I have been in regulatory affairs in the pharmaceutical industry for over 19 years and often heard of PDA in passing. In 2013, I moved into the biologics space at a manufacturing site for bulk biologic manufacturing and aseptic filling. At this time, I started truly leveraging PDA’s technical reports.
Then, in 2016, a colleague of mine asked if I would be interested in providing feedback with PDA on a U.S. FDA draft guidance. This spurred another colleague to ask about my interest in working on the ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline Guidance for Industry initiative with PDA. I have been hooked ever since.
Remember to use the time as a learning experience. You will learn at the same time as you work with your peers.
One of the best pieces of advice I have ever received—and it is almost always true in work and in life—is to “sleep on it.” It is so true that things always look better with some rest and some time to think through the facets of an issue.
Right now, I am reading some great leadership books including Brené Brown’s Dare to Lead. Brown also
delivered a great TED Talk on vulnerability and has a new Netflix special.
I wanted to establish a chapter in the Pacific Northwest. The California chapters have been so successful, creating many amazing opportunities for people on the West Coast.
At the same time, it was challenging for PDA members in the Pacific Northwest to attend meetings in California due to geographical constraints. I hope this new chapter creates the same environment that brings people, science and technology together. It has been a truly incredible experience to get our chapter kicked off through support from PDA and the other chapters. I am now the President of the Pacific Northwest Chapter.
PDA has supported my continued education by allowing me to network with industry experts in both the quality and regulatory space. Attending the PDA/FDA Joint Regulatory Conference is a highlight for me each year since I can hear from both regulators and industry leaders on the latest manufacturing, quality, supply and compliance issues.
My work life has taught me many lessons over the years. The most important has been how to create and build a strong team. When we are part of a great team, we know others have our backs and we feel supported and encouraged. We rise to face challenges together, exchange ideas, work through roadblocks, deliver on time, celebrate successes and learn from the failures along the way.
I just read an amazing book, On Fire: The 7 Choices to Ignite a Radically Inspired Life, by John O'Leary. I would love to meet the author. His message is one of inspiration and that "gratitude unlocks the fullness of life."
My journey to becoming involved in PDA is probably not the stereotypical one! In 2017, during my final year in college, I came across a poster advertising a chance to attend the PDA European Annual Conference held in Berlin (for free!). Naturally as a student and a soon to be Microbiologist, I jumped at the opportunity. Luckily, I ended up winning this PDA Bursary Competition and have been a member ever since. Before the trip I wasn’t aware of what PDA was, I had absolutely no idea what to expect. Within minutes of my arrival, with the help of a warm welcome from PDA Ireland members I came to realise what PDA stands for. It became obvious to me that PDA is a community, a community dedicated to bringing all sides of the pharmaceutical and biotech industry together. Through out my college life I was led to believe that our industry is based on competition and being better than your competitors – which of course can be true – but what I saw in Berlin was a community of experts interacting, engaging and openly offering advice to each other. It did have a profound impact on me and my views of the industry – an industry that I wasn’t even a part of at the time!
One of the other things that struck me at this Annual Conference was the lack of “Young Professionals” in attendance. As soon as I got back to Ireland, I sent Mike Morris (president of the PDA at the time) an email outlining how I would like help to bridge the age gap and increase student & young professional participation in PDA Ireland.
As the Product & Logistics Manager at a newly formed biotech start-up, my role is still in its infancy but what I have found is that with the dramatic increase in contract manufacturing comes great responsibility. There is huge complexity in managing the quality of CMO’s and the path to successfully meeting standards can be difficult. In saying that it does provide another topic or two for the PDA to cover!
There is no such thing as a stupid question!
Aidan Costigan – a long standing PDA member and QA director that I would love to see adapt to the start-up environment!
How I would survive in Aidan’s shoes? I’m not sure – but as a person in QA all his life I’m sure he’d have it all laid out for me.
I joined PDA in 2015. I was introduced initially by a colleague with whom I collaborated with on presentations for PDA conferences. The conference vibe hooked me immediately—the interactions with regulators and industry leaders, the sessions and the overall fellowship. All of this offered a link to staying current on the side of progress.
I have been fortunate to serve on the PDA task force collaborating on technical reports addressing data integrity within laboratories, manufacturing and the quality management system. The team has been highly engaged, supportive and draws from diverse experiences.
The sweeping impact of big data and artificial intelligence has completely disrupted the data integrity regulatory paradigm, which is my area of expertise. I am fascinated and intrigued by this technology, and, equally so by all the collaborative work to define regulations, including data integrity requirements.
My father was a veteran. He was fierce on integrity. Character was everything. He was genteel but demanding of goodness, courage, humility and trust. If I fell short, he never raised his voice but would get a look of disappointment that could crush an army. A day does not go by that I do not reflect and draw upon his teachings.
When I was 38, I took a year off from my career and essentially went to live on an ashram. To partake in the community you must also serve, so I was the head of the kitchen. For the first six weeks I practiced Ashtanga yoga, meditated and studied Sanskrit from 4 a.m. to 9 p.m. I also cooked breakfast, lunch and dinner for the community in between programs.
The ashram received guests from all over the world, and for the remainder of the year, I taught yoga and cooked meals for these amazing people. Everyone was seeking mindfulness and working to align themselves with the principles of absolute love. It was a total awakening for me.
The PDA is an exceptional organisation bringing together multiple disciplines in the area of parenteral medicines both in Ireland and Globally.
Annex 1 Conference Dublin, 2019 - I had a very junior role supporting Alan Kelly and the team at this highly informative and time-relevant event.
The PDA is about sharing knowledge, experiences, and challenges– both the good and the not so good. I saw it as a great way to build up my network of people who are dedicated to patient safety and operational excellence and also to give something back to the industry that has been very good to both myself and my family.
Focus on Patient Safety or as Ann McGee puts it Beyond Quality. We are fortunate in Ireland to have superb manufacturing facilities which are the envy of many outside of Ireland – however, we need to keep up the momentum.
Listen to others – focus on their needs and what do they need to hear not what you want to say.
Jack McCaffrey - what an all-rounder. A perfect gentleman both on and off the pitch.
PDA Ireland have always had a strong reputation in terms of relationships with the regulators and industry experts. Having attended many worthwhile events in the past , the opportunities for engagement and networking with both the regulators and industry experts provides unique opportunities for information sharing in an open and honest environment.
The Irish industry in general has a strong regulatory compliance reputation and PDA Ireland have really worked hard to foster this and drive opportunities to be influencers of change in the Pharma industry. Having a voice within the industry was the key reason I started to volunteer. Understanding what audiences want to discuss in PDA forums and chapter meetings is a key input for a volunteer so we can ensure we are working on the correct events and documents which will interest industry subject matter experts (SMEs). Getting these SMEs engaging openly is no better avenue to help in the creation of sub-groups to drive change across multiple topics within the Pharma environment.
I have worked in many roles in Quality Assurance over the years, most recently in Quality Risk Management (QRM). The ICH Q9 guidance has been in place since 2005, however within PDA we have been exploring how we are truly getting benefit from adopting QRM principles into our Quality Management Systems (QMS). The drive to build Quality by Design (QbD) into early phases of the QMS and into projects upfront is helping to integrate QRM principles strongly into the GMP culture. Better understanding of the “how” will bring greater drive for embracing the benefits of QRM.
Don’t ever stop learning and growing as an individual
My husband and business partner, John Masiello, joined PDA in 1991. When we incorporated our business in 1995, I started attending meetings of the New England Chapter as a sponsor. Eventually, I became an official member of the chapter.
I developed the sponsorship program which gave sponsors advance notice of events and made the meetings profitable. I also created the “metallic sponsor” program for sponsors to make contributions to the scholarship fund. As a member of the chapter’s Scholarship Committee, I am proud to say the chapter has awarded deserving students $18,000 in scholarships the last two years.
Get involved and share your talents! You will meet new friends, learn more about your industry and develop a sense of accomplishment as part of a team that produces valuable information and creates opportunities for fellow members at different stages of their careers.
I am not sure how “hidden” my talents are, but persistence and tenacity are my strong traits. I remember my brother learning to read and I was sure I could do anything he could, so at age four I learned to read. I learned to ride a bike as he was learning. And I changed a flat tire on our family car because I watched a video in driver education class.
I am sure mountains were meant for me to move.
I stopped drinking soda in 2006 and I stopped eating chocolate in 2007.
The SoCal PDA Chapter is pleased to recognize Annmarie Duran as volunteer of the Quarter Q2 2019 for her role as a Board Member, Philanthropy Chairperson and committee member for events and venues. Since Annmarie joined the SoCal PDA Chapter she has never stopped offering to help and ensuring chapter events are successful. As Business Development Executive & Events Manager for AXIS Research & Technologies, Annmarie’s experience has been a big plus supporting venue planning and day-of-event activities. In addition, Annmarie’s passionate and caring personality has made her the go-to person overseeing the chapter’s philanthropy initiatives. Annmarie as a chapter volunteer wears many hats and is always striving to do the her best.
Thanks, Annmarie for your help and support!
I became involved in PDA in 2006 when the Irish Chapter was founded, to assist in the launch of the chapter. Since then, I've held officer roles such as Treasurer and President-Elect.
I am a member of the chapter organising committee for the upcoming QRM seminar on June 20th in the Radisson Hotel Cork.
I enjoy the interaction with industry and regulatory personnel and believe the Irish Chapter provides its members with great learning and networking opportunities.
When I joined PDA in 2006, ICH Q9 QRM guidance was just issued, since then I have seen the industry struggling with its adoption, and the PDA conference entitled: Practical Implementation of QRM, Are we getting Value? Should give members an opportunity to discuss this.
Fortune follows the brave.
Bill Bryson, travel the world and finding humour in absurdities.
Describe your experience on the PDA task force developing a standard for cryopreservation in cell therapy manufacturing? So far, it has been an informative and rewarding experience. PDA staff have been incredibly helpful and allowed me to assemble a great team that is knowledgeable and passionate about addressing a critical gap that must be crossed to bring cell therapies from the benchtop to the bedside.
Why did you decide to volunteer for PDA? I was approached by PDA staff after speaking at a 2015 conference and was impressed by PDA's mission to provide vital guidance to both academic and industry professionals alike. I joined PDA and began volunteering shortly afterward.
Of your PDA volunteer experiences, which have you enjoyed the most? As a member of the organizing committee behind the 2019 PDA Cell and Gene Therapy Conference, I had a front seat view of the process from conception through realization. This particular conference has experienced rapid growth over the past three years, and participants continue to tell me how much the content has helped them in their respective organizations.
What is your advice for other volunteers? Be patient and persistent to identify the right volunteer opportunity. Once that opportunity appears, use the time to learn as much as possible from the experts to make your volunteer experience as rewarding as possible.
What are some topics you would like to see covered at future PDA events? Data integrity, data analytics and general data protection regulations.
Who is one of your heroes? Thomas Jefferson. I wish I could go back in time and meet him to understand the complexities and incongruencies of a man who wrote some of the most important documents in American history.
Having attended several PDA events in Europe and the US, I wanted to support PDA closer to home and see more events in Ireland.
Member of the team organising the PDA Irish Chapter Annex 1 event, May 3rd 2019.
I have used PDA Technical documents extensively for many years, and I wanted to get more involved.
With my background in Microbiology & Quality Assurance I think the most significant changes have been the introduction of Rapid Micro Methods; the increase in the use of formal Risk Management for better decision making; plus greater alignment between global regions through additional MRAs, ICH Guidance, etc.
"Use well the interval" (i.e., take advantage of the less busy times)
"Theresa May - give me 24 hours and I’ll sort it…….!"
I joined about three years ago when my colleague at Eli Lilly, Glenn Wright, suggested I work on a Points to Consider document for filling oxidation sensitive products in isolator systems. Since then, I have been involved with two Points to Consider documents and co-chaired the 2019 PDA Practical Application of Sterile Manufacturing Workshop.
Try to become actively involved right away.Make the most of your membership and meet other people who can help you in your work by collaborating on documents and/or organizing meetings.Over time, you will be able to get involved with even more interesting volunteer activities.Getting started may be the biggest obstacle.
Toward larger molecules, proteins and peptides, biologics applications, and smaller, more flexible systems for processing that can focus on an individualized group of patients.
Robotic applications, gloveless isolator systems and new methods for decontamination.
I always loved math and science, especially chemistry, and I wanted to do something in the medical field. Nobody in my family had ever been to college before, but I was able to visit a company making kidney dialysis equipment in high school. After witnessing the chemical engineers there, I wanted to do something similar. While an undergrad, I actually interned with that company, but decided to continue on an academic path through graduate school. I got my PhDs in Chemical Engineering and Biomedical Engineering in 1998. I then decided teaching was not for me and this led to my first job at Solvay Pharmaceuticals where I did direct manufacturing support. At times I have worked more in the development area, but I enjoy doing work that is close to manufacturing
I had attended many PDA events over the years because they were topical, of great value & provided an excellent mechanism for networking. Through engagement with active PDA members within Eli Lilly & Company and externally, I recognised the significant benefits that PDA brings to all sectors of the life sciences. PDA offers an incredible platform for the industry at a local chapter level and globally in enabling an industry voice to help to shape the future of science and regulation. The Irish chapter members have great energy, so it is a pleasure to be part of such an engaging team. Coupled with being a PDA Ireland chapter member, I am also a member of the PDA Global Regulatory Affairs & Quality Advisory Board (RAQAB). The RAQAB mission is to serve the PDA membership by influencing scientific-based regulations and providing interpretation on quality and regulatory issues affecting development, manufacturing, and control of healthcare products. I am very excited about the future in the pharmaceutical business and the vital role that PDA will continue to play into Pharma 4.0 and beyond!
To connect externally and to have a voice in potential future changes affecting science and regulation business. The annual PDA events stem from what the Irish PDA members/conference attendees want to hear/learn more about/influence. PDA offers that unique industry-regulatory platform.
I have worked in Quality Assurance (QA) roles for the majority of my professional career. I am a Qualified Person (QP) supporting Biotech operations. The role of QA has changed from one of 'Q by Rule to Q by Example' (police versus a valued partner). Robust Quality Management Systems have revolutionised QA enabling connectivity globally and facilitating knowledge management. The advent of US EU MRA implementation and the active collaboration in 'Post Approval Change' initiatives are also bringing promise to the future in science and regulatory.
Never assume! Being in QA this nugget of information has stood to me over time!
I have volunteered with PDA since 2015
when I began helping organize events for the Singapore Chapter. Now, I am
the Treasurer of the Singapore Chapter. I
also volunteer on the PDA Letter Editorial
Organizing the Singapore Chapter's data
integrity and computer systems validation
symposium has been very memorable to
me. Although the chapter knew the topic
would be interesting to many stakeholders
in Singapore, we never imagined that
we would have close to 60 attendees—
requiring us to rework the seating and
I first encountered PDA when I read PDA
Technical Report No. 49: Points to Consider
for Biotechnology Cleaning Validation.
TR-49 supports a lot of my work, and I
soon discovered that PDA has many more
industry-relevant technical reports, so I
decided to join.
I have used PDA documents extensively
in my professional career. As the industry
is grows into a risk- and science-based
approach, PDA documents like the
aforementioned technical reports and the
PDA Journal of Pharmaceutical Science and
Technology remain highly relevant.
I enjoy working in the field of risk
management. In the pharmaceutical industry, risk management directly impacts
human lives. In my current role as Technical
Director, I can impart a risk management
perspective to my colleagues. In addition,
my role allows me to be involved in the
various technical aspects of the projects
and initiatives in my organization.
I like to cook simple food that can be
enjoyed by my family and friends.
I’m a member of PDA since 2014. Initially, I joined to access the impressive range of publications available from PDA. This, of course, led to attending conferences – which were
on the most topical issues & always seemed great value. Further involvement was a gradual
adsorption process, encouraged by the many wise and experienced PDA members I met at
In October 2018, I was part of the organising committee of the PDA Ireland conference on
Advances in Aseptic Processing with a focus on Media Fill simulations. It was inspiring to be
part of such an innovative & productive team. This year, I have been more adventurous & have volunteered to lead the team organising our Cork based conference in June on Quality
Risk Management. This is a topic that I am very enthusiastic about, so it hardly seems like
I think the focus in Quality has moved from compliance to applied Quality Management, through process measurement & control. I have seen ICH Q8/9/10 evolve from a publication to an implemented control strategy. The next evolution is big data & Pharma 4.0.
Ask questions. If you are new, ask questions. If you don’t know, ask questions. If you’re investigating a problem, ask questions. If giving advice, ask questions!
The boss of Dublin Airport. I find complex logistics fascinating.
To network with industry professionals who have a common interest in the sciences, technology and regulatory elements of the pharma industry in Ireland and indeed abroad.
Lead organiser for ‘Advances in Aseptic Processing with a focus on Media Fill simulations’ - Oct 18, 2018.
To learn more about the activities which take place in the wider pharma industry. As a project engineer with over 20 years’ experience in the pharma industry, meeting technical challenges is one of my areas of expertise and one which I continue to find exciting and creatively fulfilling. Keeping myself up-to-date on best practices nationally (and internationally) is a vital part of this work. And I have always had a grá to learn more wherever possible! So, being part of PDA, then, allows me the ideal opportunity to reach out to like-minded individuals within the industry to inform myself (and one another) about the best technologies available to meet the ever-increasing standards of the pharma world.
Over the last few years there has been significant changes in terms of the technological advancements now available for multipurpose aseptic filling lines for both non-potent & potent/toxic products as evidenced by the increasing oncology market sector including increased efficiency and as result increased capacity of those filling lines. I have also noted some promising developments in automatic camera inspection technology for parenterals.
As a kid growing up in Banagher Co. Offaly, the staple diet of the 1980’s consisted of hurling, hurling & more hurling! One day, one of the All-Ireland winning senior hurlers came to our U14 training session and offered this advice: “If you want to succeed at anything you need to employ the three ‘Ds’ – “Dedication, Determination & Discipline”. I have always found that quite interesting having worked for several Pharma corporations which every couple of years launch some buzz words to hopefully inspire their workforce. The three ‘Ds’ has always done it for me.
That would have to be Bill & Melina Gates – the work carried out via their world-wide charity foundation is quite inspiring i.e. using capital investments of their own and in partnership with others to benefit the greater good in developing counties around the globe. They facilitate access to life saving health products and support technical innovations in local regions that backs-up sustainable economic growth, which has knock on effect of increasing the quality of life in those areas.