Welcome to the 2022 Lake Nona Leadership Council meeting. Thank you for joining us this year. Whether you are joining in-person at Lake Nona or virtually, we are excited for everyone to participate, exchange ideas and research, and have a part in advancing drug development and regulatory science.
Welcome from Dean Johnson
"On behalf of the University of Florida College of Pharmacy, it is my honor to welcome you to the 2022 Lake Nona Leadership Council Meeting."
On behalf of the University of Florida College of Pharmacy, it is my honor to welcome you to the 2022 Lake Nona Leadership Council Meeting. For many of us, this represents the first time in three years we have gathered in person for this annual meeting. Our college takes great pride in hosting this multidisciplinary gathering of pharmaceutical leaders and scientists to exchange ideas and advance drug development and regulatory science, and we are thrilled you can join us in Lake Nona or virtually this year.
The UF College of Pharmacy and Center for Pharmacometrics and Systems Pharmacology continues to ascend the national rankings. U.S. News & World Report currently ranks the college No. 5 nationally in its best pharmacy college rankings. In addition, 53 of our faculty are now grant-funded, and they helped the college secure nearly $28 million in annual research funding last year. According to the American Association of Colleges of Pharmacy, the UF College of Pharmacy ranks No. 3 nationally in NIH funding. Under the trusted leadership of Stephan Schmidt, Ph.D., F.C.P., the center has made significant contributions to the college’s robust research growth, and he has explored new ways to expand CPSP’s research and education programs.
As I prepare to leave my dean position in August, I want to extend my heartfelt thanks for your scientific contributions and support of our college. To see the scientific community come together for the Lake Nona Leadership Council Meeting every year has been a meaningful and insightful experience during my tenure.
Julie Johnson, Pharm.D.
Dean and Distinguished Professor
Welcome from Dr. Schmidt
"On behalf of the Center for Pharmacometrics and Systems Pharmacology (CPSP), I am excited to welcome you to the 2022 Lake Nona Leadership Council meeting."
On behalf of the Center for Pharmacometrics and Systems Pharmacology (CPSP), I am excited to welcome you to the 2022 Lake Nona Leadership Council meeting. This year’s meeting entitled, “Catalyzing success Through Scientific Excellence and Teamwork”, will be a hybrid event allowing us to transition to in-person meetings after two years of virtual only gatherings. I would like to thank you for taking time out of your busy schedule to participate in the meeting. Your active participation and feedback is very important to us as it will help refine the Center’s future direction and accelerate its growth.
Over the last decade, I had the privilege to work with world-class faculty and key opinion leaders in the quantitative clinical pharmacology arena, such as yourself, to build and grow out the Center and see it flourish. 2021 has been an important year for us with many new faculty and trainees joining the Center. In light of its accelerated growth, we have been restructuring the Center from the ground up in order to more efficiently align with our internal and external partners and achieve excellence in our research and training programs. We have also launched an online certificate in model-informed drug development (MIDD) with the intent of expanding it to an online Master’s program over the next two years. I would like to personally follow up with each of you to discuss opportunities for further engagement with the Center’s research and educational efforts during or after the meeting.
I am looking forward to working with all of you over the course of the next year on furthering the CPSP’s mission and welcoming you back to the Lake Nona Leadership Council Meeting in 2023.
Stephan Schmidt, B.Pharm., Ph.D., F.C.P.
Associate Professor & Director CPSP
Department of Pharmaceutics
University of Florida
2022 Schedule at a GlAnce
Tuesday, April 5 (Presentation Day & Zoom Available)
|8:15 - 9:00 a.m.||Check-in (& Registration) for on-site participants — Breakfast|
|9:00 a.m.||Online Attendee's Join|
|9:00 - 9:05 a.m.||Welcome & Housekeeping Remarks (Stephan Schmidt)|
|9:05-9:30 a.m.||State of the College (Dean Johnson)|
|9:30-10:00 a.m.||State of the Center (Stephan Schmidt)|
|10:00-10:15 a.m.||Online Certificate Program (Thomas Schmittgen)|
|10:15-10:30 a.m.||Coffee Break|
|10:30-10:45 a.m.||Introduction of the Computational Toxicology and Pharmacometrics Laboratory at the University of Florida (Zhoumeng Lin)|
|10:45-11:00 a.m.||Integrative pharmacology approach for precision dosing in post-bariatric surgery patients (Natalia V de Moraes)|
|11:00-11:15 a.m.||PK-PD Modeling in Translational Drug Research: From Anti-Infectives to Neglected Tropical Diseases (Francine Azeredo)|
|11:15-11:30 a.m.||Leveraging the Data Revolution in MID3 (Sarah Kim)|
|11:30-11:55 a.m.||AI @ UF Health (Patrick Tighe)|
|11:55 a.m.- 12:00 p.m.||Final remarks and online meeting closure|
|12:00-1:30 p.m.||Roundtable Discussion Lunch|
|1:30-2:30 p.m.||Poster Session – Meeting Ends|
Title: “Pharmacokinetics of carvedilol enantiomers – setting up a framework for precision dosing in obese and post Roux-en-Y gastric bypass patients”
Authors: Priscila Yamamoto, Wilson Salgado Junior, Jose Sebastião do Santos, Rafael Kemp, Ajith Sakarankutty, Cristiane Gaitani, Marcella Pavan, Rodrigo Moreira da Silva, Rodrigo Cristofoletti, Natália de Moraes
Title: “Development of a Physiologically-based Pharmacokinetic Exposure-Bracketing Approach to Assess Hormonal Contraceptives Drug-drug Interactions”
Authors: Lais Da Silva; Brian Cicali; Valvanera Vozmediano; Stephan Schmidt and Rodrigo Cristofoletti
Title: “Development of a Novel Intranasal Physiologically Based Absorption Model and Its Application in ARS-1 Epinephrine Nasal Spray Development to Enhance Understanding of Absorption in Single and Repeated Dose (L/R) in Healthy Adults”
Authors: Chaejin Kim, Jeffrey S. Barrett, Richard Lowenthal, Sarina Tanimoto, Stephan Schmidt, Valvanera Vozmediano
Title: “Defining permeability across the BBB for levetiracetam using PBPK modeling”
Authors: Parsshava Mehta, Leyanis Rodriguez, Vijay K Siripuram, Paula Muniz, Monica Rodriguez, Valvanera Vozmediano
Title: “PBPK-based exposure bracketing of subcutaneous levonorgestrel for evaluating DDIs”
Authors: Brian Cicali, Rodrigo Cristofoletti, Michelle Pressly, Soyoung Kim, Thomas Wendl, Valvanera Vozmediano, Stephan Schmidt
Title: Clinical Pharmacokinetic and Pharmacodynamic Strategies for the Treatment of Patent Ductus Arteriosus
Authors: Mohammed Almoslem, Sanket Shah, Serge Guzy, Valvanera Vozmediano, Sarah Kim, Mark Hudak, Stephan Schmidt
Title: “Does Candidemia influence Amphotericin B distribution? Using microdialysis and preclinical population pharmacokinetic modeling to address this question”
Authors: Valdeene Vieira Santos, Laiz Campos Pereira, Jackeline Marley Santos de Araújo, Matheus Antônio da Hora Borges, Carolina Magalhães Brandão, Luisa Oliveira Santos, Francine Johansson Azeredo
Title: “Optimizing type 1 diabetes prevention clinical trial designs through model-informed drug development”
Authors: Juan Francisco Morales, Rhoda Muse, Jackson Burton, Jagdeep Podichetty, Frank Martin, Mark A. Atkinson, Michael J. Haller, Martha L. Campbell-Thompson, Klaus Romero, Inish O’Doherty, Stephan Schmidt, Sarah Kim
Title: “Leveraging Imaging Data to Optimize Type 1 Diabetes Clinical Trial Designs”
Authors: Orniel Y. Caban-Varela, Deyaneira Laboy-Baiz, Seth Malhotra, Ai Quynh T. Nguyen, Keisha N. Persaud, Juan Francisco Morales, Nicholas Waddington, Yan Gong, Martha L. Campbell Thompson, Sarah Kim
Title: “Characterization of monoclonal antibodies immunogenicity using machine learning”
Authors: Mai Abdelmageed, Juan Francisco Morales; Seth Malhotra; Joanel Colon; Terrance Cripe; Hoangmy Chau; Aileen Shin-Ann; Leyanis Rodriguez-Vera; Sarah Kim; Valvanera Vozmediano; Mark Rogge; Stephan Schmidt
Title: “Dendrimer-Lipid Nanoparticles for Efficient mRNA Delivery to Myeloid Cells”
Authors: Zijing Xu, Jinjia Xu, Fan Zhang
Title: “Development and application of a web-based interactive physiologically based pharmacokinetic (iPBPK) model for meloxicam in broiler chickens and laying hens.”
Authors: Yuan L, Chou WC, Tell LA, Baynes RE, Davis JL, Maunsell FP, Riviere JE, Lin Z.
Title: “Superiority of a new route-specific versus traditional route-to-route extrapolation approach in developing a physiologically based pharmacokinetic model for gold nanoparticles in rats”
Authors: Chou WC, Cheng YH, Riviere JE, Monteiro-Riviere NA, Kreyling WG, Lin Z.
Title: “Generated MHC-I peptide aptamers induces immunogenicity for precision extracellular vesicle presentation”
Authors: Zachary Greenberg, Kiley Graim, Mei He
Title: “Light-promoted Cellular Production of Immune Functional Extracellular Vesicles”
Authors: Nina Erwin, Shaobo Ruan, Mei He
Title: “Elion: A Deep-Learning-Based Computational Platform for Drug Discovery and Optimization”
Authors: Gustavo Seabra and Chenglong Li
Title: “Transcriptional Profile of Human Pancreatic Acinar Ductal Metaplasia”
Authors: Corey Perkins, Jinmai Jiang, Hesam Hakimjavadi, Julie K. Bray, Alyssa Gosling, Lais da Silva, Gamze Bulut, Jamel Ali, Veronica W. Setiawan, Martha Campbell-Thompson, Srikar Chamala, Thomas D. Schmittgen
Title: “Systemic PK-PD Studies to understand the antinociceptive effects of mitragynine and contribution of its active metabolite, 7-hydroxymitragynine”
Authors: E.C. Berthold, S.H. Kamble, K.S.R. Raju, M.A. Kuntz, A.S. Senetra, M. Mottinelli, T. Hiranita, L.R. McMahon, C.R. McCurdy and A. Sharma