Speakers

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Leonel Vanegas
Device Clinical Development Quality
Alexion Pharmaceuticals

Day Two

Thursday, June 4

2:00 pm | How Do You Transition into the Next Generation? Discovering the Requirements for a Successful Evolution to a Next Generation CP

Pre Conference - Workshop

Tuesday, June 2

1:00 pm | Workshop B: Exploring the New Generation of Combination Products from a Quality & Regulatory Perspective

Susan Neadle
Senior Director, Global Quality Design
Johnson & Johnson

Susan Neadle joined Johnson & Johnson in 1995, and has held roles of increasing responsibility there, spanning medical devices, pharmaceuticals, consumer health, and Enterprise functions.  In her current role, she leads J&J’s Design Council, advancing world-class practices in product design to drive agility and robustness in the development of customer-centered health care solutions across J&J.  She also leads J&J's cross-sector Combination Products Community of Practice.  Over her extensive career, she has played integral roles in R&D product and process development and in Quality Engineering.  Among several achievements during her tenure at J&J, Susan led the team that defined and implemented the integrated business model to meet Combination Products health authority regulations into Janssen (J&J’s Pharmaceutical segment).  Susan was awarded the Janssen Supply Chain Inclusion Award in recognition of her global cross-functional leadership and collaboration.  She has applied her Design Excellence Blackbelt skills to drive significant business impacts, and has been awarded the Johnson Medal, J&J’s highest honor for innovation excellence. She holds numerous patents and publications.  Susan earned an M.S. in polymer science & engineering, and a B.S. in biology/chemistry, as well as Fellowship in the American Academy of Optometry.

Day One

Wednesday, June 3

11:40 am | Panel Discussion - What Does the Relationship Between Drug Development & Regulatory Agencies Need to Look Like to Optimize Combination Product Development’s Time & Cost Effectivity?

9:40 am | Combination Products Essential Performance Requirements

Kirsten Paulson
Senior Director, Global CMC Medical Device Lead
Pfizer

Kirsten Paulson, RAC, is the Senior Director, Global CMC-Medical Devices at Pfizer Inc., with the lead for Combination Products, diagnostics and software medical devices. She was previously the Senior Officer, Medical Device Initiative of The Pew Charitable Trusts and Head of the PPD Medical Device and Diagnostics group. She began her career as an FDA medical device reviewer.

Day Two

Thursday, June 4

9:30 am | Utilizing Incremental Face-Lifts to Your Product to Minimize Regulatory & Documentation Requirements to Enhance Patient Loyalty

Willy Liou
Director of Regulatory Affairs
Amgen

Day Two

Thursday, June 4

10:00 am | Spotlight Case Study - How Amgen Produced a Winning Quality & Effective Combination Product

Ram Halthore
Director of Engineering
Merck

Day One

Wednesday, June 3

3:30 pm | Effective Lifecycle Management Strategies to Implement Throughout the Product Development Lifecycle

Paul Chao
Associate Director, Combination Product Development
Regeneron Pharmaceuticals

Current role - Leading a team of managers and engineers in the planning and execution of device development activities for all combination product development projects 13 years in product development in the medical device, combination product and pharmaceutical industry

  • 10 years in drug delivery
  • 3 years in orthopedic medical devices
Masters of Science in Biomedical Engineering from Columbia University in the City of New York Bachelors of Science in Biomedical Engineering from New Jersey Institute of Technology

Day One

Wednesday, June 3

3:00 pm | The Early Adopter: Embed LCM into Your Development Program to Minimize Risks & Costs

John Weiner
Associate Director, Office of Combination Products
FDA

Day One

Wednesday, June 3

11:40 am | Panel Discussion - What Does the Relationship Between Drug Development & Regulatory Agencies Need to Look Like to Optimize Combination Product Development’s Time & Cost Effectivity?

9:10 am | Keynote Address: How to Remediate Changes to Regulations & Offer Effective Drug Delivery

H.E. Sengoku
Director, GRL Medical Devices/ Combination Products
UCB, Inc.

Day Two

Thursday, June 4

1:30 pm | Is Software the Answer – How Will Combining Software with Digital Devices Improve Health Care & Increase Patient Experience?

Raihan Hossain
Risk Lead, Device Engineering Lifecycle Management
Pfizer

Raihan has over 14+ years of experience in design, development and lifecycle management of medical devices and combination products. Prior to joining Pfizer as a risk management lead, he has worked for J&J, Bayer, Takeda and 3M managing combination product team in quality and engineering functions.

Day One

Wednesday, June 3

1:30 pm | Discover, Develop & Deploy - Pre vs Post-Launch: Exploring the Distinctions in Risk Management Strategies

Gabriel Iobbi
Device Portfolio Group Head
Novartis

  • 15+ years in medical device industry developing implantable, disposable, and diagnostic as well as drug combination products for venture funded to multinational medical device companies
  • Led technical & interdepartmental project teams responsible for the development, regulatory approvals, and launch of innovative new products
  • Joined Novartis Device Development in 2013 from Maquet Cardiovascular (San Francisco, USA) where he has worked since 2008
  • Previously served as Technical Director of Dynamic Therapeutics (London, UK), a university research spinout. Gabriel completed his PhD in bioengineering at Imperial College London, UK, in 2007

Day Two

Thursday, June 4

2:30 pm | Spotlight Case Study - Digitalizing the Next Generation: The Regulatory Implications of a Digital Future

Jonathan Amaya- Hodges
Associate Director, Regulatory Affairs CMC Combination Products & Medical Devices
Biogen

Jonathan is currently a member of the Biogen Medical Device & Combination Product Regulatory team and involved in a number of programs including drug delivery devices, digital health, and diagnostics. He has an extensive background in combination product including experience in development and quality roles, and has four years of regulatory experience. Jonathan holds ASQ CQE and CMQ/OE certifications and has a BS in Chemical Engineering from Northwestern University.

Pre Conference - Workshop

Tuesday, June 2

10:00 am | Workshop A: How to Prepare an Effective Lifecycle Management Strategy Considering Ongoing Regulatory Changes

Khaudeja Bano
Executive Medical Director, Combination Product Safety Head & Global Patient Safety
Amgen

Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional. She is an Abbott President’s award winner, avid Toastmaster and Coach.  Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products. She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC). Contact – Khaudeja@gmail.com

Day One

Wednesday, June 3

11:40 am | Panel Discussion - What Does the Relationship Between Drug Development & Regulatory Agencies Need to Look Like to Optimize Combination Product Development’s Time & Cost Effectivity?

10:10 am | Preparing for Imminent Changes – Modifications in Post-Market Safety Reporting

Andrew Yum
Director of Medical Device Development
United Therapeutics

Andrew Yum is the Director of Medical Device Development for United Therapeutics Corporation in Research Triangle Park, North Carolina. With over twenty-three years of experience, Andrew has led multiple development programs of drug delivery combination devices (such as drug-eluting stents and inhalation devices) in both medical device and pharmaceutical companies.  Andrew has a B.Eng. in Mechanical Engineering and an MBA in Applied Management.

Day One

Wednesday, June 3

4:00 pm | A Pragmatic & Strategic Framework – Balancing a Consistent Top-Level Strategy with Product Specificity

Doug Mead
Principle Consultant & President
CP Pathways LLC

Doug Mead is Principal Consultant at CP Pathways LLC, focused on regulatory submissions and strategy related to combination product submissions. Previously, he was Senior Director, Global Regulatory Affairs, Medical Devices and Combination Products, for Janssen Research & Development LLC, and was responsible for establishing and implementing the worldwide regulatory strategy for the development of drug delivery systems and drug-device combination products. These included a variety of injector and infusion systems, microcatheters, and nasal spray devices.  Before joining J&J’s Centocor in 2006, he held positions at a regulatory law firm, a pharmaceutical company specializing in drug delivery, various surgical instrument companies, and a medical device testing laboratory.  He has an M.S. Degree in Biomedical Engineering from Drexel University and over 35 years of experience in the medical device, pharmaceutical, and combination products industries.

Pre Conference - Workshop

Tuesday, June 2

10:00 am | Workshop A: How to Prepare an Effective Lifecycle Management Strategy Considering Ongoing Regulatory Changes

Brette Travaglio
President & Consultant for Drug,
Medical Device & Combination Product Manufacturers
Quality Solutions Now

Brette Travaglio partners with the health industry on critical projects like product launch, regulatory compliance, large-scale change and process improvement. As President of QSN, Brette provides project management oversight along with her roster of skilled consultants. Brette uses her years of experience to develop the best solutions to the challenges her clients face in a much regulated environment. Brette holds a BS AE where she graduated from FIT. She also holds a MBA/MSIE from UM. She is certified as a CQE, CQA, and CSSGB. Brette’s company has also been approved for certification as a Women’s Business Enterprise (WBE) by NWBOC.

Pre Conference - Workshop

Tuesday, June 2

1:00 pm | Workshop B: Exploring the New Generation of Combination Products from a Quality & Regulatory Perspective

Andrew Dundon
Connected Delivery System Lead, Jabil Healthcare & Founder
Pharmechceutics Ltd

Andrew is founder of PharMechceutics Ltd. an independent consultancy specialising in supporting clients to design, develop and industrialise robust, differentiated patient centric drug delivery systems. Andrew was formerly Head of Device Engineering at GSK R&D.

At GSK, Andrew led or assumed accountability for key deliverables in the development and market authorisation of the pMDI counter, Veramyst/Mistrpo™, Ellipta™ inhaler, a platform autoinjector and a number novel drug delivery devices.

Andrew has a passion for influencing how drug delivery systems should be most effectively developed using a risk-based approach informed by the regulatory framework within which companies are required to operate.

Day Two

Thursday, June 4

11:00 am | Breakout Session: What are the Opportunities & Barriers for Digital Medicines & Devices?

James Wabby
Executive Director of Regulatory Affairs, Combination Products & Devices
AbbVie

Over 15 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Medical Device, Digital Medicine and Combination Product areas. Regularly provides Allergan therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system arena and regulatory affairs regarding: • CMC Global Dossiers and Global Device Regulatory Strategy Registrations • EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC) • 21 CFR Part 3 and Part 4 - Combination Products • CE Marking • ISO 13485:2016/MDSAP • Product Development – Design Controls • Risk Management • Human Factors Engineering • Acquisitions/Divestitures • Import/Export – U.S. Agent • Production Controls • Regulatory Inspection Management • Materiovigilance • Health-Care Related Laws and International Regulations

Day One

Wednesday, June 3

9:00 am | Chair’s Opening Remarks

4:30 pm | Chair’s Closing Remarks & Close of Day One

Day Two

Thursday, June 4

3:00 pm | Chairs Closing Remarks & End of Summit

9:20 am | Chair’s Opening Remarks & Recap of Day One

John McMichael
Associate Director, Combination Products
AstraZeneca

John is an Associate Director of Combination Products and Medical Devices within the Regulatory CMC group at AstraZeneca. He previously acted as a Combination Products Team Lead within CDRH at the FDA, accumulating extensive pre-market and post-market review experience for all variations of combination products, standalone drug delivery devices, and digital health applications. John has a background in Biomedical Engineering, receiving a BS from the University of Virginia and MS from Johns Hopkins University.

Day One

Wednesday, June 3

11:40 am | Panel Discussion - What Does the Relationship Between Drug Development & Regulatory Agencies Need to Look Like to Optimize Combination Product Development’s Time & Cost Effectivity?

Karthik Balasubramanian
Associate Director, Global Device R&D
Teva

Dr. Karthik Balasubramanian, Ph.D is an associate director in Combination Products and Device R&D 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.