2016 Mid-Atlantic Life Sciences Showcase

This registration will allow you to register for:

• Exhibit Hall 
• Education Tracks

The Mid-Atlantic Life Sciences Showcase is quickly becoming the show to attend.  We have had overwhelming intersted in this show and we've made improvements again this year.  Be sure to spread the word that registration is only $20 to attend.

If interested, please select an education course to attend.

Track #1: Biotech Facilities Risk Assessment - This roundtable will be focused on how to perform a facility risk assessment using the ISPE Good Practices Guide for Maintenance as a basis.  Based on a set of assumptions (facility and operational), we will develop the assessment for a biotech facility transitioning from a non-commercial (pilot) to a commercial facility and share risk assessment approaches and best practices to assess risks and associated risk controls and tools (best practices).  As a roundtable, the assessment will be interactive and rely on participation from the audience to share knowledge and ideas on how to effectively minimize risk and develop an assessment that can be used as a tool for communicating with management teams.

Moderators

Joe Morin, Partner, Industry Consultant, alliancebio

Joe has over 23 years’ experience in the biotech sector and currently serves as Cofounder and Industry Consultant for alliancebio, LLC.  Joe has been involved in the design, construction, commissioning, validation and operation of multiple Biologics Manufacturing Facilities.  In his latest operations role (1997 through 2012) at Human Genome Sciences he was, as VP of Engineering, responsible for capital projects, engineering operations, facilities maintenance, metrology and validation (the service providers).  Joe has also worked for Celltech Biologics, Lonza Biologics.

Nate Forrest, Partner, Industry Consultant, alliancebio

As an industry consultant, Nate currently serves clients in capital project management and operational remediation/improvement with alliancebio. Previously at GSK’s Rockville, Maryland site, he was in a number of roles within process engineering, CMO program management and cross-functional team leadership. He has also held similar operations/engineering roles at the Aeras TB Foundation and Cambrex Bioscience (now Lonza). 

Panel Members

• Chris Holmes, Sr. Director, Facilities & Engineering, MacroGenics
• James (Jim) Baillargeon, Sr. Manager, Maintenance Planning, AstraZeneca
• Thomas Harris, Reliability Engineer, AstraZeneca
• Tim Eyler, Facilities Consultant, Innovative Solutions and Design
• Raj Vora, PE
• Bob Valdes, Partner, Industry Consultant, alliancebio
• Herman Sykes, Facilities Manager, GSK
• Matt Depola, PE, Manager, Engineering, Novavax

(2 PDHs)  $25.00, Students Free

Track #2: Closed Processing and the potential risks and impact on Biopharmaceutical Facility Design  

In response to the uncertainty of ever-changing product pipelines, the biotech industry has recently been evolving to develop flexible manufacturing solutions that can be quickly mobilized to provide a nimble response to changes in production demands. The industry has concurrently improved its ability to assess and control the risk to the manufacturing process by engineering solutions to improve the closure of the process. However, these flexible manufacturing solutions come with capacity limitations that can inhibit their applicability for certain larger scale applications. The advent of continuous processing technologies opens the door to coupling upstream and downstream unit operations to achieve a viable solution for end to end continuous manufacturing of bulk drug substances. Compounding the benefits of other enabling technologies – continuous closed processing and implementation of single-use systems, where appropriate – results in a next generation biopharmaceutical manufacturing facility that significantly reduces the facility footprint, capital investment, manufacturing cost of goods, and improves utilization of assets when compared to conventional batch processing.

Marc Pelletier, PhD - Process Specialist & Strategic Consultant for CRB

Marc is an internationally-recognized biopharmaceutical process specialist. An industry leader in the area of fermentation and cell culture based bioprocesses, Marc has helped to revolutionize the way single-use systems are used in the biopharmaceutical industry. While his primary expertise is in upstream and downstream unit operations, Marc also has extensive experience in the area of plasma fractionation. Additionally, his knowledge extends beyond unit operations to facility & process equipment design, process development & technology transfer, commissioning & qualification (C&Q); such proficiency offers practical application when he provides consulting to assist biopharmaceutical manufacturers achieve regulatory compliance in cGMP clinical and commercial production facilities. The processes and facilities that he has designed include those for the manufacture of vaccines, mAbs and small molecule therapeutics. Marc has been a pioneer in risk-based approaches to systems and process validation, most recently developing a tool allowing for assessment of closed systems.

Although Marc is formally educated as a biochemist, he has worked as a process engineer the majority of his 25+ year career. His contribution to the life sciences sector has been focused on the food and biopharmaceutical industries. Prior to consulting, Marc spent much of his time developing biotech-based processes for commercial production of biologics, blood products, nutraceuticals and food additives. He has played the role of project manager, process design lead, equipment designer, facility programmer, risk assessment moderator and validation manager on these projects.

 Rob Boulanger, PhD - Process Specialist for CRB 

Rob is a highly-acclaimed and published biopharmaceutical scientist with expertise in process optimization and technology transfer at various production scales. Before coming to CRB, Rob spent ten years at Protein Sciences, Corp. and played an instrumental role in taking their novel flu vaccine process from bench-top to commercial licensure and production. 

Rob has a rich educational background including attending Boston College for his PhD, the University of Rochester for his MBA, and the University of Massachusetts - Dartmouth for his BS, Biochemistry.

(2 PDHs) $25.00, Students Free.

Track #3: Engineering a Blockbuster Career       Do you want to recharge your career? This course will show you how to build a resume that gets you noticed, what skills will take your career the farthest, what you need in the 2016 workplace, why networking is necessary and discuss challenges that are specific to advancing an engineering career in the life sciences. This course is for everyone! 

Moderator

Chris Frew, VP, Breezio / Founder, Biobuzz

Chris has more than 10 years of experience in various roles within the life science industry, most of which is in staffing, recruiting and workforce development. He is now the VP of Sales at Breezio, a local software firm providing solutions for organizations to achieve better community engagement around content, events and learning, and also the Founder of the BioBuzz Workforce Foundation, which hosts events for the most vibrant community of life science professionals in Maryland. He is also the Biotechnology Co-Chair for WeWorkForHealth's Maryland Chapter and a partner in the BioTrain workforce development program that is run out of Montgomery College.

Panel Members

Wendy Penry - Chief Human Resource Officer at Aeras 

Wendy has worked in the HR field within the life sciences industry for nearly 20 years.  She is currently the Chief HR Officer at Aeras, an international nonprofit biotech advancing tuberculosis vaccines for the world.  Her passion is building a strong company culture that supports the strategy and helps employees reach their potential.  Wendy earned her Bachelor's degree at Virginia Tech and her Master's at the University of Maryland.

Dr. Linda Myers - Global Business Partner, Human Capital at World Wise Partners

Over the last 20 years, Dr. Linda Myers has been recognized for her leadership as a global human capital practitioner and consultant for Fortune 100 companies across industries from pharmaceutical, biotech, and healthcare, to telecommunications, IT, engineering and industrial systems, financial and insurance, energy, and professional services.Today, Dr. Myers leads WorldWise, a global human resources consulting company that partners with its clients to build and sustain sources of global advantage through innovative and best-in-class people solutions.

Kunal Chadha - Principal at Nimbus Search Partners 

Kunal Chadha is Managing Partner and Principal at Nimbus Search Partners; he has over twenty years of experience within Human Resources specializing in Talent Acquisition. Prior to his role at Nimbus, he has been Executive Director for Talent Acquisition for The George Washington University, was Head of Strategic Staffing for Human Genome Sciences where he was awarded the President's award for his contribution in building the company's commercial business unit. In addition to previous similar roles at Booz Allen Hamilton, Freddie Mac, Unisys, BioReliance, and Celera Genomics among others.

Brad Fackler - CEO for Cellona Therapeutics

Brad Fackler has over 30 years of commercial and corporate experience in the pharmaceutical and biotech industries. He is currently CEO for Cellona Therapeutics, a company developing a treatment for metastatic melanoma. In addition, he operates Kinect Point LLC, a biotech consulting agency where he coaches NIH scientists in transitioning to industry positions. Mr. Fackler holds a BA degree in Life Science from Otterbein University and an MBA degree from New York University, Leonard Stern School of Business.

Free to attend

 

 

Register Now! 

Event Sponsors:

  

Sponsorships are available for this event.  Contact Ben Skowronski at benjamin.skowronski@crbusa.com or 410-206-4662 for more information.