Co-Founder and Chief Executive Officer
Michael is the Founder and CEO of Castle Creek Pharmaceuticals, which he has built from a complete startup to one of the fastest growing specialty pharmaceutical companies in the industry. Castle Creek has rapidly assembled a robust portfolio of products backed by strong science and focused on meeting patient needs in the treatment of rare and debilitating dermatologic and head and neck conditions.
Mr. Derby is a successful entrepreneur, operating executive and investor, with 20 years of experience in the pharmaceutical industry and broader life sciences sector. He has founded or co-founded four specialty pharmaceutical companies, and has a passion for developing and commercializing innovative drugs for patients with rare diseases and other serious medical conditions.
Prior to starting Castle Creek, Mr. Derby founded Norphan Pharmaceuticals, a specialty pharmaceutical company focused on the development of drugs for orphan neurologic disease, which he ran in its early stages and sold to Marathon Pharmaceuticals in a successful financing-turned-acquisition transaction in 2013. Mr. Derby joined Marathon to oversee the transition of the Norphan assets, and also led Marathon’s business development effort through 2015. One of the Norphan products has become the first drug to gain unconditional approval in the U.S. for the treatment of Duchenne Muscular Dystrophy.
From 2008 to 2011, Mr. Derby served as a lead Healthcare Partner at the early-stage private equity and investment advisory firm, Centerstone Partners. At Centerstone, he led or co-led the formation, fundraising, corporate strategy development and early management of a number of companies spanning the pharmaceutical, clinical research and diagnostics industries, including the spinout of Omnicare Clinical Research (renamed Theorem Clinical Research) from Omnicare, Inc. in an acquisition by a major private equity firm. In 2015, Theorem Clinical Research was sold to Chiltern in a highly successful exit event. Prior to Centerstone, Mr. Derby was a venture capitalist with EGS Healthcare Capital Partners, and also previously worked in key commercial roles for Merck & Co. and Forest Laboratories.
Mr. Derby holds advanced degrees in business and science, with an M.B.A., with distinction, from New York University’s Stern School of Business, an M.S. in Neuroscience from the University of Rochester, and a B.S., with honors, from Johns Hopkins University, where he was a Beneficial Hodson merit scholar and member of the Tau Beta Pi engineering honor society.
Greg Licholai, MD
President and Chief Scientific Officer
Greg is President and Chief Scientific Officer at Castle Creek Pharmaceuticals. He is a member of the Executive Leadership Team and is responsible for all research and development activities, technical operations, medical affairs and the company’s scientific, regulatory, medical and clinical strategies.
Previously he was founder and President of Elipdera Therapeutics, which is a Moderna Therapeutics venture portfolio company and focused on developing messenger RNA therapies for rare genetic and metabolic diseases. Dr. Licholai was a partner-level consultant at McKinsey & Company, where he ran a business line devoted to complex data analytics for pharmaceutical launches. He was Senior Vice President for Real World and Late Stage Research at Quintiles, Inc. He was Chief Operating Officer at Proteostasis, a biotechnology company focused on developing chaperones for rare disease. He was one of the original employees at Amicus Therapeutics, focused on pharmacological chaperones for rare diseases. He was also co-founder of Immunome, a biotechnology firm with a proprietary antibody platform for oncology. He was a venture capitalist at Domain Associates. He was director of Ventures and Business Development at Medtronic Neurological. Dr. Licholai trained at the Brigham and Women’s, Children’s, and Massachusetts General Hospitals. He was a Howard Hughes Medical Institute Research Scholar at the National Institutes of Health. He performed research in molecular genetics at Yale University and examined variants in hereditary blood disorders. He worked in molecular oncology at Rockefeller University. Dr. Licholai received a B.S. from Boston College and Pre-Medical studies at Columbia University, an M.D. from Yale Medical School and M.B.A from Harvard Business School. He is on the advisory board of the National Tay Sachs and Allied Disease Foundation and the Partnership for Palliative Care. He is on faculty at the Yale School of Management and teaches the capstone lectures in healthcare.
Executive Vice President and Chief Commercial Officer
John has a highly accomplished career as both a strategic and operational leader in the pharmaceutical sector. As CEO, he opened a successful U.S. affiliate for a European based parent company by leveraging his strengths in strategic leadership, portfolio management, business development and innovation commercial execution. As Global Vice President, Dermatology and Respiratory Disease, he had overall launch responsibility for a major new breakthrough Biologic treatment in the areas of Severe Atopic Dermatitis and Asthma. Other specific career accomplishments include developing patient-centric strategies/cultures, turning around underperforming business models, effectively managing lifecycles of both strategic and non-strategic brands, and developing businesses from preclinical through to commercialization/go-to-market strategy. He also has effectively managed in-licensing/out-licensing activities, led due diligence teams, expanded multiple product portfolios, and acquired a solid understanding of managed care markets in the US and Europe.
Most recently in his position as Global Vice President, Dermatology and Respiratory Diseases at Sanofi -Genzyme, John had overall responsibility for the global Launch of Dupilumab, the first biologic treatment for Moderate to Severe Atopic Dermatitis. John played an active role in the setting of the corporate strategy within the area of Dermatology and Respiratory Diseases (Asthma and Nasal Polyposis). Prior to this, John was the President and CEO of LEO Pharma U.S., a $300 million privately held affiliate of Denmark based, $1.4 billion+, LEO Pharma A/S, John had full P&L responsibility leading efforts to design and build-out a diverse and cross-cultural U.S. organisation from initial stages to a premier Dermatology company in the U.S. In this role he orchestrated the turnaround of the Psoriasis Franchise and established the Actinic Keratosis Franchise in U.S. with the market leading lead brand, Picato®, championed a new patient-centric vision/strategy across all LEO activities, and raised the profit level and revenue by optimising payer and market access strategies.
In his previous positions with LEO, John was the Divisional Director, Critical Care and Dermatology at LEO Pharma/UK where with overall P&L accountability for both of the major commercial Divisions, including directing sales, marketing and medical/KOL liaison functions, he led both divisions to double digit growth, launched new products, and expanded/re-tooled the field force. In prior internationally based roles, John was Director, Corporate Licensing and Business Development, North America at LEO Pharma/Canada, where he successfully launched the North American business development function, including broad responsibilities for strategy development, opportunity identification and assessment, and process development; International Marketing Manager, Critical Care at LEO Pharma A/S – Denmark, where he led global marketing of the Critical Care portfolio in areas of international strategy, coordination of affiliate activities, optimization of product profiles, identification of new opportunities for expansion and overall product profitability.
Vice President, Human Resources
Regina Donohue joined Castle Creek Pharmaceuticals in October 2016 as Vice President, Human Resources. Prior to taking on this role, Ms. Donohue served as Vice President, Human Resources & Communications, Region U.S. for specialty pharmaceutical company LEO Pharma Inc. from 2009-2016 where she was responsible for the design and implementation of all human resources strategies, as well as, internal communications. During this time she also held the interim role of Vice President, Corporate Human Resources located in Copenhagen, Denmark for a period of fourteen months. Accomplished in leading organizational growth and change, Regina played a key role in helping LEO U.S. grow from five to almost three hundred employees during her tenure.
Prior to LEO, Ms. Donohue was the Senior Director of Human Resources for Alpharma Pharmaceuticals, leading the HR function for the $300 million specialty pharmaceutical business. In this role, Ms. Donohue designed human resources strategies and managed recruitment during three field sales expansions which enabled the business to grow from twelve to over six hundred employees over a five year period. From 2000-2009, she held a variety of key human resources positions for Alpharma and its predecessor, Faulding Pharmaceuticals. Prior to Alpharma, Ms. Donohue held human resources positions at The Star Ledger, The Greer Group and Ganymede Software.
Ms. Donohue received a Bachelor of Science degree from the University of Scranton in Pennsylvania. She holds a Senior Professional Human Resources (SPHR) certification and the Society for Human Resources Management Senior Certified Professional (SCP) designation.
Vice President, Clinical Operations
Mr. Beger recently served as Vice President, Clinical Operations at Aclaris Therapeutics, Inc. His professional experience includes positions with Vicept Therapeutics, Galderma, CollaGenex Pharmaceuticals, Bristol-Myers Squibb, Barrier Therapeutics, Cu-Tech Therapeutics, Inc., and Westwood-Squibb, primarily in topical therapeutic development. With over three decades of experience, Mr. Beger has managed clinical development teams that have supported regulatory submissions resulting in the approval of numerous prescription products. He has also led teams that developed more than a dozen over-the-counter dermatology products.
Mr. Beger is a Certified Clinical Research Associate and maintains memberships in the Drug Information Association, the Association of Clinical Research Professionals and the American Academy of Dermatology. Mr. Beger holds a B.A. in Chemistry and a B.A. in Biology from the State University of New York at Oswego.
Vice President, Technical Operations
Ron brings more than 30 years’ experience in the pharmaceutical industry. Ron is an accomplished operations executive with a broad experience base in drug development, clinical and commercial manufacturing, including biologics, aseptic processing and manufacturing of parenterals.
Ron’s career started at Johnson & Johnson where he held several leadership roles and ultimately was responsible for a worldwide launch of a new blood type and screening diagnostic. Ultimately Ron became responsible for Johnson & Johnson’s Blood Bank Operations, which included their parenteral vaccine division.
Due to Ron’s broad based background he has been key in transitioning small to mid-sized biopharmaceuticals from R & D to commercial manufacturing to accomplish successful launch. In addition to Johnson & Johnson, Ron also held several leadership roles at Liposome, Elan, Enzon, NPS and Shire Pharmaceuticals. Ron has worked on a wide range of products that encompass unique processes such as liposomal encapsulation, PEGylation, lypohilization, plasma fractionation, etc. His responsibilities have not only encompassed domestic responsibilities, but he has been responsible for CMO oversight and worked international throughout Europe and Asia.
In virtually every role, Ron has been responsible to ensure compliance with respect to cGMPs and has a vast amount of experience working with regulatory agencies such as the FDA and EMEA. He has been key in reviewing and writing INDs, NDAs, SNDAs, MBRs, SOPs, RFPs, SOWs and has been instrumental to ensure readiness for PAIs.
Ron also has an extensive background in Project Management, which has encompassed technology transfer, scale-up and build-out of sterile manufacturing facilities.
Ron holds a BS degree in biology from Rutgers University and an M.B.A. in Business from Fairleigh Dickinson University.
Vice President, Marketing
Mr Stakias joined Castle Creek Pharma in October 2016 as Vice President of Marketing. Prior to starting this role he served as Vice President of Marketing for the US affiliate of a $1.4 billion, European based specialty pharmaceutical company levering his 17 years of US and international experience in strategic brand development, launch excellence and franchise leadership. Holding various commercial leadership roles he has successfully turn around high priority brands in the US through innovative commercial execution and optimization. During the time he operated in Europe he has led commercial organizations to launch and drive brands from a global role and also from within different markets.
Most recently as the Vice President of Marketing for LEO Pharma Inc. he lead the launch of a new treatment for psoriasis with the potential to reach more than $300M in the next 3 years while managing two dermatology franchises valued at $350M. Prior to that as the Head of the Dermatology Business Unit at LEO Pharma Inc. he successfully revitalized and expanded sales of multiple dermatology product portfolios through organizational optimization and by introducing innovative strategies to penetrate untapped market segments. As a strong advocate of a patient-centric approach he followed a holistic strategy to fully engage with the stakeholder value chain putting the patient in the middle of all activities.
While in Europe, Mr Stakias operated from the headquarters of LEO Pharma in Denmark as the head of the Global Commercial Launch team for a new Dermatology franchise. During this time he designed and led the global cross-functional team to successfully launch a new global franchise in more than 23 counties including the USA and all major European and Asian markets creating a diverse cross-cultural team and developing an innovative, global launch excellence framework to drive execution.
Mr Stakias through his extensive experience in the pharmaceutical industry in the top commercial positions in sales and marking has championed diverse portfolios in Dermatology, Thrombosis, Renal, Osteoporosis and Infections in global and national organizations in the USA and in Europe.
Vice President, Market Access
Greg Wujek is a successful Biopharmaceutical Market Access & Sales Leader who has created, developed and executed on strategies in support of launch and existing prescription products. His deep data knowledge and analytics experience also creates a more confident understanding of product market nuances which further enhances the Market Access strategy development.
Over the past 25 years Greg has demonstrated the ability to build both managed care and sales departments that have successfully executed marketing plans driving sales and meeting corporate expectations. Most recently at Zimmer Biomet Greg lead the Market Access, Distribution, and HUB strategy on the company’s first prescription product, Gel-One. At Forest Laboratories Greg built the Managed Care department in support of the company’s first blockbuster Tiazac. Recruited by Andrx Laboratories, he was part of the senior management team that established Andrx in the branded marketplace and took responsibility for managing the 500 person sales team that successfully launched Altoprev and Fortamet the company’s first branded products. While at Savient Greg lead the build out of the company’s biologics arm taking responsibility for Managed Care, Sales and Operations in support of Euflexxa the company’s first biologic launch.
Greg is an associate member of the Academy of Managed Care Pharmacy, industry consultant for Reuters, Gerson Lehrman Group, Third Bridge and former Managed Markets Panel advisor at Wolters Kluwer.
Greg graduated from Illinois State University with a degree in Political Science.