PharmaLink Conference Speakers
The PharmaLink Conference speakers are handpicked by the PharmaLink Strategic Committee to deliver purpose-driven content that dives below the surface, challenge status quo, engage attendees in collaborative dialogue, and provide practical information that can be implemented. Our speakers are thought leaders who are sure to facilitate insightful discussion.
Head of Quality Compliance & Systems, Oncology and External Supply Small Molecule, Takeda
Research Fellow, Pfizer
Daniel O. Blackwoodis a Research Fellow in the Drug Product Design group at Pfizer, Inc.. He is based at Pfizer’s R&D campus in Groton, Connecticut, USA. He received his BS in Mechanical Engineering from Cornell University in Ithaca, NY and his MS in Industrial Engineering from Columbia University in New York City. During his ~28 years at Pfizer, Daniel’s research has focused on the co-development and technology transfer of late-stage drug product programs and the development of process scale-up models and advanced sensing applications supporting these activities. He is a subject matter expert in drug product continuous processing technologies.
Consultant, MGB Solutions
Grace Breen is a consultant with over 30 years of experience in the pharmaceutical industry. She is the former Head of Quality for SCA Pharma and has held global leadership roles at Impax, Hospira, and Catalent. Breen has Quality and Compliance expertise spanning APIs, solid oral and parenteral dosage forms, and infusion devices. At SCA Pharma, a 503B outsourcing company, she led a cGMP cultural transformation; at Impax, she implemented a contemporary and integrated Quality and Compliance strategy; and at Hospira, she led a global Commercial Quality team that focused on the needs and satisfaction of the customer.
Breen earned a post-graduate diploma in pharmaceutical manufacturing technology from Trinity College in Dublin, Ireland; a master’s degree in chemistry from Dublin City University, Ireland; and a bachelor’s degree in chemistry from University College Cork, Ireland. She is eligible to act as Qualified Person (QP) under EU law.
Jennifer L. Brown
Senior Director, Global Regulatory Affairs Chemistry, Manufacturing & Controls, Pfizer
Jennifer L. Brown is currently a Director in the Global Chemistry, Manufacturing & Controls group within Global Regulatory Affairs at Pfizer Inc. in Groton, Connecticut. Brown and her team are responsible for CMC strategy for a global portfolio of investigational and commercial products. Brown has a bachelor’s degree in chemistry from Muhlenberg College in Allentown, Pennsylvania, and a master’s degree in regulatory affairs from Temple University. She has been at Pfizer for over 20 years, working in Analytical R&D and then GCMC. Prior to joining Pfizer, Brown was a Peace Corps volunteer in Gabon, Central Africa, where she taught middle school science, and she also served as a Pfizer Global Health Fellow by working at the Kakuma Refugee Camp in northern Kenya for several months in 2005.
Process Modeling Head, Pfizer
Supervisor Consumer Safety Officer, FDA
Rebecca Dowd is a Supervisory Investigator in the Office of Regulatory Affairs, with over 19 years of pharmaceutical experience at the FDA. Rebecca has served as a Compliance Officer/Senior Policy Advisory in the Office of Manufacturing Quality, and a Process and Facility Reviewer in the Office of Pharmaceutical Quality, CDER. In these roles, Rebecca was involved in the compliance and capability assessments of global and domestic facilities including proposed manufacturing and testing processes, and onsite inspections. Prior to her work experience at CDER, Rebecca gained over 12 years of inspectional experience with the FDA out of the Detroit District (now Division III), including 3 years as a District Pre-Approval Manager and 2 years as a Drug Specialist. Rebecca attained Level II and Level III certification and became a member of FDA’s Pharmaceutical Inspectorate. She holds a Bachelor of Science and a Master of Science in Biology, and has experience lecturing in both academic and agency forums.
Consumer Safety Officer, FDA, Cincinnati District
Bank of America University Professor of Supply Chain Management, NCSU
Rob Handfield is the Bank of America University Distinguished Professor of Supply Chain Management at North Carolina State University, and Executive Director of the Supply Chain Resource Cooperative (http://scm.ncsu.edu/). Handfield is considered a thought leader in the field of supply chain management, and is an industry expert in the field of strategic sourcing, supply market intelligence, and supplier development. He has spoken on these subjects across the globe, including China, Azerbaijan, Turkey, Latin America, India, Europe, Korea, Japan, Canada, in multiple presentations and webinars. Handfield has published more than 120 peer reviewed journal articles and is regularly quoted in global news media such as the New York Times, Wall Street Journal, LA Times, Bloomberg, NPR, Washington Post, the Financial Times, the San Francisco Chronicle, and CNN. He served on the Joint Acquisition Task Force during COVID which led to published articles on the shortages of PPE in the Harvard Business Review and the Milbank Quarterly Journal, and led a NIIMBL research team studying distribution of test kits during the pandemic. He was also invited to serve on the Biden White House Counsel of Economic Advisors in January 2022, and has worked with many companies through the Supply Chain Resource Cooperative for several years.
Global Quality Director – Quality Risk, AstraZeneca
Alan started his career in New Zealand in the bioprocess industry with diverse roles in Automation, Process Development, and Operations Management. In 1987 Alan moved to the US and provided engineering / startup support for a number of global bioprocess projects.
Alan started in the Pharmaceutical Industry in 1996 as a Technical consultant before joining Amgen in 2006 to support their Biotechnology expansion and new product Validation programs. Alan joined AstraZeneca 4 years ago and is now responsible for the Global Quality Risk Program for the company.
Alan holds a Bachelor of Technology Degree (Biotechnology) from Massey University – New Zealand.
Regulatory Strategist, Pfizer
Connie Langer is a Director at Pfizer Global Product Development in Groton, Connecticut. She joined Pfizer in 1998 as a scientist in the Pharmacokinetics, Dynamics, and Metabolism Department, where she employed quantitative and qualitative mass spectrometry techniques to study drug metabolism, biopharmaceutics, and the environmental fate and effects of pharmaceuticals.
Langer is currently a regulatory strategist in the Global CMC department, managing and executing life-cycle CMC regulatory activities, providing global strategy and regulatory submissions for investigational studies. She’s also responsible for new commercial registrations and post-approval maintenance for licenses of pharmaceutical products. Langer co-chairs the International Consortium for Innovation and Quality in Pharmaceutical Development ICH Q12 working group and is a member of the ISPE PQLI® ICH Q12 Working Team.
She has a bachelor’s degree in chemical engineering, a master’s degree in oceanography from the University of Connecticut, and a drug development certificate from the School of Pharmacy, Quality Assurance, and Regulatory Affairs at Temple University.
Executive Director, Knowledge Management, Merck
Martin (Marty) Lipa has nearly 30 years of biopharmaceutical industry experience with 15 years in Knowledge Management (KM), where he currently leads KM for the Manufacturing Division of Merck & Co., Inc. His prior experience includes various roles in technology, engineering and IT. Marty is a Lean Six Sigma Black Belt, has a PhD from Technological University Dublin with a focus on improving KM and its interdependency with risk management, and is an active member of the global KM community as a regular speaker and author.
President of DL Advisors LLC
David is the President of DL Advisors LLC where he advises on strategy, acquisitions and provides target assessments and due diligence support. He is an Independent Director on the Boards of SK Pharmteco, a global CDMO operating predominantly in the Pharmaceutical API space, and Yposkesi, a Cell and Gene Therapy CDMO.
David has over 37 years of global experience in the Pharmaceutical and Biotechnology Industry, most recently holding Senior Vice President roles at Shire Pharmaceuticals with Global responsibility for Supply Chain and for Manufacturing.
David has a degree in Pharmacy from the Welsh School of Pharmacy, University of Wales Institute of Science and Technology (now Cardiff University).
Co-founder and CSO, Aizon
Toni Manzano is co-founder and CSO of Aizon, a cloud company that provides big data and an AI SaaS platform for the biotech and pharma industry. Since 1996 he has led software projects for international pharmaceutical companies covering the entire production process and supply chain (R&D, clinical trials, production, laboratory, quality assurance, warehousing, and logistics). In pharma manufacturing he was specifically dedicated to biotech processes, always improving critical operations. Manzano has also led projects implementing solutions based on the 3 ICH (Q8, Q9, and Q10) and executing audit, qualification, and validation tasks. Today he is in the scientific committee of the PDA Europe supporting annual events for the innovation and technology in pharma.
Manzano also worked as a researcher at the University of Barcelona as a physicist, and he teaches Big Data and Artificial Intelligence subjects related with the pharma industry in specific postgraduate courses at the University (UAB). He has written numerous articles in the pharma field and holds a dozen international patents related to the encryption, transmission, storage, and processing of large volumes of data for regulated environments in the cloud. Manzano is a physicist, master in information and knowledge society, and post-graduate in quality systems for manufacturing and research pharmaceutical processes.
Partner and Deputy Chair for FDA & Life Sciences, King & Spalding
Chris Markus focuses on federal and state regulation of drugs, biologics, biotechnology, and related products. As a partner in the FDA and Life Sciences practice and Deputy Practice Group Leader, Markus represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.
She represents drug, biologic, and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA), and related state agencies such as boards of pharmacy. Markus also represents clients in business transactions, including strategic planning, due diligence, and assessment, which involves product development and approval, safety, labeling, marketing and advertising, manufacturing, and supply chain.
SVP Quality and Regulatory, Centers for Breakthrough Medicines
Mike has over 20 years of experience in the Pharmaceutical industry, specializing in Quality Assurance, Quality Control, Operations and Regulatory Affairs. Prior to joining the Centers for Breakthrough Medicines, Mike spent 7 years as the V.P of Quality Assurance and Regulatory Affairs at WuXi Advanced Therapies and held similar leadership roles supporting the commercial manufacturing of API’s. Throughout his tenure at WuXi, Mike led the quality and regulatory organizations in support of cell and gene therapy operations which supported over 30 client products, over 500 executed batches and was integral in the lot release for over 40 commercial biological products. Mike had direct oversight of the capacity buildout for manufacturing and testing operations, expanding the site capacity from 82,000 square feet to over 440,000 square feet. While leading the Quality and Regulatory Programs for Cell and Gene Therapy, Viral Vector, and Commercial Lot Release, Mike represented Site Operations and Quality programs during inspections from global regulatory agencies resulting in successful outcomes:
CDR Jeffrey Meng
Program Division Director, Office of Pharmaceutical Quality Operations, ORA, FDA
CDR Jeffrey Meng is an engineer officer in the U.S. Public Health Service and currently serves as the Program Division Director for the Division of Pharmaceutical Quality Operations III within the ORA Office of Pharmaceutical Quality Operations. CDR Meng leads over 70 FDA pharmaceutical investigators, compliance officers, management, and support staff responsible for facility inspections, investigations, and compliance throughout the Midwest and internationally in support of FDA’s mission to provide safe and effective pharmaceuticals for consumers. CDR Meng began his FDA career in 2009 as an Investigator, with advancing roles as a Drug Specialist, Supervisory Investigator, and Director of Investigations Branch prior to his current position as the Program Division Director. He leveraged broad experiences throughout his FDA career, including rotations to the FDA Office of International Programs (OIP) China Office in Shanghai, China and to the FDA Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Quality Surveillance (OQS).
Head of Knowledge Management – Global Quality, Takeda
Since joining Takeda 5 years ago, Shirley has held a number of Quality Compliance & Systems roles, and is now responsible for the global strategy & implementation of overall Knowledge Management concepts for Global Quality. She has over 20 years’ experience in the pharmaceutical industry with a strong background of working with sites, regions and Operating Units on a wide spectrum of Quality Compliance & Systems topics. She has a Bachelor of Science degree in Biochemistry from University College Cork, Ireland & is based in Ireland with her husband and 3 children.
Foreign Pre-Approval Manager, FDA
Ashar Parikh started his career with the FDA in the San Francisco District as a Consumer Safety Officer. Shortly afterward he transitioned into the Pharmaceutical commodity and became a Level 2 Drug Specialist and the District Pre-Approval Manager. In 2018, he joined ORA Headquarters in his current position as a Foreign Pre-Approval Manager where he reviews and assesses facilities listed in NDA/ANDAs and also performs inspections of foreign facilities.
Head of Corporate Quality Compliance, Perrigo Company
Brandon Persinger has more than 20 years of experience in the pharmaceutical and biopharmaceutical manufacturing industry having held roles in operations, quality and compliance. He is currently head of Corporate Quality Compliance for Perrigo Company, with responsibility for internal audit, regulatory enforcement monitoring and compliance risk management, and oversight for Consumer Affairs including consumer call center. Brandon has held prior roles at Pfizer and Amgen. He holds a B.S. in Chemical Engineering from the University of Michigan, and resides with his wife and daughter in Saugatuck, Michigan.
CEO and President, Pathway for Patient Health
Marla founded Pathway for Patient Health in 2017, which advances quality maturity across the industry through the Chief Quality Officer Forum, Site Quality Officer Forum and the Quality Science Education Program that pretrains students to join our industry. Prior to Pathway, Marla led global FDA cosponsored initiatives for 13 years across pharma, device and artificial intelligence through Xavier University. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility.
VP, Global Regulatory Affiars CMC, Pfizer
Associate Director for Science & Biosimilar Strategy, FDA
Joel Welch is the Associate Director for Science& Biosimilar Strategy in the Office of Biotechnology Products in the Office of Pharmaceutical Quality at the US Food and Drug Administration. He is responsible for assessing emerging, complex, or precedent-setting issues impacting science policies of the office with particular emphasis on the biosimilar program. He also serves as the Rapporteur for the ICH revision to Q5A(R1) and the Vice Chair for the Emerging Technology Program. He has had a variety of roles at FDA in his 13 years, and prior to joining FDA, he spent 6 years in industry supporting late state analytical development of small molecules.