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WIB-Capital Region: Orphan Drug Boot Camp
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8/15/2018
When: Wednesday, August 15, 2018
6:00 p.m. – 8:00 p.m. EST
Where: IQVIA
8630 Fenton Street (Suite 724)
Silver Spring, MD  20910
United States
Contact: WIB-Capital Region


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WIB-Capital Region, in collaboration with IQVIA Orphan Drug Unit, present “Orphan Drug Boot Camp.”

Attendees will learn first-hand how orphan drugs are managed with special deference by regulatory agencies such as the FDA and EMA.

  • Essentials of Orphan Drug Designation
  • Pediatric/Tropical Rare Disease Priority Review Voucher (PRV)
  • Breakthrough Therapies for Orphans
  • Special Tenderness Offered to Orphans by the FDA Review Divisions.

Light food and drinks will be served. Both men and women are welcome to attend.

 

Speaker Biographies

Katherine (Katie) Laessig is a Vice President of Therapeutic Strategy in Strategic Drug Development group at IQVIA. She is a U.S. Regulatory Affairs and Infectious Disease expert with over 19 years of combined industry and regulatory experience. She earned her B.A. from Cornell University with a concentration in microbiology and her M.D. degree from the University of Maryland. Following her Internal Medicine residency she went on to complete her sub-specialty fellowship in Infectious Diseases, both at George Washington University. She then joined the F.D.A., taking on several positions of increasing responsibility in the Division of Anti-Viral Products, before joining the Division of Anti-Infective Products DAIP) where she served as the Division’s Deputy Director for eight years. In that role, Katie was responsible for review of antimicrobial drug and biologic products for the treatment as well as prevention of infectious diseases. After leaving FDA, she became Senior Vice President, Regulatory Affairs, Medical Safety, and Quality Assurance, at RRD International LLC. an early product development company focused on products from the pre-IND phase through human proof-of-concept. In that role, she provided high-level regulatory strategy and clinical development oversight of products across a variety of therapeutic areas including antimicrobials, oncology, GI, pulmonary, and medical imaging.

 

Malia Segar is an Associate Director, Regulatory Affairs, at IQVIA Orphan Drug Unit. She has experience in regulatory affairs, consulting, medical/regulatory writing, and project management.  In previous roles, Malia developed skills and knowledge of nonclinical drug development and preparation of nonclinical sections of regulatory documents, including INDs and NDAs/BLAs (CTD and legacy format). At IQVIA, Malia oversees a group of regulatory affairs professionals. She has extensive knowledge of orphan drug development and strategy, including, FDA/EMA orphan drug designations, pediatric rare disease designations, breakthrough therapy designations, and preparation for meetings with the Agency.  She earned her Master’s in Biotechnology/Biodefense from Johns Hopkins University, her Undergraduate Bachelor’s Degree in Biology from Elon University, and earned the Regulatory Affairs Certification.

 

Walk-Ins Accepted?

Yes*

* - Walk-ins will be accepted at the door until event capacity is reached.

 

Program

6:00 p.m. - 6:30 p.m.         Check-in and Networking Reception

6:30 p.m. - 8:00 p.m.         Presentation and Q&A.

 

Pricing Information

Members: $10

Non-Members: $40

 

Special Pricing for Guests

When registering, members can register guests at member price

 

Parking Information

Metered street parking and public garage parking nearby.

 

Public Transit Information

  • By Metro, RED line: Silver Spring is the closest Metro Station.
  • The location is within 0.4 miles of the Metro station.

 

Maximum Capacity

40

 

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