eLearning Seminar
Practical Considerations for the Nonclinical Testing of Specialty Oncology Biotherapeutics

Speaker Bios

Sanela Bilic, PharmD, MBA

Dr. Sanela Bilic is a highly respected professional with proven leadership skills and 18 years of broad experience within pharmaceutical drug development. She has extensive hands-on experience with all phases of drug development globally. Sanela possesses broad knowledge of drug development principles and practice ranging from target identification to early proof of concept, to tox interrogation, to IND, to early clinical development and to mature development of small and large molecules. She is especially focused on development of immuno-oncology therapeutics and ADCs. Sanela has also guided teams through the development of CAR T-cell, armed T-cell, and NK cell therapies. In addition, Sanela has extensive regulatory interaction experience with all major global health authorities.

After obtaining a Doctorate in Pharmacy and an MBA, Sanela completed a 2-year fellowship in Drug Development from SUNY at Buffalo and Novartis Pharmaceuticals in Oncology. She started her professional life in the Oncology clinical pharmacology department at Novartis. Following Sanela’ exponential professional as well as personal growth with Novartis, she joined D3 Medicine (now Certara) as a Senior Director, Clinical Pharmacology. During her years at Novartis and Certara (D3 Medicine), Sanela was an integral part of development team with extensive experience as the clinical pharmacology representative for global regulatory authority interactions. Sanela has worked as a clinical pharmacology leader between research and early development, early development, and late development, and has led due diligence efforts from clinical pharmacology perspective to aid in thorough assessment of business development opportunities. Sanela has led the clinical pharmacology strategic development of numerous assets from preclinical development/research stage to end of phase 2 and beyond. Sanela uses a unique problem-solving approach, applied in Pharma and with global regulatory agencies (FDA, EMEA, PMDA), resulting in high rate of successful solutions. She has a track record of anticipating problems and resolving them early and am responsible for nonclinical and/or clinical PK sections of over 50+ pre-INDs, INDs and IMPDs.

Frank Brennan, PhD

Dr. Frank Brennan is currently an Executive Director in the Department of Preclinical Safety (PCS), at the Novartis Institutes for Biomedical Research in Cambridge, Massachusetts (but working form his UK home). Frank works across the Novartis Biologics Portfolio, with a focus on ImmunoOncology. He has over 30 years’ experience in the immunology, immuntoxicology, immunogenicity and safety assessment of biologics in academia, the CRO Industry (HLS, now Labcorp, UK), small biotechnology companies, mid-size Pharma (Novo Nordisk, UCB) and large Pharma (AstraZeneca and Novartis). This work has led to over 75 publications in peer-reviewed journals and books. Frank is a past Chair of the Biotechnology Innovation Organization (BIOsafe) Leadership Committee and is currently an active member of a number of external industry and academic initiatives and consortia. Frank has a Bachelor of Science Degree in Immunology from the University of Glasgow (Scotland), a PhD in Immunology and Microbiology from the University of Edinburgh (Scotland) and held a Postdoctoral position in Immunology/Rheumatology at Rush Medical Center in Chicago.

Mary Ellen Cosenza, PhD, DABT, ATS, ERT, RAC

Dr. Mary Ellen Cosenza is a regulatory toxicology consultant with over 35 years of senior leadership experience in the biopharmaceutical industry in the US, Europe, and emerging markets. During her 20-year tenure at Amgen, she was an Executive Director of Regulatory Affairs and Safety and had several leadership roles included head of US Regulatory, head of Emerging Markets Regulatory and Safety and Therapeutic Area lead for Inflammation and Early Development. Previous to her roles in Regulatory Affairs, she served as the Senior Director of Toxicology at Amgen. Prior to joining Amgen, she served as a Principal Scientist in Toxicology for the Medical Research Division of American Cyanamid Company (now Pfizer).

Mary Ellen is recognized as an expert in preclinical biologic drug development and is a founding member of BIO’s BioSafe Preclinical Expert group. She was also a member of an Expert Working Group, operating under the auspices of the International Conference on Harmonization (ICH) for ICH M3(R2). Mary Ellen is well published in the field of biological drug development. Mary Ellen is a Past-President of the American College of Toxicology (ACT) and is currently the Treasurer of the International Union of Toxicology (IUTOX). She is also an adjunct professor at the University of Southern California. Mary Ellen received her BA in Biology and Chemistry from Queens College, CUNY and her MS and PhD in Toxicology from St. John’s University, New York, and her MS in Regulatory Science from the University of Southern California, Los Angeles.

Michelle Coulson, PhD, ERT

Dr. Michelle Coulson earned her PhD in Molecular Toxicology from the University of Surrey, UK. She is currently a Toxicology Project Leader in the department of Preclinical Safety at Novartis Institutes for Biomedical Research in Cambridge, Massachusetts. She has over 19 years of experience in preclinical safety assessment in the pharmaceutical industry supporting a diverse range of small molecules, monoclonal antibodies, bi-/tri-specific antibodies and antibody-drug conjugates. Dr. Coulson holds a board certification from the ERT.

Patricia Ryan, PhD

Dr. Patricia Ryan has over 25 years of experience in the biopharmaceutical industry with an emphasis on nonclinical safety testing of biologic therapeutic agents including monoclonal antibodies, gene and cell therapy, oncolytic viruses and vaccines. Currently she is the Strategic Toxicology Lead for Vaccines and Immune Therapies and leads nonclinical safety for this therapy area in AZ R&D. Prior to that she directed activities of project toxicologists in AZ Oncology Safety and before that directed toxicology in Biologics Safety Assessment at MedImmune.

Previously, Dr. Ryan was Director of Toxicology and Pharmacokinetics at Entremed, Inc. Prior to joining Entremed, Dr. Ryan directed preclinical safety and managed three centralized laboratories (Cell and Molecular Biology, Laboratory Animal Sciences, and Histology) at Genetic Therapy, Inc. (a Novartis company). Dr. Ryan obtained her bachelor’s degree in chemistry with a specialization in biochemistry at The University of Virginia and earned her master’s degree and PhD in chemistry from The Johns Hopkins University. She trained as a postdoctoral scientist at SmithKline Beecham (now GlaxoSmithKline). Dr. Ryan is currently on the Executive Council of the American College of Toxicology serving as Secretary and has been an active member of ACT since 2004. She is a member of the Society of Toxicology (SOT) and the American Society of Gene and Cell Therapy (ASGCT). She represents AZ on the IQ Consortium DruSafe Leadership Group.

Marque Todd, DVM, DABT

Dr. Marque Todd is a board-certified regulatory toxicology expert. Dr. Todd trained as a veterinarian and completed post-doctoral work in molecular immunology and cancer biology. She has more than 25 years of experience working in the biopharmaceutical industry. Dr. Todd has extensive nonclinical development experience with a variety of biologic modalities including monoclonal antibodies, bi-specific antibodies, Fc and other fusion proteins, antibody-drug conjugates, cytokines/interleukins, protein replacement therapies, nanoparticles, cell therapies, oncolytic viruses, and therapeutic vaccines. Dr. Todd has been involved in the preparation and submission of nonclinical sections of early and late-stage regulatory documents including INDs and BLAs/NDAs and has participated in numerous successful health authority meetings.

Dr. Todd is currently a regulatory toxicology consultant to several large, mid-size and small biopharma companies. Prior to becoming an independent consultant, Dr. Todd was a Research Fellow at Pfizer and served as a Principal Scientist at Amgen and Chiron. Dr. Todd also served as an Adjunct Professor with the University of California San Diego Extension, where she co-taught a course on nonclinical toxicology and drug development with sessions focused on the nonclinical development of biotherapeutics and oncology products.