Stage #1

Presentation Category: Facilities and Equipment

Description: Changes in the European Pharmacopeia no longer require the use of distillation systems to produce Water-for-Injection (WFI). In this presentation we will review the impact of this regulatory change on water system design and how Reverse Osmosis and Ultrafiltration can be used to produce WFI and offer significant lifecycle cost advantages.

Learning Objectives:

  • How to design a WFI system with non-distillation based technologies
  • Economics of membrane based WFI sytems
  • How existing industry leaders have adopted membrane WFI sytems

Level of Education: Foundational, Intermediate

Who would Benefit: Consulting Engineer, Manufacturing Facilities Professional, Operations Professional, Project Manager, Quality Systems Professional, Regulatory Professional

Speakers:

Richard Jarrett
Evoqua
Marketing DirectorRich Jarrett is Evoqua’s Pharmaceutical Business Director, leading efforts around business offerings and product requirements for the pharmaceutical industry. He has over 14 years of experience working with the pharmaceutical industry developing products and services for improved quality, reduced cycle time, enhanced manufacturing and regulatory compliance. He earned his Bachelor of Science degree from Cornell University and his Masters in Business Administration from the Kellogg Graduate School at Northwestern University.

Presentation Category: Design and Operations of Cell & Gene Therapy and Other Biotech Facilities

Description: A program that discusses the evolution of the cell and gene ecosystem in and around Philadelphia. Our presentation will focus on how cell and gene therapy is different than traditional pharmaceutical manufacturing, in terms of logistics, facility design and regulatory considerations. Four dynamic presenters representing owners’ considerations as well as industry consultants that support them.

Learning Objectives:

  • Current work being done in the Greater Philadelphia area in the Cell and Gene Therapy space.
  • How planning for regulatory compliant facilities that support Cell and Gene Therapy is different than traditional pharma/biotech.
  • The differences in Quality and Regulatory Submissions processes between Cell and Gene Therapy and traditional pharma/biotech.

Level of Education: Foundational, Intermediate, Executive

Who would Benefit: Clinical Phase Professional, Consulting Engineer, Equipment Manufacturer, Manufacturing Facilities Professional, Operations Professional, Pharmaceutical Executive, Project Manager, Quality Systems Professional, Regulatory Professional, Young Professional, Service Provider, Supplier

Speakers:

Joanne Meloro
IPS-Integrated Project Services, LLC
Senior Project Manager, CQVMs. Meloro has over 20 years of experience in the pharmaceutical industry, the past 10 of which have specifically focused on Commissioning and Qualification projects for pharmaceutical, medical device, and biotechnology clients. Joanne’s experience ranges from marketing and business development to project management and validation specialist roles. Joanne’s concentration has been in process equipment and facility utility system qualification for pharmaceutical manufacture, vivarium and animal research laboratories, cell therapy and supporting clean suite areas. She is also well versed in building automation and environmental monitoring systems and computer system validation, utilizing principles of CGMPs, GAMP 5, Annex 11, and ASTM E2500.
Allison Montalvo
Tmunity Therapeutics
Executive Director, Project Management and Clinical Supply”Mrs. Allison Montalvo has extensive experience in development and manufacturing of biologics, vaccines and cell-based products at established and emerging pharmaceutical and biotech companies. Currently, Mrs. Montalvo is Executive Director, Head of Project Management and Clinical Supply at Tmunity Therapeutics where she is responsible for Project and Portfolio management, Cell therapy manufacturing, cell logistics, and product development. Tmunity Therapeutics is a clinical stage cell therapy company in the Philadelphia area.
Prior to Tmunity, Mrs. Montalvo worked at Merck and Teva pharmaceuticals where she held positions of increasing responsibility in product development and portfolio management leadership. She holds a BS in Genetic Engineering from Cedar Crest College.”
Elizabeth Shreve
Tmunity Therapeutics
Quality ManagerElizabeth Shreve has been in the pharmaceutical industry for almost 15 years working in a Quality role. She has been involved with Quality systems, Batch Release, Validation and Computer System Validation. She is currently working at Tmunity in Quality, managing the Quality GMP operations. She has her Masters in Bioinformatics from John Hopkins University, Bachelors in Biology from Lycoming College.
Dunni Odumosu
Bridge BioDunni Odumosu is a Senior Director at BridgeBio Gene Therapy and is currently working on two products in early development. Prior to joining BridgeBio, Dunni was the Global Regulatory Lead of the Fabry program at Amicus Therapeutics. In that role, Dunni worked on the company’s first marketing authorizations leading to approvals in the EU and US as well as many other countries giving Fabry patients around the world the opportunity to have a new treatment option.
In addition to her career as a rare disease regulatory professional, Dunni is passionate about empowering other women, particularly in STEM. In 2016, Dunni was asked to charter the formation of the Philadelphia Metro chapter of Women in Bio, an organization comprised of professional women from all career areas in the life sciences with the philosophy of “women helping women”. As the Chapter Chair, Dunni works with a diverse leadership team of women from different background and levels of experience with the goal of bringing like-minded women in the emerging Philadelphia biotech hub together, providing a space for meaningful connections to take place.
Dunni holds a B.S. in Chemistry from Temple University and a Master of Science in Regulatory Affairs/Quality Assurance from Temple University School of Pharmacy.

Joanne Meloro
IPS-Integrated Project Services, LLC
Senior Project Manager, CQV

Allison Montalvo
Tmunity Therapeutics
Executive Director, Project Management and Clinical Supply

Elizabeth Shreve
Tmunity Therapeutics
Quality Manager

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Presentation Category: Design and Operations of Cell & Gene Therapy and Other Biotech Facilities

Description: World’s first Cell Therapy Manufacturing Facility focused on Solid Tumors using TIL’s: Tumor Infiltrating Leukocytes

Learning Objectives:

  • Design considerations specific to Cell Therapy Facilities
  • Design strategies to optimize throughput
  • Execution strategies to maximize client value

Level of Education: Intermediate

Who would Benefit: Consulting Engineer, Equipment Manufacturer, Manufacturing Facilities Professional, Operations Professional, Pharmaceutical Executive, Project Manager, Quality Systems Professional, Regulatory Professional

Speakers:

Emilie Pelletier
Iovance
Senior Director Process EngineeringEmilie has been in the Life Sciences Industry for 15 years. Currently, Emilie is Senior Director, Process Engineering at Iovance Biotherapeutics. Previously, Emilie was the USA Managing Partner at Laporte Consultants. Her responsibilities include leading Laporte’s biopharmaceutical activities in the USA in addition to designing and implementing biotech facilities and processes. Prior to Laporte Consultants, she was a project engineer at Axcan Pharma from 2004 to 2007. Emilie has held several positions in the DVC Chapter of ISPE and is a member of the ISPE Biomanufacturing COP committee. She obtained a B.S in chemical engineering from the University of Montreal and is fluent in French and English.
Peter Matson
CRB
Pharma Team Leader/Associate
Brian Kirk
CRB
Director, Operations

Presentation Category: Industry Trends

Description: ATMPs such as cell and gene therapies present statistical analysis and modeling challenges due to small sample sizes, inherently high variability, and complex data structures. Specifically, traditional statistical methods to evaluate risk and set manufacturing ranges and specifications are impractical at best, and in some cases simply not possible to apply. Bayesian statistical methods can be used to borrow strength from prior knowledge (including first principles), and are thus uniquely well-suited for these situations. This is true not only for initial estimates (i.e. for the first patients treated); it is also an optimal way to incorporate ongoing information as data from additional batches/patients are accumulated. In this session, the application of Bayesian will be introduced and their benefits will be illustrated by case example

Learning Objectives: Participants will be able to describe the key differences between Bayesian and Frequentist (traditional) statistical methods. Participants will be able to describe how Bayesian modeling can incorporate prior information to reduce statistical uncertainty. Participants will be able to identify potential applications of Bayesian statistical methods to their processes

Level of Education: Intermediate

Who would Benefit: Clinical Phase Professional, Consulting Engineer, Quality Systems Professional, Regulatory Professional, Young Professional

Speakers:

Katherine Giacoletti
Partner
SynoloStats LLCKatherine Giacoletti is a partner in SynoloStats LLC, a consulting firm providing strategic statistical analysis and expertise for (bio)pharmaceutical development, validation, and commercial processes. Katherine has worked as a statistician in the pharmaceutical industry for over 20 years and has expertise across the product lifecycle, from product and process development through validation and commercial supply, as well as all stages of clinical development from First in Human through licensure and beyond. She holds a Master of Statistics degree from North Carolina State University, with a focus in biostatistics, and before starting in Pharma she worked in survey research at the Research Triangle Institute. Katherine lives in the Philadelphia suburbs with her husband and daughter and 2 cats, and in her spare time is a dancer and a teacher of Scottish dancing.

Presentation Category: Industry 4.0 / Pharma 4.0

Description: Vein-to-vein time is a crucial factor in Cell and Gene Therapy (CGT) manufacturing. Getting the patient the therapy they need in the shortest time possible is utmost important. Batch record reviews must be performed quickly and this can be burdensome when dealing with equipment that is more akin to bench-top laboratory scale, that produces flat file PDF records. Automation is needed to collect critical process data and monitor and record operator interactions in an effort to streamline batch record review and product release.

Learning Objectives: Overcoming technical challenges of integrating nontraditional process equipment into manufacturing automation systems.
SCADA layer data collection and storage, using cloud-based computing resources, for individual cell processing machines.
Planning for global production, leveraging cloud-based IaaS and SaaS, and maintaining compliance.

Level of Education: Foundational, Intermediate, Advanced

Who would Benefit: Consulting Engineer, Information Systems Professional, Young Professional, Supplier, Service Provider, Regulatory Professional, Quality Systems Professional, Project Manager, Pharmaceutical Executive, Operations Professional, Manufacturing Facilities Professional, Equipment Manufacturer, Clinical Phase Professional

Speakers:

Miranda Neville
Autolus, Inc.Miranda Neville is currently the Head of Global Engineering for Autolus. She has 20+ years of experience in Project Management, Engineering Capital Projects and Operations, and Manufacturing. She has worked for North American Vaccine, Human Genome Sciences, and has been a consultant with Alliancebio, providing support for several companies. At Autolus she is responsible for managing the design through qualification of the company’s manufacturing facilities in the UK, and the US Manufacturing Headquarters in Rockville, Maryland. In addition, she is responsible for building and implementing Engineering processes for the company. She currently lives in Rockville, Maryland.
Steve Chapman
Barry-WehmillerSteve Chapman has spent the last 30 years designing, developing, installing and commissioning industrial automation and control systems in the Life Sciences, Food & Beverage and Advanced-Technology market sectors. He leads Design Group’s automation and information solutions initiative for Advanced Therapy Medicinal Products (ATMP). Steve’s daily responsibilities include directing and managing projects that incorporate engineering, design and programming of automated manufacturing and information systems. Steve strives to clearly understand end-user needs and requirements to ensure accurate development of design specifications with adherence to current industry and regulatory standards. Steve has a strong technical background in automation

Stage #2

Presentation Category: Facilities and Equipment

Description: We often find that some common utility systems critical to process support are left to run to fail. Cold storage refrigeration systems are specified based on performance, relying on installing contractors for detailed design, installation, and maintenance.

Full redundancy is designed in, with owners resigning to the fact systems fail catastrophically and require specialized knowledge to monitor. A similar approach is taken with compressed air generation, which is considered a “black box.” As our facilities age, we are conscious to proactively replace equipment, but legacy piping systems are relied upon for ongoing service with limited assessment of remaining life. These systems often serve critical functions in operating facilities, so why are they not held to the same standard as cooling, heating, or high purity water systems? They can! Predictive monitoring can be put in place to monitor and alarm these systems, often at a cost that pales in comparison to the risks they help mitigate. This presentation will outline basic frameworks to implement such monitoring, trending, and alarming, and this data can be used to manage risk and prevent catastrophic failures.

Learning Objectives:

  • Refrigerant and compressed air generation systems have temperature and pressure parameters / ranges that can be monitored and alarmed, just like other utility and process systems.
  • Aging pressure and hazardous piping systems and vessels often continue in their service lives as equipment is replaced. Risk-based monitoring of remaining life can be put into place with limited contracted and invasive testing.
  • Given the criticality of these systems and risks that failures present, predictive monitoring can be retrofitted without excessive cost. This can be used to help foresee and avoid catastrophic failures, increase safety, and reduce process downtime.

Level of Education: Intermediate, Advanced

Who would Benefit: Consulting Engineer, Equipment Manufacturer, Manufacturing Facilities Professional, Operations Professional, Project Manager, Pharmaceutical Executive, Young Professional, Service Provider

Speakers:

Justin Pagliaro, PE, LEED AP
Hargrove Life Sciences
Senior Project Manager

Justin Pagliaro is a Senior Project Manager and Associate with Hargrove Life Sciences in Philadelphia. Justin spent the early part of his career designing commercial HVAC and central utility systems for Vitetta, then transitioned to the life sciences industry in 2007 when he joined CDI Life Sciences. Since then, Justin began to specialize in cold storage, low temperature utilities, and hazardous material risk mitigation. Justin has spent a good part of the last 11 years working on various client sites managing capital projects teams, overseeing construction through qualification, evaluating process and hazard risks, implementing operational and maintenance improvements, and troubleshooting mechanical systems. In 2012, Justin helped form Hargrove Life Sciences, LLC in Philadelphia. Hargrove Life Sciences serves the pharmaceutical, biotechnology, food/beverage, and specialty chemical industries nationally and abroad. In eight years, the Philadelphia office has grown from 10 to 75 employees, and offers full-service engineering and architecture design.

Joe Mulato, PE
GlaxoSmithKline
Electrical and Instrumentation Supervisor

Joe Mulato is the Electrical and Instrumentation Supervisor at the GlaxoSmithKline Biopharmaceutical Manufacturing facility in Upper Merion, PA. His team is responsible for the electrical maintenance and instrument calibration program of two cell culture manufacturing production lines, analytical and stability laboratories, and the supporting utility systems at the Upper Merion facility. After earning his bachelor’s and master’s degrees in chemical engineering at Widener University, Joe has worn many hats through the first 18 years of his career (15 years at GSK). Most notably, as a process engineer he was responsible for the implementation of a mechanical retrofit of two existing 350sf -43C walk-in freezers and the design and installation of one new 2000sf -43C walk-in freezer at the GSK UM facility. The design, build, commissioning, and qualification of the three rooms was a collaboration of expertise and engineering between GSK, Farrar Scientific Inc., and Hargrove Life Sciences. These projects resulted in significant improvements to the reliability and sustainability of GSK’s supply chain.

Presentation Category: Facilities and Equipment

Description: The shift from traditional cleaning validation to a cleaning life cycle approach emphasizes the requirement for scientifically sound decisions in the design, qualification, and monitoring of a cleaning process. Along with the process life cycle approach, other guides have been issued by the US FDA and International Conference on Harmonization (ICH) which include the concepts of Quality by Design (QbD), Risk Management and Process Analytical Technology (PAT). The purpose of these guidance documents is to promote enhanced understanding of products and processes, to build quality into manufacturing, and to provide the basis for continuous improvement of products and processes.

Cleaning in the GMP industry is a critical process intended to prevent, or in more modern terms “reduce risk”, of contaminating the subsequent product with undesirable residues that may impact patient safety. Reducing the risk requires good understanding of the cleaning process. This presentation provides a review of the multiple elements in Cleaning Validation in which risk-based thinking is applied. This presentation will provide real-world insights into development of robust equipment cleaning programs based upon risk and compliant with current regulatory expectations.

Learning Objectives: 

  • Recognize risk elements applied to cleaning validation
  • Apply some of the common risk-evaluation tools in various aspects of cleaning validation
  • Learn how to build a robust cleaning validation program

Level of Education: Intermediate

Who would Benefit: Consulting Engineer, Manufacturing Facilities Professional, Operations Professional, Quality Systems Professional, Regulatory Professional

Speakers:

Elizabeth Rivera
STERIS Corporation
Technical Services ManagerElizabeth Rivera is a technical service manager for the Scientific Division of STERIS Corporation (Mentor, Ohio). Currently, she provides technical assistance in the areas of selection of detergents, disinfectants and sterilization assurance products including the application and use of these in the pharmaceutical, biopharmaceutical, cosmetics, medical devices, dietary supplements and related industries. In addition, she offers conferences and exhibits on educational technical forums such as IPA, Interphex, ExpoFYBI, ETIF, PDA, ISPE, Expofarma, Pharma Expo, Executive Conference and more. Also, she has published articles related to cleaning and microbial control. She has a bachelors and masters degree in Chemical Engineering from the University of Puerto Rico.Elizabeth has over 15 years of experience and travels to places in North America, Latin America and elsewhere to support customers in various aspects of cleaning and decontamination. Previously, she held positions at companies such as BMS and Eli Lilly. She has extensive experience in cleanup of active pharmaceutical programs. She has worked in the preparation, implementation and support of cleaning processes including protocols, validation, qualification of spray devices, master plans, standard operational procedures, training staff, and post-construction cleaning. Other industrial experiences include qualification of equipment, process validation, batch records, investigation of discrepancies, and corrective and preventive actions, according to good manufacturing practices (GMP) for pharmaceutical industries.

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TBD

Presentation Category: Facilities and Equipment

Description: Process Hazard Analysis (PHA) is a systematic assessment of the potential hazards/ risks associated with an industrial process assisting management in making decisions for improving safety and reducing the risk and consequences of unwanted or unplanned events. PHAs evaluate the risk(s) associated with the operation, design, and potential malfunctions of industrial processes. A PHA is directed toward analyzing potential causes and consequences of fires, explosions, releases of hazardous chemicals and it focuses on equipment, instrumentation, utilities, human actions, and external factors that might impact the process. PHAs identify; (1) the source of the hazard, (2) the consequence, impact, or effect resulting from the occurrence of the hazard, (3) safeguards, controls, or mitigative features to prevent the hazard from occurring or reduce the consequences that result and (4) recommendations if the safeguards or controls are considered inadequate or if none are in place. PHA methodologies, include: Checklist, What if?, Hazard and Operability Study (HAZOP), and Failure Mode and Effects Analysis (FMEE). The session will provide an overview of Process Safety Regulations, Elements of Process Safety Management Program, PHA Methods and Preparing and Organizing for the PHA Study. Finally, the session will include a walk-through a typical PHA for a biopharmaceutical process.

Learning Objectives:

  • Provide an overview of PHA methods
  • Outline the PHA regulatory requirements and Best Management Practices for covered processes
  • How to prepare and organize for the PHA Study

Level of Education: Foundational

Who would Benefit: Consulting Engineer, Equipment Manufacturer, Manufacturing Facilities Professional, Operations Professional, Project Manager, Regulatory Professional, Young Professional

Speakers:

George Petroka
IES
Principal

Mr. Petroka has more than 35 years of experience in environmental, safety and health, industrial hygiene, and process safety working within process industries including Sanofi, Sterling Winthrop, Sunoco and Pennsylvania Manufacturers Insurance Company (PMA).. He has extensive experience in the Pharmaceutical Industry having managed Environmental, Health, and Safety (EHS) for Sanofi and Sterling Winthrop. At IES George is a Principal responsible for Biopharma business development and executing and managing BioPharma Services and EHS Services He has been an IES member for over thirty years as a member and past chair for the Containment COP and contributing on multiple ISPE Guides including Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment aka SMEPAC, Baseline Guide for New and Renovated Facilities – Volume 2 Oral Solid Dosage Forms and Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities. Petroka holds an MS in Environmental Science and Engineering from Drexel University, and a BS in Safety Management and a BA in Biology.

Jaime Martinez
IES
Principal Consultant Process Safety and ContainmentMr. Martínez brings more than 35 years of worldwide experience in the Bio-Pharma industry. For the last 22 of his 25 years at Merck & Co., Inc., Mr. Martinez championed Process Safety Management programs, Process Hazard Analysis reviews, General Safety programs, and delivery of Engineering Controls for Containment of HPAPIs (High Potent Active Pharmaceutical Ingredients) within both, the Manufacturing and the Research Laboratories Divisions of Merck. As Merck Manufacturing Division’s functional expert on dust containment and potent compounds, he provided technical guidance in the selection of engineering solutions to existing potential exposure issues within Merck’s manufacturing and research network.
At IES Engineers, Mr. Martinez is responsible for managing and expanding the PSM services to our diverse customers in the Bio-Pharma, Chemical, and general Industrial businesses.
Michael Stolz BMS
Manager Process Evaluation• Master and Bachelor Degrees in Chemical Engineering from Manhattan College in New York City.
• Licensed Professional Engineer in New York and Pennsylvania.
• Lea Six Sigma Black Belt
• 33 Years of Engineering / Technology / Manufacturing / R&D / Supply Chain / Quality work experience in the Pharmaceutical (19 years), Chemical (6 years), and Agricultural Chemical Industries (8 years).
• Worked in Corporate, R&D, and Manufacturing Plants Globally for: Bristol-Myers Squibb, Merck, FMC Corporation, and Pfizer.
• Global Traveler & Expatriate: USA, Europe, Asia, South America, Latin America
• Designed, Built, and Started-up 20 manufacturing plants globally for life saving medicines with combined revenues of 500 billion $ over lifecycle of assets.

Presentation Category: Continuous Manufacturing

Description: Continuous biomanufacturing is still developing. There are continuous commercial scale unit operations and lab scale integrated systems in testing. To gain the experience to move systems form semi-continuous to continuous we need integrated systems to conduct development work on. This chicken-egg problem can be addressed by working through an integrated system stepwise integrating semi-continuous operations together. We should also be looking to other industries for alternative manufacturing methods to speed this development cycle. While this development work can take a significant time, that time will likely improve the drug delivery cycle beyond our current process and facility approach. This presentation will discuss how to design facilities today for the development of and future operation of integrated continuous biomanufacuting via case studies.

Learning Objectives:

  • Understand the current state of the industry in regards to continuous bioprocessing.
  • Understand the considerations for facility design to enable process intensication today and transition to full continuous bioprocessing in the future.
  • Gain insight into the different paths of the future of continuous bioprocessing.

Level of Education: Intermediate

Who would Benefit:

Consulting Engineer, Equipment Manufacturer, Manufacturing Facilities Professional, Pharmaceutical Executive, Project Manager, Regulatory Professional, Quality Systems Professional, Service Provider

Speakers:

Erich Bozenhardt, PE
IPS
Process Manager

Erich Bozenhardt, PE, is the process manager for IPS-Integrated Project Services’ process group in Raleigh, NC. He has 14 years of experience in the biotechnology and aseptic processing business and has led several biological manufacturing projects, including cell therapies, mammalian cell culture, and novel delivery systems. He has a B.S. in chemical engineering and an MBA, both from the University of Delaware.

Sherry Chen
IPS
Process Manager

Ms. Chen has over 12 years of experience in pharmaceutical, biotechnology, aseptic, and oral solid dosage process design and field support. Sherry’s specialties include process equipment design, critical utility design, hydraulic modeling, equipment specification and procurement, start-up/commissioning and construction support. She has experience with the development of key process deliverables and equipment packages such as PFD’s, UFD’s, P&IDs, equipment datasheets, utility summaries, equipment lists, and process (URS) descriptions.

Presentation Category: Facilities and Equipment

Description: Efficient Facility Design is a key part of building a robust Supply Chain. It starts with capital planning based on capacity and forecasted demand to clearly define project scope and objectives. Efficiency must continue through project delivery to make sure the project is completed and the product is manufactured when needed. Applying lean techniques and tracking key metrics from project concept through implementation keeps the team focused on efficiency and can help reduce capital investments, project schedule, operational expense

This interactive panel discussion will focus on three distinct viewpoints: Owner leadership, Design engineering, and Business/ Operational excellence to talk successes and lessons learned on recent projects. In this presentation, we will cover:

  • Securing initial funding to develop a plan and analyze options
  • Analyzing manufacturing capacity and cost justification to understand project requirements and flexibility of changing forecast demands for a robust supply chain
  • Lean project delivery to control cost and schedule
  • Keys to successful Integrated teams and shared incentives
  • Involvement of Op Ex and Operations to incorporate efficiency.
  • Metrics used to track progress and help the team be proactive instead of reactive.
  • Operational testing to prove out project assumptions.

Learning Objectives:

  • Importance of initial funding to perform preliminary funding to scope the project, determine initial project funding, and how the project fits into company objectives.
  • Applying lean techniques from project concept, implementation, and operation can ensure project success by helping drive the facility design, construction, and team to completion with a focus on cost, time, and project objectives.
  • The importance of companies to focus on Business/ Operation Excellence and track metrics to continuously improve, focus efforts on company and customer objectives, and plan for future success

Level of Education: Foundational, Intermediate

Who would Benefit: Consulting Engineer, Manufacturing Facilities Professional, Operations Professional, Pharmaceutical Executive, Project Manager, Service Provider, Young Professional

Speakers:

Kristina Pumphrey, PE
Precis Engineering
Director of Process EngineeringKristina Pumphrey, PE, is the Director of Process Engineering at Precis Engineering, Inc. She is an accomplished process engineer with 20 years of experience in the pharmaceutical and biopharmaceutical industries. Her broad knowledge base spanning industry technologies includes material handling, potent compounds, and hazard analysis. At Precis, she is responsible for translating user requirements into a working facility by specifying the equipment, controls, and interconnecting piping into an efficient layout that meets cGMP and regulatory requirements and results in a quality product. A certified Lean Six Sigma Black Belt, Pumphrey uses her lean manufacturing expertise to help clients plan for the future by improving operational efficiency. She extends her pharma industry leadership to the professional community as a member of ISPE and President of the Delaware Valley Chapter. She has spoken and published extensively; recent presentations include ISPE, Interphex, PackExpo, PEX, and Lean Construction Institute. She holds a Master of Science in Management and Technology from Widener University and a Bachelor of Science in Chemical Engineering from the Pennsylvania State University.
Mark Bellino
Precis Engineering
Director of Pharmaceutical ServicesMark Bellino is the Associate Director of Corporate Engineering at Lannett Company. He has over 25 years of engineering experience with a wide variety of responsibilities within the pharmaceutical and chemical industries on both the manufacturing and consulting sides. Mark’s background as a mechanical engineer, includes positions as corporate Global Engineering Subject Matter Expert, Manager of Design Engineering group, Project Manager, Construction Manager and Process Engineer. He has also served globally as a Regulatory Quality Auditor for TEVA North America with specific focus on facilities related cGMP compliance for OSD and Sterile facilities. Mark holds a Bachelor of Science in Mechanical Engineering from Widener University.
Holly Brunbeck
Wuxi Advanced Therapeutics
Director of Business ExcellenceHolly Brunbeck is the Director of Business Excellence at WuXi Advanced Therapies at the Philadelphia Wuxi Site. The Business Excellence Organization is responsible for Continuous Improvement, Project Management Office and Visual Management Metrics and interfaces with the other departments to deploy tools and techniques for the overall strategic business improvements. She has 20+ years of experience and has previously worked for Amgen as a Project Manager with both the Global Capital Projects Team and Supply Chain PMO. Additionally, she has worked as a Process Engineer at both Merck and at Johnson & Johnson, where she earned her Six Sigma Black Belt. She holds a Master of Science in Chemical Engineering.