Navigating Bioterrorism and Emerging Diseases

June’s program was held at the Nippon Club. To download the event summary, click here.

Bioterrorism and emerging diseases present a host of unique challenges in the research, clinical trial, regulatory, and business development spheres that companies need to grapple with when trying to bring a new product to market.

This program will tackle both emerging infectious diseases with a focus on Ebola and bioterrorism with a concentration on anthrax. Andrew Verderame will recount the history of the 2001 anthrax attacks and subsequent CIPRO approval while sharing important lessons learned, Jeremy Middleton will discuss the HHS medical countermeasure development pathway, challenges with the animal rule, and challenges of developing medical countermeasures against emerging diseases, Susan Ellenberg will talk about the need for randomized clinical trials in the context of emerging infectious diseases, and Elizabeth Petzold will discuss lessons learned in clinical trial design from a clinical trial that was designed but never implemented for Ebola in West Africa.

**Click Speaker Name for Bio

Andrew Verderame, RAC, President, PharmaLex US, LLC

Mr. Verderame serves as president of PharmaLex US, a regulatory affairs service provider specializing in FDA interactions for clients of all sizes, and is responsible for all operations, management, business development, and client relationships. He previously served as the US Head of Global Regulatory Affairs – Marketed Products, CMC, and Development support at EMD Serono, Inc. where he was responsible for overall strategy and management of the regulatory and lifestyle activities (new products, new indications, new devices, and CMC regulatory compliance) for EMD Serono’s Multiple Sclerosis, Fertility, and endocrinology product lines, totaling over $1.5 billion in sales annually.

In his 15 years as Director of Regulatory Affairs for Bayer Pharmaceuticals, he steered submitted products through FDA review achieving four NDA approvals that resulted in successful new product introductions, delivered several major sNDA approvals such as Cipro Anthrax, Cipro Pediatrics, and Avelox uSSSI, and provided the regulatory and strategic input over 6 years that led to the approval of the six month exclusivity extension for the Cipro franchise resulting in over $500 million additional revenue before genericization. He served as Bayer’s lead spokesman for over one hundred face-to-face meetings with the FDA and was selected as the first ever industry representative invited to speak at the FDA Project Manager Forum.

He has also offered his deep experience in all aspects of US regulatory affairs and FDA interactions as an independent strategic consultant.

He received his MBA from Fairleigh Dickinson University and his BS in Chemical Engineering from Clarkson University.

Susan Ellenberg, Ph.D., Professor of Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania

Dr. Ellenberg’s research has focused on practical problems and ethical issues in designing, conducting and analyzing data from clinical trials, including surrogate endpoints, data monitoring committees, clinical trial designs, adverse event monitoring, vaccine safety and special issues in cancer and AIDS trials.   At Penn, in addition to her teaching and administrative duties she serves as senior statistician for several multicenter clinical trials and directs the Biostatistics Core of the Penn Center for AIDS Research.  She chairs the organizing committee for the annual Penn conference on statistical issues in clinical trials.   She also served for many years as Associate Dean for Clinical Research, overseeing the human subjects protections programs, training and centralized research support of the Perelman School of Medicine.

Prior to her appointment at Penn, Dr. Ellenberg held positions of increasing responsibility in the federal government.  From 1993 to 2004 she served as Director, Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration; prior to that she served as the first Chief of the Biostatistics Research Branch in the Division of AIDS, National Institute of Allergy and Infectious Diseases (1988-1993), and served in the Biometric Research Branch in the Cancer Therapy Evaluation Program, National Cancer Institute (1982-1988).

Dr. Ellenberg is a Fellow of the American Statistical Association, the Society for Clinical Trials and the American Association for the Advancement of Science, and is an elected member of the International Statistical Institute.  Her book, Data Monitoring Committees in Clinical Trials: A Practical Perspective, co-authored with Drs. Thomas Fleming and David DeMets, was named WileyEurope Statistics Book of the Year for 2002; a second edition is in preparation.

Elizabeth Petzold, Ph.D., Clinical Project Leader, Duke Clinical Research Institute

Dr. Petzold is currently a Clinical Project Leader at the Duke Clinical Research Institute and co-authored research papers on the 2014 Ebola Outbreak including “Ebola clinical trials: Five lessons learned and a way forward,” and “A response adaptive randomization platform trial for efficient evaluation of Ebola virus treatments: a model for pandemic response.” She previously served as Senior Clinical Scientist at bioMerieux, Project Manager at Social & Scientific Systems, and Program Manager at the Duke Human Vaccine Institute.

She received her Ph.D. in Microbiology from the University of Manchester and her BSc in Biology from the University of Portsmouth.

Joseph Sgherza, BS, President, Clinical Research Management, Inc.

With over 26 years in clinical research, Mr. Sgherza leads ClinicalRM with extensive experience balanced between pharmaceutical, academia and CRO companies.  As a global infectious disease expert, he has years of developing programs and mega trial project management experience in infectious disease/virology, gastrointestinal, dermatology, hepatology, and core disease therapeutics from Phase I through IV.

Mr. Sgherza has product lifecycle expertise in infectious disease program development, and has provided strategic “in-country management” in the US, India, Africa, Asia, Latin America and European regions, delivering cost effective, quality data and regulatory approvals.  Additionally, Mr. Sgherza had developed bioequivalence programs with some of the largest generics companies, and has been instrumental in the successful drug launch of numerous products and extended sales in global markets.

As President of ClinicalRM, Mr. Sgherza directly oversees clinical operations, information technology, contracting and legal, government operations, business development and proposals, and compliance.  He holds a Bachelor of Science degree in Molecular Biology and is a graduate of Rutgers University.

Jeremy D. Middleton, Vice President, Corporate Development, Elusys Therapeutics, Inc.

Mr. Middleton joined Elusys Therapeutics in May 2007 and currently manages corporate development activities, including licensing and government affairs.  Prior to joining Elusys, Mr. Middleton was Vice President of Business Development at Valera Pharmaceuticals with responsibility for leading business development, strategic planning and project planning activities. Prior to Valera, he held positions of increasing responsibility at Neose Technologies, Abbott Laboratories, BASF Pharma and Boots Pharmaceuticals. Mr. Middleton has more than 25 years of management experience in the biopharmaceutical industry and holds a BSc (Hons) in Applied Chemistry from DeMontfort University in England and is a Board Member of the Alliance for Biosecurity.