LabVantage Pharma, the first pre-configured, pre-validated laboratory information management solution dedicated to pharmaceuticals, reduces cost and risk by deploying needed functionality without custom code. Serving regulated industries, the LIMS helps ensure regulatory and data integrity compliance. Download the whitepaper.
| Frontage Labs
Gene therapy has become a one-time treatment method for a complete cure by fixing genomic errors which altered protein functions of normal cells. The high titer virus packaging and purity are essential for the success of clinical gene therapy. In this presentation, we report to establish a facility to manufacture GLP grade viruses and to develop the relevant QC assays at Frontage. Our efforts will facilitate the application of this modern cutting edge technology in clinical arena. Register Now.
Learn why consolidating Discovery, Pre-Clinical, Clinical, and Post Approval processes on a single platform drives efficiencies, margin improvement, and real time collaboration internally & externally. Register now!
Join us for a live webcast that will showcase valuable case studies and new methodologies that can help the wider CDMO industry in tackling delays in project deliveries. We will also cover our strategy to ensure the delivery of drugs to customers and patients in spite of the COVID-19 outbreak. Register now.
Join us for a live webcast that will showcase valuable case studies and new methodologies that can help the wider CDMO industry in tackling delays in project deliveries. We will also cover our strategy to ensure the delivery of drugs to customers and patients in spite of the COVID-19 outbreak with additional issues such as raw material and re-homing issues. Register now.
US biopharma companies have options for ex-US expansion. But how can a company decide on its best pathway to value? In this webinar, leaders who’ve done it outline how they weighed their options and made the right decisions.
In this webinar, Catalent Biologics shares how to transition your product from pre-filled syringe to auto-injector more quickly with an experienced partner who can anticipate equipment and process needs. Register now.
Accelerate R&D processes across the value chain, maintain GxP compliance and reduce your overall IT footprint. Access, collaborate, and exchange non regulated and regulated content from one repository with Box. Register Now.
The testing landscape for companion diagnostics (CDx) in Europe will change. Register now and learn how to ensure patient access to IVDR-compliant CDx in Europe.
COVID-19 has presented the industry with many risks and challenges to the management of clinical trials. For many, the mitigation of these issues has accelerated the implementation of decentralized approaches to trials. Join us as we discuss these issues, ways they can be addressed, and Rho as a case study. Register now.
In this webinar, we will reveal the inner workings of the manufacturing and pharmacy department of a CRO/CDMO, so you understand the different regulatory and operational considerations faced by a clinical research pharmacy. You will learn about inherent challenges, and the appropriate mitigation measures and optimization solutions that deliver the most effective results and outcomes. What will you learn: Study planning, including quantity calculation, and how to minimize deviations, safely and successfully working with Schedule I products, packaging and labeling requirements for different countries and jurisdictions, and shipping and importation logistics during the COVID-19 era. Register Now.
This survey will address the activity Pharmaceutical brands experience on their social media pages, including what Adverse Event risks this poses to compliance efforts and how pharmacovigilance and drug safety teams are managing those risks. The first 50 qualified respondents will receive a $5 Amazon gift card. Take the survey.
Senior executives from 16 biopharma companies share their thoughts on how COVID-19 will change how the industry engages with its customers. Download the whitepaper.
There are a number of strategic advantages companies can achieve in pharmaceutical production by transferring production between sites. They can safeguard supply by producing at more than one site, and improve distribution by moving production closer to critical markets. Download now.
This white paper discusses how pre-commercial pharma companies that commercialize products independently can see an average market capitalization six times greater than companies who consistently license. Learn more how these decisions impact the current and future market valuation. Download Now.
Download our white paper to learn more about the growth trends, complex anatomy and intricacies of developing these armed antibodies, as well as AMRI’s approach to their discovery and development.
This webinar will place the oncology patient and the drug company at the heart of the conversation and will give situational awareness of the challenges both parties face, along with the proven solutions to help overcome these challenges. Register now.
Leverage spray drying to combat bioavailability and processing challenges. Learn more as global industry experts provide insight from early development to commercialization. Register now.
This webinar assembles experts with experience in biotech, pharma, and the FDA to discuss how to best identify the off-target liabilities of antibody and CAR-T therapies that are the primary cause of failure in preclinical and early clinical studies. Register Now.
In this webinar, learn how an advanced quality management system (QMS) that connects data across the product life cycle can provide business intelligence insights and give management a better understanding of your processes and how to improve them. Register now.
Whether you’re developing a COVID-19 treatment or introducing a new drug to the market, serialization is a requirement. Learn why a configurable solution will get you to compliance faster, future-proof your deployments and reduce total cost of ownership. Register now.
Learn how technology transfers can optimize success and mitigate risk from product development to commercial launch. Register now!
Cancer experts and pharma execs will break down the headline-making data from ESMO, sharing their insights and analysis around the conference’s most closely watched studies. This discussion will examine how groundbreaking research unveiled over the weekend will change clinical practice and prime drugs for key new indications, and panelists will fill you in on the need-to-know takeaways from oncology’s hottest fields. Register now.
The widespread adoption of smartphones and wearables makes monitoring symptoms in real time a credible option using brief measures designed for these devices – but is this acceptable and feasible for patients? This webinar will delve into the research findings of Takeda Pharmaceuticals, Cambridge Cognition, and CTRL Group, and share lessons learned adopting new technologies in clinical trials. Register now.
This webinar will explain the baseline requirements for elastomeric physicochemical and functional properties. Examples to illustrate qualification of components for intended applications will be included. Register now.
This webinar will focus on the challenges isolated populations have faced during the global pandemic related to patient adherence, and the application of formulation strategies to create more patient centric solutions. Register now.
Join experts Prof. Gerhard Bauer and Catalent’s Dr. James Crutchley as they discuss challenges and an innovative methodology to commercially scale autologous therapies. Register now.
Do you want to better engage with your customers in the new normal? Do you want to know about the secret sauce to perfecting omni-channel marketing? Join the experts to review the current strategies and discuss the key enablers to driving a personalized customer experience. Register now.
Becoming patient-centric begins with real-world evidence: Technology drives innovation, but research and trials must be accessible, privacy-safe and return value to participants. Learn how real-world evidence generation is evolving to meet patient needs. Download now.
Master protocol studies are meant to increase efficiency and expedite drug development. The challenge is the protocol is amended to follow positive signals, which can be both a costly and slow process. Modern technology is needed to support these complex trial designs to enable flexibility, speed and quality trials. Download now.
Drug Development has always been about data. Research insight that comes from data often gets muddied by its vastness and inaccessibility. In this session we discuss Takeda Pharmaceutical’s Platypus, a comprehensive set of Tableau visualizations of clinical trial data. With the power of Tableau, Takeda is able to more effectively monitor patient safety through all clinical trial phases and help ensure data quality, leading to timely analysis and ultimately a faster path to life-changing medicines that patients need. This session will explore: how to increase quality and speed in data analysis to reduce time and achieve greater results, the impact of Takeda’s approach and user testimonials, and data visualizations, such as “COVID19 Patient Visit Dashboards,” show pandemic insights and enable study teams to view patient data, behavior patterns, and trial delivery milestones. Register Now.
This webinar will detail practical implementation of innovative technologies and solutions such as multi-attribute method, modernized cell line development workflow using high-yield cell lines and automated systems, next generation purification resins. It will also showcase best practices and strategies such as phase appropriate quality systems, and integrated drug substance – drug product solutions that leverage standardized technology platforms. Register now!
Evotec presents practical and methodological approaches to preclinical drug abuse liability assessment of CNS-active candidates in light of International Regulatory Agencies’ recommendations. Two webcasts cover critical parameters that should be considered when designing animal behavioural studies. Watch the webcast.
Acorn AI is a Medidata company that represents the next horizon of the industry leader’s 20-year mission of powering smarter treatments and healthier people. Acorn AI is designed to make data liquid across the entire lifecycle and to answer the most important questions in R&D and commercialization for customers. Download the case study.
The original goal of cell and gene therapy was to deliver a single administration that would maintain therapeutic effectiveness over a patient’s lifetime. This ‘one and done’ model appears to have worked for some gene therapies, where promising follow-up data has been observed. In some instances, however, such as in the case of gene therapy for hemophilia, a single dose may not be enough and redosing may be required. In this webinar, our speakers will discuss: strategies for both one-time and redosing gene therapies, what redosing means for the commercialization strategy, considerations for manufacturing and market access. Register now.
Worldwide there are over 300 million people living with one or more identified rare diseases. The development of new treatments to address these unmet clinical needs clearly represents an important global health priority. Despite improvements, difficulties remain for drug developers in bringing these medicines to market. Download now >>
Find out how a pharmaceutical company can recognize both unfavorable drug substance properties and incompatibility between an API and its formulation to avoid potential risks to the patient as well as costly interruptions during development. Download now.
The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process, helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing. The objective of the BCS system is to predict in vivo performance of drugs from in vitro measurements of solubility and permeability. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability. Download now.
Execute fast, high-quality clinical trials through eSource direct data capture. You are under pressure to execute clinical trials quickly. Consider adopting an electronic source to meet this need. Clinical Ink's eSource platform reduces workload, increases efficiency, and improves data quality. Download now.
This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments. Download now.
Tech transfer is a multifaceted endeavor with multiple variables that must be carefully considered. Get insights on key considerations for a successful process transfer for manufacturing a drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Download now.
Extended care programs are available to help people in need. However, as the law rolls out, there are some clear communication disconnections that may make the process cumbersome. Download the eBook to read about a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all.
The volume and complexity of life science R&D data has exploded. To be successful in this new paradigm, R&D organizations must harness the full power of their data to drive faster, smarter decision making. Learn how to take your R&D data to the next level with this step-by-step guide from Benchling. Download now.
Taught by experienced professionals, Biotility’s online short courses provide the knowledge and practical skills valued by the bioscience industry. Enhance your career through coursework in one of our certificate pathways, including Document Management, Operations Management, and Quality Management. Learn more.
Optum brings together cross-industry experts to share a case study detailing how an employer, provider, payer and pharmaceutical company worked together to address a hard-to-diagnose condition: migraine. Register now.
Hybrid, Virtual, and Synthetic trials are becoming part of a growing number of drug and biologics development programs. Join us as Rho experts discuss how to maximize the benefits of decentralized trials. Register now!
Before businesses can recover, they will need to reboot, which will involve developing a holistic approach to managing new health risks, rethinking workforce safety, maximizing productivity, and furthering sales –while protecting and maintaining compliance with privacy and cybersecurity rights. Register now.
Join us to discuss strategy, timing, process, practical and execution aspects to be considered in order to achieve a target outcome. Case studies will be presented that demonstrate each of these challenges and the considerations necessary to meet fast-track timing requirements of clinical trials and registration applications. Register now.
In 2020, QED Therapeutics launched first-in-class infigratinib for cholangiocarcinoma (CCA). Learn how the launch team precisely identified and characterized eligible patients by taking an evidence-based approach to its commercial strategy. Download the case study.
In this webinar you will hear from technology company uMotif on how they collaborate with pharma companies undertaking virtual and decentralized trials. Hear how new patient populations can be reached using cloud-based technology and learn what types of research data can be collected from different devices and wearables. Register now.
Join us to gain an understanding of how to combine two different polymers, one “inside” and one “outside” the ASD to maximize performance, physical stability, and drug loading of ASD drug products. Register now.
Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now! Download Now!
Continuous manufacturing brings uncertainties with regulatory and adoption rates. Industry expert, Ajaz S. Hussain, PhD, will discuss these uncertainties and provide more insight into this innovation. Register now!
To better understand the landscape today, Catalent and FiercePharma asked 200+ people involved in the oral dose market from April to May 2020 for their views on barriers to the development of oral formulations and technological responses to them. Download the infographic now.
How can you make the process of bringing your product to market less complex while also reducing costs? This eBook identifies opportunities to simplify channel strategies for biopharma companies, their customers and patients. Discover how you can deliver savings and innovation to your business. Download now.
Pharmaceutical and biotech companies are spending years and millions of dollars developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Download now.
Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Click here to download the Case Study.
The complexity of clinical trials is increasing, and patient recruitment and retention continue to pose challenges. New platforms are providing the life sciences industry with an opportunity to improve the efficiency of clinical trials and reduce costs while remaining compliant and reducing risk. Download the whitepaper to learn more.
Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Download the Fact Sheet here.
Spray-dried dispersions (SDDs) are utilized to increase the bioavailability of poorly soluble molecules, however excipient requirements can limit their dose range. A novel platform has been developed to enable SDD dosage forms with high drug loadings, decreasing the size or number of tablets required. Download the whitepaper.
Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Click here to download the eBook.
In a BioPharma Dive industry survey of 150+ individuals with responsibility for clinical supplies, planning and forecasting were identified as top concerns for trial sponsors and were seen as activities that can yield significant benefits. In response to this need, the Clinical Supply Management (CSM) team at Catalent has developed a factbased methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Download now.
Regulatory agencies have provided recommendations on when and how to identify and characterize drug metabolites to ensure their non-clinical toxicity has been adequately evaluated. The studies conducted to comply with these recommendations are often referred to as metabolites in safety testing or MIST.
This presentation will review the origins of these recommendations and the specific requirements that need to be considered in designing studies to address the regulatory expectations. Register now.
This virtual roundtable will explore the challenges and opportunities facing companies developing oncology and rare disease products during the COVID-19 pandemic. Parexel will be joined by Sara’s Cure, a Clear Cell Sarcoma patient advocacy group and charitable foundation. Register now to learn more.
This industry survey seeks to gain insight on the drug developer’s perspective on bioavailability enhancement technologies and the reasoning behind the use of certain technologies over others in preclinical and early-stage clinical development. Take the survey for a chance to win a $5 Amazon gift card.
It’s not uncommon for companies who launch commercial drug products in the pre-filled syringe format to do so after initially using other product formats such as vials for the development and clinical trial phases. Switch-overs need careful and strategic consideration because doing so requires investment in the new format but also offers critical patient benefits and improved stakeholder outcomes. During this webinar, you will learn more about benefits and risks of changing primary components during product development and how a design of experiments approach can be used to address issues and risks. Register now.
Cell & gene therapy supply chains are inherently complex, requiring the utmost attention to quality, cold chain logistics, and chain of custody requirements. Join Thermo Fisher Scientific and Pluristem Therapeutics as we discuss lessons learned in developing the just-in-time supply chain for their phase III hip fracture study, and how these lessons are being used in their current efforts to treat severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome (ARDS) in the United States. Register Now.
This presentation will benefit scientists wanting to learn more about DILI and/or those needing guidance on crucial transporter studies for better assessment of DDI potentials that is aligned with regulatory guidance. Register for our Webinar, featuring Kan He, on BSEPcyte® and MDR3cyte®: Innovative Solutions for Investigating Drug-Induced Liver Injury.
Join this webinar to hear Joel VanderMeulen, Senior Director, N&I Commercial Strategy and Operations at EMD Serono, and Derek Choy, Co-founder and President at Aktana, discuss:
- Emerging market trends in the post-COVID world
- How commercial teams can adapt to the “next normal”
- The three key components for successful omnichannel engagement
By establishing an early dialogue with the FDA—when potential products are still in preclinical testing—companies can gain valuable insights that could boost their chances of success. This webinar will bring together experts in preclinical trial design, R&D efficiency and regulatory affairs to offer advice on how companies can best engage the FDA early in the research process. Register now.