Seema Shah Ahuja’s Post

My article today: Biosimilars have not done well as the main hurdle of efficacy testing has not been removed; unfortunately, non-scientists, including the associations representing biosimilars, continue to dwell on the wrong path. I'm not sure how I can convince our rich associations to let go of redundant and useless slogans about biosimilars. Biosimilars are supposed to save, no need to tout, but how do we get more molecules in and see the end of big pharma from biosimilars? Biosimilars CouncilBiosimilars ForumBiosimilars Europe CongressBiosimilarNews .com

🔬 Clinical Trials: Phase 1 – Laying the Foundation for Drug Development 🔬 Phase 1 clinical trials represent the critical first step in evaluating a new drug or therapy in humans. This stage focuses on determining the safety, tolerability, and pharmacokinetics of the investigational drug. Here's an in-depth look at the process: 1. Objective The primary objective of Phase 1 is to assess the safety profile of the drug. Researchers aim to identify potential side effects, evaluate how the drug behaves in the human body, and establish an optimal dosage range. 2. Participant Selection Usually, a small cohort of 20-100 healthy volunteers or sometimes patients (for more severe conditions) is selected. Strict inclusion and exclusion criteria ensure that participants are suitable for early-stage testing, reducing variability and focusing on safety. 3. Dose Escalation & Administration Phase 1 trials often employ a dose-escalation design (e.g., single ascending dose or multiple ascending dose). The process begins with administering a low dose, which is gradually increased in subsequent cohorts, ensuring that the drug’s effects are tolerable and safe. 4. Pharmacokinetics & Pharmacodynamics Key parameters like Cmax(maximum concentration), Tmax(time to Cmax), half-life, and AUC (area under the concentration-time curve) are studied to understand how the drug is absorbed, distributed, metabolized, and excreted. Pharmacodynamic data is also collected to observe the drug’s biological effects on the body. 5. Safety Monitoring Participants are closely monitored for adverse events (AEs), which are categorized by severity and frequency. Real-time safety data, including vital signs, ECGs, and bloodwork, is collected to ensure immediate detection of any harmful effects. 6. Duration & Reporting Phase 1 trials typically last several months. The resulting data is critical for determining the drug’s safety and pharmacological properties, which are compiled into a comprehensive report. These findings guide the design and methodology of Phase 2 trials. --- This phase is the cornerstone of drug development, offering the first glimpse into how new therapies interact with the human body. It’s the beginning of translating lab discoveries into potential treatments. #ClinicalTrials #Phase1 #DrugDevelopment #Pharmacokinetics #Pharmacodynamics #ScientificResearch #MedicalInnovation #Pharma #Pharmacology

As explained in the announcement issued last month about FDA’s guidance of “Considerations in Demonstrating Interchangeability With a Reference Product”, FDA’s scientific approach to when a switching study or studies may be needed to support a demonstration of interchangeability has evolved. The applicants for proposed interchangeable products may choose to provide an assessment of why the comparative analytical and clinical data provided in the application or supplement support a showing that the switching standard set forth in section 351(k)(4)(B) of the PHS Act has been met. This may be an important progress in biosimilars. Chinese Antibody Society is an independent non-profit, non-government global professional organization with focus upon antibody-based therapeutics. Our society’s official journal, Antibody Therapeutics (2023 CiteScore: 8.7), is an international peer-reviewed, open access journal published by Oxford University Press. You are welcome to visit the official website of the journal (see link below) and submit your therapeutic antibody related manuscripts to our journal. https://lnkd.in/gsTu_U2 #biosimilar #biosimilars #interchangeability #biologics #fda

💡Unlocking the Value of Healthcare Data💡 Healthcare data is one of the industry's most valuable assets—and it's only becoming more essential. The global Real-World Data (RWD) market is projected to hit $4 billion by 2030. 📈 FDA’s Support for RWD 🏥💡 Recent FDA guidance encourages the use of RWD in regulatory decisions, giving hospitals the chance to provide vital insights into drug safety, efficacy, and more. A Pivotal Opportunity for Hospitals 🔑 Hospitals are stepping into a crucial role in pharmaceutical research. By sharing patient-level data for collaborative studies, healthcare providers are driving Real-World Evidence (RWE) that shapes everything from drug development to market access - creating exciting growth opportunities along the way. Hospitals are not just improving patient care—they're becoming key players in the future of medical innovation. Read our latest blog about turning hospitals into active participants in research here: https://lnkd.in/dx2F2WSx #Healthcare #RWD #RealWorldEvidence #PharmaInnovation #MedicalResearch #HealthcareData #DrugDevelopment

FY 2023 GDUFA Science and Research Report FDA’s generic drug Science and Research Program created under the Generic Drug User Fee Amendments (GDUFA) is an essential component of FDA’s mission to protect and promote public health. The Science and Research Program is implemented through extensive research collaborations among FDA scientists and through multiple collaborations with research institutions worldwide. GDUFA-funded research aims to improve the efficiency with which generic drugs can be developed and assessed, and benefits public health in two critical ways: making it more feasible for manufacturers to develop generic drugs, which can reduce the risk of drug shortages and facilitates competition; and enhancing patient access to treatment by helping make these products more available, allowing patients in the United States to obtain the medicines they need. Each year, multiple sources of public input help FDA identify specific generic drug science and research priorities that can help expand and accelerate patient access to generic drugs. FDA then advances research in those scientific areas and publishes reports that correspond to these activities and their outcomes. In FY 2023 eight scientific areas were identified as GDUFA Science and Research Priority Initiatives. Accordingly, this FY 2023 GDUFA Science and Research report describes active research projects and outcomes organized into eight chapters corresponding to the eight priority areas with a ninth chapter reporting on additional generic drug  Table of Contents (Each link below will open a 19 MB PDF) Introduction Joint Directors' Message Chapter 1: Impurities Chapter 2: Complex APIs Chapter 3: Complex Dosage Forms & Formulations Chapter 4: Complex Routes of Delivery Chapter 5: Drug-Device Combination Products Chapter 6: Oral and Parenteral Products Chapter 7: Quantitative Methods & Models Chapter 8: Data Analytics & Artificial Intelligence Chapter 9: Other Generic Product Science & Research Acknowledgments

𝗙𝗗𝗔 𝗹𝗮𝘂𝗻𝗰𝗵𝗲𝘀 𝗻𝗲𝘄 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹 𝗰𝗲𝗻𝘁𝗲𝗿 𝘁𝗼 𝗶𝗺𝗽𝗿𝗼𝘃𝗲 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻, 𝗰𝗼𝗺𝗺𝘂𝗻𝗶𝗰𝗮𝘁𝗶𝗼𝗻 The FDA has launched a new center called C3TI to promote innovation in clinical trials for drugs. This will be achieved through: Central hub for communication and collaboration: C3TI will serve as a central point for sharing information and best practices on innovative clinical trial design and conduct. This will benefit both internal and external stakeholders, including researchers, sponsors, and patient groups. Promoting existing and future initiatives: C3TI will work to advance existing CDER programs focused on clinical trial innovation and support the development of new ones. Demonstration program: C3TI will manage a program that allows sponsors of innovative trials to interact with FDA staff and showcase their approaches as examples for others. Improved efficiency and drug development: By facilitating communication and collaboration, C3TI aims to improve the efficiency of clinical trials, ultimately leading to faster development of safe and effective drugs. The focus areas of C3TI include: Point-of-care or pragmatic trials: These trials are conducted in real-world settings, making them more efficient and potentially more generalizable to real-world use of drugs. Bayesian analyses: This is a statistical approach that can be used to incorporate prior knowledge into clinical trial design and analysis, potentially leading to smaller and more efficient trials. Selective safety data collection: This approach focuses on collecting safety data on the most important aspects of a drug, potentially reducing the burden on trial participants and sponsors. Overall, C3TI represents a significant step by the FDA to encourage and support innovation in clinical trials, with the ultimate goal of bringing new treatments to patients faster. Contact  BIOBOSTON CONSULTING today or visit our  website to learn more about how we can support your organization. #pharmaceuticals #biotechnology #medicaldevices #consulting #fda  #quality #compliance #qualityassurance #regulatoryaffairs

The US FDA New Drug Approvals in July 2024  PharmaShots, your go-to media platform for life science news, brings a condensed report highlighting new drug approvals in July 2024 by the US FDA.  Stay Tuned for more updates!  Eli Lilly and Company SUN PHARMA #regulatory #usfda #pharma #healthcareindustry #approvals #newmolecularentities #biologic #pharmashots 

Safety vs. efficacy - an assessment of pharmaceutical epistemology In their comparative analysis of Randomised Clinical Trials and observational studies, Papanikoloau et al. (2006) assert that “it may be unfair to invoke bias and confounding to discredit observational studies as a source of evidence on harms”. There are two kinds of answers to the question why this is so. One is based on metaphysical assumptions, such as the problem of causal sufficiency, modularity and other statistical assumptions. The other is epistemological and relates to foundational issues and how they determine the constraints we put on evidence Ref https://lnkd.in/eNSaCENu.

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🚨 Breaking Down the Myth of High Drug Prices 🚨 A recent study published in JAMA challenges one of Big Pharma's most common justifications for soaring drug prices: the cost of research and development (R&D). The investigation, led by Olivier Wouters from the London School of Economics, analyzed 60 FDA-approved drugs from 2009 to 2018. The finding? No correlation between R&D spending and drug prices. Why does this matter? For years, pharmaceutical companies have cited massive R&D investments to rationalize prices that can exceed $100,000 per year. However, this new evidence suggests pricing is driven more by market tolerance than by development costs. In simpler terms: drug pricing isn’t about recouping costs; it’s about maximizing profit. This reality contributes to unaffordable medicines for many Americans, who already pay 2.5x more for prescriptions than people in other countries. https://lnkd.in/ewvijDPM #JACR #BCSM #HITsm #hpm #BTSM #Lupus #MedEd #MMSM #CPHC #YAMH #dsma #BrainTumor #gbdoc #WIHI #HCLDR #bioitech #chemistry #microbiology #medicalresearch #PrecisionMedicine #LifeScience #biology #Kazmi #scicomm #openscience #biobanking #microscopy #DNA #pharma #changingtheworld #cancer