Speakers

Alan Holmer Speaker
Keynote Lunch with Alan Holmer,
Chairman of the Board for Corbus
Pharmaceuticals
  • Former Chairman of the Board of the Metropolitan Washington, D.C. Chapter of the Cystic Fibrosis Foundation
  • Prior President and CEO of the Pharmaceutical Research & Manufactures of America.

Mr. Holmer will provide insight into how the Cystic Fibrosis Foundation has created a successful drug pipeline to meet the needs of CF patients, why venture philanthropy is important and how to protect the business model of the American pharmaceutical and biotech industry.

Individual seats or tables of 10 are available.


Agenda

Pick one of the following sessions to attend after lunch:

Designing your Career: From Young Professional to Emerging Leader

PROGRAM SUMMARY: Often during his career and coaching practice Ken has encountered young professionals that have:

  • Graduated from a good program at a noted school of higher education
  • Landed a position in their field with a reputable company
  • Applied themselves diligently doing their job in their chosen profession
  • And, yet, found themselves struggling with career direction, advancement issues, and generally what to do next!

During this interactive program, Ken will lead a discussion that will inspire participants to create a new perspective on how they can accelerate their learning, ramp up the trajectory of their career, and walk away with career development models to help chart their future.

Speaker:

ken Ewan

Ken Ewan, Certified Leadership Coach, KME
Leadership, LLC
Ken is an executive coach and facilitator. He brings to coaching and consulting 45+ years of experience in the chemical, biotechnology, and pharmaceutical fields. Ken has held senior level positions at Genentech, MedImmune, Amgen, Skanska USA Building, GlaxoSmithKline, and DuPont in engineering and project management. Ken enjoys working with technical & creative professionals and leaders. He works with leaders to explore new ways to view situations, individuals, possibilities, and to develop new approaches, plans, strategies and actions. Ken believes in the power of coaching to be transformational for leaders, leading to unforeseen possibilities, and higher levels of achievement and growth, both professionally and personally

Ken is a graduate of Clemson University in South Carolina and Drexel University in Philadelphia in Architecture and has a post-graduate certificate in Leadership Coaching from Georgetown University. He is an ICF certified coach at the Associate Certified Coach level.

Ken has been a member of ISPE for over 25 years. During that time he has chaired the Education Committee, was a member of the International Leadership Forum, and chaired the CPIP Commission. In addition, he has been on the Board of Directors for the Chesapeake and CaSA Chapters.

Single Use & Shiny Stuff, Combine So You Can Produce Enough

PROGRAM SUMMARY: In the past ten to fifteen years biotech manufacturers have struggled with the decision to continue using stainless steel equipment or switch to single-use technologies. The decision largely depends on product volume and the amount of flexibility needed. Disposables are often the choice for rapid-turnaround, smaller batches and stainless steel is often the best choice for larger volumes or highly automated processes. However, increases in the available volumes of single use equipment and development of novel single use automation and instrumentation continually shift the landscape of available options. In addition, as the design of single use equipment becomes more specialized, challenges with secondary supply, complex set-up, and interconnectivity emerge. This talk will survey the recent developments in single use equipment and accessories and present case studies that demonstrate manufacturing challenges and the chosen path forward.

Speaker:

Rob Boulanger

Rob Boulanger,
Product Specialist, CRB
Teaching Old Facility New Tricks
Rob joined CRB in April 2015 where he implements his process and operational expertise in both a design and consulting role by supporting biopharm clients through their various growth stages. In addition, he is an active volunteer with the ASME BPE and currently leads the Design of SIP task group. Rob obtained a Ph.D. in Biochemistry from Boston College in 2005 and was at Protein Sciences Corporation (PSC) prior to joining CRB. He managed PSC's Production Department starting in 2006 through the beginning of 2010. During his tenure in the Production department, the processes for over 15 recombinant protein products were transferred from development scale (10L) to the 450L scale. While Rob was Production Manager, Protein Sciences filed a Biologics License Application (BLA) in 2008 for Flublok, PSC's seasonal influenza vaccine candidate. From 2010 to July of 2012, Rob managed the Upstream Processing development group. Rob was a member of the PSC's Technology Transfer Core Team which scaled up the Flublok influenza vaccine process from the 450L scale in Meriden, CT to the 2000L scale at an available facility in Pearl River, NY (which obtain licensure in May 2015).

Speaker:

Mihir Sanghvi

Mihir Sanghvi
Process Engineer, CRB
Media & Buffer Prep - Stainless vs. Single Use
Mihir has over 10 years of process engineering experience serving the Biotech and Pharmaceutical Industries. Mihir has experience with nearly all phases of facility and process engineering project execution, including conceptual design, Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), process calculations, equipment & instrument specification, construction support, plant start-up and debug, commissioning and validation (FAT/SAT, IQ, OQ, PQ). He also has technical expertise in Clean-in-Place (CIP) and Steam-In-Place (SIP) processes, including design, cycle development, commissioning and qualification. Mihir obtained Master of Science in Chemical Engineering from Illinois Institute of Technology in 2006. He joined CRB in Feb 2015. He works as a process engineer at CRB and has been working extensively on Singe Use Equipment.

Design-Build Delivery Method of cGMP Biological Manufacturing Facility

Silver Springs

The DDOMAL project is located in Silver Spring, Maryland on the United Therapeutics Campus. This presentation will cover the decision to use a design-build process for construction of the new facility in this congested urban setting. The team will discuss how together they tackled all the obstacles to keep the project moving forward from procurement to completion.

SPEAKERS: Avi Halpert, VP Corp Real Estate, United Therapeutics Thomas Kaufman, Associate Director Corp Real Estate, United Therapeutics Dan Gulbins, Principal, Ewing-Cole Jonathon Santamont, Senior Project Manager, Whiting-Turner