Lina Parra Cartagena is a seasoned FP&A professional with over 14 years of experience in corporate, commercial and operations finance across France, Mexico, Colombia, Spain and the U.S. She has worked in Consumer Goods and Pharmaceuticals, speaks four languages and excels in building FP&A teams by streamlining processes and fostering automation. At Novartis, Lina implemented AI forecasting for the Spanish affiliate's cash flow with the Global Digital Finance Team. She pursued an Executive MBA at MIT to deepen her knowledge of statistical tools. Currently based in Boston, Lina works for Vertex Pharmaceuticals in the FP&A Operations Cell & Genes Department and is involved in launching the first global CRISPR therapy for Sickle Cell Disease. Through this article, Lina Parra Cartagena highlights the transformative impact of AI on FP&A in the Life Sciences sector. She emphasizes AI's role in enhancing forecast accuracy, managing risks and improving resource allocation. Lina advises starting with data structuring and process architecture, especially for smaller companies and underscores the importance of human oversight and continuous learning in AI implementation. Financial forecasts and scenarios inform decision-making. They predict the future, influencing project plans and company budgets. Throughout history, humanity has sought to forecast and improve the future. Financial Planning and Analysis (FP&A) teams are critical in providing accurate forecasts to guide future business plans. The integration of AI in FP&A enhances the accuracy and efficiency of financial forecasts, reducing the risks associated with financial instability and increasing the opportunities for revenue generation. During the COVID-19 pandemic, the demand for forecasts increased as uncertainty rose. FP&A teams were in high demand, creating multiple scenarios to address diverse business options. AI's predictive analytics can revolutionize financial forecasting in the Life Science Finance
BioTech
Daxiang Biotech is redefining the organoids-on-chips development for drug discovery and preclinical evaluation by treating early in vitro models as decision-grade evidence rather than exploratory tools. In many pharmaceutical and biotechnology workflows, organoid models are established first, while data architectures and analytical frameworks are applied only after experimental results are generated. As datasets expand and programs approach regulatory decision points, this delayed integration weakens interpretability. Early findings become harder to validate, compare, or carry forward with confidence. Daxiang Biotech reverses this sequence through its Integrated Biomimetic Array Chip (IBAC) framework. Organoids-on-chips and artificial intelligence (AI) are co-designed from the outset, with imaging parameters, data structures, and analytical logic defined alongside biological models. By standardizing these elements at the design stage, IBAC preserves signal comparability as experimental complexity increases and programs progress toward regulatory review. “In our vision, ‘organoids-on-chips + AI’ represents a transformative technology platform that can progressively replace animal models. We treat early in vitro data not as preliminary signals for later validation, but as credible evidence capable of advancing programs directly toward key regulatory milestones,” says Zhou Yu, CEO. Advances in materials science and standardized quality control pipelines synergistically underpin this core reliability. Unlike conventional chip materials that can adsorb compounds and distort exposure data, Daxiang Biotech’s platforms use non-polydimethylsiloxane (non-PDMS) materials to reduce drug loss and preserve data integrity. Experimental conditions are optimized to enhance model stability, and products undergo verification by authoritative third-party organizations. Together, these measures have enabled the company to support numerous Chinese pharmaceutical firms in securing approval for their new drug clinical trial applications and obtaining Investigational New Drug (IND) clearances..
Cell and Gene Therapy
M Regenerative Clinic has perfected the balance between cutting-edge innovation and individualized care to deliver regenerative treatments with exceptional speed. With an on-site laboratory directly integrated with its treatment areas, M Regenerative Clinic’s setup allows immediate processing of harvested stem cells. This integration minimizes the time between cell extraction and treatment application, which is critical for preserving cell viability and enhancing therapeutic potential. The clinic’s physicians can adjust the specifics of the therapy based on the patient's health condition and needs. This approach provides personalized medical care that is both effective and responsive to each patient’s unique health circumstances. The clinic ensures every treatment offered is at the pinnacle of current scientific knowledge. Partnering with the Institute of Medical Sciences at the University of Tokyo (IMS), it actively engages in cutting-edge research on stem cells, exosomes and induced pluripotent stem (iPS) cells. “Such alliances empower our clinic with a robust, evidence-based approach, allowing us to provide patients with advanced and effective therapeutic options that extend beyond mere symptomatic relief,” says Dr. Midori Meshitsuka, director..
Life Sciences Marketing and Communication
Bringing medical devices and drugs from R&D labs to patients demands precision at every step. Accuracy in language is crucial to guarantee that scientific data, regulatory submissions and clinical documentation are correctly conveyed. A single misstep can lead to costly delays, regulatory setbacks and safety risks. Regulus Pharma Services is a trusted partner for pharmaceutical companies, biotech innovators and medical device manufacturers seeking precise, reliable translation services for global regulatory processes. From investigational drug brochures, clinical trial protocols and standard technical documents to package inserts, inquiries and biotechnology documents, Regulus Pharma ensures that complex science is translated into clear, compliant communication. In an industry where every word can make or break a breakthrough, Regulus Pharma is the silent force helping innovation reach the world. “Our mission has always been to provide consistent, best-quality translation services to help our clients seamlessly navigate the development and regulatory processes,” says Katsuo Hoshi, representative director. Regulus Pharma began as a general technical translation agency, assisting industries with translating export manuals and consumer product documentation. Later, a pivotal partnership with a bilingual Japanese-American physician shifted the organization’s focus to the medical, pharmaceutical and biotechnology sectors. Over the years, Regulus Pharma has evolved alongside industry demands. Today, it focuses on regulatory science, providing translation services at every stage of drug and medical device development. These include preclinical studies, clinical trials, new drug applications, consultations with regulatory authorities and post-approval activities, and post-marketing surveillance. Minimizing Errors, Maximizing Consistency A key element of Regulus Pharma’s strength is its carefully curated network of expert translators. Each translator brings extensive experience in medical and pharmaceutical translation, and many hold advanced academic degrees, including Ph.Ds in medical science..
Synthetic Biology
Halal Biopharma: Closing the Therapeutic Gaps
Dr. Israfil Merican, MD, MHM, Director of Pharmaniaga Marketing Sdn Bhd, Pharmaniaga Berhad [KLSE: PHARMA]
Drug Discovery and Development
Clinical Trials Landscape in APAC and Its Unique Characteristics and Opportunities
Marcia Matos, APAC Clinical Operations Hub Director, SERVIER
Medical Affairs
Elevating Medical Affairs-A Strategic Imperative for General Managers
Jon Zdon, Head Medical Governance, Evidence and Patient Access, Novartis, Australia & New Zealand
Medical Affairs
Oncology in Transition
Sarah Tregenza, Director of Medical Affairs Oncology (APAC), Pierre Fabre Group
Drug Discovery and Development
Navigating Global R&D and Pharmacokinetics in Oncology
Rose Fida, Executive Director, Program & Performance Excellence, Global R&D Portfolio & Operations Excellence, CSL [ASX: CSL]
IN MY OPINION
Therapeutics
Evolving Digital Biomarkers in Clinical Trial Space
Kazuto Yamada, Senior Director, Head of Clinical Development Planning and Supervising Five R&D Functions, Otsuka Pharmaceutical
LAST WORD
Therapeutics
Drug Delivery in Interventional Nephrology
Dr. Christopher Leo, Chairman, Medicine Cluster, Raffles Internal Medicine Centre
IN FOCUS
The Emergence of Multi-Organ-on-Chip Innovation in APAC
Multi-Organ-on-Chip platforms replicate human organ interactions for drug testing and personalized medicine, accelerating safer, cost-effective drug development in APAC by replacing animal models and enabling systemic analysis.
The Impact of Organoid-on-Chip Technologies on Pharmaceutical Research and Development in APAC
Organoid-on-chip services are transforming APAC pharmaceutical R&D by enhancing predictive accuracy, reducing costs, and accelerating drug development through advanced, human-relevant micro-physiological models and AI integration.
EDITORIAL
Powering Faster, Smarter Therapeutic Development
Organoids-on-chips are serving as standardized models for decision-making for trial sponsors who want results that are repeatable with clear use cases and strong performance in different labs and with various donors. These realistic testbeds help reduce animal testing and speed up therapy validation, reflecting regenerative medicine’s shift toward more human-focused, technology-driven progress.
Pharmaceutical translation now relies on technology and emphasizes compliance. AI-based translation is supporting controlled and traceable clinical and regulatory communication while moving toward automated systems that use connected data platforms.
Advances in cell and gene therapy are also expanding, going beyond leading programs and becoming part of a larger industry system. Companies are now developing more types of therapies for different conditions. These treatments focus on safer, more targeted genetic changes and better control of the cell environment.
This edition of Life Sciences Review APAC covers recent developments across these crucial fields that are transforming life sciences through greater standardization, regulatory alignment and precision at scale.
The latest issue features thought leaders such as Rose Fida, executive director, regional lead R&D Japan & China at CSL. She shares her insights into current developments, emerging challenges and the future of therapeutic innovation. It also features Dr. Israfil Merican, Director of Pharmaniaga Marketing Sdn Bhd at Pharmaniaga Research Center, who highlights therapeutic gaps linked to concerns over non-halal ingredients, particularly in preventive care such as vaccines and anticoagulants.
We hope this edition helps you build the partnerships needed to strengthen translational rigor, accelerate IND timelines and sharpen competitive advantage across the life sciences ecosystem.
