Advancing science. Improving connections.
We focus our research and development efforts on rare (affecting fewer than 200K patients in the U.S.) and near-rare (affecting fewer than one million patients) neuropsychiatric conditions.
Our lead product candidate, ZygelTM is a CBD gel currently being evaluated for Fragile X syndrome (FXS), Autism Spectrum Disorder (ASD) in pediatric patients, 22q, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies (DEE).
ZygelTM (ZYN002 CBD Gel)
Zygel is the first and only pharmaceutically-produced CBD, a non-euphoric cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. Zygel is being developed for patients suffering from FXS, ASD in pediatric patients, 22q, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies (DEE).
The Clinical study of Cannabidiol (CBD) in Children and Adolescents with Fragile X (CONNECT-FX) is evaluating the efficacy and safety of CBD transdermal gel (ZYN002) in children ages three through 17 years with Fragile X Syndrome. There is currently no therapeutic option approved for the treatment of behavioral symptoms associated with FXS. CONNECT-FX is enrolling eligible patients to help researchers find a potential treatment for these patients and their families.
ZygelTM is an experimental treatment. This means that it is not approved by government regulatory bodies, including the United States Food and Drug Administration (FDA) and other agencies and must be tested to see if it is an effective and safe treatment.
Chairman of the Board and Chief Executive Officer
Armando Anido has served as our Chairman and Chief Executive Officer(CEO) since October 2014. Mr. Anido has more than 30 years of executive, operational and commercial leadership experience in the biopharmaceutical industry, particularly in leading CNS transdermal patch and gel products through the entire product life cycle. Prior to Zynerba, Mr. Anido served as CEO of two publicly traded companies. Most recently, he was the CEO of NuPathe (NASDAQ: PATH), which was acquired by Teva Pharmaceuticals in February 2014. At NuPathe, he led the company through FDA approval of its lead product, Zecuity®, the first transdermal patch for migraine, to pre-launch before successfully selling the company to Teva. He also served as President and CEO of Auxilium Pharmaceuticals (NASDAQ: AUXL), where under his leadership, sales grew from $42 million in 2005 to more than $260 million in 2011 and market capitalization increased from $200 million to more than $900 million. Prior to Auxilium, Mr. Anido served as Executive Vice President, Sales and Marketing, at MedImmune and prior to that, in senior sales and marketing positions at GlaxoWellcome and Lederle Laboratories. At GlaxoWellcome, he was Vice President, Central Nervous System Marketing, responsible for the commercialization of the epilepsy, migraine and depression businesses in the U.S. He is currently a member of the Board of Directors of PABio, and he was a member of the Board of Directors of Adolor until it was sold to Cubist in December 2011. Mr. Anido earned a BS in Pharmacy and an MBA from West Virginia University.
Terri B. Sebree
Terri B. Sebree has served as our President since October 2014. Ms. Sebree has more than 30 years of executive, development and operational experience in the biopharmaceutical industry, particularly in CNS product development including epilepsy, pain, depression and schizophrenia. She has completed more than 10 regulatory submissions and approvals of new pharmaceutical products, including transdermal patch and gel products. Prior to Zynerba, Ms. Sebree co-founded and served as President of NuPathe (NASDAQ: PATH), which was acquired by Teva Pharmaceuticals in February 2014. At NuPathe, she successfully led the effort to develop, achieve regulatory approval, and complete manufacturing of the company’s lead product, Zecuity, the first transdermal patch for migraine. Before founding NuPathe in 2005, Ms. Sebree served as Senior Vice President, Development of Auxilium Pharmaceuticals (NASDAQ: AUXL), where she led the Testim® gel development and approval program. Previously, Ms. Sebree served as Executive Vice President, US Operations at Omnicare (NYSE: OCR). Prior to that, Ms. Sebree served in a variety of management roles with Abbott Laboratories for more than nine years. Ms. Sebree holds a BS from Texas A&M University.
Chief Financial Officer, Vice President, Corporate Development
Jim Fickenscher serves as Zynerba’s Chief Financial Officer, Vice President, Corporate Development. Mr. Fickenscher is a seasoned executive who has held management, financial and strategic planning roles in his 28-year tenure in the pharmaceutical industry. Prior to Zynerba, he was Senior Vice President, Chief Financial Officer, at Antares Pharma (NASDAQ: ATRS), a commercial pharmaceutical company focused on self-administered parenteral products. He has also held the role of Chief Financial Officer at both Auxilium Pharmaceuticals (NASDAQ: AUXL) and Aventis Behring, as well as additional general management, business development and strategic planning responsibilities. Mr. Fickenscher holds a BS from Bloomsburg University of Pennsylvania. He is also a Member of the American Institute of Certified Public Accountants.
Vice President, Human Resources
Joe Apostolico joined Zynerba in March 2018 as Vice President, Human Resources with accountability for all human resources and recruiting initiatives. Joe brings over 30 years of broad global healthcare and pharmaceutical human resources leadership experience to Zynerba, with demonstrated success in scaling life science organizations reflected by measurable successful business results. He most recently served Adaptimmune Therapeutics as Vice President and Global Director, Human Resources. Prior, he spent 28 years with GSK in roles of increasing responsibility, culminating in his tenure as Vice President, Human Resources, Pharmaceutical research and development where he led HR decision-making across GSK’s global R&D organization. Among other initiatives, he established a global early talent program that included a future leadership program for biologists, chemists and physicians, and a fellowship program for clinicians. Immediately prior, he served GSK as Vice President, Human Resources, Medicines Discovery and Development. Mr. Apostolico has a Master of Management degree from Pennsylvania State University, and a Bachelor’s Degree in Commerce and Engineering from Drexel University.
Donna L. Gutterman, PharmD
Vice President, Medical
Donna Gutterman, PharmD, has served as our Vice President, Medical since October 2014. Dr. Gutterman is a senior pharmaceutical executive with more than 30 years of experience in clinical development, medical affairs and commercialization in CNS therapy areas. During her career, she has led numerous successful clinical development programs, regulatory approvals and product launches. Prior to joining Zynerba, she served as head of Medical Affairs for NuPathe (NASDAQ: PATH) through approval and pre-launch of its lead product, Zecuity, the first transdermal patch for migraine, prior to the company being acquired by Teva Pharmaceuticals in 2014. Previously, Dr. Gutterman served in a variety of executive roles at GlaxoSmithKline for more than 20 years. There she was instrumental in the clinical development of Imitrex® and led the medical affairs teams in neurology and psychiatry. Additionally, she led several successful commercial product launches. She earned her Doctor of Pharmacy degree at the University of Kentucky College of Pharmacy and her MBA at the University of North Carolina (UNC) Kenan-Flagler Business School. Dr. Gutterman also serves on the Board of Visitors at UNC Eshelman School of Pharmacy and as a board member of several nonprofit organizations.
Suzanne M. Hanlon
Vice President and General Counsel
Suzanne M. Hanlon has served as our general counsel and Vice President since October 2014. Ms. Hanlon is an accomplished attorney with 32 years of legal experience, particularly in public life sciences companies. She offers expertise in contracts, licensing, compliance, clinical trials, regulatory, litigation, intellectual property and employment law. Prior to joining Zynerba, she served as Vice President, Associate General Counsel of NuPathe (NASDAQ: PATH), which was acquired by Teva Pharmaceuticals in February 2014. At NuPathe, she successfully led the intellectual property strategy and the contracts effort in addition to managing the human resources function and she partnered with senior management to complete a successful IPO. Previously, she was Chief Development Counsel at Auxilium Pharmaceuticals (NASDAQ: AUXL) and Vice President of Global Contracts at Omnicare Clinical Research (NYSE: OCR). Ms. Hanlon received her JD degree from Villanova University School of Law.
General Manager, Zynerba Pharmaceuticals Pty Ltd (Australia)
Terry Hurst has served as the General Manager of Zynerba Pharmaceuticals Pty Ltd (Australia) since October 2017. He has 16 years of executive management experience in the early phase clinical trial sector of the biopharmaceutical industry. Mr Hurst has extensive experience in General Management in both industry and academia with a focus on clinical research. He has in-depth knowledge of the Australian clinical trial sector having overseen the acquisition and execution of approximately 400 early phase clinical trials. Prior to joining Zynerba, he served as Chief Executive Officer of Q-Pharm Pty Limited, an Australian privately held Early Phase Clinical Trial facility in Brisbane, Queensland. At Q-Pharm, he was responsible for the implementation of strategic initiatives of the Board, and specialised in the management of corporate and business development. Mr. Hurst holds a Bachelor of Science degree from The University of Queensland, Brisbane, Australia, and has completed the General Managers Program at the Australian Graduate School of Management.
Vice President, Manufacturing
Ray Mannion has served as our Vice President of Manufacturing since April 2017. Mr. Mannion has more than 35 years of international manufacturing, operations and engineering experience in the pharmaceutical, medical devices and electrical connection systems industries. Prior to Zynerba, he was Senior Director, Third Party Operations for Teva Pharmaceuticals Inc. (NYSE: TEVA) where he successfully managed the production scale up for the commercial launch of the Zecuity® migraine patch while also managing all technical aspects of the project. In addition to his activities with Zecuity, he led a Supplier Relations Team where he collaborated with Teva stakeholders in managing a portfolio of key strategic suppliers in the areas of contract negotiations, product supply, new product launches and product serialization. Prior to Teva, Mr. Mannion held the position of Vice President of Commercial Manufacturing at NuPathe (NASDAQ: PATH) where he led the production scale up and process validation efforts for the Zecuity migraine patch. Prior to NuPathe, Mr. Mannion served as the Vice President of Operations for PuriCore, Inc., where he managed internal and external manufacturing, engineering, quality assurance & regulatory affairs, supply chain, customer service and field service for PuriCore’s US and UK operations. In addition, Mr. Mannion has held various Operations, Engineering and Manufacturing roles with Animas Corporation, Kensey Nash Corporation and AMP Incorporated. Mr. Mannion received a B.S. in Industrial Engineering from Rutgers University, New Brunswick, NJ and an M.B.A from Shippensburg University, Shippensburg, PA.
Vice President, Development
Carol O’Neill has served as our Vice President, Development since October 2014. She has more than 18 years of development and operational experience in the biopharmaceutical industry. Ms. O’Neill has completed regulatory submissions and achieved approvals of new pharmaceutical products including a transdermal patch and a transdermal gel. Prior to joining Zynerba, she served as Vice President, Development Operations of NuPathe (NASDAQ: PATH), which was acquired by Teva Pharmaceuticals in February 2014. At NuPathe, she successfully managed the research and development aspects of the clinical and nonclinical programs of the company’s lead product, Zecuity, the first transdermal patch for migraine. Previously, she was Senior Director Clinical Operations at Auxilium Pharmaceuticals (NASDAQ: AUXL) and Senior Director of Operations analysis at Omnicare Clinical Research (NYSE: OCR). Ms. O’Neill holds a Business Administration degree from Lakehead University, Ontario, Canada.
Vice President, Investor Relations and Corporate Communications
Will Roberts serves as our Vice President, Investor Relations and Corporate Communications. Mr. Roberts is a successful communications officer with 25 years of biotechnology/pharmaceutical experience in corporate communications, investor and public relations and preclinical research. Prior to Zynerba, he served as Vice President, Investor Relations and Corporate Communications for Adaptimmune Therapeutics plc (NASDAQ: ADAP), where he supported the company’s May 2015 IPO and developed the company’s communications strategies. He spent 10 years with ViroPharma Inc. (NASDAQ: VPHM), a biotechnology company routinely recognized for excellence in investor relations and communications, culminating in his tenure as Vice President, Corporate Communications. There he was responsible for leading global investor and corporate communications, patient advocacy, disease awareness programming and global communications support for the company’s marketed products. Mr. Roberts began his professional career at MedImmune, Inc. (NASDAQ: MEDI) in 1992. He spent 12 years with the company, transitioning from his initial role as a molecular microbiology research scientist into investor relations in 1997. Mr. Roberts received a B.A. in biology from the University of Virginia, and an M.B.A. from the Keller Graduate School of Management.
Vice President, Commercial and Business Development
Brian Rosenberger serves as Zynerba’s Vice President, Commercial and Business Development. Over his 25-year career in the pharmaceutical industry, Mr. Rosenberger has held several leadership roles in marketing, sales, business development, analytics and alliance management. Prior to Zynerba, he was Vice President, Alliance & Strategic Portfolio Management of Cipher Pharmaceuticals, a publicly-traded, Canadian-based dermatology company, where he managed the Company’s global portfolio. Mr. Rosenberger also held various roles of increasing responsibility at Auxilium, a specialty biopharmaceutical company. In his last role as Executive Director, Corporate Development & Licensing and Alliance Management, he participated in several transformational M&A, licensing and co-promotion deals through and including Endo International’s acquisition of Auxilium Pharmaceuticals (NASDAQ: AUXL) in January 2015. Mr. Rosenberger held sales managerial positions at Neurocrine Biosciences during the initial commercial build-out of the organization and spent over a decade at GlaxoSmithKline in various US and Global commercial roles within specialty markets, including NeuroHealth Epilepsy Marketing. Mr. Rosenberger received a B.A. double major in Political Science/Policy and Management Studies from Dickinson College in Carlisle, PA.
Nancy Tich, PhD
Vice President, Clinical
Nancy Tich, PhD, serves as Zynerba’s Vice President, Clinical. She has more than 26 years of clinical project management in the biopharmaceutical industry. Prior to joining Zynerba, she served as Senior Director, Project Management, Oncology, at Covance (NYSE: CVD), which was acquired by LabCorp in November 2014. At Covance, she successfully managed numerous oncology clinical projects across various stages of development. Previously, she was Vice President, Client Project Management at Omnicare (NYSE: OCR) and Senior Client Project Manager at Abbott Labs (NYSE:ABT). Dr. Tich earned a Doctorate in Cell Physiology from University of Minnesota and a Bachelor of Arts from Northwestern University.
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