Executive VP and Deputy General Counsel
Greenleaf Health
(she/her)
Kalah Auchincloss, JD, MPH is executive vice president and deputy general counsel at Greenleaf Health, Inc., providing strategic counsel to clients on compliance, enforcement and policy matters. She spent six years at FDA prior to joining Greenleaf in 2017, including time in CDER’s Office of Compliance and as deputy chief of staff to the FDA commissioner. Ms. Auchincloss was also a primary point of contact in the immediate Office of the Commissioner for the six FDA centers and other components of the Commissioner’s Office. .
Speaker has no relevant relationships with financial interests to disclose.
Lecturer, Hubert Department of Global Health of the Rollins School of Public Health
Emory
(he/him)
Cornelius Baker is a lecturer in the Hubert Department of Global Health of the Rollins School of Public Health at Emory and is currently detailed as a special advisor to the Director at the Office of AIDS Research, National Institutes of Health and liaison to the U.S. President’s Emergency Plan for AIDS Relief at the Department of States’ Office of the Global AIDS Coordinator and Health Diplomacy.
Over the past three decades, Mr. Baker has worked at every level of the HIV response, from being a volunteer fundraiser throughout the early days of the epidemic and on to leading prominent organizations and initiatives during the past two decades. Previously, he has served as the Chief Policy Advisor and the Acting Deputy Coordinator for Affected Populations and Civil Society Leadership establishing a new section addressing human rights, gender, key populations and civil society at the office of the U.S. Global AIDS Coordinator, as the senior policy advisor for the National Black Gay Men’s Advocacy Coalition, acting director of the HIV/AIDS Unit and senior technical advisor at FHI 360, executive director of Whitman-Walker Clinic, and executive director of the National Association of People with AIDS. Mr. Baker served as a confidential assistant to the assistant secretary for health from 1989 - 1992 at the US Department of Health and Human Services in the National AIDS Program Office in the George H.W. Bush Administration. From 2009 - 2014, he was an appointee to the Presidential Advisory Council on HIV/AIDS (PACHA).
Mr. Baker received his Bachelor of Arts at Eisenhower College/Rochester Institute of Technology. In July 2014, he was named Distinguished Alumnus by the Eisenhower College Alumni Association. He is the recipient numerous awards including the National Lesbian and Gay Health Association’s Diego Lopez Award for leadership in HIV advocacy. He serves on the boards of Us Helping Us/People Into Living and Broadway Cares/Equity Fights AIDS.
Speaker has no relevant relationships with financial interests to disclose.
Expedited Reviewer
he/him
VP Clinical Operations
MacroGenics
(she/her)
Ros Cheetham, recently served as Senior Vice President Clinical Solutions and Strategic Partnerships, is an established pharmaceutical development professional with over 25 years of experience in the pharmaceutical industry. The majority of her experience has been in clinical and global clinical operations where she established a record of global drug development within multiple therapeutic areas. She has successfully led global clinical trials across the development continuum from first-in-human to phase IV. She has held senior positions such as Head of Global Clinical Operations at Allergan Inc and Vice President and Medicines Development Leader at GlaxoSmithKline in neurology and rare diseases. In the latter positions she led a team that worked closely with biotech partners on the development and commercialization of the partnered assets. Earlier positions at GlaxoSmithKline included Vice President of Global Clinical Operations in Neurosciences and Head of North American Global Clinical Operations. Her drug development experience has included key markets such as Japan and China, as well as North and South America and all areas of Europe. Most recently Ros had her own consulting company where she worked predominantly with biotech clients.
Ros has an outstanding record of process improvement and change management and has led initiatives within clinical operations, and the wider company ecosystem, that have netted multi-million-dollar savings. She has led teams in the early adoption of eCRF and ePRO tools as well as the adoption of risk-based monitoring.
Ros holds a BSc(Hons) degree from Imperial College London, UK, and a MSc from the University of the Witwatersrand, South Africa.
Speaker has no relevant relationships with financial interests to disclose.
Director, Regulatory Affairs
Greenleaf Health
(she/her)
Samantha Eakes brings a diverse background of public health knowledge to her role as Director of Regulatory Affairs at Greenleaf Health. Through her public health studies and prior experience, Samantha gained critical public health knowledge that has allowed her to effectively assist clients with developing communications and advocacy strategies, staying informed on evolving regulatory requirements, and providing strategic insight on critical regulatory challenges.
In her role at Greenleaf, Samantha conducts research projects for medical device clients to use in strategic planning, such as crafting regulatory landscape analysis on key topics based on FDA databases and guidance documents. Samantha provides strategic advice to clients regarding potential regulatory pathways for their devices and assists clients with their FDA submissions and correspondence. Samantha also reviews, drafts and files premarket FDA submissions for medical device clients including Pre-Submissions, Breakthrough Device Designations, Investigation Device Exemptions (IDEs), Requests for Designation (RFDs), 510(k)s and Emergency Use Authorizations (EUAs).
Samantha currently serves on the Board of the Xavier Young Professionals Network, a purpose-driven, collaborative community for Quality and Regulatory professionals in the life sciences industry.
Prior to joining Greenleaf, Samantha gained policy and advocacy experience at Management Sciences for Health (MSH). She also previously volunteered with Arts for Dementia, an organization in London, England that provides art and music therapy for individuals living with Dementia and Alzheimer’s disease.
Samantha earned a B.A. Psychology from Boston University and an M.P.H. from Boston University’s School of Public Health.
Speaker has no relevant relationships with financial interests to disclose.
Expedited Reviewer
he/him
Expedited Reviewer
Director-Filmmaker
How to Survive a Plague
(he/him)
David France is an Oscar-nominated filmmaker, New York Times bestselling author, and award-winning investigative journalist. His directorial debut, HOW TO SURVIVE A PLAGUE (IFC Films 2012), was nominated for a Directors Guild Award. Appearing on over 20 “Best of the Year” lists, including Time and Entertainment Weekly, the documentary earned an Academy Award nomination and won top honors from the Gotham Awards, the International Documentary Association, the New York Film Critics Circle, the Boston Society of Film Critics, and the Provincetown Film Festival, among many others. After a theatrical run reaching over 30 cities, HOW TO SURVIVE A PLAGUE was aired on PBS’ Independent Lens, garnering two Emmy nominations and a Peabody Award. His 2017 film, THE DEATH & LIFE OF MARSHA P. JOHNSON, a Netflix Original Documentary, won numerous festival prizes and was awarded the Outfest “Freedom Award” and a special jury recognition from Sheffield International Documentary Festival. Critics put it on multiple “Best of the Year” lists. David’s latest book, also titled HOW TO SURVIVE A PLAGUE (Knopf, 2016), received the Baillie Gifford Prize for best nonfiction book published in the English Language. In addition, France has seen his journalistic work inspire several films, including the Peabody-winning film SOLDIER’S GIRL (Showtime 2003), based on his New York Times Magazine story of the transgender girlfriend of a soldier killed in an anti-gay attack. David premiered his newest documentary, WELCOME TO CHECHNYA (HBO Max 2020), at the 2020 Sundance Film Festival, where it won the special jury award for documentary editing and it received the Panorama Audience Award and Amnesty International Film Prize at 2020 Berlinale. Some 20 festivals have given it their top prizes, including the Best Feature Film Award at Thessaloniki Documentary Film Festival 2020, the Producing Award at DOC NYC 2020 and the Right to Know Award at One World Human Rights Documentary Film Festival in 2020.
Speaker has no relevant relationships with financial interests to disclose.
Expedited Reviewer
she/her
Expedited Reviewer
Angie Gustafson joined WCG IRB in 2007, where she held various roles in Operations and management before becoming an Expedited Reviewer in 2021. Prior to joining the IRB, Angie worked in the pharmaceutical industry in sponsor and CRO roles.
Angie is located in North Carolina, where she has lived most of her life. She obtained her bachelor’s degree from the University of North Carolina at Chapel Hill and is a lifelong UNC Basketball fan. She enjoys cooking, home improvement projects, live music, and spending time with her family and pets. She is currently trying to learn more about gardening with native plants and their benefits.
Expedited Reviewer
she/her
Lauren Harden joined WCG in 2015 and worked in Board Support as a Secretary and Revision Specialist before moving to Expedited Review in 2019. Her background in reading and writing education has translated surprisingly well to review of documents and completion of regulatory documentation.
In her personal time, Lauren is an avid reader of Sci-fi and Fantasy, tabletop roleplaying aficionado, “cozy” gamer, amateur cosplayer, and very involved auntie to two nieces and a nephew.
Expedited Reviewer
Expedited Reviewer
she/her
Ms. Jackson has a B.S. in psychology with minors in sociology and philosophy. Throughout her undergraduate career, she worked in psychiatric and cognitive psychology research, which ultimately led her to co-found an international non-profit research literacy training organization for university students. Prior to WCG, she worked in psychiatry research clinics, specializing in conducting psychedelic medicine, neurodivergence, and neurocognition research, and the study design of Investigator-Initiated Trials (IITs). Ms. Jackson has co-authored publications on psychedelics and mental health disorders and served as a psychedelic therapy facilitator in studies on major depressive disorder (MDD) and psilocybin. Outside of her role at WCG, she serves as a research consultant and medical writer, primarily drafting IIT protocols and generating pre-clinical data in mice and human cell lines for studies investigating rare-X genetic disorders. Ms. Jackson is an Australian ex-pat who currently resides in Utah with her two sons as they work on renovating their mid-century fixer-upper together.
Expedited Reviewer
She/her
Emily Kaplan joined WCG IRB in 2022 and is currently a member of the Expedited Reviewer team. She graduated from Temple University with a degree in Public Health. She started her research career as a Clinical Research Coordinator eventually making her way to the IRB side of research.
She calls the east coast home specifically right outside of Philadelphia. She enjoys spending time with her husband and son. They enjoy going camping in their pop-up trailer and spending time down the shore. She is an avid baker of all things desserts and breads, a huge sci-fi/fantasy movie buff and loves to read.
Expedited Reviewer
IRB Affairs Specialist
I have worked for WCG IRB for 6 years. Prior to WCG I worked as a manager at various jobs including McDonalds, Bath & Body Works and Vista Optical. I also spent some time working for an Oral Surgeon. However, I was in search of a more family friendly schedule. Thus, I started as a part time temp and was then hired on full time as a Scheduler for Board Support. It has been the perfect fit, and I have never looked back.
On the personal side, I have spent the last 12 years with my partner in life, helping raise his 2 boys. We have spent a lot of time at band concerts and countless baseball games. They are mostly grown now, and while we still get to enjoy watching our youngest play college baseball, we are facing a new chapter in our lives. Looking forward to finding our forever property to have a big garden, orchard and several farm animals to raise. My passions include gardening, cooking, preserving food…and I mean everything from canning to freeze drying, knitting and relaxing with a warm beverage.
IRB Affairs Specialist
(she/her)
Dr. Lindsay McNair is the Chief Medical Officer for the WIRB-Copernicus Group (WCG). She oversees the physician team within the WCG IRBs and provides consultation to institutions and pharma/biotech companies on a wide range of issues related to protocol design, regulatory compliance, human subject protection, and ethical policy development (pre-approval access, subject compensation).
IRB Operations Specialist
Expedited Reviewer
she/her
