Anthony A. Fossa
Dr. Fossa is an independent scientific consultant in preclinical and clinical cardiovascular safety. Fossa Consulting LLC offers an integrated approach when assessing cardiac safety issues.
Dr. Fossa received his Ph.D. in Pharmacology and Toxicology from Purdue University in 1983 and was employed by Pfizer as a Research Fellow from 1986-2008. During his tenure he helped form the General Pharmacology group in Pfizer Discovery in 1988 and conducted in vivo preclinical cardiovascular assessments on over 150 clinical drug candidates and was a key contributor on 5 NDAs.
Dr. Fossa was one of four original founding members of the General Pharmacology/Safety Pharmacology Steering committee that is known today as the Safety Pharmacology Society. He has authored a diverse range of publications related to cardiovascular assessment and has numerous patents related to novel therapeutic modalities. His research focused on the use of the beat-to-beat dynamics and the ECG QT – TQ interval relationship in humans and conscious dogs, to assess arrhythmia liability related to human QT prolongation. He established several in vivo models to differentiate proarrhythmic liability of drug candidates with emphasis on the impact of changes in autonomic tone. In 2007, he moved to Clinical Translational Medicine at Pfizer to set up beat-to-beat analysis for human use. This work was later commercialized by a joint venture with U. Rochester to form iCardiac Technologies where he was Vice President of Cardiovascular Safety until 2014. During that period, beat-to-beat and ECG restitution analyses were used successfully in several regulatory facing clinical studies for drug approvals. In 2014, Dr. Fossa began working independently as a cardiovascular safety consultant through his own company, Fossa Consulting LLC.
The services are:
- Protocol design, implementation, interpretation and reporting of preclinical and clinical cardiac or cardiovascular safety assessment.
- Expertise in continuous electrocardiogram dynamics using QT interval beat-to-beat and ECG restitution analyses (co-inventor and developer).
- Troubleshooting mechanistic cardiovascular issues using preclinical (in vitro and in vivo) and clinical models to define strategy for early decision making.
- Putting new FDA-CIPA cardiac ion channel data into perspective
- Interfacing with Clinical Research Organization for early and late stage development of intensive QT or Thorough QT Studies.
Dr. Rashmi Shah
Dr Shah qualified in medicine in 1970 from the St Mary's Hospital Medical School, University of London, and subsequently specialised in internal medicine and cardiology. He is a Fellow of the Royal College of Physicians and a Fellow of the Faculty of Pharmaceutical Medicine. He is also on the Examining Board of the Faculty. Dr. Shah has over 100 publications within his area of expertise.
He was a member of the team that first characterised CYP2D6 and has authored a number of papers on pharmacogenetics. He also the nominated Expert representing the EU/EMEA at the ICH E14 Topic on QT interval and has advised many pharmaceutical companies on QT-liability of drugs and has authored a number of papers on this subject. He is an honorary fellow of the British Pharmacological Society, a fellow of the Royal Society of Medicine and founding member of the Society of Pharmaceutical Medicine.
At the CPMP level, he was active at the Efficacy Working Party and involved in drafting the CPMP guidelines on drug-drug interactions and clinical trials with cardiovascular medicines, particularly chronic heart failure.
Areas of Expertise:
- EU Regulatory processes and strategies
- Pharmacogenetics in drug development
- Drug-induced QT interval prolongation
- Drug-induced hepatotoxicity
- Evaluating optimal dose and concentrations for Phase III studies
- Mechanisms of adverse drug reactions
- Stereoselectivity in drug development and toxicity
- Addressing drug interactions pre-submission
- Strategies for deregulation of prescription drugs
Kenneth J. Olivier Jr.
Dr. Olivier has been developing drugs for over 15 years and is currently Executive Director of Development at Morphic therapeutics in Waltham, MA. Dr. Olivier’s work experience includes biotechnology and pharmaceutical companies, spending time at Regeneron, Biogen, GlaxoSmithKline, Merrimack, Acceleron and Torque developing diagnostics, small molecule drugs, cell based therapies and biologics for indications in cardiology, neurology, neuromuscular, immunology, rare disease, infectious disease, fibrosis and oncology.
Though his primary duties have been safety evaluations, Dr. Olivier has held the role of Project Leader, Head of Project Management, Head of Regulatory, Head of Pharmacokinetics, Head of Bioanalytical Development, Validation and Sample Analysis and Head of Nonclinical supporting multiple INDs, IMPDs, CTAs, NDAs, BLAs and PLEs. In addition, Dr. Olivier is an adjunct faculty member at Oklahoma State University and has taught drug development courses at OSU, Harvard, MIT and through the American College of Toxicology (former elected Council Member and currently serving on the Editorial Board of the International Journal of Toxicology).
Most recently, Dr. Olivier was elected to serve on Council for the Biotechnology Specialty Section of the Society of Toxicology. Three years ago, he created what is currently the Oklahoma State graduate course on drug development attended largely by faculty, medical and veterinary students. Dr. Olivier’s publications include evaluations of toxicity related to novel therapeutics in immunology and oncology, such as interferons, bispecific antibodies and targeted liposomal nanotherapies. In 2016, he published a book on the development of ADCs covering chapters from discovery through post-market approvals with topics spanning all aspects of drug development, including CMC, Nonclinical, Regulatory and Clinical strategies.
Robert L. Hamlin
DVM, PhD, DACVIM (Cardiology/Internal Medicine), DSP
- Professor Physiology and Pharmacology, Professor Biomedical Engineering, Professor Heart and Lung Institute, Ohio State University
- Professor Emeritus, Ohio State University; Senior Scientist, QTest Labs
- BSc Ohio State University 1956, DVM Ohio State University 1958, MSc Ohio State University 1960, PhD Ohio State University 1962
- Endowed Chair, Cardiovascular Physiology and Pharmacology, Ohio State University, 1962 to 2015
- Mahanna Scholar, American Heart Association
- Career Development Awardee, NIH
- Past President, American College of Veterinary Internal Medicine
- MSc Thesis: Ventricular activation process in quadrupeds.
- PhD Dissertation: Quantitation of mitral regurgitation by double indicator-dilution technology
- Major advisor for 80 PhD and 60 MSc graduated students in physiology/pharmacology, biomedical engineering, nursing,
- More than 50 textbook chapters and more than 500 peer-review publications on: Safety Pharmacology, Langendorff preparations in various species, Clinical Cardiology and pulmonary medicine, Origins of physiological sound (breath, heart, vascular), Models of heart failure, Baroreceptor sensitivity, Myocardial contractility versus ventricular function/ventricular-vascular coupling, Systemic and pulmonary arterial impedance