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Committee & Speaker Biographies

2021 PDA Board of Directors Election

Candidates Running for 2021 Board of Directors Election

 
Bettine Boltres, PhD
Bettine Boltres, PhD

Bettine Boltres is a Principal Scientific Affairs with West Pharmaceutical Services, Inc. Her career focuses on addressing technical and regulatory challenges of drug package and delivery systems – at West with elastomer components, and previously as a Product Manager at Schott AG, with glass components. She has shared her knowledge in several articles, including the book, When Glass Meets Pharma.  

She is well recognized in the industry through the committee positions she is holding:  USP Packaging and Distribution Expert Committee, European Pharmacopoeia Commission Group of Experts 16 (elastomers), GLS Working Party (glass), and ISO TC76/WG 4 (elastomers).

Bettine has presented as frequent speaker and has chaired and moderated several conferences and technical trainings for PDA. Additionally, she is actively involved in writing the PDA Glass Handling TR and co-chairing the European PDA IG Packaging Science and Pharmacopeia. As a longtime member of the Program Planning Committee for the Parenteral Packaging Conference, she is each year highly motivated in assembling a compelling program. In 2016, she was rewarded with the PDA Distinguished Service Award, which strongly motivated her to continue her contribution.

Her scientific base is a diploma in chemistry (University Frankfurt) and a PhD in biochemistry (University Cologne).

Patrick Costello
Patrick Costello

Patrick Costello (Paddy) was appointed Director of Quality Assurance for Abbvie Inc two years ago. In his current role, he is responsible for global regulatory reporting, management review, and data analytics. Prior to AbbVie Inc, Paddy worked for 4.5 years with the European Medicines Agency (EMA) as part of the Manufacturing and Quality Compliance team. His responsibilities there included the management of quality defects, shortages, and recalls reported to the EMA, and coordinating the Union’s responses. He was an active member of EMA’s Innovation Task Force.

He also spent 13.5 years working at the Health Products Regulatory Authority (HPRA), where he was the Inspections Manager for a range of products, including advanced therapy medicinal products, blood, tissues, and organs. During this time, he served as the Ireland representative at the European Commission’s Blood, Tissues and Organs Competent Authority Meeting and played an active role in PIC/s expert groups.

Patrick has been part of PDA Europe’s Program Planning Committee for their last two Europe Annual Meetings, moderating sessions at both meetings.

He has a PhD in Immunology from University College Dublin and an MSc in Pharmaceutical Science conferring QP eligibility.

Mary Oates, PhD
Mary Oates, PhD

Mary Oates has 30 years of experience in the pharmaceutical industry in Operations, Quality, and R&D.  She is currently Vice President, Compliance Services at Lachman Consultant Services, Inc. Prior to this, Mary spent 25 years at Pfizer, holding multiple leadership roles. In Operations, she was responsible for the Biotechnology and Consumer manufacturing plants and operational excellence for the entire manufacturing division. Mary was also the Global Quality Operations leader at Pfizer for eight years, with responsibility for quality oversight of all GMP activities.

Mary is currently a member of the PDA Board of Directors, where she sits on the PDA Foundation Committee, serves as Board Liaison to the Manufacturing Science and Operations Program, and is a member of both the Covid-19 Task Force and the Remote Audits/Inspections Team. Mary has been a key contributor to an ongoing series of PDA webinars on the topics of remote regulatory inspections and assessments.

She was also a member of the ICH expert working group for Q12, a Quality Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, and she has participated in numerous Pharmaceutical Research and Manufacturers of America (PhRMA) activities throughout her career.

Mary holds an undergraduate degree in Biochemistry from Queens College and a PhD in Analytical Chemistry from the University of North Carolina in Chapel Hill.

 
Brigitte Reutter-Haerle
Brigitte Reutter-Haerle

Brigitte Reutter-Haerle is Vice President Product Management & Marketing for Vetter. In this role, she is responsible for both existing and new product and service offerings that support Pharma & biotech companies as well as marketing and public relations activities. She joined Vetter in 1996, serving in the company’s sales and marketing function and later transferring to corporate marketing. She began her career in 1983, holding various positions in the sales organizations of companies, including Hilton International and TNT Express Worldwide.

Brigitte joined PDA in 2005 and has been Vice Chair of the Marketing Advisory Board since March 2019. She has also been a leader of PDA’s Pre-Filled Syringe Interest Group/Europe since 2007, and served on various committees, including as Chair of the PDA UPS Program Planning Committee. In 2014, Brigitte received the PDA Distinguished Service Award and, in 2017, the PDA Europe Service Appreciation Award for her long-standing commitment. The awards were in recognition of special acts, contributions, or services that have helped build on the success and strength of PDA.

Ms. Reutter-Haerle earned a BA and a degree in business administration from Baden-Wuerttemberg Cooperative State University.

Osamu Shirokizawa
Osamu Shirokizawa

Osamu Shirokizawa is President and CEO of Life Scientia Ltd., an engineering consultancy firm specializing in pharmaceutical and biopharmaceutical manufacturing industries. He has more than 25 years of experience in providing a variety of engineering and compliance services to the industry. These include microbial control strategy, product sterility assurance, validation master planning, equipment qualification, and cleaning validation.

Osamu has been an active PDA member for more than 20 years and has been a representative of the PDA Japan Chapter (JPDA) since 2019. He is the current chair of the Kansai Study Group (KSG) of JPDA. KSG has the longest history among JPDA committees, and it has been working very closely with the JPDA board. KSG has been studying various topics pertinent to GxP.

Osamu has also been working in multiple volunteer activities led by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. He took a key role in establishing and revising Japanese guidance on aseptic processing and on terminal sterilization that were both issued by the Ministry of Health, Labour and Welfare (MHLW).

Osamu holds a bachelor’s degree in Biology from Tohoku University.

David Spaulding
David Spaulding

David Spaulding has more than 37 years’ experience in the pharmaceutical industry in Australasia and the ASEAN regions, specializing in training and compliance to FDA, TGA, and PICs codes of GMP, including the manufacture of sterile products. David’s breadth of experience covers production, laboratories, supply chain, quality assurance, sales and marketing, training, and consulting. He has worked for large companies such as GSK and has successfully (part) owned and managed small pharmaceutical companies, growing them to category leaders in the Australian market.

David is currently a Partner with a consulting firm based in Australia and Singapore and has carried out work in many of the ASEAN countries. He is responsible for the management of the training department and creates and delivers the majority of training courses. He has also lectured on many of the subjects in the Master of Good Manufacturing Practice Degree, which his consulting firm owns and delivers in conjunction with the University of Technology Sydney. He has been a committee member of the PDA Australian Chapter for the past seven years and served as President in 2016-17.