Company

OUR VISION

Brickell is a clinical-stage pharmaceutical company focused on the development of innovative and differentiated therapeutics for the treatment of skin diseases. Our management team and board of directors have extensive experience in product development and commercialization, having served in leadership roles at several pharmaceutical and successful start-up companies.

Our strategy is to leverage this experience to in-license, acquire, develop and commercialize products that we believe can be successful in the global dermatology marketplace. Our current pipeline consists of new molecular entities with relevant mechanisms of action in skin diseases, targeting significant market opportunities in the global dermatology market.

Vibrant

Brickell prides itself on bringing fresh, innovative ideas to the pharmaceutical industry. Our dynamic team strives to provide patients young and old with novel and differentiated therapies for the treatment of skin diseases.

Innovative

We seek to develop new technologies and differentiated therapeutics to help people with underserved dermatologic conditions. Our current pipeline features novel molecular entities with similar mechanism of actions that will revolutionize the treatment of skin diseases.

Experienced

We’re intently focused on targeting major opportunities in the global dermatology market. Brickell’s leadership team has a proven track record of success in drug development that backs up this mission.

Efficient

Brickell deploys resources and energy strategically, maximizing our positive impact on the therapeutic treatment of every patient we treat. We’re able to achieve these results by working with a diverse, well-rounded team featuring a diverse, specialized skill set.

Collaborative

Brickell embodies the power of teamwork. We know when diverse individuals unite and collaborate together in pursuit of a shared vision, the result is vastly more powerful than the sum of its individual parts.

LEADERSHIP

Robert Brown

Chief Executive Officer

Rob Brown joins Brickell as Chief Executive Officer, after having spent over 30 years at Eli Lilly and Company, where he most recently served as chief marketing officer (CMO) and senior vice president of marketing from 2009 through 2018. As CMO, Brown was responsible for building and leading marketing capabilities across Lilly’s pharmaceutical business units, including diabetes, oncology, emerging markets and Lilly Bio-Medicines.

Prior to his role as CMO, Brown held the position of vice president and chief marketing officer for Lilly USA from 2007 - 2009, where he partnered with the business units to ensure Lilly continued to develop industry leading marketing capabilities, streamline and improve marketing processes, and transform marketing by building a consumer marketing center of excellence.

From 2003-2007, Brown was the executive director of marketing for the Intercontinental region, including responsibility for Europe. As the head marketer for Lilly’s international operations, Brown was responsible for the marketing of all Lilly products outside the United States.

Brown previously served as the global marketing director for Cialis and Lilly ICOS, a 50/50 joint venture between Lilly and ICOS Corp from 1999-2003. Brown oversaw the global marketing strategy for the first competitor to Viagra and influenced the product development to ensure maximum market value. In 2004, Cialis was awarded Best Brand Launch of the Year by the Pharmaceutical Marketing Congress.

In addition, Brown held a variety of other leadership roles of increasing responsibility within Lilly’s sales, marketing and product management departments, including serving as general manager for Lilly China, where he helped Lilly establish its presence. During his tenure as GM, he managed a joint venture in Suzhou, oversaw the construction of Lilly’s first manufacturing facility and expanded the affiliate’s reach from 12 to 45 cities. Notably, Brown also helped establish STC Corporation, a generic subsidiary for Lilly, and served as its first president.

Brown joined Lilly in 1985, after receiving a bachelor’s degree in economics from DePauw University and a master’s in business administration from Indiana University. Brown currently serves on the board of trustees of Franklin College.

Andrew Sklawer

Co-Founder & Chief Operating Officer

Andy Sklawer has 15 years of experience in building and operating development-stage companies.

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. Andy currently serves as a Board Member for StartUp FIU and on the Advisory Committee of the Advancing Innovation in Dermatology Accelerator Fund.

Deepak Chadha, M.S., MBA, RAC

Chief R & D Officer

With more than two decades of regulatory experience, Deepak Chadha is responsible for leading Brickell’s R&D organization.

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.

R. Michael Carruthers

Chief Financial Officer

Mr. Carruthers has over 20 years of experience in serving as the Chief Financial Officer for publicly-traded pharmaceutical companies.

Mr. Carruthers previously served as Interim President of Nivalis Therapeutics (Nasdaq: NVLS) beginning in January 2017 and Chief Financial Officer and Secretary since February 2015. From December 1998 to February 2015, he served as Chief Financial Officer for Array BioPharma (Nasdaq: ARRY). Prior to this, his professional experience included Chief Financial Officer of Sievers Instrument, treasurer and controller for the Waukesha division of Dover Corporation and accountant with Coopers & Lybrand. Mr. Carruthers received a B.S. in accounting from the University of Colorado and a M.B.A. from the University of Chicago.

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.

Herbert R. Brinkman, Ph.D.

Vice President, Chemistry, Manufacturing and Controls

Dr. Brinkman brings more than 25 years of drug development experience in CMC activities ranging from early product development to commercial launch.

Prior to joining Brickell, Herb served as Director, Research and Development at KVK Tech where he oversaw the development of ophthalmic, injectable, and topical products. Previously, he was Vice President of Product Development at TOLMAR, Inc. where he was responsible for directing the formulation development, analytical development, and process engineering teams for TOLMAR’s topical dermatology and parenteral products. Prior to joining TOLMAR, Dr. Brinkman was a CMC a consultant for various small and midsize pharmaceutical companies specializing in the development of topical products. He was also Director of Product Development at Tapestry Pharmaceuticals, Inc. and NaPro BioTherapeutics, Inc. where he led the development of novel APIs and formulations in various therapeutic areas. Herb began is pharmaceutical career at Hoffmann-LaRoche, in the Pharmaceutical Process Development group, where he was involved in the development and scale up of 4 NDA products, including Xedola® (Capecitabine) and Rocaltrol® (Calcitriol).

Dr. Brinkman holds a BA in Chemistry from Rutgers University and a Ph.D. in Organic Chemistry from Seton Hall University.

Michael P. Doyle, Ph.D.

Vice President, Global Regulatory Affairs

Dr. Doyle has worked in the pharmaceutical industry for over 23 years with the last 15 years in Regulatory Affairs.

Prior to Brickell, Dr. Doyle served as Senior Director, Regulatory Affairs at Clovis Oncology where he was responsible for Regulatory Affairs strategy and operations in support of oncology clinical trials in the US, Canada, and the EU. Prior to joining Clovis, Dr. Doyle was Global Head of Regulatory Affairs at Novella Clinical, a clinical research organization specializing in oncology, where he was responsible for all aspects of regulatory support. Before Novella, Dr. Doyle held senior management positions in Regulatory Affairs at OSI Pharmaceuticals and Array BioPharma.

Before moving into Regulatory Affairs, Dr. Doyle held scientific positions with Somatogen and Baxter Healthcare, most recently serving as Senior Research Scientist supporting Baxter’s Hemoglobin Therapeutics program. Dr. Doyle holds a Ph.D. in physiology from the University of New Mexico School of Medicine and completed four years of post doctoral training at the University of Virginia Health Sciences Center.

Brandon Kirsch, M.D.

Medical Director and Vice President, Clinical Development

Dr. Kirsch is a board-certified dermatologist. He is the Medical Director and Vice President of Clinical Development for Brickell Biotech, Inc. Dr. Kirsch provides leadership and strategic direction for the clinical team. In his role, he has primary responsibility for overseeing development programs from preclinical to Phase 3 studies and post-approval commitments.

Dr. Kirsch started his career as a lawyer and holds law degrees from the University of Western Ontario (LL.B.) and Georgetown (LL.M. Securities and Financial Regulation). He completed medical school at Brown University, an internship at the Mayo Clinic and dermatology residency at the University of North Carolina. He is licensed to practice law in both New York and Ontario, Canada and holds medical licenses in California, Colorado, Florida and North Carolina.

BOARD OF DIRECTORS

Charles W. Stiefel

Chairman

Prior to joining Brickell, Mr. Stiefel was chairman and CEO of Stiefel Laboratories, Inc. Founded in 1847, Stiefel Laboratories was a family-owned company for more than 160 years until it was sold to GlaxoSmithKline in 2009. At the time, Stiefel Laboratories was the world's largest privately held pharmaceutical company specializing in dermatological products, with nearly 4,000 employees in more than 30 countries and products distributed in more than 100 countries. Charles first joined the company as general counsel in 1982 and was subsequently named executive vice president and then president.

In 2003, Mr. Stiefel was awarded a Lifetime Achievement Award by the South Florida Dermatology Foundation, and in 2006 he was named Ernst & Young's Entrepreneur of the Year in Health Sciences for the state of Florida.

Born in Catskill, New York, Mr. Stiefel holds an undergraduate degree from Yale University and a JD degree from Albany Law School.

Reginald Hardy

Co-Founder and Director

Mr. Hardy has over 30 years of experience in serving as the Chief Executive Officer and/or President for publicly-traded and privately-held pharmaceutical companies.

Prior to co-founding Brickell, and serving as its CEO from inception through 2018, Mr. Hardy 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.

Mr. Hardy 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.

George B. Abercrombie, R.Ph., MBA

Director

Mr. Abercrombie served as President and Chief Executive Officer at Hoffmann-La Roche Incorporated from 2001-2009 where he was responsible for leading the North American Pharmaceuticals Operations and the Canadian affiliate, Hoffmann-La Roche Ltd.

Before joining Roche, Mr. Abercrombie was Senior Vice President of U.S. commercial operations at Glaxo Wellcome, with responsibilities encompassing pharmaceutical sales and marketing, electronic commerce, the U.S. managed care system, disease management, business planning and development, and late-stage clinical drug studies. He joined Glaxo as Vice President and General Manager of the Glaxo Pharmaceuticals Division in 1993 following 10 years at Merck, where he held a broad range of positions in sales, marketing, executive sales management and business development.

Mr. Abercrombie began his career as a pharmacist after receiving a bachelor’s degree in pharmacy from the University of North Carolina at Chapel Hill. He later earned an M.B.A. from Harvard University.

William D. Ju, M.D.

Director

William Ju, M.D. is a board-certified dermatologist and has over 20 years of biopharmaceutical experience in a wide variety of therapeutic areas, including dermatology. He is the President and a Founding Trustee of Advancing Innovation in Dermatology, Inc.

Dr. Ju has been President and Chief Executive Officer of Follica, Inc. and Chief Operating Officer at PTC Therapeutics, Inc. In addition, he has held executive positions at Pharmacia Corporation/Pfizer, Inc. Merck & Co., Inc., and Hoffmann La Roche, Inc. in a broad spectrum of product development functions.

Dr. Ju served as project leader for SUTENT®, introduced CANCIDAS® into humans, and was part of the product development teams for CRIXIVAN® and TRANSLARNA™. Dr. Ju began his pharmaceutical career at Hoffmann-La Roche where he was a clinical leader for the development of dermatology compounds.

Before entering industry, he was a senior staff fellow in basic research in the Laboratory of Cellular Oncology headed by Dr. Douglas Lowy and was affiliated with the Dermatology Branch at the National Cancer Institute, National Institutes of Health. Dr. Ju obtained his M.D. with Alpha Omega Alpha honors at the University of Pennsylvania School of Medicine and his A.B. with Phi Beta Kappa honors at Princeton University.

Dennison (Dan) T. Veru

Director

Mr. Veru is a Principal of Palisade Capital and a member of the Investment Policy Committee. Mr. Veru has oversight responsibilities for all the investment strategies at Palisade Capital involving publicly traded securities.

From 1992 through 1999, Mr. Veru was the President and Director of Research at Awad Asset Management and helped oversee the firm's growth from start up to more than one billion of small cap institutional and high net worth assets.

Prior to Awad, Mr. Veru became associated with the partners of Palisade in 1984 at Drexel Burnham Lambert and later at Smith Barney Harris Upham where he held a variety of analytical roles.

In addition to his professional responsibilities, Mr. Veru is a member of the Board of Overseers of the St. Lukes and Roosevelt hospital, a member of the finance committee of the Dwight-Englewood School, and a member of the Board of the McCarton School for autistic children. A graduate of Franklin & Marshall College in 1983, Mr. Veru is a frequent guest on CNBC, Bloomberg News, Fox News and CNN. He also contributes market opinions to various financial publications.

ADVISORS

Victor J. Bauer, Ph.D.

Scientific Advisor


Dr. Bauer has more than 35 years of pharmaceutical product development and management experience with extensive US and international pharmaceutical businesses. He has a broad background in research, pre-clinical and clinical development, regulatory aspects of drug and biologics approval, intellectual property management, licensing, and executive management. Dr. Bauer was most recently Executive Vice President and Chief Scientific Officer at Concordia Pharmaceuticals, Inc. Prior to Concordia, Dr. Bauer was previously President of Hoechst-Roussel Pharmaceuticals, Inc. (Aventis). Dr. Bauer also serves as a Board Director at Titan Pharmaceuticals.

Charles J. Betlach, II, Ph.D.

Drug Development Advisor

Dr. Betlach is a long-time veteran in the pharmaceutical industry. Dr. Betlach served as Brickell’s Vice President, New Product Development from inception until his retirement in 2017. Prior to Brickell, 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.

Laurie Beth Burke, MPH

Regulatory Advisor

Laurie Burke is the Founder of LORA Group, LLC, and provides expert consultation to global medical product development organizations regarding best practices in patient-focused drug development, outcomes research, regulatory strategy, product labeling and advertising. Her primary interest is the development and incorporation of state of the science measures as clinical trial endpoints. She was a career US Public Health Service officer with the US Food and Drug Administration, Center for Drug Evaluation and Research, where she maintained regulatory policy development and oversight responsibilities related to labeling and outcomes measurement in clinical trials.

She was the lead author of the FDA Patient-Reported Outcomes Guidance published as draft in 2006 and final in 2009. She collaborated extensively on matters of PRO measurement with the European Medicines Agency, the National Institutes of Health, other US Department of Health and Human Services agencies. She is an Affiliate Associate Professor at the University of Maryland School of Pharmacy and a past International Society for Pharmacoeconomics and Outcomes Research Board Member. Her academic degrees include a Master of Public Health in Epidemiology from the Uniformed Services University of the Health Sciences and a bachelor of science in pharmacy from the University of Kansas.

John Doux, M.D.

Board Observer

Mr. Doux has been an analyst at Palo Alto Investors since 2004. He obtained a B.S. with distinction and an M.D. from Stanford University, where he was a Howard Hughes Medical Institute Fellow. He also completed an M.B.A. at the Wharton School of Business where he was a Palmer Scholar. He is board certified in dermatology and maintains an active clinical practice.

William H. Eaglstein, M.D.

Dermatology Advisor

Dr. Eaglstein is past professor and chairman of dermatology at the University of Pittsburgh and at the University of Miami, where he is currently chairman emeritus. Since 2004 he has worked in industry at Ivax Pharmaceuticals (President of Ivax Derm), Teva and Stiefel Pharmaceuticals ( Vice President of Research ) and Stiefel a GSK company (Vice President of New Product Assessment and External Research).

He is currently an independent consultant and serves as a volunteer advisor for the Stanford School of Medicine SPARK program. His medical/scientific interests include wound healing, drug development, skin infections, UV inflammation and inflammatory diseases such as psoriasis and acne. Dr. Eaglstein has been a Robert Wood Johnson Health Policy Fellow, Chairman of an FDA skin advisory panel and on the National Institute of Arthritis, Musculoskeletal and Skin Diseases Advisory Panel. He continues his interest in health and regulatory policy. His hobbies include contemporary art and bicycling. He resides with his wife, Janet, in Menlo Park, California.

Andrew Hirschberg

Investment Banker

Head of Investment Banking, Triad Securities Corp., Andy is focused on M&A and Strategic life science transactions with a focus on the specialty pharmaceutical sector. Prior to joining Triad Securities, he was a Managing Director at Roberts Mitani, LLC from July 2011 through December 2013. From May 1984 through June 2011, Andy served as President of Corporate Development Specialists Inc., a firm which provided advisory services to pharmaceutical, device, consumer and biomedical companies.

During the past three decades, Andy has worked with clients on a variety of merger, acquisition and product licensing agreements and has successfully consummated over 100 transactions, with an aggregate value exceeding $5 Billion. Andy has particular expertise in dermatology, where he has been the lead advisor on more than forty consummated transactions. Andy received a B.A. from Colgate University, a Masters in accounting from NYU Stern School of Business, and an MBA from University of Chicago Graduate School of Business.

Howard J. Maibach, M.D.

Dermatology Advisor

Dr. Maibach has been a Professor of Dermatology at the University of California, San Francisco (UCSF) since 1973 and also serves as its Vice Chairman of the Department of Dermatology. Founder of the Psoriasis Clinic at UCSF. Dr. Maibach is known worldwide for his expertise in dermatology and dermatological therapy. He is an honorary member of dermatologic societies of many countries. He is a recognized expert in the field of dermatology and specifically, dermatopharmacology and dermatotoxicology. Dr. Maibach has published more than 1900 papers and books on the various subjects in dermatology.

David M. Pariser, M.D.

Dermatology Advisor

Dr. David Pariser is an active dermatologist and a founding board member of the International Hyperhidrosis Society (IHHS). He is a professor in the Department of Dermatology at Eastern Virginia Medical School in Norfolk, Virginia, where he is also the senior physician with Pariser Dermatology Specialists, Ltd., a private group practice of 12 Dermatologists, 7 Physician Assistants and 1 Nurse Practitioner. Dr. Pariser has been an American Academy of Dermatology (AAD) fellow since 1977 and was elected 2009-2010 president of the AAD (which represents more than 16,000 member physicians worldwide). Additionally, Dr. Pariser is an internationally renowned speaker on a variety of dermatologic issues and has participated in over 350 funded clinical trials.

Dr. Pariser has treated hundreds of hyperhidrosis patients and has lectured about the mechanism, diagnosis, and treatment of hyperhidrosis at numerous professional education forums on behalf of the IHHS, the AAD, and other dermatological associations. He is the consummate researcher and is continuously pursuing new treatment methods that will improve the quality of life of his patients. Dr. Pariser feels that, in his 37 years of practice, the patients who have given him the most inspiration are the hyperhidrosis sufferers whose lives he has been able to improve.

Patricia S. Walker, M.D., Ph.D.

Clinical Development Advisor

Dr. Walker 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 served as Brickell’s President and Chief Scientific Officer from 2015 to 2018 and was instrumental in helping to lead the company to its current stage. Dr. Walker previously served as Chief Medical Officer at Kythera Biopharmaceuticals from 2007 to 2013 and Executive Vice President and Chief Scientific Officer at Allergan Medical (formerly known as Inamed Corporation) from 2004 to 2007. From 1997 to 2004, she held positions of increasing responsibility at Allergan Inc., a biomedical company, ultimately becoming the Vice President, Clinical Research and Development for skin care pharmaceuticals.

Over the past 20 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 also spread-headed the development of sofpironium bromide from early clinical stage to Phase 3-readiness.

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 Santa Barbara County.

PARTNERS

Kaken Pharmaceutical Co., Ltd.

Currently developing Sofpromium Bromide For Hyperhidrosis

Exclusive License — Mar.2015
Japan


Kaken (Tokyo Stock Exchange 4521) is a Japanese specialty pharmaceutical company with a strong presence in the market of dermatology (antifungals) and orthopedics. The company’s primary areas of R&D focus include inflammation, immunology (dermatitis, rheumatoid arthritis, and osteoarthritis) pain and antifungals.

PARTNER WITH US