Therapeutics, Inc. is committed to moving products from concept to commercialization, and all points in between. Collaborating closely with you to set realistic goals and deadlines, we expertly design, create, and execute development programs for FDA registration of topical, oral, and injectable drugs, biologics, and devices.
In addition to designing and managing Phase 1-4 dermatology studies, we maximize your commercial success, supporting management of competitive technologies, regulatory strategy, and compliance, market dynamics, competitive intelligence, reimbursement, product lifecycle, and much more.
A team is only as strong as its leadership – our experience and accomplishments in the field of dermatology speak for themselves.
Tony Andrasfay directly oversees clinical operation activities at Therapeutics. On a day-to-day basis he provides direction and management to Project Managers, Clinical Research Associates and Clinical Administrators. This clinical group is responsible for coordination and execution of all operational aspects of clinical studies, from study start-up to study closure.
Tony has over 20 years of clinical development experience in the pharmaceutical, biotechnology and medical device industries, spanning from first-in-man and proof-of-concept studies to large multi-national registration studies and post-approval studies. He has been instrumental in the successful execution and completion of clinical development programs that have resulted in NDA approvals for three new molecular entities and one drug/device combination product.
Tony received his Bachelor of Science degree in Biological Sciences from the University of California at Irvine. He is also a Chairperson and active member of the San Diego Biotechnology Discussion Group.
Therapeutics’ Vice President HR & Operations, Denise Dwyer, is responsible for general administration, human resources and management of all contracts with business partners, clinical investigators, institutions and vendors. Denise’s solid background in business and healthcare management, and most recently in dermatology, makes her uniquely qualified for her responsibilities at Therapeutics.
Denise has over 20 years of medical management experience in organizations ranging from large multi-specialty organizations to small business and start-up environments. In 1998, Denise joined Dermatology Associates of San Diego as Chief Operating Officer. There she facilitated the start-up of their skin care product company, SkinMedica and served on the executive operating committee responsible for product development, marketing activities and recruitment/training of the sales force. From 1980 through 1998, as Associate Administrator and Associate Director of Clinical Operations, she managed the clinical and business operations for the largest regional outpatient clinic and several outlying satellite clinics for Scripps Clinic and Research Foundation in San Diego. Denise also had her own medical management consulting business, PracticeCareRx, which provided general business and practice management support to solo and small group medical practices.
Denise is a member of the Medical Group Management Association (MGMA) and the Association of Dermatology Administrators and Managers (ADA/M). She earned an MBA in health care management from UOP and a baccalaureate degree in nursing from Marquette University.
Bob Gauthier is responsible for Product Development at Therapeutics, including all aspects of planning, managing, and executing product development, with an emphasis on leading cross-functional project teams to deliver novel products to the dermatology marketplace.
Bob brings significant experience in product development, program and project management and vendor management in a variety of therapeutic and diagnostic areas. Formerly Director of Project Management at Élan Pharmaceutical Drug Delivery Division, he led two global project teams in the early stage development of 2 novel pharmaceutical products. In addition, he was responsible for development of project portfolio management processes and systems and led the team responsible for a significant revision to Élan’s stage-gate development process. Prior to Élan, Bob held positions as Director of New Products and Director of Project Management at Dura Pharmaceuticals. At Dura, Bob led the creation and implementation of a product development roadmap, a comprehensive toolset for the development of new products using cross-functional project teams. He also led project teams in the development of a novel DPI and formulation for asthma, and a combination product for use in COPD and emphysema and performed technology evaluations for potential product acquisitions.
Prior to Dura, Bob was a key member of a start-up focused on closed-loop delivery of heparin. In this role, Bob invented an automated blood sampling system and rapidly advanced the project from design to initial clinical trial. His previous medical device and pharmaceutical background also includes IV pump design, clinical diagnostics instrumentation and various product development assignments at IMED, Baxter Healthcare and Gensia Pharmaceuticals.
Bob holds a Master of Science degree in executive leadership from USD and a Bachelor of Arts degree in mathematics from UCSD.
It was Dr. Dan Piacquadio’s vision that led to the formation of Therapeutics, Inc. in June of 1997. He started Therapeutics as a development business dedicated to the field of dermatology, serving the needs of biotechnology, pharmaceutical and investment communities. His experience in clinical research, medical product development, academia and dermatology practice contribute to his exceptional insight and perspective as President and CEO of Therapeutics.
Dan has been active in clinical research and medical product development since 1985, when he was director of R&D for Oncotherm, a hyperthermia company, and was responsible for regulatory affairs and clinical development. He went on to establish the clinical research program for the Division of Dermatology at the University of California, San Diego and served as director of this facility from 1989 to 1997, during which it became regarded as one of the leading academic product development groups in the United States.
Dan has been instrumental in the non-clinical and clinical development phases of a variety of soft tissue augmentation products including Hylaform (Biomatrix) and played a key role in defining regulatory strategy and clinical development of the first laser-based hair removal technology pioneered by Thermolase. As a consultant to the FDA Generic Drug Group he co-led the development of the current bioequivalency standards for topical steroids.
Dan received a Bachelor of Science degree in biomedical engineering from Rensselaer Polytechnic Institute and his medical degree from the University of Pennsylvania. He received his graduate clinical training at Brown University as an intern in internal medicine and his dermatology training at University of California, San Diego.
Tina Romano is responsible for the financial and accounting operations of the organization as well as corporate governance. She has over 30 years of biotechnology and specialty pharmaceutical industry experience in both privately held and public entities, and has been with Therapeutics, Inc. since 2006.
From 1999 to 2005, Tina served as Controller of Prometheus Laboratories, a specialty pharmaceutical company focused on gastrointestinal, autoimmune and inflammatory diseases and disorders. She was responsible for accounting operations, financial reporting, internal controls, forecasting, purchasing, tax and audit. During her tenure at Prometheus, Tina managed financial aspects of the company’s rapid growth including integration of several acquired and licensed pharmaceutical products, revenue growth in diagnostic testing services and pharmaceutical sales as well as private equity financing. Between 1993 and 1998, Tina held positions of Controller and interim CFO with Trega Biosciences, formerly Houghten Pharmaceuticals, a drug discovery company utilizing combinatorial chemistry in the discovery of novel small molecule drug therapies, and had key roles in several rounds of private equity financing as well as the company’s IPO in 1996. From 1990 to 1993, Tina managed the accounting operations at Advanced Tissue Sciences, a publicly traded biomedical company focused on tissue engineering.
Tina holds a Bachelor of Science in Business Administration and is a Certified Management Accountant (inactive).