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Planning Ahead: Using Phase 2 to Anticipate Phase 3 Clinical Supply Challenges & Solutions
October 1st 2020*** Live: Monday, Oct. 26, 2020, 11am EDT| 8am PDT| 3pm GMT| 4pm CET *** What are typical challenges sponsors encounter during Phase 3 clinical trials? How can advance preparation during Phase 2 help mitigate risks? Learn effective strategies to avoid surprises and problems in late-stage trials from experience clinical trial and supply experts. ***On demand available after final airing until Oct. 26, 2021***
Understanding Polymorphism to De-Risk Drug Development
September 29th 2020*** Live: Thursday, Oct. 15, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST *** Polymorph screening of small-molecule drug candidates enables rational selection of the proper solid form/polymorph for further development. Learn the elements and techniques of polymorph screening is and why performing it thoroughly will help de-risk drug development effort. ***On demand available after final airing until Oct. 15, 2021***
Layer by Layer: The Fundamentals of Multi-Layer Tableting
September 27th 2020***Live: Tuesday, Oct. 27, 2020 *** Multi-layer tableting offers an inexpensive and straightforward solution for a variety of challenging formulations. Learn how multi-layer formulations compare to traditional methods, gain insight to the multi-layer tableting process, and crucial tips to formulating and manufacturing robust multi-layer tablets. ***On demand available after final airing until Oct. 27, 2021***
Solid form screening and its role in drug development
September 10th 2020In this webcast, Michael Grass PhD (Head of Solid Form Services, Global R&D) will present how solid form screening is performed and the importance of this work to drug substance and drug product development. Live: Thursday, Sep. 10, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Sep 10, 2021 Register free
Extractables and Leachables of Biopharmaceutical Container Closure Systems
September 3rd 2020Learn how to navigate the regulatory requirements for extractables and leachables testing for new biologic drug products. Review the essential steps to for study design, extraction, analysis, and reporting of extractables and leachables data in this webcast. Live: Thursday, Sept. 24, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until Sept. 24, 2021
Improve Pharmaceutical Methods with Automatic Titration
September 1st 2020In this webcast, Brett Lane, Senior Chemist of Lonza’s QC laboratory in Rochester, NY will share his experience modifying titration manual methods to optimize results using autotitration. Live: Wednesday, Sept. 23, 2020 at 1pm EDT | 12pm CDT | 10am PDT On demand available after final airing until Sept. 23, 2021
Active Packaging Reimagined: Novel Technologies to Derisk Drug Product Stability
August 27th 2020Stability and moisture challenges are likely to increase with the development of more potent APIs, larger molecules, and modified-release tablets. Learn about innovative packaging solutions to address the increasing need to protect hydrophilic oral solid doses from moisture and preserve drug stability. Live: Thursday, Sept. 17, 2020 at 11am EDT| 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Sept. 17, 2021
From Candidate to Clinic: Strategies to Accelerate Your Molecule’s Development Path
August 27th 2020Review how data-driven approaches, including physiologically based pharmacokinetic (PBPK) modeling, parallel formulation screening, API sparing techniques, and optimal early dosing strategies can help avoid development pitfalls for small-molecule drug candidates on the path to clinic. Live: Wednesday, Sept. 23, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On demand available after final airing until Sept. 23, 2021
Building a More Efficient Routine Lab: Approaches to Modernizing HPLC Methods with New Technologies
August 25th 2020Listen and learn as Dr. James Grinias from Rowan University and Dr. Frank Steiner from Thermo Fisher Scientific discuss approaches and considerations to modernizing HPLC methods to increase throughput using superficially porous particles. They also discuss challenges in method transfer and describe new compliant hardware technologies built into the modern HPLC and UHPLC systems. Live: Tuesday, Aug. 25, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until Aug. 25, 2021
Injectable Implants: Manufacturing Advanced Medicines with Hot-Melt Extrusion
August 24th 2020The promises of the digital lab are enticing but getting there can seem daunting. The good news is that you can start today. It’s simply about implementation, and not waiting for innovation. Live: Tuesday, Sept. 22, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On demand available after airing until Sept. 22, 2021
NIR to the Rescue: Production Efficiency and Cost Savings for Pharma
August 13th 2020Near infrared (NIR) spectroscopy to the rescue: See how this vital process analytical technology tool can improve efficiency and cut costs in your pharmaceutical QC processes. Live: Wednesday, Sept. 9, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Sept. 9, 2021
Discover Functional Film Coating Formulations for an Easy and Fast Coating Process of SODFs
August 12th 2020What are the reasons for functional film coating of solid oral dosage forms? How do polymers influence the release of active ingredients in a tablet coating? Abderraouf Allia uses many practical examples and different formulations to show what needs to be taken into account during formulation. Participate in this webcast and learn how ready-to-use film coating systems can simplify the coating and formulation process. Live: Wednesday, Sept. 16, 2020 at 10 am EDT | 9am CDT | 3pm BST | 4pm CEST On demand available after airing until Sept. 16, 2021
The Ever-Changing World of Extractables and Leachables
August 12th 2020Join global industry and regulatory experts as they discuss current E&L hot topics on pharmaceuticals, biopharmaceuticals and medical devices. Live: Wednesday, Sept. 9, 2020 at 9am EDT | 2pm BST | 3pm CEST On demand available after final airing until Sept. 9, 2021
Gene Therapy Development: From Methods to GMP Testing
August 5th 2020The molecular complexity, size, and higher-order structure of gene therapies create a unique challenge for pharmaceutical development. This webcast will provide insights into characterizing viral and non-viral gene therapies to ensure quality. Live: Thursday, Aug. 20, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Aug. 20, 2021
Manufacturing amorphous solid dispersions by spray-drying: scale-up approaches
August 4th 2020This webcast focuses on manufacturing aspects of amorphous spray-dried dispersions to enable successful scale-up and optimization of the process. An overview of spray drying and typical scale-up challenges will be presented along with a robust process development strategy to ensure critical-to-quality attributes are maintained. Tools and methodologies that enable rapid scale-up that is right the first time from clinical to commercial scale will also be highlighted. Live: Tuesday, Aug. 4, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Aug. 4, 2021 Register free
Engineering Approaches to Respiratory Drug Delivery: Mannitol Case Study
July 30th 2020If you have a new compound for respiratory drug delivery, what particle engineering approach should you take? This webinar will explore both micronization and spray drying approaches in relation to product performance of the inhaled drug product. Live: Thursday, Jul. 30, 2020 at 11am EDT | 8am PDT | 4pm GMT | 5pm CEST On demand available after airing until Jul. 30, 2021 Register free
Editors’ Series: Cell and Gene Therapies: Laying the Foundation for a New Supply Chain
July 29th 2020Existing biopharma supply chain practices must evolve to meet the needs of personalized therapies, particularly for autologous treatments. Force fitting manual processes will no longer work. Hear about lessons learned in a pioneering “vein to vein” pilot program that aims to establish new rules for data management and exchange, scheduling, and automating workflow and supply chain practices for novel and complex processes. Live: Wednesday, Jul. 29, 2020, at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On Demand: available after airing until Jul. 29, 2021 Register free
Editors’ Series: Overcoming Commercialization Challenges for Cell Therapies and Gene Therapies
July 28th 2020The complexities of producing cell therapies and gene therapies are testing established biomanufacturing practices and the companies engaged in producing the treatment. Join this webcast to hear about the technical and regulatory hurdles associated with development and manufacturing steps, and strategies and solutions to facilitate development through commercialization. Live: Tuesday, Jul. 28, 2020, at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On Demand: available after airing until Jul. 28, 2021 Register free
Best Practices for Meeting and Exceeding Regulatory Standards in Primary Packaging USP and
July 22nd 2020Interested in learning more about the regulatory requirements for elastomeric components in parenteral drug packaging? Sign up for the July 22 webcast on “Best Practices for Meeting and Exceeding Regulatory Standards in Primary Packaging USP and ” . This webcast is part of a series focusing on “The Path to Patient Safety – Addressing Industry Concerns and Solutions for Primary Packaging Component Selection.” Live: Part II: Wednesday, Jul. 22, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST On demand available after airing until Jul. 22, 2021 Register free
Effective Imaging for Identification and Sizing API Domains
July 21st 2020Combining FTIR and Raman spectroscopy provides the insight needed to ensure appropriate distribution and concentration of APIs within tablets. Watch this webcast to learn more. Live: Tuesday, Jul. 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing Jul. 21, 2021 Register free
Expedite Regulated Documents in the Era of COVID-19: From Development to Trials and Manufacturing
July 15th 2020Technology is more critical than ever to help you keep your clinical trials on track during the era of COVID-19. Gain best practices about how to empower your remote workforce, get critical regulated documents electronically signed compliantly, and to create a safe and flexible remote patient-centric experience. Live: Wednesday, Jul. 15, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Jul. 15, 2021. Register free
How to Choose the Right Approach to Enhance Drug Solubility
June 25th 2020What is the correct approach for formulation development of poorly soluble NCEs? Dr. Umesh Barabde, director and operations head, Pharmaceutical Development Services, and Dr. Vishakh Kharat, director, analytical research, Pharmaceutical Development Services, both at Piramal Pharma Solutions discuss classic and specialized techniques to enhance solubility. Live: Thursday, Jun. 25, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing Jun. 25, 2021 Register free
Dry Powder Inhalers: Key Considerations for Combination Product Development
June 24th 2020Dry powder inhalers (DPIs) are an important delivery technology for inhaled medicines in both respiratory and non-respiratory disease areas. Andreas Meliniotis, director of device development at Vectura, helps navigate the complex area of DPI product development and highlights the key considerations for both novel- and generic-drug programs. Live: Wednesday, Jun. 24, 2020 at 11am EDT |8am PDT |4pm BST |5pm CEST On demand available after final airing Jun. 24, 2021 Register free
Instrument Systems Take on Burden of Compliance
June 23rd 2020Want to be sure your systems and processes are compliant? Learn how two enable 21 CFR Part 11 in the lab with compliant workflows and consistent testing. Be confident in your analyses! Live: Tuesday, Jun. 23, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing Jun. 23, 2021 Register free
Specialized Clinical Services for Complex Clinical Studies
June 23rd 2020This webinar will review Lonza’s integrated clinical supply services inclusive of manufacturing, primary and secondary packaging, kitting, and distribution with special emphasis on complex clinical studies and direct-to-patient shipping. Live: Tuesday, Jun. 23, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Jun. 23, 2021 Register free
