Meet The Expert: Lisa Bollinger (Mathis), MD, Expert Consultant, NDA Partners, A ProPharma Company Dr. Bollinger is a pediatrician and regulatory pediatric drug development expert with leadership experience in regulatory, industry, and clinical settings. Throughout her 13-year career with FDA, she served in leadership roles in the Center for Drug Evaluation and Research (CDER) as Associate Director, Office of New Drugs, Pediatric and Maternal Health, and Acting Director and Team Leader, Division of Pediatric Drug Development, Office of Counterterrorism and Pediatric Drug Development. In these roles, she led pediatric drug development by establishing policies and implementing them across the CDER and CBER. She began her regulatory career as a Medical Officer in the Division of Dermatologic and Dental Drug Products in CDER, while delivering primary care at Walter Reed Military Medical Center in Bethesda, Maryland. Dr. Bollinger’s experience across government and private industry, in addition to her clinical experience, will bring immense value to NDA Partners’ clients developing therapies for pediatric patients. Learn more about Dr. Bollinger: https://lnkd.in/ezHUwrFg. #ndapartners #pediatricdrugdevelopment #FDA #regulatorysciences
About us
NDA Partners, a ProPharma Company, is a life sciences management consulting organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Expert Consultants of NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.
- Website
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http://www.ndapartners.com
External link for NDA Partners
- Industry
- Business Consulting and Services
- Company size
- 51-200 employees
- Headquarters
- Washington, District of Columbia
- Type
- Partnership
- Specialties
- Strategy Consulting for Medical Product Companies
Locations
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Primary
1129 20th St NW
Washington, District of Columbia 20036, US
Employees at NDA Partners
Updates
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Interested to learn why Biologics are facing more Complete Response Letters? NDA Partner's Partner and Regulatory Expert, Daniela Drago, shares some insights about the topic. #ndapartners #FDA #regulatoryaffairs #drugdevelopment
𝗪𝗵𝘆 𝗔𝗿𝗲 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 𝗙𝗮𝗰𝗶𝗻𝗴 𝗠𝗼𝗿𝗲 𝗖𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗲 𝗟𝗲𝘁𝘁𝗲𝗿𝘀? Some of you might have noticed - There has been a significant increase in Complete Response Letters (CRLs) related to Biologics License Applications (BLAs) due to facility issues, particularly in manufacturing. This trend, was discussed this week at a Duke-Margolis CMC workshop, highlighting the growing challenges faced by the industry. During the workshop, CDER Director Dr. Patrizia Cavazzoni emphasized the importance of addressing manufacturing deficiencies early on, noting that nearly half of the BLAs reviewed in 2023 received a CRL. The key drivers? Facility readiness and compliance with current good manufacturing practices (cGMP). Here are some highlights from Dr. Cavazzoni's remarks: 🔹 A significant portion of CRLs are now tied to issues at Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs). This is creating a backlog, as multiple applications can be impacted by a single facility’s non-compliance. 🔹 She urged sponsors to maintain strong communication with their CMOs/CDMOs and to take advantage of FDA’s pre-application meetings to ensure facility readiness and avoid surprises. 🔹 FDA standards have remained consistent. The rise in CRLs reflects the need for better quality control at manufacturing facilities, not a change in FDA's expectations. If you are interested in the topic and want to know more, here are some details: https://lnkd.in/eyTU9n9c #DrugDevelopment #RegulatoryAffairs #Manufacturing #CMC #FDA
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Learn more about Finding FDA authorized devices with Predetermined Change Control Plans (PCCPs) in this insightful post by NDA Partners' Expert Consultant, Brendan O'Leary. #ndapartners #medicaldevices #FDA
In December 2022, the Food and Drug Omnibus Reform Act of 2022 provided the FDA with new authority related to the authorization of Predetermined Change Control Plans (PCCPs). A PCCP can enable significant planned modifications to be made to a medical device after the device and the plans to modify the device have been reviewed by the FDA. This post provides a summary of the law, describes how to find devices that have been authorized with PCCPs, lists devices that I found using these approaches, shows the approximate rate at which the FDA has authorized these devices over time based on the search results, and shows the device areas where PCCPs are most commonly used based on the search results. https://lnkd.in/e7jtTmYu
Finding FDA authorized devices with Predetermined Change Control Plans – Brendan O’Leary
boleary.com
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Learn about navigating market access and reimbursement strategy for medical products in this informative blog post: https://lnkd.in/eXRneTsr #ndapartners #propharma #regulatorysciences #marketaccess #reimburesmentstrategy #productdevelopmentlifecycle
Navigating Market Access & Reimbursement Strategy for Medical Products
propharmagroup.com
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Learn more about navigating FDA's 510(k) submission requirements using the FDA eSTAR Template in this insightful blog: https://lnkd.in/eWiS9ifv #regulatorysciences #ndapartners #propharma #medicaldevices #regulatorysubmission #FDA
FDA eSTAR Template: Navigating FDA's 510(k) Submission Requirements
propharmagroup.com
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Steve Silverman, NDA Partners Expert Consultant, will be participating in a panel discussion on July 31st hosted by Essenvia entitled, "Shaping the Future of MedTech: Insights at the Intersection of Regulation and Innovation." The panel of MedTech industry experts will discuss challenges manufacturers face as they work to comply with rules and regulations. The discussion will focus on topics of generative artificial intelligence (GenAI), digital health, EU MDR and IVDR, the US FDA’s Quality Management System Regulation (QMSR), and much more. Mr. Silverman joined NDA Partners as an Expert Consultant in 2022 to support medical product companies providing guidance on matters including regulatory strategy, product quality and compliance, pre-market oversight, and stakeholder communications. His professional experience includes nearly two decades in federal service with Director-level positions in FDA’s CDRH and CDER Offices of Compliance. #ndapartners #medicaldevice #qualitysystem #regulatorycompliance
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Steve Silverman, NDA Partners Expert Consultant, will be moderating a panel discussion entitled “A Life-Cycle Road Map to the Patient” as part of the 2024 Medical Device Innovation Consortium (MDIC) Excellence In Quality summit in Boston, MA on July 24th. Join the discussion to hear from industry, healthcare, and FDA leaders who will share their perspectives of benefits, rapidity, and efficiencies from transforming medical device recall notifications from antiquated paper processes to digital methodologies, and how this leads to faster and greater patient safety awareness. #ndapartners #MDIC #patientsafety #medicaldevice
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Dr. Alberto Gutierrez will be co-chairing the “Regulatory Strategies for Point-of-Care Diagnostics Special Forum” at the 16th Annual Next Generation Dx Summit in Washington, DC on August 20th. The forum begins with a keynote presentation entitled “Updates on US FDA POC Test Regulations” presented by Timothy Stenzel, MD, PhD, Former Director, Office of in vitro Diagnostics and Radiological Health (FDA). A panel discussion entitled “Regulatory Strategies for Point-of-Care Diagnostics: Learning from Success Stories and Avoiding Pitfalls” and plenary fireside chat entitled “Laboratory-Developed Tests: Proposed Rule, Reclassification Activities, Potential Impact, and Path Forward” feature FDA regulators including Courtney H. Lias, PhD, Acting Director, OHT7: Office of in vitro Diagnostic Devices (FDA), and industry experts. Join the discussion to learn more about the essential components and nuances that are pivotal for regulatory approval for point-of-care diagnostics. #ndapartners #diagnostics #FDA #IVD #LDTs #laboratorydevelopedtests #NGDx #IVDR #regulatorysciences https://lnkd.in/d_z6tMBP.
Regulatory Strategies for POC Diagnostics | Next Generation Dx Summit | August 19-21
nextgenerationdx.com
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Learn more about the FDA Animal Rule and impact on drug development in this insightful blog: https://lnkd.in/gZcvDEAG #FDA #animalrule #regulatorysciences #drugdevelopment #ndapartners #propharma
FDA Animal Rule: Overview & Impact on Drug Development
propharmagroup.com
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Meet The Expert: Ben Saville, PhD, Expert Consultant, NDA Partners, A ProPharma Company Dr. Saville is a statistical scientist specializing in the design of innovative Bayesian and adaptive clinical trials. He works primarily with medical device and pharmaceutical companies to solve challenging problems through Bayesian designs. Dr. Saville has designed Bayesian clinical trials in a variety of therapeutic areas, including cardiovascular diseases, rare and progressive diseases, infectious diseases, stroke and traumatic brain injury, respiratory and digestive disorders, and neurological diseases. He has extensive regulatory experience representing clients in FDA meetings, submissions, and advisory panels, and is a consultant to the FDA Circulatory System Devices Advisory Panel and a current member of the FDA Ear, Nose, and Throat Devices Advisory Panel. Dr. Saville’s experience in innovative Bayesian and adaptive clinical trials brings immense value to NDA Partners’ clients. His knowledge of innovative study design adds complementary experience to the firm’s existing biostatistical expertise. Learn more about Dr. Saville: https://lnkd.in/ePnmYzMk #ndapartners #clinicalstudydesign #BayesianDesign #regulatorysciences