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Industry Perspective on First-in-Human and Clinical Pharmacology Strategies to Support Clinical Development of T-Cell Engaging Bispecific Antibodies for Cancer Therapy Nagaraja Shastri, Prathap; Shah, Nirav; Lechmann, Martin; Mody, Hardik; Retter, Marc W.; Zhu, Min; Li, Tommy; Wang, Jun; Shaik, Naveed; Zheng, Xirong; Ovacik, Meric; Hua, Fei; Jawa, Vibha; Boetsch, Christophe; Cao, Yanguang; Burke, John; Datta, Kaushik; Gadkar, Kapil; Upreti, Vijay; Betts, Alison Share Save
An Innovative Approach to Optimize First-In-Human Minimal Anticipated Biological Effect Level Based Starting Dose in Oncology Trials for Bispecific T-Cell Engagers: Experience from A Solid Tumor Bispecific T-Cell Engager Zhou, Di; Kischel, Roman; Stienen, Sabine; Townsley, Danielle; Sternjak, Alexander; Lutteropp, Michael; Bailis, Julie; Friedrich, Matthias; Rattel, Benno; Mehta, Khamir; Upreti, Vijay V. Share Save
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Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper Samineni, Divya; Venkatakrishnan, Karthik; Othman, Ahmed A.; Pithavala, Yazdi K.; Poondru, Srinivasu; Patel, Chirag; Vaddady, Pavan; Ankrom, Wendy; Ramanujan, Saroja; Budha, Nageshwar; Wu, Michael; Haddish-Berhane, Nahor; Fritsch, Holger; Hussain, Azher; Kanodia, Jitendra; Li, Meng; Li, Mengyao; Melhem, Murad; Parikh, Apurvasena; Upreti, Vijay V.; Gupta, Neeraj Share Save
Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program Galluppi, Gerald R.; Ahamadi, Malidi; Bhattacharya, Souvik; Budha, Nageshwar; Gheyas, Ferdous; Li, Chi-Chung; Chen, Yuan; Dosne, Anne-Gaelle; Kristensen, Niels Rode; Magee, Mindy; Samtani, Mahesh N.; Sinha, Vikram; Taskar, Kunal; Upreti, Vijay V.; Yang, Jianning; Cook, Jack Share Save
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An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR-T and TCR-T Cellular Therapies Development Gokemeijer, Jochem; Balasubramanian, Nanda; Ogasawara, Ken; Grudzinska-Goebel, Joanna; Upreti, Vijay V.; Mody, Hardik; Kasar, Siddha; Vepachedu, Venkata R.; Xu, Weifeng; Gupta, Swati; Tarcsa, Edit; Dodge, Robert; Herr, Kate; Yang, Tong-Yuan; Tourdot, Sophie; Jawa, Vibha Share Save
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PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper Kavita, Uma; Sun, Kefeng; Braun, Manuela; Lembke, Wibke; Mody, Hardik; Kamerud, John; Yang, Tong-Yuan; Braun, Inka V.; Fang, Xiaodong; Gao, Wei; Gupta, Swati; Hofer, Magdalena; Liao, Michael Z.; Loo, LiNa; McBlane, Fraser; Menochet, Karelle; Stubenrauch, Kay-Gunnar; Upreti, Vijay V.; Vigil, Adam; Wiethoff, Christopher M.; Xia, Cindy Q.; Zhu, Xu; Jawa, Vibha; Chemuturi, Nagendra Share Save
Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR-T and TCR-T Cell Therapies: An Industry Perspective Mody, Hardik; Ogasawara, Ken; Zhu, Xu; Miles, Dale; Shastri, Prathap Nagaraja; Gokemeijer, Jochem; Liao, Michael Z.; Kasichayanula, Sreeneeranj; Yang, Tong-Yuan; Chemuturi, Nagendra; Gupta, Swati; Jawa, Vibha; Upreti, Vijay V. Share Save
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Targeting wild-type TP53 using AMG 232 in combination with MAPK inhibition in Metastatic Melanoma; a phase 1 study Moschos, Stergios J.; Sandhu, Shahneen; Lewis, Karl D.; Sullivan, Ryan J.; Puzanov, Igor; Johnson, Douglas B.; Henary, Haby A.; Wong, Hansen; Upreti, Vijay V.; Long, Georgina V.; Flaherty, Keith T. Share Save
Risk-Based Pharmacokinetic and Drug-Drug Interaction Characterization of Antibody-Drug Conjugates in Oncology Clinical Development: An International Consortium for Innovation and Quality in Pharmaceutical Development Perspective Li, Chunze; Menon, Rajeev; Walles, Markus; Singh, Renu; Upreti, Vijay V.; Brackman, Deanna; Lee, Anthony J.; Endres, Christopher J.; Kumar, Seema; Zhang, Donglu; Barletta, Frank; Suri, Ajit; Hainzl, Dominik; Liao, Kai H.; Lalovic, Bojan; Beaumont, Maribel; Zuo, Peiying; Mayer, Andrew P.; Wei, Dong Share Save
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Industrial Perspective on the Benefits Realized from the FDA's Model-Informed Drug Development Paired Meeting Pilot Program Galluppi, Gerald R.; Brar, Satjit; Caro, Luzelena; Chen, Yuan; Frey, Nicolas; Grimm, Hans Peter; Rudd, Deanne Jackson; Li, Chi-Chung; Magee, Mindy; Mukherjee, Arnab; Nagao, Lee; Purohit, Vivek S.; Roy, Amit; Salem, Ahmed Hamed; Sinha, Vikram; Suleiman, Ahmed A.; Taskar, Kunal S.; Upreti, Vijay V.; Weber, Benjamin; Cook, Jack Share Save
Physiologically-Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective Heimbach, Tycho; Chen, Yuan; Chen, Jun; Dixit, Vaishali; Parrott, Neil; Peters, Sheila Annie; Poggesi, Italo; Sharma, Pradeep; Snoeys, Jan; Shebley, Mohamad; Tai, Guoying; Tse, Susanna; Upreti, Vijay V.; Wang, Ying-Hong; Tsai, Alice; Xia, Binfeng; Zheng, Ming; Zhu, Andy Z. X.; Hall, Stephen Share Save
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