Faculty and Staff

Janice Weinberg, ScD

Professor, Department of Biostatistics
Boston University School of Public Health

Director, MS in Clinical Investigation
Boston University School of Medicine

Dr. Janice Weinberg is a Professor of Biostatistics in the Boston University School of Public Health.  She is currently teaching the Design and Conduct of Clinical Trials and has taught the Analysis of Correlated Data and Introductory and Intermediate Statistical Analysis in the past.

Dr. Weinberg is the biostatistics consultant to the Department of Medicine and is the primary biostatistician on the Back to Health study in the Department of Family Medicine.  She also serves as a statistical editor for the Journal of the American Heart Association.  Dr Weinberg served as the statistical reviewer for the BUMC Institutional Review Board for nearly a decade and has been the biostatistics member of many data safety monitoring boards for both industry and academic projects.

 

Susan S. Fish, PharmD, MPH

Sue FishProfessor, Departments of Biostatistics and Epidemiology, Boston University, School of Public Health

Dr. Fish has a long history of research in the areas of clinical toxicology and emergency medicine. She has most recently focused on research ethics in general, and application of the federal regulations for waiver of informed consent in certain emergency research circumstances. Issues relating to the design of clinical research and ethical implications of study designs are Dr. Fish’s areas of expertise.

She is the former director of the IRB for the Boston University Medical Campus and Boston Medical Center. She is currently a member of the US Environmental Protection Agency’s Human Studies Review Board.

Stacey Hess Pino, MS, MS

Hess-PinoStacey is the Assistant Director of the MS in Clinical Investigation program at Boston University’s School of Medicine, and the Director of the Graduate Certificate Programs in Clinical Investigation at Boston University’s School of Medicine.

Stacey began her career as an exercise physiologist working in both the fitness and the clinical arenas.  After a number of years, she obtained her graduate degree in research and worked in a variety of clinical research facilities in Massachusetts and in Florida.

In 2000 Stacey  started working at the medical campus at Boston University performing research in the department of cardiology.  She then moved to a position at BUMC’s Institutional Review Board, where she worked for 6+ years as a Senior IRB Analyst II.  After her involvement at the IRB, Stacey moved over to the School of Medicine where she is now involved in the academic side of research.

Amy Aulwes, JD, MPH

Amy has over 17 years of experience providing clinical and regulatory affairs consulting to industry sponsors and academic institutions.  She specializes in regulatory strategy, product submissions and clinical study compliance.  She has worked extensively with medical device, in vitro diagnostic and pharmaceutical companies on FDA submissions and management of clinical studies.  Amy previously served as Vice President at Health Policy Associates Inc. and for the past two years has been an independent consultant.  Amy received her JD from Tulane University in 1991 and her MPH (with concentrations in Health Law and Health Services) from Boston University in 1994.

Laurie A. Halloran, BSN, MS

Adjunct Assistant Professor, Boston University, School of Medicine

With over 22 years of experience in clinical affairs management with contract research organizations and biotechnology companies, Laurie is recognized as an industry expert in improving the organizational effectiveness of clinical research programs with a specialty in gap analysis and strategic planning. Laurie has executed over 25 clinical trials from Phase 1 to Phase 3 for both emerging and established companies and has managed operational budgets of up to $24 MM. Prior to founding Halloran Consulting Group, Laurie spent 10 years at PAREXEL International where she developed worldwide training capabilities with the clinical operations group. She has also established clinical operations at OXiGENE and Antigenics.

Ms. Halloran’s primary research interest is pharmaceutical business process improvement.

Sylvia Baedorf Kassis, MPH

Clinical Research Regulatory Education Manager, Clinical Research Resources Office.  Since 2009, Sylvia has been responsible for providing a variety of services designed to support investigators and study coordinators with the regulations, guidances and policies that apply to their research study activities. These services include regulatory education and training, individual consultation, and support for IRB submissions at BU/BMC.

Sylvia earned her Bachelor of Science from the University of Toronto in 2001, and her Master’s in Public Health in International Health from the Boston University School of Public Health in 2008.  She has over 10 years of clinical research experience, including 4 years of prior regulatory experience as an IRB Analyst at the BU/BMC Institutional Review Board and 6 years of prior clinical research experience coordinating studies at the University of Toronto, UMass Medical School, and the Dana-Farber Cancer Institute. Sylvia is currently the lead investigator on two research projects at BU/BMC. Her research interests include research participant experiences in research, support of study coordinators, the evolution of clinical research ethics, and proper study conduct.

Marina Malikova, PhD, MA

Executive Director of Surgical Translational Research Operations and Compliance in the Department of Surgery, Boston University, Boston Medical Center.

Dr. Malikova has over nine years of experience in the clinical research field.  She has managed Phase I – IV studies involving investigational drugs, devices and biologics (gene therapy, stem cells, and growth factors).  She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Vascular Surgery, Neurosurgery, Cancer Diagnostics and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She has a strong background in biomedical sciences and has completed her postdoctoral fellowship in the field of cell signaling and cell migration.  She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.

In her current role as Executive Director, Dr. Malikova manages research efforts in seven divisions of the Department of Surgery at Boston Medical Center.  She is responsible for clinical trials and basic biomedical research operations, risk management, strategic planning, and macro-management of research programs.  She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff.  She also provides assistance to investigators with protocol and informed consent writing, regulatory submissions, clinical trial agreements and budget development.

Lindsay McNair, MD, MPH, MSB

Lindsay McNair is the Chief Clinical Research Officer and President of Consulting Services for the WIRB-Copernicus Group, the world’s largest provider of regulatory and ethical research review.  Dr. McNair has extensive experience in the pharmaceutical industry working in clinical research and drug development.  Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials.  Dr. McNair is adjunct faculty at Boston University and teaches graduate-level courses on the scientific design of clinical research studies and the development of clinical study protocols.

Dr. McNair graduated from the University of Connecticut School of Medicine and trained in general surgery at Boston University Medical Center. She completed her Master’s in Public Health at Boston University concentrating in Biostatistics/Epidemiology and Health Policy, and her Master’s of Science in Bioethics at Union Graduate College concentrating in research ethics.  She was a member of the Institutional Review Board at Boston University Medical Center, and founded and chaired the Human Subject Protection Committee at Vertex Pharmaceuticals.  Dr. McNair serves on committees including Bioethics International’s World Council on Ethical Standards, and contributes to the Multi-Regional Clinical Trials Center at Harvard.

Juliana Merhaut, MA, CCRP

Juliana is a graduate of Youngstown State University with a BS in Applied Science and Boston University School of Medicine with an MA in Clinical Investigation.  She has over 7 years of research experience.  Juliana began her career in laboratory research at Youngstown State University, where she worked on a diverse portfolio of projects in the areas of comparative anatomy, microbiology, immunology, and biophysics/cardiac dynamics.  A little over 3 years ago she made the transition to clinical research when she began working at Boston University Medical Center.  She has worked on drug, biologic, and device trials in both hematology/oncology and surgical therapeutic areas.  While her entire clinical research career has been in the academic hospital setting, her current position in the Department of Hematology and Medical Oncology at Boston Medical Center has given her the opportunity to work very closely with the pharmaceutical and biotechnology industries.

Mary-Tara Roth, RN, MSN, MPH

Director, Clinical Research Resources Office (CRRO).  As Director of the CRRO, Mary-Tara is responsible for defining the office’s services and overseeing the implementation of those services to support clinical researchers at BUMC. In addition, she works at providing services to investigators and study teams, especially in the areas of regulatory consultation and training. Mary-Tara has worked for the past 10 years in clinical research within an academic setting, first in the context of working as coordinator/project manager/research nurse on a range of research studies, and then in the area of safety and regulatory compliance of research studies as Research Subject Advocate for the General Clinical Research Center (GCRC).  Mary-Tara’s  research interests include clinical research ethics, training, informed consent, study conduct, IRB, and quality assurance in clinical research.

Thomas Travison, PhD

Tom Travison is Assistant Professor of Medicine in the Section of Endocrinology and of Biostatistics at the BU school of public health, and leads the Biostatistical Design and Analysis Core for the Boston Older Americans Independence Center.  His research interests are in the epidemiology of syndromes of aging, and specifically endocrinologic aspects of the development of frailty and functional disability.  Dr. Travison received his PhD (biostatistics) from Johns Hopkins School of Public Health (2002), and has served previously as lead statistician on several large observational studies and clinical trials, including the long-running Massachusetts Male Aging Study (2005-09).

Rita Viegas, Bsc, MA

With 15 years of Clinical Research experience in Biotech, Pharma and CRO, Rita partners with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols. She leverages Phase and operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan and program level strategy. Rita has also independently overseen multiple trials by establishing the operational strategy and securing excellence in execution through the CRO partner. Prior to joining Biogen Idec, she was a Project Manager and Field Manager at Bristol-Myers Squibb/Lantheus Medical Imaging. Rita has also worked as a “GCP”, and “Design and Conduct of Clinical Trials” instructor at Boston University. She obtained her BSc at Kingston University, in UK, and her Masters in Clinical Investigations at Boston University.