Gary Connor, R.N.
Chief Operating Officer and Vice President, Clinical Operations
Mr. Connor leads the Embera organization as its Chief Operating Officer in addition to his clinical operations responsibilities, after serving as consulting Director of Clinical Operations at Adnexus, a Bristol-Myers Squibb R&D Company. He has more than 20 years of healthcare experience, with the past 15 years dedicated to clinical operations/project management including: study design, managing budgets and timelines, selection and management of CRO’s, managing staff, developing and implementing patient recruitment strategies, writing SOP’s, CRF Completion Guidelines and other study related documents, and assuring GCP compliance. He has worked in a vast array of indications, primarily with early and emerging companies.
Mr. Connor became a Registered Nurse in 1995 and began his career in pediatrics at Massachusetts General Hospital. He ascended quickly within the hospital’s structure to serve as the First Assistant to the Chief of Pediatric Surgery, Patricia K. Donahoe, MD. In 1999, he founded Asclepius Research Services, Inc. and later co-founded Panacea Clinical Research, a clinical research organization that specialized in the execution of early phase studies. An accomplished healthcare consultant, Mr. Connor was elected to the Maine House of Representatives in 2006 and was twice named “Legislator of the Year”. He left public service in 2010, but currently serves on the Maine Vaccine Board. During his time in the legislature, Mr. Connor served on the Maine Substance Abuse Services Commission and developed a strong interest in treatment for addiction and dependence. He is a graduate (honors) of the Lawrence Memorial Hospital School of Nursing/Regis College program.
Bruce McCarthy, M.D.
Chief Medical Officer
Dr. McCarthy is a drug development and start-up company consultant. Most recently, he was the President and CEO of Afferent Pharmaceuticals, a clinical development stage company developing treatments for pain, bladder and respiratory disorders based upon P2X3 antagonism which was ultimately purchased by Merck in 2016 transaction valued at $1.25B in cash and contingent payments. His experience includes 25 years of neuroscience drug development. At Pfizer, Inc., Dr. McCarthy served as vice president, neuroscience development. Clinicians in his organization obtained approval for Chantix® for smoking cessation. Prior to joining Pfizer, he held various roles at Abbott Laboratories, including venture head, where he managed clinical development programs for neuroscience drug candidates, including ABT-594 (an NNR antagonist for pain) and Depakote. He has previously served as an industry consultant, when Dr. McCarthy served as head of development and chief medical officer for several start-up companies including Embera, developing treatments for neurological and psychiatric disorders. Dr. McCarthy received an M.B.A. from Kellogg School of Management, an M.D. from the Johns Hopkins University School of Medicine and a B.S. in biological sciences from Stanford University. He completed his residency in neurology at the University of California, San Francisco.
Julie Ann Straub, Ph.D.
Vice President, CMC and Nonclinical Development
Dr. Straub directs Embera’s nonclinical development and chemistry, manufacturing and controls (CMC) efforts on a consulting basis. She is an experienced pharmaceutical development consultant working with a range of development stage pharmaceutical and biotech companies from concept through FDA marketing approval for a variety of products.
Dr. Straub has over 25 years of drug development experience, which includes managing IND-enabling nonclinical programs and developing and executing CMC strategies for small pharmaceutical/biotechnology companies. Prior to establishing her consultancy, she served as Executive Director of Research for Acusphere, a specialty pharmaceutical company, including working from concept as an inventor through NDA submission for a cardiovascular imaging agent. Before holding that position she was involved in drug/biologic research and development at Alkermes, and was an NIH postdoctoral fellow at Harvard. For more than 10 years she has been an independent consultant advising medical product companies and academic institutions on areas of product development, CMC, nonclinical studies, regulatory affairs, project management, and specific scientific topics such as drug delivery. Dr. Straub received a B.S. and an M.S. in Chemistry from Caltech and a Ph.D. in Chemistry from MIT.
Ann Robbins, Ph.D.
Dr. Robbins has 25 years of experience providing clinical and regulatory affairs expertise to drug development programs, from preparation of initial IND submissions to regulatory support of marketed products. Trained as a neuroscientist, her therapeutic focus is on drug treatment for central nervous system disorders and neuroendocrinologic drug products for women’s reproductive health. For the past 10 years, she has been an independent regulatory affairs consultant, providing regulatory strategy for global interactions with and submissions to regulatory bodies, lifecycle management and regulatory compliance for marketed products, and regulatory due diligence for product in- licensing and business partnerships.
Prior to becoming a consultant, Dr. Robbins held regulatory affairs leadership positions at Procter & Gamble Pharmaceuticals and Eli Lilly, served as Vice President of Clinical Development and Regulatory Affairs at Thyreos, a startup pharmaceutical company, and provided clinical trial management and regulatory affairs expertise at Organon Pharmaceuticals, and the Population Council, Center for Biomedical Research, a non-profit drug development organization. She received her B.A. in Physiological Psychology from The University of Texas, her M.A. and Ph.D. in Neuroscience from Florida State University.
Lawrence Yarmaloff, RQAP-GCP
Director, Quality Assurance
Mr. Yarmaloff has over 25 years of quality assurance (QA) and clinical operations experience. He provides Good Clinical Practice (GCP) QA support to investigational product programs of small to mid-size biopharmaceutical and medical device companies sponsors.
Mr. Yarmaloff’s GCP QA expertise includes development of quality management systems (QMS) encompassing Standard Operation Procedures (SOPs) and related process documents, training, corrective and preventative action (CAPA) development and implementation, and quality risk management.
Mr. Yarmaloff also supports Sponsor oversight as required by US regulations and international standards by performing qualification, in-process, and directed audits and other quality surveillance activities for Embera’s third party vendors and investigational sites. He also provides Sponsors with regulatory authority inspection readiness support.
Mr. Yarmaloff has maintained a clinical research consultancy for 15 years, with a focus in the past 10 years on GCP QA. Prior to his consulting practice, he worked in the CRO and biopharmaceutical venues for 10 years, including Quintiles, PRA, ImmunoGen, and Diatide. He served roles as a Clinical Research Associate, Program Manager, and eventually as a quality assurance specialist.
Mr. Yarmaloff holds a Bachelor’s Degree in Chemistry from Bates College, Lewiston Maine, and completed post graduate studies in pharmacology. Since 2012, he holds processional certification as a Registered Quality Assurance Professional in GCP (RQAP-GCP) from the Society of Quality Assurance (SQA), and serves as a member of the SQA Clinical Specialty committee.