Novan Inc: Building, Innovating, and Developing Therapeutic Products for Skin Diseases

Novan Inc

 

Novan, Inc. is building a premier medical dermatology company focused on developing and commercializing innovative therapeutic products for skin diseases. The company’s goal is to deliver safe and efficacious therapies to patients, including developing product candidates in the areas where there are unmet medical needs. Novan is developing berdazimer gel, 10.3% (SB206) as a topical prescription gel for the treatment of viral skin infections, with current emphasis on molluscum contagiosum and recently submitted a New Drug Application to the U.S. FDA seeking marketing approval for berdazimer gel, 10.3% (SB206) for the topical treatment of molluscum.

Novan completed the acquisition of EPI Health in early 2022. EPI Health equips the company with a robust commercial infrastructure across sales, marketing, and communications, as well as fully dedicated market access and pharmacy relation teams. Following the acquisition, Novan promotes products for plaque psoriasis, rosacea, and acne. The company also has a pipeline of potential product candidates using their proprietary nitric oxide-based technology platform, NITRICIL™, to generate new treatments for multiple indications.

Tomoko Maeda-Chubachi, MD, PhD, MBA: From Japan Through USA Expressing Her Passion for Dermatology

Tomoko Maeda-Chubachi, a board-certified dermatologist from Japan engaged in researching skin cancer and aging in Japan, the U.S., and Canada. After 10 years of conducting academic dermatology research, Tomoko entered the pharmaceutical industry. Starting as a drug development lead for Pfizer Japan, she led the first participation of a global clinical trial for osteoporosis before coming to the U.S. to work as a global clinical lead for ophthalmology and dermatology projects with Pfizer. Over the course of Tomoko’s career, she was fortunate enough to be involved in various dermatology projects with Eli Lilly and GSK. After GSK’s reorganization and U.S. headquarter change, Tomoko found Novan as a place to express her passion for dermatology drug development. Her role and responsibilities at Novan have evolved over 5+ years of tenure, and she currently serves as the company’s Chief Medical Officer where she provides medical input to help drive the strategy, design, and execution of the company’s development programs.

Being Passionate and Believing in Your Journey

Tomoko’s motivation for coming to the U.S. was to be involved in dermatology drug development, but the opportunity did not come right away. After delivering a successful paediatric glaucoma program for Xalatan®, she gained recognition as a late-stage drug developer when there were very few dermatologists in the industry. Once Tomoko started to lead psoriasis drug development and the pivotal studies were successful, she became more visible in dermatology. Ixekizumab (Taltz®) for the biological treatment of psoriasis was launched after she left Eli Lilly. While at GSK, she enjoyed the focus on topical drug development but her experience spanned oral, biologics, and topical drug development to treat various skin diseases. Tomoko wrote a textbook on dermatological drug development with her co-workers at GSK, and she invited them to be advisors for Novan as well. Tapinarof (VTAMA®), a project at GSK that she led phase 2b studies for topical treatment of psoriasis (and hopefully atopic dermatitis shortly), was also launched in 2022 from Dermavant.

Through her professional journey, Tomoko found that she enjoyed helping others to develop their career. The majority of her mentees are women: foreign-trained physicians and scientists who are interested in the pharmaceutical industry. They seek her advice on how to develop their careers in the U.S. despite different cultural backgrounds. Tomoko is grateful towards Novan for allowing her to mentor young dermatologists through the corporate internship program. In addition, she volunteers in mentorship programs through Women in Bio (WIB) and Dermatologists in Industry (DII). In recent years, she has been passionate about introducing a pharmaceutical career for Japanese physicians and supporting their career development and advancement. Towards the end of 2019, she recruited a robust board of directors and founded a non-profit organization to help professionals develop their pharmaceutical career paths. The membership is expanding and the organization is gaining visibility in the Japanese pharmaceutical community. Tomoko has learned many lessons over the course of her career: fearlessly tackling activities that have good causes, purposefully expanding the network, consistently pursuing what you believe, and being honest and trustworthy.

Living Life to the Fullest Without Any Regrets

After Tomoko completed her thesis in the resident/Ph.D. program and was preparing to depart for her postdoctoral fellowship program in the U.S., she experienced one of the biggest earthquakes in 1995, which killed more than 6,000 people. The earthquake caused her family to lose their house and stay in a shelter for 6 months. The natural disaster and challenging family circumstances as a result significantly shaped her mindset. Since then, Tomoko decided to live her life to the fullest possibility because she can live only once and does not want to have regrets. Because Japan was and is still a very male-dominated society, she did not see career opportunities in academia and decided to move to the pharmaceutical industry and eventually, to the U.S.

Being Authentic is the Key

Tomoko says, to understand yourself, be authentic, speak up, and take risks.

Understanding and Improving the Quality of Life for Patients

Tomoko says, “I am a dermatologist who wants to improve the quality of life for patients with skin diseases, which serves as the core of innovation in understanding the target audience.” Her drive is to understand the target disease from a clinical trial perspective. She designs clinical trials not only to assess the drug’s efficacy and safety but also to understand the disease itself, as much as possible. She likes writing medical papers through clinical findings, which she believes to be a noteworthy contribution to the medical society. Tomoko is passionate, happy and loves introducing new therapeutic options for patients.

Being Adaptable, Tech-Savvy, and Understanding the Complex Landscape

The COVID-19 pandemic impacted our lifestyle and has introduced various technologies to make daily routines and activities viable. Remote communication technology is one of them. The pharmaceutical industry relatively easily accommodates remote communications in the workplace through platforms such as Microsoft Teams, Zoom, etc. Communication with various stakeholders also became remote. Industry leaders need to be adaptable and tech-savvy to take advantage of these channels and communicate effectively: timely checking in with colleagues using a chat function, video calls, breakout rooms, recordings, and closed captions. They have to be approachable and demonstrate care for colleagues. Data science and statistics utilizing big data and the tools to analyze them are fascinating. In the pharmaceutical industry, it is imperative to understand and leverage these data and tools effectively to advance science and pipeline development. At the same time, the concept of patient-centric drug development is evolving. Understanding the complex landscape and being equipped ethical viewpoint are additional requirements for industry leaders.

Optimistic, Unpredictable but Visionary

Tomoko is cautiously optimistic. Molluscum contagiosum, the lead indication that Novan is currently working on is largely an unmet need. However, a biotech segment of the market, particularly small caps, is unpredictable. The company has experienced ups and downs along with the rest of the biotech industry in the past few years, but she believes Novan and the industry will see the silver lining shortly.

Encouraging Women to Develop Their Career Maps

Tomoko tries to be practical and pragmatic when giving advice. She always encourages her mentees to develop their career maps. The career map includes three options that you would be happy to end up with within 10 years. It also includes the areas of development and how to improve the targeted areas and timing. It is important to take time to assess your career periodically regardless of how busy you are. Visualizing the goals and checking the progress occasionally. When Tomoko developed her career map around 10 years ago, her three options included becoming a freelance consultant of dermatological drug development, a VP of a pharmaceutical company, or an R&D head of a Japanese subsidiary of mega pharma. For Tomoko, creating that career map worked and she became a VP of Novan within 5 years of setting those goals. She believes visualizing goals in this way is an effective practice to help guide a career path. She enjoys leading and helping others to grow.

Quote: “Information about diseases and treatment is readily available to patients. They have become the decision maker. It is my mission to communicate the product profile accurately, maximize the value of the product, and make sure that the product is used safely.”

Management: Tomoko Maeda-Chubachi, MD, PhD, MBA, Chief Medical Officer at Novan, Inc.

Website: https://novan.com/

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