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.

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, 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.

Dr. Sydney H. Dromgoole oversees and manages all clinical research activities at Therapeutics. His experience in clinical research runs from conception and development of study protocols through regulatory approval.

Formerly, the Director of Clinical Development for Miravant Medical Technologies in Santa Barbara, Dr. Dromgoole led the development of a topical photosensitizer through to Phase II testing in patients with plaque-type psoriasis. In 1993, Dr. Dromgoole served as head of clinical development at Oclassen Pharmaceuticals, San Rafael. During this time, potent topical steroid formulations, a wound-healing gel and several other products were approved.

From 1983 to 1991, he held increasingly elevated positions in the skin care division of Allergan Pharmaceuticals Inc., where he developed clinical protocols, set up sites, monitored clinical studies, supervised clinical staff and played a lead role in the development and ultimate regulatory approval of a unique sunscreen formulation. In addition, he evaluated potential business opportunities in the skin care field. In 1980, as adjunct associate professor of medicine at University of California, Los Angeles (UCLA) he was responsible for developing methods to measure the levels of anti-rheumatic drugs in biological fluids. He also served on the Committee on Human Studies at the Wadsworth VA Medical Center in West Los Angeles.

Dr. Dromgoole conducted post-doctoral research on musculoskeletal disease at the Division of Rheumatology, Department of Medicine at UCLA, backed by a Muscular Dystrophy Association of America scholarship. He was an assistant research rheumatologist and was a co-investigator in several pharmacokinetic drug studies.

Dr. Dromgoole received his Ph.D. in medicine at the University of Auckland in New Zealand. He has more than 40 scientific publications to his name, has made presentations to FDA advisory committees and various scientific meetings and has been an affiliate member of the American Academy of Dermatology since 1991.

Tina Zietzke is responsible for the financial and accounting operations of the organization as well as corporate governance. She has over 19 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.

Therapeutics’ Executive Director of 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.

Brendan Fowler, Director of Business Development, Clinical establishes and manages new client relationships and is responsible for the day to day clinical business development and marketing needs of the company.

Brendan has over 10 years of clinical research, management and business development experience.  He has managed clinical studies within North America, Central and South America, the United Kingdom, Western Europe, Israel and Australia.

Brendan was most recently with PRACS Institute, Ltd., serving the business development and marketing needs of the Phase II-IV Dermatology Division.  He was also previously with the Premier Clinical Research Group (aka, Therapeutic Management) as Director of Business Development and Director of US Operations where he established and grew a full service CRO with operational hubs on the East and West Coast and a decentralized network of regional employees serving the needs of companies, ranging from 'top 20' pharma to 'early stage' biotech companies.  He has also held independent consultant positions with Abbott Laboratories and The Coronary Prevention Group and worked with East Kent Hospitals Trust in a Senior Dietetic position.

Brendan holds a Nutrition/Biology B.Sc. (Hons) degree from The London Metropolitan University.

Bob Gauthier is responsible for project management infrastructure, systems and processes, as well as for leading product development at Therapeutics. He focuses on the leadership of cross-functional project teams, as well as project management systems and process development to increase velocity and quality of the services provided.

Bob brings 20 years of medical device and pharmaceutical experience in the areas of project and portfolio management, systems engineering, contractor management and product development in a variety of therapeutic and diagnostic areas. Formerly director of project management at Elan Pharmaceutical Drug Delivery Division, he led development of project portfolio management processes and systems and a team responsible for a significant revision to Elan’s product development process–a stage-gate process with defined criteria for project funding, reporting, and execution. Additionally, he led two global teams involved in early-stage product development efforts.

Prior to Elan, Bob held positions as director of project management and director of new products 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, where he defined hardware, software and disposable device elements. In this role, Bob invented an automated blood sampling system and rapidly advanced the project from design to initial clinical trial. His previous background also includes IV pump design, clinical diagnostics instrumentation and various medical device 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 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

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.

Joseph A. Tami, Pharm.D., Director, Scientific Affairs provides expertise to Therapeutics in medical writing, project management and scientific support. Dr. Tami brings a broad base of scientific knowledge, having been intimately involved in both basic and clinical research for over 20 years. He has actively participated in translational research projects for academia and industry.
 

Prior to joining Therapeutics, Joe was at Isis Pharmaceuticals for nine years as part of the Clinical Drug Development team. He held positions as Operations Manager, Director of Clinical Drug Development, and Project Team Leader in inflammatory bowel disease and dermatology. He was also involved in a variety of clinical trials in the anti-inflammatory arena, including renal transplantation and rheumatoid arthritis. He developed several clinical protocols for patients with plaque-type psoriasis.

He has written clinical sections of regulatory submissions including INDs, annual reports, NDA, as well as NIH grants that were funded to support translational research. He has more than 25 scientific publications to his name and has made presentations internationally at various scientific meetings. Professional memberships include the American College of Clinical Pharmacy and the American Association of Pharmaceutical Scientists.

Dr. Tami earned a Bachelor of Science degree in genetics from the University of California , Davis and a Doctorate of Pharmacy from the University of Southern California . He completed a 2-year clinical residency at the University of Kentucky in Lexington , and subsequently completed a 3-year post-doctoral fellowship in immunology / oncology at the University of Texas Health Science Center in San Antonio (UTHSCSA). Dr. Tami remained in San Antonio as a UTHSCSA faculty member in the Department of Medicine, Hematology. He served as the Director of the Bone Marrow Transplant Laboratory until 1995, with adjunct faculty appointments in Oncology and Clinical Pharmacy.

Dr. Ralston is responsible for systematically assessing the scientific and commercial viability of technologies and products.  He also provides technical guidance on non-clinical pharmacology and toxicology studies.

Bill's broad base of experience in the pharmaceutical and medical device industries includes 14 years experience as a toxicologist and over 13 years experience in technology assessment and business development.  He has evaluated the safety, efficacy and commercial viability of both development stage and commercial products.  Prior to joining Therapeutics Inc., Bill was Director of R&D Business Development at Elan Pharmaceuticals where he identified and evaluated 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 developed and implemented 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 joined Mallinckrodt as a Sr. 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 toxicology and an M.S. in biochemistry 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.

Greg Solz provides leadership, management and direction to the Therapeutics organization with the design and implementation of all internal procedures and Quality System Management processes.  Greg is a valuable member of the Therapeutics management team.  His responsibilities include development of crucial decision-making processes to support Therapeutics product development and clinical efforts.  He also directs quality activities in other areas such as internal compliance and vendor due diligence.

Greg has over 10 years of experience in Clinical Quality Assurance and over 15 years experience in Manufacturing Quality Assurance.  He has an extensive background in organization and maintaining certifications under ISO 9000, 9001, and 13485.  He has held Quality Management, Management Representative/Head of Quality, and U.S. Head of Quality Assurance positions at Dura Pharmaceuticals, Magellan Laboratories, Genetronics Incorporated and Chiltern International.

His experience includes managerial responsitility for Quality Assurance and Quality Systems development, financial and administrative operations of domestic and international Quality programs.  In addition, Greg has coordinated and managed cross-functional project teams, developed large Quality System development proposals and budgets, as well as assisted in development of multiple novel investigational products requiring unique regulatory, intellectual property and marketing pathways.

Greg earned a Bachelor of Science degree in Management from San Diego State University and holds CQA and CQM certifications from the Society of Quality Assurance.

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.