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The world’s pharmaceutical makers are on their journey towards the digital factory or Pharma 4.0 in the “never normal”, a world that is constantly in flux. As the global pharma industry transforms in such a changing environment, laboratory managers and professionals have many questions and challenges that need to be addressed.
From 2020 to 2021, Thermo Fisher Scientific in collaboration with Separation Science, hosted PHARMA 4.0: Transforming Pharmaceutical Manufacturing, with eminent global thought leaders covering current and future trends in analytical, process, quality and regulatory issues and their impact on the laboratory of the future as well as its connection to continuous manufacturing.
This eConference covers issues relevant to advanced pharmaceutical development and manufacture including regulatory and quality issues, the impact of COVID, streamlining biologics and analytical procedure lifecycle management. The event comprises:
Ajaz Hussain | Independent Pharmaceutical Consultant
Dr. Hussain began his career in teaching, first at the Ohio Northern University and then at the University of Cincinnati. He then moved to the FDA where he reached the position of Deputy Director Office of Pharmaceutical Science (1995-2004). His most recognizable contribution at the FDA was the establishment of Biopharmaceutical Classification Guidance, championing the PAT and Pharmaceutical Quality for the 21st Century Initiative and serving as the FDA’s lead for quality at ICH and facilitating the progress of ICH Q8, Q9 and Q10. In addition to his role at FDA Dr. Hussain has extensive industry experience and a background in academic research and teaching to include several high-level corporate leadership positions.
The epistemic crisis has deepened; multiple systems are now chaotic, fear and anxiety unabated and as expected the dominant response to the crisis is procrustean. Scenarios to consider managing pharmaceutical quality design space in traditional paradigm and in the emerging “SMARTness”? This presentation will talk about the insight, advice and solution of why, how, and what. Why epistemic, procrustean and design space? How should we select options to be more effective in pharmaceutical quality and beyond the COVID-19 pandemic. Finally, what solution makes sense to prioritize?
The presentation will cover the importance of understanding Product and Process robustness through effective application of QbD and the vision for the future state for manufacturing and Quality Control laboratories. Dr. Hussain will also discuss the history, evolution and impact over the past 16 years – where are we, what’s next and how do we improve.
Joseph Schariter | Associate Director | Moderna, Inc.
Joe is a chemist with 12 years of experience in lipid nanoparticle formulation and characterization. Joe joined Moderna Therapeutics in 2014, where he currently oversees the process characterization group within LNP Process Development. In this role, his team focuses on process understanding using heightened characterization with a diverse set of tools. With these techniques, they help guide process development decisions, scale up activities, and technology transfer. His group's work has led to several patents in the RNA formulation and process space and helped establish the current vaccine manufacturing platform, used to produce the COVID-19 vaccine.
Jonathan Bones | Professor | National Institute for Bioprocessing Research and Training
Dr. Bones' research focuses on the development and application of liquid phase separations on mass spectrometry, LC-MS and CE-MS, for the analysis of complex biological systems. His current research areas include application of quantitative proteomics, metabolomics and lipidomics to understand how alterations in bioprocess conditions yield molecular manifestations in CHO cells that result in altered product quality. Development of advanced LC-MS based platforms for quantitative glycomics with applications in bioprocessing and clinical biomarker discovery, multidimensional separations coupled to mass spectrometry for complex bioanalysis and development of analytical platforms to support process optimization and PAT.
Frank Steiner | Senior Manager Product Applications | Thermo Fisher Scientific
Frank has worked in Thermo Fisher Scientific for 15 years and has been manager in various HPLC marketing functions. Frank received his PhD degree in analytical chemistry in 1995 from Saarland University in Saarbrücken, Germany. There he became assistant professor in 1997 and associate professor in 2003, following his post-doctoral stay in 1996 at the Nuclear Research Center in Saclay, France. Frank has more than 30 publications in refereed journals and more than 10 book chapters on HPLC topics.
Join our experts and hear them discuss:
Ajaz Hussain
President | Independent Pharmaceutical Consultant
Dr. Hussain began his career in teaching, first at the Ohio Northern University and then at the University of Cincinnati. He then moved to the FDA where he reached the position of Deputy Director Office of Pharmaceutical Science (1995-2004). His most recognizable contribution at the FDA was the establishment of Biopharmaceutical Classification Guidance, championing the PAT and Pharmaceutical Quality for the 21st Century Initiative and serving as the FDA’s lead for quality at ICH and facilitating the progress of ICH Q8, Q9 and Q10. In addition to his role at FDA Dr. Hussain has extensive industry experience and a background in academic research and teaching to include several high-level corporate leadership positions.
Sannie Chong
APAC Regulatory Policy | Roche
Sannie leads the pharma regulatory policy of Roche in Asia Pacific. And as global topic lead for reliance practices engages the health authorities and key opinion leaders to ensure an optimal and robust regulatory environment that facilitates patient's access. In addition, she drives regulatory convergence in Asia Pacific Economic Cooperation, APEC. Formerly from Singapore Health Sciences Authority as branch director, Sannie Chong supervised all the reviewers responsible for decisions relating to chemistry, manufacturing, and control in both the pre and post-marketing stages. Sanie holds a PhD in chemistry from the University of Hull and a postdoctoral research fellowship from the University of North Carolina at Chapel Hill.
Ranjit Barshikar
CEO | QbD/cGMP Consulting (Biopharma / Pharma)
In a career span of more than 50 years Ranjit has a rich and varied experience in the pharma industry. Especially in quality management, R&D, manufacturing, and regulation and compliance. A winner of multiple national and international awards, Ranjit is currently CEO of QbD International, is a United Nations MPP Geneva advisor, and is a member of the editorial board, the Journal of Generic Medicines.
Lila Feisee
IP Expert | United States Patent and Trademark Office
Lila is the principal and founder of LF Life Sciences LLC. A 30-year veteran of the life sciences industry with 21+ years of experience in global health regulatory, IP, and market access policy, advocacy, problem solving and program development implementation. Lila is a former vice president for international affairs at the Biotechnology Innovation Organization. And from 1990 to 2000 was supervisory patent examiner at the U.S Patent and Trademark Office, and responsible for overseeing the examination of monoclonal antibodies, receptors and cytokines.
Jared Auclair
Global Biotech Professional | Northeastern University
Jared Auclair, Director of Northeastern's Biopharmaceutical Analysis and Training Lab. In this role, Jared leads a team committed to enabling safe and efficient drug research, regulatory approval and access for patients achieved through worldwide training, research and education from a state-of-the-art facility in the USA and various global facilities. Jared also serves in various global leadership roles, including with the ICH, and is Director of the Center of Excellence for Asia Pacific Economic Cooperation's Life Science Innovation Forum, as part of the regulatory harmonization steering committee in biotherapeutics and advanced therapies.
Understanding the quality environment for continuous manufacturing can be a challenge. In the next 5 to 10 years, without the cohesive relationship between industries, regulatory, innovative technologies, and more harmonized regulations, it is going to be difficult to realize the full potential of advanced manufacturing and continuous processing in our quest to achieve higher quality products. Join our expert panelists to hear them discuss the topic.
Richard Ladd
Independent consultant
Dr. Rochard Ladd is an independent consultant for the pharmaceutical industry, specialing in pharmaceutical development and manufacture. Having experience working in the pharmaceutical industry, leading pharmaceutical development, research, and technology. And more recently leading the pharmaceutical business and is passionate about continuous manufacturing PAT and new technology innovation.
Ajaz Hussain
President | Independent Pharmaceutical Consultant
Dr. Hussain began his career in teaching, first at the Ohio Northern University and then at the University of Cincinnati. He then moved to the FDA where he reached the position of Deputy Director Office of Pharmaceutical Science (1995-2004). His most recognizable contribution at the FDA was the establishment of Biopharmaceutical Classification Guidance, championing the PAT and Pharmaceutical Quality for the 21st Century Initiative and serving as the FDA’s lead for quality at ICH and facilitating the progress of ICH Q8, Q9 and Q10. In addition to his role at FDA Dr. Hussain has extensive industry experience and a background in academic research and teaching to include several high-level corporate leadership positions.
Christine Moore
Executive Director | Organon
Dr. Christine Moore is the head of Global Quality and Compliance at Organon. In her experience in the industry, Christine also worked at Merck for the CMC policy. And after a moment of a decade in various positions in the US FDA, where she left the affairs responsible for small molecule drug review and for manufacturing process assessment. Prior to moving into the regulatory CMC area, she spent 10 years at Pfizer and serves in the API service department, process analytical technologies, and scale technology transfer. Throughout her career, Christine has been a thought leader and the progressive regulatory approaches for pharmaceutical manufacturing in the areas of quality design, process analytical technology, and continuous pharmaceutical manufacturing.
Yoshihiro Matsuda
Pharmacist and Scientist | Pharmaceuticals and Medical Devices Agency
Dr. Matsuda is the pharmacist and senior scientist for the quality of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Dr. Matsuda received Ph.D. degree in Medicine from Tokyo Medical and Dental University, and he holds a Bachelor Pharmacy degree. Dr. Matsuda joined the PMDA in 2003 and is currently responsible for the quality assessment of medicines. He was a member of ICH Q9 Expert Working Group, ICH Quality Implementation Working Group (Q-IWG) and ICH Informal Quality Discussion Group. He is currently the regulatory chair of ICH Q13, the continuous processing manufacturing of the drug substance and drug products, and leads the Manufacturing Technology Working Group at PMDA.
Ravi Desai
Executive Vice President – Global Quality Head | Lupin
Ravi is the executive vice president and global quality head at Lupin in pharmaceutical and has an extensive working career in the pharmaceutical industry. His duty oversees the direction of Lupin's quality system to ensure business, customer, and regulatory requirements.
Pramod Dalvi
Senior Vice President of Quality Operation | Cipla
Pramod is the head of Quality Operation at CIPLA in India. Experienced Senior Vice President with a demonstrated history of working in the pharmaceuticals industry.
Peter Van Broeck
Principal Scientist | Janssen Research and Development, Johnson & Johnoson
Peter is the scientific director in Analytical Development at Janssen Pharmaceutical, with responsibility for continuous manufacturing strategy appointment for analytical development, and implementation of new analytical technology platforms for PAT and real-time release testing.
Jared Auclair
Global Biotech Professional | Northeastern University
Jared Auclair, Director of Northeastern's Biopharmaceutical Analysis and Training Lab. In this role, Jared leads a team committed to enabling safe and efficient drug research, regulatory approval and access for patients achieved through worldwide training, research and education from a state-of-the-art facility in the USA and various global facilities. Jared also serves in various global leadership roles, including with the ICH, and is Director of the Center of Excellence for Asia Pacific Economic Cooperation's Life Science Innovation Forum, as part of the regulatory harmonization steering committee in biotherapeutics and advanced therapies.
Join our experts and hear them discuss:
Joseph Schariter
Associate Director | Moderna, Inc.
Joe is a chemist with 12 years of experience in lipid nanoparticle formulation and characterization. Joe joined Moderna Therapeutics in 2014, where he currently oversees the process characterization group within LNP Process Development. In this role, his team focuses on process understanding using heightened characterization with a diverse set of tools. With these techniques, they help guide process development decisions, scale up activities, and technology transfer. His group's work has led to several patents in the RNA formulation and process space and helped establish the current vaccine manufacturing platform, used to produce the COVID-19 vaccine.
Hugh Malkin
CEO | CambTEK Ltd.
Hugh has a PhD in organic chemistry and is an expert in the automation of critical processes in clinical diagnostics and pharmaceutical manufacturing. He's the founder and CEO of the Cambridge Scientific Innovations Limited group of companies including Cambtek. Previous to this, he was VP at Tecan, responsible for liquid automation and robotics. He also worked for several years in drug discovery and pro-drug synthesis within pharmaceutical companies and academia.
Paul Gamache
Director R&D | Thermo Fisher Scientific
Paul is an analytical chemist who joined Thermo Fisher Scientific in 2011 through acquisition of Dionex Corporation. He's a director of R&D, responsible for development of analytical technologies with primary focus on charged aerosol detection and electrochemical detection for LC. Prior to joining Dionex in 2009, Paul led the development of first and second generation Corona CAD products. In addition, Paul is editor and contributing author to the book, 'Charged Aerosol Detection for Liquid Chromatography and Related Separation Techniques' published in 2017 by John Wiley & Sons.
Jared Auclair
Global Biotech Professional | Northeastern University
Jared Auclair, Director of Northeastern's Biopharmaceutical Analysis and Training Lab. In this role, Jared leads a team committed to enabling safe and efficient drug research, regulatory approval and access for patients achieved through worldwide training, research and education from a state-of-the-art facility in the USA and various global facilities. Jared also serves in various global leadership roles, including with the ICH, and is Director of the Center of Excellence for Asia Pacific Economic Cooperation's Life Science Innovation Forum, as part of the regulatory harmonization steering committee in biotherapeutics and advanced therapies.
Join our experts and hear them discuss:
Jonathan Bones
Professor | National Institute for Bioprocessing Research and Training
Dr. Bones' research focuses on the development and application of liquid phase separations on mass spectrometry, LC-MS and CE-MS, for the analysis of complex biological systems. His current research areas include application of quantitative proteomics, metabolomics and lipidomics to understand how alterations in bioprocess conditions yield molecular manifestations in CHO cells that result in altered product quality. Development of advanced LC-MS based platforms for quantitative glycomics with applications in bioprocessing and clinical biomarker discovery, multidimensional separations coupled to mass spectrometry for complex bioanalysis and development of analytical platforms to support process optimization and PAT.
Greg Pino
PAT Specialist | Takeda
Greg has worked at Takeda since 2017, previously holding the position of senior analytical development PAT specialist, where he chairs the EHS Laboratory Safety Committee. Previous to Takeda, Greg has worked as a senior development specialist at Shire Pharmaceuticals, QC analyst at Cubist Pharmaceuticals, and in analytical development at Stryker Biotech.
Jared Auclair
Global Biotech Professional | Northeastern University
Jared Auclair, Director of Northeastern's Biopharmaceutical Analysis and Training Lab. In this role, Jared leads a team committed to enabling safe and efficient drug research, regulatory approval and access for patients achieved through worldwide training, research and education from a state-of-the-art facility in the USA and various global facilities. Jared also serves in various global leadership roles, including with the ICH, and is Director of the Center of Excellence for Asia Pacific Economic Cooperation's Life Science Innovation Forum, as part of the regulatory harmonization steering committee in biotherapeutics and advanced therapies.
Richard Roger
Head of Process Analytics | Umoja Biopharma
In 2012, Rich joined the Analytical Sciences Group at Amgen. At Amgen, Rich developed a mass spectrometry-based multi-attribute method, MAM, for biotherapeutic characterization and release from QC. In 2015, Rich joined Just Biotherapeutics where he continued his work on MAM and started the MAM Consortium. In 2019, Rich joined Bristol Myers Squibb in Seattle, where he applied the principles of MAM for cell-based therapies. Recently, Rich joined Umoja Biopharma as head of process analytics.
Join our experts and hear them discuss:
Luis Francisco Flores Ortiz
Senior Fellow | Novartis
Luis has experience in leading and supporting quality and R&D teams and experience in the design of analytical strategies for bio-pharmaceutical products to establish appropriate processes and develop pharmaceutical products, supporting their registration.
Dr. Manoj Kumar Metta
Global Biologics | United States Pharmacopeia
Manoj is a subject matter expert in therapeutic proteins, monoclonals and peptides from starting material to end product. He has rich hands-on experience in analytical method development and validations pertaining to biologics. His experience also covers commercial development of protein and peptide biopharmaceutical products with particular emphasis on physical, chemical characterization, QTPP, developing control strategies, executing technology transfers and preparing CMC related regulatory documentation to support product licensure in global markets. He has also sound knowledge in handling USFDA and WHO audits. Manoj has been associated with USP India since December 2011.
Phil Nethercote
Independent Pharmaceutical Consultant
Phil was the analytical leader for the global manufacturing and supply division of GSK until he retired in 2016. He has over 30 years of experience in the pharmaceutical industry, leading analytical development and new product introduction teams in the UK and in Singapore. In his role as analytical leader in GSK, he provided leadership for analytical systems, processes, and standards across GSK's global network of manufacturing sites. He was a member of the USP expert panel on validation and verification and the EFPIA analytical quality by design working group, and is currently a member of the British Pharmacopeia AQbD Working Group.
Frank Steiner
Sr. Manager of Product Applications & Scientific Advisor | Thermo Fisher Scientific
Frank has worked in Thermo Fisher Scientific for 15 years and has been manager in various HPLC marketing functions. Frank received his PhD degree in analytical chemistry in 1995 from Saarland University in Saarbrücken, Germany. There he became assistant professor in 1997 and associate professor in 2003, following his post-doctoral stay in 1996 at the Nuclear Research Center in Saclay, France. Frank has more than 30 publications in refereed journals and more than 10 book chapters on HPLC topics.
Patrick Jackson
Investigator | GSK
Ravi is the executive vice president and global quality head at Lupin in pharmaceutical and has an extensive working career in the pharmaceutical industry. His duty oversees the direction of Lupin's quality system to ensure business, customer, and regulatory requirements.
An opportunity to discuss current technology platforms to address both small and large molecule processes. Register now to hear experts discuss.
Mike Claybourn
Director | Altair Innovation Consultancy
Mike has more than 25 years experience leading the delivery of technological and scientific solutions to commercially significant problems in several industry sectors. He had 10 years experience at AstraZeneca as a principal scientist, played a role in defining the strategic scientific direction for drug, formulation and process design and development. He then moved to the Raman Technology, focusing on technology platforms for biomedical R&D and pharmaceutical manufacturing. Mike is currently the director of Altair Innovation Consultancy, focuses on pharmaceutical materials and manufacturing process development and anti-counterfeit technology for pharmaceuticals.
Richard Ladd
Independent consultant
Dr. Rochard Ladd is an independent consultant for the pharmaceutical industry, specialing in pharmaceutical development and manufacture. Having experience working in the pharmaceutical industry, leading pharmaceutical development, research, and technology. And more recently leading the pharmaceutical business and is passionate about continuous manufacturing PAT and new technology innovation.
Peter Van Broeck
Principal Scientist | Janssen Research and Development, Johnson & Johnoson
Peter is the scientific director in Analytical Development at Janssen Pharmaceutical, with responsibility for continuous manufacturing strategy appointment for analytical development, and implementation of new analytical technology platforms for PAT and real-time release testing.
Saw Yen Ow
Associate director | Analytical biochemistry. CSL Ltd
Saw Yen is an associate director for Analytical Biochemistry at CSL Ltd and currently leads the team focus on structure characterization, attribute discovery, and clinical mass spectrometry for biopharmaceutical products.
Pauline Rudd
Professor | National Institute for Bioprocessing Research and Training
Pauline is a professor of Glycobiology at NIBRT, National Institute of Bioprocessing and Training at the University College of Dublin. She received an Honorary Doctorate at the Sahlgrenska Institute, Univ. of Gothenburg (2015), the International Glycoconjugate Organisation Award for contributions to GlycoScience (2017), and the Karger Award for contributions to GlycoScience Analytical Technologies at North Eastern, University, Boston.
Sridevi Khambhampaty
Vice Presedent | Intas Biopharma
Sridevi is the vice president of Syngene International Ltd. She joined the Manufacturing Services organization to lead the Biopharmaceutical Development team in 2021.
Jared Auclair
Global Biotech Professional | Northeastern University
Jared Auclair, Director of Northeastern's Biopharmaceutical Analysis and Training Lab. In this role, Jared leads a team committed to enabling safe and efficient drug research, regulatory approval and access for patients achieved through worldwide training, research and education from a state-of-the-art facility in the USA and various global facilities. Jared also serves in various global leadership roles, including with the ICH, and is Director of the Center of Excellence for Asia Pacific Economic Cooperation's Life Science Innovation Forum, as part of the regulatory harmonization steering committee in biotherapeutics and advanced therapies.
The new R&D model and introduction of game-changing technologies herald a transformation of the lab. Register now to hear experts discuss.
Ernie Hillier
Principal Owner | EJH Consulting
Ernie Hillier has over 35 years of experience in the analytical instrument industry. Over 20 years of PAT/CM experience including the design and implementation of industry solutions. Ernie is currently the principal owner of EJH Consultancy, and he is also a co-chair chem petrol section of IFPAC (International Forum for Process Analytical Technology).
Richard Ladd
Independent consultant
Dr. Rochard Ladd is an independent consultant for the pharmaceutical industry, specialing in pharmaceutical development and manufacture. Having experience working in the pharmaceutical industry, leading pharmaceutical development, research, and technology. And more recently leading the pharmaceutical business and is passionate about continuous manufacturing PAT and new technology innovation.
Martin Warman
Director | Martin Warman Consultancy Ltd
Professor | Practice at University of Strathclyde
Dr. Martin Warman has 30 years of experience in the industry with Pfizer and Vertex. Professor Warman is now director of Martin Warman Consultancy Ltd and professor of practice of the University of Strathclyde.
Malcolm Berry
Chemistry Consulting
Malcolm has more than 25 years of experience working as a process chemist for GSK. With the final 20 years leading GSK's continued API program and all he focuses on is chemist consulting, PAT, and continuous manufacturing.
Jared Auclair
Global Biotech Professional | Northeastern University
Jared Auclair, Director of Northeastern's Biopharmaceutical Analysis and Training Lab. In this role, Jared leads a team committed to enabling safe and efficient drug research, regulatory approval and access for patients achieved through worldwide training, research and education from a state-of-the-art facility in the USA and various global facilities. Jared also serves in various global leadership roles, including with the ICH, and is Director of the Center of Excellence for Asia Pacific Economic Cooperation's Life Science Innovation Forum, as part of the regulatory harmonization steering committee in biotherapeutics and advanced therapies.
Shaun Quinn
Senior marketing manager | Thermo Fisher Scientific
Shaun is the senior marketing manager at Thermo Fisher Scientific. He acquired 11 years of experience working in the Chromatography Software Organization, prior to joining, the pharmaceutical industry in various analytical, scientific system administrator and computer system validation roles.