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biopharma

Digital Transformation and the Smart Factory – A Conversation with Laks Pernenkil of Deloitte Consulting LLP
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Digital Transformation and the Smart Factory – A Conversation with Laks Pernenkil of Deloitte Consulting LLP

November 26, 2019

 At the 2019 edition of the Biomanufacturing World Summit series earlier this month in San Diego we spoke with Laks Pernenkil, Principal | Life Sciences Operations with Deloitte Consulting LLP. Laks shared his insights into digital transformation in general, and specifically how the ‘Smart Factory’ will change the way biopharmaceutical companies operate. — Deloitte Life Sciences Innovation starts with insight and seeing challenges in a new way. Amid unprecedented uncertainty and change, life sciences stakeholders are looking for new ways to transform their organizations using digital innovation and technologies. Deloitte’s team of thinkers and doers can help you imagine,…

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Cell and Gene Therapies and the Dawn of the Next Chapter of Biopharmaceutical Production
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Cell and Gene Therapies and the Dawn of the Next Chapter of Biopharmaceutical Production

November 26, 2019

What are some of the unique challenges and opportunities in commercializing live modalities like CAR-T? Weighing the pros and cons of centralized versus decentralized production models for these new treatments Discussing how our industry’s quality culture informs these new products from R&D right through to the patient Offering lessons learned from the first generation of cell and gene therapies. How will their example inform what we are doing now? Setting timelines for the future: What are we going to be able to do next year, five years from now, and ten years from now? What are we doing to get…

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Compliance, Quality, and Risk – A Conversation with Jack Garvey of Compliance Architects
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Compliance, Quality, and Risk – A Conversation with Jack Garvey of Compliance Architects

November 25, 2019

At the 2019 edition of the Biomanufacturing World Summit series earlier this month in San Diego we spoke with Jack Garvey, Compliance Architects’ co-founder and CEO. Jack has chaired the Quality stream of content for several Biomanufacturing World Summits, and he has deep insights to offer biopharmaceutical manufacturers looking to communicate with regulators and build their organizations to better address the issues of Compliance, Quality, and Risk. — Jack Garvey CEO Compliance Architects Jack Garvey is the Founder and Chief Executive Officer of Compliance Architects®, a leading consulting and advisory firm specializing in innovative quality and compliance solutions for FDA-regulated…

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Improving Product Quality During Technical Transfers
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Improving Product Quality During Technical Transfers

November 25, 2019

The definition of Technology Transfer and its many applications Planning for tech transfer the “right way,” using “Calculated Risk Reduction” and other tools to ensure all bases are covered Common pitfalls and best practices – what to do, and what not to do Ways to ensure optimal planning and execution using actionable tools — Eric Good Director, Compliance ProPharma Group Dr. Eric Good is an energetic leader with extensive U.S. and international manufacturing, project management, Consent Decree and quality systems experience with Fortune 500 Companies. Dr. Good has 29 years of award winning high-performance. He is an active leader in…

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Scaling Gene Therapy Manufacturing: What is Our Goal?
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Scaling Gene Therapy Manufacturing: What is Our Goal?

November 21, 2019

Highlighting the scale-up opportunity for dramatic patient benefit through the lens of a patient Outlining the inextricable link between manufacturing and the patient experience for autologous cell therapies Considering the different scaling goals: commercial viability, reliability, patient access, etc. — Derek Adams Chief Technology and Manufacturing Officer bluebird bio Derek Adams joined bluebird bio in March 2017 as Chief Technology and Manufacturing Officer leading all pharmaceutical sciences that includes process and analytical development, manufacturing, technical operations, and supply chain. Prior to joining bluebird, Derek was the Senior Vice President of CMC at Evelo Biosciences. At Evelo, Derek established the initial…

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The Centenarian and the Start Up: How Merck is Realizing its Biomanufacturing Revolution
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The Centenarian and the Start Up: How Merck is Realizing its Biomanufacturing Revolution

November 21, 2019

Discuss how today’s pipeline and technologies are reshaping our biomanufacturing Review case studies and strategies for rapid manufacturing scale up for leading products Focus on the criticality of investing in people and robust strategies to support the workforce and culture Show opportunities that allow for successful navigation in the future of manufacturing, including leveraging legacy and culture as drivers of change — Karin Shanahan SVP, Global Biologics & Sterile Operations Merck Karin is SVP, Global Biologics and Sterile Operations at Merck Pharmaceutical where she holds operational responsibility for manufacturing Keytruda and Gardasil in addition to other in-line and pipeline products….

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Technology Roadmap for the Biopharmaceutical Industry
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Technology Roadmap for the Biopharmaceutical Industry

November 19, 2019

Proving that the most valuable data in manufacturing is from production itself Choosing the right goals and outcomes to make a difference Connecting disparate IT systems together into a unified whole Building a scalable approach for the enterprise, step-by-step: Start small to go big Illustrating successful projects with concrete examples — Jun Huang Director/Team Leader, Process Monitoring, Automation & Control Pfizer Dr. Jun Huang is Director/Team Leader, with the Process Monitoring, Automation and Control group, part of Pfizer Global Technology & Engineering, based in NJ. He leads a team responsible for the development and implementation of Advanced Analytics, AI/ML, Advanced…

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Leveraging Predictive Technologies to Ensure Supply Chain Health – Case Study
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Leveraging Predictive Technologies to Ensure Supply Chain Health – Case Study

November 19, 2019

Deployed artificial and business intelligence to detect events that may create product availability issues, demand and supply related Implemented an automated management alarm and escalation system, emails and text messages, to accelerate response to supply-impacting events Implemented demand-driven scheduling system to connect production mix with actual demand Connected and integrated data across multiple platforms, e.g. PLCs, ERPs, QMS, LIMS, etc. — Jaime Velez Co-Founder Operations & Quality Systems Improvement Experts (OQSIE) For the last 15 years Jaime has supported more than one hundred consulting engagements with Life Science companies delivering significant productivity improvements in supply chain and quality systems. He…

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Global Talent Trends in Biomanufacturing 2019
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Global Talent Trends in Biomanufacturing 2019

November 19, 2019

An update on talent trends: what does it (seem to) take to make it to the top? Should I lead, over the next 10 years, the way I lead over the past 10 years? Culture: what is it (really) and how can we transform it as leaders? — Pascal Bécotte Co-Leader, Corporate Officers Sector (Global Functions) & Global Leader, Operations & Supply Chain Practice Russell Reynolds Associates Dr. Pascal Bécotte co-leads the firm’s global Corporate Officers Sector and leads the global Operations & Supply Chain Officers Practice. Pascal is also a key member of the Healthcare and Industrial Sectors, where…

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Evolving External Collaboration Models
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Evolving External Collaboration Models

November 21, 2018

Reviewing how our industry’s business partnerships have changed over time. How will this trend continue into the future? Dividing the work and sharing the burden: How should biopharmaceutical companies align their objectives of cost management, risk management, productivity, and growth? Maturing business relationships over time through common culture through two-way communication, collaboration, and cooperation Walking through examples of external collaboration: What works, what does not, and why? — Joanne Beck EVP, Global Pharmaceutical Development & Operations Celgene Corporation Dr. Joanne Beck is EVP Global Pharmaceutical Development and Operations at Celgene where she oversees the company’s Pharmaceutical Development, Global Manufacturing Operations,…

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Boosting Traceability and Security in the Supply Chain with Serialization
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Boosting Traceability and Security in the Supply Chain with Serialization

November 19, 2018

What is serialization? Global serialization mandates Impact on manufacturing and the pharma supply chain Implementation challenges Technologies – Now and into the future — George Skillin Sr. Director – Global Engineering Pfizer George Skillin is the Senior Director of Pfizer Global Engineering, where he manages a team of 35 engineering professionals in the Process, Equipment, Automation Engineering disciplines and manages the Global Serialization and Industrial Control System Cyber Security Programs for Pfizer. George joined Pfizer in 2002 taking on a 2+ year international assignment as a member of the Site Leadership Team in conjunction with the design, construction, and start-up…

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Embracing Advanced Manufacturing Processes and Technologies to Build Capability and Competitive Advantage
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Embracing Advanced Manufacturing Processes and Technologies to Build Capability and Competitive Advantage

November 19, 2018

Discussing how the evolution of manufacturing processes and technologies have transformed the biopharmaceutical industry When does new manufacturing capabilities generating product innovations, and when does product development spur advances in manufacturing? Debating the role new tools, tactics, and technology will have in overcoming the ongoing challenges currently facing the sector How should the industry continue to grow and develop the next generation of advanced manufacturing technologies? — Greg Guyer Global Head of Operations Bristol-Myers Squibb Dr. C. Greg Guyer is the Global Head of Operations at BMS. Prior to this he was SVP, Biologics Development & Operations and responsible for…

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Looking at the Big Picture: Where is Our Industry Going, and How Should We Get There?
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Looking at the Big Picture: Where is Our Industry Going, and How Should We Get There?

November 8, 2018

Debating the merits of nimble and flexible facilities versus manufacturing battleships Preparing your pilot plants and manufacturing facilities to move forward with Phase II-III approvals Forecasting requirements for optimizing manufacturing equipment, facilities and partners to increase speed to market Achieving business goals to better manage times of product and economic uncertainty Putting theory into practice: Implementing key metrics to improve manufacturing flexibility — Uwe Buecheler Corporate SVP, Biopharmaceuticals Boehringer Ingelheim Uwe Buecheler, joint Boehringer Ingelheim (formerly Dr. Karl Thomae GmbH) in 1991. During his time at Boehringer Ingelheim he held different positions in Biopharmaceuticals in Regulatory Affairs, Biological Safety and…

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Leveraging Artificial and Business Intelligence to Drive Productivity Improvement and Compliance
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Leveraging Artificial and Business Intelligence to Drive Productivity Improvement and Compliance

November 8, 2018

Common drivers for success: Leveraging Artificial and Business Intelligence to deploy automated systems to detect abnormal performance Deploying an automated management alarm and escalation system; used emails and text messages to accelerate response to performance-impacting events Creating real-time management dashboards and alerts, tailored for each role Connecting and integrating data across multiple platforms, e.g. PLCs, ERPs, QMS, LIMS, etc. Manufacturing Case Study: 300% productivity improvement in a capacity-constrained environment — Jaime Velez Partner OQSIE For the last 15 years Jaime has supported more than one hundred consulting engagements with Life Science companies delivering significant productivity improvements in supply chain and…

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Panel: The Global Talent War in Biomanufacturing
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Panel: The Global Talent War in Biomanufacturing

November 8, 2018

Learning about global talent trends influencing the job market for senior executives and those with critical, specialized skill sets Creating effective attraction, retention and development plans for top talent Navigating the generational talent gap in critical functions Understanding which leadership differentiators are needed to make it to Senior Executive and C-Level roles — Sanat Chattopadhyay EVP & President, Merck Manufacturing Division Merck Sanat Chattopadhyay is responsible for Merck’s worldwide manufacturing and supply operations supporting annual global sales revenues exceeding $40 billion. Merck is known as MSD outside of the U.S. and Canada. Sanat oversees a network of 50 pharmaceuticals, vaccines,…

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Leading and Leadership in Lean Bio-Manufacturing Operations
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Leading and Leadership in Lean Bio-Manufacturing Operations

January 31, 2018

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….

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

December 13, 2017

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…

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