Welcome to the Library, where you'll find a selection of industry resources including eBooks, Whitepapers, Webinars, Survey Reports, Research Reports and more.
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This 3-part webinar series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues. This series provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics. Download now.
The presence of biotechs in the animal health industry is growing. Companies working in this industry are using biologic processes to develop large-molecule drugs and vaccines for both livestock and pets, and to improve techniques for research, development, and manufacturing. Download this eBook to learn more about the role biotechs play in the burgeoning animal health industry.
Attendees will gain a fundamental understanding of the advanced aseptic processing utilizing Blow Fill Seal Technology (BFS) and how this innovative technology can be applied to the development and manufacturing of biologics in plastic vials. Reserve Your Spot Today!
Industry spending on post-authorization studies belies the rapid changes occurring in Phase IV research, driven by an the demand for evidence of safety and effectiveness. Download this Special Report to learn how Phase IV research continues to transform.
When Efficacy Isn't Enough: Integrating Product Commercialization Strategy into Clinical and Regulatory Planning
Undertaking commercialization strategy and planning from early stages of development can ensure that considerable R&D investment results in successful market and patient access. Join HERON, a PAREXEL Company, in a timely webinar that addresses best practice commercialization planning. Register to watch now!
Phase 2 is the end of the road for many molecules and for others the source of later delays and denials. Learn techniques for mitigating the risks that threaten your development program in the new white paper, Mitigating Phase 2 Development Risks: Design and Operational Strategies and Case Studies for Phase 2 Success. Download the white paper today!
Regulatory changes are repeatedly impacting the bottom line for both government and commercial programs. Learn why manufacturers participate in government programs, the obligations associated with such participation, the interconnectivity between various government programs, and the link between commercial pricing and contracting on government pricing. Register To Watch Now!
In this webinar, Dr. Jack Modell will provide suggestions and advice on formulating inclusion and exclusion criteria to enhance the quality of subject selection, minimize protocol violations, and avoid protocol amendments. Register to Watch Now!
Join Esker in an upcoming live webinar as we discuss the primary industry challenges, where order processing automation can drive value, and why going "paperless" is such an effective strategy for lean growth. Register Today!
Cross-contamination among production lines is an important issue in drug manufacturing, because it can put both patients and workers at risk of adverse health effects. As the global therapeutics markets grow and drugs become increasingly more potent, authorities in the U.S., Europe and elsewhere are tightening regulations to increase safety and control exposure. Download this eBook to learn more.
Optimizing Formulation Development: New HPMC Capsules Offer Expanded Options for Pharmaceutical Formulations
The evolution of technology in pharmaceutical and medical sciences has extended the range of polymers that are being developed to meet the demand for quality in capsule manufacturing. While they were initially targeted to the producers of vitamins and minerals, these plant-based capsules are now becoming an important option for pharmaceutical manufacturers. Download this eBook to learn more today!
Get the information and guidance you need from our panel of regulatory specialists, compliance professionals and industry experts. Register to watch now!
In a world of increased cost pressures and regulatory compliance, pharmaceutical sales teams need streamlined solutions on a single platform to engage health care providers, collaborate with peers and stay productive. Register today to watch now!
FierceMarkets and Veeva Systems recently conducted a survey of more than 250 Trial Master File (TMF) owners to explore the impact of growing eTMF adoption as well as the drivers, benefits, and barriers to going paperless. The survey examines the success factors for fully electronic trials and gives an industry-wide view of where organizations fall on the spectrum of paper-based to paperless TMFs. Download this free Executive Summary today!
You're invited to join fellow CSV experts for an educational overview of validating cloud systems. Life Sciences companies can safely move to the cloud if you know what changes, what to require of your vendors, and how to implement mitigating controls. Register to watch now!
Life sciences and research organizations worldwide are generating massive amounts of data. Data-intensive workflows such as these require the sustained performance and virtually unlimited scalability only parallel storage delivers. Join us to discover the power of advanced software storage solutions for life sciences. Register to Watch Now!
According to the National Organization for Rare Disorders (NORD), a disease is rare if it affects fewer than 200,000 Americans. There have been around 6,800 rare diseases defined so far, affecting around 30 million people in the US alone. Big Pharma used to ignore this segment of the market, but now developing orphan drugs to treat these rare diseases is an industry priority. Download this eBook today!
Cisco estimates that 50 billion devices and objects will be connected to the Internet by 2020. Will there be a role for developers in this area? And if so, how can developers position themselves in the months ahead on this nascent but potentially explosive opportunity? Register today to watch now!
Since 2012, the Epocrates Mobile Trends Report has tracked the utilization of digital tools among clinicians. Join us to get the first look at the 2014 report, including insights on "Digital Omnivores," task-to-screen engagement trends among key HCP segments, and first-person HCP perspectives on the industry forces fueling digital innovation in the moments of care. Register to watch now!
With all of pharma’s key markets rethinking reimbursement, the onus is on companies to find ways to deliver the evidence payers want. The rise of new sources of real-world data and the informatics capabilities to derive insights from the figures gives pharma a way to meet these demands. But to make the most of the information, the industry must re-think its practices. Download this eBrief today!
Accurately assessing perturbations in skin metabolism can provide a proximal snapshot of phenotype and is key to understanding conditions such as acne, eczema, psoriasis and signs of aging. Here we present an overview of how metabolomics can be a powerful tool in skin biology research to improve the development process for therapeutics and skin care products. Register today to watch now!
During this webinar we review how distributed computing tools (i.e., the Hadoop ecosystem) can be used to significantly advance the state-of-the-art research such as scaling genome-wide association studies and large-scale data integration of public databases. Register to Watch Now!
With clinical trials now so expensive, partly driven by costly drug failures at a late stage, effective and efficient phase IIa trials are becoming more and more important in making early go/no go decisions. Join this live event to hear expert opinions on designing an effective phase IIa Proof-Of-Concept study, what triggers a go/no-go decision at phase IIa and making the most of phase IIa data in dealmaking and collaboration. Register to watch now!
In this FastCast webcast we will focus on various encapsulation technologies and manufacturing techniques, and how they may be used to overcome formulation challenges associated with topical products. Register to Watch Now!
Realizing the potential of Risk Based Monitoring (RBM) requires coordination and collaboration across functions within both the Sponsor and CRO organizations. Dr. David Orloff and Dr. Alex Artyomenko will lead a discussion to explore the cross-functional perspectives and process alignment between Sponsor and CRO. Register to watch now!
The current market for animal drugs and vaccines (not just dogs and cats) is worth $22 billion a year and growing. Add in the huge and growing market for livestock treatments and it's no surprise pharmaceutical companies are angling to find the ideal position in animal health. This FiercePharma eBook will survey the landscape in animal health and the potential growth opportunities for investors and life sciences entrepreneurs. Download this eBook today!
"Make it go faster!" It's not uncommon to hear this phrase from investigators at Life Science organizations generating and analyzing next generation sequencing (NGS) data. In Part 2 of this 3 part series, join our expert panel as they highlight NFS and NAS guidelines and best practices for NGS mapping and alignment pipelines. Register to watch now!
CDER recently issued an updated draft guidance for Analgesic Indications. In this webinar, Brett Gordon and Ben Vaughn provide a high-level review of the agency's guidance, offer strategies for analgesic product development and share experiences with PROs and paper vs. tablet collection. Register Today!
Big pharma and biotech companies have undergone a series of consolidations, as internal research budgets continue to shrink. With much more at stake, the industry is evolving to embrace more collaborative, future-thinking tools that will not only save sponsors money, but that will also increase efficiency, expedite trials and help identify ineffective drugs sooner. Download this eBrief today!
In Part 2 of this series, we will provide a more detailed understanding of the fundamental nature of metabolomics and a visceral understanding of why it has become such a potent ally in bringing clarity to systems biology efforts. Importantly, an explanation will be provided for why metabolomics has only more recently been exploited. Register to watch now!
Throughout the history of cancer drug development, researchers have tried to make treatments more specific, reducing the side effects and increasing the efficacy. The next step in this process is the move towards therapies that are not only tailored to each individual, but that also target tumors and nothing else. Download this FierceBiotech eBook to learn more.
The cost of drugs that fail in clinical trials can be measured by far more than the cash poured into the development process. Now, through drug repositioning some of those investment costs can be recouped by giving drugs a second and often lower-risk chance in a new indication. Download this FierceBiotech ebook to learn key advantages and strategies of drug repositioning.
There are several new initiatives being undertaken in the biopharmaceutical industry aimed at making better use of the vast terabytes of information flowing out of research labs around the world. This ebook discusses the intelligent application of analytics and informatics to enable drug hunters to better understand disease, pharmacological and clinical data. Download it today.
Biomarkers have been used in the diagnosis and monitoring of kidney disease for many years. However, these are most effective in established disease, and by the time they detect injury, the damage may already be done. This ebook discusses the use of biomarkers in identifying susceptibility to kidney disease, using biomarkers to predict outcomes, as well as the limitations of existing biomarkers. Learn more.
There's no denying the power and promise of next-generation DNA sequencing (NGS) in the healthcare setting. Since 2005, when the first next-gen instruments hit the market, the field has exploded, and not surprisingly, companies have stepped in to fill unmet clinical needs. Here, we profile five businesses taking five different approaches to clinical NGS. Download today.
This year has brought a bevy of partnerships between diagnostics makers and drug companies seeking to target experimental drugs to clearly defined patient populations. Download this eBook to learn how personal medicine will develop in today's world and help the patients of tomorrow.
In order to accelerate the production of biological molecules, companies have been exploring disposable, single-use systems. Download this ebook to learn the impact and future use of single-use technologies, cost-saving opportunities, and challenges of implementing new drug development processes.
Non-profits are taking larger roles in funding clinical trials and research. With their primary goal being finding cures, rather than financial gain, the influx of non-profit research donations may help accelerate cures and advanced research. Download now.
With the clinical trial model as flawed as it is, pharma companies are turning to mobile technology as a way to increase success rate and drive down costs. So, what, if anything, can tablets and smartphones do to improve drug development? Download now.
How are drug developers and doctors tailoring prescriptions to patients? FierceBiotech outlines the principles and strategies for patient-centric drug development. Learn More.
Faced with a continuing economic crisis and an aging and increasingly obese population, healthcare providers are seeing where they can cut costs. Generics saved the U.S. healthcare system $192 billion in 2011 alone. To read more on this timely topic, download this eBook today.
The Chinese government's devotion to biotech has sparked major expansion efforts by some of the country's leading pharmaceutical players, also making it fertile ground for venture capitalists in the U.S. Click here to download the complete report today.
The role of sterility is a simple one—it is to protect people against infection and contamination. Vital steps and approaches in sterile manufacturing include employee training, process qualification and validation, processes and protocols for cleaning and decontamination, and methods to protect sterility and reduce contamination during processing. Click here to download this eBook today.
Drug developers are devoting considerable resources to rare indications and adopting some clever science to bring those orphan diseases home. To read more about the challenges and opportunities associated with bringing drugs for rare diseases to market, click here to download the complete report today.
In recent years, researchers and companies have faced increasing challenges in the discovery and development of new drugs. The challenge for Pharma companies has become maximizing the bioavailability of molecules that demonstrate activity, but are often poorly soluble and/or permeable, by selection and careful utilization of the right drug delivery technologies. Click here to download this eBook today.
For the drug developers looking to bring these products to market, ADCs represent the inevitable marriage of two sometimes hit-or-miss technologies, chemotherapy and antibodies, the next generation of anti-cancer compounds. In this Special Report FierceBiotech explores the potential and the challenges of the burgeoning field of ADCs.
The Right Fix: How Patient- Centric Data is Driving ROI and Revolutionizing the World of Pharmaceutical marketing
Advances in Anonymous Patient Level Data have empowered pharmaceutical marketers to refine their efforts to reach desired customers, accurately monitor the success of their campaigns, and ultimately generate greater ROI. Click here to download today.
A new set of FDA regulations, covering a field the agency has chosen not to supervise in the past, could be a danger on both sides. As many labs, test developers, consultants and FDA lawyers have said, it's the kind of regulation that threatens to stifle innovation with more government red tape. Click here to download.
This FierceBiotech eBook provides expert analysis and industry insights to guide biopharma professionals that face the challenges of meeting strict timelines, selecting contractors and avoiding setbacks during the planning and execution of manufacturing partnerships for global clinical trials. Download Now.
This FierceBiotechIT eBook looks at how ECM has evolved, what the challenges to biopharma are, and how those challenges and obstacles are being met by a variety of ECM approaches. Download now.
This FiercePharma eBook examines Big Pharma's need for technology to give new life to old drugs, and potentially deliver their next breakthrough medicines. This report covers some of the market opportunities, business strategies, and key innovations in the oral drug delivery field. Register Today!
China’s market growth makes it an attractive target for biopharmaceutical development. FierceBiotech takes an in-depth look at both the opportunities and challenges that come with drug development in the world’s most populous country. Download PDF now.
This FiercePharma eBook examines the changing relationship between Big Pharma and academia. Through interviews with both academic and corporate insiders, we gather perspectives from each side and address potential stumbling blocks. While there are pitfalls along the way, there is also great potential if the path can be navigated safely. Download today.