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Webinar: State of the Art in Clinical Transporter DDI Evaluation

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Originally Hosted:
Thursday, June 13, 2019
11:30am – 12:30pm EDT

State of the Art in Clinical Transporter DDI Evaluation

This presentation summarized the state-of-the-art in transporters in drug development based on four recent ITC3 whitepapers (Clin Pharmacol Ther 104, October 2018).

  • Transporters in drug development based on four recent ITC3 whitepapers
  • Overview of emerging transporters of clinical relevance
  • Best practice in design of clinical DDI studies through recent advances
  • Consideration for optimal selection of clinical probe drugs, including future potential utility of transporter biomarkers

Absorption Systems partnered with GSK to provide you with the most relevant and applicable research in Transporter DDI Evaluations

Presenter:
Maciej J. Zamek-Gliszczynski, PhD
Senior Fellow and Director, DMPK, GlaxoSmithKline

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About the Presenter: 

Maciej Zamek-Gliszczynski has 13 years of industry (Eli Lilly and GSK) experience in supporting DMPK and PK/PD aspects of oncology, endocrine/metabolic, and infectious disease programs at all stages between discovery, clinical development, and post-marketing. He is currently leading Quantitative Drug Disposition, a world-wide group responsible for mechanistic understanding of PK and DDIs in the GSK portfolio. Dr. Zamek-Gliszczynski’s research is focused on clinical PK/PD and DDI implications of drug and metabolite transport. He is the author of >100 manuscripts and presentations on this subject (>4,500 cites, h-index = 31). He serves on the editorial boards of Pharmaceutical Research and Drug Metabolism and Disposition. Dr. Zamek-Gliszczynski is a member of the International Transport Consortium (ITC) steering committee, was past chair of AAPS PPDM section and AAPS Drug Transport FG, as well as GSK management representative on IQ TALG. He has been active in organizing DMPK/clinical pharmacology meetings, including several AAPS and ITC/ASCPT Workshops. Dr. Zamek-Gliszczynski lectures in graduate-level PK/PD courses and serves as external committee advisor (including as adjunct prof at UNC). He enjoys developing scientists and has an established mentorship record at the associate scientist, junior and peer Ph.D., as well as graduate student and post-doc levels.

Presentation: In Vitro Relative Potency Assays for Commercialization of Gene Therapy Products

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Presentation:
In Vitro Relative Potency Assays for Commercialization of Gene Therapy Products


Originally Presented:
Monday, April 29, 2019
ASGCT Annual Meeting
Washington, DC

Presenter: Karen Doucette, MBA
Director of Operations, ACF Bioservices

What you will learn:

  • Considerations for in vitro potency assay development for gene therapy products with complex MOA(s)
  • Case studies demonstrating expression and functional activity in genetically modified cell lines
  • Long term considerations for the potency assay approach – R&D through commercialization and lot release

Due to popular demand, this presentation is an expanded version of Karen’s ASGCT presentation, providing a more comprehensive look at the approach for potency assay development and validation, along with case studies detailing tools, technologies, and challenges.

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Characterization of angiographic features and validation of a chronic wet AMD rabbit model induced by DL-AAA

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Characterization of angiographic features and validation of a chronic wet AMD rabbit model induced by DL-AAA
Vatsala Naageshwaran, John Quach, Nicholas Cook, Kayla Martinez, Ashley Renteria, Jenny Walters, Andrew Zhao, Jeffrey Parsons, Dinh Albright, Christian J. Hissom, Matthew Lyulkin, Scott Womble, Nurith Amitai-Crawford, Glenwood Gum, Sandeep Kumar
Ophthalmology Department, Absorption Systems, San Diego, CA

This poster was presented at ARVO, April 2019

DL-2-aminoadipic acid (DL-AAA), a retinal glial (Müller) cell toxin, has been shown to induce retinal neovascularization (RNV) and chronic retinal vasculature leakage after intravitreal (IVT) administration. Here, we have extensively characterized DL-AAA induced angiographic features in Dutch Belted (DB) rabbit eyes and established suitability of this model to test anti-neovascular therapies.

Increased Expression of IGFBP2 Induces RPE and Photoreceptor Degeneration at Senescence

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Increased Expression of IGFBP2 Induces RPE and Photoreceptor Degeneration at Senescence
Sandeep Kumar; Amrita Fnu; Mackenzie Parker; Glenwood Gum; Vatsala Naageshwaran; Yingbin Fu
Absorption Systems, San Diego, CA; Cullen Eye Institute, Houston, TX

This poster was presented at ARVO, April 2019

Insulin like growth factor binding protein 2 (IGFBP2) belongs to a highly conserved family of insulin-like growth factor (IGF) binding proteins that modulate IGF-1 actions. IGFBP2 locus 2q33-q34 is linked to glaucoma related traits. In addition, elevated levels of IGFBP2 have been detected in the vitreous and aqueous humor of neovascular eye diseases. Here, we performed in vivo imaging, histological and functional analysis of a transgenic mouse line (TgIGFBP2) overexpressing human IGFBP2.

The Effect of NaI on Stromal Loading, Distribution and Degradation of CXLO Corneal Strengthening Solution after Topical Application and UVA Exposure in New Zealand White Rabbits

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The Effect of NaI on Stromal Loading, Distribution and Degradation of CXLO Corneal Strengthening Solution after Topical Application and UVA Exposure in New Zealand White Rabbits
Gum, Glenwood; Rubinfeld; Parsons, Edward
Absorption Systems, San Diego, CA; Georgetown University Medical Center, Washington, DC; Washington Hospital Center, Washington, DC; Re:Vision, Rockville MD; CXL Ophthalmics, LLC Encinitas, CA

This poster was presented at ARVO, April 2019.

The purpose of this experiment was to validate in vivo the corneal penetration and photo-stabilization of riboflavin in solution with Sodium Iodide (NaI) and to evaluate effect of NaI on the persistence of Ribostat™ (riboflavin 0.5% & sodium iodide 0.015%, CXL Ophthalmics) using recommended clinical procedures for corneal collagen cross-linking during application and UVA exposure in New Zealand White rabbits.