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