New solution offers early-stage developers a dedicated team of experts with combined experience in end-to-end drug development to optimize delivery timelines, derisk programs, and improve outcomes.
RADNOR, PA – SEPTEMBER 19, 2024 – Certara, Inc. 글로벌 바이오시뮬레이션 선두기업(Nasdaq: CERT), a global leader in model-informed drug development, today launched its Early Development Solution. The offering enhances early-stage development programs with end-to-end services and an integrated, technology-enabled approach that optimizes development decisions, time, and cost while still generating the totality of evidence required for development success.
In today’s capital-constrained environment, early-stage biotech companies are being asked to demonstrate product viability and achieve first-in-human results rapidly to unlock larger investments. They find themselves strapped for capacity while facing large skills gaps that are filled with numerous vendors that require careful coordination, communication, and oversight. This model often reduces internal productivity by taking focus away from more critical work causing additional delays.
일반적인 스타트업 초기 개발 모델
Certara 가 제시하는 새로운 패러다임
“Today’s early-stage biotech is inundated with stringent regulatory guidelines, disparate vendors and communications, and inconsistent quality of services,” said Fran Brown, PhD., SVP of Drug Development at Certara. “I’m pleased to announce the Certara integrated offering which we designed specifically for the early-stage biotech market segment. They asked us for a single solution that includes specialized drug development expertise and data-driven technology to improve their approval chances which this solution delivers.”
In a recent interview, Dr. Brown shared additional insights on research conducted by Certara with numerous biotech and emerging companies. The findings uncovered their top three challenges:
- Sourcing a large independent network of functional experts
- Keeping all experts aligned, informed, and productive
- Onboarding and offboarding experts as the program needs evolve
The Certara Early Development solution addresses these challenges directly. It supplements internal expertise and simplifies program management with a single point of contact, providing strategic guidance to help optimize and expedite drug development programs. The virtual drug development team members flex in and out based on the stage of the program, allowing customers to take advantage of comprehensive services and software in a flexible, scalable model. Supported by Certara’s comprehensive model-informed drug development capabilities, Certara’s Early Development Solution reduces risk and provides predictability and control with data-driven decision-making at every project stage.
The results include increased productivity of sponsor resources along with greater confidence in meeting timelines and generating evidence required for the next stages of funding.
Certara has a proven track record of scientific excellence. Certara clients received 90% of new drug approvals by the FDA since 2014. The fully integrated Early Development team has hundreds of years of combined experience across key early development disciplines – DMPK, bioanalytical development, toxicology/drug safety, CMC, biostatistics, regulatory strategy and operations, clinical, clinical pharmacology, and clinical operations – that work seamlessly to strategize, plan, and advance a program efficiently. The result for clients includes increased productivity along with greater confidence in meeting timelines and generating evidence required for the next stage of funding.
Underpinned by its industry-leading modeling and simulation software and technology, Certara’s Early Development Program reduces risk and provides predictability and control with data-driven decision making at every project stage. To learn more, visit www.certara.com/early-development.
Certara 소개
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. 2,30070 Certara의 고객으로는 전 세계 62개국에 걸쳐 2,000개 이상의 글로벌 바이오 제약 회사, 선도적인 학술 기관 및 주요 규제기관들이 있다. Visit us at www.certara.com.
Certara Contact:
Sheila Rocchio
sheila.rocchio@certara.com
Media Contact:
Alyssa Horowitz
PAN Communications
certara@pancomm.com
