Brickell’s management team is comprised of seasoned executives with substantial life science industry experience gained from organizations ranging from start-ups to global pharmaceutical giants. During their respective careers, each person has participated in the building of pharmaceutical companies and the development of numerous drugs that have been successfully brought to market.
Patricia S. Walker, M.D., Ph.D.
President and Chief Scientific Officer
Patricia Walker, M.D., Ph.D. is a Board-Certified Dermatologist and Pharmaceutical industry expert specializing in the fields of medical and aesthetic dermatology. Dr. Walker is at the forefront in the arena of medical and aesthetic dermatology.
Dr. Walker previously served as Chief Medical Officer of Kythera Biopharmaceuticals, Inc. from May 2007 until March 2013. From 2004 to 2007, Dr. Walker served as Executive Vice President and Chief Science Officer at Allergan Medical (formerly known as Inamed Corporation). Prior to that experience, from 1997 to 2004, Dr. Walker held positions of increasing responsibility at Allergan Inc., a biomedical company, where she ultimately served as Vice President, Clinical Research and Development for skin care pharmaceuticals. Over the past 10 years, Dr. Walker was involved in key product approvals in dermatology and aesthetic medicine including the development and approval of Tazorac®, Azelex®, Avage®, BOTOX® Cosmetic, Hylaform®, Captique®, JUVEDERM®, Bioenterics®, LAP-BAND® and Inamed® Silicone gel-filled Breast Implants, and Kybella.
Dr. Walker received an M.D. and a Ph.D. in Physiology and Biophysics from the University of Iowa. Dr. Walker completed a residency in Dermatology and a research fellowship in the Dermatology Branch, National Cancer Institute at the National Institute of Health. Dr. Walker is an active Committee Member for the American Academy of Dermatology (AAD), is a member of the American Dermatologic Association and holds medical licenses in Iowa and California. Dr. Walker also maintains a practice located in sunny Santa Barbara County.
Co-Founder, Chief Executive Officer and Director
Mr. Hardy has successfully built an array of pharmaceutical companies. Prior to co-founding Brickell, Reginald was the co-founder and President of Concordia Pharmaceuticals, Inc. an oncology drug development company acquired by Kadmon Corporation in 2011. Mr. Hardy was co-founder and President of SANO Corporation, a pharmaceutical company focused on the development of novel transdermal drug delivery systems that was acquired by Elan Corporation. Prior to SANO, Mr. Hardy served as the President of the generics group at IVAX Corporation. Reginald has also held various corporate roles with Hoechst-Roussel Pharmaceuticals, Inc. and Key Pharmaceuticals, Inc. Mr. Hardy earned his B.S. degree in Pharmacy from the University of North Carolina—Chapel Hill and M.B.A. from UNC-Greensboro.
Co-Founder and Chief Operating Officer
Mr. Sklawer has been involved in a number of development-stage companies and prior to co-founding Brickell, he served as the Head of Operations at Concordia Pharmaceuticals, Inc., an oncology drug development company acquired by Kadmon Corporation in 2011. Prior to Concordia, Mr. Sklawer held various positions with increasing responsibility at Verid, Inc., a developer of security technology prior to and subsequent to its acquisition by EMC Corporation. Mr. Sklawer holds a B.S. degree in Marketing from the University of Florida and received his M.B.A. from the University of Miami.
Deepak Chadha, M.S., MBA, RAC
Chief Regulatory, Preclinical and Quality Compliance Officer
With more than two decades of regulatory experience, Deepak Chadha is responsible for leading the development and implementation of Brickell Biotech’s regulatory, preclinical and quality compliance efforts.
Mr. Chadha's regulatory experience encompasses regulatory submissions and projects for drugs, biologics, medical devices and combination products for clinical and marketing applications to the FDA, the EMA, as well as the global regulatory agencies. Prior to Brickell Biotech, Mr. Chadha held the role of Vice President, Global Regulatory Affairs at Suneva Medical. During his tenure, Mr. Chadha led the regulatory approval for BELLAFILL® dermal filler for acne scar correction and supported the company’s commercial products life cycle management. Before Suneva, Mr. Chadha worked at KYTHERA, where he successfully led their lead product KYBELLA® from an early clinical phase to an NDA stage, and also supported the ex-US regulatory activities. Mr. Chadha has also served as Vice President of Global Regulatory Affairs at Allergan Medical, helping build the organization’s Global Regulatory Affairs department, and was involved with the approval for JUVEDERM®, Bioenterics®, LAP-BAND® and Silicone gel-filled Breast Implants. In addition, his career has included positions of increasing responsibility at Biomeasure Inc. (IPSEN) and Stryker Biotech.
Mr. Chadha holds a BS in Pharmaceutical Sciences from Berhampur University in Orissa, India, an MS in Pharmaceutics from Hamdard University in New Delhi, India, and an MBA in International Business from California State University, Dominguez Hills.
Lawrence Romel, M.S.
Senior Vice President, Clinical Operations
Lawrence Romel has over 20 years of drug development experience in clinical and project management for multiple therapeutic indications.
Mr. Romel previously served as Vice President of Clinical Operations at Cascadian Therapeutics (aka Oncothyreon Inc.) and also served as Chief Science Advisor and Vice President of Product Development for TranSenda International, a clinical operations software company. Prior to TranSenda, Mr. Romel served as Vice President of Clinical Operations and Project Management of Xcyte Therapies Inc., Supergen and Onyx Pharmaceuticals. His breadth of experience includes the development of biologics (GVAX), viral therapies (ONYX-015), toxin-sourced therapies (Ziconotide™), small molecule-based therapies (Orathecin™, Decitabine), liposome encapsulated drug therapies (DOXIL™, Amphotec™), drug delivery devices and hospital/medical devices. He has managed Phase III development programs in both North America and Europe.
Mr. Romel holds a Master of Science degree in Chemistry from the University of Illinois, Chicago and is certified in Project Management through U.C. Berkeley.
John J. Koleng, Ph.D., R.Ph.
Senior Vice President, Chemistry, Manufacturing, and Controls
John J. Koleng is a registered pharmacist with more than 17 years of experience in the pharmaceutical industry, specializing in product development, drug delivery technology and current Good Manufacturing Practice (cGMP) for clinical trial supplies and commercial products. Dr. Koleng co-founded AlphaVektor, LLC, a life sciences development and industrialization consultancy in 2007. Prior to AlphaVektor, John was co-founder and Chief Operating Officer of PharmaForm from 1996-2007, a contract development and manufacturing organization, where he successfully grew the company to over 120 individuals in an FDA qualified 40,000 sq. ft. facility he helped build and validate. John holds a B.S. degree in Pharmacy and a Ph.D. in Pharmaceutics, both from the University of Texas at Austin. Dr. Koleng also holds an Adjunct Assistant Professor of Pharmaceutics appointment and serves on the UT College of Pharmacy Dean's Advisory Council.
Charles J. Betlach, II, Ph.D.
Vice President, New Product Development
Dr. Betlach is a long-time veteran in the pharmaceutical industry. Dr. Betlach was a Director of Concordia Pharmaceuticals, Inc. and a private investor. From 1991–1998, Dr. Betlach was co-founder and Executive Vice President, Research and Development of SANO Corporation. Prior to SANO, Dr. Betlach held various senior research positions at Key Pharmaceuticals, Inc. and Schering-Plough Corporation. Dr. Betlach has an MS degree in Cellular Biology from the University of California Santa Barbara and a PharmD in Pharmacy and a PhD in Pharmaceutical Chemistry from the University of California San Francisco and has spent a number of years in academia before moving to the pharmaceutical industry. Dr. Betlach has over 25 publications in peer reviewed journals in different areas of molecular biology, pharmacogenetics, drug discovery and clinical studies.