Working Her Dream Job: Insight from a Clinical Development Expert

Patricia Walicke MD, PhD, a core member of Advanced Clinical’s strategic advisory ecosystem, describes her experience in achieving her dream career: “I’ve followed a desire to try to make the world a better place and serve humanity through improving health and health care.”

As a strategic advisor, Dr. Walicke brings years of leadership strategy experience across several areas of clinical research, including protocol design and clinical plan development across multiple phases. Additionally, she has experience in regulatory submissions and interactions as well as medical monitoring and safety. Her expertise combined with her current work as an independent consultant for clinical development programs contributes to Advanced Clinical’s Industry Leading R&D Performance (ILRDP) framework that seeks to make the “business of R&D” more effective and efficient for Life Sciences companies.

“The team at Advanced is very bright, dedicated and determined, and, by working together, we have the opportunity to share how to operate more efficiently and effectively in the industry,” said Patricia Walicke, Advanced Clinical Strategic Advisor.

Formerly a practicing neurologist, Dr. Walicke changed careers to drug development approximately 15 years ago. She has experience with biologics and small molecules, and has worked on indications in neurology, autoimmune rheumatologic disorders, dermatology, ophthalmology and oncology. She explains that creativity, balanced by practicality, is the key to drug development: “When evaluating a potential therapeutic, first it is important to think broadly of all the possible ways that it might be used in medicine. Then the range of indications needs to be narrowed down to what is feasible. Matching the mechanism of action of the compound to the pathophysiology of the disease is also an important determinant.”

Notably, Dr. Walicke led the Phase 3 team for approval of efalizumab (Raptiva) for psoriasis; helped design extension of rituximab to non-oncology indications, particularly multiple sclerosis; obtained the first clinical proof of concept for anti-NGF in analgesia; and has been awarded several drug patents. “Drug development was a way for me to help more people more efficiently. You can potentially help hundreds of thousands of people,” said Dr. Walicke.

In addition, Dr. Walicke took a leadership role in establishing clinical groups in two start-up companies and restructuring the clinical department for biopharmaceutical company Oxigene with relocation from the East Coast to the West Coast.

Of compiling clinical teams, Dr. Walicke says, “While it is important for the team to be knowledgeable, it is perhaps most important that the team members communicate effectively and stay focused on the overall goal.”

Dr. Walicke offers advice to others in the clinical field, based on attributes to which she credits her own success: “Represent the needs and interests of patients and clinicians within industry, follow the science, keep timelines and deliverables, and pay attention along the way.”

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