Shikha Patel is a seasoned Quality Assurance and Validation Leader with over 15 years of experience in the biopharmaceutical and cell therapy industries. She earned her MS in Pharmaceutical Sciences from St. John's University, New York. Shikha has led QA and validation teams at both start-ups and established companies, driving the implementation of comprehensive quality systems and validation strategies.
Her contributions have been pivotal in developing and implementing comprehensive quality/validation policies and procedures to ensure GMP compliance and facilitate the company's transition from lab-scale operations to commercial readiness. Shikha is passionate about continuous improvement and fostering a culture of quality within organizations.
Born and raised in India, Shikha values her roles as a daughter, sister, wife, and, above all, a mother. She is a devoted mom to two terrific toddlers, Samay and Geet. Beyond her professional achievements, Shikha has a passion for music, philosophy, travel, reading, and food. Her vibrant life and career reflect a commitment to excellence and a profound engagement with her field.
Pathway to Pharmaceuticals
Shikha's journey into the pharmaceutical sciences was deeply rooted in her early passion for biology and her desire to stay connected to the healthcare industry. Despite excelling in Biology and Chemistry, her struggles with Physics meant that practicing medicine wasn't an option. Instead, pharmaceuticals became the closest choice, a path she found fulfilling.
Her academic journey took a significant turn when she enrolled in a one-year accelerated Honors program to bridge the gap between the Indian B. Pharm and the U.S. PharmD curricula. Venturing to the United States for her graduate studies was a major step, especially considering the limited information she had about studying abroad. "I had never been to the USA in my life," Shikha shares, emphasizing the challenges she faced, including adapting to the American accent and navigating a new educational system. Yet, she persevered, choosing to pursue an MS in Pharmaceutical Sciences at St. John's University, where her dedication was rewarded with a Full Tuition Scholarship. This scholarship, which came at a critical time, alleviated financial burdens and allowed her to focus on her studies and work as a Teaching Assistant. Reflecting on this support, Shikha acknowledges, "Without it, I wouldn't have been able to complete my graduate studies. I would have returned to India, and my life would have taken a completely different turn."
Her thesis, which examined the effects of a novel endothelin receptor antagonist on endotoxin-induced lung injury in hamsters, further fueled her academic interests. Despite her love for academia, Shikha ultimately decided to explore the industry side of pharmaceutical sciences, leaving the door open for a potential PhD in the future. This blend of passion, determination, and the crucial support of a scholarship shaped her path, enabling her to make significant strides in her field while keeping her options open for future academic pursuits.
Inspiration Behind Research in Pulmonary Inflammation
The drive behind Shikha's research into pulmonary inflammation was profoundly personal, rooted in her father's struggle with severe asthma. "My father was my inspiration," she explains, recalling how his condition significantly affected his quality of life, especially in a time when the solutions available today were non-existent. Witnessing his battle with the disease, Shikha was motivated to focus her research on the lungs, aiming to uncover mechanisms that could potentially lead to better treatments.
Her work zeroed in on endothelin, a potent vasoconstrictor peptide, and its role in modulating the inflammatory response in the lungs, particularly in the presence of endotoxins. By exploring the effects of endothelin agonists and antagonists, Shikha aimed to identify potential therapeutic targets for inflammatory lung conditions. "These findings could have significant implications for developing new treatments for conditions like acute respiratory distress syndrome (ARDS) or chronic obstructive pulmonary disease (COPD)," she notes, highlighting the broader impact of her research on respiratory health.
Building Expertise Through Academic Presentations
The experience of presenting multiple abstracts and posters during her Master's program played a pivotal role in Shikha's development as a researcher. These opportunities pushed her to delve deeper into her research, sharpening her understanding of complex scientific concepts and enhancing her ability to articulate these ideas clearly. "Over time, this experience helped me gain confidence and become more comfortable with public speaking," she reflects, emphasizing the personal and professional growth that came from these experiences.
Beyond the academic setting, presenting at conferences and symposia opened doors to valuable connections with other professionals in the field. These interactions continue to be a vital resource for her as a Quality/Validation professional, allowing her to stay updated on industry trends and discuss challenges with peers. "It is interesting to hear how other companies overcome similar challenges," Shikha notes, underscoring the importance of exchanging ideas to drive innovation and improvement in her work environment.
Academic Influence on Professional Role
The academic background Shikha possesses has significantly shaped her approach to professional work in Quality and Validation within the pharmaceutical industry. Her first publication, closely tied to her thesis research, was a direct result of her academic endeavors. However, as she transitioned into the industry, her subsequent publications became increasingly focused on practical issues in BioPharma Manufacturing. These papers delve into critical topics such as Data Integrity (DI), Process Validation, Phase-appropriate Good Manufacturing Practices (GMP), and Environmental Monitoring (EM). Shikha explains, "I am quite passionate about DI and Phase appropriate GMP," highlighting how her academic foundation has influenced her focus on ensuring that companies do not either overextend or underperform in these crucial areas.
Her experience in the industry has not only guided the content of her publications but has also reinforced the importance of adhering to best practices and FDA guidelines. "I always lean on the published content about industry best practices and FDA guidelines for finding appropriate solutions to challenges at work," Shikha notes, reflecting on how her academic experiences continue to inform her professional decisions. By combining her academic knowledge with industry experience, Shikha aims to contribute valuable insights to the broader field, hoping that her work will serve as a reliable resource for others navigating the complex landscape of pharmaceutical manufacturing and compliance.
The Power of Professional Networking
Conferences are invaluable for both exchanging ideas and building a network within the Pharma/Biotech industry, offering Shikha essential opportunities for professional growth. She emphasizes that simply talking to people at these events can lead to unexpected insights or solutions. "The feedback you receive might just be the solution to your problem at work, or a perspective on your research that is worth exploring," she notes, underscoring the importance of open dialogue in professional growth.
Networking, in particular, is something Shikha views as essential in such a tightly-knit field. "Pharma/Biotech is a small industry and (professional) life is far too long," she reflects, highlighting the long-term benefits of creating connections and opportunities. By fostering relationships at conferences, professionals can keep their options open and ensure they have a support system in place for future challenges.
Advice for Aspiring Professionals
Shikha offers candid and grounded advice to those considering a path in pharmaceutical sciences and biopharmaceuticals. She emphasizes the importance of understanding the realities of research, noting that it's not always about "Eureka" moments or achieving monumental recognition. "The journey can be financially challenging, and setbacks are part of the process," she cautions, urging aspiring researchers to be prepared for the tough road ahead. Yet, for those who remain passionate, she believes that "persistence (and perhaps a bit of pot) is essential for both survival and success."
For young professionals entering the Pharma/Biotech industry, Shikha highlights the importance of networking and following through on opportunities. She advises, "Show genuine interest in opportunities, and once you secure one, maximize it by connecting with as many people as possible, and giving your best effort." This early stage of a career is a prime time to explore different areas within the industry, allowing professionals to discover their true passion. Ultimately, Shikha's message is one of empowerment: "You can do anything." She reminds us that while careers may span decades, life is short, and it's crucial to prioritize what truly makes you happy.
Shikha's journey in pharmaceutical sciences is a testament to her dedication to academic excellence and her significant contributions to the field. Her story is one of perseverance, passion, and a commitment to continuous improvement, serving as an inspiration to aspiring professionals and researchers in the pharmaceutical and biopharmaceutical industries.
