INTERPHEX Podcasts
Keynote: The Future of Pharmaceutical and Biopharmaceutical Manufacturing
The pressures on the pharmaceutical industry - expiring patents, falling profits resulting from drug safety problems, and now, the economic slump - affect manufacturing operations today more than ever. As a result, manufacturing organizations must find ways to reduce costs without sacrificing quality, whether by improving process efficiency through technology and operational excellence or through outsourcing. At the same time, regulatory expectations for quality are increasing, and initiatives such as Quality by Design are encouraging many companies to invest more, not less, in process development and manufacturing process control.
G. Steven Burrill kicks off this session by presenting his vision of the future of healthcare and the overriding trends affecting the global industry. His presentation is followed by a panel discussion with senior executives from manufacturing organizations at Big Pharma and Big Biotech companies about how they are handling the major concerns affecting their organizations and what they envision for the future of pharmaceutical manufacturing.
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- Moderator:
- Laura Bush - Editor in Chief, BioPharm International
- KeyNote:
- G. Steven Burrill - CEO, Burrill & Company
- Timothy Moore - Senior Vice President, Global Supply Chain, Genentech
- Divakar Ramakrishnan, PhD - Executive Director, Manufacturing Science and Technology, Eli Lilly & Co.
- Michael Kowolenko, PhD - Senior Vice President, Biotech Operating Unit, Technical Operations and Product Supply, Wyeth Pharmaceuticals
Video Files:- Watch Part 1
Keynote Part 1: The Future of Pharmaceutical and Biopharmaceutical Manufacturing
- Watch Part 2
Keynote Part 2: The Future of Pharmaceutical and Biopharmaceutical Manufacturing
- Watch Part 3
Keynote Part 3: The Future of Pharmaceutical and Biopharmaceutical Manufacturing
- Watch Part 4
Keynote Part 4: The Future of Pharmaceutical and Biopharmaceutical Manufacturing
Lunch Keynote: Single Use Strategies in Bioprocessing: Reducing Costs, Time & Risk
Single-use technologies have been transforming the landscape of industrial bioprocessing. Approaches to assessing advantages and disadvantages to their adoption include sophisticated cost-modeling programs and development of recommended guidelines by a number of industry groups and associations. Case studies are beginning to make their way into the literature as companies explore the practicalities of their use. Still to be discussed, however, are the longer-term implications of single-use components and technologies on the future of bioprocessing: Is their use a cost-saving strategy overall? To what extent will economic factors drive their increased adoption? How are environmental considerations for their disposal - and those related costs - affecting the rate of their acceptance? What economies of scale do and do not contribute to their acceptance? A panel comprising suppliers, end-users, and association representatives will discuss economic strategies that reduce the cost, time, and risk of bioprocessing using single-use technologies. Hide
- Moderator:
- Anne Montgomery - Editor in Chief, BioProcess International
- KeyNote:
- Lisa Crossley, PhD, PEng - President and CEO, Natrix Separations
- Jerry Martin - Sr Vice President, Scientific Affairs, Pall Life Sciences
- Miriam Monge - Vice President of Marketing and Disposables Systems Implementation, Biopharm Services
- Gerard Gach - Global Product Platform Director , GE Healthcare
- James Robinson - Vice President of Preclinical and Quality Operations, Novavax, Inc.
- Rick Stock, PhD - Associate Consultant, Bioprocess Technology Consultants
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Advanced Aseptic Processing- The Next Step in the Evolution of Aseptic Production
The presentation covers aspects of advanced aseptic processing from both a facilities and an equipment perspective. The fundamental requirements for contamination prevention and risk management were discussed along with the most effective risk abatement opportunities available to industry now and in the near future. The likely evolution of aseptic processing compliance requirements which is occurring in concert with the evolution of these advanced technologies were also covered. Hide
- Speaker:
- James Akers - President, Akers Kennedy and Associates
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Overview of Sustainability, Green, and Energy Activities in the Industry
Sustainability, green, and energy activities of the pharmaceutical and related industries-a status report. Presentation of the results of a survey, plus some interesting case histories.
- Speaker:
- Richard Toro - Director, Environmental Services, Brown and Caldwell
- Gregg Belardo - Senior Director, Environment, Health and Safety, Wyeth
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Implementing the ASTM Standard for Verification C&Q
Navigating the new process can be complex from the perspective of both engineering and process management. This presentation reviews the ASTM standard in context of the current regulatory environment, provides insights into the paradigm shift that the new approach requires, reviews new and refined terminology, and examines the new roles of the internal Quality team and independent subject matter experts in this shift from impact assessment to risk assessment and from traditional qualification to system verification. Hide
- Speaker:
- Steven Wisniewski - Senior Associate and Director of Compliance, Integrated Project Services - IPS
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Engineering Considerations for Biotech Industry
This session covers major topics concerning engineering considerations for the biotech industry, including key characteristics of Biologic API's, higher regulatory expectations, engineering focuses, facility design, and technology trends.
- Speaker:
- Stephen Yu - Sr. Project Manager, BE&K
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Manufacturing Operations/Engineering Design for Just in Time Delivery of a cGMP Facility
With ever increasing construction costs and complexities in the delivery of highly integrated and technical buildings this case study provides useful insights into a successful strategy for delivering a fully functional and cost effective fill finish facility in a shorter time frame than typically seen in industry standards.
'Just in time' focuses on a new ground up 296,00 square-foot Fill Finish facility located on a 12 acre site. Along with a fast, cost effective and erricient design the project drivers were risk mitigation, capacity to fill/finish 25% of the sister company products and provide 25% for future capacity. Program areas included Formulations, Filling and finishing, Packaging, Warehousing, Maintenance, Utilities, Personnel/Administrative space, QA/QC Lab and distribution center.
Outlining key decisions to be made by Genetech and the design team early in the process the methodical 'steps to success' are identified so the reader understands the importance of sequence and timing of key milestones. Leveraging equipment technology to minimize construction costs and improve quality control to satisfy multiple markets is an increasing aspiration. Hide
- Speaker:
- Andrew Cunningham - Principal, Flad Architects
- Jim Gazvoda - Principal, Flad Architects
- Joe Miller - Principal Architect, Design Engineering, Genentech
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The Current State of International Outsourcing
With an imperative to reduce costs and open new markets for growth, pharmaceutical companies have been turning to companies in emerging markets for a broad array of services, including API and dose manufacturing, clinical research and drug discovery support. CROs and CMOs offer an increasingly sophisticated range of capabilities and scientific expertise, often (but not always) at prices that are much lower than available in North America and Europe.
At same time, however, sourcing in emerging markets is fraught with risks and obstacles. Issues like political risk, product contamination and environmental health and safety are gaining prominence even as pharmaceutical companies gain confidence in dealing with traditional concerns like intellectual property protection and GMP compliance.
This program addresses the current state of outsourcing to emerging markets and identifies the key trends that will shape sourcing practices in coming years. Hide
- Speaker:
- Jim Miller - President, PharmSource
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A Risk-Based Approach to Energy Savings in Pharmaceutical Facilities
Extremely high energy costs and an increasing public consciousness of environmental impacts are forcing the pharmaceutical industry to look at ways to reduce energy usage and consider sustainable approaches to operating and building facilities. Still, the industry has been slow to adopt innovative new energy-saving schemes and devices due to legitimate concerns that such modifications and improvements might have a negative impact on drug products and/or system reliability. It is necessary, however, for the pharmaceutical industry to develop an approach that balances energy savings and sustainability with appropriate risk mitigation. The speakers present a quantitative methodology for assessing energy conservation opportunities (ECOs) within the context of risks to drug product safety, personnel safety, environmental safety and system reliability. This methodology provides a framework for identifying significant areas affected by the proposed ECOs, weighting each of several factors such as product or personnel risk, energy saving potential, installation cost and other characteristics, and determining a total score that can facilitate the process of determining which ECOs are worth evaluating for return on investment. They also suggest program logistics for both new and existing facilities, in order to help companies meet their goal of implementing energy-efficient systems, equipment and designs that are reliable and do not compromise the essence of drug efficacy and safety. Hide
- Speaker:
- Dave Goswami - President and Chief Operating Officer, Integrated Project Services - IPS
- Mark Butler - Sr. Vice President Engineering, Integrated Project Services - IPS
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Cut Costs, Reduce Risk, and Protect the Environment: What Leading Companies are Doing
How do top pharmaceutical companies cut their energy costs by 10% or more year after year? What steps can companies take to protect their reputation and brand by reducing their carbon footprint? What risks do pharma companies face from increasing energy costs? This session features speakers from leading corporate energy programs such as Schering Plough, Eli Lilly & Company and others who discuss the steps they are taking to cut energy costs and protect the environment at the same time. Hide
- Speaker:
- Walt Tunnessen - National Program Manager, ENERGY STAR, US EPA
- Thomas Pagliuco - Director, Energy, Schering-Plough
- Martin Brown - Global Energy & Climate Change Program, Pfizer
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Commissioning: Content, Confidence, Competence, Contracts, and Compliance
This session discusses commissioning as the primary tool to gain confidence that the equipment and systems have been installed, can operate, and will perform to meet production requirements. Subjects include the content (scope) of commissioning, how to execute commissioning and gain the operational confidence, how to ensure the commissioning team is competent, how to structure commissioning contracts, and how to use commissioning, done right the first time, to ensure compliance with GMPs. Hide
- Speaker:
- Robert Chew, PE - Vice President, Commissioning Agents
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Meeting the PAT Challenge
Consistency and quality of product in manufacturing is key. Effective PAT implementation is founded on detailed, science-based understanding of the chemical and mechanical properties of all elements of a proposed drug product. However, to better support the goals of PAT, more accurate and easier to maintain analytical tools are needed. This session presents an overview of PAT and the challenges presented to manufacturers seeking to standardize manufacturing conditions with novel, robust analytical technologies. It also presents the scientific findings of an innovative technology developed for monitoring pH utilizing a self-calibrating, online system. An overview of pH technologies, their development, and current applications were presented. Data derived under actual manufacturing conditions using amperometric, potentiometric and optical sensors were presented and discussed. Hide
- Speaker:
- Carrie Kahn - Founder & CEO, Sensorin
- Sheila Magil, PhD - Senior Consultant, BioProcess Technology Consultants
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Integrated Drug Development: A Global Perspective
The ability to successfully integrate various aspects of drug development (i.e, CMC, nonclinical, clinical, regulatory strategy) is a critical determinant for obtaining marketing approval. Additionally, the extent to which the development program addresses the needs of other important stake holders (e.g, payers, patients, care providers) can have a huge impact on the success of the product in the market place. Dr. Rao's presentation provides a broad overview of some of these topics and Dr. Chrai's presentation provides a more focused discussion on some of the CMC and manufacturing related aspects. Hide
- Speaker:
- Navaneetha Rao - VP, Clinical Research and Development, Vicus Therapeutics
- Suggy Chrai, PhD - President, Chrai Associates, Inc
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