Paid Marketplace
[Workshop] Smart Drug Development & Design from Candidate to Phase I
Catalent

It is important to leverage the skills and experience of experts and connect the dots between competencies to optimize the development pathway and enable drug candidates to reach their true potential. This presentation outlines key considerations for transitioning including API and formulation development, pharmacokinetic and preclinical toxicology studies, and regulatory requirements. Find out more here!

eBook
2018 State of Technology in Clinical Research
Forte Research Systems

With this report, discover what over 800 research professionals think about technology's impact on clinical trial operations and learn the necessary steps to see more value from your research systems. Click here to download.

Paid Marketplace
[Infographic] Accelerate Your Early Drug Delivery Journey
Catalent

To successfully develop increasingly complicated molecules faster, it’s often important to supplement innovator’s expertise with broader experience in formulation and specialized drug delivery technologies. Catalent has the specialized capabilities and experience to supplement your expertise. Find out more by downloading this infographic.

Executive Summary
[Executive Summary] From Candidate to Clinic
Catalent

It is critical that drug developers execute several elements related to planning, investment, and understanding of the risks, risk tolerance, and pitfalls inherent in the drug development program. To find out what the development program should include, download the executive summary here.

Webinar
Development Advice for Gene Therapy Products
October 24, 2018 | 1pm ET / 10am PT | Rho

It has been and big year for gene therapy. This webinar will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for development of new gene therapy products from the perspective of regulatory strategy, clinical development, pharmacology/toxicology considerations, and CMC development.

Webinar
Scaling Healthcare IT in the Cloud: HIPAA and Other Considerations
October 25, 2018 | 11am ET / 8am PT | Amazon Web Services

Public cloud services adoption is appealing to healthcare organizations striving to provide truly connected health systems with the ability to scale on demand, lower infrastructure costs, and quickly analyze massive data inputs from a variety of sources. Attend this webinar and learn how to simplify your cloud journey, extend your security policies, and automate processes to help meet key healthcare regulations.

Webinar
Navigating Particle Challenges in Sterile Drugs from Component to Patient
October 30, 2018 | 11am ET / 8am PT | West Pharmaceutical Services, Inc.

Using a holistic approach to selecting and testing primary packaging and delivery systems can help pharmaceutical manufacturers mitigate particulate risk. Join West experts to learn how a holistic approach to drug product packaging, testing and evaluation can help reduce risk and overcome challenges associated with particulate. Register now!

Webinar
The Use of Electronic Informed Consent in a Blood Collection Study
October 31, 2018 | 12pm ET / 9 am PT | Roche and Medidata Solutions

Clinical research and biobanking industries are rapidly adopting eConsent as an alternative to paper. Learn how eConsent can provide patients with clear and easy-to-understand clinical trial information, improve patient compliance, reduce inspection finding, and enable process efficiencies. Register now!

Webinar
The Evolving Role of Clinical Data Management
November 6, 2018 | 1pm ET / 10am PT | Rho

This webinar will examine the effect of technology advancements on the future responsibilities of clinical data managers and discusses the needs introduced by the application of new technologies and broader data source availability.

Webinar
Using NLP at Novo Nordisk to Generate Actionable Insights from Real World Data
Wednesday, November 7 | 11am ET / 8am PT | Linguamatics

Learn how to use advanced tools and technologies, such as natural language processing, to identify macro and micro healthcare market trends in the US, detect patterns in clinical trial protocol deviations, and discern patterns in patient sentiment, compliance, routines, behaviors, and overall treatment satisfaction and outcomes. 

Webinar
QSP Approaches to Determine Best in Class Properties for Targeted Anabolic Growth Factor to Arthritic Joints
November 8, 2018 | 2pm ET / 11am PT | Applied Biomath

This webinar will introduce a QSP model of targeted anabolic growth factors for intra-articular injection for the treatment of diseased joints that was used to systematically map out drug- and target-parameter space to:

  • Identify tradeoffs between target and drug properties
  • Maximize therapeutic window and tissue targeting
  • Identify key missing data

 

Webinar
Five Foundational Steps to a Successful RIM Program
November 14, 2018 | 1pm ET / 10am PT | Veeva

Join us to hear Steve Gens, managing partner at Gens and Associates, provide real-world examples for each step and guidance on how to justify making these changes within your organization. This webinar will outline five actionable steps to help you establish roles and responsibilities, institute key processes, and improve long-term outcomes. Register Now!

Webinar
Modernizing Life Sciences Manufacturing with Machine Learning
November 15, 2018 | 2pm ET / 11am PT | Amazon Web Services

Modernizing manufacturing equipment, processes, and infrastructure with the newest technology has become a focus to improve their efficiency and overall bottom line. Attend this webinar and learn how to utilize connected IoT devices and data analytics to optimize manufacturing processes, novel ways to use machine learning technology in the cloud, and more.

Webinar
Incorporating PROs Into Your Development Program
Friday, November 16 | 12pm ET / 9am PT | Cardinal Health

Join Cardinal Health experts in the second of our three-part webinar series, as we review the qualitative phase of PRO instrument development within the context of an individual drug development program, PRO instrument modification and regulatory requirements associated with development of these measures for specific populations. Register now!

Webinar
Content Analytics for the Medical Device Marketer
November 27, 2018 | 2pm ET / 11am PT | Seismic

Tying content to revenue and proving its ROI can be difficult. Join the webinar to learn why understanding content analytics is so important to medical device marketers, what metrics you should be tracking, and how sales enablement can help tie content to revenue. Register now!

Webinar
Insights for Success with 505(b)(2), the Pathway of Choice
November 28, 2018 | 11am ET / 8am PT | Camargo

This webinar will benefit executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2), the pathway of choice. When executed properly, this regulatory pathway enables a lower cost, lower risk, and faster path to approval and market. Register Now!

Archives

Webinar
Value Creation in the Early Phase
Recorded on October 18, 2018 | Catalent

Watch this webinar to hear from industry experts on reliable approaches that have supported hundreds of small and virtual companies help build value to their lead candidates in early phases of development as well as help accelerate the development process to overcome formulation challenges. RSVP here! 

Whitepaper
Bringing Real World Evidence into Clinical Research
UBC

Life sciences companies are embracing the essential roles that real world data (RWD) and the generation of real world evidence (RWE) play in the development of new treatments for patients.

This whitepaper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies. Download now to learn more.

Webinar
3DP: Manufacturing the Future of Pharma Today
Recorded on October 16, 2018 | Aprecia Pharmaceuticals, LLC

Join this webinar to discover how ZipDose® by Aprecia enables a new world of powerful formulation solutions for NCE product candidates in Phase I or Phase II development and testing. You’ll also review how 3DP can offer formulation advantages such as better molecule protection, adjustable powder layers and flexibility in dose loading for adaptive clinical trials. 

Whitepaper
Modernizing Life Science Manufacturing: How Analytics, IoT and the Cloud are Rewriting Drug Production
Amazon Web Services

Manufacturing is one of the most challenging environments in the pharmaceutical industry. This whitepaper discusses how new data acquisition and analytic technologies can boost manufacturing intelligence and agility, how companies like Merck and Moderna optimize manufacturing operations utilizing the cloud, and more. Download it now!

Paid Marketplace
Drug Development Immersion Nov 1-2
November 1-2, 2018 | Boston, MA | Biotech Primer

Drug Development Immersion is an intensive two-day course focused on the regulatory, commercial and scientific considerations required to bring a drug successfully to market. Learn from an industry expert who has received drug approvals in both the US and Europe. Register today!

Webinar
CTTI’s Comprehensive Guide to Mobile Technologies in Clinical Trials
Recorded on October 11 2018 | Amazon Web Services

This action-oriented webinar will describe in detail the information investigators, sponsors, and service providers need to meet technical requirements, support collaborations, and understand each other’s needs and expectations—providing a pathway forward to make the use of mobile technologies in clinical trials a reality. Register now!

Research
Industry Research: Unifying Clinical Applications is an Industry-wide Priority
Veeva

Results from one of the industry's largest, global clinical operations surveys shares how pharmas and CROs are evolving clinical trial processes.  Download the report.

Webinar
Tufts Research: Strategies from Data Management Leaders to Speed Clinical Trials
Recorded on October 4, 2018 | Veeva

Learn how top pharmas and CROs plan to speed database build and data collection, as well as their top challenges and future priorities. This in-depth research from Tufts follows their industry-wide eClinical Landscape Study, examining the major cause of database build delays and their impact on trial cycle times. Register Now

Webinar
Critical Insights for Oncology Drug Development in Japan and Asia
Recorded on October 2, 2018 | CMIC

Considering oncology drug development and clinical trial for Asia market? Join the experts from CMIC Group, the largest CRO in Japan, to learn the insights on how to start your early oncology drug development and ensure clinical trial success. Register now!

Research
Linguistic and Cultural Considerations When Implementing a Global BYOD Study
RWS Life Sciences

Examine the linguistic and cultural considerations of global eCOA and BYOD. Download now!

Whitepaper
Unlocking New Business Value in Life Sciences with Digital Technology
SAP

Collaborate in a digital world to improve patient outcomes. With SAP, you can leverage cutting-edge technology to improve focus on the patient and caregiver – while enhancing global health in new and innovative ways. Download our Whitepaper Here!

Whitepaper
Is Your In-House Strategy Ready For The Uncertainties Of Biologic Drug Development?
Patheon, part of Thermo Fisher Scientific

Read this whitepaper to learn more about two main areas where a drug developer can face significant obstacles during biologics development. By evaluating these capabilities, a drug developer can answer the critical question of whether its in-house strategy is ready for the uncertainties of drug development.

Paid Marketplace
Online Graduate Programs Designed for Your Career
Drexel University Online

Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more.

Webinar
Conquering Compliance: Insights for Commercial Teams in the Medical Device Industry
Recorded on September 27, 2018 | Seismic

What can sales and marketing teams do to address the issue of compliance? Learn why compliance is so important to sales and marketing teams in the medical device industry, how digital transformation and sales enablement can help sales and marketing teams, and more. Register now!

Webinar
Ex Vivo/In Vivo Platforms for Translational Oncology Research
September 26, 2018 | 11am ET / 8am PT | Champions Oncology

Champions Oncology PDX models are the most highly-characterized, clinically-relevant cohorts of PDX models to optimally predict success and accelerate the drug development process. This webinar will provide an overview of the various unique and advanced translational tools that are offered by Champions oncology in an in vivo and ex vivo setting. 

Paid Marketplace
POCKET GUIDE - 3 Steps To Supercharge Your Literature Search
Reprints Desk, Inc.

As a scientist or researcher, you need fast, cost-effective access to scientific content. This guide covers useful tips and tools to accelerate your literature search, simplify access to papers, and minimize acquisition costs—putting you on the fast track to scientific discovery. Download Now.

Webinar
1 Year Later – Why did Thermo Fisher Scientific acquire Patheon?
Recorded on September 17, 2018 | Patheon

One year ago, Thermo Fisher Scientific completed the acquisition of Patheon, creating the world’s most comprehensive and sophisticated end-to-end CDMO partner. But what does that mean to the industry today? 

eBook
[eBook] Healthcare and Life Sciences - Data Value Chain
Amazon Web Services

Download our new eBook to learn how Healthcare and Life Sciences organizations are taking advantage of solutions from AWS and the AWS Partner Network to obtain value from critical data at every stage of the data value chain.

Webinar
Navigating Patient Reported Outcomes: Foundational Elements and Recent Trends
Recorded on September 13, 2018 | Cardinal Health

Navigating patient-reported outcomes (PROs) such as unobservable symptoms, treatment satisfaction, quality of life, and treatment adherence is a critical component of a patient centric healthcare system. Join our experts in the first of a three-part webinar series on PROs, as they provide insight on the foundational elements of PROs and recent regulatory trends. Register now!

Webinar
A Lipid Nanoparticle Quantitative Systems Pharmacology Case Study
Recorded on September 12, 2018 | Applied Biomath

This webinar will present a quantitative systems pharmacology case study which assesses a Lipid Nanoparticle to treat Crigler-Najjar Syndrome Type 1. Learn how the model was used to support translation from preclinical to clinical trials as well as first-in-human dosing.

eBook
2018 Weekly Compendium
Biotech Primer

The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry.

This eBook is a collection of Biotech Primer WEEKLYs from the past 12 months. The Biotech Primer WEEKLY is a one-page, easy-to-ready newsletter delivered each Thursday right to your inbox. If you are not already registered to receive the Biotech Primer WEEKLY register today here.

Download here: 2018 Biotech Primer WEEKLY Compendium

Whitepaper
Real-World Evidence in the Cloud: How Technology is Revealing the Big Picture in Pharma
Amazon Web Services

Life science companies are responding with Real World Evidence (RWE) programs to capture data from clinical through post-market activities from a variety of sources. Learn how the centralization of data assets enables organizational intelligence by equipping companies to understand the needs of patients and other stakeholders, and how their products can meet them.  Download this Whitepaper!

Webinar
Understanding New Drug Applications (NDAs)
Recorded on August 14, 2018 | Rho

This webinar will help you understand what is involved in an NDA including regulatory strategy, data integration and readiness, and electronic publishing, and provide tips that can help you avoid common pitfalls in the submissions process.

Executive Summary
Executive Summary: Investigator Site Payments Strategy Survey
Bioclinica

As the number of clinical trials increases so does the complexity and number of US and global sites needed to foster trial success. Read what was discovered after a survey on current site payment practices, how these practices are measured, what process improvement initiatives are currently being explored, what are some of the barriers to change, and what site payment trends will occur over the next five years. Download it now!

Paid Marketplace
BIOAVAILABILITY 101
Catalent

Develop a basic understanding of principles and concepts of bioavailability of oral drugs. This course, designed for scientists involved in pharmaceutical drug development, will simplify the concepts of bioavailability and how to manage biopharmaceutical challenges, and identify why it is an important factor in optimal therapies for patients. Enroll Now!

Survey
The State of Sales Enablement in the Healthcare Industry
FierceMarkets

Take this quick 10 minute survey on on the state of sales enablement in the healthcare industry. A $5 Amazon Gift Card will be sent to the first 50 qualified respondents. Complete the survey now!

Webinar
New Findings from the Veeva 2018 Unified Clinical Operations Survey
July 25, 2018 | 12pm ET / 9am PT | Veeva

Hear new results from one of the industry's largest, global clinical operations surveys, the Veeva 2018 Unified Clinical Operations Survey. The Veeva 2018 Unified Clinical Operations Survey examines the industry’s progress toward a unified clinical operating environment.

Survey
Industry Report: Findings from the 2018 Unified Clinical Operations Survey
Veeva

Learn why unifying clinical applications is an industrywide priority for clinical operations leaders. Read the report.

Webinar
The Changing Landscape of Real-World Evidence and its Impact on Clinical Research
Thursday, June 21, 2018 | 11am ET / 8am PT | TriNetX

Researchers are encumbered with a plethora of disparate data and analytic tools. These assets pose several challenges which need to be overcome to ensure they satisfy their intended purpose. 

Join this webinar to learn how real-time, self-service access to longitudinal patient data is changing the way researchers evaluate treatment effectiveness, safety, protocol design, and more. Register now.

Webinar
Handling Suspected Fraud and Data Fabrication in Clinical Studies
June 13, 2018 | 1pm ET / 10am PT | Rho

Fraud and fabrication is no laughing matter in the realm of clinical trials.

This webinar will outline the ways in which sponsors and CROs can remain diligent by being aware of signs of possible fraud and fabricated data throughout the course of the study.

Whitepaper
Implementing a Proactive Approach to Risk Management
Covance

A solid RBM plan will not only help you comply with the ICH guidelines, but will help you mitigate risks which could ultimately delay your trials and increase costs. Download today!

Show Preview
Your oncology trial is complex. Get specialized expertise, end to end.
Precision for Medicine, Oncology and Rare Disease

The first precision medicine CRO designed specifically for oncology and rare disease, Precision unifies translational science expertise and unparalleled clinical operations to create a more efficient process, deeper data, and an accelerated development pathway for novel treatments.

 

With 1200+ experts worldwide, one core team delivers

 

  • Clinical development planning
  • Expedited study start up enabled by Precision’s Oncology Site Network
  • Personalized clinical trial execution services
  • Specialty labs services and coordination
  • Robust biometrics teams and services

 

Schedule a meeting with our experts at ASCO, Booth 24146, and visit our website

Webinar
Best Practices to Meet Financial Objectives When Selecting an Investigator Payments Partner
Recorded on May 16, 2018 | Bioclinica

What criteria is of most value when determining the value of in-house vs. outsourced site payments strategies? Attend this webinar and discover what best practices sponsors and CROs should follow when evaluating a current or future investigator payments partner. Register now!

Webinar
505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success
May 9, 2018 | 11am ET / 8am PT | Camargo

This webinar will benefit Biotech executives interested in aligning their products for success via early strategy for 505(b)(2) drug development. Register Now

Paid Marketplace
AACR Annual Meeting 2018
Charles River

When it comes to choosing a partner, who do you want on your team? How about a provider with 52 patents, 17 candidates and work on 80% of the oncology therapies approved in 2017? Our next success can be yours. Choose Charles River to guide your therapy through the complex path to clinic with proven expertise and the industry’s most comprehensive portfolio. Learn More.

Multimedia
Back from the dead: FierceBiotech Radio at the Battle of the Biotech Bands
FierceBiotech Radio

Here’s a special “risen-from-the-grave” episode covering this year’s Battle of the Biotech Bands, an (almost) annual Boston tradition which sees bands from the biotech industry compete to win prize money for charity.  Download the episode on iTunes or Stitcher, or listen here

Whitepaper
Considering an eTMF Solution? Industry Research Reveals the Top Benefits
Veeva

The largest survey of TMF owners reveals drivers and trends in improving inspection readiness and shortening trial time. Read more.

Multimedia
FierceBiotech Radio on GSK's CEO shakeup, Lilly's Alzheimer's uncertainty, and Valeant's latest disaster
FierceBiotech Radio

FiercePharma's Eric Palmer and FierceBiotech's Damian Garde discuss the pending retirement of GlaxoSmithKline CEO Andrew Witty, Eli Lilly's bold decision with a big Alzheimer's trial and Valeant Pharmaceuticals' rough week.

Download the episode on iTunes or Stitcher, or listen here.

Multimedia
FierceBiotech Radio on the FDA's new boss, Sanofi's latest shortcut, and a little 'financial innovation'
FierceBiotech Radio

FiercePharma's Eric Palmer and FierceBiotech's Damian Garde discuss the confirmation of Robert Califf as the next FDA commissioner, Sanofi's efforts to undercut Novo Nordisk in diabetes, and a novel approach to regulating drug costs. Download the episode on iTunes or Stitcher, or listen here--and be sure to subscribe

Multimedia
Pharma's TV blitz, biotech's IPO trickle, and the M&A future of Intercept Pharmaceuticals
Catalent

FiercePharma's Eric Palmer and FierceBiotech's Damian Garde discuss the rise of TV ads for specialty drugs, signs of life in the biotech IPO scene, and the case for Intercept Pharmaceuticals as a buyout target.  Download the episode on iTunes or Stitcher, or listen here--and be sure to subscribe.

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

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.

Download the episode on iTunes or Stitcher, or listen here--and be sure to subscribe. Let us know what you think by dropping a line to [email protected]

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

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.

Download the episode on iTunes or Stitcher, or listen here--and be sure to subscribe. Let us know what you think by dropping a line to [email protected]

Multimedia
Shire's byzantine Baxalta pursuit, biotech's pragmatic winter and Valeant's CEO shakeup
FierceBiotech Radio

Fierce editors discuss Shire's increasingly complicated ambition to acquire Baxalta, the changing climate of biotech venture capital and the future of Valeant Pharmaceuticals.  Click here to listen now.