Search results “Process development drug product”
Drug discovery and development process
Discovering and bringing one new drug to the market typically takes an average of 14 years of research and clinical development efforts. Learn about the many different steps in the complex drug discovery and development process. © 2011 Novartis AG
Views: 206913 Novartis
Drug Development Process-Animated Infographic
An animated infographic outlining the steps a new drug makes from discovery to the finished product
Views: 6102 Kevin Schiel
Development and Delivery of Pharmaceutical Products  (CMC) - MaRS Best Practices
Moving from drug discovery to drug development requires a particular skillset usually not yet honed by start-ups. This phase of the development process is highly regulated and critical. Let Dr. Colin Minchom take you through the aspects of the Chemistry, Manufacturing and Control (CMC) portion of the drug development process. Watch this video to learn about the pharmaceutical product development which includes objectives of formulation, cost-effective strategies to reach key milestones and more. MaRS -- Building Canada's next generation of global technology companies. marsdd.com
The FDA Drug Development Process: GLP, GMP and GCP Regulations
This Video provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations. This Video is ideal for those who are new to the Drug Development process and those experienced researchers that need an update on FDA requirements. This webinar will address the basic Drug Development Process, nonclinical trials and human clinical trials. In addition the two major FDA submissions during Drug Development will be covered - the IND submission and the NDA submission. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected] Help us caption & translate this video! http://amara.org/v/JGhy/
Views: 24164 GlobalCompliance Panel
Advanced Pharmaceutical Manufacturing
There are a number of challenges that the industry faces in order to transition towards more competitive, systematic and efficient manufacturing. Regulatory authorities have recognized the deficiencies of pharmaceutical product manufacturing and aim to enhance process understanding through Quality by Design (QbD) and Process Analytical Technology (PAT) tools. As a result of this current effort to change the mindset in order to mimic the rest of the chemical industry, an additional transition is becoming more and more appealing: transition from batch to continuous production mode. However, continuous manufacturing requires detailed process understanding in terms of the evolution of all critical material properties as a function of its operating parameters and environmental conditions. Once process knowledge is translated into models, computer aided dynamic simulation tools will allow the design, analysis and optimization of continuous integrated processes. In this talk I will discuss the work that has been done in my lab towards the development of an integrated platform that will enable the efficient flowsheet simulation and analysis, the assessment of design alternatives, the feasibility analysis of the production line, and the control and optimization of process design and operations. The developed flowsheet model includes modules for all the necessary unit operations, namely powder feeding, mixing, roller compaction, tablet press and milling integrated to represent a tablet manufacturing line. Models used to represent each unit operation vary from empirical, first-principle or hybrid. Population balance models are developed in order to track the composition and particle size changes throughout complex powder processes dynamically. The developed flowsheet simulation is used to predict the propagation of upstream disturbances to final product quality, the assessment of recycle stream benefits, the identification of process integration bottlenecks and evaluation of different control strategies in order to retain the process within its design space. In addition, global dynamic sensitivity analysis is performed to identify critical process parameters not only within each unit operation, but also between different processes. Finally, simulation based optimization techniques enable the identification of the optimal operating conditions, as well as the optimal design sequence which leads to pharmaceutical tablets with desired characteristics. This work aims to merge knowledge, experience, experimental results and modeling tools for developing a dynamic simulation platform that will enable the safe implementation of the transition towards continuous pharmaceutical manufacturing. Biography: Marianthi Ierapetritou is a Professor and Chair in the Department of Chemical and Biochemical Engineering at Rutgers University in Piscataway, New Jersey. Dr. Ierapetritou’s research focuses on the following areas: 1) process operations; (2) design and synthesis of flexible production systems focusing on pharmaceutical manufacturing; 3) modeling of reactive flow processes; and 4) metabolic engineering with focus on biopharmaceutical production. Her research is supported by several federal (NIH, NSF, ONR, NASA) and industrial (BMS, J&J, ExxonMobil, Honeywell, Cardinal Health) grants. Among her accomplishments are the Outstanding Faculty Award, the Rutgers Board of Trustees Research Fellowship for Scholarly Excellence, and the prestigious NSF CAREER award. She has more than 180 publications, and has been an invited speaker to numerous national and international conferences. Dr. Ierapetritou obtained her BS from The National Technical University in Athens, Greece, her PhD from Imperial College (London, UK) in 1995 and subsequently completed her post-doctoral research at Princeton University (Princeton, NJ) before joining Rutgers University in 1998.
Views: 41960 APMonitor.com
Drug Discovery and Development Process | Clinical Research |
To view more lectures - Download the app from http://www.teachglobal.com/app
Views: 8882 TeachGlobal
Formulation Development, Drug Development at Xcelience
Behind the scenes at Xcelience - the pharmaceutical formulation development experts. Learn more at http://www.Xcelience.com.
Views: 3066 Marcea Hennecke
Pharmaceutical Product Development
Pharmaceutical Product Development, LLC is a global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. The company’s clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. PPD is mainly known for conducting drug development for its clients, it also invests in developing new products through its compound partnering program. This video is targeted to blind users. Attribution: Article text available under CC-BY-SA Creative Commons image source in video
Views: 1308 Audiopedia
Drug Formulation - Fill & Finish
Drug Formulation - Fill & Finish The last step of drug manufacturing represents most difficult one. Especially in terms of recombinant proteins for therapeutic application formulation drastically depends on way of application (liquid or solid formulation). Here several physical properties of the therapeutic agent must be considered. Lyophilisation represents a popular formulation technique, but also requires highest investments in biological productions. Prospective project managers dealing with fill and finish have to pay regard to individual properties of the agent before setting up an optimal formulation strategy. A long-term and easy-to-apply dosage form increases attractiveness of biotech products for therapy application. This seminar deals with current strategies of formulation development. Here case studies for therapeutic agents from different leading companies will show that there is no perfect recipe for an optimal formulation.
Views: 4315 2012Biotech
A Holistic approach of QbD in Pharmaceutical Industry
Quality by design (QbD) is an approach for process development to ensure the patients’ needs and product performance by which quality is not just tested in the final drug substance but is built within the process. (Process) A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. (Science) The prime aim of the QbD is to achieve the right quality product by right first time (Business) Facilitate continuous improvement with a reduced need for post-approval changes. (Regulatory)
Contract Drug Development, Pharmaceutical Manufacturing for Pharmaceutical Companies
Ropack Pharma Solutions supports solid oral dosage projects from early-stage formulation through clinical manufacturing, packaging, distribution, and commercial manufacturing and packaging. Ropack Pharma Solutions, a Contract Development and Manufacturing Organization (CDMO) providing pharmaceutical drug development for solid oral dosage. As a full-service pharmaceutical drug developer, Ropack can assist at any stage of the drug development process from Formulation to Market: R&D, formulation, analytics, clinical manufacturing, commercial manufacturing, clinical pharmaceutical packaging, commercial packaging, clinical trial management, and clinical distribution. Ropack Pharma Solutions is cGMP-compliant, FDA-inspected and Health Canada-certified. Facilities in Montreal, Canada, and Long Island, NY, total more than 340,000 square feet, are licensed for controlled substance management, offer level 9 security vaults with biometric access and ample cold-storage locations. Ropack Inc. – Pharmaceutical Contract Manufacturing Organization​, Pharma ​Contract Development and Manufacturing Organization for ​Solid Oral Dosage.
Views: 271 RopackInc
Drug development process overview
A short Description on drug development process
Lyophilized Drug Product Development: An Industry Perspective
To view the full webinar, please visit: https://www.spscientific.com/Drug-Product-Development/ This presentation will lay out the significance of systematic formulation and process characterization for successfully designing and developing a robust freeze-drying process with acceptable product quality attributes.
Views: 96 spscientific
From idea to medicine: drug development at Roche
Roche is a place for pioneers because we are doing now what patients need next. We have more than 18,000 employees working on research and development to deliver medical innovations that can help to improve lives of millions people. Following the first discovery of a molecule by our researchers, it takes more than 12 years and many steps before a doctor can prescribe our medicines whenever needed. Watch this video to learn more about the drug development process at Roche. To learn more about Research & Development (R&D) at Roche, visit https://www.roche.com/research_and_development.htm. Subscribe to our YouTube channel now: https://www.youtube.com/user/roche?sub_confirmation=1 Get in touch with us: https://www.roche.com/ https://www.facebook.com/RocheCareers https://www.linkedin.com/company/roche https://twitter.com/roche Roche has been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally. Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. For more information and insights visit: https://www.roche.com/
Views: 60908 Roche
Scientific and Regulatory Considerations for API Drug Development
Overview of the scientific and regulatory process and requirements for developing an API.
Views: 700 Cardinal Health
Drug Product Development and Manufacturing
CoreRx’s experienced scientists and pharmaceutical professionals lend their expertise to produce safe, effective, and innovative drug products. We offer analytical labs, formulation suites, manufacturing facilities, as well as cGMP warehousing, ensuring quality control of all the services we offer. Please call us at 727-259-6950 for more details. CoreRx Pharma 14205 Myerlake Circle Clearwater, FL, 33760 Tel Number: 727-259-6950 Toll Free Number: 877-461-4448 Fax Number: 727-259-6971 Email: [email protected]
Views: 31 CoreRx Pharma
Drug Development Process
Drug Development Process
Views: 76 Fatin Zafirah
Lifecycle Approach to API Process Validation
The goal of API process validation is to ensure the reliable production of high-quality active pharmaceutical ingredients from development through commercialization. The product lifecycle approach established in FDA's 2011 Process Validation Guidance requires different validation activities during the process design and process qualification stages, as well as continued process verification throughout the life of the commercial process. The process validation needs for pre-qualification activities and ongoing process verification can be daunting, especially for small and medium-size pharmaceutical companies. In this webinar, experts on API process validation outline the key requirements for development of a phase appropriate manufacturing plan including regulatory requirements, data collection, specification development, critical process parameters, sampling plans, and analytical method validation. Key Learning Objectives: * Understand the regulatory expectations at each clinical phase. * Determine the key validation aspects of API manufacturing including critical process parameters. * Identify analytical and stability needs as the API advances in the clinic. Moderator: Rita Peters Editorial Director Pharmaceutical Technology Speakers: Paul Wrezel, Ph.D. Director of Analytical Method Development Regis Technologies Bikash Chatterjee President and Chief Technology Officer Pharmatech Associates Inc. Paul L. Pluta, PhD Editor-in-Chief Journal of GXP Compliance and Journal of Validation Technology
Views: 12873 Regis Technologies Inc
The Drug Discovery Process
We've all been touched by the miracles of modern medicine. But few people understand how medicines are made, and the immense effort required to get them to market and into our hands.
Views: 91755 PhRMAPress
Section 1. Lecture 2 - Drug Development Overview
In this lecture, I provide a high-level overview of the drug development process, recent disease trends, and industry stakeholders. Use this link to receive a discount when you sign-up for the course: https://www.udemy.com/us-regulatory-strategy-for-biologics-pharmaceutical-drugs/?couponCode=YOUTUBE17 COURSE TITLE: US Regulatory Strategy for Biologics & Pharmaceutical Drugs CATEGORY: Business / Strategy FURTHER RESOURCES: Videos: PhRMA video “The Drug Discovery Process”: www.youtube.com/watch?v=DhxD6sVQEYc PhRMA video “The Challenge of Developing New Treatments and Cures”: www.youtube.com/watch?v=oN5ffvyluzE Genentech’s “Making Medicine” series: www.youtube.com/watch?v=g4ifLsE2tdw&list=PLS5dut9m5mUDdXMz1k85ifMK74ezcemHn Khan Academy “Conversation About Drug Pricing”: https://www.khanacademy.org/science/health-and-medicine/health-care-system/v/conversation-about-drug-pricing Articles: US FDA For Patients section “The Drug Development Process”: http://www.fda.gov/ForPatients/Approvals/Drugs/default.htm PhRMA Industry Profile 2016 Report: www.phrma.org/sites/default/files/pdf/biopharmaceutical-industry-profile.pdf BIO Clinical Development Success Rates 2006-2015 Report: https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf BIO Emerging Therapeutic Company Investment and Deal Trends 2006-2015 Report: https://www.bio.org/sites/default/files/BIO_Emerging_Therapeutic_Company_Report_2006_2015_Final.pdf DiMasi JA, Grabowski HG, Hansen RA. Innovation in the pharmaceutical industry: new estimates of R&D costs. Journal of Health Economics 2016;47:20-33.: http://www.sciencedirect.com/science/article/pii/S0167629616000291) MUSIC: Yuhup - Dreams Soundcloud: https://soundcloud.com/tranzmitter-netlabel/dreams?in=tranzmitter-netlabel/sets/tranz059-yuhup-maracuja-ep Yuhup - Bem Comigo Soundcloud: https://soundcloud.com/tranzmitter-netlabel/bem-comigo?in=tranzmitter-netlabel/sets/tranz059-yuhup-maracuja-ep
Views: 2845 Brandon Too
Richard Scheller: Drug Development Process
Richard Scheller lays out the complex steps involved in the early research and subsequent development of drug products. As Genentech's Executive Vice President of Research and Early Development, Scheller directs the early stages of the process before handing off produced molecules for further development by the company. Scheller admits that while research is his clear focus, he respects the incredible logistical challenges of trying to bring a product to market. View more clips and share your comments at http://ecorner.stanford.edu/authorMaterialInfo.html?mid=2719
Views: 1383 Stanford eCorner
How Does the FDA Approve a Drug?
Have you ever taken an over the counter medication for heartburn? How about an antibiotic for an ear infection? At some point pretty much all of us have visited a pharmacy to pick up a drug, but likely didn't consider where these drugs come from or how they are made. Whether you're talking about something for seasonal allergies or your grandparent's arthritis medication, the act of bringing a drug to market is long and complex. I'm not an expert, but HCT intern Rachel Hoffman is, and with her help, that's the topic of this week's Healthcare Triage. For those of you who want to read more, go here: http://theincidentaleconomist.com/wordpress/?p=63822 John Green -- Executive Producer Stan Muller -- Director, Producer Aaron Carroll -- Writer Mark Olsen -- Graphics http://www.twitter.com/aaronecarroll http://www.twitter.com/crashcoursestan http://www.twitter.com/johngreen http://www.twitter.com/olsenvideo And the housekeeping: 1) You can support Healthcare Triage on Patreon: http://vid.io/xqXr Every little bit helps make the show better! 2) Check out our Facebook page: http://goo.gl/LnOq5z 3) We still have merchandise available at http://www.hctmerch.com
Views: 60119 Healthcare Triage
Avoiding Potholes in Process Development Part IV: Safety Testing for Drug Products
Regis Technologies hosted a seminar with guest speaker Neal G. Anderson, Ph.D., on Avoiding Potholes in Process Chemistry. This talk discussed how to anticipate and avoid problems in process development. This fourth installment of the five videos covers FDA requirements, potential genotoxic impurities, and toxicity. A full abstract follows: The first questions that a scale-up organization asks are: How much material is needed? How soon? For what purpose? All processes are developed to be fit-for-purpose, with different requirements at different stages of development. Safe operating conditions must be identified for effective scale-up; perhaps continuous flow chemistry offers advantages, or the chemistry could be outsourced to CROs that specialize in handling energetic chemistry. Mass transfer, heat transfer, and extended operating times can impact scale-up. Workups must be designed to thoroughly quench reagents and ideally deliver the product without decomposition. For early Phase studies products can be purified by chromatography, later perhaps by extraction and crystallization. The stability of intermediates can pose problems. Thorough analytical investigations are justified to unambiguously identify compounds. Screening for the optimal final form should be carried out early, unless the product is an oil or a lyophile. Structurally related impurities, potentially mutagenic impurities, and residual elemental metals must be controlled. As a compound progresses towards commercialization processes are developed to be more cost-effective.
The sequence of drug development
Why does a drug therapy take so long to find? Hear from PKD Foundation Chief Scientific Officer David Baron, Ph.D. as he uses his decades of experience in drug development to explain the process as it relates to PKD. Originally aired: December, 2015
Views: 905 PKDFoundation
R&D – The Journey of a New Medicine
The research and development process of a medicine takes many years, with high risk and investment. BIAL shows you, in a simple way, the journey of a new drug, from the laboratory to the pharmacy.
Views: 1820 Bial Pharmaceutical
New Drug Development Process | Clinical Research |
To view more lectures - Download the app from http://www.teachglobal.com/app
Views: 2174 TeachGlobal
The Challenges in Manufacturing Biologics
Biologic therapies are typically derived from living organisms. They are made by genetically engineering living cells, and a high level of precision is required in the commercial manufacturing process to produce a consistent biologic product each time. The protein produced by the cells will be influenced by individual cell characteristics, and the environment and nutrients provided during the manufacturing process.
Views: 49717 Amgen
Trends in drug discovery and development | Dr Ken Yeong | TEDxMonashUniversityMalaysia
Dr Ken Yeong discusses the future of drugs such as re-purposing them for other medical uses and to look at innovating existing drugs. He graduated with a PhD specializing in Medicinal Chemistry and has published original research and review papers in the area of drug design and discovery. He has also delivered talks in numerous international conferences and his current research interests include identifying novel molecules to treat age-related diseases, such as cancer and Alzheimer’s via a sirtuin enzyme modulation. Prior to joining Monash University as a lecturer in the School of Science, he has worked as a senior research scientist for a biotechnology company, and later for a multinational diagnostic research corporation. This talk was given at a TEDx event using the TED conference format but independently organized by a local community. Learn more at https://www.ted.com/tedx
Views: 1564 TEDx Talks
FDA Approval: Drug Development (Part I)
Curious about discovering opportunity in pharma development pipelines. In this first of a 2-part series, investor-pharma scientist Hugh McManus shares an overview of the FDA process as we prepare to examine the path taken by the obesity solutions pursued by Arena Pharma (ARNA) and Vivus (VVUS).
Views: 9321 Manifest Investing
Drug discovery and development process
Animated Video created using Animaker - https://www.animaker.com 12 stages of drug design and development
Face To Face: The Drug Development Process
A/Prof Gavin Marx - The San Clinical Trials Unit, NSW
Views: 7 NHOG
Drug Development & Product Management I Jan D. Hirsch I Williams Ettouati I UC San Diego
The Master of Science degree in Drug Development & Product Management focuses on building the managerial, regulatory, and pharmacoeconomic skills and insight to equip graduates to effectively lead the complex facets of the drug development process from discovery-to-patient. Apply now at http://go.ucsd.edu/2jiGilW The program represents a collaborative effort between UC San Diego Extension,  and the Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS).
Drug Development Process - Phases 1 & 2
Phases 1 & 2 of bringing a biotech drug to market
Views: 16 Kimberlee Dillon
Phases of Pharmaceutical Industry
The video-clip 'Phases of pharmaceutical industry' presents, step by step, the medicine line production. A 2D animation presents both the individual phases and the overall picture of the process. The students familiarize with the requirements and the conditions of medicine production, the required technology and the importance of health and safety specifications. What follows is the acquaintance with the methods of product qualitative control, the role of the head pf production and issues of waste management. The clip is instructional as far as medicine production is concerned and can be used as an introduction to the topic 'Industries' and 'Pharmacy'.
Views: 190415 EducationalTVGreece
Jim Wells and Michelle Arkin(UCSF) Part 1: Introduction to Drug Discovery
https://www.ibiology.org/archive/introduction-drug-discovery-process/ The modern drug discovery process integrates our deepest understanding of the molecular basis for disease with fundamental understanding of how potential drug molecules interact with specific disease targets and the whole organism. These two lectures are intended to give a broad and general introduction to the drug discovery process. Part I focuses on the early stages of drug discovery. We describe the basic stages of the drug discovery process, beginning with how disease targets are identified. We then take you into the laboratory to show you how a popular approach, high throughput screening, is used to identify! compounds that can engage the molecular target or pathway of interest. See more at http://www.ibioseminars.org
Views: 36594 iBiology
Developing Biologic Drugs
Explore what it takes to translate a molecule discovered in research to a manufacturing process that can achieve the best possible yields and quality.
Views: 8697 Biogen
Manufacturing Drugs at Large Scale
Discover how Biogen Idec's industry-recognized expertise in manufacturing biologic therapies blends a combination of innovation and collaboration to ensure quality and reliable drugs.
Views: 40313 Biogen
Drug Development Pathway
For more information visit http://www.drugcostfacts.org
Quality by Design (QbD) Space for Pharmaceuticals and Beyond
Quality by Design (QbD) is a hot topic in the pharmaceutical industry, heavily promoted by the FDA. However, these tools should be used by every industry interested in producing high-quality products. The general concepts are not new, but the tools to implement them have dramatically improved in the last few years. This presentation provides a briefing on QbD along with state-of-the-art response surface methods (RSMs) for developing a robust design space.
MSc Clinical Drug Development
for more information please visit: http://www.ucl.ac.uk/medicine/education/postgraduate-taught-degrees/msc-clinical-drug-development
Views: 2300 StudyUCL
Quality by Design (QbD) in Pharmaceutical Development
A five day executive course on Quality by Design (QbD). QbD is at the very heart of modern pharmaceutical development. The implementation of QbD principles provides a cost-efficient approach to delivering high quality medicines for patients. Regulatory authorities, both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), are placing great emphasis on the QbD component as a part of regulatory filing. QbD has become a crucial element in a stream-lined drug development process. Link to course description: http://copenhagensummeruniversity.ku.dk/en/courses/qualitybydesign/
Drug development process
Overview of the stages, costs and technologies used during the making of a new human medicine
Views: 543 CreativeLifeScience
Phase Appropriate Designs using DMPK Modeling Tools in Early Drug Development
Hear from Catalent’s Vice President, Science & Technology about the stages and variables associated with a molecule’s formulation development process to ensure it has the best opportunity for patient success. He discusses overcoming difficult development challenges, a drugs success factors and the key drivers in moving a molecule forward in development: drug metabolism & DMPK assessments, developability, and efficacy. Catalent. More products. Better treatments. Reliably supplied.™ Every molecule has a challenge. We have a solution. Call: +1 888 SOLUTION Email: [email protected] Visit: catalent.com
Natural products in drug development
Natural products in drug development - Tshwane University of Technology
Views: 1965 toxicsox
#DialogueForPatientCare: The drug Development Process
At Ipsen the patient is at the heart of what we do. We continuously invest to innovate and deliver therapeutic solutions for the patient’s benefit. To hear their point of view, Ipsen CEO David Meek sat down with three patient advocates from the United States and Europe on March 13, 2017. Here participants discuss about how can patient involvment in drug development process be encouraged.
Views: 57 Ipsen Group
Drug Development Process - TOX, ADME, PK/PD, Clinical POC and Drug Approval
Art Krieg, MD, Checkmate Pharmaceuticals discusses the drug development process. The Oligo Meeting 2015.

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