PDA Annual Meeting 2023 | speaker (2023)

Dra. Janmeet Anant

MilliporeSigma

Janmeet Anant, Ph.D., PMP, RAC is a Senior Regulatory Consultant for MilliporeSigma and works specifically with sterile injectables. Janmeet advised on regulatory requirements for CMC submissions for oligonucleotides such as siRNA and viral vector-based gene therapies. Janmeet has guided clients of large, emerging multinational biopharmaceutical and biotechnology companies through these niche therapeutic modalities for which there is currently limited established regulatory guidance.
Janmeet was a key member of the Manufacturing Operations Paradigm Shift (PCMO), a Quality Risk Management (QRM) team of the Parenteral Drugs Association (PDA). In addition, Janmeet previously served on the board of directors of the Bioprocess Systems Alliance (BPSA), vice chair of a subcommittee of the standards organization of the American Society of Mechanical Engineers – Bioprocessing Equipment (ASME-BPE) and a member of BioPhorum's regulatory governance. With over 20 years of experience in the biopharmaceutical industry, Janmeet has assisted in complex regulatory strategy projects with biopharmaceutical drug manufacturers, leveraging the skills of their Project Management Professional (PMP) and Regulatory Affairs Certification (RAC). Janmeet holds a Bachelor of Science in Chemistry and a Ph.D. in pharmacology.

Frédéric B. Ayers

Eli Lilly and company

Fred graduated from Franklin College of Indiana in 1999 with a Bachelor of Science in Biology. While a student at Franklin College, he was a student athlete for four years and participated in the institution's leadership program. After graduating, Fred spent some time in the contract manufacturing industry and then joined Eli Lilly and Company in 2001. During his more than 20-year career with Eli Lilly and Company, Mr. Ayers has held various positions in the quality and technical services organizations. In each role, Fred has helped improve Lilly's regulatory compliance status and is recognized as a subject matter expert in sterility assurance. For Lilly's parenteral manufacturing facility in Indianapolis, he was responsible for the development, implementation and continuous improvement of the site's sterility assurance programs. As a global consultant, Fred was responsible for aligning Lilly's quality standards and associated sterility assurance programs with global regulatory expectations. It drives technical leadership through external alignment and engagement across the biopharmaceutical industry to influence the direction of regulatory expectations. Fred was a huge supporter and contributor to PDA. He has served on the PDA Midwest Chapter Board since 2014, served as Chapter Chair from 2020-2021, and was recently nominated and selected to serve on the PDA Scientific Advisory Board.

DR. Kakolie G. Banerjee

MilliporeSigma

Kakolie Banerjee is a Senior Scientist in the Department of Virology and Microbiological Sciences at Millipore Sigma. She has been with the company for over three years as a virologist in the process solutions area supporting the bioprocess efforts. His work includes studies of viral clearance and inactivation using mammalian virus and bacteriophage models. Prior to that, she worked as a Research Associate at Sample6 (now known as Corvium Inc.) and helped develop an AOAC-certified phage-based method for detecting foodborne pathogens. Kakolie has a doctorate. in Food Science from Pennsylvania State University and studied the mechanisms of Shiga toxin expression in E. coli O157:H7. He previously earned his Bachelor of Life Sciences from the University of Delhi and an M.S. in Food Safety from North Dakota State University to study the molecular detection of Fusarium spp.

DR. Sarah Barkau

Bristol Myers Squibb

Dr. A.S. Kurt Broson

Parexel International

Bikash Chatterjee

Pharmatech Associates

Bikash Chatterjee is CEO of Pharmatech Associates, a USP company, and has been involved in the biopharmaceutical, pharmaceutical, medical device and diagnostics industries for over 30 years. He has designed CMC and development programs that include patient-centric initiatives for multiple drug sponsors and has led the successful approval of more than a dozen new products in the US and Europe. He is a Six Sigma/Lean Manufacturing Black Belt. Chatterjee has published over 200 articles in industry and trade publications. Chatterjee is a regular contributor to editorial and technical work for several industry publications and serves on the Pharmaceutical Manufacturing and Pharmaceutical Technology Editorial Board and founding member of CPhl's Industry Expert Advisory Board. Chatterjee is the author of Applying Lean Six Sigma to the Pharmaceutical Industry. He holds a BS in Biochemistry and a BS in Chemical Engineering from the University of California, San Diego.

Carrie Colella

Lachmann consultant

Carrie Colella is a senior director at Lachman Consultants, whose more than 30 years of experience in the pharmaceutical industry includes quality and compliance system audits, training development and project management. You know the requirements of the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada (HC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) as well as the EU Medical Device regulations and ISO standards. 🇧🇷 Woman. Colella is fluent in GMP and GLP standards and has experience in GCP clinical studies. He managed and led complex compliance projects and continuous improvement initiatives, leading cross-functional teams from inception to operations. His expertise spans medical devices, combination products and OTC products (including topical dosage forms).

Dr Mauro Giusti

Eli Lilly and company

Emily Heffernan, physical education class

DPS group

Emily Heffernan, US Director of New Process Technologies, is a Process Topic Expert (SME) specializing in biological processes and plant design. During his 20 years in life sciences, he gained experience in the development of facilities for monoclonal antibodies, vaccines and new therapies, including the production of gene and cell therapies. She is recognized in the industry for her technical expertise in multimodal plants where different types of products are manufactured in the same plant due to her in-depth knowledge of complex plant designs, GMP operations and regulatory considerations.
A graduate of North Carolina State University, Emily holds two degrees: a BS in chemical engineering and a BS in biochemistry. She is also a licensed professional engineer in the state of North Carolina and an active member of the International Society of Pharmaceutical Engineers (ISPE).

Julia Jenkin

Julia works with individual patients, caregivers, patient organizations and advocates to ensure the work of the EveryLife Foundation for Rare Diseases continues to serve the needs of people living with rare diseases in the community. 🇧🇷 Julia has been working for the foundation since it was founded in 2009. Her experience of grassroots organization and legislative advocacy inspired her to create Rare Disease Legislative Advocates, Rare Disease Week on Capitol Hill and Rare Across America, programs that unite and amplify the voices of rare diseases. Patient advocate in state and federal parliaments. In 2012, Julia brought the rare patient community together during the PDUFA V negotiations to ensure that all provisions benefiting rare disease patients were included in the FDASIA, which went into effect. Julia's leadership rallied the rare disease community to support the passage of the 21st Century Cures Act of 2016 and the unanimous passage of newborn screening legislation in California and Florida. Julia is a board member of CAL Rare. He is a member of the Steering Committee and Co-Chair of the Policy Task Force for the Coalition for Rare Disease Diversity. In addition, Julia is a member of the Policy Council of the National Board of Health.

Andrea Johnston, PhD

Biophor

Maik W. Jörnitz

G-CON Manufacturing, Inc.

Maik W. Jornitz, President and CEO of G-CON Manufacturing Inc., is a 35-year industry veteran. He has extensive experience in single-use bioprocessing, aseptic processing and specializes in sterilizing filtration. He has published several books and book chapters as well as over 100 scientific papers on various topics in bioprocess engineering and plant design. He is the former Chair of the Board and Scientific Advisory Board of the PDA and a member of several PDA Working Groups, including the EU Annex I Response Team. He is an active member of ASTM E55, Advisory Board Member of the Biotechnology Industry Council, ICAV, Bondwell and Board Member of DIANT Pharma and Sunflower Therapeutics. As a faculty member for various training activities including PDA TRI, he regularly trains industry representatives and regulators.
Before joining G-CON at the end of 2012, he worked for Sartorius for 26 years, most recently as Senior Vice President of Global Product Management and Marketing for Bioprocesses. He received his M.Eng. in Bioengineering from the University of Applied Sciences in Hamburg, Germany and completed the PED program at the IMD Business School in Lausanne, Switzerland.

Jason Kerr, MBS, MBA

Redica-Systeme

Jason Kerr is an experienced quality and regulatory practitioner and has been committed to including, connecting and driving regulatory compliance in the dynamic biopharmaceutical landscape. Driven by data, it prides itself on delivering the best possible outcome while ensuring compliance and efficiency. As a Senior GXP Specialist at Redica Systems, Jason's goals include improving quality and regulatory awareness and promoting important issues such as data integrity across the industry. Previously he worked at Amgen where he monitored global regulatory information and identified quality requirements to classify, evaluate and implement to ensure compliance. This included designing and implementing a system to track the changes made and provide regular updates to key stakeholders. Jason holds a BA in Biochemistry, an MBS with a concentration in Clinical and Regulatory Affairs, an MBA and a Certificate in Bioscience Law and Industrial Practice.

Guido Kremer-van der Kamp

Merck Chemicals GmbH

Guido Kremer-van der Kamp has more than 25 years of experience in the biopharmaceutical industry with single-use and multi-use processes and plant design. He has held various positions with global responsibility in the areas of process development, operations, consulting and technology management. He is currently a Senior Consultant at Merck's Global Biopharmaceutical Center of Excellence. Guido holds a degree in biotechnology from the Mannheim University of Applied Sciences with stations at the National University of Singapore and a fellowship at the Institute of Molecular and Cellular Biology (IMCB) in Singapore.

Pablo Lopolito

STERIS Corporation

Paul Lopolito is Senior Manager of Technical Services in the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides global technical support related to process cleaning, cleaning validation and contamination control including field service, site reviews, training presentations and training seminars. Paul has over 25 years of industry experience and has held positions such as Technical Services Manager, Production Manager and Laboratory Manager. Paul is a frequent speaker at industry events and has published numerous articles and book chapters on cleaning validation and contamination control. He earned a B.A. in Biological Sciences from Goucher College in Towson, MD.

Peter J. Makowenskyj, MEng

G-CON Manufacturing, Inc.

Amanda McFarland, MS

ValSource, Inc.

Microphone McGoldrick

Merck & Co., Inc.

Mic is currently Associate Director of Technical Policy and CMC Advocacy at Merck Sharp and Dohme, Corp. last 30 years. For 15 years, Mic has worked on IND regulatory matters, new product registrations and post-marketing registrations worldwide. During much of that time he led the global evaluation of guidelines and the expansion of vaccines in emerging markets. For the past seven years, Mic has worked on the CMC Vaccine and Biologics Policy, advocating for trust, harmonization and better access to vaccines for patients.

Jeff Odum, CPIP

Genesis AEC

Kenneth Paddock

Baxter

Ken Paddock is Director of Sterility Quality Assurance at Baxter Healthcare. As Global Sterility Assurance (SA) leader within the Quality group, Ken is responsible for leading a global team of regional Sterility Assurance representatives to develop and implement a harmonized SA strategic plan for Baxter. In addition, its staff provides facility-level quality oversight of microbial control and cleanroom behavior and is responsible for regional sterility assurance compliance. Ken has over 25 years of pharmaceutical industry experience including terminal sterilization (moist heat, radiation and ethylene oxide), product/process development and environmental monitoring programs.
Ken currently serves on the PDA Chapter Board and has been elected to various positions within the chapter since 2010. He is also a member of the PDA Scientific Advisory Board.

Diane M. Paskiet, MS

West Pharmaceutical Services, Inc.

Diane Paskiet has over 30 years of experience in the pharmaceutical industry. She is currently Director of Scientific Affairs at West Pharmaceutical Services, where she is involved in scientific and regulatory programs related to the safety and compatibility of pharmaceutical packaging and combination products. Previously, he managed the local operations of West-Monarch Analytical Laboratories. Diane is a member of the Product Quality Research Institute (PQRI) Steering Committee and has been an active member of the PDA for over twenty years. She is on the faculty of the Parenteral Drug Association Training Institute. Finally, she is the author, co-author, and speaker of numerous articles and books on pharmaceutical packaging systems, delivery systems, and compounded products.

Kara Quinn

ValSource, Inc.

Kara Stockett Quinn is a senior consultant and subject matter expert (SME) in the areas of biopharmaceutical product development (clinical and non-clinical), technology transfer and validation, commercialization and pre-approval, licensing and supply manufacturing. His main experience is in quality systems, regulatory communication, process technology and clinical disciplines. He has extensive experience in facilitating and communicating directly with health authorities. Woman. Quinn is an industry thought leader, leading alignment on best practices for raw material risk assessment, qualification standards and characterization of new excipients.

Emma Ramnarine, PhD

Stephan Rönninger, Dr.-Ing.

Amgen (Europe) Ltda

Mike Salem, M.A

Sciences of Gilead

Sebastian Scheller, MSc

Innerspace GmbH

susan j schniepp

Regulatorische Compliance Associates Inc.

Kristin N. Valente, PhD

Merck & Co., Inc.

Dr.Thomas Zahel

Körber Pharma Austria GmbH

Thomas Zahel is Innovation Director at Körber Pharma Austria GmbH and has extensive experience in statistics, algorithm development and turning complex challenges into simple concepts for biopharmaceutical companies. His background is in biochemical engineering and he has a PhD in applied statistics for process development and validation. His greatest passion is the development of new statistical methods and their implementation in intuitive data science tools.