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June 2020 Issue No. 47 Frederic Moulin, Editor

CHAPTER MISSION STATEMENT 1 MESSAGES FROM THE NCAC-SOT EXECUTIVE BOARD MEMBERS

The President, Narayana Garimella 2 The Students Message Kristal Rychlik, Emily Illingworth and Emmanuel Woode 3 The Treasurer’s Report, Laine Peyton Myers 4 The Website Coordinator, Jennifer Tanir 5 The Newsletter Editor, Frederic Moulin 5

EXECUTIVE BOARD CONTACT LIST 6 MEET OUR NEW OFFICERS Gopala Krishna 7 Patrick Crittenden 7 Laine Peyton Myers 8 Emmanuel Woode 8 GOODBYE FROM OUR OUTGOING OFFICERS 9 NCAC-SOT MEMBERSHIP Members list 10 Membership form 15 NCAC-SOT SPRING SYMPOSIUM 16 NCAC OUTREACH ACTIVITIES 18 BERN SCHWETZ AWARD 19

MEMBERS ACCOMPLISHMENTS 20

CHAPTER MISSION STATEMENT

The National Capital Area Chapter of the Society of Toxicology (NCAC-SOT) was established to provide a regional focus for scientists of all disciplines interested in toxicology. The Chapter acts to:

• Sponsor and co-sponsor symposia on current issues in toxicology. • Provide annual awards to an outstanding student and postdoctoral scholars in toxicology to assist in attending the annual meeting of the SOT. • Maintain communication with the National SOT regarding current toxicology and regulatory concerns. • Sponsor Regional Chapter events at the SOT Annual Meetings.

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MESSAGES FROM THE NCAC-SOT EXECUTIVE BOARD MEMBERS

President’s Message

Dear NCAC-SOT Members:

We take this opportunity to thank NCAC-SOT’s officers of 2019-2020 term and to wel-

come new officers of 2020-2021 term. Also, we welcome new members of NCAC-SOT.

Together we all are grateful to organizations and personnel dedicated in promoting and

protecting public health, especially during the spread of COVID-19 pandemic.

As global health and health-sciences became great concerns of focus during these times,

we are organizing a half-day spring-2020 scientific symposium on 25th June, 2020.

This WebEx virtual symposium is intended to invite and facilitate global-attendees and

to value the time and efforts of national and international speakers and organizers.

Next generation tools, technologies and surrogate endpoints in toxicological assessments is the title of this

symposium. Applications of novel and existing tools, technologies, assessments and their combinations have

the potential to identify and characterize toxicity and support the selection of safer products and therapeutic

procedures. Also, they are expected to bridge data gaps, predict toxicity at the molecular level, and minimize

animal and clinical studies. These tools include but are not limited to cells, proteins, microorganisms, chemi-

cals, pharmacodynamics, endpoints, in-silico predictions, and two or more of their hybrid influences. An ex-

ample of a hybrid tool is the integration of imaging and bio-analytical methodologies. In summary, the pur-

pose of this symposium is to (1) review key biological and exposure characteristics that may impact the evalu-

ation of toxicology and risk assessments, (2) discuss current and future toxicology and safety scopes, and (3)

identify potential gaps and future tools and technologies. Speakers from industry, academia, NGOs, and testing

laboratories are presenting in this symposium.

Toxicologists, health scientists and all interested health, science and technology personnel are cordially invited

to attend this Spring 2020 WebEx Symposium of the National Capital Area Chapter of the Society of Toxicol-

ogy (NCAC-SOT). The symposium, Next Generation Tools, Technologies and Surrogate Endpoints in Toxi-

cological Assessments, will be held 8:30 AM – 1:00 PM ET on Thursday, June 25, 2020 through Society of

Toxicology’s WebEx platform.

Agenda, Details, and Registration Information of the Symposium:

https://www.toxicology.org/groups/rc/ncac/events.asp

Online Registration

Thank you.

Sincerely,

Narayana Garimella, PhD. MS, M.Tech.

NCAC-SOT President

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Student Representative’s Message Greetings NCAC Student and Postdoc Members,

We hope this newsletter finds you healthy and well.

While we won’t be able to see each other in person, NCAC will hold a virtual symposium

this spring (June 25). We want to extend an invitation to our student and postdoc members.

We encourage you to attend this year’s spring symposium because it’s important during this

time especially to stay sharp and focused. Attending the meeting will allow you to stay con-

nected and continue networking, to keep your knowledge fresh as we all step away from the

bench for a while, and to share the results you have and receive constructive feedback from

colleagues outside your immediate network. If we can do these things while we’re stuck at

home, we will be in a great place to “hit the ground running” when our workplaces resume

normal activities.

If you’re feeling stressed about COVID-19 and adapting to working from home, know that

you aren’t alone. We understand the pressure graduate students and postdocs are facing dur-

ing this difficult time, and we want to provide you with several resources to remind you and

encourage you to, first and foremost, take care of yourself.

Free mental health resources:

• Youper (This AI-powered app will have a conversation with you to help talk you

through tough moments)

• Moodpath (Moodpath checks in on you three times a day to see how you’re doing and

tracks your mood over time, helping you identify triggers and providing resources to

address them)

• Headspace (This is a free mindfulness and meditation app that provides helpful re-

sources for newcomers to mindfulness and customizable meditations for whatever

amount of time you want)

Free physical health resources:

• Fitness Blender (This app creates a unique and personalized sequence of exercises for the user based on

your preferences and what you need that day)

• Down Dog (This yoga app and all related apps are currently free from the developer. They create a unique

and personalized sequence of exercises for the user based on your preferences and what you need that day)

From all of us to you, please stay safe during this unprecedented time and take care of yourselves!

Sincerely,

Kristal, Emily and Emmanuel

NCAC-SOT Councilors and Student Representatives

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NCAC Treasurer’s Report

Greetings to all the NCAC-SOT members from your new Treasurer. I hope that all

is well given the circumstances.

First off, I want to thank the past Treasurer (Dr. Charlie Thompson) for his amaz-

ing work as NCAC-SOT Treasurer. NCAC-SOT greatly appreciates the work that

he did over the years. I hope that I can fill his shoes.

As you can see from the tabulated report (below), we are in good shape financially.

We will have final numbers for 2020 when the FY is concluded in June but we

don’t expect any major changes. We have positive cash flow for FY 2020 and

spring expenses were low due to the cancellation of the SOT Annual Meeting.

We do not yet have final information on how the changes at SOT due to the hardship of cancelling the Annual

Meeting will affect the Regional Chapters.

Recent updates are somewhat reassuring for Regional Chapters as well as SOT as a whole. In the President’s

Message (see Toxchange - June 3, 2020), he states that SOT is not in as bad a shape as was previously predict-

ed from the cancellation “… good news is that those expenses are far less than the worst-case scenario we

were facing in mid-March”. This does not mean that the SOT Regional Chapters may not see some effects of

the financial hardship at SOT. But it does give hope that the hardship isn’t as bad as previously expected.

I look forward to a productive 2020. Stay safe and healthy everyone.

Laine Peyton Myers

NCAC-SOT Treasurer

NCAC Financials (from HQ): 1 July 2019 through 30 April 2020

Income Amount ($)

• Donations --

• Dues 4575.00

• Registration (Spring) --

• Registration (Fall) --

• Total Income 4575.00

Expense

• K-12 Outreach --

• Meeting (Spring – plaques) -460.15

• Meeting (Fall – speaker travel) -659.59

• Meeting (Reception) --

• Misc./Other (t-shirts) --

• Service Charge --

• Total Expense -1120.00

Net Cash Flow 3455.00

Closing Check Acct Balance 15, 801.04

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Website Coordinator’s Message Dear NCAC-SOT Members,

As the Councilor and Website Coordinator, I invite you to learn more about NCAC-SOT

through our website. For our upcoming Virtual Symposium on June 25, 2020, you can find

the registration link and the latest agenda on the events page. Recordings and slides from

past symposia are available too.

The officers page lists the current NCAC officers and you can get to know the new officers

(Vice President, Secretary, Treasurer, Student Representative) by reading the new officers’

bios.

The NCAC newsletters page is another great resource for learning about the chapter and its members.

If you have any suggestions for improvements to the NCAC-SOT website, please contact me and I’ll see what

I can do!

Best,

Jennifer Y. Tanir, Ph.D.

NCAC-SOT Councilor – Website Coordinator

Newsletter Editor’s Message Dear NCAC-SOT Members,

Welcome to the 2020 SARS-CoV-2 edition of the newsletter. Like so many lives

upended across the world by the sudden arrival of the new coronavirus, our spring

publication loss all relevance with the cancellation of the 2020 SOT annual meeting.

The decision was not an easy one and for many days we waited, hoping against all

odds to see you all at the Fifth, overlooking the Anaheim skyline. In the end, the

SOT council made the decision to cancel the meeting, and in retrospect this deci-

sion probably protected those like me who are not so young, not so thin, a little stressed and with a single X

chromosome. We retreated into the safety of our homes to weather the pandemic and plan our come-back.

During the past four months I have had to learn, like many of you I am sure, the intricacies of Zoom and We-

bEx, how to look lively on videoconferences and how to present and discuss scientific data when the audience

is just a set of tiny pictures, oddly pixelated by delays in data transmission. For me, it was a steep learning ex-

perience.

Fortunately we are finally back. With this newsletter, and the return of our spring symposium, the NCAC is

moving into virtual space. I encourage all of you to experience our new webinar format on June 25th and re-

connect with your colleagues in the DMV area. I have been locked down into a dank Maryland basement for

much longer than I cared for, and I am very excited for an opportunity to engage with all of you again. Our

colleagues at the FDA are working hard to deliver vaccines and new therapies for Covid-19, but until those are

validated and readily available, Sars-cov-2 will continue to define our new “normal”. I wish you all a great

virtual summer, and look forward to seeing you on the 25th… with or without delays in transmission.

Frederic Moulin, DVM, PhD, DABT

NCAC-SOT Newsletter Editor

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NCAC-SOT EXECUTIVE BOARD MEMBERS CONTACT LIST President: Narayana Garimella, PhD, MS

U.S. Food and Drug Administration

nggarimella@gmail.com

Vice-president: Gopala Krishna, PhD, MBA, DABT, ATS

Parexel International

gopala.krishna@parexel.com

Treasurer: Laine Peyton Myers, PhD, DABT

U.S. Food and Drug Administration

Laine.Myers@fda.hhs.gov

Secretary: Patrick Crittenden, PhD

U.S. Food and Drug Administration

Patrick.Crittenden@fda.hhs.gov

Councilors: Jennifer Tanir, PhD

Website Coordinator

ToxServices LLC

jentanir@gmail.com

Rosie Sneed, DVM, PhD

Student Liaison

University of the District of Columbia

rsneed@udc.edu

Frederic Moulin

Newsletter Editor

U.S. Food and Drug Administration

moulinfj@gmail.com

Postdoctoral Kristal Rychlik, PhD

Representative: Johns Hopkins University

krychli1@jhmi.edu

Graduate Emily Illingworth, BS

Student Johns Hopkins University

Representative: eilling1@jhmi.edu

Graduate Emmanuel Woode, MSc, BS

Student University of Maryland Eastern Shore

Vice-Representative emmanu.woode@gmail.com

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NCAC-SOT WELCOMES OUR NEW OFFICERS VICE PRESIDENT Gopala Krishna, Ph.D., M.B.A., D.A.B.T., A.T.S.

Dr. Krishna is a Principal Consultant at Parexel International, where he serves as the Regulatory Affairs & Nonclinical Leader/Expert in drug development. As a member of PAREXEL Consulting's Regulatory & Access Team, he has worked collaboratively with a Team of highly experienced professionals from Industry, FDA, EMA and other global health authority experience. Dr. Krishna enjoys the opportunity to collaboratively work with a variety of global clients and products in an advisory role; finding tailored solutions to individual needs and executing them on behalf of clients for global regulatory submissions such as IND/IMPD/NDA/BLA/MAA and assist clients with global regulatory/health authority filings & Face to Face (F2F) meetings; getting products to patients for a win-win—

with a "patient-client" centric-approach—cost-effectively; using applicable accelerated regulatory pathways, Orphan Drug Designations, rare diseases, and a variety of other strategies, as applicable. He also supports a dedicated Team of Business Development Professionals, conducts workshops (including making a case for de-sired label), makes targeted presentations at scientific meetings and continues to learn and advance profession-ally. Previously, for over 30 years he has a proven track record at large & small pharma companies: Pfizer, Abbott Labs, Guilford/MGI, Enzon and Supernus as: Senior Scientist, Director & Vice President; contributed to bring-ing products (e.g., Lipitor, Neurontin, Lyrica, Omnicef, Humira, Oncaspar, Adagen, Nipent, Oxtellar XR, Trokendi XR), to the global market. Dr. Krishna received his PhD degree in Genetic Toxicology/Developmental Biology from West Virginia University in 1984. Dr. Krishna has authored ~70 publications, book chapters and 85 abstracts/ presentations/blogs. SECRETARY Patrick Crittenden, Ph.D.

Dr. Patrick Crittenden is a Toxicologist at the Food and Drug Administration in the Center for Food Safety and Applied Nutrition, where he reviews pre-market notifica-tions for the Division of Food Contact Substances. In this position, he assesses the safety of indirect food additives (i.e., packaging materials) by evaluating their potential for genotoxicity, carcinogenicity, and systemic toxicity. Dr. Crittenden has had a diverse career in science including experience as a waste fuels chemist for a private contract lab and as a biochemical technician in a government ag-riculture research laboratory. He has several years of experience as a study director for a contract research laboratory, where he was responsible for conducting preclinical and environmental toxicology studies for regulatory submissions. Prior to working with the

FDA, Dr. Crittenden was a professor of biology responsible for teaching courses including anatomy and physi-ology, cellular physiology, immunology, neurobiology, and toxicology. Dr. Crittenden received his Bachelor of Science in Chemistry and Microbiology from Mississippi University for Women. Subsequently, he obtained a Master of Science in Biological Sciences from Mississippi State Uni-versity with a focus in immunotoxicology, and a Doctor of Philosophy from Mississippi State University in Environmental Toxicology with a focus in neuroimmunotoxicology. He has published 6 peer-reviewed re-search papers, 3 as the first author. Dr. Crittenden has been a member of SOT since 1993 and is currently an Associate member of the society.

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TREASURER Laine Peyton Myers, Ph.D., D.A.B.T.

Dr. Myers is a Master Pharmacology/Toxicology drug reviewer for antiviral prod-

ucts at the US Food and Drug Administration. Dr. Myers received his PhD in im-

munotoxicology from LSU Health Sciences Center in 2003. He was a postdoctoral

fellow at NIOSH from 2003–2006 and later joined the US FDA as a Pharmacolo-

gy/Toxicology drug reviewer in 2006. Dr. Myers has experience in multiple thera-

peutic areas, including: antivirals, oncology, and reproductive/bone products.

Dr. Myers has served on multiple US FDA Pharm/Tox subcommittees and as chair

of the CDER Immunotoxicology Subcommittee. He also serves in several profes-

sional Societies and is the Past-President of the Immunotoxicology Specialty Section in the Society of Toxicol-

ogy (SOT) and the past chair of the SOT Membership Committee. He is currently serving as Co-Chair of the

Awards Committee for the American College of Toxicology (ACT). Dr. Myers has served on multiple other

working groups and committees for professional societies (SOT and ACT) as well as nonprofit scientific or-

ganizations (the Drug Information Association, the Pharmaceutical Users Software Exchange, and the Health

and Environmental Sciences Institute).

At the FDA, he serves as an expert on the “animal rule” for bioterrorism products as well as nonclinical immu-

notoxicology assessments at the US FDA. Dr. Myers has received multiple awards for his work at the Agency

during his tenure. His most recent approval of the world’s first therapeutic treatment of human variola virus

(smallpox) using animal efficacy data earned his group the prestigious US Health and Human Services Secre-

tary’s Award for Distinguished Service in May of 2019.

STUDENT REPRESENTATIVE Emmanuel Woode, M.S.

Mr. Emmanuel Woode is a Regulatory Affairs Specialist at the National Institutes of

Health, where he provides high-level current Good Manufacturing Practice (cGMP) con-

sultative support to the Clinical Center’s Pharmacy Department, Department of Transfu-

sion Medicine (DTM), Department of Laboratory Medicine (DLM), Positron Emission To-

mography (PET) Department, the Nuclear Medicine Department, and National Cancer In-

stitute (NCI) Surgery Branch.

Mr. Emmanuel Woode received his master’s degree in Regulatory Science from Johns

Hopkins in 2014 and is currently a first year PhD student at the University of Maryland

Eastern Shore. Mr. Woode holds a bachelor’s degree in Chemistry from the University of the District of Co-

lumbia.

Mr. Emmanuel Woode is the Co-Chair of NIH’s cGMP Advisory Committee Group and the executive secre-

tary to the NIH’s Environmental Monitoring Advisory Committee. Mr. Emmanuel Woode was recipient of

two (2) NIH Clinical Center CEO Awards in 2019.

Mr. Woode firmly believes in SOT’s vision to facilitate the scientific and professional development of its stu-

dent body via networking, scientific programs, and other SOT activities.

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GOODBYE FROM OUR OUTGOING OFFICERS

Margarett Whittaker, NCAC-SOT Past President

Over the past three months, there has been an immense change in the way that most NCAC

-SOT toxicologists practice toxicology. The impromptu transition to virtual work environ-

ments has triggered a tectonic shift in ways that many of us engage and contribute as toxi-

cologists. For myself, I’d like to share with you ways I’ve coped over the past three

months (both professionally and personally) and hope these items give you inspiration:

Attend the SOT virtual meeting: SOT has been presenting Scientific Sessions and Con-

tinuing Education (CE) courses that were originally planned for presentation in Ana-

heim. These courses run until are scheduled until at least the end of June. SOT’s CE

courses are cost-effective (only $150/course, even if you weren’t registered to attend the Anaheim meeting)

and are a great way to maintain your skill set and CV. Check out the Virtual meeting page to see the schedule

of sessions and CE courses: https://www.toxicology.org/events/am/AM2020/program.asp

Read Phillip Wexler’s Toxicology in Antiquity: While stuck at home, I’ve re-discovered the joy of reading

printed books, and treated myself to Toxicology in Antiquity (Elsevier Press, 2nd edition, available in print and

e-edition). The book colorfully describes and illustrates instances of poisoning, toxins, and toxics throughout

history, ranging from poisoning in ancient Greece and Rome, chemical warfare over time, and ancient man-

made sources of pollution. In the book’s Foreword remarks, author and well-known National Library Medi-

cine Information Scientist Phillip Wexler sagely points out that modern toxicologists have a lot of learn about

the past, in that toxicity can affect people anywhere, in any society, at any level, for many years, without any-

one being aware of it.

I am sure that COVID-19 will continue to challenge many of us working in our capacity as toxicologists. Vic-

tor Hugo said that “Great perils have this beauty, that they bring to light the fraternity of strangers.” I have

enjoyed meeting many NCAC-SOT members as part of my tenure as NCAC-SOT President and appreciated

the opportunity to serve our community. As we navigate living and working in a post-COVID-19 world, I

wish health to each of you and your families.

Meg Whittaker

Sarah Attreed, NCAC-SOT Past Student Representative

Hi all, Sarah here. It has been a privilege serving the National Capital Area Chapter and the wider SOT com-

munity for the past two years. I recently defended my thesis back on March 13th and, as of May 1st, I will be

a postdoctoral ORISE Fellow at the USDA on Plum Island in New York. There I will be developing and per-

forming immunological testing of vaccines against high consequence animal pathogens. I

am wishing the whole chapter community the best and know I am leaving fellow trainees

in good hands with Kristal, Emily and Emmanuel.

Sarah Attreed

Note from the Editor: We wish Sarah a wonderful time

on Plum Island. From our personal experience, she

will have no difficulty achieving social distancing at

her new duty station.

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Current NCAC-SOT Members

The NCAC-SOT Executive Board considers useful to publish the membership roster in each newsletter. As of June 2020, the Chapter members are listed below (First Name, Last Name, Institution):

Valerie H Adams US Army Public Health Center

Felix K Adatsi PreTrial Services Agency

Chinedu Ahuchaogu University of Maryland Eastern Shore

Devon K Andres LMI supporting JPEO-CBD Medical Countermeasures Sys-tems

Jay M Ansell Personal Care Products Council

Louise Assem Copper Alliance

Jennifer Greenlaw Ator ToxServices LLC

Sarah Attreed Johns Hopkins University

Michael A Babich US Consumer Product Safety Commission

Melissa Ann Badding Exponent Inc

Cheryl B Bast Keller and Heckman LLP

Ilona Gabriela Bebenek US FDA

Nancy B Beck US EPA

Richard A Becker American Chemistry Council

Adrienne T Black

Kenneth T Bogen ktbogen.com

Gary P Bond US FDA-CDER

Mohammed Bourdi NIH-NCATS

Ivan J Boyer Keller and Heckman LLP

Megan Boylan ToxServices LLC

Chad Nicholas Brocker US FDA

Deborah E Burgin US EPA

Jessica Aimee Camacho FDA

Joy A Cavagnaro Access BIO LC

Tracy Chen US FDA

Xinrong Chen US Consumer Product Safety Commission

Connie L Chen Health and Environmental Sciences Institute

Paola Chrysostomou Alexa Research & Engineering

Chrissy J Cochran US FDA

Joseph F Contrera Computational Toxicology Services LLC

Erdem Coskun National Institute of Standards and Technology

Gertrude-Emilia Costin Institute for In Vitro Sciences

Patrick Lee Crittenden US FDA

Lara Iza Dahora Virginia Tech

Danica Elizabeth DeGroot US FDA

Pedro L Del Valle US FDA-CDER

Paul DeLeo Integral Consulting Inc

Jose Francisco Delgado-Jimenez National Cancer Institute

John M DeSesso Exponent Inc

Laxmikant S Deshpande Virginia Commonwealth University

Deacqunita Laquade Diggs US FDA

Albert H Donnay Donnay Detoxicology LLC

Kimberly D Ehman Altria Client Services Inc

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Marion F Ehrich Virginia-Maryland College of Veterinary Medicine

Michelle R Embry Health and Environmental Sciences Institute

Neeraja (Neera) Kondapi Erraguntla American Chemistry Council

Louan C Fisher Toxicology Regulatory Services

Suzanne Compton Fitzpatrick US FDA

Thomas J Flynn Retired

Dana Michelle Freeman Johns Hopkins University

Joan D Garey Reproductive Toxicology Center

Narayana Garimella NCAC SOT

Philip Gatti US FDA

Lee E Geiger Geiger Toxicology Consulting

Chandramallika (Molly)

Ghosh US FDA

Peter L Goering US FDA

Emily Golden Johns Hopkins University

Sidney Green Howard University

James C Griffiths Council for Responsible Nutrition

Karen L Hamernik US EPA

Molly E Harmon US Environmental Protection Agency

Wafa A Harrouk US FDA-CDER-OND

Kristina M Hatlelid US Consumer Product Safety Commission

Esther M Haugabrooks Physicians Committee for Responsible Medicine

Jessica Hawes US FDA

Tala R Henry US EPA Office of Prevention Pesticides & Toxic Substances

Thomas Hill US FDA Center for Tobacco Products

Andrea R Hindman American Association for the Advancement of Science

Colette Susan Hodes US EPA-OLEM

Helena Therese Hogberg Johns Hopkins Bloomberg School of Public Health

Alan M Hood US FDA

Eric Pendleton Hooker US Consumer Product Safety Commission

Keith Alan Hostetler Toxicology Regulatory Services

Terry Hrubec Via College of Osteopathic Medicine Virginia Campus

Annette R Iannucci Occupational Safety and Health Administration

Emily Illingworth Johns Hopkins Bloomberg School of Public Health

William Andrew Irwin US EPA

Seshadri Iyengar Bayer

Sandra Ann James-Yi

David Alan Jett NIH Countermeasures Against Chemical Threats (CounterACT) Research Program

Zoe C Johnson University of Maryland Eastern Shore

Pramod S Joshi Supernus Pharmaceuticals Inc

Harriet W Kamendi Kariah Healthcare Solutions LLC

Jueichuan (Connie)

Kang US FDA

Athena Marie Keene Afton Chemical Corporation

James H Kim American Cleaning Institute

Marquea D King USDA ARS

Elaine Valerie Knight NIH-NCI

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Charles J Kokoski US FDA

Gopala Krishna Parexel International

Francis H Kruszewski American Cleaning Institute

Rohan Kulkarni MilliporeSigma

Susan A Laessig NIH ECHO

Amy Lavin Williams Exponent Inc

Emily May Lent Army Public Health Center

Jonathan A Leshin US FDA

Yizhong Liu FDA

Anne Elizabeth Loccisano Exponent Inc

Linda Loretz Personal Care Products Council

James T MacGregor Toxicology Consulting Services

Emily F Madden United States Pharmacopeia

Michael S Madejczyk WRAIR

Susan Makris US EPA-ORD

Nikki Maples-Reynolds Waterborne Environmental Inc

Laura C Markley US FDA

Joanna M Matheson US Consumer Product Safety Commission

Abigail McEwen Cardno ChemRisk

Timothy J McGovern US FDA

Colleen Elizabeth McLoughlin Scivera

Lauren M Mihalcik Amgen Inc

Beth E Mileson Technology Sciences Group Inc

Frederic J Moulin US FDA

Jorge Gerardo Muñiz Ortiz US EPA

Brian James Mulhern SciLucent LLC

Laine Peyton Myers US FDA

Gopakumar Nair Supernus Pharmaceuticals Inc

Arvind K N Nandedkar Howard University

April P Neal-Kluever Office of Management and Budget

Alexander Khoa Nguyen North Carolina State University

Tyler Nicholas Exponent

Simone Nicholson AstraZeneca

Andrey I Nikiforov Toxicology Regulatory Services

Berk Oktem US FDA

Teresa De Jesus Palacios- Hernandez US FDA

Ju Young Park Food and Drug Administration

Jin-Young Park U.S. FDA

Leslie E Patton Technology Sciences Group Inc

Geoffrey W Patton US FDA

Syril D Pettit Health and Environmental Sciences Institute

Martin B Phillips US EPA

Jennifer B Pierson Health and Environmental Sciences Institute

Anne M Pilaro US FDA

Caroline Lucia Pinto US FDA-ORISE

Karen L Porter PointCross Life Sciences

Carsten Prasse Johns Hopkins University

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Kathleen C Raffaele US EPA

Deepa B Rao StageBio

Jennifer L Rayner SRC

Gunda Reddy Army Public Health Center

Emily N Reinke Army Public Health Center

Ana C Ribeiro Virginia Commonwealth University

Alicia Carolyn Richards SRC

Paul L Roney Biomedical Advanced Research and Development Authority

Laurie E Roszell Army Public Health Center

Tinashe B Ruwona W.L. Gore & Associates Inc.

Patricia C Ryan AstraZeneca

Kristal A Rychlik Johns Hopkins Bloomberg School of Public Health

Jessica P Ryman-Rasmussen American Petroleum Institute

Louis J Scarano US EPA

Anthony R Scialli Scialli Consulting LLC

Sumitra Sengupta Johns Hopkins University

Fenna Sille Johns Hopkins Bloomberg School of Public Health

Om V Singh TSG Consulting

Amy M Skinner US FDA

Shelby Skoog US FDA

Deborah C Smegal US FDA

Donna C Smith Altria Client Services Inc

Rosie A Sneed University of the District of Columbia

Babasaheb Sonawane TRACS LLC

Martin Luther Stephens Johns Hopkins Bloomberg School of Public Health

Stephan T Stern Leidos Biomedical Research Inc

Anneliese Striz US FDA

Dale E Strother ToxSolve LLC

Evi B Struble US FDA

Jennifer Y Tanir ToxServices LLC

Sheryse Taylor National Cancer Institute

Sean Taylor Verto Solutions

Richard Dean Thomas Intercet Ltd

D Charles Thompson US FDA

Christopher Kirk Thompson Virginia Tech

Scott Thurmond US FDA-CFSAN

Vy P Tran Johns Hopkins Bloomberg School of Public Health

Richard Troast Troast Environmental Consulting Alexandra Eliza-beth Turley US FDA

Lorraine Evelyn Twerdok Twerdok Consulting LLC

Vipin Tyagi University College of Medical Sciences Delhi University

René Viñas Coca-Cola Company The

Bingxuan Wang ToxServices LLC

Zemin Wang US FDA

Ronald LeRoy Wange US FDA

Zhengxi Wei National Institutes of Health

Darmood Wei US FDA

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Kimberly Wise White

Margaret H Whittaker ToxServices LLC

Dionne Williams Delaware State University

Gary W Wolfe Gary Wolfe Toxicology LLC

Elissa Li-Yee Wong US FDA Emmanuel Kings-ley Woode ORSC

Linnzi Wright CCDC Chemical Biological Center

Charis Wynn

Menghang Xia NIH

NCAC-SOT MEMBERSHIP Did you remember to renew both your SOT and NCAC memberships this year? Annual membership fees for NCAC-SOT remain unchanged this year and are only $25 for regular memberships and $10 for full-time stu-dents. These fees are used to fund our symposium each year and to support a myriad of student activities, in-cluding student awards, travel supplements, and K-12 outreach. If you have not yet renewed your regional Chapter membership, please do so today! You can do that online or by mail using the membership application form on the next page.

NCAC-SOT 2019 ACTIVITIES

Fall Meeting Report

October 2019 seems so far away now… a time when we could come together on the NIH Bethesda Campus

without face masks, social distancing and the fear of Sars-Cov-2. In fact on the 24 of October, the NCAC

chapter of the SOT met in the Lister Hill Auditorium of the National Library of Medicine for a lively discus-

sion on safety considerations for the development of devices and drugs. I am fairly confident that none of us

realized at that time that we would not see each other again for almost a year. Here are a few pictures of the

event to remind you of happier days.

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MEMBERSHIP APPLICATION

Please check the most appropriate responses:

Please complete the information above and send with a check, money order or credit card (payable to National Capital Area Chapter SOT, no POs) to the address below. The NCAC SOT will review your application, and you will be notified within 30 days. Those not accepted will receive a full refund. Current RC members: please do not use this form since your renewal dues are billed annually through SOT.

Payment Type: Money Order______ Check ______ Credit Card ______

Credit Card # _______________________________________ Exp date ________

Name on Card ______________________________________

Signature

Please send completed form with payment to:

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Spring Virtual Symposium by National Capital Area Chapter of the Society of Toxicology (NCAC-SOT)

Title: Next Generation Tools, Technologies and Surrogate Endpoints in

Toxicological Assessments

When: Thursday, June 25th, 2020 (8:30am-1:00pm)

Where: WebEx - Society of Toxicology

The Chapter-wide NCAC is holding a local scientific and virtual research symposium to discuss current and

future tools, technological improvements and surrogate endpoints in the field of toxicology and allied regulato-

ry sciences. Both nonclinical toxicology and its clinical manifestation are influenced by genetic, transcriptom-

ic, proteomic and metabolomic considerations, as well as environmental settings and lifestyle factors. Next

generation tools, technologies and surrogates have the potential to identify and characterize toxicity and sup-

port the selection of safer products and therapeutic procedures. Herein, we aim to present scientific and tech-

nological tools that will enhance our ability to characterize toxicity in the upcoming decade. These tools in-

clude but are not limited to cells, proteins, microorganisms, chemicals, pharmacodynamics, endpoints, in-silico

predictions, and two or more of their hybrid influences. An example of a hybrid tool is the integration of imag-

ing and bio-analytical methodologies. Next generation tools, technologies, and surrogates are expected to

bridge data gaps, predict toxicity at the molecular level, and minimize animal and clinical studies.

The purpose of this symposium is to (1) review key biological and exposure characteristics that may impact

the evaluation of toxicology and risk assessments, (2) discuss current and future toxicology and safety scopes,

and (3) identify potential gaps and future tools and technologies.

About the NCAC-SOT: The National Capital Area Chapter of the Society of Toxicology (NCAC-SOT) pro-

vides a regional focus for scientists of all disciplines interested in toxicology. The Chapter acts to:

• Sponsor and co-sponsor symposia on current issues in toxicology.

• Provide an annual award to an outstanding student in toxicology to assist in attending the Annual Meeting

of the SOT.

• Sponsor Regional Chapter events at the SOT Annual Meetings.

https://www.toxicology.org/groups/rc/ncac/

2020 NCAC-SOT Spring Symposium Logistics:

When: Thursday, June 25th, 2020, 8:30 AM – 01:00 PM

Where: WebEx –Virtual Session through Society of Toxicology (URL/Link will be provided upon registration)

WebEx Registration (free of charge): https://aim-hq.webex.com/aim-hq/onstage/g.php?

MTID=e7018e674a96dc4b3ff7abeb654e9c1e0

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Time Topic Spe aker

8:30 – 8:45 am Joining WebEx NCAC-SOT, Speakers, Attendees

8:45 – 9:00 am Welcome/Introduction/Opening Narayana Garimella, Ph.D., NCAC-SOT President

9:00 – 9:30 am Modeling Delays in Chemotherapy In-duced Hematological Toxicities

Wojciech Krzyzanski Ph.D., University of Buffalo

9:30 – 9:40 am On the Services and Accomplishments of Renowned Toxicologist Dr. Bern Schwetz

Margaret Whittaker, Ph.D., M.P.H., CBi-ol., F.R.S.B., E.R.T., D.A.B.T., ToxServices LLC & NCAC-SOT

9:40 – 10:10 am Insights into the Role of a Synuclein as an Epigenetic Mediator in Environmen-tal Parkinson’s Disease

Dana Freeman, John Hopkins University

10:10 – 10:40 am

21st Century Cures Act: A Boon to the Waiting Patient – A Safety Perspective on the Opportunities and Challenges in Drug Development

Gopala Krishna, Ph.D., Parexel Interna-tional & NCAC-SOT

10:40 – 11:05 am Break

11:05 – 11:35 am Novel BSEP and MDR3 Inhibition As-says for Investigating Drug-Induced Liver Toxicity

Kan He, Ph.D., Biotranex

11:35 am – 12:05 pm Data Science for Life Science: In the post COVID-era. Avik Pal, Ph.D., CliniOps

12:05 – 12:35 pm Toxicological Assessment of Prebiotics Prabhakar Bhoite, M.V.Sc., D.A.B.T., Syngene International Limited

12:35 – 12:50 pm Q & A Session with Presenters Panel Members

2020 NCAC-SOT Spring Symposium Agenda and Speaker List:

The presentations and speakers are listed in the table below:

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NCAC OUTREACH ACTIVITIES

Reaching out to undergraduates in a time of pandemic.

NCAC continues to be involved with undergraduates in our area and beyond, through participation in two

SOT-sponsored programs called ToxScholar and the Undergraduate Diversity Program (UDP).

As ToxScholars, our president, Margaret Whittaker, our treasurer Charlie Thompson and myself (Fred Mou-

lin) returned to the campus of Trinity Washington University in October 2019 to talk about drug discovery,

toxicology and careers in general and share pizzas with the students of Dr. Shizuka Hsieh. It pains me to admit

that while I was the speaker of the day, the real star of the show was Margaret. All those young women were

glued to her every words and had so many career and life questions for her. All was not lost for Charlie and I

though, as Margaret doing most of the talking allowed us a much more thorough sampling of the pizzas on dis-

play. I have included below a couple of pictures of our visit.

The Undergraduate Diversity and Undergraduate Education programs were both devastated by the cancelling

of the annual meeting. Our undergraduate student guests were suddenly told to cancel hotel reservations and

flight, postpone their returns to campus and stay home. For many seniors, attendance and poster presentations

at SOT are essential elements of a successful graduate school application. All of those opportunities suddenly

vanished with the onset of the quarantine.

To compensate, the Committee for Diversity Initiatives created the Virtual Undergraduate Diversity Program.

The science talks planned for our Anaheim event were recorded and made available on the SOT web site. In

May, Dr. Marquea King presented the first webinar of the series titled “Introduction to Toxicology” which was

followed by a live Q&A session with all the presenters of the scientific lectures. This event was followed, two

weeks later by another virtual meeting titled “The ins and outs of Graduate School in Toxicology” where

groups of students were able to question graduate school advisors and graduate students moderators in multi-

ple “breakout rooms”. For the final webinar in early June, 12 of the Pfizer SOT Undergraduate Travel Award

recipients gave five-minute presentations of the

research that would have been featured during a

poster session at the 2020 SOT Annual Meeting

followed by 5 minutes of questions. The audi-

ence included students from the Undergraduate

Diversity Program, undergraduate meeting reg-

istrants, research mentors and guests from the

speakers. The sessions were remarkably well

attended, lively and fun for all the participants. I

enjoyed them immensely. The new look of SOT UDP

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Bern Schwetz (retired) is a nationally recognized expert in reproductive and developmental toxicology. Dr.

Schwetz served as President of the National Capital Area Chapter (NCAC) of the Society of Toxicology

(SOT) from 2000-2001. Since 2004, in Dr. Schwetz’s honor, the NCAC-SOT provides travel awards to help

promising early career research scientists attend the SOT annual meeting.

The NCAC-SOT is delighted to present the following 2020 Bern Schwetz Travel Award winner:

2020 National Capital Area Chapter Bern Schwetz Travel Award Winners

Bern Schwetz Graduate Student Travel Award

Dana Freeman is a graduate student at the Bloomberg School of Public

Health at Johns Hopkins University and a past student representative of

the NCAC-SOT. She was awarded first place for her abstract entitled

“Human Allele-Specific Methylated Regions Have Increased Resilience

to Rotenone Exposure in α-Synuclein Knockdown Neurons.”

Alas, because of the quarantine, we were unable to celebrate Dana’s achievement as she deserved, but I am

including a picture from the desk of our past president showing the award and prize that we sent to Dana to let

you all know that NCAC did honor its commitment.

We all look forward to celebrating Dana’s success at a later time, when pesky viruses finally allow us to have

fun together again. Fortunately, I was able to catch Dana last year at the NCAC reception in Baltimore.

20

MEMBERS ACCOMPLISHMENTS

The NCAC-SOT likes to acknowledge the accomplishments of its members and celebrate their successes.

AWARDS

We would like to congratulate our long-time NCAC-SOT and AGT Member,

Dr. Sidney Green of Howard University, for his 2020 SOT founder award. This

award, recognizes a Full, Emeritus, or Retired Full member who has demonstrat-

ed outstanding leadership in fostering the role of toxicological sciences in safety

decision-making through the development and/or application of state-of-the-art

approaches that elucidate, with a high degree of confidence, the distinctions for

humans between safe and unsafe levels of exposures to chemical and physical

agents. Through his more than 50 years as a practicing toxicologist, Dr. Green

has made major contributions to academia, industry, and government.

Dr. Green joined the US Food and Drug Administration (US FDA) as a pharma-

cologist in 1965, after spending several years in industry. He received his PhD in

biochemical pharmacology from Howard University in 1972. Through various

roles at the FDA— most recently as Director of the Division of Toxicological

Research—Dr. Green ensured that appropriate scientific information was available to establish safe versus un-

safe exposure levels for chemical and physical agents that humans encounter daily. His efforts as the Agency’s

chief spokesperson in the area of alternative tests contributed significantly to the establishment of the Inter-

agency Regulatory Alternatives Group, which set the stage for the Interagency Coordinating Committee on the

Validation of Alternative Methods.

Dr. Green’s contributions to safety decision-making continued through his role at the US Environmental Pro-

tection Agency (US EPA), where he served as Chief of the Toxic Effects Branch, Health Review Division, in

the Office of Toxic Substances. In this role, he represented US EPA on many Organisation for Economic Co-

operation and Development (OECD) scientific panels developing toxicological guidelines for the testing of

materials. He also chaired the US EPA GeneTox Committee, the charge of which was to review the status of

most of the methods used in genetic toxicology.

Joining Covance Inc. as Director of the Department of Toxicology in 1995, Dr. Green was charged with en-

suring the appropriateness of studies in multispecies for generating data to support safety-of-use requirements

for designated products as part of the premarket approval process. Then, in 1998, Dr. Green joined Howard

University College of Medicine as an Adjunct Associate Professor of pharmacology, a position he continues

to hold.

Dr. Green also served on the National Academy of Sciences Committee on Toxicity Testing, which 2007 pub-

lication of Toxicity Testing in the 21st Century: A Vision and a Strategy, has been instrumental in changing

the approach of toxicologists to safety evaluation. In addition, Dr. Green has authored more than 70 publica-

tions, primarily on topics involving genetic toxicology, short-term test methodology, and policy issues asso-

ciated with alternatives to animal testing.

Dr. Green has been actively involved in SOT since 1974 in appointed, elected, and volunteer capacities. His

service includes positions on Council, as Chair of the Membership Committee, and as President of several

Component Groups. In addition to service to SOT, Dr. Green is a Past President of the American College of

Toxicology, Association of Government Toxicologists, and Academy of Toxicological Sciences.