Member Orientation Webinar sponsored by Cytel
1:00 PM ET, Thursday, February 22 – Online event
ASCPT Member Advocate, Jin Yan Jin, PhD, as she will be presenting a special webinar sponsored by Cytel designed to provide you with the tools and knowledge you need about how to get involved with ASCPT, access member tools, navigate the new ASCPT website, answer any questions you may have, as well as how you can maximize your time at the Annual Meeting by participating with colleagues and ASCPT leadership.
Opening Reception sponsored by Certara
5:00 – 6:30 PM, Wednesday, March 21, 2018 in the Orange Ballroom
You won’t want to miss the first reception of the Annual Meeting! Visit with colleagues, exhibitors and poster presenters during this special networking events.
Celerion Product Theater
9:00 – 10:00 AM, Thursday, March 22, 2018 in Key West A
Oncology Drug Development: Phase I Trials in Healthy Volunteers
Through a series of case studies, Michael Di Spirito, MSc, Director, Clinical Pharmacology & Pharmacometrics, will present creative Phase l oncology study designs and explore the results that were achieved. Berry Delicious refreshments will be provided, and space is limited to 50 attendees.
Clinilabs Learning Lounge
10:00 – 10:30 AM, Thursday, March 22, 2018 in the Orange Ballroom
Six Keys to Conducting Successful Phase 1 Studies
Clinilabs will discuss six simple yet essential elements of Phase 1 success that can be employed on any Phase 1 unit. Each key will be presented in practical terms with examples to highlight each key. Attendees will learn how protocol development, subject pre-screening, subject authentication, subject diversity, standard operating procedures, and laboratory and pharmacy oversight provide meaningful and impactful advantages to Phase 1 studies, enabling each study to be a success.
Covance Hosted Event
12:30- 1:30 PM, Thursday, March 22, 2018 in Key West A
The Integrated Clinical Pharmacology Platform: Optimizing Drug Development
Join Oren Cohen, MD, Chief Medical Officer and Global Head of Clinical Pharmacology Services at Covance, as he discusses an integrated approach to optimize your early clinical development program. Learn integrated solutions like Phase I GMP manufacturing, biomarker capabilities and special population studies can advance your development program in the early phases. A full lunch will be provided, and space is limited to 50 attendees.
Nuventra Craft Beer Station at President’s Reception
5:00 – 6:00 PM, Thursday, March 22, 2018 in the Orange Ballroom
Join your colleagues for the Thursday evening President’s Reception taking place in the Exhibit Hall. While you’re networking, be sure to stop by the Craft Beer Station sponsored by Nuventra!
PRA Product Theater
9:00 – 10:00 AM, Friday, March 23, 2018 in Key West A
Q&A Driven Early Clinical Drug Development, with Case Examples on the Value of Early Learning
Join PRA Health Sciences for their special session presented by Ewoud-Jan van Hoogdalem, PhD, RPh, ClinPharm, Vice-President Scientific Affairs - Clinical Pharmacology. Sunshine State refreshments will be provided, and space is limited to 50 attendees.
Pharmaron Learning Lounge
10:00 – 10:30 AM, Friday, March 23, 2018 in the Orange Ballroom
Pharmaron will present research on their integrated services from drug metabolism including Radiosynthesis (3H/14C), in vitro
metabolism, Phase l Clinical Pharmacology Center (CPC) for human 14C studies, and Advanced Bioanalytical Sciences (ABS) including AMS technology.
PAREXEL Product Theater
12:30 – 1:30 PM, Friday, March 23, 2018 in Key West A
EMA Safety Risk Identification/Mitigation Guideline 2018 – Importance of Modeling in Early Development
Matthias Kruse, MD, will discuss the systematic approach to evaluating nonclinical data, protocol design and other key aspects to mitigate risk in First in Human (FIH) studies. The new EMA guidance, introduced February 2018, for identifying and mitigating the safety risks will be reviewed for early clinical studies. Laura Iavarone will review the role of modeling and simulation including the PK and PKPD translational aspect of preclinical data to humans, selection of starting doses and definition of exposure-limit criteria within protocols. Boxed lunches (redeemable with your lunch voucher) and Grandma’s Pantry dessert will be provided, and space is limited to 50 attendees.
IQVIA Product Theater
2:30 – 3:30 PM, Friday, March 23, 2018 in Key West A
Transforming Early Clinical Development – Using Innovative Approaches to Enhance Efficiencies, Lower Costs and Improve Outcomes
Join Ashish Jain, Vice President and Global Head, Early Clinical Development for IQVIA as he will provide an overview of the early phase delivery challenges, and how innovative approaches are proving to revolutionize the ECD space. With more early phase development using hybrid models, additional challenges are being realized. Hear how you can overcome these challenges and move to the next generation of early clinical development. Space is limited to 50 attendees, so please RSVP early!
Pharmacometrics Skills Competition Reception sponsored by Certara
BY INVITATION ONLY
6:15 PM – 7:15 PM, Friday, March 23, 2018 in Key West A
Open to contestants and organizers of the Pharmacometrics Skills Competition only, Certara invites you to this special reception to celebrate your contributions to the Competition!