# Drug Development * **Definition:** The process of bringing a new pharmaceutical drug to market, including research, testing, and regulatory approval, following the identification of a lead compound through drug discovery. * **Taxonomy:** Healthcare Topics / Drug Development ## News * Selected news on the topic of **Drug Development**, for healthcare technology leaders * 23.1K news items are in the system for this topic * Posts have been filtered for tech and healthcare-related keywords | Date | Title | Source | | --- | --- | --- | | 5/19/2025 | [**HIMSS CIO Connect brings support through shared knowledge - Healthcare Finance News**](https://www.healthcarefinancenews.com/video/himss-cio-connect-brings-support-through-shared-knowledge) | [[Healthcare Finance]] | | 5/19/2025 | [**Cycle Time is the New Currency of Drug Development**](https://hitconsultant.net/2025/05/20/cycle-time-is-the-new-currency-of-drug-development/) | [[HIT Consultant]] | | 4/28/2025 | [**AI In Healthcare Market Size to Reach $187.7 Billion by 2030 at CAGR 38.5**](https://finance.yahoo.com/news/ai-healthcare-market-size-reach-140500267.html) | [[Yahoo Finance]] | | 4/22/2025 | [**The Growing Influence of Digital Health in Pharma - LinkedIn**](https://www.linkedin.com/pulse/growing-influence-digital-health-pharma-milan-sojitra-wgdwe) | [[Linkedin]] | | 4/15/2025 | [**GC Therapeutics Expands Leadership Team with Kai-Hsin Chang and Azadeh Golipour**](https://firstwordpharma.com/story/5949790) | [[FirstWord PHARMA]] | | 4/14/2025 | [**Translating FDA guidance into action: Regulatory considerations for orphan drug developers**](https://www.biopharmadive.com/spons/translating-fda-guidance-into-action-regulatory-considerations-for-orphan/744698/) | [[BioPharma Dive]] | | 4/10/2025 | [**Odylia Therapeutics drives commitment to rare disease drug development through Rare Disease Day event**](https://www.globenewswire.com/news-release/2025/04/10/3059743/0/en/Odylia-Therapeutics-drives-commitment-to-rare-disease-drug-development-through-Rare-Disease-Day-event.html) | [[Globe Newswire]] | | 4/3/2025 | [**National Quantum Computing Centre launches Insights Paper exploring quantum computing's transformative potential in healthcare and pharmaceuticals**](https://www.news-medical.net/news/20250404/National-Quantum-Computing-Centre-launches-Insights-Paper-exploring-quantum-computings-transformative-potential-in-healthcare-and-pharmaceuticals.aspx) | [[News Medical Net]] | | 4/1/2025 | [**Project Optimus: Transforming Dose Optimization in Oncology Drug Development**](https://www.fiercebiotech.com/sponsored/project-optimus-transforming-dose-optimization-oncology-drug-development) | [[FierceBiotech]] | | 3/13/2025 | [**CRDMO Market Research 2025: A Highly Competitive $328 Billion Market by 2029 with ...**](https://finance.yahoo.com/news/crdmo-market-research-2025-highly-153900056.html) | [[Yahoo Finance]] | | 3/4/2025 | [**Lisata Therapeutics and GATC Health Consummate First Step in Strategic Collaboration to use AI to Derisk and Accelerate Drug Development**](https://finance.yahoo.com/news/lisata-therapeutics-gatc-health-consummate-133000748.html) | [[Yahoo Finance]] | | 2/16/2025 | [**The Rise of Decentralized Clinical Trials: Transforming Medical Research in the Digital Age**](https://medium.com/@anand.butani/the-rise-of-decentralized-clinical-trials-transforming-medical-research-in-the-digital-age-14de2e771e75) | [[Medium]] | | 1/7/2025 | [**The Future of Cancer Drug Development: Advancements, Challenges, and the Transformative Role of AI**](https://www.pharmacytimes.com/view/the-future-of-cancer-drug-development-advancements-challenges-and-the-transformative-role-of-ai) | [[Pharmacy Times]] | | 1/6/2025 | [**Will AI revolutionize drug development? Researchers explain why it depends on how it's used**](https://medicalxpress.com/news/2025-01-ai-revolutionize-drug.html) | [[MedicalXpress]] | | 1/3/2025 | [**Will AI revolutionize drug development? Researchers explain why it depends on how it's used**](https://theconversation.com/will-ai-revolutionize-drug-development-researchers-explain-why-it-depends-on-how-its-used-245520) | [[The Conversation]] | | 1/3/2025 | [**Will AI revolutionize drug development? Researchers explain why it depends on how it's used**](https://www.sfchronicle.com/news/article/will-ai-revolutionize-drug-development-20013075.php) | [[SF Chronicle]] | | 12/31/2024 | [**Precision Medicine Software Market Focused Insights 2024-2029, with Key Player Profiles of ...**](https://www.businesswire.com/news/home/20241231013633/en/Precision-Medicine-Software-Market-Focused-Insights-2024-2029-with-Key-Player-Profiles-of-Syapse-AccessDX-Laboratory-Fabric-Genomics-Foundation-Medicine-Intel-and-IBM---ResearchAndMarkets.com) | [[Business Wire]] | | 12/31/2024 | [**Precision Medicine Software Market Focused Insights 2024-2029, with Key Player Profiles of Syapse, AccessDX Laboratory, Fabric Genomics, Foundation Medicine, Intel and IBM - ResearchAndMarkets.com**](http://www.businesswire.com/news/home/20241231013633/en/Precision-Medicine-Software-Market-Focused-Insights-2024-2029-with-Key-Player-Profiles-of-Syapse-AccessDX-Laboratory-Fabric-Genomics-Foundation-Medicine-Intel-and-IBM---ResearchAndMarkets.com/?feedref=JjAwJuNHiystnCoBq_hl-Q-tiwWZwkcswR1UZtV7eGe24xL9TZOyQUMS3J72mJlQ7fxFuNFTHSunhvli30RlBNXya2izy9YOgHlBiZQk2LOzmn6JePCpHPCiYGaEx4DL1Rq8pNwkf3AarimpDzQGuQ==) | [[Business Wire]] | | 12/15/2024 | [**The Future of AI in Drug Development - by Kayden Break - Operations Research Bit**](https://medium.com/operations-research-bit/the-future-of-ai-in-drug-development-463121a2e30d) | [[Medium]] | | 12/11/2024 | [**CRO Services Market Surges to USD 188.54 Billion by 2030, Propelled by 12.6AGR**](https://finance.yahoo.com/news/cro-services-market-surges-usd-150100027.html) | [[Yahoo Finance]] | | 12/7/2024 | [**Regional and Segment Trends in Decentralized Clinical Trials (DCTs) Market, Global ... - LinkedIn**](https://www.linkedin.com/pulse/regional-segment-trends-decentralized-clinical-trials-lyxgc) | [[Linkedin]] | | 12/2/2024 | [**Can a consultant speed up your drug development timelines?**](https://www.news-medical.net/whitepaper/20241202/Can-a-consultant-speed-up-your-drug-development-timelines.aspx) | [[News Medical Net]] | | 11/13/2024 | [**The ultimate guide to navigating CMC in drug development**](https://www.news-medical.net/whitepaper/20241113/The-ultimate-guide-to-navigating-CMC-in-drug-development.aspx) | [[News Medical Net]] | | 10/16/2024 | [**12 Compelling Sessions to Check Out at HLTH 2024 - MedCity News**](https://medcitynews.com/2024/10/12-compelling-sessions-to-check-out-at-hlth-2024/) | [[MedCity News]] | | 10/16/2024 | [**FDA strengthens AI regulation to ensure patient safety and innovation in healthcare**](https://www.news-medical.net/news/20241016/FDA-strengthens-AI-regulation-to-ensure-patient-safety-and-innovation-in-healthcare.aspx) | [[News Medical Net]] | ## Topic Overview (Some LLM-derived content — please confirm with above primary sources) ### Key Players - **Doc.com**: A healthcare technology company aiming to integrate telemedicine and drug development. - **Callidus Research Laboratories**: A firm that offers a full range of drug product development services globally. - **Formation Bio**: An AI-driven drug developer aiming to streamline and accelerate drug development by leveraging AI. - **Dash Bio**: A startup focused on tech-enabled services for drug development, leveraging AI and robotics. - **Coronado Research**: Focuses on optimizing clinical development processes through advanced technologies. - **Anlitiks**: A company hosting a webinar focused on the role of real-world data in drug development. - **Great Bay Bio**: A company that launched the Intelligent Drug Development Ecosystem to enhance drug discovery and bioprocess development. - **Thermo Fisher Scientific**: A leading company in drug development and manufacturing, launching customizable services to streamline drug discovery. - **Iterative Health**: Utilizes machine learning to improve gastrointestinal clinical research and drug development. - **Conduit Pharmaceuticals Inc.**: Integrates AI and cybernetics into drug development processes to streamline drug repurposing and discovery. - **Hesperos, Inc.**: Specializes in preclinical drug development using Human-on-a-Chip technology to replicate human biology. - **Simulations Plus**: A provider of advanced modeling and simulation software for drug development. - **BioPhy**: A pharmaceutical company focusing on AI-driven drug discovery and development. - **Lyndra Therapeutics**: Specializes in long-acting oral therapies and collaborates with Thermo Fisher Scientific for clinical research services. - **Critical Path Institute (C-Path)**: An organization focused on accelerating drug development through collaboration and innovation. - **QuantHealth**: A company advancing AI-powered drug development platforms and trial-simulation technology. - **Aetion**: A leader in real-world evidence technology, enhancing drug development through advanced analytics. ### Partnerships and Collaborations - **Software and Pharmaceutical Companies**: Increasing collaborations between software and pharmaceutical companies to leverage advanced technology for improved drug development. - **STEERLife and Callidus Research Laboratories**: A strategic partnership aimed at accelerating drug development through advanced pharmaceutical technologies. - **TetraScience and Databricks**: Collaboration to utilize AI for enhancing drug development and clinical trial outcomes. - **C-Path Global Impact Conference**: An event promoting collaboration among industry leaders, regulatory agencies, and patient advocates to accelerate drug development. - **BrightInsight and Sanofi**: An expanded partnership to accelerate drug development timelines and enhance patient engagement. - **Koneksa and biopharmaceutical partners**: Collaboration to validate digital health tools in clinical trials through a new syndication model. - **Firefly Neuroscience and Takeda/Novartis**: Collaborations to enhance drug development in neuroscience using AI-powered analytics. - **Tevogen Bio and Microsoft**: Collaboration to enhance AI capabilities for improving drug development and accessibility. - **Conduit Pharmaceuticals and SARBORG Limited**: Partnership to utilize AI and cybernetics for improving drug development efficiency and reducing human error. - **Conduit Pharmaceuticals and Sarborg Limited**: Partnership to integrate AI and cybernetics into drug development processes. - **Schrödinger and the Gates Foundation**: An initiative to enhance predictive models for drug safety and efficacy, supported by significant funding. - **QuantHealth**: Focuses on creating enterprise-grade solutions for pharmaceutical partners amidst increasing regulatory scrutiny. - **Lisata Therapeutics and GATC Health Corp**: Collaboration to utilize AI for optimizing drug discovery and development processes. - **Onco-Innovations and Inka Health Corp.**: Acquisition aimed at enhancing precision oncology through AI-driven drug development. - **GSK and Flagship Pioneering**: A partnership to develop up to 10 new drugs for respiratory and immunology conditions, with an initial investment of $150 million. - **Lyndra Therapeutics and Thermo Fisher Scientific**: Collaboration to provide clinical research services for phase 3 studies of oral weekly risperidone. - **BIOMAKERS and TOPAZIUM**: Collaborated on a project utilizing AI and real-world DNA sequencing data to enhance immunotherapy for NSCLC. - **Clinion and Regulatory Bodies**: Clinion collaborates with regulatory bodies to ensure compliance and enhance the efficiency of clinical trials. - **N-Power Medicine and Merck Global Health Innovation Fund**: Funding to expand oncology clinics and enhance collaborations with biopharmaceutical companies. - **RTI Health Solutions and Global Pricing Innovations**: A strategic collaboration to enhance decision-making and support clients in the pharmaceutical industry. ### Innovations, Trends, and Initiatives - **Intelligent Drug Development Ecosystem**: Great Bay Bio's initiative to revolutionize drug discovery and bioprocess development. - **AI in Drug Development**: AI technologies are transforming drug development processes, improving efficiency and accuracy in R&D. - **Model-Informed Drug Development (MIDD)**: MIDD utilizes mathematical models to predict a drug's impact on disease progression, helping mitigate risks during development and commercialization. - **Accelerator™ Drug Development**: Thermo Fisher's new suite of services aimed at streamlining drug discovery and development processes. - **Fast Track and Accelerated Approval Pathways**: FDA initiatives that expedite drug review processes, allowing quicker access to new therapies. - **FDA Guidance on AI**: The FDA has issued draft guidance on the use of AI in drug development, emphasizing safety, effectiveness, and quality. - **Electrophoresis Technology**: Advancements in electrophoresis are enhancing drug development and biomarker identification. - **Digital Pathology**: Utilizes AI and data science to improve diagnostics and drug development by automating tissue analysis. - **Digi-Tech Pharma & AI 2025 Conference**: An upcoming conference focusing on advancements in pharmaceutical technology, including AI and machine learning in drug development. - **Patient-Centric Innovations**: Focus on enhancing clinical trials through decentralized approaches and the use of wearables. - **Real-World Data Utilization**: Leveraging real-world data and AI to enhance clinical trials and regulatory processes. - **Human-on-a-Chip Technology**: Hesperos is advancing preclinical testing by replicating human biology for more effective drug development. ### Challenges and Concerns - **Regulatory Complexities**: The drug development process faces challenges related to compliance with evolving regulations and ethical standards. - **Data Privacy Issues**: Concerns regarding data protection and privacy in clinical trials and drug development processes. - **Financial Risks**: High costs and failure rates in drug development necessitate support for clinical trials. - **Data Management Issues**: Poor data management leads to significant waste in drug development resources, highlighting the need for better integration of data sources. - **Data Security**: Increasing regulatory scrutiny necessitates robust cybersecurity measures to protect sensitive data in drug development. - **Complexity of Digital Transformation**: Organizations face challenges in systematically incorporating AI technologies into drug development processes. - **High Drug Development Costs**: The high-risk nature of drug R&D contributes to elevated drug prices and a low success rate for new drugs. - **Data Interoperability**: Data interoperability remains a significant challenge in ensuring seamless data flow across healthcare systems, impacting drug development efficiency. - **Data Integrity**: Maintaining data integrity is crucial for drug development, with challenges including cybersecurity threats and regulatory compliance. - **High Implementation Costs**: The adoption of advanced technologies in drug development is hindered by high costs and the need for extensive training. - **Cost of Drug Development**: Rising tariffs and costs of materials are expected to impact drug development budgets and patient prices. - **High Failure Rates**: Despite advancements, the drug development process continues to face high failure rates during clinical trials, raising concerns about the effectiveness of AI. - **Regulatory Compliance**: The implementation of AI in drug development requires careful management to ensure compliance with regulatory standards. - **Post-Approval Safety**: Concerns regarding the safety and efficacy of drugs approved through expedited pathways, necessitating enhanced oversight. - **Regulatory Hurdles**: The integration of AI in drug development faces challenges such as data quality, regulatory compliance, and ethical concerns. - **Regulatory Approval Risks**: The failure of a drug to receive regulatory approval can result in significant sunk costs for pharmaceutical companies, necessitating better risk management strategies. - **High Clinical Trial Failure Rates**: 90% of drug candidates fail during clinical trials, primarily due to lack of efficacy and poor drug properties, highlighting the need for improved methodologies. - **Data Fragmentation**: Fragmented healthcare data hinders advancements in patient care and drug development. - **Patient Non-Adherence**: Challenges in ensuring patient adherence to medication regimens during clinical trials. ## Related Topics [[Product Development]]; [[Drug Discovery]]