In the ever-evolving landscape of biotechnology and pharmaceuticals, one name stands out as a beacon of experience and innovation. Mario DiPaola, Co-Founder and CEO at Therebene, Inc, is an industry veteran with a remarkable 25-year track record and has left an indelible mark in the realm of life sciences.
Mario’s journey through the biotechnology and pharmaceutical industries is a testament to his dedication and expertise. With a focus on basic research, development, quality, manufacturing, and regulatory functions in support of protein and small molecule drug development, he has navigated the complex world of therapeutic advancement with remarkable success. His extensive experience includes involvement in the development and regulatory filings (BLA/eCTD) of several approved therapeutics, such as Alferon-N, Amevive, and Sucraid, which have brought hope and healing to countless individuals.
Beyond the confines of laboratories and regulatory processes, Mario’s impact extends to the world of academia and research. With over 60 publications to his name and several patents as a co-inventor, he has played a pivotal role in advancing the frontiers of science and innovation. His work reflects a commitment to exploring new horizons and pushing the boundaries of what’s possible in the quest to improve human health.
Mario’s entrepreneurial spirit is another defining facet of his journey. He has founded or co-founded several companies, each with a unique mission and vision. Blue Stream Laboratories Inc., a company he co-founded, achieved such success that it was acquired by Charles River Laboratories in 2016. Higher-Order Technologies LLC, which focuses on developing novel analytical equipment, is yet another example of his commitment to pushing the envelope of technology and discovery.
Approaching Targeted Disease Treatment
Therabene, a biotechnology startup founded in 2020, is pioneering the development of high-potency, low-toxicity targeted chemotherapeutic agents known as “degraders”, also referred to as PROTACs. These degraders have the potential to treat cancers, autoimmune diseases, specific viral infections, and other challenging conditions. This novel approach to drug discovery extends beyond traditional methods, which focus on directly controlling protein activity. To date, Therabene has designed and synthesized around a dozen degraders, with TB-003 and TB-008 undergoing extensive in-vitro evaluations. TB-003 has also shown promising efficacy against triple negative breast cancer in in-vivo studies, highlighting the innovative potential of degraders in medical research and treatment.
The primary objective of the company is to create degraders targeting disease-associated proteins. The initial target is CDK9, which plays a direct role in multiple malignancies, including breast, ovarian, pancreatic, and other solid tumors. The company’s immediate goal is to obtain approval for one of its leading products in the United States. Following this, expansion into international markets is planned, with a focus on Europe, Asia, Australia, Canada, and eventually South America. Therabene also intends to extend its technology to target proteins beyond CDK9, including Myc and H/KRas proteins, among others.
Principles for Growth and Development
Mario’s perspective on continuous growth and development as a business leader underscores several key principles. Staying updated on the latest trends, technologies, and best practices in the biotech/pharma industry is paramount. This involves attending conferences, enrolling in online courses when needed, and actively seeking out mentoring opportunities. Networking is also emphasized as a critical step in building strong professional connections, achieved through participation in industry events, association memberships, and interactions with fellow business leaders. Networking can yield valuable insights, collaboration opportunities, and exposure to fresh ideas.
Mario suggests that effective leadership includes actively seeking feedback from team members, peers, and mentors. Constructive feedback plays a vital role in identifying areas for improvement and refining leadership styles. Furthermore, embracing challenges and viewing them as growth and learning opportunities is encouraged, as overcoming challenges can enhance resilience and problem-solving skills. Seeking mentorship from established leaders can provide invaluable guidance, support, and insights.
Mario acknowledges that the business landscape is ever-evolving, and a successful leader must be adaptable and open to change. Continually evaluating strategies and being prepared to pivot when necessary is a critical aspect of effective leadership.
In Mario’s view, one challenge faced by emerging leaders may be a lack of resilience to persevere, particularly in adverse conditions. Additionally, some emerging leaders may prioritize quick financial rewards and swift exits over long-term growth and sustainability.
Pursuing Societal Equality and Health Equity
From a societal standpoint, Mario emphasizes the importance of achieving greater social equality. This involves promoting equal rights, diversity, and inclusion to create a more harmonious and inclusive society.
In the field of Pharma and Biotech, Mario’s aspiration is for the development of better and more effective drugs that are accessible to the entire population, rather than limited to a select subset. This reflects a desire for more equitable healthcare and medication access.
Regarding people’s lives, Mario envisions several improvements, including healthier lives driven by enhanced nutrition, reduced prevalence of diseases, and the availability of better and safer drugs to combat various illnesses. This vision aligns with the pursuit of overall well-being and health for individuals.
Leading with Vision
When it comes to building a team, Mario values qualities such as ambition, commitment, and integrity as top priorities. Strong work ethics, leadership skills, and creativity in problem-solving are also highly sought after, along with a genuine desire to make a positive impact in the workplace and society as a whole.
Mario’s role encompasses various significant responsibilities within the organization:
- Overseeing the strategic direction of the organization and formulating long-term plans.
- Creating, communicating, and implementing the organization’s vision and mission.
- Leading the development and implementation of the overall organization’s strategy.
- Seeking advice and guidance, when appropriate, from a board of directors.
- Evaluating the organization’s success in achieving its goals.
- Exploring opportunities for fresh funding or the sale of the company under circumstances that enhance shareholders’ value.
Additionally, one of Mario’s more enjoyable tasks is reviewing data and assisting the team in designing new studies and strategies as needed.
Evolution of the Pharmaceutical Industry
According to Mario, the pharmaceutical industry has experienced a significant transformation due to the integration of digital technologies. Innovations like predictive analytics, big data analysis, and AI-based tools have provided companies with the means to revamp their business processes, resulting in the more efficient and faster production of drugs. Artificial intelligence has played a crucial role in enhancing patient responsiveness to medications. Consequently, pharmaceutical companies have transitioned toward a more patient-centric approach, offering applications that empower the public to take charge of their health and interact more effectively with pharmaceutical companies through patient platforms.
Another noteworthy change in the industry, as highlighted by Mario, is the globalization of pharmaceuticals. Raw materials, excipients, and other drug components are now sourced and manufactured on an international scale, making them available on a global market platform. This represents a significant shift in the pharmaceutical sector. Additionally, over the past decade, there has been a growing trend toward global outsourcing of research capabilities and mass drug manufacturing, catering to both developed and developing markets.
Aspiring for Milestones
One of the most significant risks that Mario has undertaken was the transition from being a company employee to becoming an entrepreneur. This journey involved starting various companies during economically challenging times when funding opportunities were scarce.
Looking ahead to the next five years, Mario anticipates that Therabene will achieve regulatory approval for at least one drug for the treatment of triple negative breast cancer. There is also the possibility of gaining approval for the treatment of ovarian cancer, marking a substantial milestone in the company’s trajectory.
Written by Steve Sanchez.
