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!
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.
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!
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?
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.
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!
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!
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.
The window of market exclusivity continues to narrow dramatically in the global marketplace. Given this demanding environment, your global market access team faces increasing urgency to get the value proposition right at the time of launch. Learn how and why assessment of drug value is changing, and implications for global market access. Download this Whitepaper!
Is your go-to-customer model positioning you for success? Recent Alexander Group research explores important industry trends that can help you plan for 2019. Learn the top commercial investment strategies and how they can lead to 3x the industry average growth rate. Download Now!
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.
There is a remarkable scientific research revolution underway: technology that facilitates highly personalized research workflows is being developed and will soon become mainstream. Far more valuable than simply presenting information, personalized access tools will put the researcher in the driver’s seat, making the best of available content and data by pinpointing to what’s important. Download Now!
Discover, develop and deploy; this is a very methodical approach for any solution design, yet it is rarely followed in the creation of patient support programs. This three-part process, or 3-D, is imperative to launch a suite of services that is right for your product and your patients. Download Now!
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!
“Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Read how CDMOs are responding to this pressure.
Selecting the right sites is the most crucial decision you’ll make in your next clinical trial, and the single most important factor to consider in selecting a site is whether or not it can meet its enrollment goals. So, how do sponsors determine the best-fit sites for their studies? Download the whitepaper to find out.
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!
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!
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.
Learn why unifying clinical applications is an industrywide priority for clinical operations leaders. Read the report.
Ready to modernize your RIM environment? Secure buy-in with these tips. Download Today!
To elevate the customer experience in real-time, Pharma organizations must deploy strategies that cut through the market noise and engage customers with a higher degree of customization. Learn the right tools to implement that enable commercial teams to be more collaborative, scalable, and knowledgeable. Register now!
Where is the medical cost trend headed in 2019? PwC’s Health Research Institute (HRI) annually projects the growth of medical costs in the employer insurance market for the coming year and identifies the leading factors expected to impact the trend. Uncover the factors impacting medical cost trend - from provider megamergers and physician employment trends to health advocacy and the increasing customer centricity of healthcare - and what it means for providers, payers, pharma/life sciences companies and employers. Register now!
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.
Sponsors continually search for opportunities to contain early stage trial costs while addressing increasingly unique study needs and pressure to shorten timelines. Explore how to simplify and streamline Phase I and IIa study execution through clinical technology. Join this webinar and discover how early-stage solutions can give you the competitive edge you need to accelerate your clinical development lifecycle. Register now!
What’s the best strategy to create a holistic syringe-based combination product performance testing program? Start with the fundamentals - ISO and USP considerations. Join West packaging and performance experts as they explain how fit-for-purpose syringe-based combination product packaging involves holistic consideration and testing. Register now!
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.
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!
Discover how evaluating biomarkers in early-phase studies leverages advanced technologies and seamlessly transform millions of data points into actionable insights. This webinar will explore biomarker data trends and challenges, share real-world case studies, and dive into practical technology-based solutions that can be readily implemented. Register now!
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
How is ICH GCP E6 R2 making it easier for patients to receive the right treatment at the right time? This webinar will explore the essential elements of RBM, straight from the drawing board of ICH E6 R2 working group, and RBM's role in addressing complexities in oncology clinical trials with a roadmap to get ahead. Register now!
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!
This webinar will benefit Biotech executives interested in aligning their products for success via early strategy for 505(b)(2) drug development. Register Now
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.
The largest survey of TMF owners reveals drivers and trends in improving inspection readiness and shortening trial time. Read more.
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.
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.
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.
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.