools-and-services. Published February 18, 2015. Accessed May 1, 2017.
  8. 8. Dreyer N, Reites J, Smurzynski M.“Engaging and Retaining Patients in Long-Term Observational Studies.” In Vivo Pharma Intelligence website. https://invivo.pharmamedtechbi.com/IV004302/Engaging-And-Retaining-Patients-In-LongTerm-Observational-Studies. Published November 19, 2015. Accessed May 1, 2017.
  9. 9. Senior M.“How Patients Are Transforming Pharma R&D.” In Vivo Pharma Intelligence website. https://invivo.pharmamedtechbi.com/IV004513/How-Patients-Are-Transforming-Pharma-RampD. Published May 9, 2016. Accessed May 1, 2017.
  10. 10. “NIH Awards $55 Million to Build Million-Person Precision Medicine Study.” National Institutes of Health. https://www.nih.gov/news-events/news-releases/nih-awards-55-million-build-million-person-precision-medicine-study. Published July 6, 2016. Accessed May 1, 2017.
  11. 11. Crew D.“Niche Treatments Become Big Business.” Financial Times. September 28, 2015:2.
  12. 12. Wicks P, Lowe M, Gabriel S, Sikirica S, Sasane R, Arcona S. “Increasing Patient Participation in Drug Development.” Nature Biotechnology. 2015;33(2):135–136.
  13. 13. “Using Social Media to Improve Patient Recruitment.” Access Point. January 2016; 34(11):7. Available at http://www.imshealth.com/files/web/Global/RWE/RWE-Collateral/IMS%20RWE%20AccessPoint.pdf. Accessed May 1, 2017.
  14. 14. Looney W.“Patient-Centered Strategies for Clinical Trials and Treatments.” Pharmaceutical Executive website. http://www.pharmexec.com/patient-centered-strategies-clinical-trials-treatment. Published September 9, 2016. Accessed May 1, 2017.; for ruxolitinib, see Basch E. “Toward Patient-Centered Drug Development in Oncology.” New England Journal of Medicine. 2013;369(5):397–400.
  15. 15. Looney W., ibid.
  16. 16. Lipset C. “Engage with Research Participants About Social Media.” Nature Medicine. 2014;20(3):231. Available at www.nature.com/nm/journal/v20/n3/pdf/nm0314-231.pdf. Accessed May 1, 2017.
  17. 17. “A Third of People Track Their Health or Fitness. Who Are They and Why Are They Doing It?” GfK website. http://www.gfk.com/insights/press-release/a-third-of-people-track-their-health-or-fitness-who-are-they-and-why-are-they-doing-it/. Published September 29, 2016. See full study at http://www.gfk.com/global-studies/global-study-overview/. Accessed May 1, 2017.
  18. 18. Carman K, Murer M, Mangrum R, Yang M, Ginsburg M, Sofaer S, et al. “Understanding an Informed Public's Views on the Role of Evidence in Making Healthcare Decisions.” Health Affairs. 2016;35(4):566–574.
  19. 19. “Patients' and Consumers' Use of Evidence, Datagraphic. ” Health Affairs. 2016;35(4):564–565; Ranard B, Werner R, Antanavicius T, Schwartz A, Smith R, Meisel Z, et al. “Yelp Reviews of Hospital Care Can Supplement and Inform Traditional Surveys of the Patient Experience of Care.” Health Affairs. 2016;35(4):697–705.
  20. 20. Centers for Medicare and Medicaid Services. “First Release of the Overall Hospital Quality Star Rating on Hospital Compare.” https://www.cms.gov/newsroom/mediareleasedatabase/fact-sheets/2016-fact-sheets-items/2016-07-27.html. Published July 27, 2016. Accessed May 1, 2017; see also Budryk Z.“CMS Releases Hospital Star Ratings Amid Industry Criticism.” Fierce Healthcare website. http://www.fiercehealthcare.com/healthcare/cms-releases-hospital-star-ratings-amid-industry-criticism. Published July 27, 2016. Accessed May 1, 2017.
  21. 21. Findlay S. “Consumers' Interest in Provider Ratings Grows, and Improved Report Cards and Other Steps Could Accelerate Their Use.” Health Affairs. 2016;35(4):688–695.
  22. 22. Kaul A.“We Are Engaged! A Commitment To Patients.” Health Affairs Blog. http://healthaffairs.org/blog/2015/05/11/we-are-engaged-a-commitment-to-patients/. Published May 11, 2015. Accessed May 1, 2017.
  23. 23. Ibid.
  24. 24. Volpp K, Mohta N.“Patient Engagement Survey: Far to Go for Meaningful Participation.” NEJM Catalyst website. http://catalyst.nejm.org/patient-engagement-initiatives-survey-meaningful-participation/. Published September 8, 2016. Accessed May 1, 2017.
  25. 25. CancerCare. “2016 CancerCare Patient Access and Engagement Report.” Available at http://www.cancercare.org/accessengagementreport. Accessed May 1, 2017.
  26. 26. Merlino J, Raman A. “Health Care's Service Fanatics.” Harvard Business Review. May 2013: 2–10.
  27. 27. Sullivan HW, Aikin KJ, Squiers LB. “Quantitative Information on Oncology Prescription Drug Websites.” Journal of Cancer Education. September 2, 2016: 1–4. Available at http://link.springer.com/article/10.1007/s13187-016-1107-1. Accessed May 1, 2017.
  28. 28. Romito T.“Patient Services: Pharma's Best Kept Secret.” Accenture report, 2015; cited in Dobrow L, “Revolution.” Medical Marketing and Media, September 2015: 33–36.
  29. 29. Khedkar P, Sturgis M.“Want Better Access to Physicians? Understand What's Top of Mind: How to Broaden Your Reach—And Target Your Messaging—To Engage Healthcare Providers.” ZS Associates, 2016. Available at https://www.zs.com/-/media/pdfs/ph_mar_wp_afm_acm_2016_es_v4.pdf?la=en. Accessed May 1, 2017.
  30. 30. Gupta M, Seiter S, Von Allmen H, Jaffe H.“A New Foundation for Designing Winning Brand Strategies: The Patient Journey Re-Envisioned.” IMS Consulting Group White Paper, 2014. Available at http://www.imshealth.com/files/web/Global/Services/Services%20Resource%20Center/IMSCG_Patient_Journey_WP_090714F.pdf. Accessed May 1, 2017.
  31. 31. Fox B, Hofmann C, Paley A.“How Pharma Companies Can Better Understand Patients.” McKinsey & Company website. http://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/how-pharma-companies-can-better-understand-patients. Published May 2016. Accessed May 1, 2017.; see also Bell D, Fox B, Olohan R. Pharma3D: Rewriting the Script for Marketing in the Digital Age. McKinsey e-book, April 2016. Available at www.pharma3D.com. Accessed May 1, 2017.
  32. 32. Elton J, O'Riordan A. Healthcare Disrupted: Next Generation Business Models and Strategies. Hoboken, NJ: John Wiley & Sons, 2016:97–99.
  33. 33. Viswanathan M, Golin CE, Jones CD, Ashok M, Blalock S, Wines R, et al. “Interventions to Improve Adherence to Self-Administered Medications for Chronic Disease in the United States.” Annals of Internal Medicine. 2012;157:785–795.
  34. 34. Ibid.
  35. 35. Robinson R. “Pharma's Role in Personalized Smart Health.” PharmaVoice. May 2016:12–16.
  36. 36. Wang R, Blackburn G, Desai M. “Accuracy of Wrist-Worn Heart Monitors.” JAMA Cardiology. October 12, 2016. (doi: 10.1001/jamacardio.2016.3340).
  37. 37. Beetsch J, Vice President Patient Advocacy, Celgene, personal communication with Françoise Simon, October 12, 2016.
  38. 38. “Celgene Corporation and Sage Bionetworks Announce Technology Collaboration to develop Observational Study Using the Apple ResearchKit Framework.” Celgene website. http://ir.celgene.com/releasedetail.cfm?releaseid=994085. Published October 18, 2016. Accessed May 1, 2017.
  39. 39. Bell D, Fox B, Olohan R. Pharma3D: Rewriting the Script for Marketing in the Digital Age. McKinsey e-book, April 2016. Available at www.pharma3D.com. Accessed May 1, 2017.
  40. 40. Matthias A.“The Secret to True Patient Centricity from Big Pharma's First Chief Patient Officer.” PM360 Panorama website. https://www.pm360online.com/the-secret-to-true-patient-centricity-from-big-pharmas-first-chief-patient-officer/. Published March 18, 2015. Accessed May 1, 2017; see also LaMotta L.“What Is the Prescription for Patient Centricity?” Pink Sheet. November 24, 2014. Available at https://pink.pharmamedtechbi.com/PS076672/What-Is-The-Prescription-For-Patient-Centricity. Accessed May 1, 2017.

Chapter 7

  1. 1. Frazier K.“The Pharma All-Stars.” Panel discussion at the Forbes Healthcare Summit 2015, New York, NY, December 3, 2015.
  2. 2. Tefferi A, et al. “In Support of a Patient-Driven Initiative to Lower the High Price of Cancer Drugs.” Mayo Clinic Proceedings. 2015; 90: 996–1000.
  3. 3. Weismann R.“Doctors Challenge Vertex over the High Price of Cystic Fibrosis Drug.” The Boston Globe. July 20, 2015. Available at http://www.bostonglobe.com/business/2015/07/20/researcher-and-group-doctors-challenge-vertex-price-new-cystic-fibrosis-drug/d5PZMlj6T6uzq0usm2xLEL/story.html. Accessed May 3, 2017.
  4. 4. Carroll A.“The EpiPen, Case Study in Health System Dysfunction.” The New York Times. August 23, 2016. Available at http://www.nytimes.com/2016/08/24/upshot/the-epipen-a-case-study-in-health-care-system-dysfunction.html. Accessed May 3, 2017.
  5. 5. Saunders B.“Our Social Contract with Patients.” Allergan website. https://www.allergan.com/news/ceo-blog/september-2016/our-social-contract-with-patients. Published September 6, 2016. Accessed May 3, 2017.
  6. 6. Thomas K.“New Online Tools Offer Path To Lower Drug Prices.” The New York Times. February 9, 2016. Available at https://www.nytimes.com/2016/02/10/business/taming-drug-prices-by-pulling-back-the-curtain-online.html.
  7. 7. “Drugs in America: Seizure-Inducing.” The Economist. September 3, 2016. Available at http://www.economist.com/news/business/21706347-row-over-mylans-epipen-allergy-medicine-raises-fresh-questions-about-how-drugs-are. Accessed May 3, 2017.
  8. 8. Tufts Center for the Study of Drug Development. “Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion.” Press release, November 18, 2014. Available at http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study. Accessed May 3, 2017.
  9. 9. Berkrot B.“New Incentives Needed to Develop Antibiotics to Fight Superbugs.” Reuters website. http://www.reuters.com/article/us-health-superbug-antibiotics-idUSKCN0YI2MZ. Published March 27, 2016. Accessed May 3, 2017.
  10. 10. Brooks M.“Big Pharma Pledges to Develop New Antibiotics, with Help.” Medscape website. http://www.medscape.com/viewarticle/857627. Published January 21, 2016. Accessed May 3, 2017.
  11. 11. Silverman E.“Vermont Poised to Become First State to Require Pharma to Justify Pricing.” STAT website. https://www.statnews.com/pharmalot/2016/05/19/vermont-drug-costs-pharmaceutical/. Published May 19, 2016. Accessed May 3, 2017.
  12. 12. Organisation for Economic and Co-operative Development. “Pharmaceutical Spending (Indicator).” https://data.oecd.org/healthres/pharmaceutical-spending.htm. Accessed December 22, 2016.
  13. 13. Aitken M, Kleinrock M. “Understanding The Dynamics of Drug Expenditures.” QuintilesIMS Institute. Published July 11, 2017. Accessed July 12, 2017.
  14. 14. Long D.“The Balance Between Innovation and Smarter Spending.” Presentation at the Health and Human Services Pharmaceutical Forum, Washington, DC, November 20, 2015.
  15. 15. World Health Organization. “2015 Global Survey of Health Technology Assessments by National Authorities.” Available at http://ec.europa.eu/health/technology_assessment/docs/2014_strategy_ eucooperation_hta_en.pdf. Accessed May 3, 2017.
  16. 16. European Medicines Agency and EUnetHTA, “Report on the Implementation of the EMA-EUnetHTA Three Year Work Plan 2012–2015.” March 23, 2016. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Report/2016/04/WC500204828.pdf. Accessed May 3, 2017.
  17. 17. Vogler S, Habl C, Bogut M, Voncina L. “Comparing Pharmaceutical Pricing and Reimbursement Policies in Croatia to the European Union Member States,” Croatian Medical Journal. 2011; 52: 183–197.
  18. 18. WHO Collaboration Centre for Pharmaceutical Pricing and Reimbursement Policies. “Glossary.” http://whocc.goeg.at/Glossary/About. Accessed May 3, 2017.
  19. 19. Gemeinsamer Bundesausschuss. “Reference Prices and How They Are Set.” http://www.english.g-ba.de/special-topics/pharmaceuticals/reference/. Accessed May 3, 2017.
  20. 20. Ruggeri K, Nolte E.“Pharmaceutical Pricing: The Use of External Reference Pricing.” RAND Corporation, 2013. Available at http://www.rand.org/content/dam/rand/pubs/research_reports/RR200/RR240/RAND_RR240.pdf. Accessed May 3, 2017.
  21. 21. Nagano Y.“Japan's 2014 Drug Price Reforms Extend Price Premium Program.” PharmAsia News. January 23, 2014.
  22. 22. EY. “Life Sciences Quarterly Update, Asia-Pac and Japan.” April 2016. http://www.ey.com/GL/en/Industries/Life-Sciences/EY-vital-signs-life-sciences-sector-update-for-asia-pacific-and-japan.
  23. 23. “The 2016 Drug Trend Report.” Express Scripts, March 2017.
  24. 24. “Anthem Announces Definitive Agreement to Acquire Cigna Corporation.” BusinessWire website. http://www.businesswire.com/news/home/20150724005167/en/Anthem-Announces-Definitive-Agreement-Acquire-Cigna-Corporation. Published July 24, 2015. Accessed May 3, 2017.
  25. 25. “Aetna to Acquire Humana.” Aetna website. https://news.aetna.com/2015/08/aetna-to-acquire-humana/. Published July 3, 2015. Accessed May 3, 2017.
  26. 26. “Centene to Combine with Health Net in Transaction Valued at $6.8 Billion.” HealthNet website. http://newsroom.healthnet.com/press-release/centene-combine-health-net-transaction-valued-approximately-68-billion. Published July 2, 2015. Accessed May 3, 2017.
  27. 27. Humer C.“Express Scripts Drops Gilead Hep C Drugs for Cheaper AbbVie Rival,” Reuters Health News website. http://www.reuters.com/article/us-express-scripts-abbvie-hepatitisc-idUSKBN0K007620141222. Published December 22, 2014. Accessed May 3, 2017.
  28. 28. Miller S.“The $4 Billion Return on a Promise Kept.” The Lab: Express Scripts Insights. http://lab.express-scripts.com/lab/insights/specialty-medications/the-4-billion-return-on-a-promise-kept. Published January 27, 2015. Accessed May 3, 2017.
  29. 29. Shrank W, Barlow J, Brennan T. “New Therapies in the Treatment of High Cholesterol: An Argument to Return to Goal-Based Lipid Guidelines.” Journal of the American Medical Association. 2015; 314 (14): 1443–1444. Available at http://jamanetwork.com/journals/jama/article-abstract/2427467. Accessed May 3, 2017. See also “Landmark Outcomes Study Shows That Repatha Decreases LDL-C To Unprecedented Low Levels and Reduces Risk of Cardiovascular Events with No New Safety Issues,” PR Newswire website. https://www.amgen.com/media/news-releases/2017/03/landmark-outcomes-study-shows-that-repatha-evolocumab-decreases-ldlc-to-unprecedented-low-levels-and-reduces-risk-of-cardiovascular-events-with-no-new-safety-issues. Published March 17, 2017. Accessed July 12, 2017.
  30. 30. Senior M.“Scoring Value: New Tools Challenge Pharma's U.S. Pricing Bonanza.” In Vivo Pharma Intelligence website. https://invivo.pharmamedtechbi.com/IV004434/Scoring-Value-New-Tools-Challenge-Pharmas-US-Pricing-Bonanza. Published October 21, 2015. Accessed May 3, 2017.
  31. 31. Neumann P, Cohen J. “Measuring the Value of Prescription Drugs.” New England Journal of Medicine. 2015; 373: 2595–2597.
  32. 32. Simon F, Kotler P. Building Global Biobrands: Taking Biotechnology to Market. New York: Free Press, 2003.
  33. 33. Schleifer L.“The Pharma All-Stars.” Panel discussion at the 2015 Forbes Healthcare Summit, New York, New York, December 3, 2015.
  34. 34. Garrison L, Carlson J, Bajaj P, Towse, A, Neumann P, Sullivan S, et al. “Private Sector Risk-Sharing Agreements in the United States: Trends, Barriers, and Prospects.” American Journal of Managed Care. 2015; 21 (9): 632–640.
  35. 35. John M, Hirschler B.“France Pegs Gilead Hepatitis C Drug at Lowest Price in Europe.” Reuters website. http://www.reuters.com/article/health-hepatitis-gilead-solvadi-idUSL6N0TA2TA20141120#QRzmDbgzqdBH7rIM.97. Published November 20, 2014. Accessed May 3, 2017.
  36. 36. Vioix, H, Franzen S, Selby D, Collomb D, Hauch O, Emmas C. “Three Years of the Gefitinib UK Single Patient Access Scheme (SPA); Duration of Treatment for Patients with EGFR Mutation Positive NSCLC in NHS Clinical Practice.” Value in Health. 2013; 16 (7): A425.
  37. 37. Vioix H, Franzen S, Selby D, et al. “Duration of Gefitinib Treatment in EGFR Mutation Positive NSCLC Patients in a UK Single Payment Access Scheme.” Presented at ISPOR, June 3–7, 2012.
  38. 38. Pollack A.“Pricing Pills by the Results.” New York Times. July 14, 2007. Available at http://www.nytimes.com/2007/07/14/business/14drugprice.html?_r=0. Accessed May 3, 2017.
  39. 39. Thomas K, Ornstein C. “Considering The Side Effects of Drugmakers' Moneyback Gaurantees,” New York Times. July 10, 2017. Available at https://www.nytimes.com/2017/07/10/health/prescription-drugs-cost.html. Accessed July 11, 2017.
  40. 40. McAllister E.“Results May Vary.” BioCentury. February 2, 2016.
  41. 41. Sherman M, interview by E. Licking, January 4, 2016.
  42. 42. Garfield S, Sherman M, Longman R, Shiff S, and Licking E. “The Value Lab: Moving Value-Based Health Care from Theory to Practice.” In press. In Vivo Pharma Intelligence Website.
  43. 43. Merrill J.“Multi-Indication Pricing: Big Hurdles and Actionable Options.” The Pink Sheet. May 30, 2016.
  44. 44. Bach P. “Indication-Specific Pricing for Cancer Drugs.” Journal of the American Medical Association. 2014; 312 (16): 1629–1630.
  45. 45. Revatio [package insert]. New York: Pfizer, Inc.; June 2005.
  46. 46. Viagra [package insert]. New York: Pfizer, Inc.; November 1988.
  47. 47. Center for Drug Evaluation and Research Application Number 125418Orig1s000 [memorandum]. Food and Drug Administration. July 27, 2012.
  48. 48. Pearson S, Dreitlein B, Henshall C.“Indication-Specific Pricing of Pharmaceuticals in the United States Health Care System.” Institute for Clinical and Economic Review. March 2016.
  49. 49. Miller S. Panel presentation at the Health and Human Services Pharmaceutical Forum, Washington DC, November 20, 2015.
  50. 50. Bennette C, Richards C, Sullivan S, Ramsey S. “Steady Increase in Prices for Oral Anticancer Drugs after Market Launch Suggests a Lack of Competitive Pressure.” Health Affairs. 2016; 35: 805–812.
  51. 51. Porter M, Kaplan R.“How to Pay for Health Care.” Harvard Business Review. July-August 2016. Available at https://hbr.org/2016/07/how-to-pay-for-health-care. Accessed May 3, 2017.
  52. 52. Mechanic R.“Medicare's Bundled Payment Initiatives: Considerations For Providers.” American Hospital Association [issue brief], January 19, 2016.
  53. 53. Centers for Medicare and Medicaid Services.“Bundled Payments for Care Improvement Initiative.” https://innovation.cms.gov/initiatives/bundled-payments/. Accessed May 3, 2017.
  54. 54. Newcomer L. “Innovative Payment Models and Measurement for Cancer Therapy.” Journal of Oncology Practice. 2014; 10: 187–189.
  55. 55. Conway L.“What Can We Learn from United's Medical Oncology Episode-Based Payment Pilot?” Advisory Board Blog. Oncology Rounds. July 17, 2014.
  56. 56. Newcomer L. “Innovative Payment Models and Measurement for Cancer Therapy.” Journal of Oncology Practice. 2014; 10: 187–189.
  57. 57. Appelby J.“United Healthcare Expands Effort to Rein in Rising Costs of Cancer Treatment.” Kaiser Health News. October 29. 2015.
  58. 58. Mattke S, Hoch E.“Borrowing for the Cure.” RAND Corporation, 2015.
  59. 59. Montazerhodjat V, Weinstock D, Lo A. “Buying Cures versus Renting Health: Financing Health Care with Consumer Loans.” Science Translational Medicine. 2016; 8: 1–8.

Chapter 8

  1. 1. Centers for Medicare and Medicaid Services. “National Health Expenditure Fact Sheet, Historical (2014) and Projected (2015-25).” https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/nationalhealthexpenddata/nhe-fact-sheet.html. Accessed May 5, 2017.
  2. 2. Senior M. “Sovaldi Makes Blockbuster History, Ignites Drug Pricing Unrest.” Nature Biotechnology. 2014;32, 501–502. Available at http://www.nature.com/nbt/journal/v32/n6/full/nbt0614-501.html?WT.feed_name=subjects_pharmacoeconomics. Accessed May 5, 2017.
  3. 3. Longman R.“The Myth of the Payer.” Published in EY Annual Biotechnology Report Beyond Borders 2016: Returning to Earth. June 2016. Available at http://www.ey.com/GL/en/Industries/Life-Sciences/EY-vital-signs-the-myth-of-the-payer. Accessed May 5, 2017.
  4. 4. Centers for Medicare and Medicaid Services. “Health Insurance Marketplaces 2017 Open Enrollment Period Final Enrollment Report: November 1, 2016 - January 31, 2017.” March 15, 2017. Available at: http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-03-15.html. Accessed July 10, 2017.
  5. 5. Johnson C.“UnitedHealth Group to Exit Obamacare Exchanges in All but a ‘Handful’ of States.” Washington Post. April 19, 2016. Available at https://www.washingtonpost.com/news/wonk/wp/2016/04/19/unitedhealth-group-to-exit-obamacare-exchanges-in-all-but-a-handful-of-states/?utm_term=.9c0a38ae396c. Accessed May 5, 2017.
  6. 6. Von Ebers P.“Mega-Health Insurance Mergers: Is Bigger Really Better?” Health Affairs Blog. http://healthaffairs.org/blog/2016/01/22/mega-health-insurance-mergers-is-bigger-really-better/. Published January 22, 2016. Accessed May 5, 2017. See also Garthwaite C and Graves J. “Success And Failure In The Insurance Exchange.” New England Journal of Medicine 2017; 376: 907–910.
  7. 7. Humer C, Bartz D. “Aetna, Humana Drop Merger; Cigna Wants To End Anthem Deal.” Reuters website. http://www.reuters.com/article/us-humana-m-a-aetna-idUSKBN15T1HN. Published February 14, 2017. Accessed July 10, 2017.
  8. 8. Mathews A, Walker J. “UnitedHealth to Buy Catamaran for $12.8 Billion in Cash.” Wall Street Journal. March 30, 2015. Available at https://www.wsj.com/articles/unitedhealth-to-buy-catamaran-for-12-8-billion-in-cash-1427709601. Accessed May 5, 2017.
  9. 9. Staton T.“Heavyweight PBMs Mean Trouble for Big Pharma's Pricey New Meds.” FiercePharma website. http://www.fiercepharma.com/pharma/heavyweight-pbms-mean-trouble-for-big-pharma-s-pricey-new-meds. Published March 31, 2015. Accessed May 5, 2017.
  10. 10. Gottlieb S.“What a Drug Price Debate Reveals about Obamacare.” Forbes website. https://www.forbes.com/sites/scottgottlieb/2015/01/08/what-a-drug-price-debate-reveals-about-obamacare/#7f2735971a21. Published January 8, 2015. Accessed May 5, 2017.
  11. 11. Japsen B.“If Anthem Splits with Express Scripts, a New PBM May Emerge.” Forbes website. http://www.forbes.com/sites/brucejapsen/2016/03/22/if-anthem-splits-with-express-scripts-a-new-pbm-may-emerge/#7b8eba0014bf. Published March 22, 2016. Accessed May 5, 2017.
  12. 12. Galvin R, Longman R.“Who Has the Power to Cut Drug Prices? Employers.” Harvard Business Review. December 1, 2015.
  13. 13. Book R.“Why Are Hospitals Buying Physician Practices and Forming Insurance Companies?” American Action Forum website. https://www.americanactionforum.org/research/why-are-hospitals-buying-physician-practices-and-forming-insurance-companies/. Published February 11, 2016. Accessed May 5, 2017.
  14. 14. Lenzke L.“How Are You Responding to Changes in the Healthcare System?” EY presentation, 2015.
  15. 15. Herman B.“More Health Systems Launch Insurance Plans, Despite Caveats.” Modern Healthcare website. http://www.modernhealthcare.com/article/20150404/MAGAZINE/304049981. Published April 4, 2015. Accessed May 5, 2017.
  16. 16. Galvin R, Longman R. “Who Has the Power to Cut Drug Prices? Employers.” Harvard Business Review. December 1, 2015.
  17. 17. Gruessner V.“Why a Competitive Health Insurance Plan Matters to Employees.” HealthPayer Intelligence website. http://healthpayerintelligence.com/news/why-a-competitive-health-insurance-plan-matters-to-employees. Published January 14, 2016. Accessed May 5, 2017.
  18. 18. Longman R,“The Myth of the Payer,” June 2016. Published in Beyond Borders Biotechnology Industry Report: Returning to Earth, EY. Available at http://www.ey.com/GL/en/Industries/Life-Sciences/EY-vital-signs-the-myth-of-the-payer. Accessed May 5, 2017.
  19. 19. NHS Clinical Commissioners. “About Clinical Commissioning Groups.” http://www.nhscc.org/ccgs/. Accessed May 5, 2017.
  20. 20. Paris V, Belloni A.“Value in Pharmaceutical Pricing. Country Profile: Australia.” OECD Report, November 2014. Available at https://www.oecd.org/health/Value-in-Pharmaceutical-Pricing-Australia.pdf. Accessed May 5, 2017.
  21. 21. Asia Pacific Observatory on Health Systems and Policies. “Policy Brief: Conducive Factors to HTA Development in Asia.” Available at http://www.wpro.who.int/asia_pacific_observatory/resources/policy_briefs/hta/en/. Accessed May 5, 2017.
  22. 22. Senior M.“Scoring Value: New Tools Challenge US Pricing Bonanza.” In Vivo Pharma Intelligence website. https://invivo.pharmamedtechbi.com/IV004434/Scoring-Value-New-Tools-Challenge-Pharmas-US-Pricing-Bonanza. Published October 21, 2015. Accessed May 5, 2017. See also Institute for Clinical and Economic Review. “Final Value Assessment Framework For 2017–2019.” ICER website. Available at https://icer-review.org/final-vaf-2017-2019/. Accessed July 10, 2017.
  23. 23. Institute for Clinical and Economic Review. “CardioMEMS HF System (St. Jude Medical) and Sacubitril/Valsartan (Entresto, Novartis) for Management of Congestive Heart Failure: Effectiveness, Value, and Value-Based Price Benchmarks.” Revised Draft Review, October 9, 2015. Available at https://icer-review.org/wp-content/uploads/2016/01/CHF_Revised_Draft_Report_100915.pdf. Accessed May 5, 2017.
  24. 24. Longman R, “The Myth of the Payer,” June 2016. Published in Beyond Borders Biotechnology Industry Report: Returning to Earth, EY. Available at http://www.ey.com/GL/en/Industries/Life-Sciences/EY-vital-signs-the-myth-of-the-payer. Accessed May 5, 2017.
  25. 25. EY. “Progressions: Navigating the Payer Landscape.” Global Pharmaceutical Report, 2014. Available at http://www.ey.com/Publication/vwLUAssets/EY-progressions-2014-navigating-the-payer-landscape/$FILE/EY-progressions-2014.pdf. Accessed May 5, 2017.
  26. 26. The Harris Poll. “The 2016 Harris Poll Study of Reputation Equity and Risk Across the Health Care Sector.” Available at http://www.theharrispoll.com/health-and-life/Pharma-Biotech-Patients-Over-Profits.html. Accessed July 11, 2017.
  27. 27. Kessel M. “Restoring the Pharmaceutical Industry's Reputation.” Nature Biotechnology. 2014;32, 983–990. Available at http://www.nature.com/nbt/journal/v32/n10/full/nbt.3036.html. Accessed May 5, 2017.
  28. 28. Silverman E.“Glaxo to Change Its Compensation Program for U.S. Sales Reps.” The Wall Street Journal Pharmalot Blog. https://blogs.wsj.com/pharmalot/2015/04/13/glaxo-to-change-its-compensation-program-for-u-s-sales-reps/. Published April 13, 2015. Accessed May 5, 2017.
  29. 29. Meteos Ltd. “Principles for Collaborative, Mutually-Acceptable Drug Pricing.” Report of Conclusions from the Pharmadiplomacy Dialogue, May 2016. Available at http://www.meteos.co.uk/resources/principles-for-collaborative-mutually-acceptable-drug-pricing/. Accessed May 5, 2017.
  30. 30. Meteos Ltd., ibid.
  31. 31. Coyle B, Chapman B.“Overcoming the Key Account Management Talent Shortage in Pharma.” PM360 Online. https://www.pm360online.com/overcoming-the-key-account-management-talent-shortage-in-pharma/. Published December 18, 2013. Accessed May 5, 2017.
  32. 32. Muhlestein D.“Growth and Dispersion of Accountable Care Organizations In 2015.” Health Affairs Blog. http://healthaffairs.org/blog/2015/03/31/growth-and-dispersion-of-accountable-care-organizations-in-2015-2/. Published March 31, 2015. Accessed May 5, 2017.
  33. 33. Nussbaum A.“Health Insurance Exchanges.” Bloomberg Quick Take. http://www.bloomberg.com/quicktake/health-insurance-exchanges. Updated August 3, 2016.
  34. 34. National Institute of Health and Care Excellence. “NICE Calls for a New Approach to Managing the Entry of Drugs into the NHS.” https://www.nice.org.uk/news/press-and-media/nice-calls-for-a-new-approach-to-managing-the-entry-of-drugs-into-the-nhs. Published September 18, 2014. Accessed May 5, 2017.
  35. 35. Thomas A. “Germany Mulls Limiting Prices Drug Firms Can Charge to Health System.” Wall Street Journal. April 22, 2016. Available at http://www.wsj.com/articles/germany-mulls-limiting-prices-drug-firms-can-charge-to-health-system-1461307437. Accessed May 5, 2017.
  36. 36. Centers for Medicare and Medicaid Services. “CMS Proposes to Test New Medicare Part B Prescription Drug Models to Improve Quality of Care and Deliver Better Value for Medicare Beneficiaries.” https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-03-08.html. Published March 8, 2016. Accessed May 5, 2017.
  37. 37. “Harvard Pilgrim Negotiates First-in-the Nation Innovative Contract for Blockbuster Cholesterol Drug Repatha.” Businesswire website. http://www.businesswire.com/news/home/20151109006090/en/Harvard-Pilgrim-Negotiates-First-In-The-Nation-Innovative-Contract. Published November 9, 2015. Accessed May 5, 2017.
  38. 38. Staton T. “Lilly's Trulicity Joins Pay-for-Performance Trend with Harvard Pilgrim Deal.” FiercePharma website. http://www.fiercepharma.com/pharma/lilly-s-trulicity-joins-pay-for-performance-trend-harvard-pilgrim-deal. Published June 28, 2016. Accessed May 5, 2017.
  39. 39. Humer C.“Novartis Sets Heart-Drug Price With Two Insurers Based On Health Outcome.” Reuters website. http://www.reuters.com/article/us-cigna-novartis-drugpricing-idUSKCN0VH25K. Published February 9, 2016. Accessed May 5, 2017.
  40. 40. Sherman M.“It's Time for Biopharma to Embrace Risk-Sharing.” June 2016. Published in Beyond Borders Biotechnology Industry Report: Returning to Earth, EY. Available at http://www.ey.com/GL/en/Industries/Life-Sciences/EY-its-time-for-biopharma-to-embrace-risk-sharing. Accessed May 5, 2017.
  41. 41. Sherman M., ibid.
  42. 42. Morse S.“Dartmouth-Hitchcock, Harvard Pilgrim Join Forces on Population Health.” HealthcareIT News website. http://www.healthcareitnews.com/news/dartmouth-hitchcock-harvard-pilgrim-analytics-population-health-benevera-health. Published October 5, 2015. Accessed May 5, 2017.
  43. 43. Sherman M. “It's Time for Biopharma to Embrace Risk-Sharing.” June 2016. Published in Beyond Borders Biotechnology Industry Report: Returning to Earth, EY. Available at http://www.ey.com/GL/en/Industries/Life-Sciences/EY-its-time-for-biopharma-to-embrace-risk-sharing. Accessed May 5, 2017.

Chapter 9

  1. 1. Fallik D. “For Big Data, Big Questions Remain.” Health Affairs. 2014;33(7):1111–1113.
  2. 2. Ginsberg J, Mohebbi MH, Patel RS, Braumer L, Smolinski MS, Brilliant L. “Detecting Influenza Epidemics Using Search Engine Query Data.” Nature. 2009;457(7232):1012–1014.
  3. 3. Butler D. “When Google Got Flu Wrong.” Nature. 2013;494(7436):155–156.
  4. 4. Institute of Medicine,“Transforming Clinical Research in the United States: Challenges and Opportunities,” Workshop Summary. National Academies Press, 2010; cited in Validic and Fierce Markets, “Advancing Drug Development with Digital Health: Four Key Ways to Integrate Patient-Generated Data into Trials.” March 2016.
  5. 5. Lee SM.“How an IPhone Medical Research App Is Helping People with Asthma.” BuzzFeed News, September 29, 2015; cited in Validic, op. cit.
  6. 6. Lorenzetti L. “Pfizer and IBM Launch Research Project to Transform Parkinson's Disease.” Fortune. April 7, 2016. Available at http://fortune.com/2016/04/07/pfizer-ibm-parkinsons. Accessed May 8, 2017.
  7. 7. “Robert Wood Johnson Foundation Awards Grant to PatientsLikeMe to Develop New Measures for Healthcare Performance.” PatientsLikeMe website. http://news.patientslikeme.com/press-release/rwjf-awards-grant-patientslikeme-develop-new-measures-healthcare-performance. Published December 8, 2015. Accessed May 8, 2017.
  8. 8. PatientsLikeMe press release,“PatientsLikeMe and M2Gen Announce Partnership and Plans for Landmark Cancer Experience Study.” PatientsLikeMe website. http://news.patientslikeme.com/press-release/patientslikeme-and-m2gen-announce-partnership-and-plans-landmark-cancer-experience-stu. Published March 8, 2016. Accessed May 8, 2017.
  9. 9. Lott R. “New Players Join in the Drug Development Game.” Health Affairs. 2014;33(10):1711–1713.
  10. 10. Al-Faruque F. “Novartis and Qualcomm Partner in mHealth.” In Vivo Pharma Intelligence website. https://www.pharmamedtechbi.com/publications/in-vivo/33/1/novartis-and-qualcomm-partner-in-mhealth?p=1. Published January 27, 2015. Accessed May 8, 2017; Zimmerman Carolyne, Executive Director, Global Business Development and Licensing and Novartis Lead for dRx Capital, personal communication with Françoise Simon, October 20, 2015.
  11. 11. Friend SH. “App-Enabled Trial Participation: Tectonic Shift or Tepid Rumble?” Science Translational Medicine. July 22, 2015; Vol. 7: 297ed10: 1–3.
  12. 12. Lipset C. “Engage with Research Participants about Social Media.” Nature Medicine. 2014;20(3):231; Lipset Craig, Head of Clinical Innovation for Worldwide Research & Development, Pfizer; personal communication with Françoise Simon, October 15, 2015.
  13. 13. Roman DH, Conlee KD. The Digital Revolution Comes to US Healthcare. Goldman Sachs report, June 29, 2015.
  14. 14. Matthews C, Jones A. “Pfizer Blocks the Use of Drugs in Executions.” Wall Street Journal. May 14/15, 2016: A3.
  15. 15. Clark D. “HP Bets on 3-D Printers to Make Innovative Mark.” Wall Street Journal. May 18, 2016: B4. See also “First FDA-Approved Medicine Manufactured Using 3D Printing Technology Now Available.” Aprecia website. https://www.aprecia.com/pdf/ApreciaSPRITAMLaunchPressRelease__FINAL.PDF. Published March 22, 2016. Accessed May 8, 2017; Hicks J. “FDA Approved #D Printed Drug Available in the US.” Forbes website. http://www.forbes.com/sites/jenniferhicks/2016/03/22/fda-approved-3d-printed-drug-available-in-the-us/print/. Published March 22, 2016. Accessed May 8, 2017.
  16. 16. EY. EY Digital Overview Report. 2015.
  17. 17. Rosenberg R, VanLare J, Reinholt B, Rao S, Dertouzos J.“Capturing Value from Connected Health.” In Vivo Pharma Intelligence website. https://www.pharmamedtechbi.com/Publications/In-Vivo/33/6/Capturing-Value-From-Connected-Health?resut-3&total-32&searchquery-0%253fg%253dcapturin. Published June 18, 2015. Accessed May 8, 2017; see also Fox B, Paley A, Prevost M, and Subramanian N. “Closing the Digital Gap in Pharma,” McKinsey, November 2016.
  18. 18. Senior M.“The End of Drug Innovation in Diabetes?” In Vivo Pharma Intelligence website. https://www.pharmamedtechbi.com/publications/in-vivo/33/2/the-end-of-drug-innovation-in-diabetes. Published February 3, 2015. Accessed May 8, 2017.
  19. 19. Senior M., ibid.
  20. 20. AstraZeneca.“Fit2Me: Managing Type 2 Diabetes.” http://www.fit2me.com/managing-type-2-diabetes.html.
  21. 21. Looney W.“Sanofi's Big Bet on Integrated Patient Care.” Pharmaceutical Executive website. http://www.pharmexec.com/sanofi-s-big-bet-integrated-patient-care. Published January 9, 2015. Accessed May 8, 2017.
  22. 22. Kelly C.“Genentech Social Media Collaboration Will Focus on Patient Experiences in Cancer.” The Pink Sheet. https://www.pharmamedtechbi.com/publications/the-pink-sheet-daily/2014/4/8/genentech-social-media-collaboration-will-focus-on-patient-experiences-in-cancer. Published April 8, 2014. Accessed May 8, 2017.
  23. 23. “Pfizer Partners with Breast Cancer Leaders to Chronicle the Lives of Women with Metastatic Breast Cancer.” Pfizer website. http://press.pfizer.com/press-release/pfizer-partners-breast-cancer-leaders-chronicle-lives-women-metastatic-breast-cancer-t. Published September 30, 2015. Accessed May 8, 2017.
  24. 24. “New Online Community Quitters Circle Helps Smokers Trade Cigarettes for Real Time Support.” Pfizer website. https://investors.pfizer.com/investor-news/press-release-details/2015/New-Online-Community-Quitters-Circle-Helps-Smokers-Trade-Cigarettes-for-Real-Time-Support/default.aspx. Published June 23, 2015. Accessed May 8, 2017.
  25. 25. “Pfizer Hemophilia: The Way You Log Is About to Change.” Hemophilia Federation of America website. http://www.hemophiliafed.org/news-stories/2012/12/pfizer-hemophilia-the-way-you-log-is-about-to-change/. Published December 4, 2012. Accessed May 8, 2017.
  26. 26. Accenture 2015 survey; cited in Dobrow L. “Revolution.” Medical Marketing & Media. September 2015: 33–36.
  27. 27. World Health Organization.“mHealth: New Horizons for Health through Mobile Technologies.” Global Observatory for eHealth Series, Vol. 3, 2011; cited in IMS Institute for Healthcare Informatics, Patient Adoption of mHealth, September 2015.
  28. 28. “Things Are Looking App.” The Economist. March 12, 2016: 59–60.
  29. 29. Gallagher D. “Google Clicks in a Peak Smartphone Age.” Wall Street Journal. May 16, 2016: C6.
  30. 30. IMS Institute for Healthcare Informatics, Patient Adoption of mHealth, September 2015.
  31. 31. “Dana Farber and Fitbit Partner to Test If Weight Loss Can Prevent Breast Cancer Recurrence.” Dana-Farber Cancer Institute website. http://www.dana-farber.org/Newsroom/News-Releases/dana-farber-cancer-institute-and-fitbit-partner-to-test-if-weight-loss-prevent-breast-cancer-recurrence.aspx. Published April 27, 2016. Accessed May 8, 2017.
  32. 32. McCaffrey K.“Biogen, PatientsLikeMe Use Fitbit to Better Understand Multiple Sclerosis.” Medical Marketing & Media website. http://www.mmm-online.com/digital/biogen-patientslikeme-use-fitbit-to-better-understand-ms/article/409279/. Published April 15, 2015. Accessed May 8, 2017; see also Block VJ, Lizee A, Crabtree-Hartman E, Bevan CJ, Graves JS, Bove R, Green AJ, Nourbakhsh B, Traublay M, Gourraud PA, et al., “Continuous daily assessment of multiple sclerosis disability using remote step count monitoring,” J. Neurology (2017) 264:316–326 (doi 10. 1007/s00415-016-8334-6), published online November 28, 2016.
  33. 33. Epper Hoffman K. “First Sign of Defense.” Medical Marketing & Media. April 2016: 40–41.
  34. 34. Serrano K, Yu M, Riley W, Patel V, Hughes P, Marchesini K, et al. “Willingness to Exchange Health Information Via Mobile Devices: Findings from a Population-Based Survey.” Annals of Family Medicine. 2016;14(1):36–40.
  35. 35. Blenner S, Kollmer M, Rouse A, Daneshvar N, Williams C, Andrews L. “Privacy Policies of Android Diabetes Apps and Sharing of Health Information.” Journal of the American Medical Association. 2016;315(10):1051–1052.
  36. 36. FDA Draft Guidance, Use of Electronic Informed Consent in Clinical Investigations, March 2015, Center for Drug Evaluation and Research. Silver Spring, MD.
  37. 37. Cortez M, Cohen G, Kesselheim A. “FDA Regulation of Mobile Health Technologies.” New England Journal of Medicine. 2014;371(4):372–379.
  38. 38. Yang T. Silverman R. “Mobile Health Applications: The Pattern of Legal and Liability Issues Suggests Strategies to Improve Oversight.” Health Affairs. 2014;33(2); 222–227.
  39. 39. Pew Research Center.“Social Media Usage: 2005–2015.” http://www.pewinternet.org/2015/10/08/social-networking-usage-2005-2015/. Published October 8, 2015. Accessed May 8, 2017.
  40. 40. Decision Resources Group. Cybercitizen Health® U.S. 2015.
  41. 41. Findlay S. “Consumers' Interest in Provider Ratings Grows, and Improved Report Cards and Other Steps Could Accelerate Their Use.” Health Affairs. 2016;35(4):688–705.
  42. 42. Kear T, Harrington M, Bhattacharya A. “Partnering with Patients Using Social Media to Develop a Hypertension Management Instrument.” Journal of the American Society of Hypertension. 2015;9(9):725–734.
  43. 43. Cystic Fibrosis Foundation.“The Cystic Fibrosis Foundation's Drug Development Model.” https://www.cff.org/Our-Research/Our-Research-Approach/Venture-Philanthropy, 2015. Accessed May 8, 2017.
  44. 44. Chase J.“Lack of Expertise Limits Pharma's Facebook Use.” Medical Marketing & Media website. http://mmm-online.com/lack-of-expertise-limits-pharmas-facebook-use/printarticle/461035/. Published December 23, 2015. Accessed May 8, 2017.
  45. 45. Rhyee C, Auh J, Wachter Z. Telehealth: Bringing Health Care to Your Fingertips. Ahead of the Curve Series. Cowen Equity Research. February 20, 2015.
  46. 46. Schwamm L. “Telehealth: Seven Strategies to Successfully Implement Disruptive Technology and Transform Healthcare.” Health Affairs. 2014;33(2):200–206; See also Kvedar J, Coye MJ, Everett W. “Connected Health: A Review of Technologies and Strategies to Improve Patient Care with Telemedicine and Telehealth.” Health Affairs. 2014;33(2):194–199.
  47. 47. Decision Resources Group.Taking the Pulse U.S. 2015 Physician Research Module. Physician Mobile Strategy in 2016: Optimizing Fundamentals and Driving Innovation; see also Rhyee C, Wachter Z, Auh J. Online Content Providers: From Portal to Platform. Ahead of Curve Series. Cowen Equity Research, September 16, 2015.
  48. 48. Rhyee C, et al., Online Health Content Providers, op. cit.
  49. 49. Beck M. “Websites Misdiagnose Ailments.” Wall Street Journal. May 16, 2016: A6.
  50. 50. Rhyee, C et al, Telehealth: Bringing Healthcare to Your Fingertips. op. cit.
  51. 51. Kvedar J, Coye MJ, Everett W.“Connected Health.” op. cit.
  52. 52. Cryer L, Shannon S, Van Amsterdam M, Leff B. “Costs for ‘Hospital at Home’ Patients Were 19 Percent Lower, with Equal or Better Outcomes Compared to Similar Inpatients.” Health Affairs. 2012;31(6):1237–1243.
  53. 53. Rhyee C. Telehealth: Bringing Healthcare to Your Fingertips, op. cit.

Chapter 10

  1. 1. Siegel E. Predictive Analytics: The Power to Predict Who Will Click, Buy, Lie, or Die. Hoboken, NJ: John Wiley & Sons, 2016.
  2. 2. Gartner Group. “Gartner Says 6.4 Billion Connected ‘Things’ Will Be in Use in 2016, Up 30% From 2015.” http://www.gartner.com/newsroom/id/3165317. Published November 10, 2015. Accessed May 9, 2017.
  3. 3. IDC Technologies. “The Digital Universe of Opportunities: Rich Data and the Increasing Value of the Internet of Things.” http://www.emc.com/leadership/digital-universe/2014iview/executive-summary.htm. Published 2014. Accessed May 9, 2017.
  4. 4. Kiron D, Prentice PK, Ferguson RB.“Raising the Bar with Analytics.” MIT Sloan Management Review. Winter 2014.
  5. 5. Hughes B, Kessler M, McDonell A. The $1 Billion RWE Opportunity. IMS Health White Paper. https://www.imshealth.com/files/web/Global/Services/Services%20TL/rwes_breaking_new_ ground_d10.pdf. Published August 2014. Accessed May 9, 2017.
  6. 6. Lavorgna M. “There's No Such Thing as Digital: A Conversation with Charles Hansen, Gordon Rankin, and Steve Silberman.” Audiostream website. http://www.audiostream.com/content/draft#XArQrlELGYJSdpw6.99. Published June 24, 2013. Accessed May 9, 2017.
  7. 7. McKinsey & Co. “The Role of Big Data in Medicine.” http://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/the-role-of-big-data-in-medicine. Published November 2015. Accessed May 9, 2017.
  8. 8. Miller L.“The Origins of Big Data: An Etymological Detective Story.” New York Times. February 1, 2013. Available at http://bits.blogs.nytimes.com/2013/02/01/the-origins-of-big-data-an-etymological-detective-story. Accessed May 9, 2017.
  9. 9. Bonde A. “Small Data: A Brief History and New Design Philosophy.” Presentation at SPARK Boston, July 11, 2016. Available at https://smalldatagroup.com/2016/07/11/a-new-design-philosophy-my-talk-at-spark-boston/. Accessed May 9, 2017.
  10. 10. IBM Big Data and Analytics Hub. “The Four V's of Big Data.” http://www.ibmbigdatahub.com/infographic/four-vs-big-data. Accessed May 9, 2017.
  11. 11. Dr. David Shaywitz, Chief Medical Officer, DNANexus, interview by E. Licking, July 15, 2016.
  12. 12. EY. Progressions: Navigating the Payer Landscape. Global Pharmaceutical Report, 2014. Available at http://www.ey.com/Publication/vwLUAssets/EY-progressions-2014-navigating-the-payer-landscape/$FILE/EY-progressions-2014.pdf. Accessed May 9, 2017.
  13. 13. Reid J. Personal interview by E. Licking. September 6, 2016.
  14. 14. Davidovic D. Personal interview by E. Licking. July 25, 2016.
  15. 15. IDC Technologies. The Digital Universe of Opportunities: Rich Data and the Increasing Value of the Internet of Things. 2014. Available at https://www.emc.com/collateral/analyst-reports/idc-digital-universe-2014.pdf. Accessed May 9, 2017.
  16. 16. Perjasamy M,. Raj P. “Big Data Analytics: Enabling Technologies and Tools.” In Mahmood Z, Data Science and Big Data Computing. New York: Springer International Publishing, 2016: 221–243.
  17. 17. Hill C. Personal interview by E. Licking. August 9, 2016.
  18. 18. Gawande A. “Overkill.” New Yorker. May 11, 2015. Available at http://www.newyorker.com/magazine/2015/05/11/overkill-atul-gawande. Accessed May 9, 2017.
  19. 19. Steinberg G. “Using Big Data to Predict—and Improve—Your Health.” Aetna website. https://news.aetna.com/2014/06/big-data-can-predict-and-improve-health/. Published June 2014. Accessed May 9, 2017.
  20. 20. Hill C. Personal interview by E. Licking. August 9, 2016.
  21. 21. Siegel E. Predictive Analytics: The Power to Predict Who Will Click, Buy, Lie, or Die. Hoboken, NJ: John Wiley & Sons, 2016.
  22. 22. Robb D. “Gartner Taps Predictive Analytics as Next Big Business Intelligence Trend.” EnterpriseApps Today website. http://www.enterpriseappstoday.com/business-intelligence/gartner-taps-predictive-analytics-as-next-big-business-intelligence-trend.html. Published April 17, 2012. Accessed May 9, 2017.
  23. 23. EY and Forbes Insights. Analytics: Do Not Forget the Human Element. November 2015. Jersey City, NJ: Forbes Insights. 2015. Available at http://www.ey.com/Publication/vwLUAssets/EY-Forbes-Insights-Data-and-Analytics-Impact-Index-2015/$FILE/EY-Forbes-Insights-Data-and-Analytics-Impact-Index-2015.pdf. Accessed May 9, 2017.
  24. 24. Lazarus D. “‘Big Data’ Could Mean Big Problems for People's Health Care Privacy.” Los Angeles Times. October 11, 2016. Available at http://www.latimes.com/business/lazarus/la-fi-lazarus-big-data-healthcare-20161011-snap-story.html. Accessed May 9, 2017.
  25. 25. National Human Genome Research Institute, “The Cost of Sequencing a Human Genome.” https://www.genome.gov/27565109/the-cost-of-sequencing-a-human-genome/. Published July 6, 2016. Accessed May 9, 2017; see also Herper M. “Illumina Promises to Sequence Human Genome for $100--But Not Quite Yet.” Forbes, January 9, 2017. Accessed July 6, 2017.
  26. 26. Pollack A. “Aiming to Push Genomics Forward in New Study.” New York Times. January 13, 2014. Available at https://www.nytimes.com/2014/01/13/business/aiming-to-push-genomics-forward-in-new-study.html. Accessed May 9, 2017.
  27. 27. Dewey FE, et al. “Inactivating Variants in ANGPTL4 and Risk of Coronary Artery Disease.” New England Journal of Medicine. 2016;374:1123–1133.
  28. 28. Baras A. Personal interview by E. Licking. September 6, 2016.
  29. 29. Sanati C. “How One Company Is Using Artificial Intelligence to Develop a Cure for Cancer.” Fortune website. http://fortune.com/2015/04/16/cancer-cure-artificial-intelligence/. Published April 16, 2015. Accessed May 9, 2017.
  30. 30. Radin A. “Mission Possible: Software Driven Drug Discovery.” Life Science Leader website. http://www.lifescienceleader.com/doc/mission-possible-software-driven-drug-discovery-0001. Published April 1, 2016. Accessed May 9, 2017.
  31. 31. Warren M.“The Cure for Cancer Is Data—Mountains of Data.” Wired website. https://www.wired.com/2016/10/eric-schadt-biodata-genomics-medical-research/. Published October 19, 2016. Accessed May 9, 2017.
  32. 32. Lorenzetti L.“Here's How IBM Watson Health Is Transforming the Health Care Industry.” Fortune website. http://fortune.com/ibm-watson-health-business-strategy/. Published April 5, 2016. Accessed May 9, 2017.
  33. 33. Hay M, Thomas D, Craighead J, Economides C, Rosenthal J. “Clinical Development Success Rates for Investigational Drugs.” Nature Biotechnology. 2014;32:40–51.
  34. 34. Akmaev S. Personal interview by E. Licking. July 28, 2016.
  35. 35. Bhatt A. “Evolution of Clinical Research: A History Before and Beyond James Lind.” Perspectives in Clinical Research. 2010;1(1): 6–10.
  36. 36. EY. Beyond Borders: Unlocking Value. Biotechnology Industry Report 2014. Available at http://www.ey.com/Publication/vwLUAssets/EY-beyond-borders-unlocking-value/$FILE/EY-beyond-borders-unlocking-value.pdf. Accessed May 9, 2017.
  37. 37. “Teva, Intel to Develop Huntington Wearable Tech and Machine Learning Platform.” CenterWatch News Online website. https://www.centerwatch.com/news-online/2016/09/20/teva-intel-develop-huntington-wearable-tech-machine-learning-platform/. Published September 20, 2016. Accessed May 9, 2017.
  38. 38. Auschitzky E, Santagostino A, Otto R. “Advanced Analytics Improve Biopharma Operations.” Pharmaceutical Manufacturing website. http://www.pharmamanufacturing.com/articles/2014/advanced- analytics-improve-biopharma-operations/. Published November 13, 2014. Accessed May 9, 2017.
  39. 39. “REMEDIES Moves on to the Next Stage.” REMEDIES website. https://remediesproject.com/2015/08/27/remedies-moves-on-to-next-stage/. Published August 27, 2015. Accessed May 9, 2017.
  40. 40. Ward A. “McLaren Speeds up GSK with Racetrack Expertise.” Financial Times. December 10, 2014. Available at https://www.ft.com/content/3e2b7874-6f36-11e4-8d86-00144feabdc0. Accessed May 9, 2017.
  41. 41. Ahlawat H, Chierchia G, van Arkel P. “The Secret of Successful Drug Launches.” McKinsey & Company website. http://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/the-secret-of-successful-drug-launches. Published March 2014. Accessed May 9, 2017.
  42. 42. Licking E, Garfield S. “A Road Map to Strategic Drug Pricing.” In Vivo. 2016;34(3): 2–11. Available at http://www.ey.com/Publication/vwLUAssets/ey-in-vivo-a-road-map-to-strategic-drug-prices-subheader/$FILE/ey-in-vivo-a-road-map-to-strategic-drug-prices-subheader.pdf. Accessed May 9, 2017.
  43. 43. Hughes B, Kessler M, McDonell A. Breaking New Ground with RWE: How Some Pharmacos Are Poised to Realize a $1 Billion Opportunity. IMS Health White Paper. August 2014. Available at https://www.imshealth.com/files/web/Global/Services/Services%20TL/rwes_breaking_new_ ground_ d10.pdf. Accessed May 9, 2017.
  44. 44. Hughes B, Kessler M, McDonell A., ibid.
  45. 45. Eichler HG. et al. “From Adaptive Licensing to Adaptive Pathways: Delivering a Flexible Life-Span Approach to Bring New Drugs to Patients.” Clinical Pharmacology and Therapeutics. 2015; (97):234–246.
  46. 46. “Data Analytics Create Better Commercial Strategies.” PharmaVOICE website. http://www.pharmavoice.com/article/2016-06-data-analytics/. Published June 2016. Accessed May 9, 2017.
  47. 47. Foschini L. Personal interview by E. Licking. June 25, 2016.
  48. 48. Arora S.“Recommendation Engines: How Amazon and Netflix Are Winning the Personalization Battle.” MTA Martech Advisor website. https://www.martechadvisor.com/articles/customer-experience/recommendation-engines-how-amazon-and-netflix-are-winning-the-personalization-battle/. Published June 28, 2016. Accessed May 9, 2017.
  49. 49. Ahmed L.“Who's Afraid of a Tweet and a Pin? Strategies to Start Engaging Online,” Scrip Pharma Intelligence website. https://scrip.pharmamedtechbi.com/SC065067/Whos-Afraid-Of-A-Tweet-And-A-Pin-Strategies-To-Start-Engaging-Online. Published May 6, 2016. Accessed May 9, 2017.
  50. 50. Frank H.P. “Building Connected Health Services.” In Pulse of the Industry: Medical Technology Report 2016. EY, October 2016. Available at http://www.ey.com/Publication/vwLUAssets/ey-pulse-of-the-industry-2016/$FILE/ey-pulse-of-the-industry-2016.pdf. Accessed May 9, 2017.
  51. 51. Grover N. “Quintiles, IMS Health to Merge in $9 Billion Deal.” Reuters, May 3, 2016.
  52. 52. IBM. “IBM Watson Health Announces Plans to Acquire Truven Health Analytics for $2.6B, Extending Its Leadership in Value-Based Care Solutions.” PR Newswire website. http://www.prnewswire.com/news-releases/ibm-watson-health-announces-plans-to-acquire-truven-health-analytics-for-26b-extending-its-leadership-in-value-based-care-solutions-300222147.html. Published February 18 2016. Accessed May 9, 2017.
  53. 53. Senior M. Data in Healthcare: Underpinning the Shift to Value. Datamonitor Healthcare. November 22, 2016.
  54. 54. “Lessons from Becoming a Data-Driven Organization.” MIT Sloan Management Review. October 18, 2016.
  55. 55. Lazer D, Kennedy R, King G, Vespignani A. “The Parable of Google Flu: Traps in Big Data Analysis.” Science. 2014;343:1203–1205.
  56. 56. Lazer D, Kennedy R, King G, Vespignani A., ibid.
  57. 57. Berger M, Axelsen K, Subedi P.“The Era of Big Data and Its Implications for Big Pharma.” Health Affairs Blog. http://healthaffairs.org/blog/2014/07/10/the-era-of-big-data-and-its-implications-for-big-pharma/. Published July 10, 2014. Accessed May 9, 2017.
  58. 58. Miller J. “Big Pharma's Bet on Big Data Creates Opportunities and Risks.” Reuters website. http://www.reuters.com/article/us-pharmaceuticals-data-idUSKCN0V41LY. Published January 26 2016. Accessed May 9, 2017.
  59. 59. Kovacs E.“FDA Issues Alert over Vulnerable Hospira Drug Pump.” Security Week website. http://www.securityweek.com/fda-issues-alert-over-vulnerable-hospira-drug-pumps. Published August 3, 2015. Accessed May 9, 2017.
  60. 60. EY. “The ‘New Normal’ in Today's Digital Landscape.” Vital Signs, EY Perspectives on Life Sciences. http://www.ey.com/gl/en/industries/life-sciences/ey-vital-signs-the-new-normal-in-todays-digital-landscape. Accessed May 9, 2017.
  61. 61. Lund S, Manyika J, Nyquist S, Mendonca L, Ramaswamy M. Game Changers: Five Opportunities for US Growth and Renewal. McKinsey Global Institute, July 2013.
  62. 62. Senior M. Data in Healthcare: Underpinning the Shift to Value. Datamonitor Healthcare. November 22, 2016.
  63. 63. Kiron D, Kirk Prentice P, Ferguson RB. “The Analytics Mandate.” Findings from the 2014 Data and Analytics Global Executive Study and Research Report. MIT Sloan Management Review. 2014; Winter: 3–21.
  64. 64. EY and Forbes Insights. Analytics: Do Not Forget the Human Element. November 2015. Jersey City, NJ: Forbes Insights. 2015. Available at http://www.ey.com/Publication/vwLUAssets/EY-Forbes-Insights-Data-and-Analytics-Impact-Index-2015/$FILE/EY-Forbes-Insights-Data-and-Analytics-Impact-Index-2015.pdf. Accessed May 9, 2017.
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