Quantum Regulatory Solutions, LLC

BIA Clinical Group and Quantum Regulatory Solutions, LLC are pleased to spotlight our ongoing collaboration, providing clients with seamless clinical and regulatory development activities.?While this partnership is not new, we believe it’s time to share the tremendous benefits this brings to our clients. ? In today’s rapidly changing regulatory landscape, you deserve the best support possible. By joining forces, we’re unlocking a powerful suite of services that merges our expertise in clinical strategy and operations and regulatory affairs. ? What This Means for You: ? If you’re seeking top-tier regulatory strategies for small molecules, simple biologics or advanced therapeutics, the experienced team at Quantum is ready to assist. Similarly, if you need support in clinical strategy and operations, BIA’s dedicated team is here to guide you. ? Together, we provide an integrated, holistic approach to your needs, delivering unmatched expertise that transcends traditional consulting. We’re committed to driving your success and achieving exceptional results together! ? Learn more about our offerings by clicking the links below: ? www.biaclinicalgroup.com ? www.quantumregulatory.com ? If you’re interested in discovering how our combined capabilities can help your organization, reach out today! ? #Collaboration #RegulatoryAffairs #ClinicalOperations #BIAClinicalGroup #QuantumRegulatorySolutions #ClinicalMonitoring #MonitoringOversight #DataReviews #DataIntegrity #ClincalResearch #DrugDevelopment #FDACompliance #Pharmaceuticals #Biotech #QualityAssurance #ClinicalExcellence #ClinicalTrials #MichiganInnovation #PharmaProfessionals #LifeSciences #BiotechExperts #PfizerAlumni

We are thrilled to announce our newest team member, Anita Gmerek Fereshetian, MS, RPh. Anita comes to us with over 30 years of drug development experience and we are delighted to have her as part of the team. Welcome aboard Anita!

Don't miss this! This Friday, August 23rd at 12:00 PM ET, hear Quantum's experts (Kevin Hennegan, Ellen Truitt, RAC and Mara Gladstone Holinger, PhD, RAC) discuss the challenges and nuances of Advanced Therapies development. Join us live on Friday for a very informative conversation! https://lnkd.in/dUYCFFEu

Quantum is delighted to announce our newest employee, Kiley R Prilliman, PhD, Senior Medical Writer, to the team. Welcome Kiley, we are thrilled to have you here!

Part 2 of a two-part post: Advanced Therapies! We recently sat down with Head of Advanced Therapies, Kevin Hennegan,?to discuss Quantum's advanced therapies support for Sponsors. Check out Kevin's responses below: 3.????What are some keys to building a successful engagement with a regulatory advisor in the Advanced Therapy space? Start by assessing whether the individual or group you are considering is a good fit with your existing team. Arrange for introductory or interview calls between the candidate and the members of your team who will be working with them directly. This shouldn’t be as involved as the interview process for an FTE role, but it may be in the same ballpark. You want to find someone who is a good fit with your company culture and the individual personalities within your team. You should also evaluate the individual’s depth of experience, but don’t be too quick to dismiss someone who doesn’t fit perfectly within your company’s niche specialty. In my experience, a broad background within the product’s therapeutic class has been more important than a precise match with a specific clinical indication. Finally, work to incorporate your advisor as an integral part of your development team. Sure, a regulatory strategist can write a memo or risk assessment for you, then ride off into the sunset until the next time you call, but they will be more effective, and you will reap greater benefits, if they are aware of and engaged in updates on the development process as they happen. 4.?????Why did you decide to bring your skill sets to Quantum? I have known and worked with two of Quantum’s founders for many years now (and am really enjoying getting to know the third). Because of that shared history, I knew the kind of environment they would build within their new company, I knew the caliber of experts they would bring to the table to support product development, and most importantly for me, I knew that we had a uniquely complementary and synergistic fit of personalities, skill sets, and knowledge bases. So, when they offered me the chance to head up their Advanced Therapies practice, I jumped at it. I find the Cell & Gene Therapy space incredibly interesting and exciting. I am thrilled to be a part of the team here!

Part 1 of a two-part post: Advanced Therapies! We recently sat down with Head of Advanced Therapies, Kevin Hennegan,?to discuss Quantum's advanced therapies support for Sponsors. Check out Kevin's responses below: 1.????Why should I work with a regulatory consultancy like Quantum to develop my advanced therapy? You and your in-house scientific team will always be the foremost experts on your own product, so I understand it can be tempting to “go it alone.” However, the global regulatory environment is so complex that regulatory science has become a discipline unto itself. Engaging advisors like the Quantum team provides you with a depth of knowledge and experience at navigating this environment that may be difficult to acquire through recruiting. Sponsors early in development may struggle to find (and afford) someone with the right breadth of experience and skills to lead the development effort. In later development, you may find you need someone with greater depth of experience in negotiating complex issues with FDA or other Health Authorities. 2.????When is the best time for a Sponsor to engage a group like Quantum? There is never a bad time to ask for help! That said, there are 3 “entry points” that I think are particularly good moments to reach out to a Regulatory Strategist: a)??????In early development, as you begin to look ahead to planning clinical studies. Quantum’s experts can help you assess the best time and mechanism for reaching out to the FDA or other Health Authority. Is your program eligible for an INTERACT meeting, or would it be better to request a pre-IND meeting? Should you focus only on clinical topics, or also include CMC and nonclinical topics in your discussions with regulators? We can help you weigh these questions and get your program off on the right foot. b)?????During times of transition. This is a dynamic industry, and as one mentor once told me, we all have to “get comfy with change.” During the course of development, you may experience significant shifts in key personnel, manufacturing platforms, or even target clinical indications. During these moments, Quantum can help by providing a fresh perspective on the project direction. We can also help by stepping in to provide stability to the team, filling the gap while the company seeks to find the ideal candidate to succeed an outgoing leader. c)??????During ramp up to a marketing application, the spike in workload for your regulatory team is going to be sharp, and there simply aren’t that many folks out there who have experience leading an advanced therapy through the approval process (though that number is happily growing). Expert regulatory advice is critical at this stage to ensure a well-planned and constructed application, to advise throughout the information requests and cycle meetings during the review process, and ensure the team is ready to launch upon approval of the product.

We are beyond excited to announce that Kevin Hennegan has joined our team as Head of Advanced Therapeutics. Welcome to the team, Kevin, we know you'll help us do great things!

Post 2 of a two-part post: Quantum Publishing! We recently sat down with Associate Director, Regulatory Publishing,?Jennifer Harmon?to discuss Quantum's publishing capabilities and what sets us apart from our competitors. Check out Jen's responses below: 1.?????What would a Sponsor be surprised to learn about working with a publishing vendor? The length of time required from planning to submission of an application can be surprising- a high quality IND or NDA is often a several month endeavor and can vary widely due to many factors. At Quantum, we’ll work with you to tailor timelines to your needs and company goals. With hundreds of documents that necessitate version control, query resolution, and tracking, Project Management (PM) for a Regulatory application is critically important. Quantum publishers are equipped to support such tasks and can function independently or partner with existing PMs. Publishers possess a high level of technical knowledge and closely monitor ever-changing industry requirements. Along these lines, Sponsors might be surprised to learn that Quantum publishers can create simplified datasets that are required for some non-clinical and clinical studies, eliminating the potential need to engage another vendor. Additionally, Sponsors are pleasantly surprised with our expert document formatting support and Endnote library management. When Quantum plans a publishing timeline, we account for some document polishing in our estimates. This eliminates any pressure to send ‘perfect’ documents to publishing and allows SMEs to spend more time authoring. Quantum publishers can also maintain an Endnote library to ensure consistent citations and automate in-text links throughout your documents, which is especially helpful if your application is literature heavy. 2.?????What sets Quantum apart from other publishing vendors? Quantum is committed to providing high-quality, customized support to our Sponsors and we value those partnerships- we truly see ourselves as an extension to your team. Our publishers are extremely knowledgeable and have access to Quantum’s in-house and external network of industry resources to support all types of Regulatory activities and circumstances. We’re very collaborative and flexible, unlike some larger organizations where publishing services can feel siloed and transactional. We like to make recommendations on best practices to maintain quality and increase efficiency. However, Quantum publishers can function independently if that works best- we’re open to different team dynamics and are accustomed to working with companies of all sizes, from small start-ups to larger, established organizations. Unforeseen delays happen- we understand that and always make every reasonable effort to keep deadlines. That’s also why we never assign specific timeslots for submissions. We clearly communicate what is and isn’t possible and will get creative to minimize or even eliminate delays. We’re here to help!

Post 1 of a two-part post: Quantum Publishing! We recently sat down with Associate Director, Regulatory Publishing, Jennifer Harmon to discuss Quantum's publishing capabilities and what sets us apart from our competitors. Check out Jen's responses below: 1.?????Why should I work with a publishing vendor such as Quantum? Simply put, producing FDA submissions requires a combination of specialized eCTD software and nuanced technical knowledge. Engaging an experienced publishing vendor allows Sponsors to leverage the efficiency and knowledge of publishing experts for major milestones like INDs and NDA/BLAs, and beyond. Outsourced publishing is a scalable solution that supports the inevitable surge of activity for large Regulatory deliverables, while remaining conducive to the subsequent ‘maintenance’ phase where submission needs may ebb and flow. While some Sponsors choose to build publishing capabilities in-house, it's important to know that eCTD software is a significant financial investment that operates in a very technical and dynamic landscape. Aside from the practical conveniences of outsourcing publishing activities, a quality publishing vendor also offers access to eCTD templates. Document templates streamline authoring and formatting, which helps ensure consistency across an application- this is especially helpful when contributors are spread across different functional areas with separate workstreams. 2.?????How does Quantum prefer to work with a Sponsor? Ideally, Sponsors would engage Quantum early in the initial application planning process versus the end of the submission process. Quantum offers personalized and collaborative support, and we like to help guide Sponsors through the planning, publishing, and review processes. Regular team meetings help ensure a smooth workflow and position the team to absorb delays - we’ll determine what can be done ahead of time to prepare for late arriving pieces and get creative if we need to pivot. Quantum publishers are highly experienced and can make recommendations on document placement and requirements from a strategic perspective, for example, which documents are actually required or could be omitted at the IND stage.

Quantum Regulatory Solutions 2023 Year in Review QRS is reflecting on all of the successes of 2023 and the growth of an exciting new business. We also want to wish all or our friends and colleagues a peaceful and fruitful 2024. Thank you for all of your support in kicking off Quantum Regulatory Solutions! - QRS officially opened for business in May of 2023. The business is co-owned by 3 seasoned regulatory experts - Mark Ammann, Pharm.D., Dawn Chitty and Mara Gladstone Holinger, PhD, RAC - Since May, QRS has hired 10 full time employees and established partnerships with ~40 niche regulatory experts as well as several organizations offering complementary services. - In 7 short months, QRS has signed 36 clients. We have submitted 2 initial INDs, provided strategic planning for an NDA, authored CMC components for an IND, supported due diligence assessments for 5 products across 3 sponsors, and deployed several of our employees to provide dedicated support to large pharmaceutical companies - One of our co-founders was interviewed by Don Davis PhD, MBA, giving her the opportunity to discuss her career progression as well as the top-notch regulatory support provided by QRS. https://lnkd.in/gneRkKmE - In November 2023, QRS held it's first face-to-face meeting in Boulder, CO. The meeting was a huge success in team building and strategizing to provide the best support for our clients. Enjoy these pictures from our time together, including the serial killer escape room! #regulatoryaffairs Jennifer Harmon Michelle Price McKern Bagyashree Sundaram Toni Marie Nearing Sarah Donaldson Ellen Truitt, RAC Alexis Northcutt, PhD, RAC