2025 PDA Board of Directors Election
Marcia Baroni
Marcia Baroni has 25 years of experience in pharmaceutical manufacturing, with a heavy focus on sterility assurance. She has supported facilities across North and South America, Europe, and Asia, leading groups of up to seven hundred, from facility start up to successful Warning Letter closure. Marcia has experience across drug substance, drug product, and devices, from traditional aseptic processing to robotic isolators. Currently Marcia is the VP Quality Compliance and is responsible for the development and implementation of the global quality systems and oversees quality compliance across all Emergent BioSolutions sites.
Marcia obtained a BSc in Microbiology from the University of Toronto, and an MBA from Purdue.
An active PDA member, Marcia has just completed her second term on the Science Advisory Board and presented at PDA Micro, PDA Annual, PDA/FDA Joint Conference, Contamination Control and Annex 1 Workshops. She has served on the planning committee for PDA Annual and was a member of the Task Force for Points to Consider on Aseptic Processing, and Aseptic Processing of Sterile Pharmaceutical Products in Isolators. She is currently on the planning committee for the Kilmer Conference, a co-lead of the Annex 1 Implementation Interest Group and the liaison to the PDA Brazil chapter.
Marcia Baroni
Marcia Baroni
I am honored to have been nominated for the PDA Board of Directors. PDA is an organization where people from diverse backgrounds come together to discuss not only regulations, but also the science and technology that are at the foundation of pharmaceutical manufacturing. I see this every day; as Co-chair of Technical Report 22 Aseptic Process Simulation revision, as task force member for a new Points to Consider for RABS, and as PDA representative to the Interested Parties meeting with the EMA Inspector Working Group.
The technology supporting our industry has been evolving quickly, but our practices and regulations have failed to keep pace. If elected to the board, I will apply my expertise, leadership, and passion to continue to drive PDA’s focus towards implementation of novel technologies and approaches, by providing training, technical resources and forums that deliver on the science and promote their adoption. It is imperative that we continue to actively engage with thought leaders, academia, industry, and regulators, to understand the challenges and collaborate on solutions that help shape the future regulatory environment in pharma. I hope that you will entrust me to continue this journey, to support our members; the industry; the patient.
Mirko Gabriele
Mirko Gabriele has over 20 years of experience in the Pharma industry predominantly in Technology Transfer and Operations and he is currently consulting in this space. He has held several key roles in Technology Transfer from Project Leader to Program Manager, moving from technical feasibility assessment and tasks coordination to complex multi-sites multi-dosages project management to overall technology transfer company portfolio management (100+ active programs). These include team leading in an Agile framework, contract negotiation, financial monitoring, performance management, overall risks management and mitigations, reporting to executive and development of strategy and relationship with key stakeholders (i.e Regulatory Agencies, Sponsors, Suppliers, Executives). As a result of his ability to successfully execute all stages of the technology transfer process, he was promoted from site roles to global roles, with the opportunity to work on Technology Transfer Policy harmonization and best practices improvement and sharing. He successfully covered several dosage forms projects, from Oral to Combination products with a strong expertise in Sterile. Director/Sr Director roles in Business operations and innovation and strategy gave Mirko a full overview of the technology and pharma space, strengthening his ability to successfully lead complex teams and organizations (600+ reports). Mirko has been involved in several M&A evaluation and deployment with different roles, from innovation and technical assessor to transformational leader. He has been a QP since 2015.
Mirko has been part of the PDA since 2005 starting as volunteer after joining an amazing PDA conference on Autoclave Sterilization. A member of the Board of Directors since 2021, he joined and then led the writing task force which produced Technical Report 65 - Risk Management in Technology Transfer, and he has been involved in several PDA Europe Trainings on Technology Transfer. Mirko leads the PDA Technology Transfer Interest Group (TT IG) for Europe which has the mission to define, share and implement best practices in the industry. He is currently President of the PDA Italy Chapter.
Mirko Gabriele
Mirko Gabriele
I am a passionate advocate of networking, pharma and innovation, and a strong believer that new technology has a positive impact on people’s quality of life. Being part of PDA is a great honor and a clear responsibility because of
the opportunity to influence, shape and make more appropriate the pharma environment with competencies, strategic thinking and an open mind, never forgetting the ethical part… as pharma experts we always have to serve patients and their
families!
Andrew Hopkins
Andrew Hopkins has a BSC (Hons) in Microbiology with Genetics, and a Post Graduate Diploma in Industrial Pharmaceutical Science. His career covers several areas over 40 years
Andrew is a Director of Microbial Contamination Control at Abbvie,
the role includes assessing manufacturing sites, training and mentoring, guidance on the implementation regulatory guidance documents and interaction with regulatory agencies.
Prior to this he was an Inspector with the MHRA for nearly 14 years. This role included:
- Routine (and less routine!) inspections internationally, including joint inspections with several regulators (USFDA, TGA, TFDA and Health Canada) in several technical areas including, sterile products, biological products, blood components and plasma.
- Chairperson of the Inspectorates Compliance Management Team (working with marginally compliant companies to support them back to full compliance)
- MHRAs inspection Action Group (actions regarding non-compliant sites)
- Inspector training and mentoring
- Supporting the writing of regulatory guidance documents including:
- MHRAs Data Integrity guidance
- EMA guidance on water systems
- Chair for the working group for the revision of Annex 1
- MHRA blog regarding the fragility of VHP
- Supporting technical monographs such as PDA TR1 and PHSS TM20.
Prior to MHRA Andrew worked for over 20 years in several different areas and technologies in the pharmaceutical industry.
Andrew Hopkins
Andrew Hopkins
As somebody who has worked in the pharmaceutical industry for 40 years and as a father and husband, I am proud of the work we do. In my 40 years I worked in QC, a Production Manager, Quality Assurance Manager and a global role responsible
for Microbial Contamination Control, and have worked as a regulatory inspector. I have seen the industry evolve (not as fast as I think it could do) and have seen it from several perspectives (including different product types). I have had
different objectives in my roles but the fundamental one, getting safe, effective product to the patient, has been consistent. I believe that the pharmaceutical industry must move forward, embracing new ways of thinking and working. I have
been an advocate of more collaborative ways of working between industry, the regulators, and suppliers. The many industry bodies, PDA specifically, have a major role in facilitating this new paradigm. I hope that, if re-elected, I can indulge
a personal pleasure of helping individuals grow and learn and I can use my knowledge and contacts to support this shift, so that we all work together in a more collaborative manner, embracing innovation, for the good of the patient.
Amy McDaniel, PhD
Dr. Amy McDaniel is the head of the Microbiology Center of Excellence at Bristol Myers Squibb. In this role, she leads a global team dedicated to achieving harmonization of microbiological methods across BMS, supporting the network for complex microbial investigations, and bringing in appropriate new technologies for efficient implementation. Prior to BMS, Amy was a Microbiology Reviewer at the FDA, in CDER’s Division of Microbiology Assessors in the Office of Pharmaceutical Quality. Before the FDA, Amy held numerous roles at Pfizer, from Microbiology laboratory leadership to Manufacturing, Technical Operations, and Quality Assurance.
Amy has been a member of the PDA for 25 years. She has presented posters and podium talks at the Global Microbiology Meeting, and she was on the committee for the Global Microbiology Meeting for many years, during which time the meeting expanded, and attendee engagement consistently increased. She is currently the co-chair of the revision committee for PDA Technical Report 33: Evaluation, Validation, and Implementation of Alternative and Rapid Microbiological Methods. She has been on the PDA Board of Directors since January 2022.
Amy holds a B.S. in Biology from Grove City College and M.S. and Ph.D. degrees in Microbiology and Molecular Genetics from Rutgers University.
Amy McDaniel, PhD
Amy McDaniel, PhD
I have been involved with the PDA for 25 of my 27 years in pharma. As I have grown in my career, I have also grown in my commitment to PDA, and I am happy to be seeking re-election to the Board of Directors. In my first term on the Board, I gained experience with organizational leadership, and was the Board liaison for the Biopharmaceutical Advisory Board and the ATMP Advisory Board. In these roles I ensured that the advisory boards had visibility to the PDA’s objectives and aligned their work appropriately. I also served on the Strategic Planning committee, where we focused on strengths, weaknesses, opportunities, and threats, ensuring that the PDA is positioned for success in this new age of digitalization and technology, while staying true to our core values of connecting patients, regulators and the industry.
I bring a thoughtful, creative presence to the board, and am not afraid to ask a difficult question or bring a unique perspective. I am passionate about the mission, and I work tremendously hard behind the scenes to fulfill my responsibilities and to promote this world-class organization. I would be honored to continue this effort for another term.
Ken Paddock
As the Global Sterility Assurance (SA) Lead within the Quality Department at Baxter, Ken Paddock is charged with guiding a worldwide team of Regional Sterility Assurance Representatives in developing and implementing a cohesive SA strategy that drives the assurance of sterility which is the most important attribute for parenteral products. He has served as an industry representative for various sterilization modalities, provided technical presentations at conferences, and is currently serving a second term on the Science Advisory Board
In addition to his technical competency, Ken has also leveraged his leadership skills to connect people to drive the evolution of the Midwest Chapter and the Annual Meeting. In his tenure with the Midwest Chapter, Ken has effectively served in every Board position, including President to strengthen the operation of the Chapter and is dedicated to bringing this valuable experience and perspective to the Board of Directors. Similarly, he has served as the Co-Chair for the Annual Meeting over the past two years, during which the committee made substantial enhancements to both the structure and content of the meeting.
Ken Paddock
Ken Paddock
Being nominated for the PDA Board of Directors is indeed a privilege. PDA stands out in its mission to connect people, science, and regulation, an aspect that makes me proud to be a part of this organization that values both individual accomplishments and collective team accomplishments to fulfill a shared objective.
As the pharmaceutical and biopharmaceutical landscapes continue to advance, it's crucial for PDA to adapt by implementing suitable strategies and focusing on pertinent scientific and technological issues. If elected, my emphasis will be on advancing PDA's business strategy, technical expertise, and regulatory understanding to align with our community's needs, promoting best practices, always with a patient-centric perspective.
I am once again excited at the possibility of contributing to PDA's leadership, positively impacting our industry and, most importantly, the patients we serve.
Janeen Skutnik-Wilkinson
Ms. Skutnik-Wilkinson is the Director of Global Regulatory Intelligence and External Engagement at Moderna. Across her 25 years with PDA, she spent 12 years on RAQAB, created and co-lead the Pharmacopeial IG, co-chaired PDA/FDA planning committee (2023 and 2024), served on the PDA Letter Advisory Board and Educational Advisory Board, and worked on several commenting teams and technical reports and the first PDA/ANSI standard. She is a member of BioAB and a PDA Regulatory Authority Engagement Liaison for the EMA Biologics Working Party. She has been involved in ICH for over 20 years, serving on the ICH Assembly, Q4B, Q3D, and QDG (Quality Discussion Group).
She has been actively engaged in several non-profit organizations over the last 25 years: President of the IPEC Federation, Chair of IPEC Americas, IPEC Board of Trustees.
She holds a BS in Chemistry from the University of Connecticut and has over 28 years of experience in Quality, including roles at Biogen, NSF, Pfizer, and Merck. Her expertise spans Regulatory/Quality Intelligence and Policy, pharmacopeial affairs, documentation, change control, and method development and validation.
Janeen Skutnik-Wilkinson
Janeen Skutnik-Wilkinson
I am honored to be nominated for a position on the PDA Board. For over 24 years, PDA has been a cornerstone of my career, facilitating scientific and technical collaboration and fostering valuable professional relationships.
The pharmaceutical industry is rapidly evolving with advancements in manufacturing, adapting our thinking to support cell and gene therapy, and the integration of AI in our work. PDA is poised to lead this evolution, especially with the recent changes brought by the overturning of the Chevron Doctrine.
If elected, my focus will be on:
- Enhancing PDA’s Educational Programs: Expanding and evolving educational offerings to reach broader audiences, providing essential upskilling for members to support the industry’s continuous evolution.
- Developing Innovative Delivery Methods: Exploring new and creative ways to bring global PDA content to all our members, ensuring access to cutting-edge information and best practices.
- Promoting PDA’s Role in AI Education: Promoting PDA’s role in AI education and exploring how AI tools can enhance our work and benefit our members.
Advancing these initiatives will ensure that PDA remains at the forefront of industry advancements, driving innovation and maintaining excellence in science and quality. Through our collective efforts, we can support the global harmonization of regulatory standards, advance the integration of new technologies, and enhance the professional development of PDA members worldwide.
PDA members in good standing as of midnight EST on 31 August 2024 are eligible to vote. Voting for this election will close at 23:59 EST on 15 November 2024.