2022 Spring Symposium:
The HIV and COVID Pandemics: Lessons from 40 Years of Addressing Public Pandemics with Drug and Vaccine Therapy
Thursday April 7th, 9am - 5pm NC Biotech Ctr; RSVP to RTPDMDG.OWNER@RTPDMDG.ORG
Student/Postdoc Abstract Competition: Abstract submission by Feb 25 2022 to rtpdmdg.owner@rtpdmdg.org
(RTP-DMDG will follow the CDC and local COVID-19 mandates at the time of the event)
SPEAKERS:
Harold Kessler, MD, Rush University Medical Center and ViiV Healthcare: History of the HIV Pandemic - A Patient’s Journey from Early Days to Integrase Inhibitors.
Steve Castellino, ADME Consultant: Seizures, Metabolites and Species Differences: How MALDI Mass Spec Lead to a Mechanism on the Severe CNS Adverse Events Associated with Fosdevirine (NNRTI for HIV).
Christina Mack, PhD, VP, Epidemiology and Clinical Evidence, IQVIA: SARS-CoV-2 Transmission Risk Among National Basketball Association Players.
Nilu Goonetilleke, PhD, Assistant Professor, Microbiology and Immunology, UNC: Vaccines: Underlying Principles of Design and Testing.
Odin Naderer, VP, Clinical Pharmacology and Translational Medicine, Chimerix: Avoiding a Future Smallpox Pandemic: Development of Brincidofovir Under the Animal Rule.
Amanda Fuller Moore, PharmD, NC DHHS: Emerging Pandemic Diseases: How North Carolina is Managing COVID-19 and Preparing for the Next Possible Pandemic.
2021
Student/Postdoc Presentations: TUES, April 6th
Topics: Disease Characterization, Target Identification, Drug Development, Toxicology, Systems Biology, DMPK
Virtual Career Panel: TUES, January 28th
2020
2020 RTP-DMDG Winter Symposium, Feb 27, 2020
Genetic- and Cellular-based Therapies - Current Best Practices and Challenges
"Pre-clinical approaches for genetically modified cell therapy programs" Shawna Jackman Gangi, PhD, DABT, Sr. Principal Research Scientist, Charles River Laboratories
"Advances in genome editing for the treatment of genetic disorders and cancer" Greg Falls, PhD, DABT, Head of Translational Drug Development; and Cassie Gorsuch, PhD, Team Leader - Therapeutic Discovery; Precision BioSciences
“Regulatory considerations for cell and gene therapy" Brian Furmanski, PhD, Sr. Director, Clinical Pharmacology & PK, Nuventra Pharma
"Challenges and opportunities in developing transformative gene therapies" Paul Korner, MD, MBA, SVP, Clinical Development and Medical Affairs, Axovant Gene Therapies
2020 Summer Webinar, July 29, 2020 (Wednesday)
Crisis Management and COVID-19: Pre-clinical Insights from CRO Leadership
The Impact of COVID-19 on the Industry
Wilbert Frieling, DVM, ERT
Corporate SVP, Global Discovery Services, Charles River Laboratories
Project Risk Assessment and Aspects which Might be Impacted by COVID-19; Impact of Delays on NHP Sourcing, Solutions to Circumvent Shortage
Pete Gaskin, PhD, ERT, MTOPRA
Sr. Director, Scientific Advisory Services, Charles River Laboratories
A New Way to Continue Due Diligence Activities Deanna Talerico, RQAP-GLP Senior Director, Regulatory Compliance, Charles River Laboratories
2019
2019 Fall Dinner Meeting
“Toxicological and Pharmacological ADME Challenges While Growing-Up”
Ronald N. Hines, PhD; Center for Public Health and Environmental Assessment; Office of Research Development; United States Environmental Protection Agency
2019 RTP-DMDG Winter Symposium, Mar 5, 2019
Herding Unicorns: Rare Disease Drug Development
Although by definition rare diseases are just that, rare, the sheer number of different rare diseases suggest that one in every ten Americans is living with a rare disease. Collectively they impact more people than cancer and HIV combined. In North Carolina alone, over one million people are living with a rare disease (GlobalGene.org). Drug development in the rare disease space comes with many unique challenges and opportunities, from understanding disease mechanism of action, target identification and early drug development, to funding opportunities, health authority regulations, and clinical trial design. This symposium will cover multiple aspects of rare disease drug development from early development through clinical assessment highlighting the unique circumstances that challenge researchers to bring urgently needed therapies to small groups of people.
"Catalyzing research on rare diseases at UNC and beyond" Anthony Hickey, PhD, University of North Carolina Chapel Hill, Director UNC Catalyst for Rare Disease
"Starting small companies to translate rare and neglected disease treatments" Sean Ekins, PhD, Collaborations Pharmaceuticals, CEO
“Clinical Development Challenges in Rare Disease: Pitt-Hopkins Syndrome" Kimberly Goodspeed, MD, University of Texas Southwestern Medical Center, Assistant Professor of Pediatrics
"Rare Disease Drug Development: Leveraging the Global Regulatory Environment" Kevin Healy, PhD, Enzyvant Therapeutics, Inc., Senior Director of Regulatory Affairs
2018
RTP-DMDG Technology and Resources Symposium
Tuesday, May 15, 2018, 9:00 am - 5:00 pm
" A Lifetime in Drug Metabolism & Disposition: My Top Ten WTF Moments "
ANDREW PARKINSON, PH.D.
CEO, XPD CONSULTING
Along with A Panel of Scientific Presenters
Absorption Systems “IDAS: In Vitro Dissolution Absorption System”
Celerion “Obstacles and Opportunities in Treating Nonalcoholic Steatohepatitis (NASH)”
Celerion “Strategies for Clinical Pharmacology Studies that Support the Drug Product Label”
Charles River “Quantitative Measurement of Immune-Modulatory Mediaters within Tumors of Freely Moving Mice Utilizing In Vivo Microdialysis”
Lonza “Direct Evaluation of CYP Contribution to Drug Metabolism using SilensomesTM HLM”
Sekisui XenoTech,LLC “Dealing with Surprises in ’Easy’ In Vitro Transporter Assays”
Solvo “In Vitro Evaluation of OATP1B1- and OATP1B3-mediated Drug-Drug Interactions using Statins as Probe Substrates”
2016
Winter Symposium - “Next Gen Culture: The Future of Cell and Tissue Models in Research, Drug Development and Therapy”
“Next Gen Culture Models: Applying Nature’s Lessons to In Vitro Approaches” - Ed LeCluyse, PhD, Principal Scientist, LifeNet Health/UNC-IDSS
“Engineering Microscale Co-cultures for Drug Screening and Disease modeling” - Salman Khetani, PhD – Associate Prof of Bioengineering, University of Illinois Chicago
"3D Bioprinting of Complex, Multi-cellular Tissues and Their Application to In Vitro Modeling " - Sharon Presnell, PhD, Chief Technology Officer & EVP of R&D, Organovo
"Organs-on-Chips for Advancing Drug Discovery and Precision Medicine” - Geraldine Hamilton, PhD, President and CSO, Emulate
"Regenerative Medicine Applications” - Anthony Atala, MD, Director of the Wake Forest Institute for Regenerative Medicine
2015
Fall Dinner Meeting - “Systems Pharmacology Modeling to Predict Drug-Induced Liver Injury - Hype or Hope” – Kim L. R. Brouwer, Pharm.D., Ph.D.
Spring Dinner Meeting - “Blockbusters on a Repeated Basis: Plausible or Delusional” – Bernard Munos, Founder of InnoThink
Winter Symposium - “Drug-Drug Interactions: What we do and what value it adds”
“Mechanisms of DDI and Preclinical Options”- Christopher C. MacLauchlin, PhD
“How Do We Translate Preclinical and Clinical Research Into Labeling?” - Karen Rowland Yeo, PhD
“Drug-Drug Interactions – A Clinical Development Perspective” - Daniele Ouellet, PhD
“How Do We Use Drug-Drug Interaction Information in the Clinical Setting?” - Amanda H. Corbett, PharmD, BCPS, FCCP
“Are We Getting the Best Return on Investment from DDI Studies?” - Lawrence J. Lesko, PhD, FCP
Link to review of the Symposium by one of our sponsors (Absorption Systems)
2014
Fall Dinner Meeting - “Dermatology: It’s not just about plasma concentrations” – Virginia Schmith
Spring Dinner Meeting - “Can we predict toxicity of reactive metabolites?” – Deepak Dalvie
Winter Symposium - “Does Size Really Matter? Current Drug Development of Large Molecules”
“Complexity of PKPD for Therapeutic Proteins” - Bernd Meibohm, PhD, FCP
“Not your usual antibody stories: Case studies of Fc variants, drug conjugates, unique modes of delivery and the uses of mechanistic modeling” - Jennifer Visich, PhD
“Immunotoxicity considerations for biotherapeutics: Immunogenicity and allergenicity”- Gary R. Burleson, PhD
“Regulation of drug metabolizing enzymes in infectious and inflammatory disease and implications for biological-small molecule drug interactions”- Edward T. Morgan, Ph.D.
“When pharmacodynamics feedback on pharmacokinetics – modeling target-mediated disposition of therapeutic proteins”- Herbert Struemper, PhD