Summary
Overview
Work History
Education
Skills
Certification
Publications
Timeline
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Lexy Kelley, MD

Stone Mountain,USA

Summary

Dedicated Medical Director brings strong leadership and 19 years experience in clinical development and medical affairs roles in Pharma and Medical Device companies. Indication background includes rheumatology, autoimmune, rare disease, dermatology, infectious disease, hematology, and women’s health. Clinical development phases 1 – 4 experience including clinical development documents, regulatory support and overall patient safety responsibilities. MSL training, KOL communications and global advisory board management for pre and post marketed products.

Overview

19
19
years of professional experience
1
1
Certification

Work History

Medical Director Clinical Development

BioCryst
Birmingham, Alabama
10.2022 - 01.2024
  • Study Physician and Sponsor Medical Monitor for all trials for two compounds in phase 2 development for the rare disease paroxysmal nocturnal hemoglobinuria
  • Lead close out studies for one compound and phase 2 development for a second compound
  • Worked closely with clinical operations, regulatory, safety, medical writing and medical affairs
  • Activities included investigator meetings, protocol development, protocol execution, management of data monitoring committees.

Vice President, Clinical Development and Medical Affairs

Femasys
Atlanta Metropolitan Area, Georgia
03.2019 - 10.2022
  • Provided leadership and direction for clinical research activities in Medical Device Company for Women’s Health products
  • Input into regulatory documents and close work with FDA
  • Lead all protocol and other clinical development/ clinical operations documents including IBs, CTAs, ICFs
  • Onsite training for all US sites
  • Board presentations of clinical data and investor presentations.

Senior Medical Director

RPS/PRA/now ICON
01.2011 - 01.2018
  • Lead Central Services Reading Group for systemic lupus erythematosus including efficacy endpoint evaluation services as well as study start up activities, site selection, EDC design and training for companies in lupus clinical development
  • Served as SLE (autoimmune disease) therapeutic expert
  • Participation in bid defenses for CRO services
  • KOL engagement and advisory board management.

Medical Director, Medical Affairs

Novartis Pharmaceuticals Corporation
East Hanover, New Jersey
07.2013 - 11.2013
  • Secukinumab messaging coordination activities
  • Participation at IL17 Advisory Board, EADV Congress Istanbul 2013 and ACR 2013 KOL engagement
  • MSL training for secukinumab pre launch.

Associate Medical Director, Immunology Division

UCB Pharma
Smyrna, Georgia
01.2006 - 01.2011
  • Primary Study physician for epratuzumab (monoclonal antibody indicated for adjunctive lupus treatment)
  • Provided Medical input for trial and endpoint designs, protocol specifications, marketing strategies and operational oversight
  • Provided input to Medical Affairs group regarding the characterization of compound (epratuzumab), clinical trial design strategy and regulatory considerations
  • Significant Rheumatology KOL interactions including advisory board preparation and execution and publication of trial data
  • Medical Monitoring duties for epratuzumab and levocetirizine
  • Medical writing activities including IB update and CSR contributions.

Director, Clinical Development

Inhibitex
Alpharetta, Georgia
01.2005 - 01.2006
  • Study Physician for tefibazumab
  • Investigator Brochure update writing and management
  • SAE narrative writing
  • Site operations and management.

Education

Career Masters of Public Health curriculum -

Rollins School of Public Health
01.2005

Chief Pathology Resident and Transfusion Medicine Clinical Research -

Emory University Hospital (EUH)
01.2002

Clinical Pathology Resident -

Emory University Hospital
01.2001

Doctor of Medicine -

Southern Illinois University School of Medicine (SIU-SOM)
01.1998

Medical Student Research Externship -

Mayo Clinic
01.1997

BA Microbiology -

Southern Illinois University (SIU)
01.1994

Biology Major -

University of Illinois
01.1992

Skills

  • Regulatory Support
  • Clinical Operations all phases
  • Vendor Management
  • Strategic Planning
  • Clinical Leadership
  • Patient Safety
  • Clinical Instruction
  • Staff Management
  • Project Coordination
  • Staff Development
  • Operations Management
  • Training internal staff, investigators, customers
  • Safety oversight of trial participants
  • Protocol Development
  • KOL Engagement
  • Advisory Board Management
  • Safety Group Management

Certification

Georgia Medical License, current

Publications

  • Successful testing protocols in virology, Clinical Chemistry, 2001 Aug, Kelley VA, Caliendo AM
  • Determination of the average percent von Willebrand Factor-Cleaving Protease (VWF-CP) activity in donor plasma, Blood, 2001 November, Kelley VA, Hillyer KL, Roush KR, Long E, Barclay SB, Duncan A, Hillyer CD
  • Von Willebrand Factor Cleaving Protease (VWF-CP) activity in S-59 treated donor plasma, Blood, 2001 November, Hillyer KL, Kelley VA, Roush KR, Long E, Barclay SB, Duncan A, Hillyer CD
  • Lack of seronegative Hepatitis C Virus infections in patients with chronic renal failure, Transplantation, 2002 Nov, Kelley VA, Everett-Kitchens J, Brannon L, Connor K, Martinez EJ, Pearson T, Nolte F
  • Cost Effectiveness of Autologous Blood Donations, Abstract AABB 2002, May, Press C, Kelley VA, Phillips V, Stramer S, Hillyer CD
  • Survey of Current Surveillance Methods DRSP, MRSA, VISA/VRSA, 2005, 2005 Conference on Antimicrobial Resistance Programs: Building Bridges: Surveillance – Intervention – Evaluation, Atlanta, Georgia, April 26-29, 2005, Noggle B, Kelley VA
  • Characterization of a Humanized Monoclonal Antibody Recognizing Clumping Factor A, Antimicrobial Agents and Chemotherapy, 2006 Aug, Weems J, Steinberg J, Filler S, Baddley J, Corey GR, Sampathkumar P, Winston L, Lowy F, John J, Kubin C, Talwani R, Moore T, Patti J, Hetherington S, Texter M, Wenzel E, Kelley V, Fowler
  • Data Quality Challenges in Systemic Lupus Erythematosus Trials: How Can This Be Optimized?, Current Rheumatology Reports, Online May 2012, Pike M, Kelley L
  • Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from the ALLEVIATE study and extension SL0006, Rheumatology, 2013, online March 29, Wallace DJ, Gordon C, Strand V, Hobbs K, Petri M, Kalunian K, Houssiau F, Tak PP, Kelley L, Kilgallen B, Wegener W, Isenberg D, Barry A, Goldenberg D
  • Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus : results from EMBLEM, a phase IIb, randomized, double-blind, placebo-controlled, multicenter study, Annals of the Rheumatic Diseases, Online First, 12 January 2013, Wallace DJ, Kalunian K, Petri M, Strand V, Houssiau F, Pike M, Kilgallen B, Barry A, Kelley L, Bongardt S, Gordon C
  • Epratuzumab demonstrates clinically meaningful improvements in patients with moderate-to-severe systemic lupus erythematosus (SLE): results from EMBLEM, 8th European Lupus Meeting (ELM), Porto, Portugal, April 6-9 2011, Gordon C, Petri M, Kalunian K, Strand V, Houssiau F, Pike M, Kilgallen B, Kelley L, Wallace, D.J.
  • Epratuzumab demonstrates clinically meaningful improvements in patients with moderate-to-severe systemic lupus erythematosus (SLE): results from EMBLEM, British Society for Rheumatology (BSR), Glasgow, UK, 1-3 May 2012, Gordon C, Petri M, Kalunian K, Strand V, Houssiau F, Pike M, Kilgallen B, Kelley L, Wallace, D.J.
  • Systemic Lupus Erythematosus Responder Index assessment of responders in EMBLEM, a phase IIb study in patients with moderate to severe systemic lupus erythematosus, ACR/ARHP Scientific Meeting 2011, Chicago, IL, USA, November 4-5, Petri M, Pike M, Kelley L, Kilgallen B, Gordon C
  • Epratuzumab demonstrates clinically meaningful improvements in patients with moderate/severe flaring systemic lupus erythematosus: results from the ALLEVIATE study and extension SL0006, Rheumatology, 2013, online March 29, Wallace DJ, Gordon C, Strand V, Hobbs K, Petri M, Kalunian K, Houssiau F, Tak PP, Kelley L, Kilgallen B, Wegener W, Isenberg D, Barry A, Goldenberg D
  • Epratuzumab demonstrates clinically meaningful improvements in patients with moderate/severe flaring systemic lupus erythematosus: results from the ALLEVIATE study and extension SL0006

Timeline

Medical Director Clinical Development

BioCryst
10.2022 - 01.2024

Vice President, Clinical Development and Medical Affairs

Femasys
03.2019 - 10.2022

Medical Director, Medical Affairs

Novartis Pharmaceuticals Corporation
07.2013 - 11.2013

Senior Medical Director

RPS/PRA/now ICON
01.2011 - 01.2018

Associate Medical Director, Immunology Division

UCB Pharma
01.2006 - 01.2011

Director, Clinical Development

Inhibitex
01.2005 - 01.2006

Career Masters of Public Health curriculum -

Rollins School of Public Health

Chief Pathology Resident and Transfusion Medicine Clinical Research -

Emory University Hospital (EUH)

Clinical Pathology Resident -

Emory University Hospital

Doctor of Medicine -

Southern Illinois University School of Medicine (SIU-SOM)

Medical Student Research Externship -

Mayo Clinic

BA Microbiology -

Southern Illinois University (SIU)

Biology Major -

University of Illinois
Lexy Kelley, MD