Improving Quality of Life

Dr. Sian Bigora, Chief Development and Regulatory Officer at Processa Pharmaceuticals (“Processa”), drives her company’s drug development team. Her vast knowledge of pre-clinical and translational medicine, clinical regulatory operations, and safety has been instrumental in how the company operates. During the company’s development meetings, she has a way of remembering countless examples of what has worked in the past or things that, if reconsidered, might work even better. Her experience of having her hand in all these different departments brings the complete picture of how clinical research should be conducted.

Sian’s well-rounded knowledge of clinical trials, drug development, project management, and regulatory affairs is second to none in this industry. She will give her opinion, which can sometimes be intense, but she also actively listens to her colleagues and fellow employees and encourages people to speak up and share their thoughts. Her approach has set the tone for the company and how Processa operates and makes decisions.

Sian serves as a conduit from the development team to the CEO and C-suite of the company, and she can interpret, filter, explain, and set expectations in such a way that doesn’t put undue strain on the development team. Sian can successfully navigate a multitude of potential issues by using these skills and shoulders many burdens from these angles without having them trickle down to the team. She connects with all her staff regularly and is conscious of keeping the team motivated by empowering them to make decisions and fostering a culture of ownership. Her years of experience and vast knowledge in so many areas of drug development have made her invaluable to the development team and Processa. Her vision and decisiveness have made her exceptional at guiding the team in accomplishing Processa’s project goals. She has confidence in her staff making decisions in their role, thinking outside the box, and being more creative in any problem-solving scenarios.

For Sian, success depends on the definition; for some, success comes in the form of moving up the corporate ladder, and for some, it is a better salary, while for others, it is seeing people around them flourish. “For me, it has been a very long journey and not always easy. But although I pushed my limits and was tested on many occasions, I always bounced back and became stronger despite the circumstances,” says Sian, who has always strived to succeed at every position and task set before her.

Armed with this pioneering mindset, Sian has been taking the company to new heights. Processa is developing the next generation of chemotherapy drugs that will provide safer and more effective drugs to cancer patients, while increasing the number of patients who receive effective treatment.

Processa is a clinical stage pharmaceutical company focused on developing Next Generation Chemotherapy (NGC) drugs intended to improve the safety, tolerability, and efficacy of cancer treatment. Some of the key advantages of Processa’s NGCs are expected to be fewer patients experiencing side effects that lead to dose discontinuation, more significant cancer response, and an increase in the number of patients who will benefit from each NGC drug. The NGC drugs are modifications of existing FDA-approved oncology drugs, resulting in an alteration of the metabolism and/or distribution of these FDA-approved drugs while maintaining the existing mechanisms of killing the cancer cells.

By combining the proven cancer-killing active molecules and Processa’s Regulatory Science Approach with FDA’s new Project Optimus Oncology Initiative, Processa can provide better therapeutic options to cancer patients more efficiently while increasing the probability of FDA approval. Using its Regulatory Science Approach, the Processa team has consistently demonstrated its ability to obtain FDA approvals, as evidenced by over 30 approvals for indications across almost every division of the FDA. The company’s pipeline includes three NGC oncology treatments: Next Generation Capecitabine (PCS6422 and capecitabine to treat metastatic colorectal, gastrointestinal, breast, pancreatic, and other cancers), Next Generation Gemcitabine (PCS3117 to treat pancreatic, biliary duct, lung, ovarian, breast, and other cancers), and Next Generation Irinotecan (PCS11T to treat lung, colorectal, gastrointestinal, pancreatic, and other cancers).

A common goal brought Processa’s leadership team together: to help patients suffering from life-threatening and life-compromising chronic diseases. “The starting point for all of our programs begins with providing safer and improved treatment for cancer patients. We allocate our resources to accelerate development of these life improving solutions,” says Sian. “Working together for over 30 years, the leadership team has garnered a unique approach to developing therapies today by applying our Regulatory Science approach to efficiently position drugs for approval success.”