At an ISPE conference on pharmaceutical supply chains in early June in Baltimore, Maryland, new ISPE President and CEO Nancy Berg explained to the attendees that the ISPE board at its meeting the previous weekend made some “subtle, but at the same time very significant changes in the mission of the society.” Here is what she said:
“Good morning. My name is Nancy Berg, and I am the new President and CEO for ISPE. I joined the association after the retirement of Bob Best, starting in January of this year. I have just completed five months, which I tell my team is enough to make me dangerous. I know just a little bit about the organization and its opportunities and I am very excited to be a part of ISPE. I would like to thank the committee for allowing me to speak for just a couple of minutes about why I think this conference is so important to the industry and to the future of ISPE.
Of course, we know that drug quality and safety has always been the goal and objective of the industry. The industry has changed. We are facing cost-cutting challenges, extended supply chains that come with lots of challenges, and globalization that makes your jobs much more difficult every day. These [are] challenges to our industry, but we are looking at them as opportunities at ISPE.
We are looking at an opportunity to take a leadership role in bringing many of these issues forward in forums like this one and building teams that will be focused on problem solving and really getting into the issues along with our regulator colleagues to move the industry forward and to improve our ultimate goal of quality and safety for our patient customers.
With that in mind, in my meeting with our ISPE Board of Directors over the weekend, we made some subtle…but at the same time very significant changes in the mission of the society. I would like to share those with you.
By 2015, ISPE will be recognized globally as the leading technical organization for professionals engaged in producing quality medicines and pharmaceutical devices throughout the product lifecycle. The phrase ‘across the lifecycle’ is a significant addition for ISPE. It is very reflective of our members. We have had very significant changes in the interests and the roles and the job functions of our members. In looking at the problems the industry is facing, we need to be looking across the entire product lifecycle – and we will. We will be focused not only on medicines, but on devices as well.
We view the core purpose of ISPE as knowledge management, and we use the ICH Q10 model – which I am sure you are all familiar with – as the model that describes our technical focus at ISPE. We are very much focused on knowledge management, quality risk management, and all of the other areas across the supply chain.
In our strategic plan, we are also extending the focus of our membership to include not only individual members, but their corporations, the academic community, and the extended supply chain – which I don’t know that we have always embraced or had represented within all of the committees and the planning activities and the board of directors within ISPE.
We will be focusing our leadership role on these five core competencies: ● knowledge management ● our brand and leadership influence ● membership engagement ● best practices from an organizational perspective in both the association and pharmaceutical industries, and ● regulatory affairs – one of the most significant areas of focus for both ISPE and many of our members and their companies.
We had a really good conference yesterday with FDA. Some of you may have attended…. Ilisa Bernstein presented a new organizational chart for FDA that we had not seen yet. It had some new assignments. FDA has a new strategic plan that I am happy to say mirrors much of our strategic plan.
We will be focused on these [core competencies] – aligned to be a catalyst in working with our members within industry and to help make sure that we are in a unique position to solve problems. We will also be working with FDA and regulators throughout Europe, Asia and Latin America and some of the BRIC countries as we position ourselves to more effectively fulfill our mission.”