The Life Science Rundown The FDA Group

The FDA Group's Nick Capman sits down with Carlos Yuraszeck, an accomplished leader in biopharmaceutical compliance, operations, and quality assurance, with a specialized focus on driving innovation and efficiency in cell therapy manufacturing.

With over two decades of dedicated service in the biopharmaceutical industry, most recently serving as the Head of GMP Manufacturing at the Astellas Institute of Regenerative Medicine, Carlos provided profound insights into the pivotal role of phase-appropriate quality systems in managing drug development from research to commercialization. Our discussion focused on how these systems facilitate the rapid delivery of treatments to patients in urgent need.

Discussion points include:


Defining Phase-Appropriate Quality Systems: Carlos detailed these systems as strategic frameworks designed to adapt to the requirements of different stages of drug development, emphasizing their critical role in accelerating the development process.
Regulatory Framework and Impact: Insights into how FDA guidelines are tailored to expedite the transition from laboratory research to market, highlighting the regulatory nuances that allow for such flexibility.
Handling Variability in Drug Development: Strategies for managing the inherent variability in early development phases were discussed. Carlos emphasized the necessity of flexible, responsive quality systems that facilitate quick adaptations.
Analytical Testing and Development Oversight: Carlos explored the significant role of analytical testing in early phases, focusing on controlling and understanding variability to improve assay development continuously.
Challenges in Preclinical to Clinical Transition: He underscored the importance of maintaining consistency in the quality of preclinical materials to ensure seamless progression into clinical trials.
Importance of Effective Change Control Systems: The conversation covered how early-stage quality systems should anticipate and manage frequent changes to support rapid learning and adaptation.
Strategic Approach to Quality System Design: Carlos discussed designing quality systems that reflect the company's risk tolerance and the urgency of patient needs, effectively balancing speed, cost, and compliance.
Future Trends in the Life Sciences Sector: Carlos provided predictions on the evolution of quality systems to meet the dynamic needs of ongoing and future drug development projects.

Carlos Yuraszeck is a distinguished leader in biopharmaceutical compliance, operations, and quality assurance, specializing in cell therapy manufacturing. Over his extensive career spanning more than two decades, Carlos has significantly impacted the biopharmaceutical industry through his leadership in various pivotal roles. As the Executive Director of GMP Operations at Astellas Pharma US, he led the transformation of research groups into fully operational GMP manufacturing facilities. Earlier, as Senior Vice President of Technical Operations at Talaris Therapeutics, he managed operations focused on groundbreaking organ transplantation therapies. At Celgene, Carlos directed clinical production and supply, where he scaled up manufacturing operations to support the delivery of life-saving CAR T-cell therapies. His tenure in the industry is marked by a commitment to excellence, deep regulatory knowledge, and strategic oversight, which have driven the successful development and commercialization of novel therapies. Carlos's leadership style emphasizes collaboration, transparency, and continuous learning, aiming always to enhance patient outcomes and advance the field of biopharmaceuticals through innovative and efficient manufacturing practices.

The FDA Group's Nick Capman sits down with Stephen Poor, a physician-scientist with over 20 years of experience in the industry, mainly with Novartis — currently serving as Novartis's Global Program Clinical Head (Executive Director).

They delve into the psychological and professional impacts of organizational changes, particularly focusing on identity and adaptation during times of transition, such as layoffs or department closures.

Discussion points include:

» Stephen's transition due to organizational shutdown and his journey through change.

» Stephen's experiences and thought processes from realizing Novartis's exit from ophthalmology to starting a new job, focusing on identity in times of change.

» The importance of maintaining a positive outlook, using visualization techniques, and combating self-limiting beliefs during periods of professional uncertainty.

» Predictions for 2024 and 2025.

» Nick's upcoming book, "The Passionate Workforce," is based on 15 pillars aimed at creating a motivated and high-performing organizational culture.

» Insights into managing layoffs thoughtfully, ensuring those who leave feel respected and valued.The FDA Group's strategic plans include potential acquisitions to leverage anticipated economic growth.

» The need for positive thinking, proactive planning, and readiness to capitalize on upcoming opportunities in the life sciences industry.



Stephen Poor is the Global Program Clinical Head at Novartis, bringing over 20 years of experience in ophthalmology biotech-pharma and a strong medical background to his role. He is at the forefront of developing innovative therapies for retinal diseases, focusing on age-related macular degeneration (AMD) and geographic atrophy (GA), the leading causes of blindness in the elderly. Poor leads the clinical team for PPY998 (GT005), a Phase 2b subretinal complement factor I gene therapy for GA, a significant acquisition from Gyroscope in 2021. His responsibilities extend beyond PPY998 to overseeing undisclosed gene therapy programs and novel drug delivery devices.

In his leadership role, Stephen is pivotal in bridging the gap between Novartis's research, development, and commercial sectors through strategic collaboration and advisory duties. He plays a key role in external strategy, asset and technology review to enhance the department's portfolio, and coordination of scientific support for the portfolio.

The FDA Group's Nick Capman sits down with Nick Klingensmith, a four-time cancer survivor, motivational speaker, and mindset coach. They discuss the challenges of remote work, especially the disconnect between leadership, management, and frontline employees, and how it affects company culture and employee engagement.

Key points discussed include:


Klingensmith's journey from sales in the telecom and logistics industries to becoming a motivational speaker and coach, emphasizing resilience and overcoming obstacles.
The fundamental disconnect in remote work environments, where leaders fail to engage effectively with their teams, leading to feelings of isolation and disconnection among employees.
The perception gap between managers and employees regarding communication and engagement, with many employees feeling overlooked unless there's a problem.
The need for leaders to adapt to remote work by overcommunicating, setting clear expectations, and fostering genuine connections with their teams.
Klingensmith’s critique of the lack of training for managers on how to lead remote teams effectively, emphasizing the need for mentorship, accountability, and proactive communication.
The importance of understanding the distinction between micromanagement and accountability, and the role of empathy and vulnerability in leadership.

Klingensmith provides actionable advice for building a resilient remote workforce, such as staying present, focusing on what can be controlled, and being authentic and vulnerable as a leader. He also highlights his upcoming book, "Selling Inspired," aimed at sales professionals, and shares where he can be found online for speaking engagements.

Nick helps remote sales teams and leaders develop a warrior mindset and overcome self-sabotage, fears, and excuses to achieve success. With 20 years of sales experience and 10 years of executive leadership, he's passionate about driving revenue growth and developing people. He collaborates cross-functionally to identify opportunities, author unique value propositions, and analyze gaps to drive stronger performance.

The FDA Group helps 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.

www.thefdagroup.com

The FDA Group's CEO, Nick Capman sits down with Divya Gowdar, Founder and CEO of NubGenix to discuss the pitfalls and lessons learned on the frontlines of audit and inspection readiness throughout the FDA-regulated industries.

Discussion points include:


The need for a formalized inspection readiness program, especially highlighted by challenges in accessing critical documents like quality manuals or SOPs in a timely manner.
The complexities and confusion surrounding QMS integration post-merger or acquisition, emphasizing the importance of clear SOP adherence and SME identification.
The strategic development of an inspection readiness playbook outlining detailed procedural actions for audits, including preparation of SMEs and document management.
Common gaps in the QMS, such as inadequate design controls and insufficient risk management, and the critical area of supplier management, where many organizations struggle to maintain quality audits and qualification programs.
The distinction between R&D and commercial suppliers, underscoring the need for early and comprehensive qualification processes to mitigate commercialization risks.

Divya's top 5 takeaways:


Implement an Inspection Readiness Playbook: Develop a comprehensive playbook that details all aspects of audit preparation, from SME preparation to document retrieval, to streamline the inspection process.
Address Post-Merger QMS Integration: Carefully plan and execute the integration of disparate QMSs following mergers or acquisitions to ensure clarity in SOP adherence and effective SME role allocation.
Conduct Mock Inspections Regularly: Utilize mock inspections to test the effectiveness of the inspection readiness playbook, identifying and rectifying any gaps in readiness.
Focus on Supplier Management: Establish rigorous qualification and ongoing monitoring programs for suppliers, differentiating between R&D and commercial suppliers to ensure quality and compliance.
Adopt the PDCA Cycle for Continuous Improvement: Implement the Plan-Do-Check-Act methodology to manage QMS elements, ensuring robust inspection readiness and fostering a culture of continuous improvement.

Divya is a performance-driven and hands-on Quality leader and professional with extensive experience in the medical device and combination product industry. She has contributed significantly to quality management systems, product development lifecycle, risk management, quality compliance, quality management review, inspection management, training, change controls, supplier management, complaint management, and technical operations.

Who is The FDA Group? The FDA Group helps 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. https://www.thefdagroup.com/

The FDA Group's CEO, Nick Capman, sits down with Donna Dorozinsky, founder and CEO of Just in Time GCP, to discuss key considerations for Trial Master File (TMF) management and GCP compliance.

Discussion points include:


The TMF's significance in capturing a study's complete story, including its challenges and achievements and its pivotal role in GCP compliance.


The evolution of TMF structuring, the development of the TMF Reference Model for standardization, and its benefits for simplifying content integration across different organizations and vendors.


Donna’s three components of a quality TMF: record quality, timeliness of filing, and completeness, explaining how these factors contribute to maintaining a compliant and effective TMF.


Considerations for companies that outsource TMF management to CROs.


The adoption of eTMF systems, especially for smaller companies, and the balance between investment in technology and maintaining compliant TMF practices.


The challenges and considerations of TMF management during mergers and acquisitions (highlighting the importance of a complete and accessible TMF in these transitions).


How the TMF is utilized during regulatory inspections, the recent focus of regulatory authorities on TMF compliance, and the importance of a well-managed TMF in demonstrating the quality and integrity of a study.

Donna's top 5 takeaways:


Adopt the TMF Reference Model to standardize the structuring of TMFs across organizations. This makes integrating content from different vendors easier and simplifies regulatory inspections by providing a uniform structure that regulators have come to expect.
Focus on the record quality, timeliness, and completeness of the TMF. High-quality records without missing or draft pages, timely filing of documents to reflect an up-to-date story of the study, and ensuring that the TMF is complete with all necessary documents are crucial for a compliant TMF.
Maintain tight sponsor oversight on CRO-managed TMFs. Even if a Contract CRO manages the TMF, the sponsor retains ultimate responsibility for its completeness and quality. Sponsors should perform regular oversight activities, such as routine completeness checks and applying a risk-based approach to ensure the CRO's TMF meets regulatory standards.
Organizations, especially smaller ones, need to weigh the decision to adopt an eTMF system carefully. It's essential to align the investment in eTMF technology with the company's long-term goals and ensure it is supported by appropriate business processes and quality oversight.
When involved in mergers or acquisitions, ensure thorough due diligence on the TMF to fully understand the study's story. For regulatory inspections, having a complete, well-organized, and accessible TMF can significantly influence the outcome. A well-managed TMF supports compliance and serves as a critical tool in demonstrating the quality and integrity of clinical research to regulatory authorities.

Donna is a Registered Nurse and business consultant who has spent over 30 years in drug development with extensive experience in study operations, including clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management.

Donna is a TMF Reference Model Steering Committee member and is a member of the Association of Women Entrepreneurs. She’s a founding member of the Society of Nurse Scientists, Innovators, Entrepreneurs, & Leaders. She serves on the Board of Trustees at Gwynedd Mercy University, where she received her BSN, and also has an MSN from Widener University.

Who is The FDA Group? The FDA Group helps 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. https://www.thefdagroup.com/

The FDA Group's CEO Nick Capman sits down with Mukesh Kumar, PhD, RAC, for a deep dive into the challenges of setting up GMP facilities for cell therapy startups.

Discussion points include:

» Common questions startups have around engaging with the FDA and determining costs and timelines for GMP facility setup and clinical trials.

» Recommendations for engaging regulatory experts early and doing first-in-human manufacturing in-house rather than through a CMO to reduce costs and time.

» The importance of educating oneself on regulations before meetings with experts or the FDA to get the most benefit from those interactions.

» Best practices for GMP facility setup and clinical trials in a cost-effective manner to advance cell therapies to patients.

Dr. Mukesh Kumar is CEO and Founder of FDAMap, a Washington DC-based firm helping manufacturers and developers of FDA-regulated products in regulatory affairs, quality assurance, clinical trials, and smart development strategies. His key expertise is in global regulatory project management, regulatory submissions, compliance inspections, operational management, supply management, clinical operations, and multi-national project management for medicinal and diagnostic products. He has led the clinical development of over 100 products over the last 20 years.

He has been a leader in more than 150 clinical trials in about 34 countries, including countries in the EU, Taiwan, Korea, Japan, China, Canada, countries in South America, Australia, and India. He has led more than 100 GCP, GLP, GMP, and GACP audits in the US and several countries in Europe, North and South Americas, and Asia in the last 15 years. He has conducted numerous training workshops on FDA compliance-related issues and has authored numerous articles in peer-reviewed journals.

His weekly blog, FDA Puran, is subscribed by over 80,000 readers globally. He is also the Professor (Adjunct), Regulatory Sciences, at the School of Medicine, George Washington University, Washington DC. Dr. Kumar is a PhD in Biochemistry and a certified regulatory professional by the Regulatory Affairs Professionals Society, USA.

Who is The FDA Group? The FDA Group helps 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. https://www.thefdagroup.com/