Research suggests that medications are not taken as prescribed half of the time, which could lead to reduced efficacy of the treatment and increased risk of negative health outcomes. In addition, nearly half of all drug launches underperform as compared to prelaunch expectations. These statistics highlight the drawbacks of the traditional development approach, which is largely driven by cost and timelines.
The incorporation of patient-focused drug design principles early in the development cycle is critical to developing safe and effective treatments that address the specific needs of target patient populations in-terms of appropriateness, preference and usability. Ultimately, patient preference and differentiation from competitors are two factors that can lead to market acceptability.
Join this webinar to discover the current state of patient-focused dose design through clinical evidence, real-world case studies and patient preference-driven drug design solutions that can help develop better treatments and successful real-world outcomes.
David Tan, PhD, Senior Scientist in Formulation Sciences, AbbVie Inc.
Dr. David Tan is a Senior Scientist in Formulation Sciences at AbbVie Inc., North Chicago, IL, United States. Dr. Tan graduated with a bachelor’s degree in pharmacy and a doctorate in pharmaceutics from the National University of Singapore. He has experience in formulation development and strategies, manufacturing process scale up, technology transfer and regulatory submission. Dr. Tan has keen interest in pediatric age-appropriate formulations, taste masking technologies, modified release formulations and process analytical technology. He is also on the AbbVie’s Development Sciences Pediatric Taskforce and actively engaged in US and European based pediatric drug product development consortia.
Jim Spavins, Principal, Spavins Consulting LLC.
Jim is currently the principal of Spavins Consulting LLC and is the former SVP of Pfizer’s industry leading Pharmaceutical Sciences organization. He has experience spanning 40 years developing and bringing innovative new medicines to patients. Unique to his experience is leading global groups across all the technical disciplines of CMC development, as well as regulatory, Quality, clinical supply, commercial manufacture, continuous improvement, statistics, environmental impact and economic analysis.
For his leadership approach, Jim brings a strong focus beyond the necessary technical disciplines and regulations, looking at the interplay of culture, teamwork and behavior for successfully advancing programs in an effective and efficient manner. Jim has lead organizations in the US, UK, Japan and China.
Jim has a M.A. in analytical chemistry and M.S. in chemical engineering, both from SUNY Buffalo.
Nélio Drumond, PharmD, Principal Formulation Scientist, Catalent Pharma Solutions
Dr. Nélio Drumond is a registered Pharmacist with more than six years of experience in the pharmaceutical industry, providing scientific leadership within development projects focused on oral solids drug delivery. His PhD was conducted in the emerging topic of Patient-Centric pharmaceutical drug product design, which targets the development of drug products that can better meet the needs of heterogeneous patient populations.
Due to his specialized training, Dr. Drumond has keen interest in considering the special needs of the concerned patient populations during drug product development, by appropriately selecting formulations and packaging designs that can improve acceptability and compliance of supplied drug therapies. Other interests include physical characterization of powders (active ingredient/excipients) and the use of statistical tools for predicting suitable formulations, including their correlation to manufacturing processes.
Who Should Attend?
Companies with molecules in late Phase I or Phase II, or in need of advanced dose form for life cycle management purposes. Roles may include:
- Senior/Director, New Product Strategy & Development
- Project Leaders/Project Management
- Senior/Director, Product Development
- Head/Senior/Director, CMC
- Senior/Director, Strategic Sourcing
- Senior/Director, R&D
- Formulation Scientists
What You Will Learn
In this webinar, attendees will learn about:
- Real-world case studies that highlight the need for patient-focused drug design
- Clinical evidence on patients’ appropriateness, acceptability, usability and preferences for pharmaceutical preparations
- Advanced drug design solutions (i.e., dosage forms and packaging) driven by clinical evidence and patient preferences
Catalent is the leading global provider of advanced delivery technologies, development and manufacturing solutions for drugs, biologics, gene therapies and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in the 2019 fiscal year, generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.