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Janmeet Anant (Senior Regulatory Consultant at Millipore Sigma)

Janmeet Anant

Senior Regulatory Consultant at Millipore Sigma

Janmeet Anant, Ph.D., PMP, RAC serves as a Senior Regulatory Consultant at Merck KGaA Life Sciences, focused on biopharmaceutical manufacturing., Janmeet serves as a member of the Regulatory Governance Team at BioPhorum. With over 20 years of experience in the pharmaceutical industry, Janmeet has been consulting on complex regulatory strategy projects with pharmaceutical drug manufacturers, leveraging skills from his Project Management Professional (PMP) and Regulatory Affairs Certification (RAC). Janmeet has a Bachelor of Science degree in Chemistry and a Ph.D. in Pharmacology.

Peter Baker (President at Live Oak Quality Assurance LLC)

Peter Baker

President at Live Oak Quality Assurance LLC

Peter E. Baker, President, Live Oak Quality Assurance LLC, has been consulting nationally and internationally since April 2019. Prior to joining Live Oak Quality Assurance LLC, Peter spent 11 years as a U.S. FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity and has special interest in big data management and compliance with 21 CFR Part 11. He speaks Chinese (Mandarin) and Spanish and has performed more than 100 foreign drug inspections around the world on behalf of the FDA. His inspection experience includes performing six systems manufacturing inspections of APIs, intermediates, and finished dosage, including complex small and large molecules.

Lisa Bennett (Senior GMP Compliance Consultant & Trainer at SeerPharma)

Lisa Bennett

Senior GMP Compliance Consultant & Trainer at SeerPharma

Lisa is an active member of the PDA Regulatory Affairs and Quality Advisory Board (RAQAB) and the PDA Australia Chapter. Lisa’s experience comes from a background in Forensic & Analytical Chemistry, accompanied by a Masters in Forensic Science. After beginning her career s an analytical chemist in the petrochemical industry Lisa moved into roles within the Pharmaceutical Industry where she gained hands on experience in a wide breadth of disciplines such as QC, Stability and Clinical Trials, Supply Chain Logistics, R&D, Aseptic Fill and Finish, QA, Release for supply and auditing. The majority of her time in industry has been in roles working within the CSL group which manufactures biological products such as vaccines, antivenoms and blood products.

Cristiana Campa (Global Advisor and Fellow, Technical R&D at GSK)

Cristiana Campa

Global Advisor and Fellow, Technical R&D at GSK

Cristiana Campa, PhD, is currently a Technical R&D Advisor and Fellow at GSK Vaccines. After her PhD and Post-Doc, she worked at Bracco Imaging SpA (2002-2006), first as a senior researcher and then as head of Trieste research laboratory. She joined Novartis Vaccines in 2006, first as analytical senior manager and then as Head of Analytical Development, Italy. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Global Technical R&D, covering QbD, Knowledge Management and Development roadmaps.

Brooke Casselberry (Associate Vice President at NNIT)

Brooke Casselberry

Associate Vice President at NNIT

Brooke Casselberry is Associate Vice President at NNIT and a seasoned Regulatory expert who has been in the industry for over 20 years. She specializes in Regulatory Informatics and has made a name for herself by actively leading, participating in, and supporting various industry organizations and their educational efforts. She was recently appointed to the DIA Annual Meeting Committee where she is part of a global team of volunteers who help to identify important themes and shape cross-functional programming for the Annual Meeting.

Robert Caunce (Technical Manager at Baxter Laboratories Pty Ltd)

Robert Caunce

Technical Manager at Baxter Laboratories Pty Ltd

Robert Caunce is a Technical Manager at Baxter Laboratories. He has been in the industry for 30+ years, in various quality assurance management roles from Sterile Injectables to sunscreen / cosmetics and he can finally take products home. He also was a senior inspector at Therapeutic Goods Administrator.

Jesusa Joyce Cirunay (Director IV of the Center for Drug Regulation and Research at Food and Drug Administration, Philippines)

Jesusa Joyce Cirunay

Director IV of the Center for Drug Regulation and Research at Food and Drug Administration, Philippines

Jesusa Joyce N. Cirunay, Director IV of the Center for Drug Regulation and Research, Food and Drug Administration, Philippines. Before her current post, she headed various FDA offices in different timelines, Director II in various Field Offices (FDA Inspectorate); OIC-International Affairs Office; OIC-Center for Food Regulation and Research; Division Chief in the GMP Inspectorate; OIC-Marketing Authorization; OIC-Distribution Inspectorate, OIC-FDA International Affairs Office; FDA Spokesperson; QMR for ISO 9001:2008 and ISO 9001:2015; ASEAN Harmonization-Pharmaceutical Sector as Delegation Head or Delegate. On publications, lead author in several scientific articles published in peer-reviewed international journals; speaker for local/international engagements; as university faculty.

Matt Davis (Senior Inspector at Therapeutic Goods Administration - Australian Government)

Matt Davis

Senior Inspector at Therapeutic Goods Administration - Australian Government

Matt Davis is a Senior Inspector – Team Leader, inspection section with the Manufacturing Quality Branch. Matt has been with TGA since 2009.
Before joining TGA, Matt held positions in the pharmaceutical industry sector in quality and technical roles, and has spent time in the UK as a GMDP Inspector for the MHRA.

His current role at the TGA involves performing both domestic and overseas inspections of manufacturers. Matt is also the Chair for the PIC/S Working Group on Data Management and Integrity, and is the TGA representative for the PIC/S EMA revision of Annex 1.

Derek Duncan (Director of Product Line at LIGHTHOUSE)

Derek Duncan

Director of Product Line at LIGHTHOUSE
https://www.lighthouseinstruments.com/

Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics. He moved into industry and has been based at the LIGHTHOUSE office in Amsterdam since 2003, responsible for developing applications for pharmaceutical process monitoring and finished product inspection. Dr. Duncan has been a regular contributor to PDA conferences and was the recipient of the 2015 PDA Europe Service Appreciation Award and the 2020 PDA Edward Smith Packaging Science Award. He holds a degree in Physics and Mathematics from Louisiana State University and a Ph.D. in Atomic & Molecular Physics from the University of Virginia.

Michael Edey (Senior Principal Engineer at Pfizer)

Michael Edey

Senior Principal Engineer at Pfizer

Michael Edey is a Senior Principal Engineer, Global Technology & Engineering at Pfizer Inc. The role is undertaken as a member of a corporate team with responsibilities for Primary Packaging for the Pfizer Sterile Injectables Network. Michael has a diverse background in Pharmaceuticals with over 25 years’ experience in Production Management, Quality Assurance and Technical Leadership. More recently with a global technical role in packaging innovation including leading CCIT initiatives, with an emphasis on quality risk management as part of the application of a holistic science-based approach.

Contributor to global quality/technical conferences and article publication for multiple industry organizations.

Max Fernandez (Vice President at Intellective Bio)

Max Fernandez

Vice President at Intellective Bio

Dr. Max Fernandez is a regulatory, quality and compliance professional with over 20 years of experience and global leadership in biologics development, regulatory strategy, CMC, quality and compliance, manufacturing and tech transfer covering preclinical to commercial product lifecycle management.

Dr. Fernandez has been based in California for most of his career, making significant contributions to Baxter’s global efforts in the recombinant and plasma products space, and culminating in the US FDA licensure of VONVENDI, the first and only recombinant protein therapy for von Willebrand disease, in 2015. Before coming to China, he was the Head of Global Regulatory Affairs at Samsung Biologics in Korea, where he helped international and domestic clients obtain more than 100 approvals from major health authorities (US FDA, EMA, PMDA, Health Canada, ANVISA, Cofepris, etc.) for over 40 commercial products in 3 years. This remarkable success rate was enabled by over 20 on-site regulatory inspections with no critical observations. As Vice President of Intellective Bio, Dr. Fernandez is committed to helping one of China’s fastest-growing CDMOs meet global standards and making accessible advanced therapies for all.

Dr. Fernandez received his PhD in Analytical Chemistry from the University of California.

Dr Celeste Frankenfeld Lamm (Director, Global Regulatory Affairs - CMC of MSD)

Dr Celeste Frankenfeld Lamm

Director, Global Regulatory Affairs - CMC of MSD

Celeste Frankenfeld Lamm, Ph.D., is currently a Director of Global Regulatory Affairs – CMC at MSD with 15 years of industry experience. In this capacity she is responsible for regulatory strategy, engagement with regulatory authorities, and preparation of clinical CMC dossiers as well as marketing applications. Additionally she leads technical advocacy and policy activities, and sits on the PhRMA GQM Work Group in addition to several ISPE regulatory subteams. In previous roles within the company, she led analytical development efforts to support both drug substance and formulation development, as well as a cross-functional team tasked with advancing a candidate from pre-clinical through clinical studies. Dr. Frankenfeld Lamm holds a B.A. in Chemistry and Biology from Greenville University, and a Ph.D. in Pharmaceutical Chemistry from the University of Kansas.

Dinesh Khokal (Director, External Affairs, JAPAC and Intercontinental - LatAm of Amgen)

Dinesh Khokal

Director, External Affairs, JAPAC and Intercontinental - LatAm of Amgen

Dinesh. as a Director and Regional Lead of External Affairs in Amgen, is currently responsible for shaping external regulatory and GXP landscape in collaboration with industry peers and regulators in Japan Asia Pacific. Additionally, Dinesh holds the position of Adjunct Associate Professor at the Faculty of Health and Medical Sciences, Taylor’s University, Malaysia.

He is an accomplished pharmaceutical professional with distinguished career of over 35 years of combined experience in regulatory agency, biopharmaceutical & diagnostic industries, and academia.

Prior to Amgen, Dinesh held the role of Director of Therapeutic Products Branch at the Singapore Health Sciences Authority (HSA). During his tenure in HSA, Dinesh held many different roles including Senior GMP Inspector. He has also played several key roles in multiagency consortiums and World Health Organization initiatives working towards capability building, shaping regulatory landscape, regulatory harmonisation, and mutual reliance.

Dinesh received his Ph.D. in Cell and Molecular Biology from the National University of Singapore. Dinesh he is currently on the PDA Regulatory Affairs and Quality Advisory Board (RAQAB). He is a recipient of 2020 PDA Distinguished Service Award.

Niels Leander (Associate Vice President, Regulatory Affairs at NNIT)

Niels Leander

Associate Vice President, Regulatory Affairs at NNIT

Dr. Niels Buch Leander is Associate Vice President and Global Head of Regulatory Affairs at NNIT. He has 14 years of R&D IT experience and hence extensive experience with regulatory data standards and digital transformation in R&D. He advises global pharmaceutical and medtech companies on their digital transformation strategy. He is a member of EMA SPOR Task Force.

Bruce Loxley (Senior GMP Compliance Advisor at GlaxoSmithKline Vaccines)

Bruce Loxley

Senior GMP Compliance Advisor at GlaxoSmithKline Vaccines

Bruce provides inspection readiness and compliance guidance to GSK Vaccines manufacturing network, focusing on AsiaPac. He is responsible for performing pre- Prior Approval Inspection (PAI) Assessments, and now has a specific remit on (i) preparing sites for first inspection, and on (ii) sharing knowledge on regulatory updates and trends into the organization.
Bruce has more than 30 years in the Pharma and Vaccines businesses, including a variety of roles in Validation and Compliance in both Drug Substance and Drug Product Manufacturing in UK, France and Singapore.

Bruce has been a PDA Singapore Chapter member since 2014, and was Chapter President from 2020-2022. Since July 2022 he has been a member of PDA’s Science Advisory Board (SAB).

Steven Mendivil (External Affairs at Amgen)

Steven Mendivil

External Affairs at Amgen

Worked at Syntex, Genentech and finally 20 years at Amgen now part time Sr. Advisor for Amgen Quality. I was on the PDA Board of Directors for 10 years, ICH Q11 EWG member, ICH Q7 Q&A IWG member. PDA Quality Metrics and Quality Culture Task Force leader from 2013 - 2021.

Jackie Milne (Director, Process Development (Attribute Sciences) of Amgen)

Jackie Milne

Director, Process Development (Attribute Sciences) of Amgen
Di Morris (Senior Auditor, Development and Product Quality Group at AstraZeneca)

Di Morris

Senior Auditor, Development and Product Quality Group at AstraZeneca

Di Morris is a chemist and microbiologist and a Qualified Person who has worked in the pharmaceutical industry for over 40 years including working for the UK MHRA as a Medicines Inspector.

Di has worked in the areas of Quality Control, Quality Assurance and Regulatory Affairs. Di is Co-Deputy Chair of the not-for profit UK organisation PHSS and co lead on the sterile and contamination control strategy special interest groups.
Di has worked with a wide range of dosage forms including sterile products, biological, and non-sterile products (solids, liquids and creams etc).

Di now works as Senior Auditor in the Development Quality/Product Quality Group of AstraZeneca.

Dr Dominic Nguyen-Van-Tam (Compliance Senior Manager at Amgen)

Dr Dominic Nguyen-Van-Tam

Compliance Senior Manager at Amgen

A former MHRA Pharmacovigilance Inspector with 10 years of inspection experience currently working as a Senior Compliance Manager for a global biotechnology company. Previous industry experience includes roles in case processing, case processing quality and pharmacovigilance data reporting and analysis. Holder of a PhD, an MSc in Cognitive Neuropsychology and a BSc in Behavioural Science. Also, a former NHS intensive care nurse with experience in UK teaching hospitals in London and Birmingham.

David Ross (Program Lead, Accumulus Synergy AZ, Regulatory Affairs at AstraZeneca)

David Ross

Program Lead, Accumulus Synergy AZ, Regulatory Affairs at AstraZeneca

David Ross has led enterprise projects at AstraZeneca and Abbott Labs. He is the AZ Accumulus Lead. David implemented enterprise solutions at AZ for cross-functional CSR Initiative, Early Clinical Authoring and CTA Quality and Acceleration improvements in alignment with EU CTR 2022. He has delivered strategic and process improvements in labelling, CMC and Non-Clinical. He led the first eCTD Implementation in AZ. David is the AZ representative of the PhRMA Regulatory IT Knowledge Group. He leads the GSO IRISS industry Forum. He has a BA.Sc. Chemical Engineering, BSc. Biochemistry, MBA, Engineering Management Graduate Degree University of Ottawa / McGill University.

Micheal Schafferius (Application Specialist at Sartorius Australia)

Micheal Schafferius

Application Specialist at Sartorius Australia

Micheal Schafferius currently holds the position of Application Specialist for Separation Technologies and quality at Sartorius Australia, working for Sartorius for the past 10 years. Micheal has worked in the pharmaceutical and biopharmaceutical industries for more than 20 years. His experience includes roles focused on Filtration, Single Use Technologies, Quality Assurance, Validation and Sterile Manufacturing with local and international companies. Micheal is the current PDA Australia chapter President.

Phil Tregunno (Head of Vigilance Operations, Safety and Surveillance at Mhra)

Phil Tregunno

Head of Vigilance Operations, Safety and Surveillance at Mhra

Phil is the Head of Vigilance Operations within MHRA’s Safety & Surveillance function and has over eighteen years of experience working in pharmacovigilance. Prior to his current role Phil spent nine years leading and developing the Signal Management function, including systems, processes, and relevant aspects of Pharmacovigilance Legislation.

He is accountable for the operational delivery of the Patient Safety Monitoring team, including the Yellow Card Scheme and Signal Management across medicines, vaccines, devices, and defects.

Gopi Vudathala (Global Head, GRA CMC at Incyte Corp)

Gopi Vudathala

Global Head, GRA CMC at Incyte Corp

Dr. Vudathala, Ph.D., is currently Global Head, RA CMC at Incyte Corporation. He was formerly Executive Director of RA CMC at Intarcia Therapeutics, Head of Quality Advocacy at GSK Vaccines and Global Head of Regulatory CMC at Novartis Vaccines. He was also Associate Vice President of Regulatory Affairs CMC at Sanofi-Aventis. He has extensive experience in CMC regulatory strategy for Global Development and Life-Cycle Management Projects and contributed to over 25 NDA and BLA approvals and 50 INDs. Dr. Vudathala has had numerous interactions with global regulators on project related CMC matters as well as on key ICH initiatives.