Introducing Our CSS 2019 Keynote Speakers


The annual PHUSE US Computational Science Symposium in Silver Spring, Maryland attracts professionals from industry, academia and regulatory alike to come together to share and discuss their progress, findings and achievements across mutual working areas of interest.

Year on year, PHUSE invites keynote speakers to impart their knowledge and experience in topics of primary relevance to the CSS attendees. This year will be no different, for we are fortunate to welcome seven leading experts from CDER (the Center for Drug Evaluation and Research) and CBER (the Center for Biologics Evaluation and Research) at the FDA. In presenting their perspectives in the use of study data and analytics for drug and biologics reviews, they will undoubtedly spark engagement, idea sharing and discovery.

Here, just one week ahead of the CSS 2019, we take time to introduce our eminent guest speakers.

Alan Shapiro, MD, PhD, FAAP, is a Paediatrician Infectious Diseases Specialist in the Office of Computational Science (OCS) at CDER at the FDA. He has been a medical officer at CDER since 2003. We are delighted to welcome Dr Shapiro and thank him for his valuable contribution to the CSS. 

Andrew O’Carroll is a pharmacology/toxicology reviewer in CBER’s Office of Vaccine Research and Review, where he reviews nonclinical studies conducted for the safety assessment of vaccines indicated for the prevention or treatment of infectious diseases, allergenics, probiotics and phage-based products. He also provides subject matter expertise to CBER’s Data Standards staff, as well as to external stakeholders, to establish differences in data expectations, as pertained to SEND. We thank Andrew ahead of the conference for sharing his expertise and giving us an insight into his career.

Lilliam Rosario is the Director of the Office of Computational Science (OCS) in the Office of Translational Sciences at CDER. Lilliam is a very familiar face within the global PHUSE community. She was a keynote speaker at the Annual Conference 2017 in Edinburgh, and she co-led the Working Groups Discussion Club and presented in the Submissions & Agencies Stream at the EU Connect in Frankfurt in 2018. Lilliam and Ethan Chen won Best in Stream for their presentation on FDA View: Technical Rejection Criteria for Study Data at the US Connect 2018 in Raleigh. More recently, Lilliam co-chaired and presented in the Submissions & Agencies Stream at this year’s US Connect in Baltimore. Lilliam chaired and presented at last year’s US CSS, and we are very much looking forward to her keynote presentation in 2019.

Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. He and Lilliam Rosario shared success at our first-ever US Connect, in Raleigh, winning Best in Stream for their presentation on FDA View: Technical Rejection Criteria for Study Data. Ethan then presented in the Submissions & Agencies Stream at our second US Connect, in Baltimore, in February 2019. We are pleased to be welcoming Ethan at Silver Spring next week.

Darcie Everett, MD, MPH, is a clinical reviewer for CBER’s Office of Vaccine Research and Review. Her duties include review of the protocols and results of all phases of clinical trials for investigational vaccines and other biologics. Her professional interests include maternal immunisation and tools designed to support the review process. The CSS community extends a warm welcome to Darcie in advance of the conference.

Dr Matilde Kam is Associate Director of Analytics and Informatics in the Office of Biostatistics (OB) at CDER. She has strategic and oversight responsibility for matters pertaining to analytics and informatics. Dr Kam participated in our most recent monthly Webinar Wednesday, where she introduced the FDA Analysis Data Standards Public Meeting, which she will be leading on 12 June, the day after the close of the CSS. For further details and to register for these public sessions, please click here. We are thrilled to welcome Dr Kam to the CSS 2019 and hope many of you will be able to hear her speak on advancing analysis data standards after the PHUSE conference.

Matthew Whittaker has been with the FDA since 2011 and is a Nonclinical Reviewer in the CDER Office of New Drugs (OND), Division of Pulmonary, Allergy & Rheumatology Products (DPARP). He has been involved in SEND-related initiatives at the FDA since 2013 and is currently Co-Chair of the Janus Nonclinical Advisory Group. Matthew presented in the Submissions & Agencies Stream at this year’s US Connect on the Impact of SEND Data on FDA Review of Nonclinical Studies. Just a few months on from Baltimore, we are delighted to listen to Matthew share his professional experience with our CSS community, in Silver Spring.


More detailed biographies can be found on our website.

We anticipate our keynote speakers’ presentations to provoke deep discussion and friendly debate. We thank them in advance for their invaluable contributions and for enhancing our delegates’ CSS experience. Our attendees certainly have lots to look forward to over the three days in Silver Spring.  

If you have not yet registered for the CSS, there is still time to secure your place. Please complete your registration via our website.

The CSS presentations will be made publicly available on our online archive in due course. We wish you all an enjoyable CSS and look forward to this fantastic opportunity to get to know new people, catch up with old friends and participate in idea sharing and collective learning.


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