***2017 Speakers will be posted soon.
In the meantime, check out our 2016 speakers below.***
Northeast Lounge in East Clubhouse
The Boston Area Chapter Educational Program Committee has been hard at work developing a cutting-edge innovative education program. They have come up with three relevant and timely topics – providing the know how you need to advance your business. In each session, top thought leaders offer insights on issues essential to the industry and provide a wealth of information relevant to your business. Below is a list of our tracks and confirmed speakers.
11:30 am – 1:00 pm
This presentation covers some nuances of lifecycle validation implementation at CMOs. Much has already been written on the general implementation of best practices for lifecycle validation, including the elements of Quality by Design (QbD) and determining the number of PPQ batches. CMOs have unique considerations for lifecycle validation implementation. These include differentiating responsibility for various stages of lifecycle validation for both the CMO and the customer; implementing quality systems that allow flexibility for various CMO and customer approaches; process knowledge transfer mechanisms between the CMO and the customer; change management; facility / equipment and process performance qualification (PPQ); and generating a quality agreement that captures the elements of lifecycle validation.
Speaker: Rusty Morrison | Director | Commissioning Agents, Inc.
Rusty (Russell) Morrison is a Senior Consultant for CAI Consulting (a division of Commissioning Agents, Inc.), where he is responsible for the support and execution of qualification, process validation and technology transfer projects. He has directed multiple process validation efforts, including the complete process validation for the startup of a large cell culture monoclonal antibody manufacturing facility, and remedial process validation for a manufacturer of numerous small volume sterile parenteral products, including designing a continued process verification program. In addition, he has supported various technology transfer projects, including transfer of a biologic drub substance process from one CMO to a second site of manufacture for the same CMO.
Mr. Morrison is a member of PDA and ISPE, and is serving as a member of ISPE’s Process Validation Implementation Team. In addition, he is a past president and board member of the PDA New England Chapter. Prior to CAI, Mr. Morrison held management and engineering positions with Protein Sciences Corporation, INNCOM International, and Sonalysts, Inc. He has a BS in chemical engineering with honors from the University of Minnesota, an MBA in Information Systems from Rensselaer Polytechnic Institute, and has received ISPE’s Certified Pharmaceutical Industry Professional (CPIP) credential.
1:30 pm – 3:00 pm
Facility expansions and retrofits to GMP manufacturing facilities present unique challenges and complexities. These projects can cause a significant disruption to ongoing operations. This presentation details the best practices for the executing these projects.
- The key business drivers that form the basis for project justification
- The Pros and Cons of retrofitting vs greenfield construction
- The extra level of planning and coordination required for retrofits
- How to balance project needs vs concurrent GMP manufacturing
Speaker: Joseph Musiak | Director of Engineering | Acorda Therapeutics
Joe Musiak is currently Director of Engineering at Acorda Therapeutics. In this role he is responsible for all engineering activity at Acorda’s manufacturing facility in
Chelsea, MA. These activities include technical support to the manufacturing organization and execution of all capital projects on the site.
Joe previously spent 21 years at Biogen. During this time he held various positions in process engineering, automation, and project management. During this time, he supported or led multiple capital projects. Most recently he was Associate Director Strategic Innovation. In this role he was responsible leading and implementing global transformational strategic innovation programs.
Joe holds a BS in Chemical Engineering from the University of Massachusetts, Lowell. He is an active member of ISPE. He is past President of the Boston Chapter of ISPE.
This presentation will describe the various project delivery methods such as…
- Design – Bid – Build
- Design – Build
- Engineering, Procurement & Construction Management (EPCM)
- Integrated Project Delivery (IPD)
Dean will draw upon his many years as an “owner”, consulting engineer, and construction manager to answer the following:
- What are the key differences, benefits and pitfalls of each method?
- How do a project’s objectives and particular circumstances point to the best delivery method?
- How well can the parties’ incentives align to assure a positive outcome for each project objective?
- How does risk transfer for each contracting methods and what is the cost of the risk transfer?
The presentation will utilize consolidated case study information and will feature participant interaction to maximize the learning aspect of the session. As an attendee, you will come away with a better understanding of which project delivery method is best for your specific project and situation.
Speaker: Dean Poillucci | Senior Vice President | Skanska
Dean Poillucci is Senior Vice President for Skanska and provides leadership to Skanska’s Life Science Center of Excellence. He has more than 25 years of experience as an owner, engineer and constructor in the planning, design, preconstruction, construction and commissioning of large complex, Research and Development, Pilot Plant and cGMP Manufacturing facilities. He has led projects throughout the USA, Puerto Rico, Sweden and the UK.
Dean holds a Bachelor of Science in Chemical Engineering from Northeastern University and serves on the Industrial Advisory Board for the Northeastern University Department of Chemical Engineering.
3:30 pm – 5:00 pm
This presentation will highlight the historical development of the biotechnology field and the recent advances in bioprocessing and biomanufacturing as the result of this progress. Dr. Rashid will explain the impact of this technology on human health, environment and the agriculture sector.
Speaker: Kamal Rashid, PhD | Director & Research Professor | WPI Biomanufacturing Education and Training Center & Department of Biology/Biotechnology, Worcester Polytechnic Institute
Dr. Kamal A. Rashid has over thirty five years of academic experience in both research and Biotechnology program development. During his career he has developed, directed and implemented biotechnology and biomanufacturing training courses at Worcester Polytechnic Institute, Utah State University, Penn State University and internationally. He has delivered bioprocessing training programs on-site in numerous countries, including, China, Dominican Republic, Egypt, Indonesia, Iraq, Korea, Malaysia, Philippines, Puerto Rico, Vietnam, Thailand, Taiwan, and Singapore.
He received his Ph.D. from Penn State University with emphasis on toxicology and genotoxic effects of environmental pollutants on human health. He has over forty publications in peer reviewed journals and has delivered over 70 invited presentations at national and international conferences. Presently he is the Director of the Biomanufacturing Education and Training Center and Research Professor in the Department of Biology/Biotechnology at WPI.