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Special Topic: Risk Management in Combination Product Development

This event is now offered in a new entirely virtual format.


Speakers

  • James  Wabby, MHS

    James Wabby, MHS

    • Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
    • Abbvie, United States

    James Wabby is the Executive Director of Regulatory Affairs (Emerging Technologies and Combination Products) at AbbVie in Irvine, California. He has over 20 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Nutritional, Cosmetic, Branded Pharmaceutical, Generic, Biologic, Medical Device and Combination Product areas. James received his undergraduate and graduate degrees from Duquesne University and received his Health Care Compliance Certificate from Seton Hall University Law School. He is a member of various regulatory and quality work groups including RAPS, OCRA and the ASQ Orange Empire Section.

  • John Barlow Weiner, JD

    John Barlow Weiner, JD

    • Associate Director for Policy, Office of Combination Products, OCPP, OC
    • FDA, United States

    John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with ensuring the sound and consistent regulation of combination products and also with the classification and assignment for regulation of medical products (drugs, devices, biological products, and combination products).

  • Jonathan  Amaya-Hodges

    Jonathan Amaya-Hodges

    • Senior Principal Consultant
    • Suttons Creek, Inc, United States

    Jonathan has over 16 years of multidisciplinary background in regulated medical products (drugs, biologics, medical devices, and combination products) with practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of products and a focus on drug delivery. Other areas include digital health (connected devices and SaMD), IVDs, along with clinical development (bridging) and LCM. Jonathan is engaged with the global community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics. He holds a BS in Chemical Engineering from Northwestern University and is an ASQ CQE and CMQ/OE.

  • Karthik  Balasubramanian, PhD, MS

    Karthik Balasubramanian, PhD, MS

    • Director, Combination Products and Semisolids, Generic CPD
    • Teva Pharmaceuticals, United States

    Dr. Karthik Balasubramanian, Ph.D is Director in the Combination Products and Semisolids Group at Teva Pharmaceuticals. He has over 15 years of experience in all phases of medical device and combination product development, from R&D to Technical Operations. Prior to joining Teva, he has worked in numerous device areas in roles of increasing responsibility, from syringes to large scale diagnostic systems, as well as in sterile injectables and radioactive contrast imaging devices. He has a bachelors in Biomedical Engineering from Columbia University, and a Ph.D in Mechanical Engineering from Drexel University.

  • Susan W. Neadle, MS, MSc

    Susan W. Neadle, MS, MSc

    • Medical Device, Combination Products, Design Thinking, Process Excellence
    • and Program Management Expert, United States

    Susan Neadle, MS, BS, FAAO, a DEx and PE Black Belt, is Executive Director, Combination Products, Devices , Diagnostics & Digital Health RA, at Amgen. This follows a very successful career of 25+ years at Johnson & Johnson, where she held integral leadership roles in R&D and QA/QE, spanning devices, pharmaceuticals, consumer products and the Enterprise. In her most recent role, she was Chair of J&J’s Design Council, advancing best practices in product & process design and development to drive robust, customer-centric health care solutions across J&J. She also led J&J's Combination Products CoP. Among several achievements, Susan led the global organization’s efforts to meet Combination Products health authority regulations.

  • Chin-Wei  Soo, DrSc

    Chin-Wei Soo, DrSc

    • Global Regulatory Head, PTR Devices and Combination Products
    • Genentech, A Member of the Roche Group, United States

    Chin-Wei Soo is the Global Regulatory Head, Combination Products, Devices, and Digital Health at Roche/Genentech. He is accountable to provide technical regulatory oversight to Roche’s entire device, combination product, and digital health portfolio, covering all large (BLA) and small molecules (NDA) throughout the product lifecycle. Chin has 18 years of regulatory and quality experience, including strong expertise in combination products and digital health.

  • Kimberly  Trautman, MS

    Kimberly Trautman, MS

    • Medical Device, IVD, and Combination Product Expert
    • *, United States

    Experienced Medical Devices, IVD and Combination Product Expert with over 30 years of experience, including 24 years working at the U.S. FDA CDRH. Author of the 1996 Medical Device Quality System regulation and member of the authoring group for Combination Product GMPs in Part 4. US Expert on GHTF and IMDRF 1991-2016, working with Regulatory Agencies around the globe. At FDA conceived and developed the Medical Device Single Audit Program (MDSAP) and in the private sector opened an Auditing Organization and a new Notified Body in Ireland for EU IVDR/MDR Designation. Executes regulatory and QMS services to include consulting, auditing, and education. Masters degree in Biomedical Engineering.

  • Ricki  Chase

    Ricki Chase

    • United States

  • Erin  Keegan, MS

    Erin Keegan, MS

    • Combination Product Policy Analyst
    • Food and Drug Administration, United States

    Erin Keegan has worked at the FDA since 2014. For the first five years of her FDA career she was a Lead Reviewer in CDRH's Office of Health Technology 5 where she primarily reviewed premarket submissions for neurostimulation systems for neurological disorders. In her current role as a CDRH Product Jurisdiction Officer, she works with internal and external stakeholders to provide guidance on combination product policy as well as the overall classification and jurisdiction of medical products. Over the past year, she has also provided support on CDRH's EUA activities. Erin received her Bachelors and Masters Degrees in Biomedical Engineering from the University of Rochester in Rochester, NY.

  • Enric  Calderon, MS

    Enric Calderon, MS

    • Associate Director Combination Products and Devices R&D
    • Teva Pharmaceuticals, United States

    Enric Calderon works as Associate Director Combination Products and Devices R&D at Teva. He received his BSc and MSc in Electrical Engineering from La Salle Ramon Llull University in Barcelona, Spain. He worked on implantable neurostimulators at the Barcelona Institute of Microelectronics (IMB-CNM, CSIC) (1998-2000), and at Neurostream Technologies in Vancouver, Canada (2001-2004). In 2004 joined a spinoff company of IMB-CNM working on electrical impedance spectroscopy. In 2010 joined Cetemmsa Technological Centre as research manager for printed electronics and sensors. In 2013 joined Teva Pharmaceuticals Ireland leading the technical development of Digihaler, the first digital inhaler with built-in sensors and Bluetooth® technology.

  • Molly Follette Story, PhD, MS

    Molly Follette Story, PhD, MS

    • Senior Advisor, Medical Device Development Unit
    • Sanofi , United States

    MOLLY FOLLETTE STORY, PhD is a Senior Advisor in Sanofi’s Medical Device Development Unit. She was formerly Senior Director of Sanofi’s Global Usability Engineering and Risk Management group. Before joining Sanofi, Dr. Story was Human Factors and Accessible Medical Technology Specialist at the U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, where she had an appointment to the Senior Biomedical Research Service. Dr. Story is an expert in human factors engineering of medical devices. She is a Fellow of the Association for the Advancement of Medical Instrumentation and Co-chair of its Human Factors Engineering Committee.

  • Eric  Chan, MS

    Eric Chan, MS

    • Teva Pharmaceuticals
    • Director of Product Management, Digital Health, United States

    Eric Chan serves as Director of Product Management in Digital Health at Teva Pharmaceuticals. He is responsible for the development of software solutions that complement Teva’s portfolio of medications by increasing patients’ awareness and understanding of their medication and health condition, and facilitating patient-provider communication by presenting providers with objective data. Eric has over 15 years of experience in the healthcare IT, holding product management positions at various software and medical device startups.

  • Mark  DeStefano

    Mark DeStefano

    • Director: Combination Products and Device R&D
    • Teva Pharmaceuticals, United States

    Mr. Mark DeStefano is Director, Combination Products and Devices Research and Development for Teva Pharmaceuticals focusing on advanced technology identification and development for Teva pipeline products. He is an experienced Device Development Professional with a demonstrated 30+yr history of product innovation, design, development, and launch in many areas of the medical device industry. Mr. DeStefano holds a Bachelor of Science in Mechanical Engineering from Drexel University.

  • Christiana  Hoffman, DrSc

    Christiana Hoffman, DrSc

    • Regional Manager Focus topics
    • TÜV SÜD bei TÜV SÜD, United States

    Christiana Hofmann is a Biologist with a main interest in the biomedical area. She completed her PhD at the Helmholtz Research Centre of Munich in cooperation with the Technical University of Munich in the field of Toxicology with focus on risk analysis. After gaining several years of experience in the pharmaceutical industry, e.g. Novartis, she joined TÜV SÜD in 2016 as a team lead of experts and auditors for non-active medical devices. In between she has taken over the role of the Regional Manager Focus Topics. Where she is overall responsible for Article 117 and Annex XVI in the DACH & Nordics region. Two fields where she can combine her passion for biomedicine and her experience in medical devices gained over the past years.

  • Arlesa  Hubbard, MS

    Arlesa Hubbard, MS

    • Global Head Quality Device Risk Management & Monitoring
    • Sanofi, United States

    Arlesa has a background in medical device development with specific training in risk management, design controls, and quality systems management of medical devices. She is passionate about developing safety systems and currently fills a role at Sanofi where she supports the development of various technologies to assist with the treatment and/or management of diabetes and select rare diseases. In her current role, she focuses on the design and development of both combination drug-device products and standalone software as medical devices and their connected ecosystems.

  • Kristina  Lauritsen, PhD

    Kristina Lauritsen, PhD

    • Combination Products Regulatory Policy Advisor, OEP, CDER
    • FDA, United States

    Kristina Lauritsen, PhD serves as a Combination Product Policy Advisor within the Center for Drug Evaluation and Research (CDER) at the FDA. In this role, she is responsible for engaging in development of CDER's policies related to combination product review and regulation, including activities such as guidance development, facilitating coordination with the FDA's Office of Combination Products, CBER and CDRH, and representing CDER in cross-center combination product working groups. Prior to joining CDER in 2014, she spent four years in the Center for Devices and Radiological Health, followed by seven years in the Office of Combination Products. She holds a B.S. in Biology from Shippensburg University.

  • Emily  Luvison

    Emily Luvison

    • Principal Lead Cybersecurity Compliance for Digital Health Technologies
    • Genentech, United States

    Emily Luvison is the Cybersecurity Compliance Lead for Genentech’s Digital Health Technologies (DHT) organization, where she leads the strategic development and execution of a cybersecurity compliance framework for digital health products and solutions in line with healthcare industry standards and regulations. Prior to this role, Emily has led cybersecurity and privacy teams to meet their compliance objectives for digital products and brings rich experience from her career in security consulting and auditing in the healthcare and technology sectors.

  • Matthew  Gloss, JD, MBA

    Matthew Gloss, JD, MBA

    • Co-Founder, Chief Operations Officer
    • Belletorus Corporation, United States

    Co-Founder, COO, BelleTorus Corporation. BelleTorus is a global AI/ML startup with headquarters offices in Toulouse, France, Cambridge, MA, and the Silicon Valley. First to market with Full Body PASI AI™, Belle seeks to digitize the entire skin health and wellness value chain for our leading clinical research, drug manufacturers, centers for healthcare excellence, and telehealth licensees. With our team of more than 27 deep math PhDs, our cadre of leading data scientists, our full-stack software engineering team, and our global network of preeminent dermatologists, Belle's AI solutions for skin health and wellness remove bias, establish treatment efficacy, and increase patient adherence. See us at belle.ai.

  • Theresa  Jeary, MSc

    Theresa Jeary, MSc

    • Technical Specialist & Scheme Manager
    • BSI, United Kingdom

    Theresa Jeary holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries. In addition to her product development and global regulatory expertise, Theresa has over 12 years Notified Body experience, first at BSI as a technical expert for devices with ancillary medicinal substance and borderline classifications moving then to LRQA where she held the role of Head of Notified Body for several years. Theresa re-joined BSI in August 2020, as a Technical Specialist in the Medicinal and Biologics Team, with responsibility for the combination product area.

  • Robert  Labaczewski

    Robert Labaczewski

    • Director- Device Quality
    • Bracco Diagnostics, United States

    Robert has over 22 years of experience in Medical Device quality systems and engineering, with extensive knowledge in QSR 820, ISO 13485, ISO 14971, and International Regulations/Standards including Canada, Europe, Japan, & Australia. Robert has worked at medical companies that include Datascope Corporation (now Maquet & St. Jude Medical), and BD (Becton Dickinson). Robert is currently the Director- Device Quality at Bracco Diagnostics, Inc. (BDI), responsible for quality for all BDI medical devices distributed World-Wide. Robert earned a B.S. in Biology from Providence College, is a certified Quality Auditor, and is certified as a Lean Sensei for Lean Six Sigma. This is Robert’s first time presenting at a DIA conference.

  • Phillip  Robledo

    Phillip Robledo

    • Associate Director, Regulatory Affairs
    • Abbvie, United States

    Phillip Robledo is an Associate Director of Regulatory Affairs (Emerging Technologies and Combination Products) at AbbVie in Irvine, California. He has over 20 years of experience with increasing responsibilities within R&D, quality and regulatory affairs for manufacturers of medical devices and combination products. His previous experiences provide him with a strong emphasis in design control, risk management and quality system auditing. He is an American Society of Quality (ASQ) Certified Quality Auditor (CQA) and Certified Medical Device Auditor (CMDA).

  • Tycho  Speaker, PhD

    Tycho Speaker, PhD

    • Director, Drug Delivery and Biomaterials
    • Abbvie, United States

    After earning a PhD in Physical Chemistry at UCSC, Tycho entered a first career in semiconductor manufacturing as a process engineer, eventually leaving to found his own company to commercialize an encapsulation chemistry. Associated topical formulation consulting launched a third career in drug delivery, in which he developed a variety of delivery systems, including a novel microneedle patch technology. This company was acquired by Allergan and subsequently AbbVie, where Tycho now works in Drug Delivery Sciences on primarily early stage innovation delivery platforms.

  • Carolyn  White, MS

    Carolyn White, MS

    • Executive Director, R&D Quality
    • Allergan/AbbVie , United States

    Carolyn is the Executive Director of R&D Quality for Medical Devices & Combination Products at AbbVie. Her team is responsible for design assurance throughout the development of the medical device lifecycle.? Carolyn joined Allergan/Abbvie in Sep 2015 in Core Team Leader role within the R&D organization where she was responsible for leading cross-functional device development teams. Prior to joining Allergan/Abbvie, Carolyn held positions in Operations Quality and Mfg Engineering at Medtronic. Carolyn holds a BS degree in Mathematics from the Univ. of Massachusetts and a MS in Industrial Engineering from Arizona State Univ.? She is a Certified Lean/Six Sigma Black Belt and received a Project Management Certification from UC, Irvine.