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BMWS19

Industrialization of Drug Discovery: Manufacturing and Discovery Reimagined Through Artificial Intelligence
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Industrialization of Drug Discovery: Manufacturing and Discovery Reimagined Through Artificial Intelligence

Illustrating how AI is already changing the small molecule side of the pharmaceutical industry in both drug discovery and R&D Extrapolating from these examples to suggest biopharmaceutical manufacturing applications Drawing parallels from the industrialization of biologics manufacturing. How far away are we, and what should we as an industry be doing now to get ready? Discussing what small pilot programs and early test cases might look like, and the timelines involved in moving from proof of concept to industry-wide applications — Tina Larson Chief Operating Officer Recursion Pharmaceuticals Tina M. Larson is Chief Operating Officer at Recursion Pharmaceuticals. Recursion is…

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Digital Transformation in the Biopharmaceutical Industry – A Conversation with Randy Erwin of Cloudleaf
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Digital Transformation in the Biopharmaceutical Industry – A Conversation with Randy Erwin of Cloudleaf

 At the 2019 edition of the Biomanufacturing World Summit series last November in San Diego we spoke with Randy Erwin of Cloudleaf about how biopharmaceutical manfuacturers are embracing Industry 4.0 solutions to their unique challenges. Randy Erwin VP Sales Cloudleaf Cloudleaf’s mission is to create significant value across the end-to-end supply chain network by dramatically increasing visibility of product flow and condition. Customers increase revenues, reduce operational material losses, and enhance the reliability of operations. Our supply chain Visibility Platform delivers complete, real-time views and insights across the ecosystem from suppliers through production and distribution to customers. Using IoT,…

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Case Study: Challenges and Opportunities in Analytical Development for Cell and Gene Therapies
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Case Study: Challenges and Opportunities in Analytical Development for Cell and Gene Therapies

With no standardized methods in analytical development of cell and gene therapies, we must define our own best practices Looking at the evolution and industrialization of analytical development in biologics over the past 20 years: what did we learn and how can we leverage it now? With the current speed of evolution, what new tools will emerge to help us solve these complex challenges The high cost of analytical development and need for greater efficiency begs the question how do we get to where we need to be… And where do we need to be? — Stacey Ma EVP Technical…

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Keynote: When Your Process Equipment is a Raw Material and Your Raw Material is a Human: The Adaptation of Biotechnology CMC Skills to Cell Therapy
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Keynote: When Your Process Equipment is a Raw Material and Your Raw Material is a Human: The Adaptation of Biotechnology CMC Skills to Cell Therapy

CMC/Operations disciplines have an important role in the commercialization of powerful new cell therapies Well understood development principles can be applied, though there are challenges It is important to identify when to draw on experience and when to adapt/grow to address gaps Comparability is key in an emergent technology space, but may be limited by product understanding Growing development skills to advance important new medicines — Alison Moore Chief Technology Officer Allogene Therapeutics Dr. Alison Moore is Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as senior vice president, Process Development,in Amgen Operations. Moore was previously…

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Engineering Cold Chain Solutions to Support Ebola Clinical Trials – A Conversation with Dan Littlefield of Modality Solutions
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Engineering Cold Chain Solutions to Support Ebola Clinical Trials – A Conversation with Dan Littlefield of Modality Solutions

At the 2019 edition of the Biomanufacturing World Summit series last November in San Diego we spoke with Dan Littlefield of Modality Solutions. Dan recently worked with the National Institute of Health to support clinical trials to help fight Ebola in the Democratic Republic of Congo. In this interview, Dan talks about some of the challenges of working in an unusual environment, and how Modality Solutions’ experience designing and implementing bespoke cold chain solutions contributed to an important project. — Dan Littlefield Principal Modality Solutions Daniel J. Littlefield is a founder of Modality Solutions. He has helped establish Modality Solutions…

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The Future of Biomanufacturing: Leveraging Flexible Networks, Quality Culture and Cutting Edge Innovation
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The Future of Biomanufacturing: Leveraging Flexible Networks, Quality Culture and Cutting Edge Innovation

 How biomanufacturing can address the dichotomy of small volume precision medicines and high volume blockbuster drugs Building flexible global manufacturing networks to meet our industry’s evolving needs Leveraging cutting edge innovation to maximize process intensification and augment flexibility Creating high performance teams and building and maintaining a culture of quality, reliability and innovation as key differentiator and foundation for continued success Please note: Q&A appears in this separate video: — Jens Vogel President & CEO, BI Fremont Inc. Boehringer Ingelheim Biopharmaceuticals GmbH Dr. Jens Vogel is President and CEO of Boehringer Ingelheim Fremont Inc., the US arm of Boehringer…

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Keynote: The Successful History of Biologics Manufacturing Provides Foresights and Strategies for New Bio Modalities

Establishment of broad communities of practitioners in both manufacturing and process development accelerated maturation of both disciplines Convergence of these process and manufacturing technologies was driven by excellence and capacity in selected CMOs Manufacturing portability has provided remarkable stories of win-win capacity-exchange between proprietary companies Process convergence has resulted in remarkable progress in process yields and cost improvement Intro to Vir Bio: Capacity and cost improvements in bio-manufacturing facilitate global access to medicines for Infectious Disease — Michael Kamarck Chief Technology Officer Vir Biotechnology Michael Kamarck is Chief Technology Officer at Vir. Previously, he was senior vice president of Global…

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Digital Transformation for Biopharmaceutical Manufacturers – A Conversation with Amos Dor of Applied Materials
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Digital Transformation for Biopharmaceutical Manufacturers – A Conversation with Amos Dor of Applied Materials

At the 2019 edition of the Biomanufacturing World Summit series earlier this month in San Diego we spoke with Amos Dor, Applied Materials’ Pharma General Manager & CTO. Industry 4.0 solutions are transforming the way biopharmaceutical manufacturers do business, and Amos offered his insights into some of the challenges they are facing and the decisions they need to make as they bring these powerful new tools into existing operations. — Applied Materials provides pharma manufacturers an opportunity to leverage decades of experience in increasing productivity. SmartFactory Rx™ is a suite of advanced manufacturing software which enables pharma companies to achieve…

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Panel: Staying Ahead of the Curve in the Increasingly Complex Regulatory World of Cell and Gene Therapy
LIFE SCIENCES

Panel: Staying Ahead of the Curve in the Increasingly Complex Regulatory World of Cell and Gene Therapy

Discussing the growing regulatory complexity in the world of pharmaceutical manufacturing. How are new guidelines and regulators’ expectations during inspections changing? Taking a process-based approach to impact assessment, and customizing a setup that identifies and acts on signals proactively Bringing a structured approach to your advocacy within your network of industry and trade organization connections Embracing the idea that keeping things simple even in a complex environment generates the best outcomes — Pat Yang Former EVP at Juno Therapeutics, Roche and Genentech Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management…

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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

 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

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

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

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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Manufacturing Autologus Ex Vivo Genetically Modified Cell Therapies have Challenges, but the Future is Bright
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Manufacturing Autologus Ex Vivo Genetically Modified Cell Therapies have Challenges, but the Future is Bright

Review the supply chain Examine the contributors of costs Solution for industrial scale viral vector manufacturing Cell processing and viral transduction hubs Rapid analytics for product testing Brighter future for patients with fitter cell therapies — Joseph Tarnowski SVP, Cell & Gene Therapy, R&D Medicinal Science and Technology GSK Prior to his current role in CGT, Joe was the Senior Vice President of Biopharm CMC R&D. Before joining GSK in June, 2010, Joe was the Senior Vice President, Biologics Manufacturing and Process Development in the Technical Operations division of Bristol-Myers Squibb Co. in New Brunswick, NJ. Joe was responsible for…

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

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

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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Panel: Setting Ambitious Goals to Improve the Biopharmaceutical Ecosystem
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Panel: Setting Ambitious Goals to Improve the Biopharmaceutical Ecosystem

Discussing the growing regulatory complexity in the world of pharmaceutical manufacturing. How are new guidelines and regulators’ expectations during inspections changing? Taking a process-based approach to impact assessment, and customizing a setup that identifies and acts on signals proactively Bringing a structured approach to your advocacy within your network of industry and trade organization connections Embracing the idea that keeping things simple even in a complex environment generates the best outcomes — Pat Yang Former EVP at Juno Therapeutics, Roche and Genentech Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management…

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