Archives: Speakers

Jonathan Riek, PhD serves as the Vice President of Musculoskeletal & Metabolic Imaging for BioTel Research. He has a PhD in Electrical Engineering from the University of Rochester, and his doctoral thesis was on motion and artifact reduction in MRI. He worked on the development of a 3D CT scanner as a postdoctoral researcher, then spent 7 years in the research labs at the Eastman Kodak Company. While at Kodak, Jonathan worked in the areas of motion estimation, frame rate conversion, and video compression. He also served as the liaison between the image science division and the corporate software group. He joined VirtualScopics in 2000 to return to medical imaging and apply his skills interfacing between image science and software. In 2004, he led the development of the system that is still used to run clinical trials and analyze medical images. In his current role, Jonathan has scientific responsibility for all of BioTel Research’s musculoskeletal and metabolic imaging studies, including arthritis, muscle diseases, diabetes, and liver diseases such as NASH and NAFLD. He holds four patents and has published many articles on various topics regarding MRI.

Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. Currently he is the CEO of Certum Bio in San Francisco Bay area. Over the past 30 years his focus has been in the areas of drug substance as well as drug product R&D, manufacturing and outsourcing the small molecules as well as biologics. The therapeutic areas include: Cancer, CV, CNS and infectious diseases. He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). He has been actively involved on both sides of the business in managing CDMOs and CROs.

Of the several programs he worked at Pharma and Biotech companies, three culminated in making to the market [PaclitaxelTM – Bristol-Myers Squibb; SensiparTM – Amgen and DuexisTM – Horizon Therapeutics). As the Founder and Chairman, he spearheaded the ACS ProSpectives international conferences on, ‘Process Chemistry in the Pharmaceutical Industry’, and as the chair, speaker and the moderator at numerous national and international conferences on API Process Chemistry and Drug Discovery & Development. He has been a visiting professor at Catholic U., Louvain, Belgium and U. Pittsburgh, Pittsburgh, PA and visiting speaker at Humboldt U. in Berlin, Germany. In addition to several peer reviewed publications and patents he published two volumes on, ‘Process Chemistry in the Pharmaceutical Industry’ and currently is working on the third volume entitled, ‘Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry’ jointly with the bio-process leaders at Pfizer. Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia.

Antonieta Sosa has over 20 years of experience in the pharmaceutical and biotech industry holding positions in Safety, Regulatory Compliance and Clinical Operations in both small biotech and large pharma.  In her current role as Director in the Clinical Innovation group, she is responsible for leading the strategy and hands-on execution of a portfolio of transformational projects dedicated to driving innovation into the clinical operating model.  She holds degrees in Biology and Health Sciences from the University of Southern California.

Iris Sison is the Director, Head of Clinical Operations at IGM Biosciences, Inc. She has over 15 years of experience with a variety of leadership and technical roles from the site level, CRO to big and small biotech settings. She has experience in clinical trial management across therapeutic areas in Phase I-IV with a strong emphasis on Phase I oncology in Solid Tumors and Hematology Oncology. Iris has led numerous study teams in operationalizing complex multicenter global studies through innovative study design and development. Over the course of her career, she has played a key role in the development of a number of successful new drugs to market e.g. Avastin, Lucentis, Herceptin, Zelboraf, Keytruda, and Ibrance.

Her experience at the site level, CRO and clinical trial management gives her a unique perspective and knowledge for patients, sites and CROs. This insight gives her an understanding of the operational challenges that would need to be managed efficiently and effectively in order to conduct a successful multi-centered global clinical trial. Iris is very passionate about delivering high quality results and continue to strive to be innovative in order to improve the speed and efficiency of drug development and eventually treat and find cures for patients with cancer and other debilitating diseases.

Jill Hacker has over 20 years of direct data management experience in the Biotechnology/Pharmaceutical Industry. She has worked on many Solid Tumor and Blood Related Cancer Clinical Trials over her career. She was part of the Rituxan and Zevalin approvals at IDEC Pharmaceuticals for Non-Hodgkin’s Lymphoma. Her biggest achievement to date has been in the Cell Therapy space where she was one of two data managers vital in obtaining accelerated approval for Yescarta in the United States and Europe. Yescarta is the first CAR T therapy approved for adults living with large B-cell Lymphoma. Jill earned her RN/BSN from Johns Hopkins School of Nursing and also has a Bachelor’s Degree from The University of Pennsylvania in The History and Sociology of Science.

Jim Langford has been a leader in the biopharmaceutical clinical development industry for over 25 years, where he has founded and managed several companies to leadership positions in the industry.  He was the founder and President of The PHOENIX, a Contract Research Organization (CRO) that provided clinical research services to the biopharmaceutical industry, until it was sold in in 2002 to an international CRO based in Canada.  While managing The PHOENIX, Jim founded an electronic data capture (EDC) software company, DataLabs, which was spun out as an independent company in 2001.  DataLabs was one of the leading EDC companies at the time of its acquisition by ClinPhone, Plc. in 2006, which was subsequently acquired by PAREXEL International.  In 2009, he formed a consulting company, White Star Consulting, which provides executive management services within several cell and gene therapy companies to assist them in improving their clinical development process in clinical operations, clinical logistics and how they integrate with manufacturing processes. Jim is currently the Vice President of Clinical Operations for AIVITA Biomedical where he is leading their clinical development with a dendritic cell therapy for indications in glioblastoma, ovarian cancer and metastatic melanoma.

Dr. Rosenberg is a 30 plus year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical and contract research organization sectors. With his diverse background which includes executive management, clinical and regulatory operations, business development, eclinical technology solutions and new product/licensing evaluations, he brings tremendous hands on insights to optimizing the drug development cycle, from the early start-up stage to global product registration across many key therapeutic areas including CNS and oncology.

Dr. Rosenberg is Managing Partner of eP2Consulting, Inc. since 2001. He also currently serves as Head, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society. Dr. Rosenberg received his Ph.D., from the Kellogg Pharmaceutical Clinical Scientist Program, University of Minnesota, College of Pharmacy and his Bachelor of Science, Pharmacy, from the Philadelphia College of Pharmacy and Science.

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Les serves as Vice President of Clinical Development of Erasca, bringing more than 20 years of experience as a scientifically-driven oncology drug developer in early phase clinical development and translational medicine. Les joined Erasca from Neon Therapeutics, where he led the clinical development of the personalized neoantigen vaccine program.  He also led the clinical development of their shared neoantigen vaccine program resulting in the recent filing of the IND for this program. Prior to this, he served as the Program Team Leader of IPI-549, a PI3K-gamma inhibitor, at Infinity Pharmaceuticals. At Infinity, Les was responsible for the strategic and operational aspects of the molecule including the first-in-human study, IND filing and development of the overall clinical strategy. He began his career at Eli Lilly and Company in their early phase Oncology drug development group where he was the clinical lead on multiple programs, responsible for Phase I and II development. Les worked closely with the pre-clinical development teams to optimize the characteristics of the drug development candidates with a focus on clinically relevant biomarkers.

He earned his Ph.D. in Medical Biophysics from the University of Toronto.