Tag

Panel

Panel Discussion: Pharma 4.0 – Biopharmaceutical Production in the Digital Age
LIFE SCIENCES

Panel Discussion: Pharma 4.0 – Biopharmaceutical Production in the Digital Age

  • Addressing the state of the biopharmaceutical industry today: Which emerging trend will see the most growth?
  • Embracing modular automation, PAT and continuous processing to increase agility, flexibility and improve efficiencies
  • People and technology: How are these forces working together to grow and mature our industry?
  • IoT- how will cloud based data, data analytics and data integrity evolve compliance and quality towards continuous improvement
  • How will these technologies affect patient and product needs towards more individualized therapies?

Moderator:

Alison Moore is Senior Vice President, Process Development for Amgen serving both Operations and R&D organizations. She has held a number of senior roles within Amgen overseeing operations technology, process and product engineering , and corporate manufacturing where she oversaw supply chain, contract manufacturing, global distribution, manufacturing technologies, and operations risk management. She also headed up Amgen’s Fremont, California, manufacturing facility (AFR). Before heading up the AFR facility, Moore was a director in chemistry, manufacturing and controls regulatory affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the process development organization. Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England.

Panelists:

Rohini Deshpande is the VP Process Development of Amgen. She joined Amgen in 1997 as a scientist in R&D. At present, she is Vice President Process Development and Head of Attribute Sciences. Attribute Sciences is a multi-modality global group across six Amgen sites. The scope spans preclinical to commercial. Previously, Rohini was Executive Director of Drug Substance group for Amgen Thousand Oaks. Her team developed production cell lines and processes for many Amgen biologics products. Prior to her 20 years at Amgen, Rohini did her post-doctoral work in antibody structure function at UCLA, before that she worked as a post-doctoral fellow establishing a Yeast two hybrid system at University of Michigan, Ann Arbor, and prior to that she did her Ph.D. in Biology with an emphasis on Immuno endocrinology at SUNY Binghamton.

Christie Bielinski is the Vice President of Product Quality Management of Janssen Pharmaceuticals. She leads a world-wide organization of quality professionals accountable for the development, manufacture and launch of pharmaceutical products across the Janssen therapeutic areas. The scope of her responsibilities include assuring that the quality requirements are built into the product in early and late-stage development, that proactive identification of ‘critical to quality attributes’ are identified, and that the associated risk is quantified so that defects can be prevented during the entire lifecycle of the product. In her 11-year career with Johnson & Johnson, Christie has held positions in both the Medical Device and Pharmaceutical segments and has had responsibility for marketed products that span a diverse portfolio of Pharmaceuticals, Biologics, Devices and Combination Products. Her responsibilities during this tenure have included new product development and lifecycle management, supplier quality, validations/site qualifications, laboratories, quality operations and network optimization.

Craig Beasley is the Vice President of Manufacturing Operations at Juno Therapeutics, a clinical-stage cell immunotherapy company focused on revolutionizing medicine by re-engaging the body’s immune system to treat cancer. Prior to joining Juno Therapeutics, Craig worked at Biogen for sixteen years in roles of increasing responsibility in process engineering, manufacturing, supply chain, site operations, and financial planning functions. Craig has a BS in Chemical Engineering from Purdue University.

Panel: Disrupting the Biotech Industry- How Small & Mid-Sized Innovators Create a Competitive Advantage
LIFE SCIENCES

Panel: Disrupting the Biotech Industry- How Small & Mid-Sized Innovators Create a Competitive Advantage

  • Advantages of smaller more agile organizations’ ability to react to patient, regulatory & market pressures
  • Discussing internal innovations in production technologies and working with external partners to do the same
  • How do we adapt our leadership, organizational structure and people management strategies?
  • Lean implementations as a Smart Risk management tool
  • Leveraging collaborations with big pharma to foster innovation and increase speed to market

Moderator:

Alison Moore is Senior Vice President, Process Development for Amgen serving both Operations and R&D organizations. She has held a number of senior roles within Amgen overseeing operations technology, process and product engineering , and corporate manufacturing where she oversaw supply chain, contract manufacturing, global distribution, manufacturing technologies, and operations risk management. She also headed up Amgen’s Fremont, California, manufacturing facility (AFR). Before heading up the AFR facility, Moore was a director in chemistry, manufacturing and controls regulatory affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the process development organization. Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England.

Panelists:

Tina M. Larson is Vice President of Technical Operations at Achaogen, a biopharmaceutical company committed to the discovery, development, and commercialization of novel antibacterials to treat multi-drug resistant gram-negative infections. Ms. Larson is accountable for Process Development, Manufacturing, Supply Chain, Quality Assurance and In Vitro Diagnostic Devices. Prior to Achaogen, she was at Genentech/Roche for 20 years where she was involved in every commercial biologic product launched by Genentech through roles of increasing responsibility in Automation Engineering, Manufacturing Science and Technology, Process Development, and Global Business Operations. Ms. Larson was a member of both Genentech’s and Roche’s Technical Development leadership teams, leading functions in the U.S. and Europe. She was recognized nationally in 2012 as a Healthcare Businesswomen’s Association (HBA) Rising Star. Ms. Larson received her B.S. in Chemical Engineering from Colorado State University.

Ashraf AmanullahVP of Biologics Development and Manufacturing of aTyr Pharma, is a drug development and manufacturing executive with more than 20 years of demonstrated leadership experience in global pharma and biotechnology organizations, with expertise in process development, technical operations, cGMP clinical manufacturing, commercialization and life cycle management of antibody therapeutics, vaccines, gene therapy, cell-based therapeutics and recombinant proteins. Prior to joining aTyr Pharma, Ashraf was Senior Director at Gilead Sciences where he built a world class CMC organization, Director of CMC Development at Genentech. Prior to Genentech, Ashraf held various positions at Merck & Co. Inc. over nine year tenure, with responsibility for process development, cGMP manufacturing, and technology transfer and commercialization of vaccines. He is the author of 55 peer-reviewed publications, and his work has been presented at over 90 conferences. Ashraf received his Ph.D. in Chemical Engineering from The University of Birmingham (UK) and conducted post-doctoral studies with The University of Birmingham, Novo Nordisk, Merck & Co. Inc. and University College London.

Mayo Pujols is currently VP Global Head Car-T Operations and Technology at Celgene located in Summit, New Jersey. Prior to Celgene, he was the SVP of Technical Operations at Advaxis, Inc., a clinical-stage biotechnology company located in Princeton, New Jersey. He leads a team responsible for manufacturing, quality operations, process/analytical development, engineering, supply chain/logistics, and project management. Prior to this role, he was Advaxis’s VP of Technical Operations. Prior to that role he was Executive Director of Technical Operations at Merck supporting the vaccines and biologics franchises. Mayo has also worked in a number of other global and domestic roles throughout his career, including the areas of technology transfer, new product launches, validation, regulatory submissions/inspections, commercial/clinical manufacturing, and quality assurance/systems at Astra-Zeneca (MedImmune), Schering-Plough, and Merck.

Heidi Hoffmann, Senior Director, Supply Chain and CMC Team Lead of Sutro Biopharma, has 22 years of experience in biotechnology, specializing in process development, technology transfer, and manufacturing of vaccines and biological therapeutics. She began her career at Aviron working on vaccines for EBV, PIV, and influenza (FluMist®). She then joined Valentis, where she led the team responsible for process development, technology transfer, and clinical production of plasmid DNA for gene therapy. Dr. Hoffmann returned to vaccine work by joining VaxGen, working on process development and manufacturing of anthrax vaccine. Later, she transitioned into a technology transfer role, hiring and leading the VaxGen oversight team for the successful transfer of production of Bristol-Meyer Squibb’s Orencia® (abatacept) into the Celltrion manufacturing facility in South Korea. Dr. Hoffmann joined Sutro in February, 2011 and currently heads CMC and directs outsourced cGMP manufacturing for protein therapeutics and ADCs.

MANUFACTURING

Panel: Increasing Cooperation with Purchasing, HR, IT, Product Development and Supply Chain Teams

  • How can organizations realistically work towards a “one business, one goal” mentality?
  • Discussing ways to align the actions of front-line workers with the company’s corporate values and goals from the top down and the bottom up
  • Offering best practices to eliminate silos within support organizations to advance the innovation trajectory

Moderator:

Alistair Hirst, SVP Global Supply Chain, Kellogg Company

Alistair Hirst has been Senior Vice President, Global Supply Chain, Kellogg Company, since 2012. He is also a member of the company’s Global Leadership Team. Mr. Hirst joined Kellogg Company in 1984 as a Food Technologist at the Springs, South Africa plant. While at the facility, he was promoted to Quality Assurance Manager and Production Manager. In 1993, he accepted an assignment at the company’s Botany, Australia plant as Production Manager. In 1994, he returned to South Africa when he was promoted to Plant Manager, and in 1997, he was named Director, Supply Chain at the facility. Mr. Hirst relocated to the Manchester, England facility in 2001 when promoted to Director, Procurement, and in 2004, he was named European Logistics Director. In January 2005, he relocated to the U.S. when promoted to Vice President, Global Procurement. Mr. Hirst was promoted to Senior Vice President, Snacks Supply Chain in January 2008 and to Senior Vice President, North America Supply Chain in October 2011.

Panelists:

Ebly Sanchez, Director Volvo Production System – Region Americas, Volvo Trucks North America

Ebly Sanchez has worked in the Volvo Group  since 2008 both in Sweden and in USA mainly in the area of Continuous Improvement. Before 2008, he worked for the Ford Motor Company for almost 20 years in several areas of manufacturing including quality, production, manufacturing engineering, new product launches and general operation management in USA and South America, particularly Brazil, Argentina and Venezuela. Currently, Ebly has overall responsibility for Continuous Improvement in Region Americas including strategy, deployment, and coaching for the whole organization including Manufacturing, Sales/Marketing, Purchasing, Product Development and the support organizations such as HR, Group IT, logistics, customer service, business control and financial services.

Susan Freije, VP Quality Assurance, Benjamin Moore

As part of the Senior Management team, Susan is responsible for leadership in all areas of Quality Systems, Color and Product Standards, Customer Satisfaction, and Supplier Quality Management. Her team is focused on developing processes and standard practices to assure quality across the supply chain, from supplier materials, through Product Development, on to Manufacturing and Distribution, and finally at the customer level. Susan’s additional area of focus is leading the Continuous Improvement effort. This team, working with the entire Operations organization, implements standards of excellence to improve efficiency and effectiveness measured using metrics. Susan came to Benjamin Moore in 2013 after a long career as Director of Quality Systems at Colgate-Palmolive. During her tenure at Colgate, Susan developed and implemented the company’s first Good Manufacturing Practices initiative and subsequent audit program of more than 60 sites around the world. 

Jorge Perez, GE Aviation Supply Chain Growth Playbook Leader, GE Aviation

Jorge joined GE in 2001 and is a graduate of the Operations Management Leadership program. He has amassed broad experience across Aviation including Engine Assembly, Overhaul, Systems and Component Manufacturing. Roles ranged from front line leader, black belt and operational leader to plant leader at three different supply chain sites. This positioned him well to lead the strategic initiatives including ‘Brilliant Factory’ for GE Aviation Supply Chain. In addition, he has a demonstrated track record of delivering results in uncertain times and growing and developing strong diverse teams. Jorge has a bachelor’s degree in Manufacturing Engineering from Boston University. Outside of GE, he enjoys spending time with his wife Caroline and two young daughters Gabriella and Sophia. He is an avid runner and enjoys training for marathons.

Panel: Improving Communication and Collaboration Up and Down the Supply Chain
SUPPLY CHAIN

Panel: Improving Communication and Collaboration Up and Down the Supply Chain

This was the final panel discussion on September 13th of the 2016 edition of the North American Supply Chain Executive Summit. The discussion revolved around improving communication and collaboration up and down the supply chain. The panelists from left to right are:

Jeff Moorefield, SVP of Global Operations, Tennant Company
Jeff Moorefield is responsible for worldwide operations including supply chain, manufacturing, logistics and distribution. Since joining Tennant in 2015 Jeff is focused on eliminating waste in the process to driving speed and velocity into the overall supply chain, while understanding and improving the total customer experience. Before joining Tennant Company Mr. Moorefield spent 12 years in plant management and global operations leadership roles for several Pentair global business units including technical solutions, filtration and process, and water purification. In addition to these positions, Mr. Moorefield earned extensive experience in operational leadership roles with Emerson Electric Company from 1987 to 2001, after starting his career as a Design Engineer at Kentucky-based Smith & Proffit Machine & Engineering. He holds a degree in Industrial Technology from Western Kentucky University.

Alan Harrah, VP Global Supply Management, Pentair
Alan Harrah joined Pentair in 2008 to lead their global efforts in indirect sourcing and process excellence. Alan is now responsible for driving overall global sourcing performance and process excellence in Pentair’s 300 person supply management organization and developing and directing Direct Material and Indirect Procurement strategic sourcing initiatives for Pentair’s $2.0+ billion supply base. Alan joined Pentair from Whirlpool Corporation, where he served as the North American Sourcing Director for Indirect Procurement managing over $400M in spend across 100+ operations. Prior to that, he was the Executive Director for Direct and Indirect Strategic Sourcing for Fisher Scientific Product’s global operations managing $300M in spend across nearly 40 operations. Alan started his career at General Motors Corporation where he spent 16 years in various progressive roles in procurement, supply chain, manufacturing, engineering, and business development.

Alex Blanco, EVP & Chief Supply Chain Officer, Ecolab
Alex Blanco is Executive Vice President and Chief Supply Chain Officer for Ecolab Inc. In this position, Blanco oversees the company’s global supply chain operations, including Ecolab’s more than 300 manufacturing plants, distribution centers and other supply chain facilities around the world. Previously, Alex worked for Procter & Gamble Co. (P&G) for 30 years. Most recently, he served as Vice President, Product Supply Global Beauty Sector, responsible for strategy, planning, procurement, manufacturing, engineering, quality assurance and logistics. In previous roles, he led Supply Chain operations for other key P&G divisions and held several international assignments. Blanco has a bachelor’s degree in Mechanical and Aerospace Engineering from Princeton University. He also serves on the Board of Directors of the YMCA Twin Cities.