Let's Combinate - Drugs + Devices with Subhi Saadeh

By Subhi SaadehScience Life Sciences

Let's Combinate - Drugs + Devices with Subhi Saadeh episodes

December 14, 2022 063 - Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman
On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda.
Niedre discusses:
- Challenges with global regulatory strategies for combination products
- Impact of regulatory strategies on patients and product adoption
- Becoming an FRAPS, and building wide expertise in QA & RA
- Being a great teammate/colleague
Niedre Heckman, PhD, MPH, FRAPS is the Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. She's a fellow of Regulatory Affairs Professionals Society (RAPS) (FRAPS), and holds an MPH and PhD in Public Health. Niedre has worked at Takeda, Baxter International Inc., Shire, Baxalta, 3M, and GSK. Niedre has a wide career in Regulatory Affairs, Quality, and Research with focuses in many modalities of medical devices, pharmaceuticals and combination products. Niedre couples her background in RA & QA with her expertise in public health to bring a uniquely patient centric point of view.
49 min
December 07, 2022 062 - Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer
I love talking to fellow podcasters and on this episode, I was joined by Dr. Stefan Walzer, the CEO of MArS Market Access & Pricing Strategy.
Stefan discusses:
Discounts, Rebates, and how Co-Payment is different in Europe
How data is presented to payers in Europe and European Reimbursement
Germany/AMNOG Process
Negotiation
Dr. Stefan Walzer is a healthcare economist, podcaster, and CEO of MArS Market Access & Pricing Strategy GmbH based in Germany. He previously worked as a payer consultant for various global pharmaceutical and medical device / diagnostic companies, successfully launching their products across the world. Dr. Walzer was also the Global Payer Strategy Leader for various products and compounds of F. Hoffmann – La Roche AG, where he successfully developed early payer strategies as well as launching and maintaining the reimbursement process for top brands and early compounds. Dr. Walzer is experienced in the development of early payer strategies and the related evidence generation. Furthermore he is also capable in translating the clinical and economic evidence into successful reimbursement submissions and pricing negotiations especially in Austria, Germany and Switzerland. Additionally he also teaches at the Master course of Consumer Health Care at the Charité in Berlin (Germany) and is a tutor in market access and health technology assessment at the State University of Baden-Wuerttemberg (Germany).
From 2018-2019 Dr. Walzer was the head of the committee “Inpatient care” of the German Health Economic Association (DGGÖ). Furthermore he is a leading member of the Special Interest group for Medicial Nutritions at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Dr. Walzer is also a member of the Austrian Health Economic Association (ATHEA) and the newly founded Swiss Health Economic Association. Additionally, he is also a member of the Access Advisory Committee of the Global Pneumonia Prevention Coalition.
Dr. Walzer received a Master of Science in Economics from the University of Tuebingen (Germany), a PhD in Health Economics from the University of Zurich (Switzerland) and a Diploma in Clinical Trials from the London School of Hygiene and Tropical Medicine (UK). He is co-author of more than 40 peer-reviewed scientific articles and more than 100 scientific abstracts. Furthermore Dr. Walzer is the Editor in Chief of the German Journal of ClinicoEconomics (www.germanjournal-clinicoeconomics.de) and the lead author of the book chapter “Vergütungshöhe und Preissetzung” [Reimbursement value and pricing] in Business Planning in Health Care (http://www.springer.com/de/book/9783658081850).
MAP Podcast: Link
MAP Youtube Channel: Link
38 min
November 30, 2022 061 - Taguchi, Pugh, DFSS, Robust Design and Tolerancing with Skip Creveling
On this episode, I was joined by Skip Creveling, President and Founder of PDSS Inc.
Skip walks through:
Learning from Genichi Taguchi and Stuart Pugh
The 7 Steps to Robust Design
Design for Six Sigma(DFSS)
Six Sigma in Marketing
Tolerancing and Critical Parameters
Clyde "Skip" Creveling is the President & Founder of PDSS Inc. Skip has led the DFSS initiatives at Merck, Motorola, Carrier Corporation, StorageTek, Cummins Engine, Becton-Dickinson, Mine Safety Appliances, Callaway Golf, 3M, Samsung SDI, Sequa Corp. and Universal Instruments. Prior to founding PDSS, Skip worked at Eastman Kodak for 17 years as a product development engineer within the Office Imaging Division and spent more than 10 years as a systems engineer for Heidelberg Digital as a member of the System Engineering Group. Skip also served an Assistant Professor at Rochester Institute of Technology, developing and teaching undergraduate and graduate courses in mechanical engineering design, product and production system development, concept design, robust design, and tolerance design. Skip is also a certified expert in Taguchi Methods.
45 min
November 23, 2022 060 - Why People Leave, Starting Elemed and Trusted Advisory with Elena Kyria
Elena Kyria, CEO of Elemed joins the podcast and discusses:
- Why People stay in roles and why they leave
-Starting Elemed
-The trusted advisory role that recruiters play
-Community work on EU MDR and RAPS
Elena Kyria is an award-winning talent acquisition specialist in the Medtech industry. She is the CEO of Elemed and in charge of executive placements across Europe. Elena runs one of the largest linkedin groups focused on EU MDR and is the Head of Communications/Marketing for the Switzerland chapter of RAPS.
43 min
November 16, 2022 059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower
On this episode, I was joined by Ethan Drower, of Citemed. Ethan is a prolem-driven, software engineer and fellow Chicagoan who's focused on making literature review for EU MDR Clinical Evaluation Reports(CER) more efficient, traceable and robust.
Ethan and I discuss:
- A problem-driven career
- Challenges with EU MDR Clinical Evaluation Reports(CER's)
- Literature Search and Literature Review
Ethan Drower is the Co-Founder and Operating Partner of CiteMed, which is revolutionizing the European Union Medical Device Regulation (EU MDR) process. Literature Search and Review is the cornerstone of medical device companies’ Clinical Evaluation Report, and CiteMed has made this process more streamlined and optimized than ever. CiteMed’s top goal is to help companies get their medical products to market as quickly as possible, all while maintaining state-of-the-art compliance with the European Commission regulations.
42 min
November 09, 2022 058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano
On this episode, I was joined again by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss:
- PMSR and Risk Management
- Patient Safety, Pharmacovigilance, Medical Affairs, Clinical Affairs in Medical Device and Pharma companies.
- PMSR Regulatory Landscape Globally (Outside of the US)
Dr. Khaudeja Bano is the VP of Combination Products Quality at Amgen. Executive director of combination product safety. She's held multiple roles at other companies as well like Abbvie, Abbott, and Guidant and is the chair of the Post Market Safety committee for the combination products coalition.
45 min
November 02, 2022 057 - Conferences, Expos, LinkedIn and Launching a Podcast with Rizwan Chaudhrey
On this episode, I was joined by Rizwan Chaudhrey, of RSK Life Sciences Media. Rizwan and I discuss:
Launching Chats with Chaudhrey during the Pandemic
Conferences and Expos
How to use LinkedIn to build your personal brand
Getting Started
Rizwan is a blogger on Life Science/ Pharma Bio-Pharma from Drug Discovery to Drug Delivery and all things in between. He aims to connect and Inform those working across the whole value chain, through news, video interviews, podcasts and content.
Rizwan's Podcast Series: #ChatsWithChaudhrey The Podcast can be found on his YouTube Channel: RSK Life Science Media
https://youtube.com/channel/UC9vdET2xLlGweqveW6JmQdQ
47 min
October 26, 2022 056 - "Non-Promotional Compliance" with Darshan Kulkarni
On this episode I was joined by Darshan Kulkarni, Host of DarshanTalks, Attorney at the Kulkarni Law Firm and Adjunct Law Professor at Drexel University.
Darshan and I discuss:
- Non-Promotional Speech and Scientific Discussion
- Medical Affairs vs. Sales and interaction with HCP's
- Free Speech in Tech and what it might mean for Pharma
Darshan Kulkarni is an FDA regulatory lawyer, author, professor, and speaker, who takes a holistic approach to the healthcare and life sciences industries. Through the lens of patient centricity, including the underlying concepts of privacy, transparency, innovation, and access, Darshan looks at the broader implementation of programs by life sciences companies and healthcare professionals. With a background in creating companies, developing products, and helping guide finished products through the approval process where he has sold products as a pharmacist, Darshan has a unique perspective on how the pharmaceutical, regulatory, and life sciences industries intersect and function.
34 min
October 19, 2022 055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis
On this episode, I was joined by Alexandra Benbadis, Usability Leader at Sanofi. Alexandra and I discuss:
- Critical Tasks: What the guidance says , how to select them and what it means for HF study design
- Knowledge Tasks: Meeting regulatory expectations and evaluation the IFU
- Usability, HF Studies and Residual Risk
Prior to joining Sanofi as Usability Leader, Alexandra Benbadis was a Senior Human Factors Consultant at Emergo by UL. She's a two-time Tufts alumna and has taught two courses through the Tufts Experimental College focused on the design of public spaces and inclusive design.
51 min
October 12, 2022 054 - "EUDAMED" with Richard Houlihan
On this episode, I was joined by Richard Houlihan, CEO of Eirmed. Richard and I discuss:
- History of Eudamed (Starting with EU Legislation in 2010)
- The 6 modules of Eudamed (PMS, Vigilance & Post-Market Surveillance, Clinical Investigations, Certificates, Market Surveillance, Actor Registration)
- Responsibilities for Economic Operators (Manufacturers, Importers, Authorised Representatives, System and Procedure Packs)
Richard Houlihan is the CEO of Eirmed, a company focused on helping companies achieve compliance with the EU Commission EUDAMED requirements including training, software, data preparation and processing, and support. He has been in the IT space for more than 25 years with almost 10 of them with the EU Commission. He can be reached at eudamed.com.
29 min