2023 PDA Honor Awards: Service Appreciation Award

Meir Batito

Mark Bogs

Mark Bogs is the Senior Director of Sterility Assurance at ICU Medical and is responsible for supporting pharmaceutical moist heat terminal sterilization, medical device Gamma, E-Beam, X-Ray, Ethylene Oxide sterilization, and aseptic manufacturing across global ICU Medical sites and third party manufacturing. He has 30 years industry experience in start up aseptic filling operations, established aseptic filling operations for small volume parenterals and Blow Fill Seal, and Ethylene Oxide, Gamma and E-Beam radiation sterilization. Mark is a board member of PDA Midwest and was chapter President from 2022-2023.

Javier Camposano, MBA

Emily Cheah, PhD

Javier is the Vice President of Drug Product Operations at Samsung Biologics, a global CDMO company based in South Korea.

Emily Cheah is a Senior Managing Director and Head of APAC Operations at Charles River Laboratories, a global contract research organization that provides essential products and services to help pharmaceutical and biotechnology companies accelerate their research, drug development and manufacturing efforts. As a registered pharmacist with a doctorate in pharmaceutical technology and a global executive MBA from INSEAD, I have more than 15 years of experience in strategic and technical operations management, as well as business development in the pharmaceutical and medical device manufacturing market.

Michael Cutter

Derek Duncan, PhD

I am a healthcare professional transforming organisations to improved performance.

I joined Biocon Biologics at a time when global healthcare is at an inflection point for biosimilars and as Biocon acquires the biosimilar business of Viatris. Leading the transformation of the Quality organisation on our journey to bring access to healthcare through affordable biologics at a transformative time for healthcare, I bring 30 years of experience to a driven and passionate organisation.

Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into industry holding various Product & Application Development positions. Currently at LIGHTHOUSE and based in Amsterdam since 2003, Dr. Duncan is responsible for developing applications for pharmaceutical process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection. Dr. Duncan has been a PDA member since 2004 and has been a regular contributor to PDA conferences, IG Groups, and Conference Program Committees.

Mauro Giusti, PhD

Marc Glogovsky, MS

Giusti holds a master’s degree in chemistry from the University of Florence; he is board-certified by the National Chemist Association and a Technical Director (Qualified Person) by the Italian Minister of Health. More than 16 years, Giusti has served as a member of the Italy Chapter of PDA, with several participations to national and international forum both as speaker and as chairman. In November 2019, Giusti has been appointed as Co- Chair for the Process Validation Interest Group. In August 2020, Giusti was appointed to the PDA Science Advisory Board and in December 2021, Giusti was appointed President to the PDA Italy Chapter.

My inspiration came from one of my first interactions with PDA as a student. I was asked by one of my fellow members of Beta Beta Beta Biology Honor Society to go along with him to the PDA Annual meeting in Philadelphia. I was thrilled with being able to skip organic chemistry that morning to go to a conference (only for 1 day and it was just over an hour's drive). I really enjoyed chatting with some of the industry leaders and unfortunately, didn’t have the mindset to appreciate being there (I know, sorry!). Fast forward a few years when I was working for a generic drug manufacturer, my boss at the time, Mary Huynh (who I can never thank enough for hiring me, and she is still a very active PDA member herself!), allowed a colleague and myself to join PDA as we were tasked with validating an autoclave and improving our routine EM program. This was all new to both of us, so the technical reports were paramount to our success as I didn’t have a clue how to validate or qualify anything.

Beth Haas

Joseph Kudla

With over 30 years in the industry, Beth has versatile experience across product lifecycle phases covering product development, CMC requirements, cGMP manufacturing, and CDMO management focusing on new product introductions and technology transfers for both APIs and drug products.

Amelia (Amy) Mutere

Leonidas Orjuela

Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.

Proven leader Business with 40+ years of international experience in Business Development, Sales Management and Consulting, OPEX, Information Technology, GRC, Supply Chain, and Pharma Event Sales/Operation in America and Europe. Excellent communication and project management skills. Founder and President of PDA BRAZIL CHAPTER.

Darius Pillsbury

Jim Polarine Jr., MA

Darius Pillsbury is a senior consultant at ValSource. He holds a Bachelor of Science in Chemical Engineering from Tufts University and has more than 20 years of experience working within the Biotech/Pharmaceutical industry.

I was inspired to get involved with PDA with the excellent opportunities to network and learn the latest advances and regulations in the BioPharma and Medical Device industries. I have been an active PDA member since 2001. I have enjoyed getting involved with interest groups, technical reports, points to consider, and reviewing PDA journal articles while being an active PDA member. I was honored to receive mentoring and guidance from Richard Johnson and Georg Roessling while at PDA. I won the prestigious Michael S. Korczynski Award in 2019 and since then I was elected to the PDA Scientific Advisory Board in July of 2023.

Mathias Romacker

Micheal Schafferius

I joined PDA in 2004 when I still lived in Europe, and I was interested in organizing a conference for pre-filled syringes and looking for someone to partner with. Somehow all the arrows pointed to PDA. Back in the day, they already had some infrastructure in Europe. We reached out to see how we could partner in this effort and now it is the biggest conference of the year for PDA.

Vishal Sharma

Eva Urban

I was introduced to PDA when I started working for a filtration and downstream processing company. PDA Technical Report No.26 Sterilizing Filtration for Liquids became a go-to document for me. In 2010 I joined the organization and became a volunteer, but my activity remained limited to downloading technical reports and PDA Journal of Pharmaceutical Science and Technology articles. I realized the full potential of membership when the opportunity presented itself in 2013, and I embraced it with both hands, to become the founding member of the India Chapter. The journey from then on has been very rewarding. I volunteered for several initiatives, including serving in various capacities on the India Chapter Board since 2013, and recently tenured as Chapter President in 2023. I also got an opportunity to volunteer for the task force constituted for the Points to Consider Remote Inspections and Audits document. Apart from that, I currently volunteer as a Member of the RAQAB and the Technical Report No. 3 revision task force. I strongly feel that PDA membership is a must for any professional who is looking to make a career in sterile manufacturing.

Joining PDA in 2006, I found immense value in PDA’s Technical Reports and articles for industry benchmarking and understanding regulations - a value that persists today. However, my journey took a transformative turn when I began volunteering for the PDA Quality Risk Management (QRM) Interest Group (IG). Collaborating on a webinar about QRM for excipients opened incredible opportunities. Through active participation in and leadership of various Interest Groups, task forces, conferences, and workshops, I’ve gained extensive knowledge, formed meaningful connections with colleagues I highly appreciate, and found lasting friendships. I am proud to be part of the PDA family.

Greg Williams has over thirty (30) years of quality and regulatory compliance experience in the biologic, medical device, pharmaceutical, and radiopharmaceutical industries. He has served in varying levels of responsibility in his career from quality control inspector to Global Vice President. He has recently started his own consulting company (C Gregory Williams LLC) specializing in compliance remediation, quality audits, and process improvements.