The Life Science Rundown

The FDA Group's CEO, Nick Capman sits down with Ram Konduru, CEO of PrimeSoft Inc (North America & Europe) and Co-Founder of Coherence Health. Ram discusses his experience in leadership and management, highlighting the importance of having a common purpose and goal for a team. Ram and Nick also discuss the need for leaders to create strong bonds within their teams, provide opportunities for team members to bond, and be humble and relatable.

Other discussion points include:

» Ram’s personal growth journey as a leader, the impact of his mentors on his development, and the importance of self-reflection, practice, and having a genuine belief in the company's mission. 

» The idea that money is a byproduct of value creation.

» The challenges of being a modern leader and manager—and the importance of staying curious and maintaining a learning attitude.

» Life-impacting questions.

» The importance of personal relationships and reflecting on one’s actions.

» A few book recommendations.

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 David Marlin, President of MetaComet Systems, a company specializing in royalty automation software. David shares his background, thoughts on leadership and management, and the importance of working towards a common goal. He emphasizes the value of joining peer groups, vulnerability, trust, and using the Entrepreneurial Operating System (EOS). He credits the concept of "letting go of the vine" for reducing stress and improving overall business performance.

David also discusses:

MetaComet was founded in 1999 to revolutionize royalties through automation. More than two decades on, it remains steered by founder and President, technologist and publishing expert David Marlin, and continues to strive for the highest levels of efficiency. MetaComet serves many different industries, and more than 140 companies of all sizes and types trust it to make royalties effortless. https://metacomet.com/

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 Dan Barker, CEO of Wikimotive, to explore perspectives on management and leadership. Dan shares his unique professional journey and dives into the importance of vulnerability and constant learning in leadership and management, as well as discussing other topics, including:

In 2023, Dan Barker was named as successor to [owner and founder] Tim Martell, accepting the role of Wikimotive’s Chief Executive Officer. Since joining the company in 2018, Dan’s extensive background in both personnel and project management, combined with his insatiable pursuit of knowledge, fueled his trajectory through nearly every role that Wikimotive had to offer. Inspiring optimizations and efficiencies along the way, the impact of Dan’s expansive knowledge, sound decision-making, and measured management style can be felt in every facet of Wikimotive’s daily operations. https://wikimotive.com/

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 Regulatory Consultant Trey Thorsen, MS, RAC, to answer some of the most frequently asked questions about navigating the 510(k) premarket notification process.

Trey brings experience in Class I, II, and III devices, such as active implantables with MRI functionality, external therapeutic devices indicated for pain, devices that have software functionality, transvaginal catheter systems that evaluate fallopian tube patency, sterile and non-sterile wound care devices, compression devices, surgical booms, surgical lights and devices indicated for incontinence. He also has experience with 513(g)s, Pre-Subs and CFGs, UDI/GUDID implementation, as well as EU MDR technical file development and remediation.

Some of the questions Trey tackles include:

Need expert 510(k) assistance? At The FDA Group, we help you move through the 510(k) submission process quickly and efficiently. Our regulatory affairs consultants, many of whom are former FDA personnel, have years of experience working with and within the agency. Learn more about our 510(k) consulting services and get in touch with us to access the industry's best regulatory affairs consultants.

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. Learn more »

Earlier this year, Deloitte released its Global Life Sciences Outlook report, featuring a section devoted to "transforming the talent experience." 

The FDA Group's CEO, Nick Capman, sat down with Larry Stevens, RAC, to unpack some of Deloitte's findings and what they might mean for life science teams looking to innovate their workforce strategies and navigate a hyper-competitive specialized labor market.

Read Deloitte's full report (PDF): https://www.deloitte.com/content/dam/assets-shared/legacy/docs/perspectives/2022/gx-lshc-dei-global-life-sciences-outlook-report.pdf

Some key excerpts:

Page 29:

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"Life sciences companies are still optimizing virtual ways of working, and other issues of concern for life science leaders in 2022 include:

"Life sciences companies that want to succeed in the future of work will need to be flexible in how work is done and how talent is sourced, trained, and managed. Human resources is also undergoing a massive transformation. Instead of trying to predict the future, leaders might consider how they can develop an open culture of experimentation, learning, and iteration."

Page 30:

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"Throughout the next year, many life sciences companies will continue to grapple with how to solve these issues, and each will land in a different place on the spectrum. The 'Great Resignation' is calling for a 'Great Re-imagination', and a winning strategy includes creating value for workers as whole human beings and key stakeholders—including internal and external workers.

"Successful companies are no longer concentrating on just hiring the smartest people, but rather on having access to the smartest people. New workforce ecosystems include in-house employees combined with a diverse mix of external contributors—e.g., contractors, app developers, other gig workers, external partners and suppliers, and even software bots. According to recent research from MIT Sloan Management Review and Deloitte, only 28% of global managers feel they are sufficiently preparing to manage a workforce that will rely more on external participants."

"One agile strategy is to shift from a hierarchical structure to a more team- and networked-based approach that may combine internal and external workers into specialized or cross-functional teams."

Page 35:

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"According to a recent Fortune/Deloitte CEO Survey, attracting and retaining talent in a tight labor market has ascended to the top of CEOs’ list of strategic priorities. Companies should reimagine work as a landscape of tasks and skills that dynamically evolves with business priorities."

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The FDA Group helps life science companies act on all of these recommendations, enabling RA/QA/Clinical teams to 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 connect with us: https://www.thefdagroup.com/

The FDA Group's Nick Capman discusses the recent news that the FDA is once again returning to its quality metrics program for pharma manufacturers.  

The agency’s focus on quality metrics began in 2015 and continued with a heavily revised draft guidance on submitting metrics data, including quality-related complaints. The guidance led to two FDA pilot projects in 2018.  

In a new update, FDA stressed that additional quality data can help both the FDA and the supply chain, which needs to have a better understanding of which manufacturers are going above and beyond the status quo.

Current GMP compliance “does not necessarily indicate” whether a manufacturer is investing in improvements and striving for consistent control over its manufacturing performance and quality, FDA said.  

“To provide flexibility to manufacturers, FDA would focus less on standardization of quality metrics and definitions,” the agency said Tuesday. “Instead, FDA would identify practice areas that are critical to ensure sustainable product quality and availability and would permit manufacturers to select a metric(s) from each practice area that are meaningful and enable establishments to identify continual improvement opportunities.”  

Rather than set metric definitions on how establishments calculate particular metrics, the FDA said it will allow reporting establishments (i.e. API and finished dose manufacturers, among others) to select the most appropriate metric(s) from each practice area and inform FDA how the metrics were calculated.  

Based on feedback from the pilot participants, the agency said it identified four general areas as appropriate for its metrics program:  

Examples of quality metrics associated with each of these areas include (for area number 1) a metric on the proportion of lots manufactured without the occurrence of a non-conformance, (for area number 2) a measure of the proportion of recurring deviation measures, (for area number 3) a measure that indicates a lab’s ability to accurately perform tests, and (for area number 4) a measure of the extent to which shipments are delivered to their destination containing the correct quantity and according to the order’s schedule.  

As far as questions for industry, the FDA wants to know if stakeholders agree that reporting should be aggregated at an establishment level, and whether reporting at an establishment level would help facilitate the submission of quality metrics data by contract manufacturers.

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

Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over FDA's fiscal year 2021. They may play a key role post-pandemic.  

As remote records reviews conducted during the pandemic accounted for a growing share of warning letters, experts have advised the industry to prepare for remote FDA oversight to continue even after routine site inspections resume and the pandemic recedes.  

The FDA, which historically relied solely on on-site inspections as a basis for drug adulteration warning letters, only based 28% of warning letters issued in the first 11 months of fiscal year 2021 on-site inspections, with 62% based on sample testing and 10% on remote records reviews.  

In this episode, we sit down with former FDA professional, Larry Stevens, RAC, to talk about how inspection alternatives may become a permanent facet of FDA's oversight program and what companies may want to consider doing to prepare accordingly.  

FDA official: Growing number of enforcement actions stem from inspection alternatives: https://www.raps.org/news-and-articles/news-articles/2021/11/fda-official-says-increasing-number-of-enforcement (RAPS)   

About Larry Stevens, RAC: Larry has held almost every field position within FDA during his 21-year career with the Agency. He has over 18 years of experience in the medical device industry, rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers. He specializes in planning, creating, and auditing quality systems as well as creating clinical plans, including protocol development, case report form development, and implementing and managing clinical trials. He also assists in design control to meet FDA requirements. Larry is a professional speaker who regularly trains on all aspects of FDA requirements while offering practical, successful solutions to FDA problems.  

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

For the first time since March 2020, the FDA’s inspections of US-based biopharma sites have returned to normal, according to FDA acting commissioner Janet Woodcock. 

“I’m pleased to say that as of this month, we’ve begun transitioning back to standard operations for domestic inspections while continuing to prioritize mission-critical work for foreign inspections,” Woodcock said.  

The return to normalcy will be welcomed by industry, which has grappled with a growing backlog of mostly surveillance inspections, although some of those delayed inspections have also delayed the approval of new drugs.  

According to a report from FDA in May, an estimated 68 applications (including 48 for human drugs) have been delayed due to FDA’s inability to conduct pre-approval, pre-market, or pre-license inspections as of March.  

The agency said it postponed nearly 8,000 non-mission-critical surveillance inspections in 2020 due to the pandemic. Surveillance inspections are routine inspections that monitor conformance to FDA requirements to identify quality problems and adverse trends, but unlike others, they’re planned in advance by applying established risk factors and statutory inspection frequency mandates.  

Read more in Endpoints News: https://endpts.com/fdas-domestic-biopharma-inspections-return-to-normal-as-agency-faces-backlog-of-8000/

About 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.  We help thousands of firms find the resources they need, when and where they need them, through the optimal workforce model. Our resources are located in several dozen countries and have expertise throughout the life sciences. https://www.thefdagroup.com/

The FDA Group’s CEO, Nick Capman, sits down with Tobias Kuners of Koenders, Managing Consultant at Tob Management, to discuss his integrated approach to implementing and interpreting qualitative and quantitative metrics in the GMP and non-GMP sides of a life science business. Read his full column in Pharmaceutical Online: https://www.pharmaceuticalonline.com/doc/quality-management-review-benchmarking-quantitatively-0001

Tobias has worked with Biogen, Ipsen, Thermo Fisher, Kite Pharma, and Danone, among other companies, gaining hands-on experience in engineering services, equipment qualification, maintenance, supply chain, warehousing, and distribution. He has led the design, engineering, and construction of multiple facilities to meet cGMP requirements. He performs audits, identifies gaps, and develops remediation plans, working within organizations to assist with deviation investigations and CAPA implementation and to develop scientific, risk-based solutions. You can contact him at [email protected].

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.

The FDA Group’s CEO, Nick Capman, sits down with Mary Denigan-Macauley, Director of Health Care in the Government Accountability Office (GAO) to understand the situation the FDA finds itself in with respect to a pandemic-induced inspection backlog, and what measures the agency may take to address it.

Mary joined GAO in 2001, managing a diverse portfolio related to science and animal health for GAO’s Natural Resource and Environment team. This work covered cross-cutting topics such as foreign animal diseases, antibiotic resistance, food safety, and emergency preparedness. Prior to joining GAO, Mary taught various courses in public policy and public affairs at Sam Houston State University, Troy University, and the Georgian Institute of Public Affairs.

Over the past year, Mary and her team at the GAO have published two FDA-specific reports:

Need expert help preparing for a potential increase in FDA inspection and enforcement activity? 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.