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In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Ben Locwin, Chief Scientist, Head of Clinical Services and Project Sciences at Black Diamond Networks (BDN). Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Ben, covering: Being part of the Lonza growth story in its 'scrappy' years Learning never to say no to a good opportunity and how that's opened many doors Becoming part of the more significant patient conversations at Biogen Dropping in seal teams to help companies do what they may never have achieved Why is change always inevitable in our sector, and what may the future hold for us all? As the saying goes, we're all a product of our growth and past experiences. Ben Locwin is an industry and healthcare executive who has been variously described as a "Remarkably talented speaker" by the Association for Talent Development, a "Rockstar epidemiologist" by NPR, a "healthcare futurist" by Contract Pharma and Rodman Media, and "a good friend" by ...his friends. He began his journey as an astrophysicist 30 years ago and then transitioned into the world of biotech in the 1990s when the nascent industry was yet poised to take over the world. He has specialized training as a neuroscientist and has worked with some of the top companies in the industry, both as a leader and a consultant. He has been a member of several Boards, association committees, steering teams, Task Forces, and scientific advisory panels. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is also sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.
Ben Locwin discusses the science, quality, and future of GLP-1 receptor agonists, revolutionary drugs used in diabetes and obesity treatment. The episode explores the history and development of GLP-1s, their commercial viability, manufacturing challenges, and regulatory landscapes. Ben dives into the mechanisms of GLP-1s, including their influence on appetite, blood sugar, and gastrointestinal effects. They also touch on the capacity issues in production, the impact of compounding, and the sustainability concerns associated with injector pens. The conversation provides an in-depth look at the pharmaceutical industry's response to the surge in GLP-1 demand, highlighting the broader implications for patient care and market trends. 00:00 Introduction to GLP Receptor Agonists 00:46 Guest Introduction: Ben Locwin 01:48 Historical Context of GLP-1 Development 05:54 Mechanisms and Effects of GLP-1 09:51 Market Impact and Manufacturing Challenges 11:16 Regulatory and Advertising Considerations 17:44 Sustainability and Injector Pen Issues 19:40 Risk Management and Future Directions 23:31 Conclusion Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
In this episode of Evaluating Biopharma, host Ben Locwin and Scott Endicott, executive leader of Healthcare Solutions Integration, talk about data governance and data provenance—why they matter and how the industry can achieve them. With 30 years of experience, Endicott has a deep understanding of training AI and ML models, particularly when patient data is included, and offers advice on how to navigate the challenges of data governance and provenance in the near-term future. Links from this episode: Evaluating Biopharma Black Diamond Networks Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
GLP-1 drugs have become a game-changer in treating obesity and type 2 diabetes, forecast to reach a $100 billion market value by 2029. However, their rapid rise raises important questions about resource allocation in pharmaceutical development and manufacturing, as well as affecting the dynamics between patients, healthcare providers, and biopharma. In the latest episode of the PharmaSource podcast, Ben Locwin, Chief Scientist at Black Diamond Networks, explains that GLP-1 drugs represent a significant breakthrough in the treatment of obesity and diabetes and the unintended consequences they are bringing to the industry. Read the article here
In this informative episode of Let's Combinate, host Subhi Saadeh and frequent guest Ben delve into the key aspects of quality management across various organizational structures. Through their engaging discussion, they highlight the independence of quality units to prevent conflicts of interest, drawing parallels with finance and HR functions. They examine models like centralized, decentralized, and federated structures, supported by industry benchmarks and practical experiences. The conversation emphasizes the necessity of centralized ownership for consistent quality outcomes, despite quality being everyone's responsibility. Additionally, they explore the nuances within pharmaceutical companies, referencing a McKinsey study that underscores the importance of cultural and procedural elements over structural setup. Distinctions between Quality Assurance and Quality Control are clarified, focusing on the need for proactivity and integration for optimal results. This episode provides comprehensive insights into the structural, cultural, and procedural dimensions of effective quality management. 00:00 Introduction and Guest Welcome 00:19 Questioning the Quality Unit's Independence 01:19 Avoiding Conflicts of Interest in Quality 03:39 Organizational Structures and Quality 09:09 Centralized, Decentralized, and Federated Quality Models 12:06 Understanding Quality Reactivity 12:20 Insights from the McKinsey Study 13:36 The Importance of Quality Culture 14:23 Identifying Problematic Structures 15:19 Designing Non-Reactive Quality Systems 17:13 Quality Management System (QMS) Structures 19:05 QA vs. QC: Key Differences 22:07 Conclusion and Final Thoughts Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.
In this month's episode of Evaluating Biopharma, host Ben Locwin and Chris Major, founder and partner of BioProcess360 Partners, discuss the best ways to start a company to address technology gaps, why it is beneficial to collaborate with competitors (instead of going against each other), and the challenges encountered when planning to de-risk portfolios in advance. Major also talks about how he approaches funding, the best practices and lessons he learned about time-to-exit strategies, and how his organization is paying it forward to the industry. Links from this episode: Evaluating Biopharma Black Diamond Networks BioProcess360 Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
In this month's episode of Evaluating Biopharma, host Ben Locwin and Tony Arulanandam, SVP and head of R&D at Cytovia Therapeutics, discuss how AI is impacting the antibody R&D field, how companies are using AI to generate better sequences and improve efficacy, and methods on approaching regulators and tackling regulatory challenges. Arulanandam also talks about how he got started in biotech, getting therapies to underserved patient populations, and his thoughts on the promise of antibodies to treat cancer, autoimmune, and metabolic diseases. Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
In this month's special episode of Evaluating Biopharma, host Ben Locwin interviews Mara Strandlund, chief people officer at National Resilience, and Niamh Alix, chief human resources officer at Prime Medicine, about the upcoming Talent in Biopharma Leadership workshop at the 2024 Bioprocessing Summit. Their conversation covers a wide variety of topics about talent management, including prioritizing talent retention, building agility into talent acquisition strategies, the importance of brand and culture, and more. They also share tips on what goes into creating a team of exceptional talent, as well as a sneak peek into the key themes of their opening keynote. Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: 01:53 Material Qualification Discussion Begins 02:23 Material Qualification in Drugs vs. Devices 04:00 Quality Standards in Different Industries 08:54 Quality Tools and Their Applications 11:22 Material Qualification and Supplier Management 26:37 Regulations and Quality by Design 27:45 Closing Remarks and Guest's Current Work Ben's Article: Catalent Acquisition by Novo Holdings: Evolution of the Industry(?) Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.
In this month's episode of Evaluating Biopharma, host Ben Locwin and Joaquim Vives, head of production of advanced therapies at Banc de Sang i Teixits, discuss cell and gene therapies and what sets them apart from other therapeutics in terms of their processes. Vives also talks about the top characteristics of good starting materials and particular modes of handling logistics. He also delves into correlating a particular donor for a certain patient and shares where he sees the future of cell and gene therapy going. Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
In this episode of Evaluating Biopharma, host Ben Locwin speaks with Dr. Stefan Schmidt, CEO of evitria AG, about bispecific antibodies. Dr. Schmidt goes into detail about current trends (from a CRO's perspective) regarding the discovery and development phases of bispecific antibodies, why they are being made, and potential manufacturing issues. He also discusses the future of bispecific antibodies and concerns over intellectual property immunity influencing consistency and production. Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
In this episode of Evaluating Biopharma, host Ben Locwin and Jamie Martin, PMP, senior consultant at Black Diamond Networks, discuss the tips and tricks of successful program management. Martin shares his mental checklist of must-haves to ensure a successful start, techniques on what to do when things fall off-track, and the keys to continuous success as the program is running. He also provides advice for listeners who may have newer programs or are new to program management, as well as the “best-in-class" tidbits they can immediately use. Links from this episode: Evaluating Biopharma Black Diamond Networks Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
In this episode of Evaluating Biopharma, host Ben Locwin speaks with Brian Tham, principal consultant at Peregrine Bio, LLC, on how various projects are run in the pharmaceutical industry, how to improve the outcome and processes of projects, and how to continue improving processes and operational excellence. They also delve into the history of how the car manufacturing industry influenced the quality management models and standards of the biotech and pharmaceutical industries. Finally, Tham shares his thoughts on the key differences between biotech and pharmaceuticals and other manufacturing industries, what this means for how development programs are managed, and what the future holds for process improvement. Links from this episode: Evaluating Biopharma Black Diamond Networks Peregrine Bio Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
In this month's episode of Evaluating Biopharma, host Ben Locwin speaks with Nesredin Mussa, PhD, president of Dynamica Biologics, about navigating the challenges of securing successful CDMO-sponsor relationships for a rare disease manufacturing and testing paradigm, the key contributing factors that may pose within the partnership between the sponsor and CDMO, and how small companies can manage with the enhanced regulatory demands due to the nascent nature of these particular therapeutic platforms. Mussa also provides advice on how to reframe one's thinking when facing challenges, as well as techniques on keeping grounded when the going gets tough. LINKEDIN URLS: Ben Locwin Black Diamond Networks Cambridge Healthtech InstituteEvaluating BiopharmaNesredin Mussa, PhD Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: Dealing with CDMO's and CXO's Supply Chain and Logistics and Pharma and Medical Devices Reverse Knowledge Transfer Building Trust with CXO's and Leveraging Surveys The future of the CDMO Market Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.
rocess intensification can be an overwhelming experience. In this episode of Evaluating Biopharma, host Ben Locwin speaks with Dr. Stefan Schmidt, CEO of evitria AG, about strategies and approaches that can help you understand and figure out how to navigate process intensification. Schmidt discusses ways to produce consistent results while using different equipment and technologies, how to find a balance between volume and capacity, and his experiences of putting proper support infrastructure as you go along the process. He also breaks down life cycle strategies and talks about downtime and its impact on the costs of the intensification strategy. Links from this episode: Evaluating Biopharma Black Diamond Networks evitria AG Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
In this episode of Evaluating Biopharma, host Ben Locwin speaks with Santoshkumar Khatwani, Director – Analytical Development, Late-Stage CMC Analytical Team Lead at Sangamo Therapeutics, about impurities in gene therapy processes and the ways to identify them. Khatwani discusses how to determine if these impurities are from the product, the process, or the host cell. He also talks about using multiple different analytical methods to help understand how good your process is or isn't, what to look out for when prioritizing by phase, and how to choose the best approach to measure process attributes. Finally, he shares his thoughts on leveraging data to its fullest potential to improve processes and how data can provide a more holistic view of how the process is performing. Links from this episode: Evaluating Biopharma Black Diamond NetworksSangamo Therapeutics Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
What are some strategies that companies can use to get to IND filing quickly? In this brand new conversation, Evaluating Biopharma podcast host Ben Locwin discusses the risks and rewards of speed-to-IND strategies with Susan Jones, Chief Technology Officer at Tourmaline Bio. Susan delves into her 30 years of experience in the biotech industry, how quality by design impacts IND filing, and the pitfalls of using platform approaches to accelerate early development. Finally, she shares some case studies where accelerated timelines led to unexpected outcomes, as well as advice on knowing your situation and risks, and spending time understanding your molecule first. Links from this episode: Evaluating Biopharma Black Diamond Networks Tourmaline Bio Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
In this episode of Evaluating Biopharma, host Ben Locwin, Vice President of Project Solutions at Black Diamond Networks, speaks with Jonathan Tsang, Senior Director, Manufacturing Sciences & Technology at Kite Pharma, who shares his experiences and provides advice on how autologous cell therapy companies can better prepare for commercial manufacturing, including: addressing the challenge of variability of patient cell behavior, process development characterization using healthy donor vs. patient cells, volume and logistical complexity of personalized therapy, and planning and implementing fast and efficient business systems to support scale-out. He also discusses critical quality attributes he looks for during process development and his thoughts on developing processes that can cope with variability in reagents, media, and more. Links from this episode: Evaluating Biopharma Black Diamond Networks Kite Pharma Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
In this episode of Evaluating Biopharma, Ben Locwin, Vice President of Project Solutions at Black Diamond Networks, speaks with Susan D'Costa, Chief Technology Officer at Alcyone Therapeutics, who shares her experiences and provides advice on how your company can identify and overcome CMC challenges in gene therapy, including: understanding and monitoring DNA constructs, identifying starting material challenges, prioritizing potency assays, and the impact of viral vector delivery and development of capsid tropism. D'Costa also talks about her hopes for the future of gene therapies and building better CMCs, processes, and characterization tools that will provide more accessible treatment for patients. Links from this episode: Evaluating Biopharma Black Diamond Networks Alycone Therapeutics Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
Marty Giedlin, vice president and head of technology operations at Senti Bio, speaks with moderator Ben Locwin, vice president of project solutions at Black Diamond Networks, to share his experiences and provide advice on how allogeneic cell therapy companies can implement better manufacturing strategies. He discusses understanding and managing manufacturing expectations, letting biology drive strategic operations, and why data must drive chemistry, manufacturing, and controls. Giedlin also outlines how to best characterize starting materials, why a one-size-fits-all approach to process manufacturing is unrealistic, his predictions for the industry over the next five years, and his work developing NK-CAR treatments for various cancer cells. Links from this episode: Evaluating Biopharma Senti Biosciences Black Diamond Networks Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
Welcome to the Greetings and Felicitations, a podcast where I explore topics which might not seem to be directly related to compliance but clearly influence our profession. Today we delve into the most controversial topics of the day with guest Ben Locwin. We speak about postmodernism - a philosophical movement that emerged in the late 1800s, challenging traditional views of universal truths and the idea of an objective reality. Ben believes that rejecting the thought process of our predecessors has become popular, with an emphasis on fashion and social media. He says it's important to get facts from reliable sources, not just from viral content. Ben stressed the importance of primary education, advocating for the teaching of scientific methods to uphold the value of evidence-based opinion. Join us on Greetings and Felicitations as we explore the pressing topics of today with genuine and thoughtful conversations. Key Highlights The Postmodern rejection of the Enlightenment and its impact on Society [00:05:10] Innovation and Disruption in Established Fields of Science [00:09:30] The Impact of Popular Culture on Society [00:13:41] The Perils of Social Media's Echo Chambers: Recognizing the Need for Evidence-Based Truths [00:17:51] The Dangers of Alternative Facts [00:22:10] Role of Primary Education in Constructive Correction and Critical Thinking [00:26:48] Notable Quotes 1. "It's really a broad topic. It is an interesting 1 to me because it's ultimately very philosophical, and I tend to try to stray away from that. On a daily basis." 2. "Postmodernism suggests that it's fashionable to reject clear minded rational thinking. It basically distinguishes itself from other schools of thought by rejecting universal truths, by rejecting an objective reality." 3. "Another big 1 is reject any idea that through the use of reason and logic that human beings can change themselves in societies for the better." 4. "John Adams once observed, I'll have to paraphrase it, but something like facts are stubborn things. And whatever may be our wishes or inclinations or the dictates of our passions. They can't alter the state of facts and evidence."" Resources Ben Locwin on LinkedIn
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: - FDA Drug Shortages Report - Drug Shortages and Drug Pricing - How he approaches Mastering new skill sets and building deep understanding in new areas Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.
Parrish Galliher, an independent bioprocess consultant, speaks with moderator Ben Locwin, vice president of project solutions at Black Diamond Networks, about the context-dependent issues that arise when scaling-up protein production. Gallaher uses a case study involving scaling challenges in E. coli bioprocesses that produced a product at 50% potency. He also talks about the three main focus points every company should prioritize when assessing process development limitations, how to design scale-down studies to pinpoint causal factors, and how to use high-throughput screening for media optimization. Finally, he advises hiring first-rate process development experts to mitigate scaling issues from the start. Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
In the biopharma space, nearly every moving part is contingent upon a functioning supply chain. In this month's episode, moderator Ben Locwin, vice president of project solutions at Black Diamond Networks, speaks with Rich Musa, director and head of supply chain at Cipla Therapeutics, about anticipating supply chain disruptions and planning for shortages. Musa talks about maintaining materials inventory, structuring robust supplier contracts, securing backup suppliers, and investing in a third-party supply chain analysis. He also outlines the proper way to forecast materials, manage risk versus loss, and prepare suppliers to meet demand requirements in a dynamic environment. Links from this episode: Evaluating Biopharma Cipla Therapeutics Black Diamond Networks Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
Dave Backer, founder of DB Biologics and former chief commercial officer at Oxford Biomedica, speaks with moderator Ben Locwin, vice president of project solutions at Black Diamond Networks, about the complex business and technological decisions companies face when navigating supply chain issues in the cell and gene therapy (CGT) market. Today's companies must decide whether to build new facilities and produce their own supplies, continue buying from CDMOs despite excessive lead times, or choose a hybrid model. In this episode, Backer outlines the critical factors every CGT company should consider before venturing into manufacturing. He talks about why companies must think of plasma, lentivirus, and autologous cell therapy lines as separate entities, the value of developing solid partnerships with CDMOs, and how a hybrid model can protect intellectual property while still maximizing productivity. Links from this episode: Evaluating Biopharma Oxford Biomedica Black Diamond Networks Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
Welcome to Automating Quality. Mandy Gervasio is your host, and she's on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today's episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. The topic of today's episode is good machine learning practices for the medical devices industry. Ben discusses some good machine learning practices (GMLP) and discusses the importance of standardizing those across the industry over time. Key Takeaways 01:00 Today's topic is good machine learning practices for the medical devices industry 01:20 Introducing today's guest: Ben Locwin 03:30 Ben introduces good machine learning practice guiding principles 06:43 How quickly will there be a set standardized framework for good machine learning practices (GMLP)? 11:10 Why this topic matters a lot 12:15 Will new competencies need to be developed for understanding the regulations and techniques in the field of machine learning? 14:36 Thank you to our guests and listeners!
In this episode, Josefine Persson, Genentech associate director, and Ben Locwin, Black Diamond Networks vice president of project solutions, discuss how the cost of oversampling from clinical GMP runs versus development sources equates to high expenses and lost opportunities in moving a new project into GMP manufacturing. Persson also talks about the role judicious sampling plays in testing and verifying process operations and how she worked with various Genentech departments to reduce product sampling volumes by more than 50 percent. She goes on to discuss the importance of changing the company mindset to encourage behaviors based on department needs rather than wants, especially with smaller indication products. Finally, Persson details how conservative clinical GMP sampling dramatically impacts direct and indirect costs, increases speed to market, and reduces environmental impact. Links from this episode: Evaluating Biopharma Genentech Black Diamond Networks Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today's decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.
Welcome to Automating Quality. Mandy Gervasio is your host, and she's on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today's episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. Today's topic of discussion is artificial intelligence and machine learning. Ben delivers some background on those buzzwords, how they relate to the FDA's action plan, how this will impact the medical device industry moving forward, and more! Key Takeaways 01:22 Introducing today's guest Ben Locwin 03:26 Some background on artificial intelligence and machine learning 05:24 Common misunderstandings about those buzzwords 07:10 What is deep learning versus machine learning and AI? 08:43 How do these areas relate to the FDA's action plan? 14:05 How will this impact the medical device industry moving forward? 18:40 Mandy thanks Ben for joining us on the show
Welcome to Automating Quality. Mandy Gervasio is your host, and she's on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today's episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. The topic of today's discussion is the Real-World Evidence framework as defined by the FDA. We highly recommend listening to the previous episode on Real-World Data and Real-World Evidence before diving into this one. Key Takeaways 00:17 Mandy introduces Ben back to the show 01:13 Today's topic is the Real-World Evidence framework 02:24 What is the FDA's definition of Real-World Evidence? 06:50 What is being looked at for the framework? 09:16 What are the 4 Vs of data? 11:18 How do you define your hypotheses in advance when looking at data? 15:44 Mandy reflects on today's discussion
Welcome to Automating Quality. Mandy Gervasio is your host, and she's on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today's episode features a conversation with guest expert Ben Locwin. Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. The topic of today's discussion is about defining what are Real-World Data and Real-World Evidence (RWD & RWE). Key Takeaways 01:13 Introducing today's guest: Ben Locwin 03:03 Philippe discusses the link between Real-World Data and its connection with technology 05:05 Ben defines Real-World Data and Real-World Evidence 10:28 Philippe discusses the importance of the integrity of data gathered from different sources 12:18 The importance of looking at the data with a specific hypothesis in mind 15:45 There is a lack of standardizing in data that leaves some concern 17:07 What is the FDA looking for regarding Real-World Data and Real-World evidence? 20:00 Ben shares his closing thoughts on the topic Contact us at solabs-podcast@solabs.com
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: - Behavioral Neuroscience and the soft skills of Quality - Quality, Compliance and Risk Management - Pharmacogenomics and Orwell - Combination Products Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.
As Russia invades Ukraine, Tom and Jay settle in and are back looking at some of the week's top compliance and ethics stories this week in the Russia Invades edition. Stories What Russia invasion could mean for corporate governance. Michael Peregrine in Forbes.com. What do sanctions mean for US companies? Jaclyn Jaeger in Compliance Week (sub req'd) Why is subculture audits so critical? Vera Cherepanova explains in the FCPA Blog. KT Corp. settles FCPA enforcement action. Tom (FCPA Compliance and Ethics Blog) and Mike Volkov (Corruption Crime and Compliance) both have 3-part series. Matt Kelly's take in Radical Compliance. Tom and Matt in Compliance into the Weeds. National Cryptocurrency Enforcement Team and what it means. Kathleen McDermott and Mark Krotoski in CCI. David Smagalla in WSJ Risk and Compliance Journal. How Credit Suisse facilitated crime, corruption, and dictators. Jessie Drucker and Ben Hubbard in the New York Times. Why diversity on investigation teams matters. Karin Portlock and Jabari Julien in Compliance and Enforcement. Could small-cap directors & officers could face ESG liability. Lawrence Heim in practicalESG. Global trends in corporate governance for 2022. Richard Fields, Rusty O'Kelley III, and Laura Sanderson, in Harvard Law School Forum on Corporate Governance. Roger Ng trial in danger of collapse due to prosecution 'inexcusable error .'Stewart Bishop in Law360. (sub req'd) Using the FCPA to fight the demand side of bribery. Matthew Stephenson in GAB. Podcasts and More In February on The Compliance Life, I visited with Ellen Smith, a former Director of Trade Compliance who recently started her consulting firm. In Part 1, she discussed her academic background and early professional career. In Part 2, Ellen discussed her move in-house. In Part 3, Ellen discusses being a part of the Compliance Dream Team at Weatherford. In Part 4, Ellen moves into the world of consulting. On the FCPA Compliance Report, Tom began a 2-part series with Trade Compliance guru Matt Silverman on possible Russia sanction (Part 1) and the corporate response (Part 2). Part 2 posts Monday, February 28. CCI releases a new e-book from Mike Volkov, "Compliance Culture Revolution ."Available free from CCI. Gwen Hassan has a special 2-part pod series on Hidden Traffic with Jeff Bond, from the Global Fund to End Modern Slavery, on the impact of climate change on modern slavery. Part 1 and Part 2. Are you a Star Wars fan? How about an uber-Geek? You will love the 5-part series on Science of Star Wars in the Greeting and Felicitations podcast series on the Compliance Podcast Network if you are either or both. In this series, Tom visits astrophysicist Dr. Ben Locwin on the following topics: Episode 1-Traveling in Hyperspace, Episode 2-Fighting with a Light Saber, Episode 3-Mechanical Prosthetics, Episode 4-Cyborgs, and Robots and Episode 5- Death Star. It is a ton of fun, and you will love it. Tom Fox is the Voice of Compliance and can be reached at tfox@tfoxlaw.com. Jay Rosen is Mr. Monitor and can be reached at jrosen@affiliatedmonitors.com. Learn more about your ad choices. Visit megaphone.fm/adchoices
Star Wars continues to be the most successful movie franchise in history. The movies are great fun, the story telling is excellent, thoroughly based on the Hero's Journey and the characters are some of the most beloved in cinema history. Whether your favorite scene is the from jump into hyperspace, the climactic lightsaber duel between Obi Wan Kenobi and Darth Vadar, Vadar intoning “I am your father”, or the destruction of the Death Star they all still resonate today. But what of the science of Star Wars. Are these great scenes and effects even possible? Do they violate the laws of physics and nature as we understand them today? Join Tom Fox and Dr. Ben Locwin, a healthcare executive, who in addition to his medical expertise is a degreed astrophysicist, as the look behind some of the most exciting scenes in Star Wars to look at the portrayal of science in Star Wars. In this concluding Episode 5, they discuss the Death Star. Some of the topics covered are: 1. How is it constructed? Can you build a small planet in space? 2. How would you generate the energy to fully arm the weapon? 3. Why is there no kinetic free lunch in space ? 4. How does the James Webb Telescope apply to the Death Star? 5. What are LaGrange Points and how do they apply to the Death Star?
Star Wars continues to be the most successful movie franchise in history. The movies are great fun, the story telling is excellent, thoroughly based on the Hero's Journey and the characters are some of the most beloved in cinema history. Whether your favorite scene is the from jump into hyperspace, the climactic lightsaber duel between Obi Wan Kenobi and Darth Vadar, Vadar intoning “I am your father”, or the destruction of the Death Star they all still resonate today. But what of the science of Star Wars. Are these great scenes and effects even possible? Do they violate the laws of physics and nature as we understand them today? Join Tom Fox and Dr. Ben Locwin, a healthcare executive, who in addition to his medical expertise is a degreed astrophysicist, as the look behind some of the most exciting scenes in Star Wars to look at the portrayal of science in Star Wars. In Episode 4, they discuss the Robots and Cyborgs. Some of the topics covered are: 1. Where did the term ‘robot' derive from? 2. Is Darth Vadar a cyborg? 3. Are these stories simply Pinocchio brought forward? 4. What is the difference in strong v. weak AI? 5. How does the Turing Test apply?
Star Wars continues to be the most successful movie franchise in history. The movies are great fun, the story telling is excellent, thoroughly based on the Hero's Journey and the characters are some of the most beloved in cinema history. Whether your favorite scene is the from jump into hyperspace, the climactic lightsaber duel between Obi Wan Kenobi and Darth Vadar, Vadar intoning “I am your father”, or the destruction of the Death Star they all still resonate today. But what of the science of Star Wars. Are these great scenes and effects even possible? Do they violate the laws of physics and nature as we understand them today? Join Tom Fox and Dr. Ben Locwin, a healthcare executive, who in addition to his medical expertise is a degreed astrophysicist, as the look behind some of the most exciting scenes in Star Wars to look at the portrayal of science in Star Wars. In Episode 3, they discuss the mechanical prosthetics as used on Luke after his forearm is severed by Darth Vadar. Some of the topics covered are: 1. Sequential current must be deployed to detract muscles to create motion. 2.The role of artificial intelligence and machine learning in mechanical prosthetics. 3. Regenerative cell therapy for skin covering? 4. How are chambers powered?
Star Wars continues to be the most successful movie franchise in history. The movies are great fun, the story telling is excellent, thoroughly based on the Hero's Journey and the characters are some of the most beloved in cinema history. Whether your favorite scene is the from jump into hyperspace, the climactic lightsaber duel between Obi Wan Kenobi and Darth Vadar, Vadar intoning “I am your father”, or the destruction of the Death Star they all still resonate today. But what of the science of Star Wars. Are these great scenes and effects even possible? Do they violate the laws of physics and nature as we understand them today? Join Tom Fox and Dr. Ben Locwin, a healthcare executive, who in addition to his medical expertise is a degreed astrophysicist, as the look behind some of the most exciting scenes in Star Wars to look at the portrayal of science in Star Wars. In Episode 2, they discuss dueling with lightsabers. Some of the topics covered are: 1. As cool now as it was in 1977. 2. How to generate the photon beam of light? 3. Could the beam be similar to lightening? 4. Would the ‘blades' pass through each other? 5. Blaster photons would pass through them.
Star Wars continues to be the most successful movie franchise in history. The movies are great fun, the story telling is excellent, thoroughly based on the Hero's Journey and the characters are some of the most beloved in cinema history. Whether your favorite scene is the from jump into hyperspace, the climactic lightsaber duel between Obi Wan Kenobi and Darth Vadar, Vadar intoning “I am your father”, or the destruction of the Death Star they all still resonate today. But what of the science of Star Wars. Are these great scenes and effects even possible? Do they violate the laws of physics and nature as we understand them today? Join Tom Fox and Dr. Ben Locwin, a healthcare executive, who in addition to his medical expertise is a degreed astrophysicist, as the look behind some of the most exciting scenes in Star Wars to look at the portrayal of science in Star Wars. In Episode 1, they consider traveling in hyperspace. Some of the topics covered are: 1. The visual effect of light bending. 2. Does traveling in hyperspace violated Einstein's Law of Special Relativity. 3. What would traveling in hyperspace do to the human body? 4. How does one navigate in hyperspace.
Super Sunday passed with fun but poorly played, poorly officiated, and poorly coached. Tom and Jay are back to look at some of the week's top compliance and ethics stories this week in the Rams Win It All Edition. Stories Ericsson is in more FCPA trouble. Mengqi Sun in the WSJ Risk and Compliance Journal. Aaron Nicodemus in Compliance Week. (sub req'd) DD impeding compliance in developing markets? Katya Lysova explores in the FCPA Blog. ESG-no longer a nice to have. Karen Alonardo in Risk and Compliance Matters. State AGs are waiting. Ashley Taylor and Chris Carlson in CCI. The latest case on CCO liability. Matt Kelly in Radical Compliance. Broken windows and compliance enforcement. Anthony O'Reilly in Compliance and Enforcement. Companies yet again ask the EU for rules around ESG. Lawrence Heim in practicalESG. White-collar enforcement trends in 2021. Jamie Rosenberg in Grand Jury Target. HP-Autonomy from the auditors' perspective. Francine McKenna in The Dig. South African courts deny Zuma's attempt to remove the SA corruption prosecutor. Rick Messick in GAB. Podcasts and More In February on The Compliance Life, I visited Ellen Smith, a former Director of Trade Compliance who recently started her consulting firm. In Part 1, she discussed her academic background and early professional career. In Part 2, Ellen discussed her move in-house. In Part 3, Ellen discusses being a part of the Compliance Dream Team at Weatherford. Tom and Richard Lummis are in the middle of their annual review of Best Picturing winning movies on 12 O'Clock High, a podcast on business leadership. Part 1 reviews Schindler's List for leadership and ethical lessons. In Part 2, the look at Gladiator. CCI releases a new e-book from Mike Volkov, "Compliance Culture Revolution." Available free from CCI. Tom looks at some innovation in compliance with a 3-part blog post series in the FCPA Compliance and Ethics Blog. Topics include Compliance Ecosystem Governance, Compliance Branding, Building Culture & Compliance Coaching. Are you a Star Wars fan? How about an uber-Geek? You will love the 5-part series appearing next week on the Greeting and Felicitations podcast series on the Compliance Podcast Network if you are either or both. In this series, Tom visits astrophysicist Dr. Ben Locwin on the following topics: Traveling in Hyperspace, Fighting with a Light Saber, Mechanical Prosthetics, Cyborgs and Robots, and the Death Star. It is a ton of fun, and you will love it. Each episode will post at 10 each day next week. Check it out daily. Tom Fox is the Voice of Compliance and can be reached at tfox@tfoxlaw.com. Jay Rosen is Mr. Monitor and can be reached at jrosen@affiliatedmonitors.com. Learn more about your ad choices. Visit megaphone.fm/adchoices
Scott Endicott and Ben Locwin with host Tom Fox are back for this concluding capstone episode in the Understanding Lyme Disease Podcast series. In this episode, they talk about the most current developments in Lyme Disease treatment, what's new in diagnostic treatments and what is on the horizon for both treatments and Lyme Disease patients. Resources Scott Endicott | LinkedIn Ben Locwin | LinkedIn | Twitter American Lyme Disease Foundation www.aldf.com LymeDisease.org International Lyme and Associated Diseases Educational Foundation ILADEF International Lyme and Associated Diseases Society
Scott Endicott and Ben Locwin with host Tom Fox are back for part 5 of the Understanding Lyme Disease Podcast series. In this episode, they talk about living with chronic toxicity and co-infectious agents. A Useful Approach to Knowledge The best way to help yourself, and loved ones who have been diagnosed with Lyme disease, is to seek out accurate information to make sure that you get the best treatment options available. The earlier treatment is applied, the more effective it is. The Next Steps Scott talks about a few innovative initiatives regarding Lyme disease. Focusing on diagnostic criteria and treatment approaches will be a great opportunity to turn the disease around. Currently, there is an increased acceptance of the disease and less stigma so that will go a long way in creating more options and opportunities for treatment. “There's been a much broader acceptance of Lyme in health insurance claims that's actually gone from being a very difficult diagnosis to one that's much more accepted,” Scott tells Tom. On the chronic side of the disease, Scott recommends that persons afflicted with tick bites get doxycycline in their systems as soon as possible. Knowing The Cause The more patients understand about Lyme disease, the more they would be able to apply smarter resources to improve prevention and care. They can be able to manipulate the neutrophils [the disruption of the immune system]. The more they understand about the science behind the causative agents, the easier it will be to fight it. Resources Scott Endicott | LinkedIn Ben Locwin | LinkedIn | Twitter
Is compliance the happiest profession? Are you passionate about compliance? If you are either or both, you are not alone. Guest Host Karen Woody and Tom Fox look at these and other stories this week in the Happiest Profession edition. Stories Is Compliance the happiest profession? Amii Bernard-Bahn explores in Compliance Week (Sub Req'd) Report on SEC Enforcement Activity: Public Companies and Subsidiaries for 2021. Tom Gorman in SEC Actions. Supply chain and compliance. Mike Volkov in Corruption Crime and Compliance. Dick Cassin in the FCPA Blog. What does ESG mean for the SEC? Commissioner Crenshaw remarks to the Pepsico-PWE Conference in the Harvard Law School Forum on Corporate Governance. Corruption as psychic revenge. Richard Bistrong in the FCPA Blog. Mitigating cyber risks. Debevoise Plimpton lawyers in Compliance and Enforcement. COP26 wrap up. What are the lessons for compliance? Lawrence Heim in PracticalESG. SEC broke all whistleblower awards in FY 2021. Aaron Nicodemus in Compliance Week (Sub Req'd) Carrie Penman says it's a wakeup call for companies in Ethics and Compliance Matters. Diversity at the top. Jim Deloach in CCI. How did Classical Athenians define corruption? Kellam Conover in GAB. Podcasts and Events Have you or a loved one been impacted by Lyme Disease? This week I have run a 5-part series on this most misunderstood malady with Dr. Ben Locwin and Scott Endicott. In Part 1 we looked at Origins. In Part 2 we considered the Diagnosis Dilemma. In Part 3 we reviewed Treatment and Innovation. In Part 4, we discussed Prevention and Immunity. In Part 5, we looked ahead for where this disease detection, prevention and treatment might be heading. Are you exasperated? Then check, F*ing Argentina. In this podcast series co-hosts Tom Fox and Gregg Greenberg, author of F*ing Argentina explore the current American psyche of being overworked, over leveraged, overtired and overwhelmed. Find out about modern America's exasperation with well…exasperation. In Episode 10, a trip on the New Jersey Turnpike. This month on The Compliance Life, I visit with Wendy Badger, CCO at Tennant. In Part 1, she details her academic career and early professional life. In Part 2, changing ladders to advance your career. In Part 3, Wendy moves into the CCO Chair. How does a Compliance Bible become a best-seller? Check out Tom's appearance on the C-Suite Network's Best Seller TV to find out. Purchase The Compliance Handbook, 2nd edition here. Tom Fox is the Voice of Compliance and can be reached at tfox@tfoxlaw.com. Karen Woody is Associate Professor at Washington and Lee University School of Law and can be reached at kwoody@wlu.edu. Learn more about your ad choices. Visit megaphone.fm/adchoices
Scott Endicott and Ben Locwin with host Tom Fox are back for part 4 of the Understanding Lyme Disease Podcast series. In this episode, they talk about the immune system as the body's first line of defense, how to boost your immunity, and take charge of your health. Prevention Beats Correction Prevention beats correction every time, and the best way to treat Lyme disease is to reduce your chances of contracting it at all. Ben advises listeners to take precautions when entering areas where ticks are common. Wear long-sleeved shirts, long pants, and boots if possible. Use tick repellent, salves, and sprays. If you do happen to find a tick on you, only remove it with tweezers; do not use petroleum jelly or try to burn it off. Post Treatment Lyme Disease Syndrome Some patients who have been treated for Lyme disease still feel lingering symptoms. This used to be considered Chronic Lyme Disease. Evidence shows that no persistent infection is left within patients so the official term is now Post Treatment Lyme Disease Syndrome. Building Your Immunity One of the best things a person can do is work on building their self immunity. Improving your diet, exercise, and stress levels are key to your recovery. A consistent exercise regimen especially helps to build back your immunity. "Many of the side effects and symptoms of persistent Lyme or Post Treatment Lyme Disease are psychiatric and mental," Scott tells Tom. Doing your best to fortify your body and mind is going to do wonders with strengthening your immune system. Take Charge of Your Health You need to take charge of your health, both physically and mentally. "Being discerning about your own health and being your own advocate is probably one of your best defenses," Scott says. Do what you can to ease stress: yoga or meditation are good options. Make use of the information that is available; get educated about what's happening around you so you can make decisions about your own medical care. Resources Scott Endicott | LinkedIn Ben Locwin | LinkedIn | Twitter
Tom Fox welcomes back Scott Endicott and Ben Locwin to part 3 of the Understanding Lyme Disease Podcast Series. In this episode, they look at treatment solutions for Lyme disease. The Current Lyme Treatment The current treatment for Lyme disease is more focused on adults. It's a non innovative approach, however, as Ben points out. The current standard treatment is a 100 milligram dosage of Doxycycline twice per day for 10 to 12 days. Patients will typically get three weeks worth of prescription. For children, they are prescribed Amoxicillin as they can't tolerate Doxycycline. This dosage would be 50 milligrams, three times a day. The current treatment protocols are inadequate for the population who have Lyme disease symptoms, Ben tells Tom. Both the infectious disease community and the academic research and physician community are holding fast to their own views on how Lyme disease is to be treated and what works and what doesn't. This poses a challenge, Scott remarks. The Need For Innovation "The Health and Human Services (HHS) just put together a working group that is actually looking at emergent innovative approaches, and some of those innovative approaches are ones that the Lyme specialists have been using for many years, like PICC lyme antibiotics, essentially intravenous antibiotics in order to arrest very accelerated symptoms and symptoms that have taken patients to a place where there needs to be massive changes to their health or things are going to continue... to just get worse," he adds. This kind of innovation needs to be more normalized, and clinical experts need to remove themselves from their old school way of thinking. When new data is coming in from patient case reports, experts should be able to build new hypotheses, Scott and Ben argue. They shouldn't have such an emotional conviction to past beliefs that they can't be moved by new data. Innovating patient care and treatment is to understand exactly what is clear within the data, and for what isn't clear, to make adjustments. The Next Step Research and medication needs to adapt. What was believed to be effective in the past is no longer so in the present. "Frankly in clinical medicine, the endpoints to show that something is efficacious are either to demonstrate improvements and how a patient feels or functions or survives," Scott says. Measuring survivability is important but if patients are presenting that they don't feel well, or aren't functioning the same, and medical experts turn a blind eye to that, then there will be no innovation in terms of truly tackling the disease. The next step for treatment would be diagnostic testing that gets much closer, and that which puts data back into the hands of clinicians, so they can advise patients properly and with better protocols. Resources Scott Endicott | LinkedIn Ben Locwin | LinkedIn | Twitter
Tom Fox welcomes back Scott Endicott and Ben Locwin on this episode of the Understanding Lyme Disease Podcast Series. Scott - who has had Lyme disease - is a clinical researcher, and Ben deals with Healthcare Policy at Maven. In this episode, they look at the changes that occur in the body when you contract Lyme disease. Testing For Lyme Disease There are blood tests that are carried out to determine whether a patient has Lyme disease, and it's a two step process. The first half of the test is called the Eliza test which detects antibodies the human body may or may not be producing against the organism that causes Lyme disease. The second half of the blood tests is called the Western blot which looks at antibodies to specific proteins in the Borrelia Burgdorferi organism. These tests are the original diagnostic tests and have been used since the beginning. The Problems with Diagnosis Scott explains that PCR testing has come about after these tests and is there to identify the infecting agent. The challenge with PCR testing, however, is the way that the Borrelia Burgdorferi organism actually behaves in real time. The challenge with the Eliza and Western blot as well is that both tests can give false negatives for weeks because the organism has a way of mutating and masking itself. Diagnosis has been dependent on the primary symptom of Lyme disease which is the bullseye rash, a symptom only 30% of patients have. This makes it challenging and confusing for these patients. Clinicians are being given a primary symptom that only one third of patients experience. "There is a real disparity there with as far as how clinicians view this and very often...they'll basically look at it and say, ‘Well if it's not a rash, then I'm not going to treat you at this point,'" Scott remarks. Infectious disease experts will advise patients to treat with Doxycycline, and essentially hope for the best. Dilemma of Diagnosis With a disease that mutates, there is an urgent need to identify and treat it quickly. Infectious experts look at it as a challenge to diagnostic criteria as opposed to treating prophylactically and leave details for later. This ends up putting patients in a bind between standard medical treatment and other unconventional methods. Many Lyme disease clinicians are Lyme disease sufferers themselves, and so are forced to act outside of accepted protocols in order to properly address symptoms. Resources Scott Endicott | LinkedIn Ben Locwin | LinkedIn | Twitter
Scott Endicott and Ben Locwin are Tom Fox's guests on the first episode of the Lyme disease series. Scott is the Executive Leader of Healthcare Solutions at CliniHealth Solutions. Ben is a TEDx speaker, healthcare and pharmaceutical executive with experience in senior management teams. They join Tom to talk about how Lyme disease first came about, symptoms, and the misinformation surrounding the disease. The Discovery of Lyme Disease Lyme disease has been around for millions of years, however, it evaded detection until the 1960s. The first diagnosed cases were occurring around Old Lyme, Connecticut which is how the disease got its name. It was first detected within children who had pediatric rheumatoid arthritis symptoms. A man named Willy Burgdorfer, who was a researcher, was trying to find the cause of the symptoms. He had been looking at spotted fever as well as other tick-borne diseases at the time and turned his attention to Old Lyme, Connecticut. In 1981 he found an organism within the affected children, and so the organism itself is named Borrelia Burgdorferi after him. The First Diagnosis There has been a lot of confusion regarding the symptoms related to Lyme disease, so it is important to know what the true symptoms of the disease are and what to look out for. “The diagnostic criteria has been a moving target since 1975," Scott begins. The original Lyme disease epidemic was juvenile arthritis, and that was the trigger that pushed the community at the time to do further investigation as arthritis is not contagious. That confusion set the tone on how the disease was first diagnosed. The Evolution of Lyme Research Lyme has been detected in all US states of America except Hawaii. At one point it was believed that germs in the air was the cause for the disease going around. This was called germ theory. Today, the research and science has evolved, and information exchange and diagnostic criteria are becoming aligned. Nowadays, Lyme disease can be treated with simple antibiotics with very high efficacy. This is because there are more clinical professionals who are able to identify the disease early, and treat it effectively. Resources Scott Endicott | LinkedIn Ben Locwin | LinkedIn | Twitter
Welcome to newest edition to the Compliance Podcast Network: Greetings and Felicitations, a podcast where Tom Fox visits with a wide variety of guests on a wide variety of topics. In today's inaugural episode I visit with Compliance Podcast Network fan favorite Dr. Ben Locwin. We take a deep dive into where we are into where we are with the Delta Variant, immunization, health care economics and delivery of health care services.
As Tom records from an undisclosed location, he and Jay are back to take a look at this week's stories top compliance and ethics stories which caught their interest on This Week in FCPA in the Live from Portland edition. Stories Tom takes up the call for Design Thinking to be used in compliance. Part 1-the steps in design thinking. Part 2-using design thinking to operationalize compliance. Part 3-into your compliance program. I screen, You screen, We all screen (but not for ice cream). Szilvia Andriasik in the FCPA Blog. The pandemic redefined the role of the GC. Did it do the same for the CCO. Abbott Martin and Rosie Griffin in How to train managers in COI. Jeff Kaplan in COI Blog. The Bribery Act at 10. Neil Hodge in Compliance Week (sub req'd) Expanding your DD horizons for ESG. Alek Chance In Navex Global's Risk and Compliance Matters. Upgrading your compliance program in 5 steps. Joe Murphy in Compliance Week (Sub Req'd) Is your training sticky? Gio Gallo in CCI. Using data analytics to uncover anomalies. Jessica Ellsworth in CCI. Internally communicating about cyber security issues. Davis Polk lawyers in the Harvard Law School Forum on Corporate Governance. Podcasts and Events Career Can Do, the latest edition to the Compliance Podcast Network, premiers this week. Recruiting guru Mary Ann Faremouth discusses all facets of the hiring process. In Episode 1, she interviews Jessica Levine. In Integrity Through Compliance, AMI's Dionne Lomaxspeaks with Joe Miller, the co-chair of Mintz Levin's antitrust practice. They focus on recent developments in antitrust compliance — specifically, compliance with government consent decrees and what might be occurring behind the scenes at federal enforcement agencies once a company has settled antitrust charges. This week on Greetings and Felicitations, Tom is joined by Ben Locwin to look at some of the science behind Star Trek, the Original Series. Mirror Mirror and Transporters, Where No Man Has Gone Before and Phasers; The Naked Time and Warp Drive; Tomorrow is Yesterday and Black Holes, White Holes, and Wormholes; and Journey to Babel and the Medicine of TOS. A new month on The Compliance Life! In July I visit with Asha Palmer, CECO at Convercent. In Episode 1, from Claire Huxable to the DOJ. In Episode 2, ‘What do you think about Abu Dhabi?' The tables are turned on Tom by the Brothers Gallo and Jason Mefford as they interview him for their respective pods. Nick and Gio on The Ethics Experts. Jason on Jamming with Jason. The Compliance Handbook, 2nd edition is released. Learn about it here. Purchase it here. Tom Fox is the Voice of Compliance and can be reached at tfox@tfoxlaw.com. Jay Rosen is Mr. Monitor and can be reached at jrosen@affiliatedmonitors.com. Learn more about your ad choices. Visit megaphone.fm/adchoices
As Tom celebrates the release of The Compliance Handbook, 2nd edition, he and Jay are back to take a look at this week's stories top compliance and ethics stories which caught their interest on This Week in FCPA in the Trump Organization Indicted edition. Stories The Compliance Handbook, 2nd edition is released. Learn about it here. Purchase it here. Four ways to update you ABC compliance program right now. Ann-Maire Zell in the FCPA Blog. John Wood Group DPA with SFO. Tom has a 2-part series on the FCPA Compliance Report. Part 1-deplorable conduct and Part 2-lessons learned. Alex Cotoia takes a deep dive into the EU Whistleblower Directive in a 4-part series. On Compliance Crime and Corruption. Emerging trends in 3rd Party Risk Management. Jaclyn Jaeger in Compliance Week (sub req'd) Mengqi Sun interviews Sherron Watkins in the WSJ Risk and Compliance Journal. Anti-trust concerns at the Board level. Elizabeth Ising, Stephen Weissman, Cassandra Tillinghast and Chris Wilson in NYU Compliance and Enforcement Blog. How to avoid buying a FCPA issue. Valerie Charles, Jamen Tyler and Robert Johnston in CCI. Compliance on the inside v. outside. Amy Landry in CCI. Compliance officers are disciplinarians (at times). Dick Cassin in the FCPA Blog. Podcasts and Events How does history inform compliance? What are the leadership lessons from ancient Greeks and Romans? Find out in this special 10 part podcast series on famous Greeks and Romans from Plutarch's Lives this week on 12 O'Clock High, a podcast on business leadership, hosted by Richard Lummis and Tom Fox. In Episode 5, they mined Plutarch about the lives of and leadership lessons from the Greek Epaminondas and the Roman Scipio Africanus. A new month on The Compliance Life! In July I visit with Asha Palmer, CECO at Convercent. In Episode 1, from Claire Huxable to the DOJ. Tom premiers a new podcast, Greetings and Felicitations. In the inaugural episode, CPN fan fav Dr. Ben Locwin is back to discuss the current state of the Covid-19 pandemic and where we might be headed. Trekking Through Compliance Returns! Tom reviews all 79 episodes of Star Trek, the Original Series beginning June 1. Each day at 3 PM on the Compliance Podcast Network. This week's offerings included The Apple, The Doomsday Machine, Catspaw, I, Mudd and Metamorphosis. On July 13, join K2 Integrity for its Virtual Compliance Conference on Environment, Social, and Governance Compliance Risks for Financial Institutions. Information and Registration here. Join Tom, Asha Palmer and Stephen Martin for a coming out webinar for The Compliance Handbook, 2nd We will focus on 3rd party risk management. Attendees will receive a special article and offer. Best of all, it's at no charge. Details and registration here. Tom Fox is the Voice of Compliance and can be reached at tfox@tfoxlaw.com. Jay Rosen is Mr. Monitor and can be reached at jrosen@affiliatedmonitors.com. Learn more about your ad choices. Visit megaphone.fm/adchoices
Welcome to newest edition to the Compliance Podcast Network: Greetings and Felicitations, a podcast where Tom Fox visits with a wide variety of guests on a wide variety of topics. In today's inaugural episode I visit with Compliance Podcast Network fan favorite Dr. Ben Locwin. We take a deep dive into where we are in the Covid 19 pandemic, what may be down the road and how the global vaccination response has worked to slow down this global pandemic.
Innovation in Compliance with Ben Locwin Companies need to be more innovative when it gets down to compliance. Thus, compliance practitioners should ensure that ethics and compliance are central to the business operation in response to today's evolving and fast-paced regulatory environment. Consequently, compliance programs should be innovative, behavior-based, yet consistent with organizational systems and policies. However, one loophole with many compliance officers is they have legal professional backgrounds—the majority proceeds from the general counsel's office and private practice. Frankly, innovation is not high on the charts for what most compliance officers are taught. Instead, they were familiarized with the Socratic method to read cases and learn how to argue points. So, how can a Corporate Compliance Officer think about an innovation strategy for any risk management program? Ben Locwin, a well-known innovator in a wide variety of fields, is here to throw in some light about Innovation in Compliance. Key takeaways discussed in the episode: Decipher that connecting innovation and compliance is the pursuit of understanding the truth in the false positives and the false negatives. Come to know that there's a marked difference between innovation and invention. Innovating the compliance infrastructure is always much more straightforward than creating something from scratch. See through the truth that we're drowning in data but thirsting for information. Updating your beliefs with better data will always lead to better risk management outcomes. Change the way you're looking at information so that you can position your company at the front edge boundary of what's accurate and correct. Be reminded that the paradigm is changing; companies don't stay static, people's behavior doesn't stay static. Thus, continuous monitoring leads to constant improvement. About Thomas Fox: Thomas Fox, the Compliance Evangelist®, is one of the leading writers, thinkers, and commentators on anti-bribery and anti-corruption compliance. In this latest edition of The Compliance Handbook, he continues to arm seasoned compliance professionals and those new to the realm with the practical, actionable guidance and tools needed to design, create, implement and continually enhance a best practices compliance program. The "Nuts and Bolts" for Creating a Comprehensive Compliance Plan The first chapter of this unique work lays out a succinct yet thorough 31-day approach to operationalizing a company's compliance regimen. Beginning with a section on what 2020 brought to the compliance landscape, the chapter methodically outlines best practices for everything from establishing policies, procedures, and internal controls, to assessing risk, training, handling investigations, and more. Each day ends with three key takeaways you can implement at little or no cost. Understanding Compliance Responsibility Across the Organization The Compliance Handbook also takes a close look at all professionals' roles with compliance responsibility, from Compliance Officers and Boards of Directors to Human Resources, to Internal Audit and Internal Controls and Communications and Training professionals. In-Depth Treatment of Hot Topics and Trends The Handbook provides an in-depth look at the latest thinking and trends for the full range of critical compliance topics, including: • Compliance and business ventures • Third-party risk management • The Board's Role in Compliance • Continuous improvement • Compliance innovation • And much more Order your copy OR copies of The Compliance Handbook: A Guide to Operationalizing Your Compliance Program. Save 25% off. http://www.lexisnexis.com/fox25
The FDA Group's CEO, Nick Capman, sits down with Ben Locwin, Senior Consultant for Public Health Outreach at the CDC, and Executive Advisor for Valeocon Management Consulting, to discuss what life science leaders should expect from the FDA in 2021 as it pertains to quality system management, regulatory approvals, GxP compliance, and more. Ben has extensive experience working with the FDA and international regulatory officials. His project work includes Pre-IND, NDA, Ph1-3, and marketed/post-market drug products, as well as PMA and 510(k) medical devices. Ben has trained FDA inspectors within their headquarters and has participated in the design of the FDA's Global Quality Metrics Initiative. Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more and get the conversation started: www.thefdagroup.com.
To connect with the speaker, links and detailed show notes please visit: www.lifesciencesuccess.com Ben Locwin recently published an article titled “Use These 7 Tools For Breakthrough Quality And Performance In 30 Days”. We walk through each of the seven tools and discuss its use, history of the tool, and actual implementation. This interview is filled with interesting facts about each one of the tools discussed along with areas that Ben has seen them applied. I would highly recommend downloading the article in the links section to have for reference as you listen to this episode.
Listen to in an interactive and hopeful conversation about the safety and future of reuse in America with epidemiologist Dr. Ben Locwin and entrepreneurs Tom Szaky and Lindsey Hoell. We discuss how reuse solutions and systems can help:- save businesses money- get people back to work- protect public health- stop plastic pollution & reduce waste
Welcome to the 38th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode is a little different than usual. Philippe Gaudreau will be joining Mandy as a co-host in a conversation with guest expert Ben Locwin. Ben is the SVP of Quality at Lumicell and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. This week, they are discussing Data Integrity and Data Governance in today’s landscape. Ben explains the difference between data integrity and data governance, discusses the challenges of remote work during COVID-19 from a GxP perspective and breaks down some tips for companies to incorporate work from home in their company culture in a safe and efficient way! Key Takeaways 0 :33 : Mandy introduces today’s co-host Philippe Gaudreau. 1:22 : Mandy introduces today’s guest, Ben Locwin. 2:15: Today’s topic is Data Integrity and Data Governance in today’s remote work culture. 3:02: Ben provides an overview of his background in Life Sciences. 9:15: Ben explains the difference between data integrity and data governance. 9:50: The guests discuss the unique challenges for handling work from home and COVID-19 from a GxP Data Integrity perspective? 11:57: Philippe details some of the dangers for data integrity with employees working from home and shares his opinion on the future of online security. 14:31: Ben stresses the importance of the Quality / Regulatory and IT / Security team members work hand in hand to ensure the integrity of data. 17:15: Ben discusses the delicate balance between ease of use and standardization of inputs and outputs within software. 20:14: The group discusses tips and tricks for remote workers to improve their efficiency. 23:39: Ben insists on the importance of having a routine on the human psyche. 26:10: Mandy insists on the importance of recording important meetings to keep track of information 27:28: Philippe gives some tips for companies to incorporate work from home in their company culture in the long term. 30:27: Mandy suggests reviewing data governance policies and ensuring that the team is comfortable with working from home. 31:55: Ben stresses the importance of having clear data governance policies in the future. 33:53: Mandy thanks Ben and Philippe and reflects on today’s learnings. Mentioned in this episode Ben Locwin on LinkedIn Mandy.Podcast@Solabs.com
Ben Locwin chats with Tom Fox about COVID-19 and the risk management issues associated with the disease in this week’s Innovation In Compliance show. What is Coronavirus? Ben says that coronaviruses have been around for a long time. During flu season, about 10% of patients with upper respiratory symptoms test positive for a type of coronavirus. The epicenter of the outbreak of this particular strain of the coronavirus is Wuhan, China, and there seems to be some correlation with the open air markets there. Though it’s suspected that the virus may have crossed from animals to humans, the nexus of the disease is unknown. He goes on to explain how the virus got its name and how it affects human cells. Symptoms and Spread Tom asks about the symptoms of the coronavirus (officially called COVID-19) and how it spreads. Symptoms, Ben says, include respiratory symptoms similar to a chest cold, such as coughing, having trouble breathing, and fever in more severe cases. In a relatively few cases, patients experience organ failure and septic shock and other serious issues, including death. Ben explains that this particular coronavirus spreads through aerosolized droplet infection: when an infected person coughs or sneezes in a public place, fine particulates of saliva and mucus are introduced into the air. Anyone there can inhale these particles and contract the disease. They can start experiencing symptoms within 2 to 14 days. Common Sense Prevention Ben comments on the stigma associated with COVID-19. While travel restrictions and other such responses make good sense, he points out that the outbreak of the virus is not yet a pandemic. If you’re experiencing upper respiratory symptoms, see your healthcare provider right away to have a test done. Your sample will be sent to the CDC for testing to determine if you have COVID-19. He advocates common sense prevention measures, the most important of which is hand hygiene: wash your hands regularly. When you’re in a public place try not to touch your eyes, nose or mouth and don’t touch food without washing your hands first. Face masks may also be useful. If you feel ill, stay at home, he advises. Smart Risk Management Practices Tom comments that many businesses are struggling with how to manage the risk associated with the disease. He asks Ben to give some advice in this regard. Ben responds that companies should take a smart approach. While you shouldn’t start panic buying and selling, and cease all travel, you should certainly limit non-essential travel whenever possible. “That’s just essentially limiting our exposure to risk,” he says. Tom adds that there are a number of modern communication tools that can be used instead of traveling to meetings. It’s sad that it takes situations like this to force companies to examine their business operations, Ben comments. However, by cutting out non-critical practices, businesses not only limit their risk exposure, but it also allows them to employ operational excellence. Resources CDC.gov/Coronavirus Learn more about your ad choices. Visit megaphone.fm/adchoices
As Donald Trump invites Russia back into the G7 and plans the next summit at his resort. Tom and Jay look at that COI and discuss some of this week’s top compliance and ethics stories which caught their collective eyes. 1. How deep is the ocean? Jeff Kaplan asks that metaphorical questions as a way to introduction his piece on Trump’s conflicts of interest. 2. Why is there is no easy answer to the supply side of bribery? Jessica Tillipman explains. 3. Matthew Stephenson says it is time to retire the term “passive bribery”. 4. The use of monitors in licensing and disciplinary proceedings. Jay continues his series. 5. Deutsche Bank settles ‘sons and daughters’ hiring case.. 6. Fraud allegation hits academia. Jonathan Rausch explains. 7. What happens when the middle of your organization is rotten? Mike Volkov explains. 8. What are some of the issues for AI in Compliance? Tom explores in a 4-part blog post series, all on the FCPA Compliance Report. 9. Interested in the Science of Star, Trek the Original Series? Then this week has been the week for you on the Compliance Podcast Network as Tom was joined by Ben Locwin to look at some of the science from TOS. 10. Join Tom and Jay and a host of other great speakers and guests at Converge19 in Denver October 2 & 3. Listeners to this podcast can obtain a complimentary ticket by using the promotion code foxvip, for registration and information, click here. Tom Fox is the Compliance Evangelist and can be reached at tfox@tfoxlaw.com. Jay Rosen is Mr. Monitor and can be reached at jrosen@affiliatedmonitors.com. For more information on how an independent monitor can help improve your company’s ethics and compliance program, visit our sponsor Affiliated Monitors at www.affiliatedmonitors.com. Learn more about your ad choices. Visit megaphone.fm/adchoices
What is the intersection of innovation in your compliance program and the requirements of an effective compliance program? Today, Tom Fox continues his 5-part series on the front lines of compliance with Hallmark 10 of the Ten Hallmarks of an Effective Compliance Program.Hallmark 10 states that: “A good compliance program should constantly evolve. A company’s business changes over time, as do the environments in which it operates, the nature of its customers, the laws that govern its actions, and the standards of its industry. In addition, compliance programs that do not just exist on paper but are followed in practice will inevitably uncover compliance weaknesses and require enhancements. Consequently, DOJ and SEC evaluate whether companies regularly review and improve their compliance programs and not allow them to become stale.” What does that actually mean? In short, it’s about putting compliance into the fabric of your organization. There are many ways to go about doing this, and one of the most effective ways is through the continuous improvement technique of ‘internal inspection.’ Ben Locwin discusses this in Episode 266 of the FCPA Compliance and Ethics Report Podcast.With internal inspection, you’re looking at your program from the inside out. Ben Locwin explains it like this: “We have a problem. Let’s not run away from it. Let’s embrace it.” To do that, you should ask what you can do better, and what can you do next. The willingness of the organization to look at itself is key to continuous improvement.It’s not enough to admit there was a mistake and get rid of the employee who made it. Tom talks about how people aren’t willfully ignorant; they try to do the right things. It could be as simple as a clarity issue with how they understand their role or their work, and if that’s the case, the next employee could easily make the same mistake.Instead of laying blame at the people in the organization, it is wiser to do a ‘root cause analysis’ to determine and develop the preventative actions that can keep the problem from happening again. In other words, you fix the system and processes that led to the problem in the first place.Ongoing EducationIf you’re a compliance professional looking for a convenient and effective way to fulfill your continuing education requirements, visit Tom’s website and choose from 4 hour-long training packages that will keep you up to date with the latest developments in the compliance field. Learn more about your ad choices. Visit megaphone.fm/adchoices
Ben Locwin is a Ph. D. MDA, and MS who’s held many executive roles for top 10 companies including biotech, big pharma, and hospitals and clinics. In the final episode of this 5 part series, Tom and Ben review the relationship between profitability and compliance. Learn more about your ad choices. Visit megaphone.fm/adchoices
Ben Locwin is a Ph. D. MDA, and MS who’s held many executive roles for top 10 companies including biotech, big pharma, and hospitals and clinics. In Part 4, Ben and Tom talk about integrating compliance operations into the staff level of a business. Learn more about your ad choices. Visit megaphone.fm/adchoices
Ben Locwin is a Ph. D. MDA, and MS who’s held many executive roles for top 10 companies including biotech, big pharma, and hospitals and clinics. In part 2 of this five-part series, Ben and Tom discuss forecasting’s role in helping to plan for contingencies. Learn more about your ad choices. Visit megaphone.fm/adchoices
Ben Locwin is a Ph. D. MDA, and MS who’s held many executive roles for top 10 companies including biotech, big pharma, and hospitals and clinics. In part 3 of this five-part series, Ben and Tom discuss how to avoid being a compliance firefighter at your company by practicing prevention rather than correction. Learn more about your ad choices. Visit megaphone.fm/adchoices
Ben Locwin is a Ph. D. MDA, and MS who’s held many executive roles for top 10 companies including biotech, big pharma, and hospitals and clinics. Ben and Tom talk about the common problem of compliance existing in an ‘ivory tower.’ How can compliance be brought closer to the front lines in a way that also improves business efficiency and profitability? Learn more about your ad choices. Visit megaphone.fm/adchoices
Ben Locwin is a Ph. D. MDA, and MS who has held many executive roles for top 10 companies including biotech, big pharma, and hospitals and clinics. He’s a proponent of analyzing data, and today he and Tom discuss the innovations in data, whether big or small data is right for your business, and how they relate to compliance. Learn more about your ad choices. Visit megaphone.fm/adchoices
I continue my discussion of operationalizing your compliance program through the risk management process by considering risk-based monitoring. I continue this series based upon interviews with Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to explore risk forecast, risk assessment and risk monitoring for the compliance profession. Locwin said, “Risk-based monitoring is really about continuous, ongoing monitoring for those things which provide the most potential future risk to you. In other words, instead of a static risk registry that may come in part with forecasting, where you would say, “We’re trying to anticipate these risks.” By using risk-based monitoring to review issues on an ongoing basis, and the models that are behind the risk-based modeling, risk-based monitoring models, they’re continuously refined based on incoming data.” The problem for many companies is they are siloed in not only their data but also in the systems. Locwin explained that because of the disparity of data systems, “They may not be tracking rigorous, quantified information all the time.” He cited to an example from the pharmaceutical world where a company could well have 50 worldwide sites where a drug product is being tested. Some patients receive a placebo and some patients receive the medication being tested. As data comes in you begin to note patterns in certain patients and groups, which might actually point towards a variety of testing errors by physicians administering the test. Through the use of risk-based monitoring, you can begin to see things in “almost real-time, time-based trends of real data that you can then jump on and try to make adjustments before things get really wacky.” The implications to the compliance practitioner? Having access to information around sales, the sales process and corporate largess in things from Corporate Social Responsibility (CSR) work to gifts, travel and entertainment to conferences for customers and end users. Through the use of such risked-based monitoring a compliance professional would have the opportunity see trends developing which could allow an intervention for a prescriptive solution which could prevent an issue from becoming a Foreign Corrupt Practices Act (FCPA) violation. Yet Locwin cautioned that compliance professionals should guard against bias. In an article by Locwin, entitled “Be Careful When Appraising Industry Trends”, he stated, “Social media has rapidly accelerated the agility with which the public can change allegiance and direction. It used to be that when information dissemination was slower and more compartmentalized within regions and market segments, that the market resistance to fluctuation was more robust. Now well-placed advertising, social commentary, or public response to corporate missteps can swirl into a maelstrom of market changes within hours that is agnostic to region or market segment.” In today’s world, the speed at which reputational damage reigns out can overwhelm a corporation’s ability to respond. Here one might consider Wells Fargo and how fast the situation spun out of control for them after its $185MM fine was announced. It is through the use of risk-based monitoring, which allows for this almost real-time input, that a response to a forecasted, assessed or even unassessed risk can be developed. In the compliance world, such tools could be brought to bear when considering not only the expense side of such areas as gifts, travel and entertainment but also sales side data. This could be internal company data on its own salesforce and also information developed from or concerning your third-party sales team. In Locwin’s primary world of pharmaceutical testing and product development, the need for such real-time information can be more critical. Yet through the development of these techniques as compliance tools, the compliance profession can add value to an organization through the use of risk-based monitoring. With the plethora of data on where and how corruption is likely to occur, coupled with meaningful sales and expense data, the compliance professional should be able to move from detect to prevent to prescriptive compliance solutions to prevent legal violations. Finally, the beauty of all these techniques is that they are tools that can make companies more efficient and, at the end of the day, more profitable. They also move compliance into the fabric and DNA of an organization or in the terminology of the Department of Justice (DOJ) Evaluation of Corporate Compliance Programs, operationalize compliance. The DOJ has made clear what it expects around the risk management process. You need to develop your response now. Three Key Takeaways Risk-based monitoring is a follow on from forecasting and risk assessments in the risk management process. Risk based monitoring can provide real-time feedback and input from your operationalized compliance program. Use risk-based monitoring to cut through corporate siloes. This month’s podcast series is sponsored by Oversight Systems, Inc. Oversight’s automated transaction monitoring solution, Insights On Demand for FCPA, operationalizes your compliance program. For more information, go to OversightSystems.com. Learn more about your ad choices. Visit megaphone.fm/adchoices
In this Part III to a three part podcast series, I visit with noted risk management expert, Ben Locwin on risk-based monitoring as a adjunct to forecasting and risk assessments. We discuss how to accomplish it and how to integrate into your overall monitoring and feedback loops. We conclude with a stitching together of the risk management process. For More Information see my five part blog series on the Risk Management Process. 1. Forecasting 2. Risk Assessments 3. Risk-Based Monitoring 4. White Noise and Interpreting Data 5. What does it all mean? Learn more about your ad choices. Visit megaphone.fm/adchoices
At its heart, every business tries to plan for its future. It is a critical aspect of any management of any organization, non-profits, privately owned for profits and, of course, publicly traded companies. It is important that management be able to set out what it opines will happen in the next three, six, twelve and twenty-four months. Noted health care process expert Ben Locwin has said this “is really something that the businesses try to wrap their heads around in such a way that they can shunt resources where they think is appropriate in order to meet these future demands. Forecasting really at its heart is an educated guess and really as much as it becomes a reliable model more so and less so a guess, is based on the quality of the input data.” It is a process through which you are attempting to “prognosticate what the future will bring to you”. Unfortunately, forecast models are only as good as the data which are put into them or the GIGO (Garbage In, Garbage Out) Principal. Three Key Takeaways Risk management is a process and forecasting is the first step in that process. GIGO and the only constant is change. Forecasters must always remember that more than one outcome is possible. This month’s podcast series is sponsored by Oversight Systems, Inc. Oversight’s automated transaction monitoring solution, Insights On Demand for FCPA, operationalizes your compliance program. For more information, go to OversightSystems.com. Learn more about your ad choices. Visit megaphone.fm/adchoices
In this episode, I begin a three-podcast series on risk management in compliance with Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to explore risk forecast, risk assessment and risk monitoring for the compliance profession. Today we consider forecasting in the risk management process. Learn more about your ad choices. Visit megaphone.fm/adchoices
Ben Locwin discusses data quality and why he thinks statistics is a requirement for good science.
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