The Library

Welcome to the Library, where you'll find a selection of industry resources including eBooks, Whitepapers, Webinars, Survey Reports, Research Reports and more.

If you are interested in submitting items to the Library, please contact our advertising team

LIBRARY

The Basics of Biotech 101, 201 & 301

Webinar | Price: $299

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.

Analytic Methods for Identifying Quality Risks in Clinical Trials

Webinar | February 17, 2016 | 11am ET / 8am PT | Presented By: Medidata

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. Reserve Your Spot Today!

Rare Disease 20/20: A Look at the Challenges and Opportunities in Rare Disease Clinical R&D

Webinar | Tuesday, February 23 | 2pm ET / 11am PT | Presented By: BBK Worldwide

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

Webinar | February 23 | 12pm ET / 9am PT | Presented by Amazon Web Services

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 Now!

Special Considerations for Managing Immuno-oncology Studies - A New Paradigm

Webinar | March 9 | 11am ET / 8am PT | Presented by: Medpace

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!

Physician Prescribing Trends & Opportunities for Health System-Pharma Collaboration

Webinar | Wednesday, March 16 | 11am ET / 8am PT | Presented By: athenahealth

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. Reserve Your Spot Today!

Life Sciences and Mobile Apps

Webinar | March 17 | 1pm ET / 10am PT | Sponsored By: Appian

This webinar will examine app strategies in the life sciences industry and how they're changing in the wake of new regulatory requirements. Register Now!

Novel Technologies to Deliver Oral Oncology Therapies

Webinar | March 29 | 11am ET / 8am PT / 4pm GMT | Presented by: Catalent

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!

2016 Biotech Primer WEEKLY Compendium

eBook | PUBLISHED: Feb 2016 | AUTHOR: BIOTECH PRIMER

Biotech for non-scientists. Learn the latest science driving the biotechnology industry. Become more science literate. Understand biosimilars, immunotherapies, molecular diagnostics, and so much more. Each topic is easy-to-read and 1-page. Download BioTech Primer's free, interactive eBook now.

FierceBiotech Radio on pharma's day on the Hill, biotech's paucity of M&A, and the gathering storm of biosimilars

Multimedia | February 11, 2016

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.

Clinical Research Statistics for Non-statisticians

Webinar | March 17 | 1pm ET / 11am PT | Presented by Rho

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 Now!

FierceBiotech Radio on Gilead's wide-open future, biotech's long winter and Sanofi's ongoing makeover

Multimedia | February 4, 2016

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.

The Paperless TMF: An Industry Benchmark

Survey | Published: February 4, 2016 | Presented by: Veeva Systems

This research survey will examine industry attitudes toward electronic master files (eTMFs). How are eTMFs holding up against trial documents on paper? As a thank you for your time and input, a $5 donation will be made to Doctors Without Borders Foundation for each full, valid completion. Take the survey today!

Drug Manufacturing Solutions in a Complex Industry

Webinar | Now Available On-Demand | Presented by: Catalent

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!

Why You Should Transform Your Regulatory Affairs Processes

Whitepaper | Sponsored by: Veeva Systems

Optimizing regulatory affairs processes is central to overcoming the challenges facing life sciences. Read how improving document management can reduce time to approval and ultimately time to market. Download the whitepaper today!

Literature Surveillance in Pharmacovigilance; Current Trends, Methods and Challenges

Webinar | Now Available On-Demand | Presented By: Elsevier

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

Webinar | Now Available On-Demand | Presented by Rho

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

Webinar | Now Available On-Demand | Presented by: Catalent

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

Webinar | Now Available On-Demand | Presented by Veeva

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!

Fastest Route to Clinic and Market Enabled by Optimizing API Properties and Formulation

Webinar | February 24 | 10am ET / 7am PT | Presented by: Catalent

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 now!

Improving Commercial Content Compliance & Productivity: Results from New Industry Survey

Webinar | Now Available On-Demand | Presented by Veeva

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

Webinar | Now Available On-Demand | Presented By: Medidata

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!

Survey | Patient Support Programs: Their Use and Value

Survey | Published on: January 20, 2016

This survey seeks to understand the use and perceived value of patient support programs in the pharmaceutical and biotech industries. As a thank you for your time and input, the first 50 respondents will receive a $5 Amazon gift card. Take the survey today!

Enhancing the Customer Experience with Engaging Patient Services Applications

Webinar | Now Available On-Demand | Presented By: Salesforce

Patients increasingly have more control over their healthcare and information, and expect support services, access to their data, and anytime engagement. Join Harvey Guindi and Arun Bhaskar from Health Network Laboratories to hear how they transformed their patient relationships with an engaging suite of applications built on the Force.com platform. Register to Watch Now!

Tracking Trends in Consumer Health Dose Formulation

eBook | Published: January 5, 2016 | Sponsored by: Catalent

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

eBook | Published: December 14, 2015 | Sponsored by: Catalent

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!

Moving Along the TMF Maturity Continuum

Webinar | Now Available On-Demand | December 10th, 2015

Join us for this webinar to learn how the Veeva TMF Maturity Model for Life Sciences can help you evaluate your TMF operating model and create a strategy that propels your organization along the TMF continuum. Register to watch now! 

FierceBiotech Radio on the burning hole in Gilead's $25B pocket and AbbVie's future in hematology

Multimedia | December 10, 2015

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

eBook | Published: December 8, 2015 | Sponsored by: Catalent

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

Multimedia | December 3, 2015

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.

Supporting Data Integration for Translational Research with Sustainable Technology Infrastructure

Webinar | Now Available On-Demand | Presented By: PerkinElmer

The goals of translational R&D have placed a particular premium on the ability to rapidly collect, curate, and integrate information from a variety of sources. This presentation will discuss some of the challenges in building a sustainable technology infrastructure to support these activities, which will enable more sophisticated analytics and decision support. Register to View Today

What's in Your Lab? Address Risk, Cost & Productivity with Chemical Inventory Management

Webinar | NOW AVAILABLE ON-DEMAND | Presented by: BIOVIA

Learn in this webinar how a comprehensive centralized chemicals Inventory system that is tightly integrated with other lab informatics systems – such as Electronic Lab Notebooks – reduces chemical management safety and compliance risks, allows laboratories to be more efficient, and reduces overall complexities and costs. Register to Watch Now!

What's in Your Lab? Address Risk, Cost & Productivity with Chemical Inventory Management

Webinar | NOW AVAILABLE ON-DEMAND | Presented by: BIOVIA

Learn in this webinar how a comprehensive centralized chemicals Inventory system that is tightly integrated with other lab informatics systems – such as Electronic Lab Notebooks – reduces chemical management safety and compliance risks, allows laboratories to be more efficient, and reduces overall complexities and costs. Register to Watch Now!

FierceBiotech Radio on the ins and outs of 'Pfizergan' and whatever it is Martin Shkreli's doing

Multimedia | November 24, 2015

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

Multimedia | November 12, 2015

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

Multimedia | November 5, 2015

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.

UDI Class II Device Submissions: What You Need to Know

Webinar | NOW AVAILABLE ON-DEMAND | Presented by: Reed Tech

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.

FierceBiotech Radio on doomsdays for Valeant, Biogen and biotech VC

Multimedia | October 21, 2015

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

Multimedia | October 14, 2015

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

Multimedia | October 7, 2015

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

eBook | Published: October 5, 2015 | Sponsored by: Catalent

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

eBook | Published On: October 5, 2015 | Presented By: UPS

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

Multimedia | September 30, 2015

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.

How to enable anywhere, any data access without compromising security

Webinar | NOW AVAILABLE ON-DEMAND | Sponsored by: M-Files

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!

FierceBiotech Radio on Turing Pharma, Martin Shkreli and the magic of Twitter

Multimedia | September 22, 2015

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

Multimedia | September 18, 2015

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

Multimedia | September 11, 2015

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

Multimedia | September 4, 2015

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

eBook | Published: September 1, 2015 | Sponsored by: Validic

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

Multimedia | August 20, 2015

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

Multimedia | August 13, 2015

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

Multimedia | August 6, 2015

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

Multimedia | July 30, 2015

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

Multimedia | July 23, 2015

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

Multimedia | July 16, 2015

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

Multimedia | July 9, 2015

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

Multimedia | July 1, 2015

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

Multimedia | June 22, 2015

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

Multimedia | June 19, 2015

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

Video | June 18, 2015

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

Multimedia | June 12, 2015

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

eBook | Published: May 26, 2015 | Sponsored by: Catalent

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

Multimedia | May 7, 2015

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

eBook | Published: May 6, 2015 | Presented By: Polycom

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

eBook | Published: May 4, 2015 | Sponsored by: Catalent

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.

Life Science Innovations Explained

eBook | Published: April 2015 | Author: Biotech Primer

Written for the non-scientists. Learn about the science, products, companies and competitors in the biotech industry. Topics include: gene therapy, immunotherapies, RNAi medicines, antibody conjugates and so much more. One topic per page. Download Biotech Primer's free eBook now.

FierceBiotech Radio with J&J Innovation's Ken Drazan

Multimedia | April 1, 2015

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

eBook | Published: March 30, 2015 | Sponsored by: M-Files

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

eBook | Published: March 30, 2015 | Sponsored by: Catalent

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

Multimedia | March 26, 2015

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

Multimedia | March 24, 2015

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?

Video | March 23, 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.

FierceBiotech Radio with Express Scripts' Steve Miller

Multimedia | March 10, 2015

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

Multimedia | March 3, 2015

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

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

eBook | Published: January 16, 2015 | Sponsored by: Catalent

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?

Video | January 13, 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

eBook | Sponsored by: Catalent | Published: December 16, 2014

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

eBook | Published: October 27, 2014 | Sponsored by: Covance

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

Video | October 21, 2014

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

eBook | Published: September 29, 2014 | Sponsored by: Covance

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

eBook | Published: September 15, 2014 | Sponsored by: Catalent

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

eBook | Published: July 25, 2014 | Presented by: One 2 One

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

eBook | Published: July 18, 2014 | Presented by: Capsugel

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

eBook | Published: July 7, 2014 | Sponsored by: Veeva

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

eBook | Published: May 19, 2014 | Sponsored by: Catalent

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

eBook | Published: May 5, 2014 | Sponsored by: Enclarity, a LexisNexis company

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

eBook | Published: March 17, 2014 | Sponsored by: Catalent

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

eBook | Published: February 18, 2014 | Sponsored by: NextDocs

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

eBook | Sponsored by: MPI Research | Published: November 22, 2013

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

eBook | Sponsored by: Catalent | Published: November 18, 2013

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

eBook | Sponsored by: Certara | Published: November 4, 2013

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

eBook | Sponsored by: EMC Isilon | Published: October 7, 2013

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

eBook | Sponsored by: Blinded Diagnostics | Published: August 26, 2013

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?

eBook | Sponsored by: Merrill Datasite | Published: July 22, 2013

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

eBook | Sponsored by: Akamai | Published: July 15, 2013

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

eBook | Sponsored by: Catalent | Published: April 29, 2013

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

eBook | Sponsored by: Catalent | Published: March 25, 2013

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?

eBook | Sponsored by: BioClinica | Published: March 18, 2013

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

eBook | Sponsored by: Aptalis Pharmaceutical Technologies | Published: March 8, 2013

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

eBook | Sponsored by: Catalent | Published: February 28, 2013

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.

Facing Up to the Biosimilar Challenge: Preclinical and Beyond

eBook | Sponsored by: MPI Research | Published: January 22, 2013

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.

Special Report: China's Rise Drives Investment in Biotech Drugs

eBook | Sponsored by: Catalent | Published: January 22, 2013

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.

Special Report: Rare Disease and Orphan Disease Drug Development

eBook | Sponsored by: Catalent | Published: November 5, 2012

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.

Sterile Manufacturing of Semi- Solids and Liquids

eBook | Sponsored by: DPT Laboratories | Published: October 30, 2012

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.

Moving from Preclinical to Clinical

eBook | Sponsored by: MPI Research | Published: October 15, 2012

In this new eBook from FierceBiotech, learn how the industry has re–emphasized translational medicine to usher molecules from preclinical development to initial human studies. Click here to download this eBook today.

Bioavailability Challenges

eBook | Presented by: Catalent | Published: October 8, 2012

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.

FierceBiotech Special Report: Armed Antibodies Readied for War on Cancer

eBook | Sponsored by: Catalent | Published: September 29, 2012

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

eBook | Sponsored by: IMS Health | Published: August 13, 2012

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.

Waiting for Guidelines, Will FDA Take the Reins of Laboratory-Developed Tests?

eBook | Sponsored by: Myraqa, Inc. | Published: May 21, 2012

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.

Supplying Global Clinical Trials: Keys to Avoiding Costly Delays

eBook | Sponsored by: Catalent | Published: April 16, 2012

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.

Trends in Enterprise Content Management in BioPharma

eBook | Sponsored by: OpenText | Published: March 19, 2012

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

eBook | Sponsored by: Catalent | Published: March 12, 2012

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

eBook | Sponsored by: Merrill Datasite | Published: February 20, 2012

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

eBook | Sponsored by: Quintiles | Published: February 6, 2012

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.

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