Regional Pharma Manufacturing Expo
November 17, 2016 - DoubleTree Hotel - Somerset, NJ
Expo Hall: 2:00pm - 9:00pm
Talks: 4:30pm - 8:00pm
Workshops: 12:00pm - 4:30pm
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KEYNOTE: Innovating Biologics for the Future
David Pollard, Ph.D., BioProcess Vaccines & Development, Merck & Co. Inc
Abstract: We face an unprecedented era with the expanding influence of biologics to an increasing set of therapeutic areas. This wider range of biologic novel targets requires modalities beyond standard mAbs to a diverse set that include bispecifics, nanobodies and peptides. Agile and flexible solutions are required to develop and produce the diverse drug portfolio while driving down costs and providing a global supply presence.
Case study examples of innovative technology solutions will be provided that were enabled by strong collaborations with both academics and suppliers. High throughput tools have been developed to accelerate both cell line development and process development. Novel next generation production approaches will be described that include automated continuous bioprocessing with multi column chromatography and process analytical technology for real time quality control. The process fit of these technologies into clinical and commercial production will be discussed.
Healthcare Science Advisors
Joanne Beck, Ph.D.
EVP Global Pharmaceutical Development and Operations,
Haripada Maity, Ph.D.
Research Advisor, Formulation Development, CMC Development
Eli Lilly and Company
USDM Life Sciences
Lead IT Project Management Office
The Lancer Group
CNCM Consulting, LLC
Consultant & CEO
Michael Falkow, Managing Director, The Lancer Group
Michael Sarachman, Program Manager, USDM Life Sciences
Claudia Campbell-Matland, Consultant and Managing Member, CNCM Consulting, LLC
Robert Hall, Sales Engineer, Strategic Accounts, Active Power
Dalfoni Banerjee, Consultant & CEO, 3Sixty Pharma Solutions, LLC
Haripada Maity, Ph.D., Research Advisor, Formulation Development, CMC Development, Eli Lilly and Company
Harvey Greenstein, former Director, Lead IT Project Management Office, Celgene
Haro Hartounian, Ph.D., President & CEO, Diavics, Inc.
David Pollard, Ph.D.,Executive Director of BioProcess Technology & Expression, BioProcess Development, Merck
Joanne Beck, Ph.D.,EVP Global Pharmaceutical Development and Operations, Celgene
Ben Locwin, Ph.D., President, Healthcare Science Advisors
Michael Falkow is the Managing Director of The Lancer Group, a consortium of Independent Consultants serving the FDA–regulated industries. He has served as a regulatory compliance and quality assurance executive with multi-facility/international companies and was an FDA Compliance Officer and Senior Investigator/Drug Specialist. Michael has subject matter expertise for quality and regulatory compliance, quality auditing, quality assurance, quality control, supplier evaluation and certification, and compliance remediation. He has been approved by FDA as a GMP certifying authority and is qualified to provide Expert Witness testimony for GMPs.
Michael Sarachman is a member of the USDM Unique Device Identification (UDI) practice, where he helps healthcare companies enhance their master data, labeling systems and supply chain to meet the challenge of the US FDA UDI regulation while leveraging industry standards to improve supply chain execution. In his current assignment, Michael leads the UDI implementation program at a major medical device manufacturer, overseeing teams supporting data management, internal and external manufacturing and artwork development.
In his previous role, he implemented project management practices while leading the Standards Development group of GS1, an international standards development organization focused on supply chain standards for the retail, healthcare and logistics industries.
Mike previously worked for Johnson & Johnson, starting as a manufacturing engineer and progressing through positions of increasing responsibility. In his most recent role, Mike managed a global program to implement a standardized product identification system across all master data, order management and distribution systems for the Medical Device and Diagnostics sector.
Mike is a certified Project Management Professional (PMP) since 2004 and holds an MBA degree from Drexel University in Philadelphia, PA and a Bachelor of Science degree in Mechanical Engineering from Rensselaer Polytechnic Institute in Troy, NY.
Ms. Campbell-Matland's over 30-year career in the diagnostics industry has included leadership positions in R&D, Business Development and Marketing. A certified Project Management Professional and Quality System auditor, her experience has included management of a variety of business-critical programs such as new product development programs from conception to commercialization, product acquisitions, functional department integrations and remediation of Quality System and Regulatory audit deficiencies.
As an independent consultant, she is leveraging her expertise to assist start-up and small medical device companies with project management and compliance services for new product development and other programs, and assisting universities with their research commercialization efforts. She received her M.S. in Microbiology at the Rutgers University Graduate School of Biomedical Sciences/UMDNJ.
Robert Hall is the Sales Engineer, Strategic Accounts for Active Power. A skilled critical power systems engineer, Robert Hall has more than 35 years of experience in working with high power, three phase uninterruptible power supply (UPS) systems. He has a proven track record in leading technical sales organizations as well as designing and executing strategies for complex customer projects across a variety of mission critical applications including pharmaceutical environments.
His career also includes senior sales, marketing, and engineering roles at Piller Power Systems and Hitec Power Protection, both global suppliers of rotary based UPS products and other critical power infrastructure equipment for mission critical applications. In these roles, Hall built and led sales, service, and applications engineering teams.
Dalfoni Banerjee has 25+ years of experience in the pharmaceutical and biotechnology industries, where she has led drug development, clinical operations and marketing efforts, including multiple new-product launches. After a lengthy career at Merck, Dalfoni founded the consultancy 3Sixty Pharma Solutions, LLC in 2011, where she serves as CEO. 3Sixty Pharma Solutions provides subject-matter expert project management that drives the achievement of business-critical goals for its clients. Dalfoni and 3Sixty Pharma Solutions are recognized as thought-leaders in the fusion of efficient and effective development and analysis with the ability to inform content and execute with excellence, which enables accelerated success. Dalfoni earned her Bachelor’s degree in Biology f Temple University and maintains expertise in a variety of therapeutic categories, leadership and functional areas, and related regulations and guidelines.
Haripada Maity, Ph.D. is the Research Advisor, Formulation Development, CMC Development, at Eli Lilly and Company. He brings more than 24 years of research experience in the area of protein chemistry. His primary areas of research include protein formulation development, biophysical characterization including thermodynamic analysis of protein stability, comparability assessment, solubility measurements, protein folding/unfolding studies, hydrogen exchange monitored by NMR, chromatography, structure-function relationships, protein-ligand interactions, and protein-protein interactions. Haripada obtained his Ph.D. from Tata Institute of Fundamental Research, India in 1998.
He performed his major postdoctoral research work in the Department of Biochemistry and Biophysics at the University of Pennsylvania School of Medicine, USA. Haripada was awarded Extraordinary Effort Award of Lilly NJ twice both in 2008 and 2011. He was also awarded BHU Medal (Gold Medal) from Banaras Hindu University, India in 1991. At present, Haripada has already authored/co-authored twenty eight articles in scientific journals/Book. In addition, he has twenty three conference publications in the form of posters and abstracts. Haripada has presented multiple external presentations on pharmaceutical research as an invited speaker including the role as chairperson and panelist. He is an Editorial Board Member of the journal “Current Pharmaceutical Biotechnology”.
Harvey Greenstein is the former IT Project Management Office (PMO) Director for Celgene Corporation. While at Celgene, he designed and managed the PMO. During his tenure, the team grew to over 45 employees and contractors with a portfolio of projects valued at over $65 Million. Harvey accelerated the culture of project management and matured the project management capabilities of Celgene. He was also a valued subject matter expert in the deployment of validated and non-validated systems ranging from risk management, ERPs, laboratory, HR, and clinical trial.
Prior to joining Celgene in 2004 Harvey held positions at BMS, Merrill Lynch, and J&J. He has a BS in Engineering and a MS in Management, from NJIT. Harvey is a Project Management Institute certified Project Management Professional (PMP).
Haro Hartounian, Ph.D. President & CEO, Diavics, Inc.
Joanne Beck, Ph.D. is EVP Global Pharmaceutical Development and Operations at Celgene where she oversees the company’s Pharmaceutical Development, Global Manufacturing Operations and Supply Chain, Engineering and Quality. Prior to Celgene, she was SVP of Pharmaceutical Development at Shire. Prior to Shire she held roles of increasing responsibility in Process Development at Genentech and Amgen and in Operations at Abbott’s Pharmaceutical and Vascular Divisions. Beck holds a BA in Chemistry from Lewis and Clark College, a Ph.D. in Biochemistry and Molecular Biology from University of Oregon Medical School, and completed a postdoctoral fellowship in the department of Pharmaceutical Chemistry at the University of California, San Francisco.
David Pollard, Ph.D. is an executive director within Bioprocess Development of Merck & Co Inc. He has over 20 years’ experience of bioprocess development for the clinical and commercial production of anti infectives, bioconversions, vaccines and biologics, using a range of expression systems. This includes CMC project lead for early and late stage drug candidates.
David’s current assignment is leading a team that encompasses cell line development for Merck’s biologics pipeline and also driving the development of next generation technologies to improve the efficiency and lower the cost of biologics production platforms. This involves building end to end innovation from cell line development, upstream, purification, formulation/fill and analytics for new technology approaches that support both cell culture and microbial expression systems. David is also tasked with coleading the Single Use Network, to ease implementation of single use for simpler, faster and lower cost processing across Merck.
Since completing his PhD in Biochemical engineering at University College London David has written over 20 first author manuscripts covering a diverse range of bioprocessing activities. This includes the first industrial example of fermentation monitoring using in situ Mid IR, fermentation scale up strategy, bioconversion development, high throughput process development that includes codeveloping the Ambr250 technology and continuous processing.
David’s current interests involve innovative process design and fit to the modular facilities of the future. This recently included the first example of the automated ‘lights out’ end to end continuous bioprocessing of CHO mAbs enabled by single use technology.
Ben Locwin, Ph.D., MBA, is an author of a wide variety of scientific articles in books and magazines and gives worldwide speaking engagements on healthcare topics. He is an expert contact for the American Association of Pharmaceutical Scientists (AAPS), a committee member of the American Statistical Association (ASA), and a leader in the Association for Talent Development's Healthcare Community of Practice.