When I began my career as an engineer in a major pharmaceutical company, I worked in an engineering department filled with highly experienced senior engineers. I admired their depth of knowledge and the way they had accumulated a wealth of practical information over decades. Their grasp of systems, processes, and equipment was impressive and humbling. I found myself anxious to build that same...

ISPE reached new heights in its 45th year with the launch of the ISPE Academy, a new podcast, and the 20th anniversary of the Facility of the Year Awards (FOYA). As 2025 comes to a close, Pharmaceutical Engineering®...

When I began my journey in the pharmaceutical industry over 25 years ago, the environment was markedly different from what we see today. We operated in a world dominated by paper-based systems, outdated training videos from the 1980s, and a heavy reliance on self-directed reading. Career progression was more about navigating an informal ladder—gaining experience, demonstrating capability, and...

There is a dated leadership model known as the “Great Man” theory. It posits that history has been largely shaped by highly influential and exceptional individuals who, through natural attributes such as superior intellect, heroic courage, and outstanding leadership skills, have had a decisive impact on historical events.

“Excellence, then, is not an act, but a habit,” wrote the historian and philosopher Will Durant. However, when considering habits of excellence, or quality, we ought to first consider the origin of these habits. These habits originate from our thought patterns and are the architects of our actions. This means that quality actions begin with quality thoughts.

As fall approaches, it brings with it one of the most anticipated events in our industry: the 2025 ISPE Annual Meeting & Expo. More than just a conference, it’s a dynamic gathering where pharmaceutical professionals from around the world come together to exchange ideas, explore innovations, and strengthen our global community.

ISPE is proud to celebrate its 45th anniversary of working with regulators and professionals from across the industry and around the world to shape the future of pharma. This year also marks the 20th anniversary of the ISPE Facility of the Year Awards (FOYA), which celebrates extraordinary achievements in pharmaceutical manufacturing.

Companies must proactively build a healthy culture, as it lays the foundation for organizational success. Those that foster a culture of innovation, dedication, and enthusiasm among employees are best positioned to achieve sustained success.

Like other industries, the pharmaceutical industry is struggling with pain points of inflation, economic and geopolitical uncertainty, and big waves of retiring employees—all factors that have barely been tackled.

Talk show host Oprah Winfrey once said, “A mentor is someone who allows you to see hope inside yourself.” Mentoring can be a powerful force in shaping an individual’s professional career and growth in a profound way. For some of us, we would not be where we are today without the wisdom and guidance of a mentor.

ISPE is dedicated to advancing AI and digital transformation for the industry. The ISPE International Board of Directors fully supports this initiative. We are making significant strides in supporting the pharmaceutical industry’s pursuit of digital transformation, including the exploration and potential strategic implementation of AI.

Empowerment is providing employees with the autonomy, tools, and trust to make decisions that impact their roles and the organization. It requires a shift from the more traditional directive or micromanagement style to fostering a sense of ownership and accountability.

Each year, the ISPE Europe Annual Conference includes a dedicated Women in Pharma^® session, providing an open and collaborative space on professional and personal development. The session fosters meaningful discussions, mentorship, and knowledge-sharing to empower individuals and drive positive change within the industry.

Biopharmaceuticals continue to proliferate in the pharmaceutical industry leading to advancements in advanced therapy medicinal products (ATMPs), cell and gene therapy (C&GT), and other biological products. ISPE supports its membership base of over 22,000 members across more than 120 countries by informing strategies, supporting solutions, and improving processes in this continually...

Crafting and communicating a vision for the organization is one of the most important and visible jobs of a leader. It is also a difficult job, and executing plans to realize the vision is even more difficult.

The expectations for the workforce joining the industry right now are slightly daunting. It can feel like being required to be everything at once: flexible but driven by purpose, extremely adaptable but stable at the core, empathetic but independent, and knowledgeable but versatile.

Being a working mom has shaped my career in unexpected ways. Early in my career, a colleague who had just become a mother told me that you can’t “have it all”—a thriving career, a happy home life, and a fulfilling personal life.

Our March/April issue focuses on the workforce of the future. This is a critical theme for us: ISPE’s vision includes a focus on member and workforce development, as well as technical, regulatory, and quality leadership, as we continue to shape the future of the global pharmaceutical industry. This is particularly important with the industry’s growing skills gap.

Mahatma Gandhi, Winston Churchill, and Golda Meir were some of history’s greatest leaders. One thing they all had in common was that they were leaders of incredible personal character. General Norman Schwarzkopf said, “Leadership is a potent combination of strategy and character. But if you must be without one, be without the strategy.”

For decades, success within the pharmaceutical sector was governed and constituted by linear career paths. A linear path, though predictable, may disregard an individual’s personal drivers and goals. Professional success should not only be defined through the height of your ladder position, but also by the alignment of your work to personal interests.

For nearly half a century, ISPE has served as a resource for the industry. With a global footprint that includes 22,000 members representing 120 countries, we continue to provide guidance to address pressing challenges within the industry.

Mike Martin assumed his new role as President and CEO of ISPE and the ISPE Foundation in January.

I am enthusiastic and humbled to have the opportunity to author a column on leadership for the ISPE membership. The subject of leadership has been a passion of mine since the very start of my career, 45 years ago. From the shop floor to the C-suite, I have been an ardent student of the subject.

The pharmaceutical, biotechnology, and medical device industries continue to grow as patients require more access to medicine, data that allows them to make informed decisions, and personalized care. Achieving sustainability across the supply chain while adhering to quality compliance requirements presents a challenge.

As we approach the end of another impactful year, it is a pleasure to reflect on the outstanding achievements and contributions of ISPE’s Women in Pharma community, both regionally and internationally.

As we come out of the 2024 ISPE Annual Meeting & Expo and move toward the end of the year, I find myself looking back and reflecting on what the ISPE community has accomplished over the past year.

ISPE’s regulatory initiatives and programs bring visibility and solutions to significant regulatory and quality challenges faced by the industry, facilitate the flow of information between ISPE members and global health authorities to find solutions, and promote interaction between regulatory bodies in the interests of harmonization.

We are excited about the 2024 ISPE Annual Meeting & Expo in Orlando, Florida! A special thank you to the sponsors and planning committee for the Hackathon. We appreciate your commitment to ensuring that recent graduates and college students will benefit from this challenging and...

In the dynamic realm of regulatory affairs, a significant transformation is unfolding—a movement that empowers women to assume pivotal roles in decision-making, policy formulation, and leadership.

I hope everyone had the opportunity to enjoy the summer. The ISPE International Board of Directors and ISPE staff have kept busy through the summer months, launching two new Communities of Practice: Sustainability and Artificial Intelligence.

Every year we celebrate the achievements of state-of-the-art pharmaceutical facility projects through the Facility of the Year Awards (FOYA). The buildings are beautiful, energy efficient, and sustainable; the...

Long gone are the days of early morning Women in Pharma breakfast meetings at ISPE international conferences—well, sort of. The long-awaited 2024 ISPE Annual Meeting & Expo is on the horizon and it’s time...

As we get into the peak of the summer months and everyone is preparing for a well-deserved vacation, ISPE is in full swing. We just had a great Biotechnology Conference in Boston. Attendees heard about topics ranging from the use of digitization and artificial intelligence in manufacturing to quality systems maturity and the quality culture required to manufacture safe and efficacious...

It is an exciting time to be an ISPE Emerging Leader! With conferences, professional development support, mentorship, and other opportunities, joining ISPE as an Emerging Leader can help boost your career and expand your network.

The emergence of new modalities and innovations on drug development and research, such as advanced therapy medicinal products (ATMPs) and personalized and precise therapies, presents new opportunities for the treatment and management of diseases and injuries. As these innovations continue to evolve, the regulatory landscape likewise evolves and this has led to the production of higher-quality,...

It is hard to believe that we are halfway through the year for the ISPE programs and the Board of Directors in 2024. We have continued to progress through the 2023–2025 ISPE Strategic Plan with engagement from Chapters, Affiliates, the ISPE Foundation, and ISPE committees and volunteers.

Personalized medicine provides a treatment alternative that utilizes patients’ genetic material to produce therapeutics. According to Market Research Future, the US currently accounts for the largest share of the personalized medicine market, and it is expected to reach US $27.5 million by 2030.

Over time and with effort and determination, women in key leadership positions have proven that these positions are genderless for individuals with the correct set of abilities and knowledge.

ISPE has started 2024 with great momentum, having two technical conferences in the first quarter, the 2024 ISPE Facilities of the Future Conference in San Francisco, California and the 2024 ISPE...

ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) outlines how to apply a risk-based approach to GxP computerized systems and is aligned with the FDA draft guidance “Computer...

An ISPE campaign in 2016 piqued my interest in the Women in Pharma committee because I’m an advocate for women in the workplace. When I became President of the ISPE Philippines Affiliate in 2017, I knew that Women in Pharma...

Next year promises to be a busy one for ISPE. The year starts with the 2024 ISPE Facilities of the Future Conference in San Francisco and is quickly followed by the

We welcomed 2023 with high hopes and dreams of what Women in Pharma^® could eventually be. As I prepare to conclude my time as the Chair of ISPE’s International Women in Pharma Steering Committee, I do so with immense gratitude.

This is my last column in Pharmaceutical Engineering^®. It has been my real pleasure and an honor to serve as your International Board Chair. Thank you for your support and I, like you, look forward to another phenomenal year for ISPE in 2024.

As my first year on the ISPE Board of Directors draws to a close, I find myself reflecting on a year filled with unprecedented learning, growth, and valuable insights.

The healthcare field is being transformed by artificial intelligence (AI) in remarkable ways, providing never-before-seen chances to enhance the well-being of patients. And the use of AI is transforming the job market and bringing numerous benefits to both employees and employers.

For the past few months, ISPE Asia Pacific Affiliates and Chapters have been busy reconnecting with colleagues through in-person conferences. Collaboration, innovation, and technology are common themes; events also incorporate quality culture and excellence.

Where has 2023 gone? The year is already three-quarters over. The 2023 ISPE Annual Meeting & Expo in Las Vegas, Nevada, is just a few weeks away. And I will be...

The pharmaceutical industry is highly regulated, with strict standards for the production and distribution of medications. However, the concept of continuous manufacturing (CM) has revolutionized the way pharmaceutical products are made.

The multigenerational environment we work in poses unique challenges that make effective communication skills as essential today as they have ever been.

It is starting to become more real that my term as Chair is winding down because the 2023–2024 International Board elections are happening.

ISPE’s Emerging Leaders (EL) Steering Committee is taking time to get our foundation right so that we can help drive change and empower young pharmaceutical engineering professionals to pursue their dreams. Our vision and mission will serve as the pillar for how we engage with Emerging Leaders and students around the world, stay true to our goals, and adapt to regional requirements.

As a woman in the pharma industry, I have witnessed firsthand the growth of the industry in the Germany/Austria/Switzerland (D/A/CH) region and the opportunities it has brought for women like me.

It is hard to believe that by the time this column is published, my term as Chair will be half over. We’ve accomplished much, and I’m left wondering, “Where has the year gone?”

Sustainability is a buzzword that has been tossed back and forth across industries for decades. For a while, it was seen as something that consumers didn’t really care about, but now the reality is different. According to a 2022 study, nearly 80% of consumers think about sustainability when purchasing products. Sustainability efforts can range from a specific product to an entire brand,...

2023 continues to move right along—the first quarter is almost over. I remain very optimistic about this year as ISPE International, with support from the International Board, continues to make progress on our 2023 objectives and the 2023—2025 ISPE Strategic Plan.

Arriving in the United States at the age of 17 to pursue my dreams was one of the greatest challenges of my life. It was through this experience that I learned the importance of challenging my perspective. This was made possible through my involvement with ISPE, and four years later, I’m proud to announce the launch of Mentor ISPE.

As a woman of science, I can confidently say that I believe in magic. I believe in the magic that spurs from innovation rooted in desperation, necessity, and determination.

When I started working in the pharmaceutical industry, I was looking for ways to grow my knowledge, my community, and my skillset. When I founded the Emerging Leaders committee within the ISPE D/A/CH (Germany, Austria, and Switzerland) Affiliate, I knew I had found that way.

As we head into 2023, it is hard to believe that it has been four years since the COVID-19 pandemic started to impact our lives and transition us to a new normal. It is also amazing how much technology and innovation continued to advance in those four years to allow our industry to develop new vaccines and innovative products to meet the world’s challenges.

The inclusive nature of ISPE promotes diversity in thought, providing pharma professionals of all levels, geographic, and cultural backgrounds the opportunity to share their knowledge and collaborate across borders. ISPE’s...

We don’t often take time for reflection, except when in times of trial or transition. I recently needed to update my resume, which forced some reflection on what I had done of note since my last update. This reminded me that we are coming up on the end of the year, a transition to new leadership and new goals, and maybe even cleaning up our toolboxes.

Has it really been a year since I began my term as Chair of the ISPE International Board of Directors? It seems like yesterday, and now the

Most people in their careers have to work with others at some point, and in these work interactions there are exchanges of ideas. In pushing business processes forward, determining methodology for a new experiment, or designing a manufacturing facility, multiple stakeholders come from different points of view and with varying priorities. Working with others in any capacity and having the exact...

Over the last two years, ISPE’s Women in Pharma® (WIP) initiative remained undeterred in its mission to connect women throughout the global pharmaceutical industry. Through virtual engagement opportunities—including book clubs,...

Summer is over and we are all back to our workplaces. This year has been different than the two previous years with vaccination against SARS-CoV 2 decoupling the infection rates from hospitalization, intensive-care units, and fatalities. That is an unprecedented achievement in such short time, and we as the pharmaceutical industry have helped make it happen to get back to a new normal.

When opportunity presents itself, how do we know? And who is the opportunity for? How do we evaluate and determine if it is a “good” opportunity? What needs to line up in order to point all the arrows to “yes”?

Knowledge management is powerful. It can be a catalyst for organizational success and create a major competitive advantage, or be a major contributor to organizational failure. We live in a world today where knowledge is literally at our fingertips. To access knowledge in quite literally any topic, we Google it. Merriam-Webster has even added the word “google” as a verb to the dictionary.

Why do I volunteer at ISPE? It is a question that I and surely many of you get asked. Indeed, why?

What do innovating new therapies, surviving the start-up phase of a company, and entering an industry workforce have in common? All three of these, if successful, demonstrate resilience.

As a part of taking care of yourself, one must risk something. For me, taking a risk can be scary. I get nervous, anxious, and, at times, begin to doubt myself. Then I remember why I’m taking a risk and what the potential rewards will be, and confidently move forward with my decision.

The unprecedented speed in the development and global rollout of vaccines and treatments for COVID-19 over the last two years has made it possible to get back to a new normal. The 2022 ISPE Facilities...

Now that the year is underway and people continue to learn how to live with COVID-19, there appear to be some areas where life and work will be changed for an extended period. Adapting and coming up with new tools and approaches will be key.

Pandemic or no pandemic, the pharmaceutical industry is growing at an unprecedented pace, and it is very gratifying to be part of that process. COVID-19 has brought our industry to the daily news, and while the public is getting a better grasp of how we work and need to work, there are still so many misconceptions that need clarification.

The past two years have turned things upside down and forced change in a way that has made many aspects of our lives become unfamiliar. The unforeseen stresses of these changes have pushed many people and companies to their breaking points. Some of these challenges were expected, but came on like a train that we couldn’t stop. I’ve been there, feeling like I don’t have the tools to deal with...

ISPE Women in Pharma® (WIP) wants to kick off the new year by focusing on your journey in taking care of your total self. Whether it is your professional or personal mission to better yourself, Women in Pharma®...

Who would have thought at the beginning of the pandemic that we would have several highly effective vaccines against the coronavirus and billions of doses administered by the end of 2021? I am still amazed what we as the pharmaceutical industry have achieved.

Pharmaceutical Engineering® has announced the finalists and winners of the

The 2021 ISPE Biotechnology Conference and Workshop began on 22 September with a series of keynote presentations on a range of topics related to cell and gene therapies and...

“The only constant in life is change.” This quote is as true today as it was 2,500 years ago when Heraclitus laid out his philosophy. In the last five years, the word “cure” has been used to describe new therapies targeting many different cancer and hereditary diseases. The potential of these therapies to improve human health is profound. These breakthrough therapies utilize advancements in...

The 2021 ISPE Annual Meeting & Expo brings my year as ISPE International Chair of Emerging Leaders (EL) and Emerging Leaders representative on the

Thank you! It has been the honor of my life to serve as the ISPE International Board of Directors Chair in 2020–2021. I could never have imagined COVID-19 would still be such a significant issue at the end of my term.

It is easy to forget to enjoy your success. We all get so focused on the drive to be better, do more, prove ourselves, prove something, and grow that sometimes we forget to stop, be grateful, and enjoy and celebrate all of our success.

Innovation is generally associated with driving business outcomes and processes, adapting to technology, and developing creative management approaches. In the pharmaceutical industry, innovation takes on a more extensive and specific meaning. It is acknowledged to be continuous as it involves dynamic thinking on how to integrate technology into drug development, manufacturing processes, and...

Excitement for restarting face-to-face conferences is building and as plans at local and international levels are in progress, we continue to enjoy the benefits of remote interactions. Innovation and collaboration achieved through fully virtual conferences and seminars in the past year and a half show us that both have great benefits.

I live in Indianapolis, Indiana, truly a great place to live. It is not difficult to understand why I like Indy so much: humble, down-to-earth people, farming (I grew up on a farm), readily available participant sports, and many spectator sporting event opportunities including football, soccer, baseball, and racing. Especially during the month of May, racing and the Indy 500 in particular are...

Optimism is in the air as we move through the summer months and the restrictions that have become second nature are slowly lifting. As I continue the second half of my year as the Emerging Leaders (EL) Chair and representative on...

Remembering the “why” of our pharma industry is so important and, for me, also very personal. My sister Linda was 69 and her four grandchildren were the light of her life. In November 2017, she was diagnosed with appendix cancer (a rare cancer, closely related to colon cancer). After four months of nasty chemotherapy, Linda entered hospice care and died the next month. Previously, my mother...

Organizations wanting to ensure the well-being and growth of their employees need to invest in robust mentorship and recognition programs. Mentoring has played a key role in my career development. In the 1990s and early 2000s, I worked in Novartis and engineering services companies where I was part of informal mentoring groups with some senior directors and trusted collaborators across the...

2020 was a year for finding new ways of working for the entire ISPE Emerging Leaders (EL) community. In February, Emerging Leaders stepped up the challenge by holding the first fully

This year’s Women in Pharma® (WIP) theme of “Fueling the Fire” harnesses the energy and passion that drive women to achieve career advancement, personal growth, and satisfaction. The 3 March webinar focused on the Diversity...

I used to think “home detention” was no punishment at all, but this last year has dramatically changed my thinking. Despite working from home for over a year, my house is a wreck! Like many of you, I feel busier than ever, despite not traveling and not driving to and from work. Disruption used to be rare and now it is common: having to adapt to new ways of doing most everything, like buying...

The ISPE Women in Pharma® (WIP) theme for the month of March is entrepreneurship. This word can mean different things to different people, but WIP defines it as the creation of value. Communications, events, and activities...

Understanding and utilization of Pharma 4.0™ technologies will be critical for students and Emerging Leaders (ELs) as they develop in their careers in the pharmaceutical and life sciences industries. To learn more, I spoke with Edoardo Schiraldi, an Emerging Leader based in Florence, Italy, who works as a Corporate R&D Business Solutions Specialist with Menarini Group, about the “pillars”...

The last 12 months have felt like the slowest and fastest of times. The days drone on, yet the months fly by. I have now been working from home for a year—5% of my time at Lilly. I feel sadness for so many families who have lost loved ones and/or spent the holidays alone. Dogs and cats appearing in virtual meetings are no longer a huge distraction but a welcome glimpse of social...

My parents always told me when I was growing up that I could be anything I wanted to be. They strongly steered me in the direction of engineering at North Carolina State University, so that I would be able to earn a degree that would ensure my future was my own. When I was eight years old, I was introduced to a pharma company my dad worked for and you could say my love of this industry has...

I think everyone will join me in celebrating the start of 2021! With all the challenges brought by 2020, last year also demonstrated the resilience and innovative thinking of ISPE members. With collaboration and perseverance in mind, I was delighted to begin my tenure as ISPE International Emerging Leaders Chair at the virtual

I was a skeptic. When the Women in Pharma® (WIP) program started in 2016, I had previously attended several other professional women’s programs and usually left disappointed, as these programs did not provide the information I...

As this is my last Young Professional (YP) column for Pharmaceutical Engineering®, I wanted to start with a quote from Winston Churchill that I feel summarizes my two-year journey as the International Young Professional Chair: “Success is not final, failure is not fatal: it is the courage to continue that counts.”

2020 has been a super-busy year for ISPE Women in Pharma® (WIP). We started 2020 with aggressive goals, including to set up global Mentor Circles; start a monthly Women in Pharma® newsletter, The Bridge;...

Given the events that have transpired over the last 12 months, I have penned the title of my final column as ISPE Chair to reflect the temperament of our times. Coincidentally, and please pardon my digression, the title also happens to be the name of a hit album of topical songs by Tom Lehrer, recorded live in July of 1965 at the “Hungry I” nightclub in San Francisco, California.

As many of you read this, I am sure your social and work life have been turned upside down, flipped around, and now are possibly settling into “the new normal.” I personally cringed when I wrote that—I was so tired of hearing that phrase about three weeks into the pandemic.

Because of the global pandemic, we have experienced unexpected joys, learned new skills, adjusted to long days of video conferencing, and dealt with drops in income and potential job losses. At the same time, we have also experienced an increased sense of urgency, collaboration, and pride because we are a part of the industry that has been tapped to heal all our nations from this unexpected...

How many times have you heard phrases like these over the last several months: unprecedented marketplace disruptions, staggering economic conditions, or maybe insurmountable business challenges? If you’re like me, probably more than you can count.

I wanted to take a break from my usual column and highlight a few Young Professionals (YPs) around the world. These individuals have not let COVID-19, or anything else, get in the way of their career development. Each joined...

How is your calendar looking these days? As I write this, we have all been living a bit differently today than we were one year ago. I’ll bet you have seen an increase in webinars, virtual trainings, and video conference calls, and likely having far fewer face-to-face interactions.

Since January, nothing has been normal. Nothing, especially when we try to compare it to anything we have experienced in the recent past. So how do we begin to move forward as the efforts of both the public and private sectors combine to offset the advance of the impact to businesses due to COVID-19?

Did you know that Women in Pharma® (WIP) has launched a program to initiate Mentor Circles around the globe? While great strides have been made to support women in the workplace, women are still significantly underrepresented in upper management in the pharmaceutical industry. The ISPE Women in Pharma® Mentor Circle program...

Spring is finally here, signaling a time of new beginnings. Today finds me thinking about International Women’s Day (IWD, observed annually on 8 March), a global day of celebrating the social, economic, cultural, and political achievements of women. This year, International Women’s Day has the theme of equality, a very fitting theme for the topics I want to share with you. This issue’s column...

Brazil’s regulatory authority is working hard to make the nation a larger player in the global pharmaceutical market, and these efforts appear to be working: the life sciences industry has expanded in recent years, and market projections are positive. These ongoing developments represent opportunities for the ISPE Brazil Affiliate as it undergoes its own transformation.

I recently had dinner with a friend and colleague who was looking at taking on a new job role. She asked me what I thought about her salary request as part of this new opportunity. I asked, “Is that what you think you are worth?” She looked very confused by my response, and I realized that many of us do not often step back and determine our business value.

On 26–27 October 2019, the first Global Student & Young Professional Hackathon was held at the 2019 ISPE Annual Meeting & Expo. Thirty-six

As I sit at my computer to write my first column as ISPE International Board Chair, my thoughts are centered on how I can personally help drive our unifying vision, “Connecting Pharmaceutical Knowledge,” and how we as members of ISPE have an outstanding opportunity in the year ahead to provide outreach and resources to expand our networks of people, technology, and information to accomplish...

The pharmaceutical industry is ever-changing, as we saw demonstrated during the 2019 ISPE Annual Meeting & Expo, and at other ISPE conferences around the world. In fact, change is accelerating—and to...

Memorandum of intent creates ISPE affiliate in Eurasia

Reducing water wastage and effluents in biopharmaceutical production