Robert Allen Walls
 
Chief Executive Officer

Mr. Walls is CEO of xFDA, LLC. His business career and government employment span over 40 years. His experience with the US Government in high level positions of increasing responsibility include: Senior Consultant in the Office of Economic Opportunity – Office of President, Deputy Regional Director – Office of Minority Business Enterprise, OMBE, US Department of Commerce, DOC, Director – Office of Business Relations – Agency for International Development (AID) Director Office of International Business Development – US Department of Agriculture, USDA, Executive Director, Presidential Council for Vocational Education, PCVE…He has over 25 years of successful business experience. Read more...

Marilyn A. Apfel, PhD
 
Chief Operating Officer

Dr. Apfel is Co-Founder and COO of xFDA.  She brings over twenty five years of experience in pharmaceuticals including five years in industry and eight years in the Center for Drug Evaluation and Research  at the FDA.

Dr. Apfel  is a former FDA CMC expert and is an expert in FDA regulatory submissions. She provides chemistry, manufacturing, and controls (CMC) guidance to the pharmaceutical industry, interprets regulations, and prepares or advises on the preparation of the CMC portion of applications for FDA submission. She advises on analytical issues, impurities, clinical supplies and packaging issues, drug substance and drug product stability issues, and all facets of the planning of the CMC portion of a project from the early stages through post approval. She also has a working knowledge of protein purification and chemical peptide synthesis. Read more...

John Kenneth Hautman, Esq

Executive Vice President Legal Affairs

Mr. Hautman provides general counsel and strategic advisory services as Executive Vice President for Legal Affairs of xFDA.   He is also Director of the PatentProtectPlus division of xFDA.

As a business lawyer, entrepreneur, healer and strategic adviser, Mr. Hautman has provided assistance to companies for over 30 years in the areas of intellectual property protection, technology commercialization and licensing. He co-founded two biotech companies and has extensive experience guiding emerging technology companies and their founders.  Read more... 

James H Sherry, MD, PhD

Executive Vice President of Business Development and Clinical Affairs

Dr. Sherry serves as the Executive Vice-President of Business Development and Clinical Affairs.   He is a board certified in Neurology with over 20 years of clinical, research, and regulatory experience.   Prior to joining xFDA, Dr. Sherry was the Medical Director at Mylan Laboratories and Vice-President, Clinical Research at Mylan-Bertek Pharmaceuticals.   His duties as Medical Director included managing the pharmacovigilance program for over 100 drug products, assisting with business development, and working with the Marketing departments.   During his time at Mylan-Bertek Pharmaceuticals, he was responsible for the development of branded products.   He successfully led the development of three compounds through NDA submission.   One of which received a priority review and rolling submission.   Prior to joining Mylan, Dr. Sherry served as a Medical Reviewer in the Division of Neuropharmacologic Drug Products at the Food and Drug Administration (FDA). Read more...

Press Release

PatentProtectPlus(TM):
A New Service to Enhance and Strengthen a Patent Portfolio

xFDA Launches PatentProtectPlus to Strengthen Patents by Applying Innovative Know How and Technology.   Our Experts Have Experience Working With a Company's Patent Lawyers to Enhance the Company's Patent Portfolio and Defending the Company's Patents from Challenges by Industry Giants. Read more