SMAC - Key Persons
Amira has worked within the anti-infective pharmaceutical industry and most recently for
in vitro diagnostics within clinical microbiology. She has experience interfacing with multiple cross functional teams, such as R&D on relevant future improvements and new assays, as well
as field-based teams to support clinical and laboratory implementation. She worked to help develop research strategies to support evidence generation plans with respect to clinical outcomes and various clinical microbiology projects. She completed her postgraduate training (PGY-1 Pharmacy residency) at the Philadelphia VA & PK/PD Fellowship at the Center for Anti-Infective Research & Development.
Hina is a director level Medical Affairs manager with over 15 years of experience in the pharmaceutical industry. As a Clinical Scientific Director with primary responsibilities of interfacing with external customers both nationally and internationally. Her experience has included working with Business Development on evaluating potential assets, working with Government Affairs on potential legislation, building out a strategy for global expansion of a company, and assisting on the build out of Medical Affairs functions from the ground up with a focus on strategic imperatives and differentiation.
As Executive Vice-President of SMAC, she focuses on strategic planning for small Biotechnology companies to help align the key stakeholders within a company. Utilizing her scientific and medical affairs expertise, she specializes in global scientific strategies, including scientific platform development, publication planning, data gap analysis, and lexicon development.
Hina earned her PharmD at the University of North Carolina at Chapel Hill School of Pharmacy. She also completed a pharmacy practice residency at the University of Virginia Health Sciences in Charlottesville, VA. Hina spent 9 years in clinical practice primarily as a Critical Care Pharmacist (Medical Intensive Care Unit) at Emory Healthcare prior to her experience in the pharmaceutical industry. Her 13 years in the industry have all been in the infectious diseases space with experience at Cubist/Merck Pharmaceuticals, Tetraphase Pharmaceuticals, and most recently, Achaogen, Inc. She has several publications in peer-reviewed journals and authored a book chapter in Rau's Respiratory Care Pharmacology.
Judith is an accomplished pharmaceutical executive with 20 years of experience in biotechnology and small pharmaceutical companies in pre-commercial and commercial settings. She has a strong background in scientific and medical affairs, with expertise in drug development, medical strategy, post-approval research, stakeholder engagement, and tactical execution.
Job Titles:
- Physician
- Senior Consultant
Mike is a Physician and Medical Affairs consultant with extensive experience in oncology and imaging sciences. As part of his research activities, he was involved in clinical applications research involving PET/MRI neuroimaging for glioblastoma, lymphoma, and CNS infections. Recently, he was involved in the study design and protocoling of several oncology projects which utilized next-generation sequencing of circulating tumor DNA with novel imaging applications. As part of this work he is in regular communication with key opinion and thought leaders in order to identify clinical gaps where emerging technology can fill important needs.
Noah has thirteen years of experience across both academia and industry. He cut his teeth in Clinical Operations for both an academic site and sponsors, and has worked in Medical Affairs for the last eight years at small to medium sized pharmaceutical companies. His focus is building Medical Affairs teams for early stage infectious disease, rare hematology, oncology and other rare disease focused companies. This includes helping new organizations build out the infrastructure necessary for pre/peri/post-launch success. With a deep background in IT, he has worked closely with leadership to come up with right-sized systems and solutions for field, medical information, scientific communications and HEOR. He has helped multiple teams roll out and manage solutions like Medical Legal Review Committees, CRMs, Medical Information Call Centers, publications/citation management and library services.
Rolf Wagenaar has over 25 years of marketing, sales, and management experience.
Most recently as Executive Director and Brand Leader of an antibiotic portfolio at Allergan/AbbVie. Prior to joining AbbVie, he successfully led the commercial efforts for cefepime since launch and aztreonam with Élan Pharmaceuticals.
He has extensive launch experience with 8 anti-infective product (re)launches in the US. Rolf has strong relationships within the infectious disease community and is a member of the Society of Infectious Disease Pharmacist (SIDP) and the Surgical Infection Society (SIS). During his career he has moderated over 75 scientific advisory boards, is actively involved in early-stage clinical trial planning, business development, lifecycle strategy, and post marketing strategic data generation.
Rolf has been an invited speaker and panelist at scientific meetings such as ECSMID/ASM, AMR World Conference and BIO and authored several articles on antibiotic development. Growing up in The Netherlands, he holds a BS and advanced teaching degree from The Hague University of Applied Sciences.
Shelley is a highly qualified board-certified medical microbiologist with extensive experience in both clinical and public health microbiology. Over the past four years, she has been employed at an in vitro diagnostics (IVD) company, where she has played a crucial role in various aspects of clinical trials, FDA-regulated studies, and product development.
As a Principal Investigator and Study Coordinator, Shelley has successfully managed FDA-regulated pre-clinical and clinical studies. She has been involved in the development and review of pre-submissions, protocols, and clinical reports, ensuring compliance with regulatory requirements. Shelley's involvement in diagnostic development has allowed her to collaborate extensively with research and development, strategic marketing, and regulatory departments. Her deep understanding of clinical microbiology has been instrumental in providing key insights for company products. She has led over 20 studies, including both sponsor- and investigator-initiated projects, while also engaging in numerous projects with the Clinical Laboratory Standards Institute (CLSI).
Shelley's educational background includes a PhD from the University of Irvine, followed by a 2-year Medical and Public Health Microbiology Postdoctoral Fellowship at UCLA. During her fellowship, she received comprehensive training in various areas of clinical microbiology, including virology, bacteriology, antimicrobial susceptibility testing (AST), and molecular diagnostics.