Knowing and Protecting Your Assets

Discussing options for biomanufacturing capacity management: Effective strategies for capacity utilization Spreading capacity among and across different business partners...

Informed Decision-Making in a Volatile, Ever-Changing World

What qualifies as a World-Class Supply Chain? Why is it so difficult to maintain? Discussing how the challenges facing...

Leading and Leadership in Lean Bio-Manufacturing Operations

Lean applications in Bio-Manufacturing is both complex and simple Sustaining lean performances in Bio-Manufacturing is both science and art...

The 'Googley' Approach to Global Supply Chain Management

Be bold, “shoot the moon” and take risks. During the 2017 edition of the North American Supply Chain Executive...

Biotech Business Bootcamp – Treating Cultural Sclerosis…

Repetitive engagement survey results with no sustainable action plan for improvement? Meeting mania dominating each and every day? Data,...
Uncategorized
Knowing and Protecting Your Assets
SUPPLY CHAIN
Informed Decision-Making in a Volatile, Ever-Changing World
LIFE SCIENCES
Leading and Leadership in Lean Bio-Manufacturing Operations
SUPPLY CHAIN
The 'Googley' Approach to Global Supply Chain Management
LIFE SCIENCES
Biotech Business Bootcamp – Treating Cultural Sclerosis…
Knowing and Protecting Your Assets
Uncategorized

Knowing and Protecting Your Assets

  • Discussing options for biomanufacturing capacity management:
    • Effective strategies for capacity utilization
    • Spreading capacity among and across different business partners
    • When is the right time to hedge with CMOs?
  • Understanding the attraction, retention, and development trends for talent assets
  • Illustrating these trends with metrics and examples from AstraZeneca’s own experience

Darren Dasburg currently serves as VP & Head, Learning and Development Global Operation at AstraZeneca. Bringing over 30 years of professional experience in a variety of settings, he was appointed Vice President-Site Head for the Boulder Manufacturing Center in September 2015 when AstraZeneca/MedImmune acquired the former Amgen biologics production facility. Previously, Darren held the position of Vice President of Capacity Utilization with MedImmune where he led capacity sharing arrangement to support bio-manufacturing efforts. Prior to that, he was a Founding Partner of Cinteger LLC where he provided executive management consulting in the areas of construction, facilities operations, project engineering, service-provider outsourcing, real estate and business management. Darren also served as Vice President of Corporate Engineering with GlaxoSmithKline. He is a licensed Professional Engineer and certified Outsourcing Professional, being the first person to obtain that certification.

Informed Decision-Making in a Volatile, Ever-Changing World
SUPPLY CHAIN

Informed Decision-Making in a Volatile, Ever-Changing World

  • What qualifies as a World-Class Supply Chain? Why is it so difficult to maintain?
  • Discussing how the challenges facing a global operation’s supply chain have evolved over time
  • Highlighting the role of teamwork in fostering innovation in a fast-changing environment
  • Looking forward: How does one strike a balance between agility and efficiency?

Meredith (Meri) Stevens is currently the Vice President, Strategy & Deployment, Johnson & Johnson Supply Chain responsible for leading end-to-end strategy and transformation to enable Johnson & Johnson to meet the needs of patients, customers and consumers in today’s dynamic healthcare market. In this role, Meri drives the deployment of leading practices in the areas of Supply Chain Innovation, Digitalization, Value Chain Management, Planning and Performance.

Prior to J&J, Meri was the Chief Supply Chain Officer at Newell Rubbermaid. Before Newell Rubbermaid, she spent several years at Tyco International as VP, Global Operations. Meri has also held previous positions at General Electric, Bertelsmann, Inc. and Knoll Inc.

Meri holds a B.S. in Mechanical and Electrical Engineering and an M.S. in Industrial Management, both from Rensselaer Polytechnic Institute. She has been recognized in Supply & Demand Chain Executive (2014) and the Profiles in Diversity’s 2014 Women Worth Watching list.

Leading and Leadership in Lean Bio-Manufacturing Operations
LIFE SCIENCES

Leading and Leadership in Lean Bio-Manufacturing Operations

  • Lean applications in Bio-Manufacturing is both complex and simple
    Sustaining lean performances in Bio-Manufacturing is both science and art
    Good versus Great Lean leadership… It matters
    Successful OE polynomial equation for Lean Bio-Manufacturing = … ?

Jacks Lee is an industry executive with global experiences in biopharmaceutical, small molecule drugs and vaccines. His 25+ years of experiences spans across technical, operational and strategic leadership roles in Science-Technology, Engineering, Quality, Supply Chain and Manufacturing. He currently serves as the Senior Vice President of Merck Manufacturing Division-Global Vaccines Operations. Jacks joined Merck in 2007 as head of Global Technology & Engineering. Prior to that, he was with Sanofi and its predecessor companies in varying capacities including serving as heads of US Biological Operations and Global Pharmaceutical Products Division. He is a member of the Vaccines Advisory Board, and was previously nominated and served on the United States Pharmacopia (USP) Expert Committee of Biostatistics.

The ‘Googley’ Approach to Global Supply Chain Management
SUPPLY CHAIN

The ‘Googley’ Approach to Global Supply Chain Management

Be bold, “shoot the moon” and take risks.

During the 2017 edition of the North American Supply Chain Executive Summit, Executive Platforms was proud to partner with SupplyChainBrain to conduct a number of onsite interviews between our speaker faculty and SupplyChainBrain’s Editor-in-Chief Russell Goodman.

Daniel Kaulfus is the Global Head of Logistics and Operations at Alphabet (aka Google), a $90B American multinational technology company that specializes in internet-related services and products. These include online advertising technologies, search, cloud computing, software, and hardware. It is the most visited website in the the world and has extended it presence into multiple other industries including mobile phones, home automation, self driving cars, global wi-fi access and biotechnology. In his current role he is responsible for Alphabet global operations, transportation, trade compliance and warehousing across 40 international sites. Prior to joining Google, Daniel was the Head of Worldwide Procurement at Amazon.com responsible for over $5B of goods and services spend.

Daniel has over 25 years of global supply chain and operations management experience with First Solar, Applied Materials, Lutron Electronics and Proctor & Gamble working extensively in Asia, Europe and the Middle East. He has a successful track record building global teams, developing strong supply chain networks and negotiating major global contracts. Prior to entering industry, Daniel worked with Deloitte Consulting Group and received his MBA from Carnegie Mellon University and a BS in Mechanical Engineering from Texas A&M University.

Russell W. Goodman has worked in newspapers, newsletters and magazines, with a focus on logistics, business and trade, for nearly 30 years. He also has specialized in editing and writing for publications in world affairs, politics and legal matters. Prior to joining Global Logistics & Supply Chain Strategies, Goodman directed editorial coverage for two leading international commerce magazines. Goodman was managing editor of the Journal of Defense & Diplomacy, a bimonthly edited in Washington that reported on and interpreted the interplay between security and political issues. From Washington, Goodman, as editor-in-chief of Middle East Insight magazine, directed coverage of business and political affairs in that critical part of the world. He also developed and edited Eastern Europe Law Week, a newsletter that covered legal reform in post-Soviet Europe.

 

Biotech Business Bootcamp – Treating Cultural Sclerosis…
LIFE SCIENCES

Biotech Business Bootcamp – Treating Cultural Sclerosis…

  • Repetitive engagement survey results with no sustainable action plan for improvement?
  • Meeting mania dominating each and every day?
  • Data, metrics, KPI’s, and scorecards – Thermometers or Thermostats?
  • OPEX tools and governance models that feel abstract and disconnected?

Struggling with any of these symptoms? If so, your organization is suffering from Cultural Sclerosis. While not fatal, it is debilitating. Fortunately, we have developed a ‘Sustainable Treatment Plan’ based upon 25 years of work with organizations including GSK, Pfizer, Genentech, Gilead, and Alcon that will drive Clarity, Connectivity and Consistency into both your team and leadership culture.

Shane A. Yount is a nationally recognized author, consultant, and principal of Competitive Solutions, Inc., an international Business Transformation consulting and software firm. Shane’s team pioneered the acclaimed organizational governance system known as Process Based Leadership® (PBL) – A robust governance methodology designed to create a sustainable cadence of clarity, connectivity, and consistency. Shane’s ability to diagnose inefficient governance models and quickly design and deploy solutions that accelerate and amplify team performance has made him and his firm long-term partners with such organizations as Genentech, Pfizer, Alcon, Roche, GSK, Meridian Medical Technologies, and many others. Since 1991, Shane has led the offices of Competitive Solutions, Inc. while publishing three best-selling business novels. His latest novel, Leading Your Business Forward is required reading within many leadership development curriculums being taught within industry today.

Supply Chain Planning Process Transformation – A BP Fuels North America Case Study
Uncategorized

Supply Chain Planning Process Transformation – A BP Fuels North America Case Study

  • Successful planning process transformation using Integrated Business Planning (IBP)
  • Scaling regional IBP processes into one process serving all North America
  • Tangible and intangible benefits of a successful IBP process
  • Key success factors for sustaining the process through change management, process development and continuous improvement

Cheryl McKinney
VP Strategy and Portfolio at BP Fuels North America
As a member of the leadership team of one of BP’s largest refining and marketing businesses, Cheryl McKinney is accountable for strategy, investment, and business development across North America. Her remit includes the BP refineries in Toledo, Ohio, Whiting, Indiana, and Bellingham, Washington, as well as the BP U.S. Pipelines business, and the BP North American Sales and Marketing businesses, which carry both the BP and Arco/ampm brands. Cheryl serves as President of the holding company for the BP-Husky joint venture at the Toledo Refinery and an Executive Committee Member for the Advance Biofuels Association. She serves as executive sponsor for BP’s corporate relationship with the Society of Women Engineers, and the BP Chicago Women’s business resource group.

Robert Hirschey
Principal at Oliver Wight Americas Inc.
Robert Hirschey has nearly 25 years of experience in a diverse background including strategy development, execution, and measurement; business planning and analysis; capital investment analysis; mergers and acquisitions, and various corporate development activities. Bob’s experience extends to the private label consumer products industry, where he helped start up a new division for a company in the disposable personal care products business. Bob has held positions such as VP, Finance & Planning; VP, Finance and Administration; VP, Strategy; VP, Corporate Development; and CFO. Bob’s experience from executive suite to plant management makes him uniquely qualified to lead organizations through their business process transformation initiatives. Bob earned his bachelor’s degree in economics from Harvard University and an MBA in general management from the Amos Tuck School of Business Administration at Dartmouth College.

Breakthrough Designations – How Can Quality Enable Speed to Innovation?
LIFE SCIENCES

Breakthrough Designations – How Can Quality Enable Speed to Innovation?

  • Offering an overview of how breakthrough therapy designations have historically worked and how that process is changing
  • Are we as an industry ready for major changes in how drug development is expedited?
  • Discussing how our organizations’ Quality Culture must be an integral part at all stages of this transition
  • Working with all stakeholders to ensure we do not sacrifice safety and quality as we increase the pace of innovation
  • What should we be doing right now to prepare for the future of these developments?

Christie Bielinski, Vice President of Product Quality Management at Janssen Pharmaceuticals, 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.

Panel: Are We Embracing the 4th Industrial Revolution the Right Way?
SUPPLY CHAIN

Panel: Are We Embracing the 4th Industrial Revolution the Right Way?

  • How should we as leaders within our organizations incorporate these new tools and technologies into the work our people do every day?
  • What does an analytics-driven decision-making process where Big Data is the visualizer and enabler of change really look like?
  • Setting realistic goals: What do we want to be able to do in terms of communication, collaboration, and visualization with these new tools?
  • Discussing how Digital Supply Chain insights can balance product availability while managing inventory levels and improving cost to serve
  • Is improvement across the board possible? Working towards continuous process excellence and driving reduced lead times to serve more customers in less time

Moderator:

Elliott Rodgers, the Senior Vice President, Logistics of Ulta Beauty, leads retail and ecommerce distribution and transportation for the United States’ largest beauty retailer. During his four years at Ulta, he has led the transformation of the supply chain in support of Ulta’s strategic imperatives. Prior to joining Ulta, Elliott held operational leadership roles spanning, retail, hospitality, and financial services at Target, Citibank, and the United States Army. As an Army Officer, Elliott served in various assignments including leading logistics support operations for humanitarian service missions. Elliott holds a B.S. in Political Science from the United States Military Academy at West Point, and an MBA from the Harvard Business School. He is a recipient of the Corporate Values Award from Target Corporation and the Honorable Order of Saint Martin for distinguished military leadership in logistics.

Panelists:

Linsey Vasilenko, Logistics Director, North America, Global Supply Chain for Schneider Electric, is responsible for transportation in North America for Schneider Electric. She is currently leading the group to a world class organization through strategic carrier alliances, collaboration across the supply chain and high performance culture. Previously Linsey led the Global Costing Organization at Schneider Electric transforming the negotiation approach. Linsey has worked across Supply Chain Management at Raytheon Space & Airborne Company and IBM. Linsey is a Michigan State Alumni in Supply Chain Management and earned her MBA at Thunderbird School of Global Management. In her free time, she enjoys quality time with family and friends.

Lisa Cotter, Sr. Director, Reverse Logistics of Best Buy, has over 20 years of experience leading all areas of Supply Chain.  Her current position is Sr. Director of Reverse Logistics where she is the lead for two complex cross functional end to end Lean projects as well as leads Reverse Logistic at 3rd Parties, Reverse Sales and Operational Planning, End of Life Inventory Management, After Sales Vendor Programs, and Development of New System and Process Capabilities.  Prior to this role, she had leadership roles in Distribution Management, Inventory Management, Process and System Design, Supply Chain Network Design, and Facility Design at Best Buy, Musicland, and Hewlett Packard.  She holds a Bachelor of Science in Industrial Engineering from Iowa State University and a Master of Science from Stanford University in Industrial Engineering.

Mark Pizov, Director, Global Sales & Operations Planning of US Steel Corporation, is responsible for demand plan consolidation as part of S&OP process for US Steel’s North America Flat Rolled products business unit (NAFR). Responsible for infrastructure support of NAFR S&OP team (tools and processes).  US Steel global inventory program owner.

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.

Reducing Supply Chain Risk Susceptibility
SUPPLY CHAIN

Reducing Supply Chain Risk Susceptibility

Refusing to deal with risk, which is an integral part of supply chain competence, is impermissible.

During the 2017 edition of the North American Supply Chain Executive Summit, Executive Platforms was proud to partner with SupplyChainBrain to conduct a number of onsite interviews between our speaker faculty and SupplyChainBrain’s Editor-in-Chief Russell Goodman.

Antonio Galvao is a supply chain executive with over 26 years of experience encompassing planning, logistics, sourcing, engineering, manufacturing, product portfolio management, marketing operations and a proven track record of managerial success in generating multimillion dollar cost savings and double-digit percentage improvements in both customer service levels and productivity. He has lived and worked in Brazil, England, United States, Switzerland and Netherlands leading local, regional and global teams. He has served on the APICS Board since 2016. His specialties include change leadership, restructuring, turnarounds, win-win negotiations, conflict management, mergers and acquisitions, strategic sourcing, logistics, planning and channel management. He has experience working in the Oil and Gas, chemicals, industrial, food service, lodging, health care, retail, building service contracts and facilities management sectors.

Russell W. Goodman has worked in newspapers, newsletters and magazines, with a focus on logistics, business and trade, for nearly 30 years. He also has specialized in editing and writing for publications in world affairs, politics and legal matters. Prior to joining Global Logistics & Supply Chain Strategies, Goodman directed editorial coverage for two leading international commerce magazines. Goodman was managing editor of the Journal of Defense & Diplomacy, a bimonthly edited in Washington that reported on and interpreted the interplay between security and political issues. From Washington, Goodman, as editor-in-chief of Middle East Insight magazine, directed coverage of business and political affairs in that critical part of the world. He also developed and edited Eastern Europe Law Week, a newsletter that covered legal reform in post-Soviet Europe.

A New Way to Rapidly Develop Biomanufacturing Capacity and Add Greater Value to the Decision to Build
LIFE SCIENCES

A New Way to Rapidly Develop Biomanufacturing Capacity and Add Greater Value to the Decision to Build

  • Investing capital in capacity expansion when a drug is early in development is challenging. There are new manufacturing models that reduce risk and add value to your decisions through a concept called optionality
  • Balancing options and critically evaluated risk against probability of success in to-build decisions
  • Introducing a new biomanufacturing solution that leverages manufacturing ecosystems to reduce the need to build infrastructure
  • Effectively transfer non-value added work from the manufacturing site to service providers with this new manufacturing model

Daniel Palmacci has nearly 20 years of leadership experience in Biologics in the area of manufacturing, technical development, supply chain, and Operations Management. He is a member of Novartis Biologics Leadership Team and is Technical Operations Head of Austria’s Country Executive Committee. In his previous role he was the Head of Biologics External Supplier Organization that manages all Contract Manufacturers (CMO) for the cross divisional network of Novartis, Sandoz and Alcon. Daniel was also responsible for Technical Development Project Management organization. As a Member of Sandoz Biologics Executive Committee he managed all TechOps activities (end to end) by coordinating internal and external manufacturing and supply chain to ensure supply of commercial Biosimilars. Prior to joining Novartis Daniel worked for BayerHealthCare for several years in positions with progressively senior roles in leading cross-functional teams responsible for Production, Manufacturing Science, Technical development, Operational Excellence, Supply Chain, Quality Assurance and Engineering.

The Process Improvement Conundrum: Standardizing Before Outsourcing, or Outsourcing Before Standardizing?
SUPPLY CHAIN

The Process Improvement Conundrum: Standardizing Before Outsourcing, or Outsourcing Before Standardizing?

  • Driving regional requirements within a broader global supply chain ecosystem
  • Tangible benefits of process automation and robotics
  • Debating the pros and cons of insourcing and outsourcing
  • Process automation as a bridge to future state design and ultimately, Supply Chain as a Service

During the 2017 edition of the North American Supply Chain Executive Summit, Executive Platforms was proud to partner with SupplyChainBrain to conduct a number of onsite interviews between our speaker faculty and SupplyChainBrain’s Editor-in-Chief Russell Goodman.

Mark Bakker is Head of Supply Chain Operations – Americas at HP Inc., managing Supply Chain execution for the Americas Region. He is responsible for enabling achievement of the financial goals established by the company for Printing, Graphics and Personal Systems product categories. Mark leads and oversees the end-to-end operational experience of customer and channel orders for both Commercial and Retail routes to market. This includes order management, demand and channel planning operations, physical claims, regional logistics sourcing strategies and cost & delivery optimization for business operations and logistics in the AMS region. Mark reports to the Chief Supply Chain Officer and dotted lines to the Americas President.

In his previous role, Mark was the Vice President of the Asia Pacific Supply Chain Operations at Hewlett Packard, managing Supply Chain execution for the Imaging and Printing Group (IPG) in the APJ region. Mark has been with HP since 1994 and prior to joining the IPG EMEA Supply Chain Operations organization in 2005 he worked in a variety of Customer Service and Support positions for Network Servers, PC Products and Imaging and Printing Products.

Russell W. Goodman has worked in newspapers, newsletters and magazines, with a focus on logistics, business and trade, for nearly 30 years. He also has specialized in editing and writing for publications in world affairs, politics and legal matters. Prior to joining Global Logistics & Supply Chain Strategies, Goodman directed editorial coverage for two leading international commerce magazines. Goodman was managing editor of the Journal of Defense & Diplomacy, a bimonthly edited in Washington that reported on and interpreted the interplay between security and political issues. From Washington, Goodman, as editor-in-chief of Middle East Insight magazine, directed coverage of business and political affairs in that critical part of the world. He also developed and edited Eastern Europe Law Week, a newsletter that covered legal reform in post-Soviet Europe.

Development of Biologics in China for Global Markets: Lessons From Wuhan, China
LIFE SCIENCES

Development of Biologics in China for Global Markets: Lessons From Wuhan, China

  • Discussing the approach required to success in the unique business environment of the region
  • Walking through recent changes in the regulatory and operating environment in China
  • Offering lessons learned by JHL Biotech, a biologics development and manufacturing firm with headquarters in Taiwan and a commercial-scale production site in Wuhan, China
  • Highlighting JHL Biotech’s path to rapidly building and operating two production facilities in Asia, with an emphasis on JHL’s use of modular and single-use technologies to accelerate facility construction and accelerate product timelines

Racho Jordanov
CEO & Co-Founder
JHL Biotech Inc.

Racho Jordanov is Co-Founder, President, and CEO of JHL Biotech, a biologics development and manufacturing firm headquartered in Hsinchu, Taiwan. Mr. Jordanov started his biopharma career at Genentech in 1981, where he became a leader in technical operations. In addition, Mr. Jordanov has held senior leadership positions at Serono, Cholestech, and Telios Pharmaceuticals. Mr. Jordanov earned his B.S. in chemical engineering from the University of California, San Diego and his M.B.A. from National University, San Diego.

LIFE SCIENCES

Establishment of Efficient Cell Culture Supply Chain through Partnerships

  • Understanding GMP production of biologic therapies is a long-term commitment throughout the life-cycle of a product
  • Discussing how for CDMOs this includes developing strong relationships with suppliers
  • Demonstrating the importance of a solid supplier partnership, from early stages of technology implementation, is essential for long-term success
  • Illustrating a successful Supplier-CDMO relationship in action using GE Healthcare and FUJIFILM Diosynth Biotechnologies as an example
  • Showcasing how this partnership rapidly added cell culture manufacturing capacity through the implementation of single-use production systems

Jeff Carter
Strategic Projects Leader
GE Healthcare

Dr. Carter has been a supplier to the bio/pharmaceutical manufacturing industry for over twenty years, and he has been with GE Healthcare Life Sciences since 2005, serving in R&D and Marketing capacities. He has served in R&D, product management, and acquisition integration. His present role as Strategic Projects Leader is to serve as an internal and external voice for evolving regulatory and de facto expectations related to the global implementation of single-use manufacturing. He has been active in organizations such as the Parenteral Drug Association, ASTM E55, and ASME-BPE, and is first vice chair and technical pillar lead of BPSA. He is presently co-leading BPSA efforts, in conjunction with BPOG, to develop best-practice stimuli on single-use Change Notification and User Requirements. Dr. Carter holds a PhD degree from Penn State University in molecular microbiology.

Redefining Competition: Thinking About Our Industry in a Revolutionary Way
LIFE SCIENCES

Redefining Competition: Thinking About Our Industry in a Revolutionary Way

  • What are we doing today to get ready for the realities of our industry a decade from now?
  • Debating what we will need in terms of leadership, people, technology, territory, and resources to grow into new markets with new products in an ever-changing regulatory landscape
  • Is the answer steady growth, or improving agility and versatility, or some third option?
  • Making the case that our industry needs to work together better as individual actors on a shared stage

Kimball Hall serves as the Senior Vice President and Head of Drug Substance Biologics Manufacturing and is a member of the Genentech Executive Committee (GEC). Prior to joining Genentech in 2016, she previously worked at Amgen in a variety of leadership positions, most recently as the Vice President for Manufacturing of the Future, where she established advanced manufacturing facilities in Singapore that utilize disposable upstream technology. Kimball’s organization is responsible for managing the biologics drug substance supply – the active ingredient that gets filled at the drug product sites before delivery of the medicines to our patients. The biologics network is comprised of six sites in North America, Europe and Asia. At Genentech, she sponsors the Operational Development Rotational Program and is an advisor to the Genentech Women’s Professional Group.