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Surviving Change in the 21 st Century

Surviving Change in the 21 st Century. Florida Association of Blood Banks Annual Meeting Richard R. Gammon, MD Medical Director. Learning Objectives. Discuss past model of blood center operations Cover current challenges Give an overview of current and future opportunities .

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Surviving Change in the 21 st Century

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  1. Surviving Change in the 21st Century Florida Association of Blood Banks Annual Meeting Richard R. Gammon, MD Medical Director

  2. Learning Objectives Discuss past model of blood center operations Cover current challenges Give an overview of current and future opportunities

  3. Past Model of Blood Center Operations

  4. Ancient Times • Prehistoric man • Left drawings of himself pierced by arrows • Aware of blood • Fearful as life flowed red out of body of animal or enemy Cave of Lascaux Rossi’s Principles of Transfusion Medicine. 2009

  5. Blood has Mystical Qualities • Romans • Fountain of youth • Medea prepares cauldron of sacrificed black sheep • Gives to Jason’s father Aeson • His hair and beard…assumed the blackness of youth…limbs of vigour and robustness Bullfinch’s Mythology

  6. Middle Ages • 1492 Pope Innocent VIII on deathbed • Physician used blood drawn from three boys 10 years of age to save life • All died-no blood received

  7. First Animal-to-Human Transfusion • June 15, 1667 • Jean Baptiste Denis • Blood of lamb administered to 15 year-old boy – less impurities • Boy had fever and lethargy • Symptoms relieved by transfusion of 9 oz of blood

  8. Denis’ Experience • Performed transfusions on 3 additional patients • Number 2 survived, but 3 and 4 did not • Patient 4 – 34 year-old Anthony du Mauroy • Experienced bouts of maniacal behavior • Transfused blood of a calf two times

  9. The Fate of Mr. du Mauroy Two months later he began to experience maniacal behavior Wife sought transfusion therapy Transfusion could not be accomplished and patient died the next day Wife tried to extort money from Denis or threatened a malpractice lawsuit Denis refused and an investigation was launched

  10. …and the Answer Is? • Madame du Mauroy had poisoned her husband with arsenic • Judgment April 17, 1668 • Denis was exonerated • Madame du Mauroy was held for trial • Transfusion should not be performed unless approved by the Physicians of the Parisian Faculty

  11. 1700s-Early 1800s • Within 10 years transfusion banned from England and France • Leeches for phlebotomy common • Contributed to death of George Washington Death of Washington by Howard Pyle

  12. The Beginnings • Early 1800s • James Blundell • London obstetrician • Noted frequency of death after delivery

  13. The Beginnings • Performed 10 transfusions • 5 were successful • Developed devices to facilitate transfusion • Against animal transfusions Blundell’s Gravitator

  14. The Victorian Era • Media used for transfusion • Milk • Cows • Goats • Human milk • Abandoned when saline became available Adler J. 1892

  15. Era of Modern Blood Banking • 1900 • Karl Landsteiner discovered ABO System • 1913 • Reuben Ottenberg • Describes compatibility testing • O as “universal” Dr. Landsteiner

  16. Wars and Technology • Anticoagulants • Sodium citrate - WW I • ACD - WW II • Indirect transfusion -- WWII • Blood collected now • Transfused later Soldier Receives Transfusion

  17. Wars and Technology – WW I Battlefield Blood Bank

  18. Transfusion WW I Blood Brothers- L'Illustration – 11/21/1914

  19. War and Technology-World War II • US begins “Plasma for Britain” project • Dr. Charles Drew heads project • 14 million units collected by war’s end

  20. The Rise of the Community Blood Center • 1937 Dr. Bernard Fantus established first blood storage facility • Cook County Hospital in Chicago • Blood bank • Save in one place • Obtain as needed

  21. The Rise of the Community Blood Center • 1941 • Irwin Memorial Blood Bank opens • First US community blood bank

  22. Blood Centers The Early Days Donor RoomLaboratory

  23. Blood Centers The Early Days

  24. The Creation of Components • 1960s • Move to component therapy/plastics • Allows extended storage • Multiple products from one donation

  25. Derivative Therapy • WW II – Cohn develops cold ethanol method of plasma fractionation • Albumin, fibrinogen, globulin become available • Clotting factor concentrates • 1965 Pool discovered Factor VIII could be harvested from cryoprecipitate • Hemophiliacs benefited greatly-reduced disability

  26. Volunteerism • 1962 • Connection made between paid donations and posttransfusion hepatitis • 1970 • 1970 January designated as National Volunteer Donor Month • US moves to all volunteer donor base

  27. The 1980s • Discovered that HIV could be transmitted in blood – 20 month infant • Up to 1% of single-donor unit transfusions were infected with HIV • Public confidence in blood supply at all-time low • Concern with slow action by regulatory/professional associations

  28. The late 20th/Early 21st Century • Improved testing methods • Nucleic Acid Testing Introduced • HIV (1999) • Hepatitis C (1999) • West Nile Virus (2003) • Hepatitis B (2012)

  29. 2010s • Error reduction • Barcodes/RFID • iTrace – FDA clearance 05/29/13 • Emerging pathogens • Hemovigilance • Pathogen Inactivation • Cellular Therapies • Blood management http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm354186.htm 05/13

  30. Current Challenges

  31. Paradigm Shift B. Grigsby ABC Meeting 08/11

  32. Hospitals Employ More Than 259,000 Physicians, Up 31% From 2000 R Umberstock ABC Meeting 03/13

  33. Adapting to Change

  34. Adapting to Change

  35. More Change…

  36. Affordable Care Act

  37. Seizing Opportunity

  38. Seizing Opportunity

  39. Diversification J Fredericks. ABC Meeting 03/12

  40. Diversification - Transplantation

  41. Diversification – Transfusion Medicine

  42. Opportunities – Current and Future

  43. Role of the Blood Center ABC Webinar 12/08/10

  44. Processing Services

  45. Cord Blood Processing and Banking

  46. The Possibilities

  47. Cumulative Stem Cell Trials Worldwide

  48. Cell therapy companies & their products ABC Webinar 0212 ~300 therapeutic companies with ~250 cell-based therapies in the market or in some stage of clinical development. These therapies can be roughly broken down into the following stages*: ~110 Phase I ~70 Phase II~30Phase III ~40 Commercial (marketed in at least one country) Only ~1/3 of the therapies currently marketed (~13) required and received regulatory approval. In contrast, an estimated 90% of the therapies in development are “products” requiring pre-market approval. __________________________________________________________________________________ * Note that these numbers are limited to industry-sponsored trials and may not capture fully products in early-stage trials where industry “sponsorship” is less than transparent.

  49. Have the fundamentals changed? • Cell therapy is here – instances of it being routine clinical practice & commercial • There has been incremental success • CT is now very much a part of individual, corporate, academic, policy, and financial consciousness • CT is now part of routine clinical practice and commercial products • Emerging metrics of a maturing industry (e.g., players, orgs, FDA, etc.) • On financial sector’s radar • Now working on second generation (not first generation) products. • Very little of this was true 10 year’s ago.

  50. Today’s Market

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