An Interview With Fotis Georgiadis
Reduced human error — Reduce human error and other predictable risks when you simplify and modernize processes and workflows using applications that are fully customized to your teams’ needs.
As a part of our series about “How To Use Digital Transformation To Take Your Company To The Next Level”, I had the pleasure of interviewing Alice Redmond.
Alice Redmond, Ph.D. is the Vice President of Europe Operations at Commissioning Agents, Inc. She has more than 29 years of experience in the lifecycle management of pharma facilities inclusive of regulatory compliance, facility & process design, technology transfer, commissioning, qualification, and validation. Previously Ms. Redmond worked for Sandoz/Novartis in Basel, Kundl, and Ireland in the areas of quality, validation, and technical operations. Following Novartis, Alice led the Global Regulatory, Commissioning, and Qualification Group for a Global Engineering Company for 13 years. Alice has large global project experience in green field facilities including fill finish, biotech, gene therapy, medical devices, small and large molecule API, and OSD from design through to operational readiness.
Thank you so much for joining us in this interview series. Before we dive in, our readers would love to “get to know you” a bit better. Can you tell us a bit about your ‘backstory’ and how you got started?
I’m an engineer, scientist, lifelong learner, and all in all a biotech “nerd.” I earned my degree in Biotechnology and Chemical Engineering, and from there, I grew a passion for all things engineering and biotechnology. Throughout my educational career, I pursued the path of cancer research, eventually finding a niche interest in multiple drug resistance in human tumors (lung and ovarian cancer). This experience is what ultimately led and inspired me to pursue a career in the pharmaceutical industry. Since then, I have never looked back, working across the globe in various different sectors and modalities of drug products. Mostly, I geek out about all the new modalities that are now becoming the norm and mapping the future of how patients are treated.
I’ve also spent a great deal of time promoting STEM throughout my career. It’s a passion point that I have fostered, both during my undergraduate and postgraduate studies, and then through different leadership levels. I’m a founding member of Women in Technology and Science (WITS), and on the ISPE Women in Pharma (WIP) steering team. ISPE WIP provides women in the pharmaceutical industry a forum for genuine collaboration and connection on technical and career advancement topics, and it’s an honor to work with and meet amazing, hard-working, intelligent women across the globe. Through this community, I’ve been fortunate to harness the power of networking, mentoring, and tapping into resources across all levels to gain and help foster balanced professional growth.
Can you share a story about the funniest mistake you made when you were first starting? Can you tell us what lessons or ‘takeaways’ you learned from that?
Early in my career, I was tasked with the responsibility of executing a Good Manufacturing Practice (GMP) audit for the entire manufacturing site I supported at the time. Once I finalized the audit, my supervisor asked me to send a detailed email to the full site leadership team, inclusive of sensitive information regarding the site’s process, testing, training, and personnel. And while my supervisor asked me to copy a specific list of people, somehow I managed to send the email to the ENTIRE company. From then on, I always check…and recheck the target email addresses. It’s important to be careful when handling reports of a sensitive nature!
None of us are able to achieve success without some help along the way. Is there a particular person who you are grateful for who helped get you to where you are? Can you share a story?
While completing my Ph.D. program, I met a female oncologist who had a very successful clinical practice. She did an inspiring job of balancing both a busy work life and a personal life — raising four children — while concurrently supporting many young female engineers like myself. To me, she was like Superwoman. Through drive and perseverance, she forged her own inspiring and successful career path and was always eager to learn and grow. She was a very influential person and I felt lucky to meet her during my undergraduate program. To me, her success was built on many fundamental skills and characteristics, but what struck me as a 21-year-old was her ability to connect with people of all cultures, ages, and all levels within healthcare, industry, and academia. Her communication style was customized, factual, diplomatic, and appropriate. Her feedback was spot on. When you asked her opinion on something she would always challenge you to think of many different aspects of the same scenario. I’ve carried this experience and interaction with me throughout my career, and today, I am grateful for the guidance she provided me so early on in my adult life. Even now, occasionally I ask myself that question, “what would Maeve say?” and attribute much of who I am today, both professionally and personally, to her. For other young professionals, I highly recommend making as many professional connections as possible throughout your career. There is so much to be learned from others’ experiences and beliefs.
Is there a particular book, podcast, or film that made a significant impact on you? Can you share a story or explain why it resonated with you so much?
John Crowly’s story continues to inspire me. He is an American biotechnology executive and entrepreneur, currently chairman and CEO of Amicus. When his children were diagnosed with Pompe disease, John moved the family to be closer to the right doctor and got a job at Bristol-Myers Squibb to immerse himself in health research. Later, he co-founded Novazyme Pharmaceuticals then acquired by Genzyme, and was able to provide the enzyme replacement therapy for Pompe disease to his children. In 2006, he was profiled in the book The Cure: How a Father Raised $100 Million — And Bucked the Medical Establishment — In a Quest to Save His Children, and was then the inspiration for the movie Extraordinary Measures.
John’s story is one of true perseverance, science, and honoring the voice of the patient. A good friend of mine has two children suffering from Pompe disease, and ever since, John Crowly’s story has continued to inspire me.
Extensive research suggests that “purpose-driven businesses” are more successful in many areas. When your company started, what was its vision, and what was its purpose?
Since our founding in 1996, CAI has had one main purpose: to accelerate our clients’ path to success. We put the client’s interests first. We don’t stop until it’s right. And we’ll do whatever it takes to get there. We’ve developed and changed over the years to better serve our clients, but have always stuck to our core values and main mission.
At CAI, we believe that world-class operations successfully plan and integrate three areas: product, process, and end-user requirements; people; and equipment, automation, and facility technology. We focus on integrating these areas, as applied to regulated manufacturing, mission-critical facilities, energy-efficient buildings, patient-critical facilities, and complex operations.
Our clients demand technical and project management expertise, attention to detail, tenacity, innovation, and responsiveness to meet a wide range of requirements and overcome a broad range of contingencies. And since the beginning, we’ve tried our best to deliver consistently, expertly and completely.
Are you working on any new, exciting projects now? How do you think that might help people?
At CAI, we have seen a shift in BioPharma Services requirements toward operational workforce support, due to a combination of market talent challenges. Our strategic positioning of an integrated Operational Readiness (OR) best-in-class early engagement model and Operational Excellence (OE) approach includes the support staffing plans and operational scheduling, SOPs development & Batch Record drafting, development of Training and Qualification programs and content and human error deviation closure & reduction.
We are conducting speed-to-patient OR workshops early in the project lifecycle, ideally during basic and front-end design. This helps to further develop key interactions, stakeholder management, and deliverables timing. The OR model deployment helps our client improve their comprehension of the activities necessary to achieve their goals. It is like putting together a jigsaw that has removed organization and process barriers and all the pieces mesh together.
Thank you for all that. Let’s now turn to the main focus of our discussion about Digital Transformation. For the benefit of our readers, can you help explain what exactly Digital Transformation means? On a practical level, what does it look like to engage in a Digital Transformation?
Absolutely! In simplest terms, Digital Transformation is the process of evaluating and implementing innovative technologies into business processes to transform the operations of an organization. If done right, it can provide a competitive edge that will ultimately lead to better services, both for customers, employees, and the communities the organization serves.
Digital transformation is the primary driver of the 4.0 stage within the manufacturing/pharmaceutical industry. There is a huge call for a mix of emerging technologies that tackle age-old industrial objectives: boost production, improve quality and reduce equipment downtime. Among the IT developments, manufacturers hope to harness include cloud and edge computing, 5G networks, and AI rank.
In our experience at CAI, we help our clients through the everyday challenges of digitally transforming — from identifying business processes ripe for transformation to rapid application design and implementation, business integration, and quality support and maintenance.
We work closely with our clients, existing technologies, legacy systems, and processes to streamline complex engineering and mission-critical project management workflows. Strategically leveraging the latest technology is imperative, not only for our client’s business growth but for survival in today’s fast-moving market and to stay ahead of the competition.
Which companies can most benefit from a Digital Transformation?
As we progress further into the phase of Pharma 4.0, the amount of companies within the industry that would benefit from the digital transformation has drastically increased. Many more industry sectors are able to leverage artificial intelligence (AI) technology and digital twinning to get over hurdles and provide the public with better products more efficiently. For example, there is now use in check transfer, in programming, in modeling, and in data analytics. With use in the developmental stages and now the following stages, we are able to experience a holistic digital transformation within the market.
We’d love to hear about your experiences helping others with Digital Transformation. In your experience, how has Digital Transformation helped improve operations, processes, and customer experiences? We’d love to hear some stories if possible.
Digital technology and this transformation have impacted the industry from the point of facility design, product design, clinical trials, and the patient experience. For example, CAI and our clients are using digital twinning technologies for employee training and for process optimization. We have a human performance element to what we do, and a lot of that is based on the use of online technologies for training, specifically AI technologies for training. We are only tipping the iceberg now. For us, the use of these technologies of AI, machine learning, and blockchain have to be a part of the strategy to be able to compete tomorrow, but also to integrate and work with others from a global perspective.
Has integrating Digital Transformation been a challenging process for some companies? What are the challenges? How do you help resolve them?
In this day of digitization, manufacturing companies struggle to navigate their way through the digital transformation process. It’s challenging to introduce new technologies into your organizations, as the transition from the tried and true legacy systems and processes is difficult.
However, the macroeconomic forces and cost pressures along with technological improvements will result in inevitable digital transformation in the years to come and soon businesses will require a data-centric architecture.
At CAI, we have incorporated digital platforms, streamlined complex engineering, & mission-critical project management workflows to enable the clients with both a faster time to market and cost efficiencies, now with reduced risk and improved productivity.
Ok. Thank you. Here is the primary question of our discussion. Based on your experience and success, what are “Five Ways a Company Can Use Digital Transformation To Take It To The Next Level”?
- Regulatory Compliance — Fast track regulatory compliance and site management tasks and issues with customized applications that automate the process for you
- Use cloud technology as a competitive advantage — Deliver new drugs, MedTech, and other devices to market faster than your competitors with a digitized core.
- Reduced human error — Reduce human error and other predictable risks when you simplify and modernize processes and workflows using applications that are fully customized to your teams’ needs.
- Modernize your data management program — Take advantage of cloud flexibility and scalability by transforming how you manage data security and data protection and use real-time data dashboard analysis tools.
- Manage operations more efficiently — Improve productivity, automate manual and repetitive tasks, and track your operations more efficiently.
In your opinion, how can companies best create a “culture of innovation” in order to create new competitive advantages?
CAI has always, first and foremost, been committed to our people. We are a global company that prides itself on fostering and supporting a diverse workforce of people from different backgrounds and experiences. Because we work in the office spaces and factories of many of our clients as we serve them, we often find ourselves in many diverse places and among many diverse people. At our core, we are built on relationships with the people we serve inside and outside of the organization.. Providing the best customer service through our talented team of employees is core to our value proposition. We recognize that great service is built through trusted relationships. An organization can establish this by fully understanding who they’re serving, clients knowing the organization on a deeper level, and then providing a high-level performance. Through trust, an organization possesses the power to integrate both its talent team into other varying corporate cultures and geographies and the ability to adapt quickly. We stand firm with the belief that a positive experience with a client will blossom if these global learnings are applied, but on the flip side, it can also quickly deteriorate.
Can you please give us your favorite “Life Lesson Quote”? Can you share how that was relevant to you in your life?
“The journey of your success will always begin with the small step of taking a chance. In business, in relationships, and in life, it all begins with a small step grounded in a desire and determination to be better and do better.”
Each small step I took in the journey helped me to grow and learn from those experiences. Each small win and mistake was what I needed to grow in my career, and I’m grateful for it all.
How can our readers further follow your work?
Those who would be interested in following me can do so on LinkedIn. If you are interested in others outside of just me, I’d encourage you to check our CAI resources page. There you can read the latest and greatest sources written by our team of experts — with everything from role-based talent planning for operational readiness to industry survival in the face of an evolving workforce — case studies of our client success stories and more. We also have a company blog where we share our newest ideas and thought leadership hot takes!
Thank you so much for sharing these important insights. We wish you continued success and good health!
Alice Redmond Of CAI On How To Use Digital Transformation To Take Your Company To The Next Level was originally published in Authority Magazine on Medium, where people are continuing the conversation by highlighting and responding to this story.
