Archive for the ‘Medication Remote Compliance Monitoring’ Category

The Convergence of Medical Devices & Drugs: Advances in Drug Delivery May 3, 2018 12:00 PM – 5:00 PM, Westin Hotel, Waltham, MA

Westin Waltham Boston 
70 3rd Avenue Waltham MA US 02451

MassBio’s second annual Medical Device Event will focus on opportunities and advances in drug delivery, including the unique developmental and regulatory challenges these products face, the many scientific advances in the space and new opportunities for funding.  Panelists will discuss innovation and commercialization strategies.

Advances in drug delivery technologies are improving the safety and efficacy of new and existing therapies. The success of many new therapies in development is contingent on the development of effective delivery systems.   Traditional drug delivery methods won’t work for some compounds and biologics.   Stability issues create challenges for storage and transport.  There are opportunities for combination drug delivery products to extend the patent life of drugs on the market.  From diffusion based polymer systems to complex delivery devices utilizing diagnostic sensors and sophisticated control systems for precise and timely delivery of life-saving agents, a diverse set of scientific and engineering disciplines are being brought to bear within this space.  However, combination products involve components that would normally be developed under different types of regulations, design criteria, and controls.  This symposium will explore many of the diverse aspects impacting drug delivery products.

This event will feature an active exhibit hall, panel discussions, a keynote speaker and networking sessions. This is an excellent opportunity for companies to reach a diverse audience that represents nearly every aspect of the life sciences industry, including academic researchers, entrepreneurs, device engineers and biopharma executives.

Clinicians will discuss the medical challenges for which drug delivery innovations have provided a unique solution.  Academic researchers will discuss scientific advances which may lead to breakthrough products.   Entrepreneurs will discuss strategies for funding new product ventures, and development issues specific to drug delivery products.  Corporate speakers will discuss the challenges across the value chain of manufacturing and selling combination products globally.  Regulatory speakers will address current thinking and approaches to drug delivery products within government agencies, both US and internationally.



12:00 pm  12:30 pm

Opening Remarks

12:30 pm  12:45 pm

Keynote Presentation

12:45 pm  1:15 pm

Innovation & Development Panel

1:30 pm  2:45 pm

Networking Break

2:45 pm  3:15 pm

Commercialization Pathways Panel

3:15 pm  4:30 pm

Networking Reception

4:30 pm  5:30 pm


  • Bob Coughlin, President & CEO, MassBio

Keynote Speaker: Michael J. Cima, Ph.D., Associate Dean of Innovation, MIT

  1. Intraperiotneal Chemotherapy needed to remove the few cells left after surgery _ delivery of drugs to a single compartment
  2. Hyperthermic Intraperiotneal Chemotherapy
  3. Tumor burden – stage 3 women ovarian cancer
  4. Extended IP drug exposure
  5. device for drug delivery to the bladder (cancer): Inflammatory bladder disease, overactive Bladder, bladder (cancer); bladder removal (radical cystectomy – residual tumor size 3 cm tumor)
  6. Local Drug delivery for stone disease in ureter
  7. Change the pharmacology and change the lesion in the bladder – lesion disappeared in a single compartment
  8. Mutation burden in Brain Cancer and in Ovarian Cancer much smaller than in Lung cancer
  9. local drug delivery to one location in the brain and the drug will be carried to the entire body – pathology of the brain leads to different disease related to the Human Brain. Treatment of hemorrhage
  10. Cervical cancer under MRI deliver drug to the tumor hypoxy of the tumor, guide the drug dosage using imaging MRI is Radiation therapy not drug therapy

PANEL 1: Product Development: Drug-Device Technology moderated by Kristina Bieker-Brady, Ph.D., Partner, McDermott Will & Emery LLP

  1. Basic research to clinical development: Drug delivery System
  • Benjamin S. Bleier, MD, FACS, FARS, Associate Professor, Director of Endoscopic Skull Base Surgery, Co-Director Center for Thyroid Eye Disease and Orbital Surgery, Massachusetts Eye and Ear Infirmary, Harvard Medical School
  1. BBB – Invasive, Non-invasive, Drug modification
  2. Platform technology , Enabling technology to pass BBB Scalable technology: SAfe
  3. Nasal bleed
  4. Nasal Cavity – ENTRY point to the brain use vascularized tissue
  5. nasal mucosa more permeable that any other tissue – diffuse drugs into the brain
  6. Autologous tissue – Nasal Mucosa: Proteins Oligonucleotides,
  • Maria Palasis, President and CEO, 480 Biomedical, Inc.
  • Maria Berkman, MD, MBA, Director and Head of MedTech practice, Broadview Ventures
  • Evan Sherr
  1. Brent Buchine, Ph.D., Co-Founder and CTO, Windgap Medical, Inc.

 PANEL 2: Commercialization Challenges

Moderator: Harry Glorikian, General Partner, New Ventures Funds

  • Paul Just, PharmD, Senior Principal, Medical Device Health Economics, ICON plc
  1. VALUE (outcome achieved per $) is the currency for market ACCESS knock down barriers Care COST
  2. Physician choose product that they wish to use while providing therapy as the lowest cost
  3. Assessing Differentiating Value and Reimbursement
  4. No guidance for combination products: New method of treating patients: Drug-Device
  5. Value: Who benefits from the Value – Target stakeholders: 90 days vs 18-24 month, long term value
  • Pamela J. Weagraff, Director, MedTech Regulatory, IQVIA [Quantile merged IMS]
  1. MedTech meet BioPharma
  2. Clinical data requirements for medical devices on the increase but not not necessarily in many cases
  3. Combination Products: Microfluidics, micronization – not chemistry but features of the drug delivery device
  4. Option 1,2,3 for Combination Product Pathways: Draft Guidance –>> FINAL immediately in effect
  • Jessica Ballinger, Chief Operating Officer, Lyndra
  1. Lyndra’s Ultra-long drug release – Extended Release Oral Capsule: 7 days
  2. Dosage Form – Safety
  3. Drug delivery – material manufacturing for long term resident inside the human body
  4. Candidates: AD, Diabetes
  5. Encapsulation automated – 3 partners assembly in several int’l locations in the supply chain: complications in making tablets – three years before the launch, freeze design 1st generation, 2nd generation
  • Steven Rosenberg, Otsuka Pharmaceutical



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FDA Approval of Anti-Depression Digital Pill Tracks Use When Swallowed and transmits to MDs Smartphone – A Breakthrough in Medication Remote Compliance Monitoring


Reporter: Aviva Lev-Ari, PhD, RN


The so-called digital pill is a version of Otsuka Pharmaceutical Co.’s Abilify, which treats depression, bipolar disorder and schizophrenia. The sensor, developed by Proteus Digital Health, is activated by stomach fluids, sending a signal to a patch worn on the patient’s torso and transmitting the information to a smartphone app.

  • Sensor in depression pill transmits data to a smartphone app
  • Lets doctors track patient’s use, prevent missing medicines


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