A DV E RT I S E M E N T F E AT U R E
Southern Research
southernresearch.org
Southern Research: unique capabilities
in pandemic preparedness
Southern Research is a nonprofit, full-service contract research organization with more than 80 years of experience
in drug discovery and development. The organization was poised to respond to the COVID-19 pandemic, and it stands
ready to respond to emerging pathogens through the development of vaccines and rapid response therapeutics.
When severe acute respiratory syndrome corona-
virus 2 (SARS-CoV-2) emerged in late 2019, and
rapidly spread across the world in the first few
months of 2020, researchers and governments
were unprepared for an infectious disease of unprec-
edented scale. Based on historical modelling, the
next pandemic arising from a circulating or emerging
pathogen could be just around the corner.
One of the goals of Southern Research, a United
States end-to-end preclinical contract research
organization (CRO) based in Birmingham, Alabama,
is to take the learnings from the coronavirus 2019
(COVID-19) pandemic to ensure that it, and its clients,
are mission-ready to respond to emerging infectious
disease threats with treatments and prophylactics.
“Our role is to take our clients’ concepts in
neglected, rare, and emerging diseases and shepherd
them through to the clinic,” said Jennifer Pickens,
director of infectious disease research.
Southern Research is the highest US National
Institutes of Health (NIH)-funded non-academic
research centre in Alabama, with more than 200 sci-
entists employed. As part of its Roadmap Initiative,
the NIH designated the Southern Research High-
Throughput Screening (HTS) Center as the Infectious
Disease Specialty Screening Center in 2008. Due to
previous work with SARS and pandemic flu, Southern
Research scientists quickly helped identify and refine
one of the first approved treatments for COVID-19.
The organization has originated the development
of 20 US Food and Drug Administration (FDA)-
approved therapeutics and has helped hundreds of
clients on their paths to FDA approval.
Partnering to build the science
Southern Research provides drug discovery and
development services throughout the preclinical
process, from drug design, medicinal chemistry,
and hit-to-lead optimization to safety, toxicology,
“
Our role is to take our
clients’ concepts in
neglected, rare, and emerging
diseases and shepherd them
through to the clinic
Jennifer Pickens, Director of
Infectious Disease Research,
Southern Research
A D V E R T I S E R R E TA I N S S O L E R E S P O N S I B I L I T Y F O R C O N T E N T
Southern Research: pandemic preparedness partner.
and proof-of-concept efficacy. In the vaccine efficacy
and preclinical safety space, this includes immuno-
genicity assays, neurovirulence testing, antibody-
dependent enhancement and vaccine-associated
enhanced disease models and assays, gold standard
virology assays, and large and small in vivo models.
To bridge the gap from preclinical to clinical tri-
als, many vaccine developers want data from pre-
clinical studies that combine efficacy, toxicology, and
pharmacokinetics. Southern Research’s virologists
and toxicologists can provide the information and
analysis that companies need to submit to regulatory
authorities worldwide.
Its accredited and good laboratory practice (GLP)-
compliant biosafety level 3 (BSL-3) laboratories make
Southern Research one of only a few CROs in the US
that can work with highly pathogenic agents such
as anthrax and monkeypox in large animal models.
While much of its recent focus has been on pan-
demic and infectious disease research, Southern
Research also has worked across many other
disease areas, with additional expertise in oncol-
ogy, pulmonary disease, cystic fibrosis, and other
genetic therapies.
Collaborative work
Researchers at Southern Research work alongside
government, academic and commercial partners.
When working in partnership, Southern Research
assigns a study team that is dedicated to that proj-
ect and any subsequent ones. The team ensures
that the client is updated regularly on the status
of the project.
“Building trust with our clients, establishing rela-
tionships through effective service delivery, and
creating a long-term partnership is important to
us. We are a tight-knit, small company of scientists
and professionals who are deeply invested in the
research, acting as if our client’s projects were their
own,” said Pickens.
As an example of collaborative work, BioNTech
and Southern Research, led by Sanjay Sarkar, senior
scientist, infectious disease research, are working
together to develop a scalable multivalent mRNA
vaccine against monkeypox and related orthopox-
viruses. Published research shows that the vaccine
suppressed lesions and prevented death in a lethal
monkeypox virus challenge in cynomolgus macaques.
Preparation for the next pandemic
To be prepared for the next pandemic, Southern
Research has an established infectious disease repos-
itory that contains most BSL-2, BSL-3, and Tier 1 agent
bacterial and viral pathogens. The repository will be
updated continually to include emerging pathogens
or new variants and strains of concerns for circulat-
ing pathogens. The company also has a collection of
critical supplies and reagents as well as its processes
for the rapid development of animal models.
Southern Research’s in vitro assay platforms are
based on gold standard approaches and criteria
and allow the company to develop bridging assays
as quickly as possible to respond to potential out-
breaks. Following the FDA Modernization Act 2.0,
these bridging studies can also be used to support
developers of animal model alternatives.
Small and medium pharma and biotech companies
may still need support beyond preclinical studies,
and Southern Research also provides bioanalytical
services, help with clinical trial kit assembly and
phase 1–3 immunogenicity assessment studies
(BSL-2 and BSL-3).
Growing and developing
Southern Research is currently in the process of con-
structing a new $120 million flagship research building
with approximately 117,000 square feet of laboratory
and office space that will open in the third quarter of
2025. The organization is investing in the growth of its
campus to continue expanding its ability to help clients
move products from concept to clinic efficiently.
Jennifer Pickens
CONTACT
Director, Infectious Disease Research
Southern Research
Birmingham, AL, USA
Tel: +1-205-581-2894
www.nature.com/biopharmdeal | June 2024 | B28