The Life Science Rundown The FDA Group

The FDA Group's Nick Capman sits down with Eric Busenburg, President of Euro-American Worldwide Logistics, where he oversees GMP storage and international shipping solutions for life science manufacturers.

They discuss the critical challenges and solutions for storage in the life sciences industry, particularly for manufacturers experiencing rapid growth.

Discussion points include:

Understanding Storage Challenges: Eric explains the common storage issues that arise as life science manufacturers grow, including unexpected large orders and fluctuating production demands.

Evaluating Storage Options: Eric outlines the pros and cons of building additional infrastructure versus outsourcing to third-party providers, including considerations of control, cost, and time.

Quality Considerations: Eric emphasizes the importance of maintaining high-quality standards when outsourcing, and how third-party providers can align closely with manufacturers' in-house processes.

Time and Cost Implications: Eric discusses the extended timelines for building new infrastructure post-pandemic and how outsourcing can provide more immediate solutions.

Selecting the Right Provider: Eric provides key factors to consider when choosing a third-party storage provider, including proximity, size, expertise, and flexibility.

The Importance of Location: Eric explains the strategic advantage of providers located within a one-hour radius of manufacturing facilities, particularly in biotech hubs like Massachusetts.

Long-term Cost Analysis: Eric shares insights on the long-term cost comparison between building and outsourcing, including the typical 10+ year crossover point.

Flexibility and Risk Management: Eric discusses how outsourcing can provide more flexibility to adapt to market changes and mitigate risks associated with long-term investments.

Leveraging Outsourced Expertise: Eric explains how manufacturers can benefit from the immediate access to expertise that outsourcing provides without the need to hire and train new staff.

Future Outlook: Eric shares his perspective on the future of storage needs in the life science industry, including the role of government initiatives and the importance of support services.

For project or resource needs, visit thefdagroup.com.

The FDA Group's ⁠Nick Capman⁠ sits down with ⁠Aaron Snyder⁠, the Vice President of Quality Assurance at Allotex, where he oversees the development and implementation of quality systems for medical devices and pharmaceuticals.

They discuss the critical elements of building and leading a successful QA team in the life sciences industry.

Discussion points include:

Recognizing the Need for Change: Aaron explains how to identify early signs of strain in the quality system and the importance of transitioning from a small to a larger, more structured QA team to support business growth.

The Interview Process: Aaron emphasizes the importance of vetting potential employers by asking direct questions about management styles, conflict resolution, and organizational support.

First 90 Days in a New Role: Aaron outlines the initial steps for understanding team dynamics, identifying stakeholders, and learning the organization's goals to set a solid foundation for improvements.

Creating a Strategic Plan: Developing a strategic plan with tools like Gantt charts and accountability charts, and engaging team members for feedback to ensure alignment and progress.

Effective Communication and Meeting Cadence: Aaron stresses the need for a structured meeting schedule, including daily stand-ups and weekly reviews, to maintain momentum and accountability.

Building the Right Team: Assessing team members' roles and reallocating based on strengths, while supporting career development to ensure high performance and job satisfaction.

Making the Business Case for Team Expansion: Preparing a comprehensive business case for hiring additional staff, using metrics and workload analysis to justify the need for expansion.

Utilizing Contractors: Leveraging contractors to manage immediate workload increases while recruiting full-time staff, and using their insights to refine job descriptions and onboarding processes.

Continuous Improvement and Adaptability: Implementing continuous improvement initiatives, regularly updating processes, and engaging in feedback sessions to keep the quality system effective and relevant.

Leveraging Experience and Young Talent: Combining experienced leadership with young talent to foster innovation and create a dynamic team environment.

For project or resource needs, visit ⁠thefdagroup.com⁠.

The FDA Group's Nick Capman sits down with Tagg McGurrin, who most recently served as the President and Chief Business Officer (COO/CFO) at Neumentum, Inc., where he led corporate strategy, capital markets, corporate financing, accounting, legal, investor relations, and business development.

They discuss the critical elements of planning, governance, and capital access necessary to build a strong foundation for a pharmaceutical startup in today’s economic environment.

Discussion points include:

Access to Capital: Tagg emphasizes the crucial role of securing capital in starting a pharmaceutical company. He shares strategies for identifying and cultivating relationships with high net worth investors and specialized investment groups. Tagg highlights the importance of prioritizing "smart money" – investors who understand the long-term nature of pharmaceutical investments.

Board and Leadership Structure: Tagg discusses the need for a committed board with proper governance and checks and balances. He recommends separating the roles of CEO and executive chairman to ensure accountability and effective oversight. Additionally, Tagg underscores the necessity of having a dedicated full-time team with a long-term vision, avoiding reliance on part-time or fractional roles for key positions.

Clear Mission and Objectives: Establishing clear, dynamic annual goals and objectives aligned with value inflection points is vital. Tagg highlights the importance of setting specific, measurable, attainable, relevant, and timely (SMART) goals and revisiting them regularly to ensure alignment with the company's progress. He also advocates for a structured meeting schedule with weekly, annual, and substantive quarterly meetings to maintain focus and accountability.

Effective Investor Pitching: When pitching to investors, Tagg advises highlighting the executive team, commercial opportunity, and technical aspects of the asset. He emphasizes the importance of transparency and objectivity to build and maintain trust with investors. Tagg also suggests including a detailed business model in the pitch, outlining expected outcomes and the company's strategy for achieving them.

Due Diligence and Investor Relationships: Tagg stresses the importance of conducting thorough due diligence to avoid nefarious individuals posing as well-connected investors. He recommends asking detailed questions to understand potential investors' past performance and seeking references from other companies they have supported. Transparency and regular communication with investors are key to maintaining trust and support.

Leadership Synergy and Conflict Management: Tagg underscores the importance of a management team that is committed to the company's mission and strategy. He advises proactively addressing potential conflicts of interest to maintain the integrity and performance of the company. Ensuring independence in both fact and appearance is crucial to prevent personal motives from hijacking investor value.

Growth and Communication Strategies: Maintaining efficient communication and growth is essential. Tagg highlights the importance of keeping investors informed with regular updates, even during slow periods, to sustain trust and support. He also emphasizes the need to stay nimble and efficient, avoiding bureaucratic complexities.

Incentivizing Key Players: Tagg advocates for using innovative incentive structures, such as reverse vesting, to retain top talent and ensure their long-term commitment to the company's success. This approach helps align the interests of key players with those of the company and its investors.

Combining Experience with Young Talent: Tagg emphasizes the value of combining experienced leadership with young talent to drive innovation and success. This synergy blends the wisdom of experience with the energy and creativity of younger team members, fostering a dynamic startup environment.

For project or resource needs, visit thefdagroup.com

The FDA Group's Nick Capman sits down with Adam Foresman, Head of Quality & Regulatory Affairs at VideaHealth, to explore the intersection of AI, machine learning, and diagnostics within the FDA's regulatory environment. Adam brings over 15 years of experience in medical device design, quality management systems, and regulatory affairs, with a recent focus on AI in the dental diagnostic market.

Discussion points include:


The Regulatory Landscape for AI in Dental Diagnostics: Adam shares his insights on how AI and ML are becoming integral in dental diagnostics, aiding in identifying previously missed detections, enhancing patient education, and streamlining administrative tasks. He highlights that early adopters in healthcare and dental organizations are reporting significant benefits from AI, encouraging broader adoption.
FDA Clearance for Pediatric AI Applications: Adam sheds light on VideaHealth's recent 510(k) clearance for a dental AI application for pediatric patients. he offers pointers for successful software as a medical device (SaMD) submissions, emphasizing the importance of Q-submissions, thorough software documentation, and specific considerations for pediatric applications.
Predetermined Change Control Plans (PCCPs): Adam explains the concept of PCCPs, allowing manufacturers to include future design changes in pre-market submissions, potentially avoiding re-submissions. While he sees broader applications outside of AI, he notes the challenges AI manufacturers face in predicting future design changes accurately.
Comparative Regulatory Approaches — US vs. EU: Adam compares regulatory frameworks between the US and the EU, noting that while both aim to ensure clinical benefits outweigh risks, their methodologies differ. He praises the EU’s focus on post-market surveillance and risk management processes, suggesting the FDA could benefit from similar approaches.
AI Transparency and Bias Considerations: With growing concerns about AI transparency and bias, Adman discusses the FDA's recent emphasis on these issues. He advocates for clear communication of AI test results by subgroups and suggests that the FDA might develop more detailed transparency guidelines in the future.
Role of Regulatory Affairs Professionals: Adam encourages regulatory professionals to promote AI understandability and transparency within design teams, ensuring that patient and clinician perspectives are considered in AI development.
Future Trends and Recommendations: Adam predicts an increase in AI submissions that bundle multiple models, urging adherence to FDA guidelines for such complex submissions. He also emphasizes the importance of engaging with regulatory bodies early in the design process and maintaining robust QMS processes.



Adam Foresman is the Head of Quality & Regulatory Affairs at VideaHealth. with over 15 years of experience in the medical device industry, Adam excels in product quality, quality systems, and regulatory compliance. His expertise encompasses design controls, statistical analysis, internal and external auditing, CAPA management, product performance, metrology program management, cGMP practices, and ISO 13485 & 21 CFR 820 quality management activities.

At VideaHealth, Adam has co-developed and executed business strategies, globalization, and the clinical roadmap. He leads efforts in product quality, quality systems, pre-market approvals, and regulatory compliance for cutting-edge artificial intelligence and machine learning diagnostics. Adam is also a champion of cybersecurity and HIPAA activities, ensuring robust protection and privacy for sensitive health data.

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.