Recognizing the achievements of women in STEM is a priority for the team at Xtalks, and today on International Women’s Day, we are celebrating the incredible women who have presented in our webinars over the past year. From March 2018 to March 2019, Xtalks has been proud to host 40 webinars led by entirely all-female speakers, with 20 of them featuring two or more women who are experts in their field.
In reflecting on these events featuring female speakers from the life science, pharmaceutical, and medical device industries, here are ten women-led, educational webinars that can keep you informed this International Women’s Day and beyond. Follow the links to watch these free, on-demand webinars now.
1. Different Approaches for Preparing a Marketing Application: A Review of Successful NDA/MAA Preparation Strategies
Speakers:
Amanda Truesdale, MA, MBA, Vice President of Biometrics, Veristat
Kimberly Newton, MA, Senior Director of Medical Writing, Veristat
Martha Plaza, MBA, Project Director of Submissions, Veristat
Topic:
Preparing your marketing application for one or more regulatory agencies is a very exciting time and a milestone in the drug development process. However, it can be a very complicated and time-sensitive endeavor which is fraught with the coordination of many sequential and parallel activities and typically an immovable submission date/deadline. The most effective way to plan your submission timeline is to work backwards from your target submission date.
2. Case Study: Solving Unique Challenges in Oncology Trials Using Advanced IRT Functionality
Speakers:
Lisa Li, Director of Services, Suvoda
Heather Nonnemacher, Project Manager, Suvoda
Racquel Mangaser, Lead Analyst, IVRS Central Management, Celgene
Topic:
Oncology trials have unique requirements that can present challenges for interactive response technology (IRT) systems. An advanced IRT system that has the flexibility to handle unique aspects of oncology studies can simplify the complexity of managing such studies and dramatically reduce the burden on the sponsor. To implement a flexible IRT system successfully, it’s important to look at new ways to approach system functionality that can account for the “known” unknowns that make oncology trials especially difficult to design and maintain.
3. Expediting Dry Powder Inhaler Formulation Development Through Modelling and Advanced Characterization
Speakers:
Beatriz Fernandes, PhD, Scientist DPD, Hovione
Eunice Costa, Group Leader Inhalation, R&D Drug Product Development, Hovione
Topic:
Dry powder inhalers are gaining increasing momentum for drug delivery to the lungs. One of the most used and flexible delivery technologies are capsule-based dry powder inhalers. The successful development of a dry powder inhaler formulation is strongly influenced by the choice of excipient and the ratios between the excipient and active pharmaceutical ingredient (API). The rheological behavior of the powder mixture and its microstructure have a significant impact on several aspects of the final product, such as content uniformity and stability of the formulation, overall aerodynamic performance, deposition patterns and also on the robustness and effectiveness of the capsule filling process.
4. HEOR & RWE: Global Sourcing Strategies and Best Practices
Speakers:
Julie Carter, Category Director, RWE & HEOR, Scientist.com
Patti Peeples, RPh, PhD, CEO and Founder, HealthEconomics.com, and Principal Researcher, HE Institute
Mary Beth Ritchey, PhD, Director, Epidemiology, Medical Devices, RTI Health Solutions
Topic:
As incorporating Real World Evidence (RWE) in Health Economics and Outcomes Research (HEOR) strategy is gaining attention within the life sciences, and pharma in particular, global research organizations need to learn how to navigate the complexities of gathering and analyzing this data to demonstrate product value. It is becoming apparent to many organizations that one of the best solutions is to leverage experienced service providers, who are often also knowledgeable about the Health Technology Assessment (HTA) and regulatory requirements across various regions. These challenges make outsourcing expert service providers inevitable and a key to driving the value story of products. However, outsourcing can lead to long contracting times and difficulties in locating the right supplier, especially as the demand for RWE as part of an HEOR strategy increases. All of this leads one to ask: how does outsourcing support RWE for generating value evidence when the practice of outsourcing itself presents its own challenges?
5. Next Generation Data Management Strategies for Clinical Trials
Speakers:
Lilia Fenelon, Associate Director, Clinical Data Management at Karyopharm Therapeutics Inc.
Diane Lacroix, Director, Data Management, eClinical Solutions
Topic:
This webinar will highlight how pharmaceutical companies like Karyopharm are employing new methods, business models and technologies for more effective data management outcomes in oncology. The discussion will include perspectives from the sponsor and provider highlighting experience-based best practices from eight trials, including defining a data strategy for improving the end to end clinical data acquisition and cleaning processes and leveraging the benefits of the elluminate® clinical data hub for integrated data analysis and review.
6. Fit-for-Future Pharmacovigilance Sourcing Strategies
Speakers:
Humaira Qureshi, SVP of Pharmacovigilance, Bioclinica
Topic:
The challenges and demands of pharmacovigilance in today’s climate has shifted significantly. How do we determine what should and can be sourced differently compared to our traditional models? Offshore-outsourced blended models are becoming increasingly popular. Join this webinar for a discussion of the challenges and benefits of the different sourcing models to manage pharmacovigilance in a compliant and efficient manner.
7. Strategic Implementation of a Rapid Molecular Blood Culture Panel for Gram-Negative Bacteremia
Speakers:
Dr. Maggie Box, Infectious Diseases Clinical Pharmacy Specialist, Scripps Memorial Hospital
Dr. Kimberly Claeys, Assistant Professor, Department of Pharmacy Practice and Science, University of Maryland School of Pharmacy
Topic:
Gram-negative bacteremia is an increasingly difficult condition to treat due to the emergence of multidrug-resistant Gram-negative organisms. Rapid diagnostics have been developed to help identify these organisms quickly along with other Gram-negative infections, enabling more timely treatment decisions. This webinar will explore a molecular option for this testing, how the rapid detection of Gram-negative organisms along with genotypic resistance can help guide therapy decisions, and strategies to promote successful implementation within your institution.
8. Using Virtual Skin and Tissue Modeling to Accelerate Development of Novel Therapies and Devices
Speaker:
Sara Dutta, Ph.D., Business Consultant – Life Sciences Industry, Dassault Systèmes
Topic:
Modeling and simulation technologies have advanced to the point where they can accurately simulate skin and tissue response to both devices and fluids to accelerate innovation for biopharma and medical device products. This means saving money and resources by discovering and developing therapies and devices in silico before stepping foot inside the lab.
9. Planning for Quality in Your Medical Device Clinical Trials
Speakers:
Vicki Gashwiler, Executive Director, Strategic Development, Medical Device & Diagnostics, Premier Research
Kirsten Welz, Project Leader, Medical Device & Diagnostics, Premier Research
Topic:
For more than a decade, this concept of risk-based monitoring (RBM) has been discussed, implemented and refined in the pharma and medical device worlds. Most large sponsor companies in the medical device industry have adopted RBM in their clinical trials. Meanwhile, smaller medical device companies, seem to be slower to embrace the concept. Despite years of conversation and availability of regulatory guidance from the Food and Drug Administration (FDA), European Medicines Agency (EMA), and ICH-GCP E6R2, these smaller organizations continue to be hesitant about adopting this tried-and-tested monitoring method.
10. Implementing ICH E6(R2): Getting the Balance Right
Speakers:
Karen McCarthy Schau, Director Consulting Services, Health & Life Sciences, CGI
Julie Peacock, Client Services, Comprehend
Topic:
You have created a project to address R2 guidance, identified partners, and started sharing data. Now what? Are you dealing with information overload? If so, you are not alone. In light of the ICH E6(R2) guidelines, sponsors and CROs are assessing how well they work together. This webinar will include real-world stories that explain where to draw the line on roles and responsibilities, reveal relevant metrics and the data that drives them, and show how your R2 process can run more efficiently.
While the STEM industry still has some way to go in reaching full gender parity, significant progress has already been made, as demonstrated by the number of women-led webinars on Xtalks. This blog celebrates these courageous and hard-working women on International Women’s Day, as we prepare for our next phase of women-led talks. Of the 37 upcoming events, 11 will feature female speakers. Register for these upcoming webinars to stay on top of the latest the life science industry.
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