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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FDA's Breakthrough Therapy, Accelerated Approval, Priority Review, and Fast Track may speed product approval. In this webinar, David Shoemaker will explain the differences, describe strategies to determine which program may be right for you, and discuss FDA requirements for each. Register Now!
The FDA's Unique Device Identification (UDI) compliance date of September 24, 2016 for Class II device labelers is now less than one year away. Register today to learn why Class II UDI compliance is the biggest challenge yet, 5 steps to a timely submission, and more.
Attend this webcast for an interactive panel discussion around the findings of a blinded industry survey on eSource in clinical trials – including current and anticipated growth, capabilities critical to eSource, and expected vs. actual benefits. Reserve Your Spot Today!
The next revolution in clinical trial execution is taking shape in the rapid adoption of mHealth technologies. PPD experts discuss how current PPD-conducted studies assess the feasibility of wearable data collection devices in trials to achieve focused endpoints and improve the patient experience. Register Now!
Clinical trial enrolment continues to be a challenge for the pharmaceutical industry. We will look at how utilizing a Functional Service Model can allow you access to experts that can develop, execute, and analyze your recruitment (and retention) strategies to achieve enrolment success. Register to Watch Now!
For the biopharma industry in particular, regulatory compliance is a huge issue. In this webinar, we will discuss how an effective Content Management program can provide a framework to aid biopharma companies in compliance. Register Today!
Over the past several decades, the number of clinical trials conducted outside of the United States has risen dramatically, as sponsors look to conduct trials in countries where they will likely be able to recruit patients more easily, with potentially less red tape and lower costs. Download today!
Biopharma firms have moved quickly into emerging markets over the past 20 years. They have added manufacturing and clinical trial sites to their networks, while also gaining access to a new population of consumers. Yet such gains have come at a cost. Download today.
This webinar will discuss how the emergence of the ability to share documents and data across thousands of miles instantly has pulled biopharma companies in two opposing directions. Companies want, even need, the interconnectivity that is facilitated by the Internet, but feel equally strongly about controlling who can view and interact with their data. Watch it now!
Learn the Five A's for adding engaging content into your current training programs, based on courses used by more than 70,000 Life Science professionals in the past three years. Download the whitepaper today!
This webinar will feature experts in drug development, regulatory processes and managed care who can shed light on the impact of escalating drug prices and provide tips on navigating these challenges. Register to Watch Now!
Over the past decade, a series of supply chain shortages have illustrated the risks such events pose to businesses and the patients they serve. Maps of supply chain risks can give companies an overview of each node in their supply chains, from tier one down. Download today.
In this webinar, Dr. Frank Smith will explore advances in precision medicine and how it is affecting clinical research. As a pediatric hematologist/oncologist, he will use his extensive clinical and research background as a backdrop for the discussion. Register to Watch Now!
Toward the end of 2010, the agenda for a new one-day meeting called "Mobile Pharma" promised to "answer the age old question 'Is this finally the year of mobile?'" A few months later, Ernst & Young published a report that seemed to answer that question with a resounding "yes." Download this eBook to learn more!
Join us for a deep dive into the pricing challenges and the best-practices you can follow to not only survive the new cost-out/value-in ecosystem trying to disrupt the Med Tech industry, but actually exploit these changes to establish competitive advantage. Register to Watch Now!
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the controversial FDA approval of the first libido drug for women, what Allergan should buy next, and Retrophin's lawsuit against former CEO Martin Shkreli.
With biopharma companies hitching their long-term growth plans to success in emerging markets, they can ill-afford for logistical difficulties in new territories to scuttle their ambitions. This is a real risk, though. Transporting drugs to patients in Brazil, India and China is fraught with multiple challenges for which experience of shipping products in the West offers scant preparation. Register to Watch Now!
FierceBiotech Radio on Amarin's First Amendment crusade, Martin Shkreli's Twitter, and Kim Kardashian's Instagram
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss a court ruling that could change how pharma companies market drugs, a biotech CEO's nuanced relationship with Twitter, and how Kim Kardashian's Instagram drew the ire of the FDA.
Pharma companies can employ several strategies for obtaining expedited approvals-including, in some cases, acquiring them from other companies. This webinar will feature regulatory experts from the pharma industry who can provide tips on navigating these programs. Register to watch now!
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss Shire's $30 billion bid for the nascent Baxalta, the promise of Merck's vaccine for Ebola, and the latest corruption allegations against GlaxoSmithKline.
With the relentless drive to reduce costs and increase innovation, B2B collaboration is increasingly becoming the mainstay of research and development (R&D). From pharmaceuticals to energy, healthcare to consumer goods, IDBS helps R&D teams make discoveries that have the potential to transform the lives of populations worldwide. Reserve Your Spot Today!
FierceBiotech Radio on Allergan's 'transformational' moves, Sanofi's new bet on Regeneron, and the (latest) biggest-ever biotech
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the week's biggest news in biopharma, including a surprise one-eighty from Allergan, an unsurprising deal involving Sanofi and Regeneron, and the latest biotech IPO stirring fears that there's a bubble soon to burst.
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the week's biggest news in biopharma, including new data on some closely watched treatments for Alzheimer's disease, the latest on a new group of would-be-blockbuster cholesterol drugs and an ad campaign for contraceptives that targets Millennials.
Biopharma companies can never eliminate the risk of supply chain disruption, but they can prevent some problems and prepare themselves for others. Knowing every company in the supply chain--from tier one down--and having contingency plans in place are essential steps to foreseeing and responding to disruptions. Maps of supply chain risks give companies this knowledge. Register to Watch Now!
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the week's biggest news in biopharma, including Celgene's planned acquisition of Receptos, Sanofi's latest corporate restructuring and an alarming new ad from GlaxoSmithKline.
FierceBiotech Radio on big approvals for Novartis and Vertex, Mylan's real estate controversy, and @brentlsaunders
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the week's biggest news in biopharma, including Novartis and Vertex Pharmaceuticals scoring big FDA approvals, Mylan's headquarters scandal, and the refreshing approach to Twitter of Allergan's CEO.
FierceBiotech Radio on the cost of CAR-T, the future of Zoetis, and gentrification in Kendall Square
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the week's biggest news in biopharma, including Celgene's big-money partnership with Juno Therapeutics, buyout rumors surrounding Zoetis, and the latest Big Pharma to move into Cambridge, MA.
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the week's biggest news in biopharma, including buyout rumors surrounding GlaxoSmithKline, the new face of Allergan and a biotech IPO that's turning heads around the industry.
FierceBiotech Radio is back with a two-part special from the BIO conference in Philadelphia. In Part I, FierceBiotech Editor-in-Chief John Carroll moderates a discussion on cancer R&D, featuring leaders from AstraZeneca, Juno Therapeutics, Merck, Johnson & Johnson and GlaxoSmithKline. And in Part II, Damian Garde takes the pulse of the conference, talking to executives from Roche, uniQure, Alexandria Real Estate and Egalet.
Cancer drug R&D has attracted billions of dollars in new investments as biopharma companies rush to stake out leading positions in hot new fields of research. At the 2015 BIO conference in Philadelphia, FierceBiotech Editor-in-Chief John Carroll moderates a discussion on the future of cancer R&D, featuring leaders from AstraZeneca, Juno Therapeutics, Merck, Johnson & Johnson and GlaxoSmithKline.
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the week's biggest news in biopharma, including the ongoing squabble between Teva and Mylan, the debate over a new class of cholesterol treatments, and the regulatory saga of a long-delayed female libido drug.
It's time to transition your molecule discovery to a commercial drug launch. This guide is your roadmap for arriving at your desired destination quickly and without making costly mistakes along the way. Download now.
This research survey will examine industry attitudes toward pharmaceutical and biotech promotional content management process and systems. Are there areas for efficiency improvement? As a thank you for your time and input, the first 50 qualified respondents will receive a $5 Starbucks eCard. Complete the Survey Today!
Editas Medicine CEO Katrine Bosley, one of FierceBiotech's 2010 Top Women in Biotech, joins FierceBiotech Radio to discuss gene editing, the Biogen alumni network and life in biotech's boomtown.
Biopharma R&D, from drug discovery through to late-phase clinical trials, suffers from two fundamental, near industry-threatening problems: It is too slow and too expensive. Something has to change. Fortunately for the industry, tools and tactics that can shave time and money from drug development already exist. Download this eBook to learn more.
On March 6, 2015, 5 years after the Biologics Price Competition and Innovation Act of 2009 was signed into law, the FDA finally approved a biosimilar drug. Although the approval capped the FDA's years-long process to establish a pathway for biosimilars, experts question whether much has actually changed for the prospects of getting biosimilars to market in the U.S. Download this eBook to learn more.
This webinar will summarize the core scientific concepts needed to develop a global observational study protocol that describes or evaluates a therapeutic treatment in patients under conditions of usual care, in terms of clinical, humanistic and economic outcomes for a variety of key stakeholders. Register to watch now!
Hear how Kythera Biopharmaceuticals reduced their TMF reconciliation time by 40% with their TMF strategy. Sign up for the webinar here.
Ken Drazan, head of J&J Innovation's California outpost, joins FierceBiotech Radio to discuss how the pharma giant approaches external R&D, how partnering has changed in modern biopharma and why med tech so often lags other fields in life sciences.
Over the past few years a series of events have crystallized fears about data security into solid intel on real and significant threats against biopharma businesses. And yet, with biopharma globalizing and disaggregating, companies cannot afford to shut off from the world. This is the dilemma faced by biopharma CIOs in 2015. Download today!
Oral dose development is the goal of many drug developers. The translation of a drug-design concept to the delivered oral dose can be complicated, and understanding the needs of drug company clients, as well as patients and doctors, is a vital part of the process. Download this eBook to learn more.
In this bonus episode of FierceBiotech Radio, John Carroll sits down with Bloomberg Intelligence analyst Asthika Goonewardene to discuss the results of an informal survey in which readers weighed in on whether the unprecedented bull market for biotech is sustainable or has transformed into a fragile bubble ready to pop. Then, FiercePharma's Carly Helfand discusses #FierceMadness, a single-elimination tournament of drug names going on over at FiercePharmaMarketing.
EP Vantage's Amy Brown joins FierceBiotech Radio to talk about her retrospective look at a big year for biotech and peek ahead at what might be in store for 2015.
FierceBiotech Editor-in-Chief John Carroll sits down with Bloomberg Intelligence analyst Asthika Goonewardene to discuss the results of an informal survey in which readers weighed in on whether the unprecedented bull market for biotech is sustainable or has transformed into a fragile bubble ready to pop.
Steve Miller of Express Scripts ($ESRX), the nation's largest pharmacy benefit manager, joins FierceBiotech Radio to discuss the future of drug pricing, the impending debut of biosimilars in the U.S. and how he got into the PBM business.
New Enterprise Associates Partner Carol Gallagher joins FierceBiotech Radio to talk about her journey from Big Pharma to small biotech and eventually to venture capital, along the way shedding light on just what VCs do all day.
The industry-wide Paperless TMF Survey seeks to understand the drivers, benefits, and barriers to moving to paperless clinical trials. An annual survey, it also provides insight into trends over time and the life sciences industry's adoption of electronic trial master files (eTMFs).
Please take a moment to share your thoughts in a 15-minute survey, and the first 50 respondents will receive a $5 Amazon gift card. Click here!
As the knowledge of the basic biology behind disease increases, and as drugs become more advanced, delivery challenges increase for oral and other formulations. Because of this, delivery solutions need to become more sophisticated and more effective. Download this eBook to learn more.
FierceBiotech Senior Editor Stacy Lawrence moderates an executive breakfast panel Is there more room to book in biotech in 2015? at the J.P. Morgan Healthcare Conference in San Francisco, CA. Lawrence's panel features Ken Drazan, the head of Johnson & Johnson Innovation in California; Dennis Aisling, founder of Aisling Capital; Rajeev Shah, portfolio manager at RA Capital; Rahul Chaudhary, managing director and head of capital markets at Leerink; and Kurt von Emster, partner at Abingworth.
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.
Life used to be simpler for pharma commercialization teams. Once a drug won regulatory approval, the path to sales was relatively clear. Now a drug must prove to payers its value over existing treatments and continue to do so throughout its lifecycle. Download this FierceBiotech Special Report to learn more.
FierceBiotech Editor-in-Chief John Carroll moderates an executive breakfast panel, Fast Phase IIIs at the BIO International Convention in Boston, MA. Carroll's panel features bluebird bio CEO Nick Leschly, Pfizer Senior Vice President Jose-Carlos Gutierrez-Ramos, Agios CEO David Schenkein, GlaxoSmithKline Vice President Jason Gardner and Sanofi Head of Boston R&D Jim Burns.
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.
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.
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!
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!
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!
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!
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!
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!
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.
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.
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.
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.
As FierceMedicalDevices looks ahead at device innovation in 2013, there are plenty of products in the pipeline that score kudos for both being technologically advanced and coming packaged with economic arguments for reimbursement.
To read more on this topic click here to download this eBook 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 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!
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.
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.