2023 Speaker Synopsis

Blake Bevill, FDA

FDA ORA Update – Current topics of interest and looking forward to FY24

November 28, 2023 – 8:45-9:15 AM

Alex Smith, Hogan Lovells LLP

Medical Device AI Submissions and AI Predetermined Change Control Plans

November 28, 2023 – 9:15-9:45 AM

Joseph (Robby) Roberston, UCB

Developing AI based SaMD using Real World data – Perspectives of a Data Scientist

November 28, 2023 – 9:45-10:15 AM

The explosion of real-world data and innovations in AI has resulted in a rich ecosystem that enables the creation of invaluable Software-based Technology Solutions to benefit the entire spectrum of healthcare. One of the critical areas is developing AI-based Software intended for medical purposes. Due to potential patient risk, such software is subjected to Regulatory purview under the Software as a Medical Device (SaMD) framework. The regulatory framework is still evolving to accommodate the nuances of AI-based software. The presentation gives an overview of the opportunities and challenges for entrepreneurs, businesses, and Data Science/AI professionals who are interested in developing AI-based SaMD.  The presentation will cover, at a high level, the current state of real-world data and insights into looking at the evolving regulatory framework from the perspective of a Data Scientist.

Mark R. Prausnitz, Georgia Tech

Translation of drug delivery devices from lab to clinic

November 28, 2023 – 10:30-11:00 AM

Drug delivery devices play an important role in pharmaceutical therapies by facilitating drug administration into the body, controlling the kinetics of drug release, and targeting drug delivery to target tissues in the body. We are developing microdevices that leverage microneedle technologies for patch-based vaccination, long-acting contraception that can be self-administered, targeted drug delivery in the back of the eye, topical delivery of biologics to the skin, and nucleic acid delivery by electroporation without lipid nanoparticles or viral vectors. This talk will discuss the design, development, and clinical translation of these novel drug-delivery devices.

Helin Raagel, Nelson Labs

Biocompatibility Evaluation and Current Regulatory Expectation for Testing

November 28, 2023 – 11:00-11:30 AM

Before market release, medical devices must undergo biological safety evaluations to ensure they do not pose unforeseen risks or adverse reactions during clinical use. This is usually the last step in device development and should be performed per ISO 10993-1. One of the pressing challenges in this evaluation is navigating a constantly evolving regulatory environment, which often also differs across global agencies.

This presentation offers an overview of the current regulatory expectations for biocompatibility assessments and subsequent testing. To note, there has been a clear shift towards a more informed risk-based analysis, rather than simply performing all the testing defined by the relevant endpoints. By leveraging available data, the aim of a biological evaluation is to identify knowledge gaps that might necessitate further testing. In cases where additional tests are needed, factors such as test sample preparation and testing conditions, as well as the correct methods that are defined or expected by the specific regulatory region, need to be considered in order to facilitate a smooth submission.

Melissa O’Connor, StimLabs

Human Tissue Product Regulation – a Comparison of CBER and CDRH Oversight

November 28, 2023 – 11:30 AM-12:00 PM

Advancements in the regenerative medicine space have required the FDA to develop appropriate regulatory pathways to ensure the protection of the public health, but how does the path to the market change depending on who has regulatory oversight of human cells, tissues, and cellular and tissue based products at the end of the day? Find out here!

Peter Shearstone, Thermo Fisher Scientific

Pre-market challenges: Using the FDA’s Q-Sub process strategically

November 28, 2023 – 1:00-1:30 PM

Peter Shearstone will discuss the strategy the Quality Assurance and Regulatory Affairs organization at Thermo Fisher Scientific has utilized to overcome pre-market challenges – using the FDA’s Q-Sub process strategically. While there’s a great deal of focus on the 510(k)-submission phase of the pre-market period, Peter will focus on a pre-market topic that doesn’t seem to receive as much attention – the FDA’s Q-Sub process. He’ll be discussing:

• How a company approaches the FDA’s Q-Sub process can have an impact on its success
• Determining regulatory requirements, which define the next steps
• Showing just as much attention detail to the quality of documents and submissions as is given to everything else. The quality of outcomes will be affected by the quality of submissions
• Utilizing meetings with the FDA as part of the Q-Sub process to listen and learn
• Recognizing the value of FDA’s input, feedback and questions well beyond obtaining clearance

John Doucet, MCRA

The FDA Breakthrough Device Program:  Strategies for Obtaining and Using a Breakthrough Device Designation

November 28, 2023 – 1:30-2:00 pm

The Breakthrough Device Program is intended to help patients have more timely access to medical devices that could more effectively treat or diagnosis patients with life threatening or irreversibly debilitating medical conditions.  The Program supports special interaction mechanisms for breakthrough devices to promote focus and collaboration between FDA and Industry.  The goal of these unique mechanisms is to expedite the development, assessment, and review of breakthrough devices, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.  The learning objectives of this presentation are the following:  (1) Understand the purpose and benefits of the breakthrough device program; (2) Understand key strategies for obtaining the breakthrough designation, and potentially new strategies due to recent updates to FDA guidance published in September of this year; (3) Understand how to use the special FDA interaction mechanisms only available to breakthrough devices.

Frances Cohen, Promenade Software

Software validation and mobile applications – Focus on cybersecurity risk

November 28, 2023 – 2:00-2:30 PM

Security for medical device mobile applications requires special considerations.  This presentation delves into the controls and considerations necessary to write secure mobile applications and the associated testing needed.

Alan Minsk, Arnall Golden Gregory, LLP

Quality Agreements and What You Should Know and Consider (in 30 minutes!): A Regulatory Lawyer’s Perspective

November 28, 2023 – 2:30-3:15 PM

Johnathon Bis, BSI

MDR/IVDR rollout: A status update

November 28, 2023 – 3:30 – 4:00 PM

Qianqian Zhu, Intuitive Surgical

Exemption of clinical trials with RWD in China

November 28, 2023 – 4:00 – 4:30

The landscape of Real World Data (RWD) and Real World Evidence (RWE) is undergoing significant changes in China, with growing acceptance by the National Medical Products Administration (NMPA). Notably, the Hainan Medical Products Administration (MPA) is actively promoting the utilization of RWE in both regulatory and reimbursement decision-making processes. Despite these advancements, RWE research in the “Boao Lecheng Pilot Zone” is in its early stages. Boao Lecheng currently holds the distinction of being the exclusive “RWD Application Pilot Site” in China, streamlining the approval process for international innovative medical devices. However, it’s crucial to note that, in the current developmental phase, real-world evidence serves as a supplementary element in the clinical evaluation of medical devices, complementing existing clinical evidence rather than replacing established evaluation pathways

Evangeline Lou, Emergo by UL

Recent Changes in Brazil, Mexico, and other countries in Latin America: Towards Global Regulatory Alignment

November 29, 2023 – 4:30-5:00 PM

This presentation will present recent regulatory developments in Latin America which demonstrate the efforts related to global regulatory alignment. The activities of a new global organization as well as MERCOSUR will be mentioned. The discussion in Brazil will revolve around RDC 751/2022 which is a major legislative update to medical device registrations which further aligns the legislation with the European legislation as well as the International Medical Device Regulators Forum (IMDRF). Two recent consultations will be shared as well which relate to the Medical Device Single Audit Program (MDSAP) and leveraging regulatory authorizations.  The Suplemento para Dispositivos Medicos Mexican Pharmacopoeia Edition 5.0 which was released in Mexico earlier this year is also similarly intended to align with the European legislation and IMDRF. There will also be regulatory updates on Costa Rico, Argentina, and Columbia.

Mary Millner, FDA

Investigator Insights from Inspections and Strategies for Managing Inspections

November 29, 2023 – 8:45-9:15 AM

Erica M. Katherine, FDA

Navigating Pathways to Solutions: Effective Communication with the FDA

November 29, 2023 – 9:15–9:45 AM

In the complex, dynamic domain of regulatory affairs, effective communication is paramount. Whether you’re a regulated entity, industry professional, or concerned citizen, the ability to communicate with the Food and Drug Administration (FDA) can significantly impact the resolution of issues concerning medical products and public health. This presentation, “Navigating Pathways to Solutions: Effective Communication with the FDA,” aims to clarify the process and provide you with some recommendations to ensure your voice is heard. We will explore three pathways for issue resolution:

1. Communication with the Team & Supervisory Chain

2. Contacting the Ombudsman

3. Pursuing Formal Appeals and Petitions

Join this enlightening 30-minute session, where you’ll acquire valuable insights, practical guidance, and a broader understanding of effective communication with the FDA.

Mark Chan, FDA

Strategies and best practice for communicating recalls w/FDA

November 29, 2023 – 9:45-10:15 AM

This presentation will cover the overall process of Medical Device Recalls.  The presentation will briefly cover the Recall Regulations (21 Code of Federal Regulations Part 7) and Medical Devices Corrections and Removals (21 Code of Federal Regulations Part 806).  The main focus of the presentation will cover a walk through the elements of a Customer Notification Communication and the Corrections and Removal Report and provide strategies/best practices on submitting a complete Corrections and Removal Report.

Kimberly Trautman, Medicept

Risk Management – FDA Transition to ISO 13485

November 29, 2023 – 10:30-11:00 AM

Nelson Anderson, FDA

CDRH Portal and eSTAR Program for Streamlining Submissions

November 29, 2023 – 11:00-11:30 AM

Allison Komiyama, RQM+

Deciding when to interact (or not interact) with FDA: Q-subs, 10-day calls, AI responses, and more!

November 29, 2023 – 11:30-12:00 PM

Interactions with FDA are inevitable and can be extremely beneficial…but can also come with some risk. Medical device companies can request interactions with FDA before, during and after regulatory decision points. Q-Submissions are a powerful way to establish a relationship with FDA, introduce a medical device, and gain useful insight into the appropriate regulatory strategy with which to approach a premarket submission. We will discuss:

• When to consider a Q-Submission, including the regulatory approach
• When NOT to consider a Q-Submission
• The contents of a Q-Submission package and how it is assembled
• The various types of submissions that are available
• The kinds of feedback will be provided, and how to read between the lines of a reviewer’s comments

David Van Houten, FDA

Current compliance trends and Responding to Issues found by FDA

November 29, 2023 – 1:00-1:45 PM

This talk covers current trends in compliance findings during medical device inspections.  The talk will cover the main areas that are being found more often now to be out of compliance and provide some tips for improving in these areas.  The talk will also include tips and advice on providing responses back to the FDA to address issues noted during an inspection.

Clare Mattie, Network Partners

Regulatory Approaches for Combination Products

November 30, 2023 – 8:45-9:15 AM

Combination products are always a device integrated with either a drug or a biologic. However, the same combination product may be regulated differently in different markets. In this presentation, we’ll compare and contrast the way combination products are defined, designated, and regulated by the US Food and Drug Administration and by Health Canada.

James Wabby, Abbvie

Disruptive Medicine Innovation – Next Generation Combination Products: Strategies for Combination Products that includes a Devices

November 30, 2023 – 9:15-9:45 AM

Combination products are emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges.

New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative, or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality, and performance of combination products. Taken together, the fast development of combination products with great potential in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.

With the dawn of a new millennium and the rapidly aging baby-boomer population, the pressure for companies to create safer and more effective treatments is growing. Combination products are one of the solutions that have emerged to meet the more rigorous demands of patients. Drug-enhanced devices, including drug eluting stents and antimicrobial-coated catheters, have already proven themselves on the market. Pre-filled syringes and transdermal patches, which are novel drug delivery systems, have also been widely used treatments. However, the combination products that are some of the most innovative are regenerative medicine products. These types of products can provide cures for previously untreatable conditions, which can truly change the face of the industry.

Upon completion of each session, participants should be able to:

• Analyze latest regulatory expectations and challenges
• Understand potential future innovation platforms
• Acknowledge potential and future Global Convergence/Harmonization intiatives for combination products
• Understand the regulatory challenges and opportunities ahead

Renish Delvadia, FDA

Strategies for Combination Products that include Devices: Regulated by CDER

November 30, 2023 – 9:45-10:15 AM

This presentation will primarily focus on CDER-led Drug-Device Combination Products. The presentation will provide an overview of these drug-device combination products, explaining their significance in healthcare and how they merge pharmaceuticals with devices. Key topics will include the advantages of these products, the development paradigm they follow, and the factors impacting drug-device interactions. Attention will also be given to the ICH and FDA guidances shaping their development, and the regulatory challenges they face. The presentation aims to offer a high level understanding of the approaches in developing and regulating CDER-led drug-device combination products.

Johnathon Bis, BSI

MDR/IVDR rollout: A status update

November 30, 2023 – 10:30- 11:15 AM

Nick Morley, Element Materials Technology

Regulatory Development & Submission Strategies for Drug-Device Combination Products Within the EU

November 30, 2023 – 11:15 AM-12:00 PM

This presentation provides an overview of the regulatory landscape and submission strategies for drug-device combination products in the European Union (EU). As the pharmaceutical and medical device industries increasingly converge, understanding the intricacies of regulatory pathways becomes increasingly important. The session will discuss some of the regulatory requirements and challenges associated with drug-device combination products, and insights into some key considerations for successful product development and market approval within the EU.

Topics covered include:

• An overview of the regulatory framework governing drug-device combination products in the EU
• Categories of combination products and the impact on regulatory pathways
• An understanding the roles of notified bodies and competent authorities in the EU regulatory process
• Specific challenges that may be encountered

Lisa Hawkins, Network Partners

Gaining Real World Experience: NPG’s Leadership Program

Lunch Presentation: November – 30, 2023 1:00-2:00 PM

If you are new to the industry and need real-world experience in performing all types of regulatory activities, consider joining Network Partner’s Leadership program.  We offer intensive training and placement on client projects with SME support to help you gain experience in a wide range of regulatory activities.