Danforth Advisors Acquires Advyzom, Establishing Complete Range of Clinical and Regulatory Services for Life Science Companies
September 10 2024 - 8:00AM
Danforth Advisors, LLC, today announced the acquisition of Advyzom,
LLC, a leading regulatory affairs consultancy, creating a single,
comprehensive resource for life science companies to access the
expertise required on the path to proof-of-concept, regulatory
approval, and market entry.
Danforth’s clinical and regulatory bench now spans experts
across preclinical and medical advisory, clinical development
operations, regulatory strategy, FDA liaisons and submissions,
medical writing, and clinical and CMC outsourcing. By assembling
the critical functions of asset development under one roof,
Danforth maximizes operational efficiency for life science
companies and applies the benefit of deep institutional knowledge
across key roles.
Founded in 2011, Advyzom comprises approximately 30 specialists
with backgrounds in biotechnology and big pharma, providing
expertise in global regulatory strategy, FDA relationships as US
agents, document publishing, regulatory submissions, and medical
writing. The team serves as a primary interface to health
authorities and has led or supported the achievement of hundreds of
regulatory milestones for clients, including INDs, NDA/BLA filings
and approvals, and numerous FDA designations to expedite
development and approval. Founder and CEO Cindy Dinella will
continue in her leadership role.
“Advyzom brings top talent and an exceptional track record in
regulatory strategy, timely execution, and positive working
relationships with health authorities – all critical to achieving
clients’ drug development and commercialization objectives. We now
have a fully integrated suite of clinical and regulatory services
that can adapt to every stage of development,” said Chris Connors,
CEO of Danforth Advisors. “More broadly, this latest acquisition
advances our vision to be an agile foundation for life science
companies – providing the variable teams and skill sets they need
to run the business, develop assets, and launch products.”
“We are privileged to work with pioneering innovators to help
much-needed treatments reach patients, and in Danforth we found a
team that shares our passion for this cause,” said Dr. Dinella. “We
are excited for the opportunity to partner with more life science
companies who require thoughtful leaders and hands-on collaborators
to navigate the regulatory landscape across the development
journey.”
Advyzom is the fourth organization to join Danforth, following
the acquisitions of BW Health Group in 2024, Elite BioPharma
Consulting in 2023, and Argot Partners in 2022. In December 2021,
Danforth announced an investment by Avesi Partners, LLC, to
accelerate plans to meet an ever-broadening scope of strategic and
operational needs for life science companies.
About Advyzom
Advyzom is a leading boutique consulting company specializing in
highly strategic regulatory and development advice and services for
clients in the pharmaceutical and healthcare industries. The
company is headquartered in New Jersey and supports the development
programs of clients at all stages as a virtual or embedded
extension of their teams. Additional information is available at
www.advyzom.com.
About Danforth Advisors
Danforth is the life science industry’s trusted partner for
strategic and operational support across corporate, clinical, and
commercial functions. The company advises and executes in the areas
of finance and accounting, strategic communications, human
resources, risk management, clinical and regulatory, and commercial
readiness and launch. Founded in 2011, Danforth has partnered with
more than 1,000 life science companies, private and public, across
all stages of the corporate lifecycle. The company serves clients
around the globe from its base in Waltham, Massachusetts and
regional operations in New York, Pennsylvania, New Jersey,
Maryland, California, and London. Additional information is
available at www.danforthadvisors.com.
CONTACT:
Felicia Krupps, Danforth Advisors
(617) 418-9434
fkrupps@danforthadvisors.com