Patagonia Pharmaceuticals is a private, family-owned company founded in 2013 to address the unmet medical needs of people with rare and serious dermatological conditions. The FDA defines a “rare disease” as any disease affecting less than 200,000 people in the US. Rare skin diseases are among the most neglected therapeutic areas in the pharmaceutical industry. Over 450 different rare skin diseases have been identified, and yet there have been only 17 FDA Approvals for 8 different rare dermatological conditions since the Orphan Drug Act was passed in 1983.
Co-Founder & CEO
Jonathan Rome is an executive and entrepreneur with more than 35 years of experience in the pharmaceutical industry. In 1989, Mr. Rome joined Zenith Laboratories, Inc. as the Executive Vice President of the team assembled to bring the Company out of bankruptcy. In less than 5 years, Zenith grew from $28 million in sales to over $250 million leading to the Company’s acquisition by Ivax Pharmaceuticals, Inc. for $600 million in 1994.
In 2000, Mr. Rome started ThePharmaNetwork (TPN), LLC, an API procurement and product development company with offices in New Jersey, Connecticut, Shanghai, and Rome. Ascend Laboratories, LLC, a wholly owned subsidiary of TPN, was started in 2003 as a generic pharmaceutical development and sales & marketing company. Ascend became the third fastest growing generic drug company in 2011 (IMS Health), and in 2012, TPN and Ascend were acquired by Alkem Laboratories, Ltd. Mr. Rome has also served as Chairman of the Board at Crown Laboratories, Inc., a fully integrated specialty pharmaceutical company focused on topical dermatological products.
Mr. Rome has been diagnosed with X-linked ichthyosis and has suffered from various skin conditions throughout his life. He has the unique perspective of being both a patient and stakeholder to the orphan drug industry.
Co-Founder & President
Zachary Rome is a science educator turned inventrepreneur. He has been focused on healthcare since 2011 and has two drug delivery systems, three Rx drugs, and one medical device currently in development. He’s the lead inventor on all of Patagonia’s products and is responsible for the day-to-day management of the Company. Zach served as Vice President, Business Development and Executive Vice President before becoming President in 2017.
Prior to 2011, Zach was a middle school science teacher and the Founder and Executive Director of The Schooba Academy, a nonprofit after-school program that taught students from low-income communities science through scuba diving. Zach has degrees in Marine Science and Biology from the University of Miami and an MST in Adolescent Science Biology from Pace University. Zach is a NYC Teaching Fellow, the Grand Prize Winner of the 2041 International Teachers' Contest (sponsored by Random House), a PADI OWSI Instructor, a First Aid/CPR Instructor, and a former volunteer Emergency Medical Technician. Zach has worked and/or traveled in over 50 countries and all 7 continents.
Edward Ciolkowski, Ph.D.
Vice President, CMC Development
Dr. Edward Ciolkowski, Ph.D. is Vice President of CMC Development at Patagonia Pharmaceuticals. His responsibilities include providing both strategic and tactical solutions for the scientific, technical, and project management aspects of Patagonia's product development programs. Ed also currently serves as the Vice President of CMC Development and Outsourcing at Syner-G Pharma Consulting.
Ed has over 20 years of experience in the pharmaceutical industry in various aspects of CMC development. Prior to joining Patagonia, Ed was Director of Global Pharma Technical Services at Bausch & Lomb, with responsibility for all R&D Analytical and Process Engineering activities supporting the pharmaceutical product pipeline. In this role, Ed provided leadership for pharmaceutical product and manufacturing process development applying science and risk-based approaches and Quality-by-Design principles. He was also responsible for the project and portfolio management of post-approval changes supporting the company’s US and EU manufacturing sites. Earlier in his tenure at Bausch & Lomb, Ed had responsibility for leading CMC technical development teams for both NDA and ANDA ophthalmic drug products, and also for managing the clinical material supply chain for pharmaceutical and medical device clinical programs.
Ed began his career in 1993 at The Upjohn Company providing analytical method development expertise and later, both analytical chemistry and formulation leadership for the company’s veterinary medicine business. In 1998, he moved to the company’s human health business and switched his focus to solid-oral dosage forms. There he led a function responsible for the integration of biopharmaceutics, formulation design, process capability and regulatory science to support and justify the selection of the dissolution/drug release test methods, the bridging of formulation and process changes during the development cycle and the final drug product specifications. Ed earned his Ph.D. in Analytical Chemistry from the University of North Carolina at Chapel Hill in 1993 and a bachelor’s degree in Chemistry from Wabash College in 1988. His work has resulted in nine publications and two patents. He is a member of the American Association of Pharmaceutical Scientists (AAPS) and the American Chemical Society (ACS) and has been an invited speaker at the AAPS National Meeting, USP/Industry forum and at the Midwest Clinical Supply Group National Meeting.
Robert A. Frasco, JD, CPA
General Counsel & Vice President of Finance
Robert Frasco is an attorney and financial executive with over 30 years of experience in the pharmaceutical, multimedia, and food manufacturing industries. As General Counsel and Vice President of Finance, Robert is responsible for legal, financial, and tax strategy for the Company.
Prior to joining Patagonia, Robert was the Vice President, Tax Counsel at Taro Pharmaceuticals, an international pharmaceutical company specializing in the development, manufacturing, and distribution of prescription and OTC drug products. As head of global taxation, Robert was responsible for all international and domestic tax planning and transfer pricing policies, strategy, and management. Taro’s annual sales grew from approximately $300 million to $1 billion during the time Robert was with the Company.
Robert previously spent 15 years as the Vice President, General Counsel and Corporate Secretary at Devon Group, Inc., a publicly traded advertising and multimedia company. During Robert’s tenure, Devon more than doubled in growth, held an IPO in 1986, and sold to Applied Graphics Technologies Inc. for $460 million in 1998. Robert has also served as the Chief Financial Officer of a privately-owned food manufacturing and distribution company. Robert earned his law degree at Albany Law School of Union University, is a member of the New York State Bar Association, and is a Certified Public Accountant.
Vice President, Business Development
As Vice President of Business Development, Joshua is tasked with identifying, qualifying, and managing industry relationships to help the Company execute its goals. He brings unique expertise to Patagonia, formerly holding multiple Business Development and Operations roles at Adobe Systems. Prior to joining Patagonia in 2015, Joshua was a Business Development Manager at Adobe, where he was a key member of the team responsible for launching and scaling the Digital Publishing Suite. The Digital Publishing Suite went on to become one of Adobe’s fastest growing products and an integral component of their core offerings, allowing Joshua to gain valuable experience learning the intricacies of growing a new venture within an existing corporation. He has broad international experience and has forged partnerships with a global portfolio of internal and external stakeholders.
Joshua graduated from the Robert H. Smith School of Business at the University of Maryland with a degree in Business Management. During his tenure there, he spent his summers working in his father’s businesses, ThePharmaNetwork and Ascend Laboratories, attending industry conferences and familiarizing himself with the pharmaceutical industry.
Jonathan K. Wikin, MD, FAAD
Founding Director (retired), Division of Dermatology and Dental Products, FDA
Jonathan K. Wilkin, MD, the founding director (retired) of the Division of Dermatology and Dental Products at the US Food and Drug Administration, remains active in regulatory matters after over 12 years of FDA service which included membership on the FDA’s Dermatology Drugs Advisory Committee. Before going to the FDA, he was Director of Dermatology at the Ohio State University and Professor of Pharmacology and Medicine. He has over 130 publications in dermatology and clinical pharmacology.
Dr. Wilkin received his BA and MS in zoology from Ohio State University in Columbus, followed by his medical degree from the Ohio State University College of Medicine. After a year of residency in obstetrics and gynecology at the University of Louisville, School of Medicine in Kentucky, he completed a residency in dermatology at the University of Tennessee Health Science in Memphis, where he was Chief Resident.
Dr. Wilkin has served as chairman of the medical advisory board for the National Rosacea Society from 1998 to 2012 as well as having chaired their Expert Committees on the Classification and Staging System for Rosacea. He also has served on the American Academy of Dermatology’s (AAD) Ad Hoc Task Force on the Academy’s Efforts with FDA and on their Environment and Drugs Committee. Dr. Wilkin has been active in the American Society for Clinical Pharmacology and Therapeutics, having chaired the Dermatologic and Allergic Diseases Section and the Constitution and By-laws Committee for several years, as well as serving in other capacities.
Dr. Wilkin is a fellow of the AAD, a member of the American Dermatological Association and board certified by both the American Board of Dermatology and the American Board of Clinical Pharmacology.
Peter Elias, MD
Professor, Department of Dermatology, UCSF; Staff Physician, VAMC - San Francisco
Peter M. Elias, M.D. is a Professor in the Department of Dermatology at the University of California San Francisco, and a Staff Physician at the Veterans Affairs Medical Center, San Francisco. He received his medical degree from the University of California San Francisco and trained in dermatology at Harvard University. Dr. Elias has authored or co-authored over 600 peer-reviewed scientific articles and review articles, and he has edited or co-authored three books on the subject of the skin barrier in health and disease. He is an invited speaker at national and international scientific meetings, and has been a consultant to the pharmaceutical and cosmetic industries.
Dr. Elias has contributed to the present wealth of knowledge on both the structure and myriad functions of mammalian stratum corneum. His pioneering research since the 1970's has dispelled the myth of the stratum corneum as a "dead, keratinized, basket-weave" structure, to establish the iconic "brick and mortar" model. Through his efforts, the stratum corneum is now viewed as a metabolically active, two-compartment composite that functions as a biosensor. The resultant "outside-in" concept of the barrier as a prime mover in the pathogenesis of cutaneous disease has also been a highlight of his work, with the paramount role of skin barrier dysfunction in disease pathogenesis now widely recognized.
Over the past 30-plus years, Dr. Elias' lab has been the destination for more than 70 young investigators, representing multiple countries, a trend that still continues to enrich the field of academic dermatology with an armamentarium of techniques and disciplines on the cutting edge of science on epidermal structure and function. Dr. Elias continues to mentor his vast network of associates and postdoctoral fellows, past and present, several of whom have achieved leadership roles in academia and industry the world over.
Marlene Haffner, MD, MPH
Former Director of the Office of Orphan Products Development at the FDA;
CEO, Haffner Associates, LLC
For 20+ years, Dr. Haffner was the Director of the Office of Orphan Products Development at the Food and Drug Administration. In addition to assisting in the development of more than 300 products in the US, she is credited with assisting in the development of programs in Japan, the European Union, Australia, and beyond and in focusing attention on rare diseases and the need for therapy world-wide. Trained as an internist and hematologist, Dr. Haffner graduated from the George Washington University School of Medicine and did further training at the Columbia University School of Medicine and the Albert Einstein College of Medicine, in New York City. She received her Masters of Public Health from the Johns Hopkins Bloomberg School of Public Health in Baltimore.
Following her tenure at FDA, Dr. Haffner served as Executive Director, Global Regulatory Intelligence and Policy for two years at Amgen, the largest biotech company in the world. Dr. Haffner has worked in the Washington, DC metropolitan area for more than 30 years. She has seen many changes in the regulatory environment during that period of time and is both sensitive and knowledgeable about politics and the political landscape. She knows “FDA think” and maintains close ties with her friends and colleagues in the agency.
Developing Treatments for Rare Dermatological Diseases
Gary W. Wolfe, PhD., D.A.B.T.
Principal Toxicologist, Gary Wolfe Toxicology, LLC
Dr. Wolfe is a board-certified toxicologist with over 35 years of experience in the conduct of nonclinical toxicology studies, director of nonclinical laboratories, and preparation of regulatory submissions and documents. He received his M.S. and Ph.D. in pharmacology and toxicology from Purdue University in 1976 and 1978, respectively. He is a member of the Society of Toxicology, American College of Toxicology, and Teratology Society. He has made over 40 presentations at the annual meetings of the Society of Toxicology and American College of Toxicology and has authored numerous manuscripts.
He served as study director on many nonclinical studies intended for FDA or EPA submissions as well as holding positions of increasing responsibility in both technical and management roles at Hazleton Laboratories (now Covance) and TherImmune Research Corporation (also known as R.O.W. Labs and GeneLogic Labs). At TherImmune he served as Chief Scientific Officer and Senior Vice President. He also served as the Principal Investigator for the National Toxicology Program’s General Toxicology and Reproductive Assessment by Continuous Breeding Programs for over 15 years.
Dr. Wolfe has designed drug development programs for small molecules and biologics and identified and placed nonclinical studies at various domestic and international contract research laboratories. He has also authored the nonclinical sections of numerous regulatory documents, e.g., IND, NDA, position papers, for submission to the FDA.