On-demand: Pharma 4.0 – Transforming Pharmaceutical Manufacturing

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 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.

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 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, 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.

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.

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.

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.

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 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 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 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, 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.

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 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 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, 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.

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 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, 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.

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.

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.

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 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 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.

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.

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.

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 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 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 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 is the vice president of Syngene International Ltd. She joined the Manufacturing Services organization to lead the Biopharmaceutical Development team in 2021. 

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.

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).

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.

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 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, 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 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.