PSMA: Imaging Biomarker Development

Presenters: Michael Groaning, Ph.D. | US Medical Advisor – Prostate Cancer, Novartis

Marco Gottardis, Ph.D. | Vice President of Oncology and Innovation Leader, Janssen

Mark Salvati, Ph.D. | Executive Director, Global Product General Manager, Amgen Oncology Early Development

Phillip Kuo, M.D., Ph.D. | Senior Medical Director, Invicro

Jacob Hesterman, Ph.D. | Founding Partner and Chief Technology Officer, Invicro

Moderator: Matthew Silva, Ph.D. | Chief Executive Officer, Invicro

In this roundtable discussion, the panelists will highlight the role of PSMA-PET imaging biomarkers to help with patient management spanning from early to late disease state. The group will discuss the importance of PSMA-PET as an additional endpoint to shorten the clinical development timelines of novel therapies. Finally, a focus on the technical framework needed to operationalize multi-site studies with PSMA-PET and centralized analysis of the collected data to produce highly impactful response criteria will be covered.

In this discussion, the panel will:

  1. Examine the opportunities and challenges in developing PSMA imaging as a biomarker in clinical trials including patient selection, dosimetry, monitoring response and post-approval
  2. Discuss the advantages and disadvantages of utilizing 68Ga vs. 18F labeled agents
  3. Discuss the hurdles to success, including supply chain and regulatory approval in US/EU/Global

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US Medical Advisor – Prostate Cancer., Novartis

Dr. Groaning attended Colorado State University until 2000 when he moved to Zurich, Switzerland for his post-doctoral studies at the Swiss Federal Institute of Technology (ETH). 

Dr. Groaning started his career in the pharmaceutical industry at F. Hoffmann – La Roche in Basel, Switzerland in their Discovery Chemistry group before transferring to Boulder, Colorado as a process research chemist where he optimized the production of a key intermediate for Tamiflu®.  He finished out his career with Roche back in Basel before taking a job with Endocyte in West Lafayette, Indiana.  While at Endocyte, Dr. Groaning completed the first total synthesis of Tubulysin B which became the warhead of two lead small molecule drug conjugates in Endocyte’s portfolio. 

Dr. Groaning later moved into regulatory affairs where he was the primary author of the CMC sections (Modules 3 and 2.3) for three conditional MAAs which were given a positive opinion by the CHMP before taking over as program lead for their PSMA targeted small molecule drug conjugate.  It was through this program that Endocyte developed their expertise in prostate cancer and lead to the in-license agreement with ABX for PSMA-617. 

Once PSMA-617 was acquired and the pivotal VISION study was started, Dr. Groaning continued leveraging his relationships with KOLs around the world to build a network of experts to develop the clinical plan for PSMA.

In late 2019 he transitioned into his current role as US Medical Advisor – Prostate Cancer.



Vice President of Oncology and Innovation Leader, Janssen Pharmaceuticals

Dr. Gottardis has 25 years experience as a cancer research investigator in both biotech/large pharma and over 29 years of experience overall in translational cancer research. Dr. Gottardis has had a role in the development of multiple drug approvals in his career. These include, the first approval of ERLEADA for non-metastatic castration resistant prostate cancer, the seminal pre-clinical studies leading to the development of Tamoxifen as a chemo-preventive for breast cancer and the approval of SERMS, Retinoid and RXR drugs for cancer while he was a Senior Investigator at LIGAND Pharmaceuticals, San Diego (6 years).

Prior to  Janssen, Dr. Gottardis was Executive Director of Oncology and Immuno-Oncology Research and co-leader of the Oncology Discovery Group at BMS. Here he was an established leader in Oncology Discovery Research for 14 years with efforts spanning exploratory research to IND candidates. 

Dr. Gottardis obtained his BS from Columbia College, Columbia University, his Ph.D. at the Wisconsin Clinical Cancer Center, University of Wisconsin and he completed his post-doctoral fellowship at Vincent T Lombardi Cancer Center Georgetown University. He has co-authored over 100 publications and is co-inventor on multiple patents.Dr. Gottardis is externally recognized as an industry and scientific leader in prostate cancer research and oncology.

In his current role at Janssen, in collaboration with the Data Sciences Group, Dr. Gottardis is exploring new uses of Machine Learning and AI platforms for use in drug discovery and competitive technology landscape analyses. Dr. Gottardis is also working on evaluating and developing new platforms for expansion of the oncology therapeutic pipeline


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Executive Director, Global Product General Manager, Amgen Oncology Early Development

Dr. Salvati has over 28 years of experience in the Oncology field with positions spanning from Synthetic Organic Chemist, Molecular Biologist, Discovery Working Group Leader, Medical Affairs, Early Development Lead, Clinical Biomarker Lead and Clinical Lead.  Dr. Salvati has been involved in the discovery and launch of several Oncology drugs such as gemtuzumab, neratinib, ixabepilone, cetuximab and nivolumab during his tenure at Lederle Laboratories, Wyeth-Ayerst Research, Bristol-Myers Squibb and Janssen Pharmaceuticals.  Over his years in the Pharmaceutical field, he has lead projects spanning across small molecules, antibody drug conjugates, bidirectional antibodies and cellular therapies in both the solid tumor and hematological space. Currently Dr. Salvati is an Early Development Lead at Amgen Oncology managing a portfolio of Bidirectional T-Cell Engager (BiTE®) molecules being explored clinically in the Prostate Cancer, Lung Cancer and Neuroendocrine Cancer areas. 



Senior Medical Director, Invicro

Dr. Kuo is a tenured Professor in the Departments of Medical Imaging, Medicine, and Biomedical Engineering at the University of Arizona. Beyond his academic work, Dr. Kuo has vast experience as a consultant, reader and speaker for CROs and pharmaceutical companies.

Dr. Kuo has authored over 90 publications and has received numerous grants covering a diverse range of disciplines. Dr. Kuo received his A.B. from Harvard University, M.D. and Ph.D. from the University of Virginia, completed his Internal Medicine Residency at UCLA Medical Center, Diagnostic Radiology Residency at Yale New Haven Hospital, and Nuclear Medicine Fellowship at Yale New Haven Hospital.

At Invicro, he supports the design, performance, and analysis of clinical trials and also supports regulatory approval and post-approval activities such as reader training.



Founding Partner and CTO, Invicro

Dr. Hesterman’s team develops novel image processing, machine learning, and modeling methods; as well as image processing tools used to extract quantitative information supporting projects spanning multiple imaging modalities and therapeutic areas.

Prior to joining Invicro, Dr. Hesterman managed Bioscan’s NanoSPECT/CT project in Budapest, Hungary, and served as a visiting scientist in the Frangioni Lab at Beth Israel Deaconess Medical Center, a Harvard Medical School Teaching Hospital.



CEO, Invicro

Dr. Silva is CEO of Invicro and leads the strategic vision and mission to support the the drug discovery and development community.

Dr. Silva holds a PhD in Biomedical Engineering from Worcester Polytechnic Institute and brings 17 years of diverse imaging experience from pharmaceutical and contract research organizations. Prior to Invicro, he was Senior Director of Translational Biology at Vertex Pharmaceuticals, where he ran the imaging and histopathology groups.

Previously, he led imaging groups at Amgen, Millennium and Takeda Pharmaceuticals, focusing on the broad use of imaging biomarkers to support drug discovery and development