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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The Basics of Biotech 101, 201 & 301
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.
UDI Crunch Time: Preparing Your Data for Submission to FDA
The FDA's Sept. 24 UDI compliance date for Class II device labelers is fast approaching. Join this webinar to learn how to locate, gather, check and submit your data to the FDA before the deadline. Reserve Your Spot Today!
Novel Technologies to Deliver Oral Oncology Therapies
In this webinar, you'll learn about innovative technologies for oral delivery of oncology therapies, enhancing both therapeutic performance and the patient experience. Presented by Dr. Mark Ratain (University of Chicago Medicine), Mr. Julien Meissonnier and Dr. Jeff Browne (Catalent Pharma Solutions). Register now!
End-to-End Evidence Management Can Enable Value-Based, Personalized Healthcare.
Value-based, personalized healthcare is evolving the product conversation for Life science organizations to focus on evidence to deliver a more compelling value proposition to customers. Hear from Deloitte leaders around the importance of an end-to-end evidence management process. Register Now!
Minimizing Risk to Maximize Coverage for the Global Supply of Vaccines
Join us for this informative webinar: Minimizing Risk to Maximize Coverage for the Global Supply of Vaccines, featuring Bill Hartzel, Director of Strategic Execution, Advanced Delivery Technologies, Catalent Pharma Solutions. Register now!
Quantitative Systems Pharmacology Modeling (QSPM) Case Study in Immuno-oncology
Quantitative systems pharmacology modeling (QSPM) approaches help answer complex, critical Go/No-go decisions in drug R&D. Learn how to leverage QSPM to shorten timelines, lower cost, and increase the likelihood of developing best-in-class drugs. Register Now!
Inspection Readiness Considerations with AbbVie
Moving from paper-based to electronic processes not only requires a shift in technology but also a change in mindset. Hear AbbVie’s lessons learned from a mock inspection and other considerations for maintaining an inspection ready TMF. Register now!
UDI So Far: Lessons for Class II Labelers
Class II medical device labelers are working feverishly to meet the FDA's September 24, 2016 UDI compliance date. What should they know about the efforts of other device labelers so far? Reserve Your Spot Today!
Unapproved Animal Drugs: Don't Get Caught "Misbranded"
Join this webinar from Cardinal Health to learn how to evaluate the risk of marketing unapproved animal drugs and the regulatory pathways that will help minimize the possibility of FDA enforcement action. Register Now!
UDI After Submission: Managing the Lifecycle of a UDI Record
Medical device labelers have been working hard to comply with the FDA's Final Rule for Unique Device Identification (UDI). But what happens to a UDI record after submission? Reserve Your Spot Today!
Life Sciences and Mobile Apps
This webinar will examine app strategies in the life sciences industry and how they're changing in the wake of new regulatory requirements. Register to watch now!
Clinical Research Statistics for Non-statisticians
Through real-world examples, webinar participants learn strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes as well as tips for collecting the right data to answer your scientific questions. Register to watch now!
Physician Prescribing Trends & Opportunities for Health System-Pharma Collaboration
athenahealth conducted a study to learn how health systems and new reimbursement models are impacting prescribing behavior. We'll discuss our findings, including opportunities for pharma marketers, with a health system leader during this webinar. Register to Watch Now!
Special Considerations for Managing Immuno-oncology Studies - A New Paradigm
Immuno-Oncology Webinar: We are in a new era for researching cancer treatments. Join Medpace medical and operations experts as they discuss the unique considerations for managing immuno-oncology studies as well as insights into best practices. Register now!
Order Management’s Importance to the Life Sciences Industry
Download this new white paper to discover how improved order management can help life sciences companies simplify operations amidst spinoffs, M&As and divestitures, and be more agile in an ever-changing marketplace. Download here!
Advancing Drug Development with Digital Health: 4 Key Ways to Integrate Patient-Generated Data into Trial
Digital health is not only changing the way patient data is collected in healthcare, but it is also disrupting the way the pharmaceutical industry gathers data from clinical trial participants. Download this eBook to learn 4 key ways pharmaceutical companies can leverage patient-generated data to implement a digital health strategy.
Fastest Route to Clinic and Market Enabled by Optimizing API Properties and Formulation
The clinical and commercial success of a new chemical entity (NCE) requires pre-formulation studies of drug candidates and development of suitable formulations based on the physicochemical and biopharmaceutical properties. Through expert content and case study examples, this webinar will highlight the strategies and state-of-art screening, particle size reduction and formulation technologies to optimize the properties and formulation of your drug candidates. Register to watch now!
Rare Disease 20/20: A Look at the Challenges and Opportunities in Rare Disease Clinical R&D
Join the National Organization for Rare Disorders (NORD), Xenon Pharmaceuticals and BBK Worldwide as they take a closer look at the challenges and opportunities in rare disease clinical R&D. Registration is free – click here.
Next Generation GxP Systems in the AWS Cloud
Amazon Web Services (AWS) has developed a compliance resource that provides guidance to organizations who use AWS in their GxP systems. This webinar will illustrate ways the AWS Cloud facilitates GxP compliance and helps improve infrastructure transparency, consistency, and auditability. Register to watch now!
Reduced Risk and Faster Time to Market with Sigma Quality Hard Capsules
Over the past several decades, as the FDA has introduced a number of rapid tracks for drug approval, pharmaceutical companies looking to take advantage of those pathways have increasingly chosen hard capsules over other dosage forms. Download today!
Analytic Methods for Identifying Quality Risks in Clinical Trials
Join this webinar on analytic methods to help you minimize regulatory review cycles. Learn how automated systems are using advanced statistical algorithms and machine learning techniques to help sponsors shave months off their quality audit processes and avoid deficiencies. Register to Watch Now!
FierceBiotech Radio on pharma's day on the Hill, biotech's paucity of M&A, and the gathering storm of biosimilars
FiercePharma's Eric Palmer and FierceBiotech's Damian Garde discuss a bizarre congressional hearing, how biotech's slump affects the buyout climate, and a major development in the world of biosimilars.
This week's episode is sponsored by Catalent.
FierceBiotech Radio on Gilead's wide-open future, biotech's long winter and Sanofi's ongoing makeover
FiercePharma's Eric Palmer and FierceBiotech's Damian Garde discuss the future of Gilead Sciences, biotech's continued slump on Wall Street, and the latest move in Sanofi's efforts to right the ship.
This week's episode is sponsored by Catalent.
Drug Manufacturing Solutions in a Complex Industry
Through expert content and case study examples, this webinar will focus on flexible manufacturing solutions to address the unique needs of today’s pharmaceutical pipelines, with an emphasis on successful technology transfer and tailored manufacturing services. Register to watch now!
Literature Surveillance in Pharmacovigilance; Current Trends, Methods and Challenges
Scientific and medical literature is an important source of information to identify suspected adverse reactions with medicines. Join us to learn more about drug safety and literature monitoring for pharmacovigilance. Register to watch now!
Protocol Design: What You Need to Know to Ensure a Successful Study
Solid protocol design is critical to clinical development. No matter how well executed a clinical study is, if the underlying design is flawed, it wasn't worth doing. In this webinar, David Shoemaker, SVP R&D, will point out common mistakes and challenges associated with developing a protocol. Register to watch now!
Optimizing Your Clinical Supply Chain Strategy for Asia-Pacific Studies
In this webinar we will explore how to leverage the major clinical supply centers of China, Singapore and Japan to support clinical trials within the Asia-Pacific region for both local and global study sponsors. We will explore clinical packaging, logistics and import/export considerations that should be taken into account when developing a clinical supply strategy and why there is no substitute for on-the ground local expertise. Register to watch now!
Quality Documentation Control: How to Move From Paper to Regulated Cloud in 4 Weeks
How do you maintain control over regulated content with a mobile and global team? Learn how Medicines360, a nonprofit company, moved from paper-based to electronic content processes in just 4 weeks with Veeva Vault QualityDocs. Register to watch now!
Improving Commercial Content Compliance & Productivity: Results from New Industry Survey
Discover new trends and strategies to improve compliance and marketing productivity. See how your organization compares. Register to watch now!
Capturing the Voice of the Patient - ePRO, Real World Data, and the Future of Clinical Trials
Regulators are becoming wary of self-assessments captured on paper, so join this session to learn what is currently driving ePRO decisions. Register to Watch Now!
Tracking Trends in Consumer Health Dose Formulation
Consumer preferences are helping to drive developments in the shapes, forms and dosages of prescription and over-the-counter (OTC) drugs. At the same time, the need to drive down healthcare costs and increase efficacy—coupled with a favorable regulatory climate—is driving development of novel delivery technologies. Download today!
How Digital Technology is Revolutionizing Animal Health
Digital technologies are being developed to foster communication between veterinarians and the owners of the animals they serve. These new tools are designed not just for pet owners, but for farmers, too, and they promise to streamline healthcare in an industry that has long been fragmented and paper-based. Download today!
FierceBiotech Radio on the burning hole in Gilead's $25B pocket and AbbVie's future in hematology
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the discussion around Gilead Sciences' huge cash reserve and the many things the company might buy. Plus, a look back at AbbVie's blockbuster buyout of Pharmacyclics and a consideration of how a certain biotech entrepreneur is bringing attention to an FDA loophole.
Addressing Development Challenges from Early Development Phase
Although many challenges arise once drugs are on the market, adherence has emerged as a major focus of scientists and developers. This eBook discusses topics including: tackling patient compliance, top-to-bottom drug design, making clinical trials more high-tech and more. Download today!
FierceBiotech Radio on Gilead's maxed-out revenue and BioMarin's FDA struggles
In an episode free of Valeant Pharmaceuticals ($VRX) and Martin Shkreli, FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss a Senate investigation into Gilead Sciences' ($GILD) pricing of the hepatitis C drug Sovaldi, BioMarin's ($BMRN) efforts to win approval for a rare disease treatment and GlaxoSmithKline's latest woes in China.
FierceBiotech Radio on the ins and outs of 'Pfizergan' and whatever it is Martin Shkreli's doing
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the long-awaited merger agreement between Pfizer and Allergan, Martin Shkreli's CEO double duty, and the whimpering conclusion of two hostile takeovers.
FierceBiotech Radio on Sanofi's middling future, Amgen's $10B shopping list, and a novel pharma lawsuit
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss Sanofi's uninspiring forecast, Amgen's return to high-dollar dealmaking and a lawsuit that accuses a drug company of deliberately being bad at making drugs.
FierceBiotech Radio on the latest Valeant drama, Pfizergan and Shire's latest buyout
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the latest turns in the Valeant Pharmaceuticals saga, the seeming inevitability of a Pfizer-Allergan merger, and Shire's up-and-down efforts to buy stuff it wants.
FierceBiotech Radio on doomsdays for Valeant, Biogen and biotech VC
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss a rough day for Valeant Pharmaceuticals and Biogen, plus the changing in winds in biotech venture capital.
FierceBiotech Radio on Lilly's latest pipeline peril, Mylan's M&A broken record, and German Merck's big rebrand
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss a major blow to Eli Lilly's late-stage pipeline, Mylan's ongoing courtship of Perrigo, and Merck KGaA's big push to distance itself from that other Merck.
FierceBiotech Radio on biotech's Wall Street malaise, Valeant's Washington woes, and immuno-oncology's primetime slot
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss another rough week for biotech stocks, Valeant Pharmaceuticals' doggedness in the face of congressional inquiry, and a curious new trend in pharma advertising.
Navigating the Logistics of Global Clinical Trials
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!
Executive Summary | How to Prepare Your Supply Chain for Emerging Markets’ Novel Challenges
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.
FierceBiotech Radio on Valeant feeling the Bern, biotech buckling on Wall Street, and Bristol-Myers turning to Family Feud
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss how concerns about drug pricing have affected biopharma companies large and small, the latest threat to the biotech bubble, and Bristol-Myers Squibb's interesting televisual choices.
FierceBiotech Radio on Turing Pharma, Martin Shkreli and the magic of Twitter
FierceBiotech's John Carroll discusses his personal experience with the ongoing fallout over Turing Pharmaceuticals' drug pricing and CEO Martin Shkreli's public response.
FierceBiotech Radio on 'amazing' diabetes data, biotech's VC boom, and Severin Schwan's hot mic
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss some surprising trial results for a diabetes drug from Eli Lilly and Boehringer Ingelheim, the continued flow of money into private biotech companies, and the public frankness of Roche CEO Severin Schwan.
FierceBiotech Radio on GSK's latest setback, Kyle Bass' 'truthful irrelevancy,' and Horizon's web presence
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the latest setback in a bad run of form for GlaxoSmithKline, Kyle Bass' trouble with drug patents, and a new twist in the buyout battle between Horizon Pharma and Depomed.
FierceBiotech Radio on Valeant's fantasy football M&A, the gathering PCSK9 storm, and Novartis' alarming new campaign
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss Valeant Pharmaceuticals' latest reclamation projects, the bad-cholesterol horse race between Sanofi and Amgen, and Novartis' apparent horror-movie aspirations. Peace to Wes Craven.
Healthcare Companies Capitalize on the New Mobile Health Climate
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!
FierceBiotech Radio on Addyi's approval, Allergan's M&A future, and a biotech lawsuit
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.
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.
FierceBiotech Radio on Shire's $30B gambit, Merck's Ebola vaccine, and GSK's corruption scandal
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.
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.
FierceBiotech Radio on #AAIC2015, the first PCSK9 approval, and selling drugs to Millennials
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.
FierceBiotech Radio on Celgene's $7.2B splash, Sanofi's shakeup, and GSK's big, bad wolf
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.
FierceBiotech Radio on GlaxoSmithKline rumors, Allergan's new identity and Axovant's IPO
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 at #BIO2015
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.
Blazing a short path to an accelerated approval in oncology
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.
FierceBiotech Radio on Teva vs. Mylan, 'female Viagra' and the next cardio blockbusters
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.
Bringing a Small Molecule to Clinic: A Guide for Start-Up Development Programs
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.
FierceBiotech Radio with Editas Medicine's Katrine Bosley
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.
Ending Stagnation: How Collaboration Tools are Enabling a New Era of R&D
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.
Biosimilars: Getting Cheaper Biologics to the Market
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.
FierceBiotech Radio with J&J Innovation's Ken Drazan
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.
Biopharma's Balancing Act: Information Access vs. Security and Compliance
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!
What Do Customers Need in Oral Dose Development
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.
FierceBiotech Radio on the biotech bubble and #FierceMadness
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.
FierceBiotech Radio and EP Vantage on biotech's big 2014
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.
Is this a biotech bubble?
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.
FierceBiotech Radio with Express Scripts' Steve Miller
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.
FierceBiotech Radio with NEA's Carol Gallagher
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.
2015 Paperless TMF Survey
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!
New Technologies for Complex Oral Formulation and Drug Delivery Challenges
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.
Is there more room to boom in biotech in 2015?
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.
Targeting cancer treatments: A progress report
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.
Analyzing Real-World Data for Lifecycle Management
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.
Fast Phase IIIs
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.
Special Report | The Changing Landscape of Phase IV Research
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.
Animal Health Leaders Embrace Biotech R&D
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 in Drug Manufacturing: The Regulatory Trends
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!
Executive Summary | Veeva 2014 Paperless TMF Survey: An Industry Benchmark
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!
Next-Generation Orphan Drug Delivery
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!
eBrief | Work Smarter: How Data and Informatics are Reshaping Post-Approval for Pharma
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 Future of Animal Health
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!
eBrief: Securing Clinical Documents in Cloud-Based Collaborations
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!
Renal Biomarkers: Driving Drug and Diagnostic Development in Kidney Disease
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.
New Drugs For Old: Failed Drugs Gaining a Second Chance
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.
Picking Winners: Data Mining for Drug Discovery
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.
eBook | Next-Generation DNA Sequencing in the Clinic
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.
Bolstering Clinical Trials With Diagnostics
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.
Your Peers Expect a VDR. What Are You Using?
While previously companies have kept their important paperwork in physical rooms, virtual data centers have recently become more popular. Download this ebook to learn how VDRs can make viewing classified documents safer and easier.
Collaborations in the Cloud
Cloud-based technologies are proving to be useful within the life sciences industry. Download this ebook to learn how pharma and biotech companies are embracing efforts toward accessible and secure information for research collaborations.
Single Use Technology: From Bioprocess Convenience to Drug-Development Driver
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.
FierceBiotech Special Report | Foundations Fuel Risky Biotech Ventures
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.
Tablets for Trials: Will Mobile Tech Make Development More Efficient?
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.
Patient-Centric Drug Formulation Principles: Formulating Drugs for Children and the Elderly
How are drug developers and doctors tailoring prescriptions to patients? FierceBiotech outlines the principles and strategies for patient-centric drug development. Learn More.
Conversations with World-Class Biotech Innovators
What elevates a researcher to the top of the industry? FierceBiotech profiled five prominent researchers and asked them how they garnered such success. Download for free today.
Special Report: China's Rise Drives Investment in Biotech Drugs
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.
Trends in Enterprise Content Management in BioPharma
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.
Oral Drug Delivery Technologies: Tackling Clinical and Commercial Challenges
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!
Academic and Pharma Partnerships: Tapping the Ivory Tower for the Next Blockbuster
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.
Including China in Drug Development Programs: Opportunities & Challenges
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.