Join our exhibitors as they host the following special events at this year’s Annual Meeting. Space is extremely limited at select events, so you are encouraged to click on the RSVP link to secure your spot where reservations are recommended!
Opening Reception sponsored by Certara
5:00 – 7:00 PM, Wednesday, March 18, 2020
Network with colleagues, visit exhibitors and enjoy light refreshments during this special event kicking off the 2020 Exhibit Hall activities. Don’t forget to stop by Certara’s special margarita station in booth #101!
Celerion Product Theater
9:00 – 10:00 AM, Thursday, March 19, 2020
A Decade of Translating Science into Medicine: The Future of Pharmacy
Speaker: Kate Reese, PharmD, Clinical Research Pharmacist in Charge
Join Celerion, the leader in early clinical development, as they host snacks and a special presentation for Annual Meeting attendees. The presentation will feature:
Please click here to RSVP
- Phase 1 Pharmacy Checklist
- GMP or Extemporaneous Compounding: What do you need?
- Pharmacy Compounding: Clinical Development Efficiencies for Early Phase 1 Studies
- Emerging FDA Requirements for Hazardous Drugs
- Celerion Pharmacy Services
Micro-Learning Coffee Talk Sponsored by AltaSciences
10:00 – 10:30 AM, Thursday, March 19, 2020
Strategic Considerations for a Successful CNS Clinical Development Pathway
Speaker: Beatrice Setnik, PhD
Central Nervous System (CNS) drug evaluation requires the assessment of specific safety endpoints, such as the drug’s potential to cause impairing effects on driving, the likelihood that it may be abused or misused, or the risk of causing withdrawal symptoms if abruptly discontinued. Evaluation of CNS effects in early Phase I studies can be very helpful in determining if dedicated driving simulator, abuse, and dependence studies are needed. Furthermore, inclusion of drug effect evaluations and measures of cognition into early studies enables better pharmacological characterization since larger dose ranges are studied. Methods for determining the need for additional studies will enable developers to accurately project their clinical development timeline and have more informed discussions with regulatory agencies. Learn how to leverage your early
Visit AltaSciences in Booth #301 to learn more about this special presentation!
Covance Lunch Presentation
12:00- 1:00 PM, Thursday, March 19, 2020
Optimizing Success of Phase I Healthy Volunteer and Patient Hybrid Trials: The Role of a Comprehensive Early Development Plan
Paul Rothenberg, MD, PhD
Executive Director, Product Development Strategy, Covance
Ganguli, BSc(Hons/Pharm), MBChB, MRCP(Edin)
Senior Medical Director, Medical & Scientific Affairs
Clinical Pharmacology Services, Covance
For novel drugs, demonstrating clinical “proof-of-concept” (POC) is a critical milestone on the road to success. Preparing a comprehensive development plan (CDP) – one that integrates early clinical trial designs and program strategy with the other key disciplines (e.g., pre-clinical, regulatory, CMC, commercial) – can shorten overall timelines, reduce costs and increase success rates. Creating a thoughtful C DP that includes Phase I hybrid trials (enrolling healthy subjects and patients with the target disease) can help attain the earliest possible clinical POC. Planning a successful Phase I hybrid trial requires aligning the right therapeutic area, the right molecule, the right study design and endpoints, as well as considering regulatory requirements. This special presentation will explain what a CDP is, how pharmaceutical companies create and use CDPs, focusing on the central role of clinical pharmacologists in devising efficient drug development programs. We’ll explain what Phase I hybrid trials look like, and how they provide an important advantage in early drug development.
Please RSVP: email@example.com
President’s Networking Reception Sponsored by Nuventra
5:00 – 6:30 PM, Thursday, March 19, 2020
Network with friends and colleagues during this reception celebrating ASCPT’s President, David Y. Mitchell, PhD. Visit Nuventra’s Corn Hole games located throughout the Exhibit Hall for your chance to test your skills and be sure to stop by and visit Nuventra in booth #205 for your chance at earning a bonus drink ticket!
Headshot Lounge Sponsored by PRA Health Sciences
Visit the special Headshot Lounge in the Exhibit Hall during the following hours:
5:00 PM – 7:00 PM, Wednesday, March 18, 2020
9:00 AM – 1:30 PM and 5:00 – 6:30 PM, Thursday, March 19, 2020
8:00 AM – 2:00 PM, Friday, March 20, 2020
PRA Product Theater
12:00 – 1:00 PM, Friday, March 20, 2020
Adaptive Dose Escalation in Phase I
Speaker: Ewoud-Jan van Hoogdalem, PharmD PhD, Vice President, Scientific Affairs – Clinical Pharmacology, PRA Health Sciences’
The dose escalation scheme in first-in-human studies is often of traditional design, with fixed cohort sizes throughout the escalation scheme. PRA is currently exploring a pharmacology-guided rule-based adaptive dose escalation design that aims at making ‘best use’ of healthy subjects participating in early clinical programs. PRA proposes an escalation design that adapts the sample size when approaching doses of potential clinical relevance. In retrospective evaluation of this design in 40 recent studies, none of the simulations overshot the actually reported top dose; 1 simulation resulted in a top dose that was within 20% under the estimated maximum tolerated dose in the original study. The adaptive dose-escalation design accomplished this with a 37% median reduction in the total number of subjects required. The audience will be updated on prospective testing of the adaptive dose escalation design, to further justify this method in future first-in-human studies, to make ‘best use’ of PRA’s trial subjects.
Please RSVP to secure your seat: firstname.lastname@example.org