Experience

KLA Breakthrough Consulting

• United States
• Biotechnology Research
• 1 - 100 Employee

• Regulatory Specialist » Orphan Drugs | Rare Diseases | FDA | Regulatory Submissions

  • Jun 2019 - Present

  I specialize in navigating regulatory affairs pathways to achieve FDA Orphan Drug Designation (ODD), European Medicines Agency (EMA) ODD, and Pediatric Rare Disease Designation, as well as accelerated approval, Fast Track, Breakthrough, and RMAT designations. My focus is on guiding start-ups with therapies in pre-clinical or clinical development to capture designations that attract investors. At an affordable rate, I provide the same high-quality submissions for start-ups that larger consulting firms do, at a much more affordable rate. ► 300+ FDA Orphan Drug Submissions ► 100+ EMA Orphan Drug Submissions ► 100+ FDA Pediatric Rare Disease Submissions ► 100+ Fast Track, Breakthrough, RMAT Submissions Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Regulatory Affairs Specialist » Orphan Drugs | Rare Diseases | FDA | Regulatory Submissions

  • Jun 2017 - Jun 2019

  Here, I specialized in bringing therapies to treat rare diseases from pre-clinical to IND stage. I facilitated Fast Track, Breakthrough, and RMAT, as well as FDA ODD, EMA ODD, and Rare Pediatric Disease Designations. My scope encompassed writing, conducting quality control, and strategically reviewing FDA and EMA submissions. I routinely reviewed agency content requirements for various documents to ensure compliance, and performed GAP analyses. I facilitated discussions between clients and the agencies. For each individual drug or biologic, I integrated, interpreted, and summarized data from a variety of sources, including study reports, protocols, investigators’ brochures, and raw client data, to build a storyline that explained the importance of these therapies to patients and caregivers. ► Defined process for writing Target Product Profiles (TPP) and RMAT applications, then structured templates for the team. Show less



KLA Scientifc Consulting

• United States
• Pharmaceutical Manufacturing

• Regulatory Specialist » Orphan Drugs | Rare Diseases | FDA | Regulatory Submissions

  • May 2016 - May 2017

  I launched this consultancy, and in just 1 year wrote or edited 50+ applications to the FDA or EMA for designations (FDA ODD, PRD, Breakthrough Therapy, Fast Track, and EMA ODD). I also performed strategic reviews to determine client eligibility for designations. ► Built 2 custom templates for applications (FDA ODD, FDA PRD) for client consultancies. ► Developed all clients based solely on word of mouth and a reputation within the rare disease consultancy community. I launched this consultancy, and in just 1 year wrote or edited 50+ applications to the FDA or EMA for designations (FDA ODD, PRD, Breakthrough Therapy, Fast Track, and EMA ODD). I also performed strategic reviews to determine client eligibility for designations. ► Built 2 custom templates for applications (FDA ODD, FDA PRD) for client consultancies. ► Developed all clients based solely on word of mouth and a reputation within the rare disease consultancy community.



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Product Quality Analyst

  • May 2015 - Apr 2016

  This role centered on conducting after-market surveillance of medical devices in a high-volume environment in which I managed 4-5 new cases daily. I met Medical Device Report (FDA) and international reporting requirements for the entire line of Abbott Vascular devices. I followed up on cases to discover and document details of each incident. Also, I determined reportability for Japan, US, and country of origin, then wrote the requisite reports. ► Earned promotion into clinical group, which also monitored device use in clinical trials via databases (sometimes blinded to site researchers). ► Reported every case correctly and on time. Show less



Cote Orphan (now defunct)

• Regulatory Affairs Specialist

  • May 2014 - May 2015

  Wrote and edited submissions to the FDA requesting Orphan Drug, Fast Track, and Breakthrough Therapy Designations. Worked as part of an experienced team, and gained an understanding of the "unwritten rules" pertaining to special designations. Wrote and edited submissions to the FDA requesting Orphan Drug, Fast Track, and Breakthrough Therapy Designations. Worked as part of an experienced team, and gained an understanding of the "unwritten rules" pertaining to special designations.