Education Sessions:

#1) Introduction to Phage Biology

Joseph Fackler, MD
Joseph Fackler

Speaker: Joseph Fackler, MS Director, Manufacturing Adaptive Phage Therapeutics

Bacteriophages (‘phages’) are viruses that infect and replicate in bacterial cells. Phages are among the most common biological entities on the planet and have been important models for the study of molecular biology and played important roles in biotechnology and treatment of multi-drug resistant (MDR) pathogenic bacteria. The purpose of this talk will be to provide an introduction to both the history and basic biology of phage. The historical review will cover the discovery of phages and the early use of phage as a therapeutic prior to the antibiotic age. The introduction to phage biology will focus on the general structure of phage and provide an overview of phage infection and replication cycles in their host bacteria. The talk will conclude with a brief comment on the resurgence of bacteriophage therapy as an answer to the continuing rise in MDR pathogenic bacteria.


#2) Cell & Gene Therapy 101:

Brian Stamper
Brian Stamper

Speaker: Brian Stamper, Director of Manufacturing, Kite Pharma

Topics include: Cell vs Gene therapy, how is it different from traditional therapeutics, what new skills/roles are needed, what are the big challenges, etc. Come learn from industry experts and get your questions answered.


#3) Planning for the future – From Concept to Facility Operations

Dave Jenkins
Dave Jenkins

Speaker: Dave Jenkins, President, Atlantic Technology Group, Inc.

Dave brings decades worth of laboratory equipment and process equipment manufacturers to clients up and down the East Coast in a cost efficient and thoughtful manner. The ATS team has depth of knowledge of the process coupled with the living lessons learned to improve deliveries of Projects. ATS has provided these services with a variety of manufacturers so end users can be assured of consistent experience and high quality performance.


Bill Deckert
Bill Deckert

Speaker: Bill Deckert, Global Consultant, CAI

Edited and Approved - Bio: Bill developed and lead operations for the CAI team and now provides global consulting and guidance based on the projects he has lead all over the globe. He has been developing clean compliant facilities & processes for more than 30 years. CAI provides valuable resources to clients who need to guidance and support in this heavily regulated and scrutinized industry. Providing valuable resources to clients, CAI’s consulting team helps to confirm first in kind or prototype facilities are operational per the design parameters and handles the trouble shooting when issues arise.

CAI encourages thinking strategically about how to plan for the full building life cycle from concept thru buildout to decommissioning and repurposing. The CAI team is not afraid to take on new work and collaborate to get to the needed results.

Bill has recently enjoyed working on facilities like Emergent in Baltimore, Cel-Sci in Elkridge, MD, ICU in Texas, Terumo in Elkton, Maryland and more than 20 startups worldwide.


Bill Gaudreau
Bill Gaudreau 

Speaker: Bill Gaudreau, Managing Principal, EwingCole

Bill brings decades worth of laboratory design, strategic planning to clients from small start up companies to large real estate investment trusts, he developed the regionally pre-eminent design firm known for high quality lab design and development. Bill and his team can help bring to life the vision of their clients by thoughtfully gathering the information coupled with their expertise in this sector.


Jonathan Santamont
Jonathan Santamont

Speaker: Jonathan Santamont, Senior Project Manager, Whiting-Turner Contracting Company

Jonathan knows how to motivate and execute projects on time, under budget and without issue. He is a proactive problem solver who often has multiple alternate options already ready when conversations and team meetings occur. He is open to trying and supporting innovation and thinking outside the box. He leads large teams with precision, diligence and thoughtfulness that is very hard to come by in this marketplace. He expects the best for his clients and delivers best in class customer service coupled with a high quality end product that his teams are proud to say they contributed toward at the end of the day.


Thomas Kaufman
Thomas Kaufman

Speaker: Thomas Kaufman, Director Corporate Real Estate, United Therapeutics

Thomas has a passion for the strategy and sustainability around real estate and has worked to innovate in his department. He knows the efforts needed to shepherd and cultivate these often quickly changing requirements based on corporate direction. He has worked diligently and thoughtfully to create a strategy to better prepare his organization to be flexible, nimble and able to adapt quickly when changes or direction comes to his department. Leading the development of a more strategic thought process for this large organization will continue to put the United Therapeutics organization at the leading edge of innovation in building design and execution.

Speed, Efficiency, Agility and Flexibility; words often used when expressing requirements but what does that mean about strategic preparation? This panel will dive into the questions often asked from a variety of perspectives. Current topics including: Biosafety and Biosecurity and cGMP regulatory recent changes as well as shifts in the marketplace based on the growth of the cell therapy space.


#4) Unconscious Bias – Driving Growth through Understanding

Speakers: TBO

Description: Grow personally and professionally in your awareness of the people that surround you at work and outside of work. This SME lecture-style session will address the basics of unconscious bias; how it exists in our lives, and how it impacts our lives and other’s lives. Attendees will gain an understanding of how they can contribute to their workplace and fellow employees to maximize their value through inclusion, understanding, and collaboration.


#5) Cell & Gene Therapy 201: Diving into 3 of the top technical challenges companies are addressing

MNeville

Speaker: Miranda Neville

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.


Kulkarni

Speaker: Niranjan S. Kulkarni, Ph.D.

Niranjan S. Kulkarni, Ph.D., is the Director, Operations Improvement with CRB Consulting Engineers, Inc. Niranjan has over 15 years of experience in business process and data modeling, process simulations, operations improvements, layout optimizations and supply chain management. He has worked with pharmaceuticals, biotech, food, chemicals, semiconductor, electronics assembly & packaging, manufacturing and finance industries.


Cell therapies are emerging as an important class of next-generation medicines. This domain currently has several concerns, such as, uncertainty in demands, variability due to raw material or manual operations, and challenges with new technology, to name a few. As many novel treatments move from development to commercialization, manufacturers are challenged to design and operate optimal facilities. Designing optimal facilities and production operations also has a significant impact on the Cost of Goods.

With improvement in computing power, Simulations and Artificial Intelligence (AI) techniques can be better employed to address the above-mentioned concerns. Computer modeling and simulations from an operational perspective can support the development of an optimal facility design along with developing operating strategies that will enable cell therapy manufacturers to meet the needs of patient populations, while better managing the Cost of Goods.

Learning Objectives :

  • Learn how to improve facility design using operational models and computer simulations
  • Understand how machine learning using neural networks, a technique within the AI domain, can be used to better estimate machine reliability
  • Learn how to maintain these models as the process matures