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...

Tracy L. Clemmer’s experience has spanned the globe, and she has an impressive list of ISPE roles on her résumé. In addition to being a past President and Chair of the Training and Education Committee of the ISPE Singapore Affiliate, she was a Board Member and Chair of the Training and Education Committee of the...

I was recently meeting with one of the individuals I am lucky enough to call a mentor and friend. During our dinner, we talked about various topics from general life items to questions about work. One of the questions she asked that inspired me to write this article was, “If leaders are people with experience and wisdom, how can I be seen as a leader when I am just starting my career?”

The November-December issue of Pharmaceutical Engineering is published in the months of the Thanksgiving holiday in the US and the year-end holidays celebrated around the world, so it seems appropriate to note the many changes to the magazine this year and give thanks to those who have contributed to and supported those changes.

In his 17 years as a member of the ISPE United Kingdom Affiliate, Jon Youles has worn many hats, including Editor for the newsletter, Chair of the Southern region’s committee, and Secretary and Vice Chair of the Affiliate. Now, as Chair of the Affiliate, he leads an engaged membership that is thriving even as the...

In a world dominated by social media and online profiles, the art of getting to know someone has been transformed. So, in this age, when you can connect with someone by “swiping right” on a dating app, how do you build a professional network? Face-to-face interactions remain a great starting point. Therefore, whenever I attend a conference or other professional event, I make sure that I am...

As I write my last Chairman column for Pharmaceutical Engineering, I reflect on what has happened over the past year globally and within ISPE. The pace of change in the industry has accelerated and will continue to accelerate with new technologies and business models being deployed.

Many of us have heard of Moore’s Law, named after Gordon Moore, cofounder of Intel1 . Moore’s Law predicted that...

• 1Intel. “Fueling Innovation We Love and Depend On.” Accessed 22 May 2019. https://www.intel.com/content/www/us/en/silicon-innovations/moores-law-technology.html

I’ve been to numerous ISPE conferences in the United States. This was my first ISPE Europe Annual Conference, held 1–4 April, and it did not disappoint! The Young Professionals (YPs) were an integral part of...

Initially, the American College of Rheumatology urged caution around the use of biosimilars. Information about the manufacturing process for a branded biologic is proprietary; a biosimilar manufacturer will not have access to the details of the process, so how could they guarantee their product would be the same? It is now well accepted by the scientific community that biosimilars are safe,...

From the time when we were young, we have been taught to avoid failure. You are told to get the best grades in school, which will lead to getting into college. And when you graduate, you’ll get a good job, work hard, and the promotions will come. At no point did anyone ever tell us to fail! But failure is part of life and we all have personal and professional failures despite our best...

Jim Breen

GAMP® CoP Benelux members

Magazine had a great year in 2018 with the launch of PE Online. In case you missed them, here are the most popular PE Online articles from 2018.

Six women shared stories about building their diverse pharmaceutical industry careers, including challenges encountered along the way and their recommendations for other women in the profession, during a roundtable session on Women in Pharma®. The Roundtable opened the second day of the

Many members think of ISPE as a family of professionals, colleagues, and friends. Two of ISPE’s active members, George and Peter Millili, have taken this a step further; they’ve made ISPE part of their family.

Teamwork and collaboration are becoming increasingly critical in today’s professional arena. The drive to produce innovative, disruptive products calls for interdisciplinary teams. To function effectively, these diverse groups require creative problem-solving, conflict resolution, and interpersonal skills. Even the hiring process has become centered on these skills, which have traditionally...

I have always held myself to a high standard and kept high expectations for myself. I always thought that setting this high bar for myself would push me harder, make me better, and ultimately help me succeed. However, when I didn’t meet the expectations that I had set, I was so hard on myself. I would lie awake at night replaying where I went wrong over and over in my head, and all this did...

It is an exciting time for the pharmaceutical and life sciences industries in Ireland. The country has firmly established itself as one of the world’s centers of excellence and the number one European location for pharmaceutical and life science investment. It is equally exciting for ISPE’s Ireland Affiliate, which enters its 30th anniversary year as the host of the

The past two decades have changed the pharmaceutical sector and health care delivery in both developed and emerging economies. The increasing use of generic medicines globally, 1

• 1Quintiles IMS Institute. Outlook for Global Medicines Through 2021: Balancing Cost and Value. December 2016.

Across industries, the trend is toward speed to market. - Whether it’s meeting consumer expectations for instant service or being the first to bring an innovation to shelves, companies have plenty of incentives to make products and services available faster.

Maritime discipline took the Boston Area Chapter President from a trawler to the boardroom. - It might seem odd to connect commercial fishing to the study of chemical engineering— and perhaps even more unlikely to connect commercial fishing to a career in the biopharmaceutical industry. But for Kevin Chronley, Vice President...

Happy 2019! The last time I saw many of you was at the ISPE 2018 Annual Meeting & Expo in Philadelphia, where I started my tenure as the ISPE International Young Professionals Chair.

Over 2,000 attendees from more than 28 countries gathered in Philadelphia for the 2018 ISPE Annual Meeting & Expo on 4–7 November. Highlights below show the many ways that presenters captured the conference theme of...

A wide range of pharmaceutical products is produced using two complex fermentation processes. Anaerobic fermentation takes place in the absence of oxygen, and aerobic fermentation requires oxygen, supplied via blower and compressor systems, to yield microorganisms and produce the desired product. This article examines the role of aeration equipment in aerobic fermentation, considerations when...

Richi Sethi, a Design Engineer for Biocon, India’s largest biopharma company, knows that process engineering involves constant adaptation. “We have to be very dynamic,” she explained. “People want to try new things, and we have to be on the forefront.”

Six Sigma is an approach for pharmaceutical manufacturing quality that can help to eliminate drug shortages and recalls and improve performance issues. Lawrence Yu, PhD, Deputy Director, Office of Pharmaceutical Quality, FDA Center for Drug Evaluation and Research (CDER), provided an overview of key factors around the move to Six Sigma quality in pharma manufacturing in his presentation “The...

Adoption, Applications, and Regulatory Guidance

On 19 June, ISPE officially launched the ISPE Foundation. The philanthropic arm of ISPE "will enhance ISPE's ability to support its members and the pharmaceutical industry as they prepare to address new and evolving industry demands," according to Michael A. Arnold, ISPE Foundation Board Chair, and John E. Bournas, ISPE CEO and President.

Attending Large Conferences and Navigating Exhibitor Halls

I write my final "Message from the Chair" article full of a range of thoughts and emotions. Perhaps the best way to sum up my feelings is just to say, "Time flies when you're having fun."

ISPE's Board of Directors is working to refresh the Strategic Plan.

I finally landed a great job. How can I get started on the right foot?

My conversation with six members of ISPE's Board of Directors continues this month.

I am pleased to have another opportunity to share some thoughts and provide a quick update about the progress of ISPE. It is hard to fathom that we are halfway through 2018, and summer is upon us (at least those of us in the Northern Hemisphere). ISPE had a very busy first half of the year, with three major conferences in North America, a very successful Europe Annual Meeting in Rome, and...

In our industry, as in many others, the most important goal is developing and delivering a product that satisfies our customers. In our industry, the end customer is the patient.

Imagination is more important than knowledge. Knowledge is limited. Imagination encircles the world.
—Albert Einstein

Memorandum of intent creates ISPE affiliate in Eurasia

Reducing water wastage and effluents in biopharmaceutical production

Fellow members, it is my pleasure to provide a short update on some of ISPE's accomplishments, its strategic plan, and ongoing activities.

The United Kingdom's (UK) "Brexit" vote to leave the European Union (EU) by March 2019 has created challenges for the European pharmaceutical industry. Among the first important decisions resulting from the impending departure was where to relocate the European Medicines Agency (EMA), currently headquartered in London. On 20 November 2017, the EU's European Council resolved this concern when...

New Board Chair Tim Howard Plans for Continued Success

A hero is someone who has given his or her life to something bigger than oneself.

— "The Hero's Adventure," in 'The Power of Myth', by Joseph Campbell with Bill Moyers, 1988

Hi David, I've had a few phone interviews recently, but I never go any further in the process. What am I doing wrong?

After 48 years of service, MECO Vice President Robert "Bob" Gray is retiring.

"Local and regional relevance" is a key component of our strategic plan, and one that is critical to our success as an organization. It pledges us to "understand and shape strategy to the business, culture, and regulatory issues of local and regional markets." Here are a few ways in which we are doing just that:

Hi David, I've had several interviews, but have yet to receive an offer. What could I be doing wrong?

Novel methods of drug delivery

"The only constant is change."

Happy 2017 and welcome back from the holiday season! I hope you all enjoyed some quality downtime with family and friends.

An Interview with Lou Schmukler, President of Global Manufacturing and Supply at Bristol-Myers Squibb