Therapeutics, Inc. prides itself on being a leader in the field of dermatology. Our experience and accomplishments speak for themselves. Please take a moment to review our team profiles.
Tony Andrasfay, Vice President, Clinical Development
Denise Dineen Dwyer, RN, BSN, MBA, Vice President HR & Operations
Bob Gauthier, MS, Vice President, Product Development
Charles E. Holland, PhD, Executive Advisor, Corporate Development
Dan Piacquadio, MD, President, CEO & Founder
Tina B. Romano, BS, CMA, Vice President, Finance
Department Head Profiles
Dwain K. Allen, MS, MPH , Director, Quality and Regulatory Compliance
Timothy B. Crosson, Sr. Director, Business Development
Maria Eller, MS, RD, CCRP, Sr. Director, Clinical Operations
Eric Feffer, MBA Director of Clinical Operations
Mary Beth Ferdon, PhD, Sr. Director, Data Management & Statistics
Garet Heintz, BS, Director, Regulatory Affairs
William H. Ralston, PhD, Sr. Director, Licensing and Business Development
Becky Tong, MS, Sr. Director, Regulatory Affairs
Dan Piacquadio, M.D., President, CEO & Founder
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.
Dr. Piacquadio 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.
Dr. Piacquadio 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.
Dr. Piacquadio 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.
Charles E. Holland, Ph.D., Vice President, Corporate Development
Charles E. Holland, Ph.D., Vice President, Corporate Development, identifies and evaluates business opportunities and establishes licenses and collaborations for Therapeutics. Dr. Holland brings a broad base of scientific and business expertise, having been intimately involved in the development and/or partnering of several dozen pharmaceutical products.
Prior to joining Therapeutics, he led the U.S. Business Development group of Élan Pharmaceuticals. From 1996 to 2000, Dr. Holland headed the arthritis, pain and inflammation section of the worldwide licensing group at Searle Pharmaceuticals (acquired by Pharmacia), where he participated in crafting and executing the COX-2 (Celebrex & Bextra) partnership and out-licensed another COX-2 inhibitor for use in veterinary medicine. From 1981 to 1995 at Glaxo Inc., he held various executive positions in clinical research (Zantac), development project planning and management, human resources and strategic planning. He oversaw development, FDA submission and approval of eight dermatologic products during his last five years at Glaxo as group director of dermatology business and product development.
Dr. Holland earned a Bachelor of Science degree in biology (chemistry minor) from Albright College, Reading, PA and a Ph.D. in zoology (endocrinology) from Rutgers – The State University, New Brunswick, NJ. He also held NIH post-doctoral fellowships in biochemistry (St. Louis University Medical School) and pharmacology and cardiothoracic surgery (University of Illinois at the Medical Center). Professional memberships include the American Academy of Dermatology and Licensing Executives Society
Tina B. Romano, BS, CMA, Vice President, Finance
Tina Romano is responsible for the financial and accounting operations of the organization as well as corporate governance. She has over 25 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 BS in Business Administration, is a Certified Management Accountant and a member of the Institute of Management Accountants
Denise Dineen Dwyer, RN, BSN, MBA, Vice President HR & Operations
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, M.S., Vice President, Product Development
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.
Tony Andrasfay, Vice President, Clinical Development
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.
Maria Eller, Sr. Director, Clinical Operations
Maria Eller is responsible for developing and maintaining the infrastructure of all clinical operations functions through providing leadership, management and direction of the Clinical Team. This includes supervision, management and training of clinical research associates and clinical administrative staff to ensure the effective, on time completion of clinical projects with drugs and devices.
Maria has over 15 years in clinical research. Prior to Therapeutics, she held project management positions in private and academic clinical research centers. During the past five years, she served as Senior Clinical Project Manager at Therapeutics, Inc. She was responsible and accountable for several clinical trials and managed all aspects of clinical development projects to ensure effective and ongoing communication of the clinical development activities and on time regulatory submission.
Maria holds a BS and MS in Nutrition and Dietetics, is a Registered Dietitian and a Certified Clinical Research Professional (CCRP) with the Society of Clinical Research Associates (SoCRA).
Eric Feffer, MBA, Director, Clinical Operations
Eric Feffer is responsible for oversight and support at Therapeutics pertaining to clinical operations/workflow management, management of active projects, and clinical personnel. This includes the development and implementation of work instructions and standard operating procedures, project scheduling and ongoing status review, mentoring of clinical operations personnel, and the supervision, management, and training of clinical monitors.
Eric has over 20 years of clinical research experience, including extensive expertise in clinical operations and clinical project management. Prior to joining Therapeutics, Eric was a Director of Project Management at Agility Clinical, where he was responsible for departmental direction, operations management, personnel supervision, mentoring, and training; as well as clinical trial management and project oversight.
Eric received his Bachelor of Science degree in Biopsychology from the University of California at Santa Barbara, and his MBA from the University of Southern California.
Timothy B. Crosson, Sr. Director, Business Development
As Sr. Director, Business Development, Tim Crosson maintains extensive knowledge of the current pharmaceutical industry. He leads business development activities at Therapeutics: building and sustaining key customer relationships, identifying new business opportunities, and negotiating business contracts from first contact to fulfillment. Tim integrates components from clinical, finance, corporate functions and third party vendors into cohesive RFP-directed proposals. He also oversees the development of marketing materials, surveys and client communications, as well as representing the Company at all trade shows.
Tim Crosson has over 14 years of experience in commercial operations, trade relations and strategic planning in the pharmaceutical and diagnostic industries. He has proven success leading cross-functional teams, managing operational initiatives including sales and marketing planning and commercialization of multiple new-to-market products. He received his Bachelor of Arts in Business Administration (concentration in Finance/Entrepreneurship) at Point Loma Nazarene University in San Diego, CA.
Dwain K. Allen, MS, MPH, Director, Quality and Regulatory Compliance
Dwain Allen’s primary role is to oversee quality and regulatory compliance for all product and/or clinical development activities at Therapeutics, and to provide support for the Regulatory Affairs Department with respect to development of drugs, biologics and devices from the investigational phase to post marketing.
Dwain has worked in the pharmaceutical industry for over 30 years in a variety of capacities, including positions in QC, chemistry, clinical research, regulatory affairs, professional services, and QA. Dwain earned his B.S. degree in Chemistry and Biology (dual major) from Northern Arizona University; an M.S. degree in Nutritional Sciences from the University of Arizona; a Post-Baccalaureate Certificate in Hazardous Materials Management from the University of California, Los Angeles; and a Master of Public Health (M.P.H.) from National University.
Garet Heintz, BS, RAC, Director, Regulatory Affairs
As Director of Regulatory Affairs, Garet Heintz is responsible for the lifecycle management of all regulatory applications, including new IND/NDA Applications, Annual Reports, Amendments, and coordinating FDA meetings. Garet represents many of our clients as their authorized regulatory agent and serves as FDA’s primary point of contact. In this role, Garet has successfully managed multiple new IND submissions and NDA approvals. Garet also provides regulatory strategy support that includes product positioning, optimizing regulatory pathways, intelligence research, and general consultative advice.
Garet brings 15+ years of experience in the pharmaceutical industry. Prior to joining TI, Garet has worked in a variety of regulatory roles of increasing responsibility that cover all phases of product development from pre-IND to commercial launch and marketing. Garet also brings a strong understanding of electronic submissions that has enabled TI to offer eCTD services to our clients. Garet earned his B.S. degree in Biology from San Diego State University and has maintained his Regulatory Affairs Certification since 2008.
Becky Tong, MS, Sr. Director of Regulatory Affairs
Becky Tong is responsible for defining/assessing regulatory strategies, interacting/negotiating with Health Authorities, managing regulatory submissions, conducting regulatory intelligence research, and ensuring regulatory compliance. She brings 25 years of pharmaceutical research and development experience including a decade in worldwide regulatory affairs. Her past regulatory responsibilities covered various stages of product development, from pre-IND to post marketing life cycle management of new molecular entities and biologics in many therapeutic areas, as well as generic and orphan drugs.
Prior to joining Therapeutics, Becky was an Associate Director of Regulatory Affairs at Chugai Pharma USA where she managed registration strategies and directed day-to-day regulatory activities for the oncology, cardiovascular and dermatology projects. She was also a project leader, and prepared/reviewed regulatory-related company policies/ SOPs/guidelines.
During her 25-year tenure with Pfizer in Michigan (Formerly Pharmacia/Upjohn), Becky held different positions in regulatory affairs, project management and planning, and the research departments. From 1994-2003, she was a senior regulatory manager responsible for numerous INDs, NDAs, MAAs and international dossiers in the anti-infective, dermatologic, cardiovascular, reproductive, metabolic, and anti-viral areas. These included worldwide responsibilities of CLEOCIN T (clindamycin topical solution, gel, and lotion) for acne vulgaris, CLEOCIN Vaginal Cream/Ovule for bacterial vaginosis, and the original NDA submission of CAMPTOSAR for colorectal cancer. From 1980 to 1994, she held a senior position in project planning and managed project development timelines and milestones for products such as XANAX, MOTRIN, and ROGAINE. During her early years with Upjohn, she also conducted research on prostaglandins and worked at the research clinic.
Becky received a Master of Science degree in Biology from University of Akron in Ohio and held a Hematologist Certificate from the American Society for Clinical Pathology (ASCP) Board of Registry. She also took MBA courses at Western Michigan University, co-authored several research papers, and presented at professional meetings.
William H. Ralston, Ph.D., Sr. Director, Licensing & Business Development
Dr. Ralston has business development and contract development and management responsibilities for the Corporate Development and Clinical Development groups within Therapeutics Inc. Corporate Development activities include participation in the drafting, review and/or negotiations of licensing, product co-development collaborations and miscellaneous other agreements with external business entities. He serves as the internal lead on a variety of intellectual property activities and is the primary interface with external IP counsel. Clinical Development activities involve the development, negotiation, mediation and management of contracts with external sites, sponsors and vendors.
Bill has over 25 years of broad base experience in the pharmaceutical and medical device industries, working early on as a pharmaceutical toxicologist and subsequently in technology assessment and business development. He has evaluated the safety, efficacy and commercial viability of both development stage and commercial pharmaceutical and medical device products. Prior to joining Therapeutics Inc., Bill was Director of R&D Business Development at Élan Pharmaceuticals where he identified, evaluated and negotiated late research-stage and early clinical-stage therapeutic in-licensing opportunities. During his 1984-2000 tenure at Mallinckrodt Inc. as Director of Technology Assessment, he worked on the development and implementation of corporate level strategic technology growth plans. As Associate Director of Technology Planning he identified and evaluated in-licensing opportunities and directed collaborative extramural research programs. He initially joined Mallinckrodt as a Research Toxicologist where he directed pre-clinical GLP pharmacology and toxicology studies. Bill has also consulted with a number of early stage biotech companies on business development matters.
Bill earned a Ph.D. in Biomedical Sciences (focus on toxicology) and an M.S. in Biological Chemistry at Wright State University and a B.S. in Biology at Bowling Green State University; both in Ohio. He is the inventor on seven patents, an author on 13 scientific manuscripts and is an active member of the Licensing Executives Society.
Mary Beth Ferdon, Ph.D., Sr. Director of Data Management & Statistics
Dr. Ferdon is responsible for statistical analysis and data management for all phases of clinical trials carried out by Therapeutics. She also supervises the daily activities of the data entry/management team.
Dr. Ferdon has over 18 years of experience in the pharmaceutical industry. Prior to Therapeutics, she was president of FASTAT, Inc., a data management company that provided services to the pharmaceutical industry for Phase I-IV clinical trials. In this capacity, she managed protocol and case report form development, created and integrated statistical reports for individual protocols and assisted with NDA submissions.
Dr. Ferdon earned her Ph.D. in biometry at the Medical University of South Carolina. She was an assistant professor in the department of statistics at the University of Central Florida, where she taught courses on the introduction to statistics and biostatistics. Dr. Ferdon is a member of the Drug Information Association, Biometric Society and American Statistics Association.