Education:

University of New Orleans: Chemistry, B.S.

Regulatory Affairs Professional Society: Devices, R.A.C.

Texas A&M: Business, M.B.A.

About:

Isabella currently serves as the Director of Regulatory Affairs at Proxima Clinical Research, Inc.  Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development. Prior to joining the Proxima team, Isabella served as the Senior Regulatory and Quality Manager for a medical device company where she was charged with outlining the regulatory strategy and putting together design controls and design history documentation, and as the Director of CMC and Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.  

Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications. Isabella is a judge and mentor for MedTech Innovator, and in her spare time, she serves as a TMCx advisor and speaker, helping companies with regulatory affairs, quality, and clinical development questions, and as a MassChallenge Houston judge and mentor.  She also serves as a pitch coach for SXSW Pitch Competition.

Positions and Honors:

Proxima Clinical Research, Houston, Texas
Director of Regulatory Affairs
Regulatory Affairs Consultant

ColubrisMX, XCath, Houston, Texas
Senior Regulatory and QA Manager

Repros Therapeutics., The Woodlands, Texas
Director of CMC and Quality

Repros Therapeutics, The Woodlands, Texas
Regulatory Affairs Associate

Repros Therapeutics, The Woodlands, Texas
Clinical Research Associate

University of New Orleans, New Orleans, Louisiana
Research Assistant

Contributions to Science:

Ms. Schmitt has played an important role in the development of the following medical products:

  1. Drug for Male Testosterone
  2. Drug for Endometriosis
  3. Drug for Uterine Fibroids
  4. Drug for Vaginal Atrophy
  5. Drug for Colon Cancer
  6. Drug for COVID-19
  7. Drug- Oncolytic Virus
  8. Nutritional Supplement for Cystic Fibrosis (pediatric)
  9. Medical Device for Group B Streptococcus (pediatric)
  10. Medical Device for Asthma Monitoring (pediatric)
  11. Medical Device- IVD for Sepsis Detection
  12. Medical Device- Software for Sepsis Detection
  13. Medical Device for Gas Collection
  14. Medical Device for Urine Flow Measurement (pediatric)
  15. Medical Device for Spinal Fusion
  16. Medical Device for Neuromodulation (x4)
  17. Medical Device- Software for Wound Management
  18. Medical Device- Surgical Robot
  19. Medical Device- Vascularization imaging surgical device
  20. Medical Device- Catheter Guidewire
  21. Medical Device- Balloon Catheter
  22. Medical Device- Heart Valve (pediatric)
  23. Medical Device- Left Ventricular Assist Device (LVAD) or MCS (x4)
  24. Medical Device- Non-Invasive Blood Pressure Monitor (x3) (one pediatric)
  25. Medical Device- Software for Atrial Fibrillation Detection
  26. Medical Device- Biliary Catheter and Pump
  27. Medical Device- Software for Flow Cytometry Data Analysis
  28. Medical Device- Detection of Cerebral Blood Flow for Stroke Rehabilitation
  29. Medical Device- IVD for Melanoma Risk Assessment
  30. Medical Device- Anchors for Fetoscopic Surgeries (pediatric)
  31. Medical Device- Gastric Sleeve and Anchor
  32. Medical Device- Breast Localization Wire
  33. Medical Device- Gallbladder Cryoablation
  34. Medical Device- Noise attenuation for neonates (pediatric)
  35. Medical Device- Surgical margin detection device (x2)
  36. Medical Device- Organ Perfusion Device
  37. Medical Device- Perfusion Catheter
  38. Medical Device- Surgical Adhesion Material
  39. Medical Device- IVD for bacterial detection  
  40. Medical Device- Sleep apnea relief
  41. Medical Device- Vascular patch
  42. Medical Device- Software for radiology  
  43. Medical Device- Heart Rhythm management device
  44. Medical Device- Laboratory Robots
  45. Medical Device- Gastroscope (pediatric)
  46. Medical Device- Software for cancer management
  47. Medical Device- Software for autism treatment (pediatric)
  48. Medical Device- Intra-urethral valve pump and activator (x2) (pediatric)
  49. Medical Device- IVD for Barret’s Esophagus  
  50. Medical Device- IVD for necrotizing enterocolitis (pediatric)
  51. Medical Device- Camera for ophthalmology
  52. Medical Device- Infusion pump
  53. Medical Device- Software for depressive disorder
  54. Medical Device- Stroke Cooling Device  
  55. Medical Device- Ventilator
  56. Medical Device- IVD for COVID-19
  57. Medical Device- Infant feeding measurement device (pediatric)
  58. Medical Device- Software for attentional deficit disorders (pediatric)
  59. Medical Device- Diagnostic for ear infection (pediatric)
  60. Medical Device- Neonatal Incubator (pediatric)
  61. Medical Device- Scoliosis (pediatric)
  62. Medical Device- Intubation system
  63. Medical Device- Ultrasound surgical system  
  64. Medical Device- Nasal spray delivery
  65. Medical Device- Coronary stent
  66. Medical Device- Epilepsy (pediatric)
  67. Medical Device- Diabetes test (pediatric)
Additional Information:

Contributed to Regulatory Focus

Honors Graduate

Magna Cum Laude

Dean list

American Chemical Society Undergraduate of the Year

Poster presentations at ACS and MRS National Meeting

Undergraduate Research Award

President Chemistry Club

Oral presentation ACS National Meeting

OriginallY From:
New Orleans, Louisiana
Fun Fact:
When Isabella was a little girl, the casting agents for interview With a Vampire requested to meet with her, but she was too shy to talk to them.
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