May / June 2024

Frances Zipp Receives 2023 Professional Achievement Award

Frances Zipp Receives 2023 Professional Achievement Award

Frances (Fran) M. Zipp was awarded the ISPE Joseph X. Phillips Professional Achievement Award at the 2023 ISPE Annual Meeting and Expo. The award is named in honor of Joe Phillips, longtime supporter of ISPE and a leader in establishing the Society as an “integrator” of industry and regulators, both during his years of service with the FDA and later when he became International Regulatory Affairs Advisor to ISPE.

Fran is President and CEO of Lachman Consultant Services, Inc., which provides compliance, regulatory, and technical consulting services to global pharmaceutical and related industries, delivering strategic guidance and direction toward implementation of effective solutions to client needs across the biopharmaceutical network.

Fran has assisted and counseled senior-level management in a broad variety of areas involving corporate governance, compliance enhancement, 483 and Warning Letter responses and corrective actions, drug shortages, regulatory strategies, and compliance-policy-related matters. Fran has been part of the biopharmaceutical industry for over 40 years in both pharmaceutical manufacturing and consulting.

“As a longtime member of ISPE and former ISPE Board Chair, Fran’s contributions to ISPE over the years have been remarkable and she’s been direct-ly responsible for multiple initiatives in ISPE,” said Thomas Hartman, ISPE President and CEO. “She is one of the founding members of the ISPE Women in Pharma® international program. Fran also provided her leadership in the ISPE Drug Shortages Initiative and the ISPE Metrics Program.”

“Fran inspired the ISPE International Board to invest in the workforce of the future,” Hartman said, “and through the DAF-ACT enabled ISPE to play a key role in the COVID-19 industry response and positioned ISPE for opportunities of this type with the government in the future. She has been instru-mental in the development of the Board Advisor program and ISPE Foundation. She has been generous with her time to ISPE programs over the years and these accomplishments demonstrate unprecedented ambassadorship.”

In addition to these activities, Fran has been a regular presenter or moderator at many ISPE conference events, volunteered her company’s time for GMP and data integrity training, has served as an expert panelist or facilitator on multiple regulatory driven events and webinars, and served as a reviewer for many ISPE guidance documents.

ISPE staff talked to Fran about her career and what ISPE means to her.

From left to right, ISPE Board of Directors Immediate Past Chair Michael L. Rutherford, Frances Zipp, and current ISPE Board Chair Scott W. Billman.
From left to right, ISPE Board of Directors Immediate Past Chair Michael L. Rutherford, Frances Zipp, and current ISPE Board Chair Scott W. Billman.

What Was Your First Job Out of College?

I started out in a laboratory in a quality control department of Ciba pharmaceuticals. I only applied for the job and accepted the position because of the location of the firm—it was close to my favorite mall where I held a part-time job. My first line supervisor was an inspirational leader and he relayed to his team that we were an important element in availing drugs to patients. I was conducting the now extinct United States Pharmacopeia heavy metal testing on raw materials—not exactly glamourous or cutting edge—but we knew our role was important and we treated our tasks with the utmost integrity and respect.

I would drive home from work every day convinced I was making a difference and that I had the best job in the world. We would have weekly team meetings in the content uniformity lab and our supervisor would explain how our work connected to patients. I was hooked. My minimum wage job was helping patients, it was the most important task I could do, and the pharma industry was giving me this amazing opportunity. I never forgot that and to this day, I am thankful every day that I had that experience.

As I look back after 40 years, I think it was my passion for learning as much as I could about this wonderful industry and the many opportunities I was offered, and also pushed to be offered, that allowed my career to span across departments, technologies, and geographies within the biopharmaceutical industry.

Tell Us About Your Current Role and What You Do.

Once again, I have to start with how thankful I am for the role in which I currently serve the industry and my team. As noted, I am the President and CEO of Lachman, and in this role, I have the opportunity to support and interact with an amazing team across the globe, all of whom share that same conviction I have carried with me since I was in my twenties: working within the pharma industry is a privilege and that industry makes a real difference.

Our team has, over 40 years, proactively partnered with the industry to help our clients achieve product and quality system excellence, enhance technologies, implement efficient and effective processes and systems, and understand regulatory challenges and opportunities. We never lose sight of why we do this: Our clients are serving patients. At some point in our lives, we all are patients or support loved ones who are. What could be more personal or important? Our value proposition sums it up: “We deliver high-value consulting, enabling clients to achieve product and quality system excellence for the patients that they serve.”

What Do You Enjoy Most About Your Work?

Every day I am humbled and inspired by the knowledge, drive, and commitment of our industry. I have learned so much from pharma colleagues, industry groups, regulators, and my team. I still end my workday, now not driving a short distance, but often running through an airport, thinking “I have the best job in the world.” So, answering what I enjoy most is a tough question. I think what I am most proud of, as I enjoy every aspect of providing support, often in times of industry or client-specific challenges, is that I know my team of industry and regulatory professionals and subject matter experts shares my passion and commitment to excellence in all services we provide. We know we must be proactive, remain current on all aspects of our industry, give back to our industry by mentoring and participating in industry forums, and, most important, act with the urgency and integrity, which are the cornerstones of the pharma industry.

Tell Us About a Project You’re Proud of or Enjoyed Working On.

One focus of our team that I personally feel energized by involves our work on educating on and helping implement practical solutions and controls in the areas of data integrity, data governance, and artificial intelligence–driven solutions in quality and manufacturing. There are so many opportunities for our industry, especially in controlled and efficient use of cutting-edge technologies, to transform the way our industry works—not only in manufacturing, development, and distribution, but in laboratory and quality assurance activities.

Robust and targeted regulatory compliant data, and the speed of decision-making based on this data, supports the timely delivery of quality products to patients. We all are aware of the shortage on a global basis of critical medicines. Helping firms that are clearly dedicated to addressing this crisis by partnering with them on advanced solutions in a sustainably complaint manner is, well, thrilling and a personal mandate.

What Do You See Next for Your Area in the Pharmaceutical Industry?

With the rate of change in science and innovation in our industry, it is paramount that companies like ours [Lachman] are a guiding partner and leader for our clients. The world of pharmaceutical innovation is borderless, with more and more collaboration between regulators around the globe, and more access to technology that drives new treatments and therapies. Groups such as ISPE provide excellent forums for collaboration within our industry and continued participation is critical. Our focus, as an industry and industry partners, on being proud of what we do will continue to drive our success.

What Advice Would You Give Emerging Leaders in the Pharmaceutical Industry?

Be proud of what you do and approach your job with the highest level of integrity and commitment. Network, push yourself, never stop learning, be humble in the face of the accomplishments of our industry, and be grateful that you can contribute and make a difference. This difference not only helps others but will also guide you through your career.

What Have You Enjoyed About Being a Member of ISPE?

There is really not one program or project that I have enjoyed more than another. It is the people and resources I have encountered over my career. I always say, everything about work is personal, and ISPE is very personal to me. I grew up in ISPE and would not have had the opportunities I was afforded without the dedication of so many people, the great programs, education, and partnerships. I hope to continue to grow old (older?) with ISPE and continue learning. I welcome any opportunities to give back and I value all my interactions.

About the ISPE International Honor Awards

Award categories include the Max Seales Yonker Member of the Year, Richard B. Purdy Distinguished Achievement, Joseph X. Phillips Professional Achievement, Affiliate and Chapter Excellence, Committee of the Year, and Company of the Year.

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