[Volume 13. AI-Powered Drug Development Innovation Leader - Certara]

Paul
Sep 17
8 min read

Accelerating Korea's Biopharmaceutical Industry's Global Leap through Model-Informed Drug Development Platform

Introduction: Korea's New Leap in Biopharmaceutical Industry

Korea's biopharmaceutical industry is facing a new turning point on the global stage. NASDAQ-listed Certara, a world leader in regulatory science and model-informed drug development (MIDD), is accelerating strategic partnerships with Korea's pharmaceutical ecosystem.

Certara has been consecutively establishing partnerships with major domestic biopharmaceutical companies. The company signed agreements for strengthening global drug development support through clinical trials and regulatory strategy cooperation with LSK Global Pharma Services (LSK Global PS), followed by a memorandum of understanding (MOU) for drug development cooperation with global biopharmaceutical company Celltrion. Additionally, Samsung Biologics and Samsung Bioepis are also collaborating with Certara in AI-based drug development. This represents more than simple corporate partnerships—it signals an innovative transformation of Korea's entire biopharmaceutical ecosystem.

Strategic Partnership with Celltrion Through the agreement with Celltrion, Certara has assembled a team composed of world's top 2% scientists with over 25 years of rich experience and numerous former FDA and European Medicines Agency (EMA) reviewers. Based on their experience collaborating with global top 25 pharmaceutical companies including Pfizer, Novartis, and Johnson & Johnson from early-stage drug development to market launch, they announced their commitment to support Celltrion's successful drug development.

Celltrion is expanding its business into next-generation drug development based on accumulated R&D capabilities from its success in the global biosimilar market. The company unveiled its innovative drug pipeline development roadmap based on antibody-drug conjugates (ADCs) and bispecific antibodies, presenting Celltrion's vision for future growth through novel drugs.

Particularly noteworthy is Celltrion's plan to initiate development of 13 novel drugs, including 9 ADCs and 4 multispecific antibody-based therapeutics. Tangible results are already emerging. The company presented preclinical research results for ADC candidates 'CT-P70' and 'CT-P71', with CT-P70 and CT-P71 receiving Investigational New Drug (IND) approvals from the U.S. Food and Drug Administration (FDA). CT-P70 also obtained IND approval from Korea's Ministry of Food and Drug Safety, marking full entry into global drug development.

Enhanced Clinical Trial Cooperation with LSK Global PS Previously, Certara signed an agreement with LSK Global Pharma Services (LSK Global PS), Korea's premier clinical partner CRO. Through this agreement, both companies are pursuing cooperation in four core areas: ▲clinical trial optimization ▲FDA and EMA regulatory response ▲pharmacokinetic/pharmacodynamic analysis ▲non-clinical to clinical bridging research support.

LSK Global PS, with over 187 global clinical trial experiences and Multi-Regional Clinical Trials (MRCT) capabilities, is establishing optimal clinical strategies utilizing Certara's modeling and simulation-based clinical design.

AI Drug Development Collaboration with Samsung Biologics and Bioepis Samsung Biologics and Samsung Bioepis are also collaborating with Certara in AI drug development. As Samsung Group strengthens biopharmaceutical industry competitiveness as the next growth engine following semiconductors, Samsung Biologics aims for global top-tier CDMO status while Samsung Bioepis targets innovative drug development beyond biosimilars, both utilizing Certara's advanced technology.

This trend extends beyond these companies. Leading drug development companies like Alteogen have already adopted Certara solutions to accelerate candidate substance development. Major domestic pharmaceutical companies including Yuhan Corporation (KRW 1.8589 trillion revenue) and Chong Kun Dang (KRW 1.6694 trillion revenue) are also competitively introducing Certara's solutions and services. In fact, over 120 domestic clients including major pharmaceutical companies are accelerating drug development through Certara, and Certara has smoothly supported the entire process from early development stages to approval for approximately 90% of FDA-approved drugs since 2019.

Korea now stands as the world's third-largest nation in drug development, following the United States and China. Beyond Songdo's world-class biopharmaceutical manufacturing complex centered on Samsung Biologics and Celltrion, Korea is now leaping forward as a top-tier drug development nation globally.

Traditional methods make it difficult to shorten drug development timelines and are inefficient. This is precisely why Certara's solutions and services are receiving such attention in Korea's pharmaceutical industry, despite Korea's relatively late entry into the biopharmaceutical market. The strategic decision to secure global competitiveness through AI and big data-based model-informed drug development (MIDD), overcoming existing limitations, represents a paradigm shift.

Company Overview

Company Name: Certara, Inc. (NASDAQ: CTVA)

Website: https://certara.com

Areas: AI-based Model-Informed Drug Development (MIDD), Biosimulation, Regulatory Science, Clinical Data Analysis

Core Solutions:

Phoenix NLME: Pharmacokinetic/pharmacodynamic (PK/PD) modeling platform - Global standard for nonlinear mixed-effects modeling
Simcyp PBPK: Physiologically-based pharmacokinetic (PBPK) simulator - Predicting drug absorption/distribution/metabolism/excretion reflecting human physiological characteristics
D360: Integrated drug development data platform - Small molecule and biologics research solution used by over 6,000 scientists
GlobalSubmit: Regulatory submission data management and eCTD (Electronic Common Technical Document) solution
Certara.AI: AI-based data analysis solution for enhancing productivity across life sciences R&D
QSP (Quantitative Systems Pharmacology): Systems pharmacology platform for integrated modeling of disease mechanisms and drug actions

Headquarters: Princeton, New Jersey, USA

Employee Count: Approximately 2,000 worldwide

Major Clients: Over 2,300 life science companies including 23 global regulatory agencies

Major Competitors:

Dassault Systèmes (BIOVIA): Molecular modeling and simulation solutions
Schrödinger: Computer-aided drug design and molecular simulation platform
IQVIA: Clinical data analysis and healthcare intelligence
Medidata Solutions: Clinical trial data management and analysis
Charles River Laboratories: Preclinical and clinical development services

Differentiation Factors:

Proven technology validated by supporting over 90% of FDA-approved drugs
World-class expert network including over 700 former FDA and EMA reviewers
Comprehensive platform integrating modeling, simulation, and regulatory science
Direct collaborative relationships with global regulatory agencies (FDA directly uses Certara solutions)

Innovative Business Model

Certara's core competitive advantage lies in 'Model-Informed Drug Development (MIDD)'. Since 2019, the remarkable achievement of supporting approximately 90% of FDA-approved drugs through software and technical support services demonstrates this capability. The agreement with Celltrion being Certara's first strategic MOU with a domestic pharmaceutical company makes it even more significant.

1. Software Platform

Certara's goal is to significantly transform existing drug development models to improve productivity and optimize resources. Through software including Phoenix NLME, Simcyp PBPK, and D360, they provide pharmacokinetic modeling, physiologically-based pharmacokinetic analysis, and integrated data analysis.

2. Regulatory Science Services

Synchrogenix, a Certara subsidiary and regulatory science division, accelerates regulatory submissions for global medical innovation through customized regulatory solutions including strategy, communication, operations, and technology.

3. Consulting and Technical Support

Certara supports over 120 domestic clients including major pharmaceutical companies in accelerating drug development. Experts with over 25 years of experience provide science-based decision support throughout the entire drug development process.

Rapid Expansion and Success in Korean Market

Certara's entry into the Korean market has been highly successful. Through partnerships with domestic companies leading innovative biopharmaceutical development, they are establishing foundations to deliver innovative treatments to patients worldwide faster, based on Certara's advanced MIDD capabilities and expertise with global regulatory agencies.

Certara Korea emphasizes that "accurate understanding of pharmacokinetics/pharmacodynamics-based strategy development and translational research from non-clinical to clinical stages are crucial in drug development," and "strategies for effective communication with global regulatory agencies based on scientific data cannot be overlooked."

Korea's biopharmaceutical industry's rapid growth is confirmed by numbers. Samsung Biologics leads domestic pharma/bio company revenue at KRW 3.6945 trillion, followed by Celltrion at KRW 2.1764 trillion. Certara and similar advanced technology platforms play crucial roles in this growth backdrop.

Particularly, Alteogen has focused R&D on platform technology converting IV (intravenous) formulations to SC formulations as their 'cash cow'. As domestic biotech companies secure global market competitiveness based on unique technologies, Certara's modeling and simulation technology plays a pivotal role.

Future Prospects and Expected Effects

Celltrion stated, "We expect Celltrion's global drug development capabilities to be significantly strengthened through this cooperation," and "We will actively pursue more efficient and rapid drug development that meets global regulatory standards."

LSK Global PS emphasized, "Systematic clinical trial and regulatory strategies are essential for domestic pharmaceutical companies and bioventures to secure drug development competitiveness in global markets," and "We expect domestic companies to achieve more efficient synergy in global clinical and approval processes through cooperation with Certara."

This represents more than technological innovation—it signifies a fundamental paradigm shift in drug development. Traditional drug development processes requiring over 10 years can be significantly shortened through AI and modeling technologies, providing foundations for delivering treatments to patients faster.

Developer's Perspective

As a data analysis software developer, Certara's approach is highly impressive because it provides solutions focused on practical problem-solving rather than technology for technology's sake.

From my experience developing the protein structure analysis solution DockerMaster Songdo (https://www.paulncompanies.com/dockmaster-songdo), approaches using intersection-structural stability analysis of verified PDB data and datasets for docking solutions have limitations. Methods finding drug candidates only from known datasets can constrain innovative drug discovery. This is precisely where Certara's differentiated value becomes clearer.

Certara provides advanced drug development solutions enabling pharmaceutical and biotech companies to rapidly advance from early research to successful market approval. Particularly, Phoenix NLME's pharmacokinetic modeling and Simcyp PBPK's physiologically-based simulation represent systematic approaches implementing complex biological systems as mathematical models to enhance predictability. From a developer's perspective handling frontend to backend and algorithms, this represents highly systematic and integrated platform architecture.

More importantly, Certara's solutions provide predictive modeling that transcends existing data limitations to explore new possibilities. This becomes the core driving force opening new horizons for innovative drug discovery.

Conclusion: Leap from Bio-Manufacturing Powerhouse to Biopharmaceutical Development Leader

At this crucial moment when Korea is emerging as both a bio-manufacturing powerhouse and a leading biopharmaceutical development group, Certara's partnerships with domestic companies hold highly strategic significance. The world's largest biopharmaceutical manufacturing infrastructure centered on Samsung Biologics and Celltrion in Songdo already sets global standards. Korea is now evolving beyond a simple production hub into an R&D powerhouse creating innovative drugs.

At the heart of this transformation lies the adoption of advanced technology platforms like Certara. Model-informed drug development (MIDD) and AI-based biosimulation technologies are becoming core drivers enabling Korean biopharmaceutical companies to secure differentiated advantages in global competition. The transition from traditional trial-and-error drug development to efficient development through scientific prediction and precise modeling enables qualitative advancement of Korea's biopharmaceutical industry.

Particularly, the combination of Celltrion's ADC drug development, Samsung Biologics and Bioepis' AI-based innovation, and LSK Global PS' enhanced global clinical capabilities with Certara's technology is elevating the entire Korean biopharmaceutical ecosystem's competitiveness. This is becoming the driving force for Korea's emergence as the world's third-largest drug development nation following the United States and China, with prospects for more innovative drugs to be delivered to patients worldwide under the 'Made in Korea' brand.

ADC Development Boom and Early Discovery Ecosystem Transformation

Korea currently forms a very hot market for antibody-drug conjugate (ADC) development. Led by Alteogen, Legochem, and ABL (AbTis), numerous small and medium-sized and emerging biotech companies are actively participating in the early discovery market. These companies are dedicating efforts to developing differentiated ADC candidates based on their unique technology platforms, representing exemplary cases showing the diversity and dynamism of Korea's ADC market.

However, realistic challenges facing these small and medium-sized biotech companies are also clear. For companies with limited human resources and capital, efficient and effective discovery of drug candidates becomes a core element directly linked to survival. Securing advantages in global competition through traditional drug development methods is realistically difficult with limited resources.

This is precisely where Certara's value is maximized. From the perspective of a data analysis and software developer, Certara's model-informed drug development platform provides optimal solutions for companies with limited resources. Precise pharmacokinetic modeling through Phoenix NLME, physiological simulation using Simcyp PBPK, and D360's integrated data analysis capabilities can shorten processes previously requiring years of experiments and enormous costs to weeks or months.

Particularly for complex drug systems like ADCs, predicting and optimizing complex interactions between antibodies, linkers, and payloads is key to success. Certara's sophisticated modeling technology systematically analyzes this complexity and provides scientific evidence for early selection of the most promising candidates.

Moreover, what many bioanalysis solutions focus only on analysis while being weak in regulatory submission processes and reporting, Certara's GlobalSubmit eCTD solution possesses very strong competitiveness in this area. While analysis is important in drug development, communication with regulatory authorities and approval processes are equally crucial, and Certara provides integrated solutions seamlessly connecting this entire process. This is becoming core competitiveness enabling small and medium biotech companies to compete with global big pharma despite limited resources.

Ultimately, Certara's partnerships with Korean biopharmaceutical companies represent more than simple technology adoption—they signify a historic turning point for Korea's leap as a global biopharmaceutical innovation hub. The synergy created by combining bio-manufacturing powerhouse infrastructure with advanced drug development technology will open a new golden age for Korea's biopharmaceutical industry, with innovation in early discovery ecosystems centered on ADCs becoming new growth drivers for 'K-Bio' that the world is watching.