Archives

Webinar
Unlock Industry Perspectives on the Advantages and Challenges of Developing Advanced Dosage Forms
Recorded on October 22, 2019 | Catalent

Register for this webinar to learn about the tools and technologies for creating dosage forms such as orally disintegrating tablets (ODTs), multi-particulates, and modified release formulations.

Webinar
Exploring What Physicians Know and Don’t Know About Nucleic Acid-Based Medicines
Recorded on October 16, 2019 | InCrowd
Webinar
CIOs’ Perspectives: Driving Clinical Trial Innovation with a Unified Platform
Recorded on October 15, 2019 | Medidata

In this webinar, you will hear from Alan Louie, Ph.D, Research Director at IDC, Bill Swavely, CIO at Pharm-Olam, and Rama Kondru, Ph.D, CIO at Medidata about the need for a platform approach in clinical research, the rationale for switching from disparate systems to a unified platform, and the benefits that could be realized. Register now.

Webinar
The Promise of Real-World Data: Using Technology to Enable the Standardization, Transparency, & Replicability of RWD Research
Recorded on October 10, 2019 | SHYFT Analytics

This webinar will address how the use of technology for deploying data and analytic standards can be utilized to meet the challenge of understanding and comparing findings between studies conducted by different researchers, by facilitating the standardization, transparency, reproducibility, and replicability of RWD research. Register now.

Webinar
The Value of Real World Data in Orphan and 505(b)(2) Drug Development
Recorded on October 9, 2019 | Camargo

In this webinar, we'll share insights to harness the strategic value of real world data to build optimized drug development programs that minimize the time and cost of sponsor-driven studies. Register now!

 

Webinar
Biosimilars and Drug Pricing
Recorded on October 3, 2019 | Elsevier

Join us for this webinar as we bring together a panel of industry experts to discuss the changing landscape of biosimilar development and how it will affect pricing in the future.

Webinar
Synthetic Controls: Best Practices and Regulatory Perspectives
Recorded on October 2, 2019 | Medidata

With increasing competition for patients, the ability to effectively and efficiently execute on clinical development plans has increased focus on alternative data sources. In this one-hour session attendees will hear from former FDA leaders and industry experts who will address what Synthetic Control is and how it can be leveraged in clinical development.

Webinar
Process Characterization: Ready For the FDA?
Recorded on October 1, 2019 | Thermo Fisher

Eight years after the FDA issued its guidance of process validation, some still ask the question “Is process characterization optional anymore?” This webinar will cover the basics of process characterization, whether it is optional or not, and what “good” process characterization really looks like. Register now!

Webinar
Effective Combination Products Risk Management Programs: Special Considerations for Control and Analytical Testing Strategies
Recorded on September 26, 2019 | West Pharma

Developing a combination product? Join experts Susan Neadle, Sr. Director, Global Value Chain Quality Design, Johnson & Johnson and Jennifer Riter, Sr. Director, Lab Services, West to learn how you can create an effective risk management program. Register Now!

Webinar
Building the Digital Biotech Company
Recorded on September 25, 2019 | AWS and Moderna

Hear from Moderna’s Chief Digital and Operational Excellence Officer how they have eliminated data siloes to accelerate data-driven decisions at an enterprise level, and established a production environment capable of consistent delivery of complex drug products including a “batch of one”. Register Now!

Webinar
De-Risking the Solid Form Landscape of an API
Recorded on September 19, 2019 | Cambrex

This presentation will discuss how predictable stability and solubility can minimize development timelines and cost. Attend to hear about two case studies exemplifying the importance of understanding the hydration space of an API and how hydrate formation may be avoided by development of a robust crystallization procedure.

Webinar
Overcoming Challenges of Bioanalytical Method Development for Oligonucleotides and Large Molecules
Recorded on September 18, 2019 | CMIC

Please join the experts from CMIC Group, Japan’s largest CRO with over 30 years of analytical service experiences in US and Japan, to learn the insights and tips on developing an immunogenicity assay in a regulated laboratory, selecting a format for the neutralization assay for immunogenicity assessments, and quantitative Bioanalysis of Oligonucleotides by LC-MS. Register Now!

Webinar
Flexible Manufacturing Strategies: What’s Best for Your Product?
Recorded on September 17, 2019 | Catalent

In this webinar, manufacturing experts will discuss the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. Register now!

Webinar
Challenges with Fast Enrolling Post-Operative Acute Pain Studies
Recorded on September 11, 2019 | Rho

Enrollment can be very fast for post-operative acute pain studies which brings with it unique challenges in study execution. This webinar will address the differences between bunionectomy and abdominoplasty models, the importance of rater and site training, and considerations for data collection and analysis.

Webinar
Achieve Better Patient Outcomes with Clinically Supported, Tech-Enabled Adherence Programs
Recorded on August 29, 2019 | Lash Group

Join Lash Group’s Vice President of Market Development and Strategy, Michael Craig, and Product Director of Adherence Services, Dale Hanna, as they discuss the critical nature of clinical expertise in tech-enabled patient support solutions and the importance of training teams in empathy. Register now.

Webinar
A Paradigm Shift to Realize Intelligent Clinical Trial Oversight
Recorded on August 8, 2019 | Medidata

Nick Dyer ( CEO, Catalyst Clinical Research ) and Stacey Yount ( VP of Product, Trial Management Solutions, Medidata ) will discuss the industry challenges and share how Medidata’s Rave CTMS breaks down operational silos by providing a centralised solution to manage issues, deviations and associated actions. Register now.

Webinar
Three Ways to Save Time and Execute a Successful RIM Implementation
Recorded on July 30, 2019 | Veeva

Join this webinar to hear from two of Veeva’s subject matter experts, Lalana Dararutana and Serena Peirson, on ways to achieve a successful RIM implementation. Register Now!

Webinar
End-to-End Analytical Technology for Process and Quality Improvements in Biologic Drug Production
Recorded on July 25, 2019 | Thermo Fisher Scientific

Join this webinar to learn how Raman, NIR, and mass spectrometry provide raw material ID and bioprocess monitoring for:

  • cell culture and fermentation monitoring
  • moisture analysis of lyophilized materials
  • near real-time discrimination of bulk protein product

Register Now!

Webinar
Accelerate Your Life Sciences Business Through a Modernized and Compliant Process
July 24, 2019 | 2pm ET / 11am PT | DocuSign

Join this webinar to learn how industry leaders are using DocuSign to modernize their systems of agreement while implementing GxP validation processes. Hear best practices about how to simplify and scale your business processes while also reducing your regulatory risk.

Webinar
Accelerating Site and Patient Enrollment for Phase 1 Trials
Recorded on July 23, 2019 | Medrio

This Fierce webinar will feature clinical trial site leaders and R&D executives, who will pass along the latest strategies for boosting site and patient enrollment in phase 1 trials. They will discuss best practices for communicating with both investigators and patients. Register now to learn more.

Webinar
The 505(b)(2) Pathway: Getting to the Clinic Faster
Recorded on July 16, 2019 | Camargo

You’ve identified your product as a candidate for approval via the 505(b)(2) pathway and completed a successful pre-IND meeting. What comes next? Register now to find out!

Webinar
The Missing Link in Marketing: HCP Impact
June 26, 2019 | 2pm ET / 11am PT | 81qd

Understanding the existing relationships among health care professionals not only optimizes your ability to connect with them, but it also maximizes the impact of marketing communications in achieving the desired clinical behavior change that will improve patient care.

Join our webinar to learn more about how you can do more with less through “HCP Impact” strategies. 

Webinar
Innovative and Flexible Solutions for an End-to-End Patient-Centric, Lean Supply Chain
Recorded on June 20, 2019 | Catalent

Register for this webinar to get insights from industry experts on:

  • Demand led manufacturing and supply
  • Forecasting and inventory management
  • Innovations and considerations in labeling
  • Direct-to-patient distribution
Webinar
Tools to Meet the Challenge of Complex Protein Expression
June 19, 2019 | 10am ET / 7am PT / 3pm GMT | Lonza

Join us to learn how recent enhancements to protein expression platforms can significantly increase expression levels for complex proteins. New technologies for simplifying and increasing expression levels of multi-chain and complex proteins will be presented. Register Now!

Webinar
Unified Platform Defined
June 18, 2019 | 12pm ET / 9am PT | Medidata

Join this webinar to learn the five characteristics of a unified platform and how each benefits clinical research both for a single trial and across your suite of research efforts. Register Now!

Webinar
The Importance of Early Patient Involvement in Clinical Trial Design
Recorded on June 13, 2019 | Rho

Patient-centricity gets a lot of buzz, but what are the benefits of involving patients in the planning of a clinical trial? This webinar looks at where in the process to get patient input, the benefits, and what tactics to use to get input. Register now.

Webinar
The Emergence of Simulated Data for Life Sciences
Recorded on June 12, 2019 | Cardinal Health

A new, promising data source that could help explore and unlock new discoveries lies in the use of simulated data that can be used in place of real patient information. Join our experts as they provide insight on this newly emerging data source. Register Now!

Webinar
Applying Technology to New Science: Biopharma’s New Growth Engine
Recorded on June 11, 2019 | Salesforce and Accenture

Join senior leaders from Accenture and Salesforce to find out how future-focused Biopharma companies are delivering growth amid compressive disruption and leveraging that investment in digital technologies by embracing New Science to drive value for the healthcare ecosystem, including, and most importantly, to raise the standard of care for their patients. Register Now!

Webinar
Global Site Payments; How Clear is Your Financial View?
Recorded on June 6, 2019 | Medidata

Join this webinar and learn strategies designed to help improve financial health, fuel innovation and increase compliance by combining automated clinical finance solutions and industry best practices. Register Now!

Webinar
The 505(b)(2) Pathway: What is it? And What Does it Mean for Pre-IND and NDA Submission?
Recorded on May 29, 2019 | Camargo

To bring a new drug to market, it can take more than a decade and cost upwards of $1 billion. What if there were a way to address global patient needs faster, less expensively, and with better outcomes? Register Now!

Webinar
Why are Lipid Formulations Commonly Used to Enhance Bioavailability?
Recorded on May 23, 2019 | Patheon

During this webinar, Thermo Fisher Scientific's Kaspar van den Dries and Helena Teles will discuss potential mechanisms of increased absorption with lipid formulations and appropriate screening tools that are used during the development approach of these formulations. Register Now!

Webinar
How and Why Celgene Adopted Medidata Rave eCOA
Recorded on May 16, 2019 | Medidata

If your company is looking to adopt a new eCOA solution or have issues with your current one, this webinar is a must attend. Companies of all sizes will be able to learn from how Celgene made the case internally for change by redefining their implementation strategy for collection of clinical outcome assessment data (eCOA). Register now!

Webinar
Transforming Real-World Data into Real-World Evidence: Best Practices & Lessons Learned
Recorded on May 9, 2019 | SHYFT Analytics

This webinar will address challenges encountered when leveraging Real-World Evidence such as finding the “right” data set, identifying high priority use cases to show quick wins, and creating integrated evidence plans across a product’s lifecycle. Register Now!

Webinar
Pediatric Dosage Form Development – Challenges and Opportunities
Recorded on May 8, 2019 | Cambrex

The number of pediatric drug approvals has increased 5 fold over the last 20 years, rising from 10-20 approvals per year to 50-60 annually today. Increased awareness around pediatric medicine and FDA support for pediatric clinical research are just some of the factors contributing to this growing market. Register Now!

Webinar
Development Advice for CBD Products
Recorded on April 24, 2019 | Rho

This webinar will discuss development considerations for CBD and other cannabis-derived products from a clinical, preclinical (pharmacology/toxicology), CMC, and regulatory perspective. Register now.

Webinar
New Drug Pricing Strategies for a Changing Global Market
Recorded on April 24, 2019 | PwC

During this webinar, PwC’s Health Research Institute will review findings from a new global survey of industry executives, and provide analysis and commentary on key drug pricing issues. Register Now!

Webinar
Optimizing Oncology Trials with a ctDNA Test Custom-Built for MRD and Molecular Monitoring
Recorded on April 9, 2019 | Natera

Join this webinar to discover the advantages of using Signatera™ (RUO), a novel assay custom-designed for each patient that detects circulating tumor DNA (ctDNA) with high sensitivity and specificity to monitor molecular residual disease, early recurrence, and treatment response across solid tumors. Register Now!

Webinar
Innovative OTC Remedies for Seasonal Flu Epidemic
Recorded on March 28, 2019 | Catalent

In this webinar, we will review the current OTC remedies for cough, cold and allergy categories and discuss strategies to grow your share on shelf space with innovative dosage forms. 

Webinar
Embracing Emerging Technology in Drug Development
Recorded on March 27, 2019 | Accenture

Technology is impacting every aspect of our lives, and the life sciences industry is no different—it is changing the way companies operate. The need to embrace change is an imperative for these companies to stay competitive and continue to deliver on patient needs. Register Now!

Webinar
3 Lessons Learned: Agile Approach to Data Management
Recorded on March 26, 2019 | Medidata

To achieve adaptable and scalable trial execution, a mindset change and more flexible approach to data management is necessary. Join this webinar to hear industry experts discuss three key lessons learned when applying Agile Development Methodology principles into your work in data management.

Webinar
Is Your Scientific Research Platform Helping you Make the Right Decisions?
Recorded on March 21, 2019 | PerkinElmer

Join Dr. David Gosalvez to see how R&D productivity can be improved in three critical areas: Lead Discovery, Screening and data capture. Register Now!

Webinar
Serialization 2.0 – Moving Beyond Compliance
Recorded on March 19, 2019 | Systech

Serialization is a great achievement for our industry. However, most executives now realize that it is only part of the solution and serialization alone cannot solve the escalating problems of counterfeiting and diversion within the Pharmaceutical industry. 

In this webinar we will discuss going beyond serialization and understanding why it’s not enough and the need to stay innovative and add value and protection to your current solutions. Register now.

Webinar
Right-to-Try or Right-to-Ask? Understanding Right-to-Try and FDA’s Expanded Access
Recorded on December 11, 2018 | Rho

This webinar will explore both Right-to-Try legislation and existing Expanded Access Programs, including:

  • Understanding sponsor responsibilities under these programs and when products may be eligible for these program
  • Evaluating options such as treatment protocols, treatment INDs, and emergency use
  • Discussing development risks associated with participation in these programs
Webinar
Insights for Success with 505(b)(2), the Pathway of Choice
Recorded on November 28, 2018 | 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!

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.

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. Register Now

Webinar
Navigating the Path to Compliance: Two Pharmas Discuss Their Challenges and Successes
Recorded on July 12, 2018 | Systech

Join Joe Lipari, Director - Global Traceability from Systech, as we map out a proven route to serialization success along with Steve Kane, Head of Product Integrity Program Global IT for Shire and Ann Schaefer, Director - Supply Chain Management at Acorda Therapeutics. The panel will discuss complexity of the regulations, hurdles they overcame, and solutions that carried them over the finish line. Register Now.

Webinar
The Changing Landscape of Real-World Evidence and its Impact on Clinical Research
Recorded on Thursday, June 21, 2018 | 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. 

Watch 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
Overcoming Manufacturing Challenges for Accelerated Approvals
Recorded on May 2, 2019 | Catalent

In this webinar you will hear from industry experts on:

  • How to manage stability challenges for accelerated approval programs
  • Fit-for-purpose manufacturing strategies
  • Overcoming scale-up challenges
  • Developing a comprehensive solution for unexpected challenges
  • Avoiding typical pitfalls in accelerated programs