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Project Management: Regulatory Affairs and Clinical Trials Class Presentation - Round 1 of Product Development

Project Management: Regulatory Affairs and Clinical Trials Class Presentation - Round 1 of Product Development

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  • 1. Technology: Hematology Lead Product: Blood BackUp
  • 2. Message from CEO
  • 3. Mission Statement
    • BioPharmic is a global enterprise with core competencies in the field of health care. We are working towards improving patients’ lives by providing customers with innovative science and differentiated healthcare solutions; delivered by diverse and engaged talent with integrity, passion and focus on performance.
  • 4. Heather Juhan
    • B.S. in Biology and Management from Columbia University
    • PhD in Hematology from John Hopkins University School of Medicine
    • Previous Jobs:
      • President and Chief Executive Officer at Merck & Co.
      • Vice President of Research and Development for Abbot Laboratories
      • Head Project Leader for Product Development Teams at Eli Lilly and Company
    Chief Executive Officer and Project Leader
  • 5. Samson Adewale
    • B.S. in Biotechnology and Marketing from Kennesaw State University
    • PhD in Biotechnology from Emory University
    • Previous Jobs:
      • Vice President of Research and Development for Wyeth
      • Director of Research and Development for GlaxoSmithKline
      • Director of Research and Development for Solvay Pharmaceuticals
    Vice President of Research and Development
  • 6. Amish Chhita
    • B.S. in Biomedical Engineering from the University of California, Berkley
    • P.E. certification in California
    • PhD in Immunology from Baylor College of Medicine
    • Previous Jobs:
      • President of Operations and Manufacturing at Pfizer
      • Professor of Immunology at University of Southern California
      • President of Operations and Manufacturing at Bristol-Meyers Squibb
    Vice President of Operations and Manufacturing
  • 7. Ubani Chinedu
    • B.S. in Biotechnology from Kennesaw State University
    • Master of Science in Clinical Research Program, University of California, Los Angeles
    • Previous Jobs:
      • Vice President of Clinical and Regulatory Affairs at Wyeth
      • Researcher for Clinical Studies with Drug Studies for America
    Vice President of Clinical and Regulatory Affairs
  • 8. Concept of Blood Substitutes
    • During the Vietnam war, the United States Army launched a project with the aim to develop a preparation that could be infused rapidly and in massive quantities to injured battlefield combatants in far-forward areas and mobile surgical theaters before the injured could be evacuated to more sophisticated field hospitals for definitive care. This is where the concept of “Blood BackUp” emerged.
  • 9. OUR Concept
    • Attract investors to help supply the unmet needs for a blood substitute in the United States, and the World.
    • Use our knowledge to prepare a blood substitute that will be safe and effective for males and females over 18 years of age.
  • 10. Quick Facts
    • Every two seconds someone in the U.S. needs blood.
    • More than 38,000 blood donations are needed every day.
    • One out of every 10 people admitted in a hospital needs blood.
    • Total blood transfusions in a given year: 14 million (2001)
    • Sickle cell disease affects more than 80,000 people in the U.S. Sickle cell patients can require frequent blood transfusions throughout their lives.
    • More than 1 million new people are diagnosed with cancer each year. Many of them will need blood, sometimes daily, during their chemotherapy treatment.
    • The demand for blood transfusions is growing faster than donations .
    • Less than 38% of the U.S. population is eligible to donate blood.
  • 11. Product and Services
    • Blood BackUp is a human hemoglobin-based temporary oxygen-carrying red blood cell substitute in development for the treatment of life-threatening blood loss when an oxygen-carrying fluid is required and red blood cells are not available.
    • Blood BackUp is a solution of chemically modified human hemoglobin which simultaneously restores lost blood volume and hemoglobin levels and is designed for rapid, massive infusion.
  • 12. Unmet Needs
    • Military and civilian disasters where numerous injuries occur
    • Military battlefield use where blood is not readily available
    • During the transport of a critical victim by ground or air ambulance
    • Unanticipated hemorrhaging during surgery
    • Hospitals where blood is in limited supply; such as rural areas
    • Lack of compatible bloods
    • Someone’s religious objection to blood  
  • 13. Competitive Advantages
    • Carries a shelf life of 12 months, nine times longer than donor blood, which expires in 42 days.
    • Universally compatible, meaning any blood type can accept it, and it can be transfused immediately.
    • Thinner than normal blood, so it can be transfused more rapidly and can safely be transfused in large volumes.
    • No risk of contracting diseases; which you can from donated blood.
  • 14. Problems with other hemoglobin based products.
    • Heart attacks due to small tetrameric species of hemoglobin, hence not transporting enough oxygen to the heart, or releasing carbon dioxide from the body.
    • Cardiovascular toxicities and organ dysfunction due improper filtration and purification techniques.
    HAS FIXED THESE PROBLEMS!
  • 15. OUR Advantages
    • Blood BackUp, with the addition of rHuEPO (Recombinant Human Erythropoietin) helps increase the number of red cells, which means more hemoglobin, thus more oxygen being carried throughout the entire body.
    • Our filtration and purification techniques have been mastered to stop the majority of possibilities of organ dysfunction and cardiovascular toxicities.
  • 16. How it works?
    • Previously, all synthetic blood products had a high risk of heart attacks.
    • The lack of oxygen caused these cardiac issues.
    • Blood BackUp, with the addition of rHuEPO helps increase the number of red cells; decreasing the chance of heart attacks.
    • http://www.youtube.com/watch?v=_ZV5140OykE
  • 17. Dosage and Administration One unit of Blood BackUp is equivalent to 50 grams of synthetically modified hemoglobin, which is approximately the same mass of hemoglobin delivered by one unit of red blood cells. Blood BackUp will be administered intravenously to patients by a healthcare professional. Based on dose ranging studies, the most rapid rate comprises of the infusion of 20 units in 20 minutes during rapid hemorrhaging. This dose is equivalent to 2 times the blood volume of an average adult.
  • 18. How is it Made?
    • Produced by using expired human blood obtained from blood banks and hospitals.
    • Human hemoglobin extracted utilizing a polymerization process which modifies the red blood cells and then they are placed into an electrolyte solution.
    • Addition of the Recombinant Human Erythropoietin (rHuEPO).
    • For every 1 pint of blood, 2 pints of Blood BackUp are produced.
  • 19. First, hemoglobin is extracted from red blood cells and filtered to remove impurities. This purified hemoglobin is then chemically modified and purified using a multi-step process to create a polymerized form of hemoglobin.
  • 20.
    • The modified hemoglobin is then incorporated into an electrolyte solution.
    • Polymerization is intended to eliminate the undesirable effects historically associated with hemoglobin-based blood substitutes: vasoconstriction, kidney dysfunction, liver dysfunction and gastrointestinal distress.
  • 21. Blood BackUp
    • Produce our own IV bags that are PVC-free (Patent 5374682, issued on 09/08/09).
  • 22. Blood BackUp
    • Our package includes 2 IV bags, along with the needles for both bags.
    • Shelf life is 12 months.
    • The blood is manufactured to be stored at room temperature.
    • Ability to withstand extreme temperatures for a brief period.
    • Administered by Health Care Professionals only.
  • 23. Price of Blood BackUp
    • Not for sale for personal use!
    • Available to hospitals and all other medical care.
    • Each product includes 2 IV bags and 2 accompanying needles for $350.
    • Normal blood cost of a pint of blood as of 09/20/09 according to the Red Cross was $250 per pint.
  • 24. Manufacturing & Distribution Centers
    • Washington D.C.
    • Galveston, TX
    • Newport Beach, CA
    • Miami, FL
    • Future Locations
      • New Orleans, LA
      • St. Louis, MO
      • Denver, CO
  • 25. Production
    • Each plant is capable of producing 4000 units per annum.
    • Within the plant, there are separate buildings for the manufacturing of the pvc-free bags and the needles.
    • Production is limited to 4000 per annum based on the confirmed supply from the hospitals and blood banks .
  • 26. Activities in Process
    • BioPharmic is currently applying for a Biologic License Application from the FDA.
    • We have submitted a provisional patent for Blood BackUp.
    • As of right now, the patent for Blood BackUp has not been issued.
    • The patent office has assured our company that everything is in order and ready to go to obtain our patent.
  • 27. Present Stage
    • BioPharmic has created the prototype.
    • Currently beginning work on animal testing in pigs.
  • 28. Animal Studies Demonstrating Safety and Effectiveness
    • Summary of Study
    • 20 pigs were divided into 2 groups of 10 pigs each. The first group was given donated red blood cells, and the other group was given HBOC (Hemoglobin Based Oxygen Carriers), our BloodBackUp.
    • Blood was withdrawn from each pig to the point that their bodies were deprived of oxygen, and blood transfusion was required.
  • 29. Animal Studies
    • The first group of pigs was given donated red blood cells, and the other group was given HBOC (Hemoglobin Based Oxygen Carriers).
    • The HBOC (Blood BackUp) was able to restore oxygen to the bodies of the pigs safely and effectively just as the donated red blood with no adverse events.
    • More compilation of this similar study is needed for our BLA application. Another reason why we need your help.
  • 30. Timeline
    • Microsoft Project
  • 31. Market Analysis
    • Patient Population: Males and females over the age of 18.
    • Size of target market: Worldwide!
      • As we have stated previously, the unmet needs are so demanding that the size of the target market as of right now is an exponential increase.
  • 32. Financial Data
    • $1.50 per share
    • Issued Shares = 10,000,000
    • Requesting $8,000,000
      • Building new manufacturing centers
      • Developing product
      • Animal studies
    • Our Company is based in Washington D.C.
      • Minutes away from American Red Cross
  • 33. Finances Within BioPharmic
    • Heather Juhan; CEO - 40%
    • Amish Chhita; VP of Operations - 20%
    • Samson Adewale; VP of R & D - 20%
    • Ubani Chinedu; VP of Clinical & Reg. Affairs - 20%
  • 34. Expected Return on Investment
  • 35. Exit Strategy
    • There have been talks of Northfield Laboratories either merging with BioPharmic, or a take-over.
    • If we do decide to sell, the selling price would be $60,000,000.
  • 36. Future of
    • Establish new manufacturing plants in other countries.
    • Create alternatives to human blood; produce synthetic blood using human stem cells.
    • Advances in the formulation of Blood BackUp.
    • Supply all hospitals with Blood BackUp.