Pharm Forum Speakers & Schedule
Pharm Forum Speakers
Keynote Speakers
Russell Weiner, PhD
President, American Association of Pharmaceutical Scientists
Russell Weiner, PhD, FAAPS is a globally recognized leader in the biopharmaceutical field with over 30 years of expertise in drug development, personalized medicine, regulated bioanalysis, and the development of biomarkers and companion diagnostic assays. In his most recent role as VP, Head of Translational Sciences at Alexion Pharmaceutical/AstraZeneca, Dr. Weiner is responsible for rare disease translational strategy, translational research, biomarker development, regulated bioanalysis, companion diagnostics and the rare diseases biorepository. This end-to-end team supports discovery through phase IV life cycle management.
Dr. Weiner earned his PhD in Biochemistry from Albany Medical College. His career includes leading roles in regulated bioanalysis, translational biomarker sciences, and companion diagnostic development at major organizations such as Bristol-Myers Squibb, Merck, Daiichi Sankyo, the Bill & Melinda Gates Medical Research Institute, and Takeda. His work has significantly advanced personalized medicine approaches for cancer. He played a key role in the development of Erbitux® for oncology and contributed to the advancement of several immuno-therapeutics, including the checkpoint inhibitors Orencia® for rheumatoid arthritis and Nulojix® for kidney transplantation. Dr. Weiner was also instrumental in the development and approval of pioneering checkpoint inhibitors, Yervoy® and Keytruda®, including the associated Agilent/Dako companion diagnostic assay, PD-L1 IHC 22C3 pharmDx. An active member of the American Association of Pharmaceutical Scientists (AAPS) for over 30 years, Dr. Weiner currently serves as AAPS President. His past contributions include chairing the Biotech Section, serving as a Member-at-Large on the AAPS Board of Directors, and chairing the AAPS Annual Meeting (PharmSci 360). Known for his sense of humor and dedication to mentorship, Dr. Weiner also serves as Adjunct Faculty in the Department of Pharmaceutics at the University of Florida College of Pharmacy. He frequently travels to universities both domestically and internationally to provide training in soft skills, interview preparation, and career guidance.
Speech Title: Challenges of Conducting Clinical Trials in Low- and Middle-Income Countries: Case Studies on the Importance of Preanalytics
Abstract
Conducting clinical studies, particularly those involving bioassays, presents significant challenges, which are further amplified in low- and middle-income countries (LMICs). While tasks like shipping samples are routine in high-income countries, they often become major hurdles in LMICs, jeopardizing the quality of precious clinical samples. These challenges are compounded by frequent infrastructure failures, such as power outages, water shortages, staffing instability, and protests. Operating outside major cities introduces additional obstacles. Successfully conducting clinical studies in such environments requires constant problem-solving, meticulous attention to detail, a contingency plan, and, above all, a can-do attitude to address the needs of underserved patients. This presentation will delve into the many pre-analytical challenges one must consider using the extreme case of conducting clinical trials in LMICs.
Donghua Yin, PhD
Vice President and Head of Clinical Pharmacology, Pfizer Oncology Division
Donghua Yin, PhD is currently Vice President and Head of Clinical Pharmacology, Pfizer Oncology Division. He has more than 20 years of experience in developing small molecules and biologics drug candidates, mainly in the oncology area. His main expertise is on pharmacokinetics and pharmacodynamics, and their applications in facilitating efficient and quantitative drug development. He has authored over 100 scientific publications and conference presentations and is co-inventor of 10 US patents. He also serves as Adjunct Clinical Professor at the College of Pharmacy, University of Michigan. He received his PhD in Pharmaceutics from the University of Tennessee Health Science Center and completed post-doctoral training at the Ohio State University.
Speech Title: Applications of Model-Informed Drug Development in Oncology
Abstract
Modeling and simulation (M&S) have been an important tool to facilitate efficient and accelerated drug development. The applications of M&S across different stages of drug development have transformed the oncology drug development paradigm, as oncology therapeutics evolved from traditional cytotoxic agents to modern targeted therapies. The current presentation will highlight how various M&S techniques have been used to support preclinical to clinical translation, dose selection and optimization, Go/No Go decisions, and different clinical pharmacology assessments in oncology drug development. Case studies involving the use of M&S to support early- or late- stage development of different modalities of oncology investigational agents will be provided.
Aseem Ansari, PhD
Chair, Chemical Biology & Therapeutics, St. Jude Children's Research Hospital
Speech Title: Chemical Induced Proximity in the Development of New Therapeutics
Aseem Ansari, PhD, is an internationally recognized scientist who has contributed key insights into chemical control of genes and has pioneered the field of “Transcription Therapy”. As the Chair of Chemical Biology and Therapeutics at St. Jude Children’s Research Hospital, his program develops rationally designed synthetic gene regulators (SynGRs) as therapeutic agents for a range of human diseases, including childhood cancers, neurodegenerative disorders, and other catastrophic diseases. In 2017, Dr. Ansari co-founded Design Therapeutics to develop SynGRs as “induced proximity” therapeutics. A first-in-class molecule, DT-216, developed by the startup is currently in clinical development as a treatment for Friedreich’s ataxia. The Lego-like modular assembly of SynGRs has fueled the development of promising therapeutic leads for a growing list of previously undruggable human diseases.
Abstract
Abstract : As genomic campaigns reveal new therapeutic targets, many of these are considered undruggable due to a lack of defined pockets for small molecule binding. Examples include transcription factors, fusion oncoproteins, and unstructured segments of disease-driver proteins. To surmount the difficulties of finding potent and selective therapeutics for such challenging targets new chemical modalities that go beyond the classic “Rules of Five” of drug development are being actively explored. The “beyond the rules of five” strategy is anchored on the resounding success of not-so-small molecules that induce proximity between cellular proteins to drive desired therapeutic outcomes. At St. Jude, engineering small molecules to rationally engage targeted cellular partners is yielding potent, selective and effective bioactive molecules against oncogenic and neurodegenerative targets that have previously evaded chemical intervention. These new therapeutic modalities rely on parallel development of novel means of targeted delivery to diseased cells. These intertwined advances in design of “induced proximity” therapeutics and in the delivery of such complex molecules to target cells/tissues/organs will drive the next phase of drug development. Recent successes, the future promise, and extant challenges will be presented.