Arkayli is a team of seasoned professionals with extensive experience in drug development, formulation, and commercialization, as well as clinical care of infants and children with vascular anomalies

Leadership Team

Thomas Rossi, PhD
Co-founder & Chairman

Katie MacFarlane, PharmD
Chief Executive Officer

Beth A. Drolet, MD
Co-founder & Clinical Lead

Paul F. Manley, PharmD
Regulatory Advisor
Consultant

Ric Stanulis, PhD, DABT
Head of Toxicology &
Non-Clinical Development,
Consultant

Seth Reno, MBA
Consultant

  • Dr. Rossi is an experienced drug development executive with a track record of product development and approval in large and small pharmaceutical companies. He has raised significant capital and has brought multiple products through all stages of development and regulatory approval. He is a co-founder and the Chairman of Arkayli Biopharma, Inc, whose lead product is a preclinical topical formulation for the treatment of infantile hemangiomas. Recently, he served as the Chief Executive Officer of Venthera, Inc., a company developing a topical formulation of a novel PI3Ka inhibitor as a potential treatment of venous and lymphatic malformations. In his past CEO roles at Agile Therapeutics and SansRosa he raised over $60 million dollars of capital and created two commercial products: Twirla® a 7-day contraceptive patch and Mirvaso® a first-in-class treatment for the erythema of rosacea. He held various roles in drug development organizations of two major pharmaceutical companies: Johnson & Johnson and SmithKline Beecham. At Johnson & Johnson, he served as the Vice President of Global Pharmaceutical and served on the board of The R.W. Johnson Pharmaceutical Research Institute. He earned his Ph.D. in Chemistry from Texas A&M in 1985, and his B.A. in Chemistry from Western Connecticut State University in 1980. He is the author of numerous scientific publications, inventor of numerous patents, a frequent speaker at national and international scientific meetings, and a member of the American Chemical Society, The International Society for the Study of Vascular Anomalies, and the Pediatric Dermatological Research Association.

  • Dr MacFarlane has more than 35 years of experience in drug development and commercialization of pharmaceutical products. She currently serves as the CEO of Arkayli Biopharma. Prior to Arkayli, Katie was Founder and Managing Partner of SmartPharma LLC, offering commercial and strategic consulting services to biopharmaceutical companies. Previously, she was Chief Commercial Officer at Agile Therapeutics, Vice President of Marketing, Sales and New Product Planning at Warner Chilcott, and Senior Director of Marketing at Parke-Davis (now Pfizer). Dr MacFarlane is a Director of Neurizon Therapeutics (ASX:NUZ) and a former Director of Mayne Pharmaceuticals (ASX:MYX), RespireRx Pharmaceuticals, Inc., and INMED Partnerships for Children, an NGO. Katie is an affiliate faculty member of the Purdue University School of Pharmacy, and a Founding Member and Advisor to IPhO. She has a Bachelor of Science and Doctor of Pharmacy from Purdue University and completed a Postdoctoral Fellowship in Clinical Research with Rutgers University and Hoffmann-LaRoche.

  • Dr. Drolet has over 30 years of experience in leadership in academic medicine. She has served in successive leadership roles, including the Chief of the Division of Pediatric Dermatology, the Medical Director of the Vascular Anomalies Center, Clinical Vice President of Ambulatory Services, and Chief Experience Officer at the Children’s Hospital of Wisconsin. In March of 2019, Dr. Drolet was named Geneva F. and Sture Johnson Distinguished Chair of the Department of Dermatology at the University of Wisconsin-Madison. Her research has focused on discoveries related to birthmarks, vascular anomalies, and infantile hemangiomas. She has created and led several multi-site research networks focusing on infantile hemangiomas and vascular anomalies. She is past-President of the Society for Pediatric Dermatology and past-President of Hemangioma of Infancy Group (HIG). Dr. Drolet has published over 175 peer-reviewed manuscripts. By leveraging next-generation sequencing technology, her team has helped to identify genetic causes of vascular anomalies and set the stage for the development of novel targeted therapies. Her varied experiences in healthcare administration and research, along with her broad exposure to patient and family perspectives, have resulted in the development of innovative approaches to patient-centered care delivery. Her research efforts have been supported by the National Institute of Health, Greater Milwaukee Foundation, Dermatology Foundation, and Pediatric Dermatology Research Alliance.

  • Paul F. Manley, has accumulated 35+ years of experience in regulatory affairs, compliance and overall drug development, across a range of therapeutic areas within the pharmaceutical, biologic and consumer products industries.
    Mr. Manley’s corporate career encompassed senior management andtechnical leadership positions within the US and Europe in both large corporations (VP, Global Regulatory Affairs – Oncology, J&J) and start-up-like entities (VP, Regulatory Affairs and Compliance, Genta Incorporated).
    In 2007 Mr. Manley established Orvieto Consulting, LLC, providing strategic advice to numerous companies across a wide range of scientific disciplines and through all phases of development through to post-marketing.

  • Dr. Stanulis is a board-certified toxicologist with over 25 years of experience in pharmaceutical drug development, serving as a nonclinical consultant since 2017. Ric is currently the President & CEO of Akkeri, Inc., a nonclinical development consulting firm. Previously, he has been the head of nonclinical safety assessment for several biotechnology companies. Ric has successfully led multiple nonclinical development programs across a spectrum from pre-IND through NDA. Ric is experienced in the unique perspective and needs of small/virtual biotech companies as they maneuver through the drug development process and interactions with regulatory authorities. Dr. Stanulis received his PhD in Toxicology from the Medical College of Virginia/Virginia Commonwealth University and is a Diplomate of the American Board of Toxicology.

  • Mr. Reno has over 30 years of experience in the Bio-Pharmaceutical industry. He has extensive experience in building commercial capabilities to successfully commercialize both small and large molecules across a range of therapeutic areas. Seth is the former CEO of Arkayli Biopharma, and now serves as a consultant to the company. Prior to Arkayli, he served as a commercial advisor for NeuroBo Pharmaceuticals, a Boston-based biotech company focused on neurodegenerative diseases. Before merging with NeuroBo pharmaceuticals, Mr. Reno was the Chief Commercial Officer at Gemphire Therapeutics, a NASDAQ-listed company. As Medimmune’s Head of Commercial Operations, he spent five years building commercial teams and capabilities that focused on launching complex biologics and specialty products with orphan designation status into rare disease markets. Mr. Reno spent ten years at AstraZeneca across a number of roles in Sales, Commercial Operations, Managed Markets, and Brand teams. He led the Commercial Insight’s team for the dyslipidemia franchise, most notably the successful launch of Crestor’s atherosclerosis indication. Prior to joining AstraZeneca in 2001, Mr. Reno spent eleven years at Wyeth in commercial operations and sales account management. He holds a B.S. in Human Resources from the University of Delaware and an MBA from Strayer University.