Innovation & New Opportunities in Pulmonary Drug Delivery for Local & Systemic Treatment of Chronic Diseases

Tuesday, April 29 2014
8:00 am – 10:00 am

Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA

The pharmaceutical industry has realized the value of inhaled therapies to treat chronic diseases by local delivery to the lungs and pursued the potential of systemic delivery via the pulmonary vasculature.  The failure of high profile inhaled insulin programs in the last decade brought in to question the value of such innovative products.  However, opportunities remain (see April 2, 2014: One Small Step for MannKind: FDA Panel Recommends Afrezza® to Treat Diabetes ) to improve patient outcomes with pulmonary delivery and this is driving continued development of new technologies in this area. 

Our panel of experts will discuss areas for innovation including:

  • Novel inhaled therapies and therapeutic agents that go beyond asthma
  • State-of-the-art inhalation systems, delivery systems, “smart-delivery” and self-monitoring/dosing devices to improve patient outcomes
  • Clinical translation using existing and novel pulmonary deposition methods
  • Accelerating  clinical optimization of inhaled therapeutics

Come join us to learn how new vision and insight could fundamentally change the treatment of chronic diseases.

 

Speakers (in order of presentation):

David Hava, PhD, Chief Scientific Officer, Pulmatrix

Title: “iSPERSE:  A Novel Dry Powder Platform Enabling Inhaled Therapeutics”

Jose G Venegas, PhD, Associate Professor of Anesthesia (Bioengineering), Harvard Medical School & Massachusetts General Hospital, Co-Program Leader, Inhalation Technology, Center for Integration of Medicine & Innovative Technology (CIMIT)

Title: “Imaging Pulmonary Drug Delivery: Not a Black or White Issue”

Hongshi Yu, PhD, Principal Scientist, Merck Research Labs – Boston

Title: “Formulation Development Enabling Inhaled Drug Discovery for the Treatment of Respiratory Diseases”

Philip Kuehl, PhD, Associate Research Scientist, Lovelace Respiratory Research Institute

Title: “Preclinical Drug Delivery to the Lung, Translating to the Clinic” 

Lorna Patrick, Senior Director, Project and Portfolio Management, Quotient Clinical Limited, The Translational Pharmaceutics Company

Title: “Transitioning Inhaled Drugs into Clinical Development and Accelerating to Proof of Concept”

Moderator:

Craig Dunbar, PhD, Vice President Product Development, Blend Therapeutics

 

This Forum is presented by the Formulation & Drug Delivery Forum Working Group.

 

Speaker Bios:

Craig Dunbar, PhD, Vice President Product Development, Blend Therapeutics

Craig Dunbar is Vice President of Product Development at Blend, with more than 15 years of experience in drug product development, formulation design, process development, and analytical chemistry. Previously, he was Senior Director of Formulation Development at Vertex Pharmaceuticals, where he contributed to the development and approval of Incivek™ and Kalydeco™. Prior to that, Dr. Dunbar served in multiple leadership roles at Alkermes, including Director of Analytical Development and Director of Aerosol Science. Dr. Dunbar received a B.Eng. in Mechanical Engineering from the University of Manchester (UK) and a Ph.D. in Mechanical Engineering from the University of Manchester Institute of Science and Technology. He conducted postdoctoral studies at the University of North Carolina and GlaxoSmithKline.

David Hava, PhD, Chief Scientific Officer, Pulmatrix

As CSO, Dr. Hava leads the Research and Development organization in the development of iSPERSE dry powder delivery platform. In addition, Dr. Hava directs and manages the company’s therapeutic strategy to identify and prioritize drug targets and drugs that are enabled by the iSPERSE dry powder delivery platform.  Dr. Hava joined Pulmatrix in 2006 as one of the first Senior Scientists and has been involved in the early stage research and development programs that identified and characterized several of the key aspects of the Pulmatrix technology.  Dr. Hava earned his PhD. in Molecular Biology and Microbiology at Tufts University and completed his post-doctoral training studying immunology and host-pathogen interactions at Harvard Medical School.  Dr. Hava has co-authored over 20 papers and abstracts focused on pulmonary infectious disease, immunology and chronic lung diseases

Philip Kuehl, Associate Research Scientist, Lovelace Respiratory Research Institute

Dr. Kuehl is currently a Research Scientist and the head of the Analytical Chemistry department at Lovelace Respiratory Research Institute.  Dr. Kuehl’s research interests are in the area of inhalation formulation and its effects on deposition, pharmacokinetics and pharmacodynamics.  Aerosol formulations have included both therapeutic, disease inducing and infectious aerosols.  His current interests are focused on work to establish a pre-clinical and clinical deposition program to quantify deposition patterns of orally and nasally inhaled formulations.

Dr. Philip Kuehl holds a bachelor’s degree in biochemistry of Hamline University in St. Paul, MN and he completed his PhD at the University of Arizona, College of Pharmacy in Pharmaceutical Sciences in 2007. In 2007 he joined the Chemistry and Inhalation Exposure Program at LRRI.

Lorna Patrick, Senior Director, Project and Portfolio Management, Quotient Clinical Limited, The Translational Pharmaceutics Company

Lorna Patrick is currently Senior Director, Project and Portfolio Management at Quotient Clinical Limited, a UK provider of early development services. She has held various Project Management roles of increasing responsibility over the past 7 years, working with global Biotech & Pharma companies on First-in-Human (Phase I) to Proof-of-Concept (Phase IIa) clinical trials with new medicines for respiratory, antiviral and oncology indications. Prior to this, Lorna spent a number of years in a cGMP manufacturing role and also has significant experience of UK and EU clinical trials regulations.  Lorna has a Bachelor’s degree with Honours in Chemistry from the University of Bath, UK.

Jose G Venegas, PhD, Associate Professor of Anesthesia (Bioengineering), Harvard Medical School & Massachusetts General Hospital, Co-Program Leader, Inhalation Technology, Center for Integration of Medicine & Innovative Technology (CIMIT)

Dr. Venegas is an associate professor in anesthesia (bio-engineering) at Harvard Medical School, and is with MGH in the Department of Anesthesia and Critical Care. His career has been involved in developing an understanding of asthma and other conditions through single-isotope ventilation/perfusion PET scanning for quantitative assessment of topographical distributions of inflammation, ventilation, perfusion, intrapulmonary shunts and gas trapping. In addition to being the PI or Co-I in several NIH Grants, Dr. Venegas has worked on the development of devices for accurate exposure to inhalation gases for spontaneous breathing in small animals and human subjects and a device for enhanced inhalation therapy for emphysema.

Under the leadership of Dr. Venegas, the Pulmonary Imaging and Bioengineering Laboratory has been established at the MGH. This core lab offers cutting edge techniques for imaging the lungs of large animal models of lung disease and of human patients, quantification of the anatomical intrapulmonary deposition of aerosol therapeutics and the distribution of gaseous molecules within the lung and imaging methods combined with advanced computational models.

Hongshi Yu, PhD, Principal Scientist, Merck Research Labs – Boston

Hongshi Yu currently is a Principal Scientist within Discovery Pharmaceutical Sciences department at MRL Boston. She has made significant contributions to several programs from drug discovery to early development within oncology, Respiratory and Immunology franchises since 2001 she joined Pharmaceutical Research and Development department at Merck Frosst Canada. Hongshi was relocated to Discovery Pharmaceutical Science group in Boston in 2009. Since then, Hongshi has been leading the efforts to build inhalation formulation developments capability in Boston to support pulmonary drug discovery for Asthma. Her current interests focus on drug delivery and optimization of physicochemical property within early drug discovery.

Hongshi had spent one year in Ithaca, NY, as a postdoctoral research fellow in Chemistry and Chemical Biology department at Cornell University after received her PhD in Chemistry from Queen's University, Kingston, Ontario, Canada.

Share MassBio

 

Janitronics

EvaluatePharma


 

MassBio