SOURCE: Medpace

Medpace

April 02, 2015 09:20 ET

Medpace VP of Regulatory Affairs, Dr. Steven B. Johnson to Present at Partnerships in Clinical Trials

Medpace to Launch the Power of Giving Campaign

CINCINNATI, OH--(Marketwired - Apr 2, 2015) - Medpace's Vice President of Regulatory Affairs, Steven B. Johnson, will lead a Think Tank Session at the 24th annual Partnerships in Clinical Trials Conference (PCT), April 22-24 in Boston. Sessions will begin on April 22 at 3:30 p.m. Dr. Johnson will facilitate discussion on the topic: Breaking Through Regulatory Barriers in Eastern Europe: Do's, Don'ts and Keys to Success. There will be three 30-minutes think tank session followed by a recap of key findings at 5:00 p.m.

Specific CEE challenges exist for drug and device developers such as biosimilar labeling, drug import/export laws, and the new EU Regulation No. 536/2014. Regulatory strategy for these emerging markets continues to change. Developers crafting a global strategy with CEE countries in mind for their compound will benefit from attending this session.

With tremendous growth in the study of complex biological assets taking shape in the European markets, Medpace, long regarded as one of the strongest CROs in terms of regulatory expertise continues to strengthen the Global Regulatory Affairs platform through the expansion of regulatory intelligence and operations groups. Medpace is meeting market demand by enhancing its already robust EU regulatory presence to meet the growing demand and focus on Orphan & Rare Disease, Regenerative Medicine, and Pediatrics experience.

Medpace Launches the Power of Giving Campaign at Partnerships

Medpace will launch a new campaign that aligns with the company's key therapeutic and specialty areas in which it designs and executes clinical trials for drug, biologic and medical device sponsors. Beginning with PCT, Medpace will invite conference attendees stop by booth 417 to "choose a charity" to which a $5 contribution will be made. A maximum of $5000 will be donated to each charity at the end of the year.

The six charities include:

  • American Heart Association (cardiovascular research)
  • American Diabetes Association (metabolic and endocrine research)
  • American Cancer Society (oncology and hematology research)
  • amFAR - Foundation for AIDS research (infectious disease research)
  • Rare Disease Foundation (rare disease and orphan indication research)
  • Children's Miracle Network (pediatric research).

The Power of Giving Campaign will continue throughout the year at conferences such as DIA and others where Medpace is a sponsor.

Designate a donation online: For more information, or to choose a charity to receive a $5 contribution, visit: http://www2.medpace.com/Power-of-Giving. Your votes will be tallied for the year-end contribution to the charity.

ABOUT STEVEN B. JOHNSON, PharmD

Dr. Steven B. Johnson is the Vice President of Regulatory Affairs for Medpace, and is globally responsible for all regulatory affairs and medical writing activities. Dr. Johnson completed his Bachelors of Science, Bachelors of Pharmacy, and Doctor of Pharmacy degrees from Washington State University. He has over 18 years of experience in regulatory drug development, of which 8 were at the FDA as a Clinical Pharmacology Extern, Clinical Pharmacology Reviewer, and eventually, a Master Reviewer in the Division of Metabolic and Endocrine Drug Projects (Rockville, MD).

Dr. Johnson's regulatory expertise spans across many areas, including global regulatory strategy development, clinical development, licensing applications (NDA, BLA, MAA), investigational applications (IND & CTA), and regulatory planning, review, critique, and plan execution. He has gained extensive knowledge through his work with the following regulatory agencies: US FDA, EMA (CHMP; PDCO); EU National Authorities (e.g. DHMA, PEI, BfRM, MHRA); Health Canada; PMDA.

ABOUT MEDPACE

Medpace is a global full-service clinical research organization (CRO) providing Phase I-IV core development services for drug, biologic, and device programs. Medpace has strong experience supporting development programs across a number of therapeutic areas including oncology, cardiovascular, metabolic/diabetes, infectious disease, neuroscience, regenerative medicine, gastrointestinal diseases, pediatrics, and orphan disease. With extensive medical expertise, and renowned regulatory affairs department, Medpace employs 2000 employees and has clinical trial experience in over 45 countries and 6 regions -- North America, Europe, Asia Pacific, Latin America, Africa, and the Middle East. From feasibility, research site compatibility, safety, and logistics, Medpace brings efficiencies and operational excellence to both drug and device development programs. In addition, Medpace offers integrated imaging, central and bioanalytical lab capabilities, and clinical pharmacology through wholly-owned business units to provide cohesive, streamlined, and standardized trial management.

For more information visit the Medpace website at: www.medpace.com.