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Symposium

Development of Drug/Device Combinations


Speakers: Paul Feldman, Ph.D. (Intarcia Therapeutics); Deepa Deshpande, Ph.D (Universal Regulatory, Inc.); Vladimir Bantseev, Ph.D. (Genentech); Christopher Rhodes, Ph.D. (Drug Delivery Experts); James Oberhauser, Ph.D. (Gilead); Louis-Georges Guy, Ph.D. (AccelLAB); Mark Bush, Ph.D. (Nuventra)
Organizers: Doris Zane, Ph.D. (Intarcia Therapeutics)
Date: 2020-02-11
Time: 8:45-17:00 Pacific Time
Registration fee: (USD): Regular: $195; Academic: $125; Students & Unemployed: $35
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (1)Biomere
Vendor show vendors registered to date: (7)Absorption Systems; CoreRx; Foster Delivery Science, Inc; Intertek Pharmaceutical Services; Nuventra Pharma Sciences; ReechPharma; Viitai
Registration: http://www.PBSS.org
Registration deadline:2020-02-09  (it will close sooner if the seating cap is reached)

About the Topic

As defined by FDA, combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. The Agency expects to receive large numbers of combination products for review as technological advances continue to merge product types and blur the historical lines of separation between FDA’s medical product centers, which are made up of the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH).

As Drug/Device combination products typically involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they raise challenging regulatory challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development, such as preclinical testing, marketing applications, manufacturing and quality control. This symposium will cover some of these challenges faced in the development of drug/device combination products presented by speakers from Industry, FDA and Contract Research Organizations.

 

Symposium Agenda

8:45-9:00 AM: Doris Zane, Ph.D., DABT, Intarcia Therapeutics; and Shichang Miao, Ph.D., President, PBSS. Introductions.

9:00-9:45 AM: Deepa Deshpande, Ph.D., RAC, President, Universal Regulatory, Inc. Drug-Device Combinations-Overview of Regulatory Landscape and Development Considerations.

9:45-10:30 AM: Louis-Georges Guy, Ph.D., Director, Science, AccelLAB. Preclinical evaluation of drug device combination products: particularities and challenges. 

10:30-10:50 AM: Break

10:50-11:35 AM: James Oberhauser, Ph.D., Senior Director of Device Development and Clinical Packaging Engineering, Gilead. Injectable Device Solutions for Complex Formulations.

11:35 AM-12:20 PM: Paul Feldman, Ph.D., Head of Discovery and Translational Medicine, Intarcia Therapeutics, Inc. Application of The Intarcia Medici Drug Delivery SystemTM for Long Acting HIV Prevention for Global Health.

12:20-1:20 PM: Lunch

1:20-2:05 PM: Vladimir Bantseev, Ph.D., FAAO, Senior Scientist, Toxicology Therapeutic Area Lead – Ophthalmology.  Safety Assessment. Nonclinical toxicology strategies for Drug/device combination: PDS with ranibizumab for nvAMD as an example.

2:05-2:50 PM: Christopher A. Rhodes, Ph.D., President & CEO, Drug Delivery Experts. Exenatide and Its Life Cycle. 

2:50-3:10 PM: Break

3:10-3:55 PM: Mark Bush, Ph.D., Vice President, Clinical Pharmacology and Pharmacokinetics, Nuventra, Inc. Drug/Device Combination Products:  A Pharmacokinetic Perspective. 

3:55-4:25 PM: Speaker Panel Forum

4:25-4:30 PM: Closing


About the Speakers

Deepa Deshpande, PhD, RAC
President, Universal Regulatory Inc

Dr. Deshpande is a regulatory affairs professional with over 20 years of experience in pharmaceutical industry. Dr. Deshpande is founder and President of Universal Regulatory Inc a regulatory affairs consulting firm based in the San Francisco bay area focused on regulatory strategy, operations, compliance and medical writing. Over the years she has held industry positions of increasing responsibility in pharmaceutical development and regulatory affairs including Sr/Vice President/Head of Regulatory Affairs for publicly traded companies and small to mid-size biotechnology firms. As a consultant Dr. Deshpande has served as an advisor to >75 biotechnology/pharma companies, investment firms, Board of Directors, providing strategic and tactical guidance on product development and regulatory affairs.

Her background includes multi-functional expertise in Regulatory Affairs and pharmaceutical development with knowledge of domestic and international regulatory environments. She has provided regulatory guidance and strategic leadership for >100 Investigational New Drug (IND) including first-in-human products, global clinical trial applications, several successful marketing authorizations (US, EU), and negotiations with global health authorities.

Deepa received her Masters and Ph.D in Pharmaceutical Sciences from West Virginia University and is RAC certified. Dr. Deshpande is a recognized contributor in pharmaceutical community, twice elected by membership of American Association of Pharmaceutical Scientists (AAPS) including Secretary and Chair of the Biotechnology Section. She has served as chairperson and speaker at several workshops, symposia on topics related to regulatory affairs and product development and professional development topics such as achieving successful careers as women in pharmaceutical sciences.

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Louis-Georges Guy, PhD, Director Science AccelLAB : Dr. Guy is a executive manager combining scientific and business formation and expertise. After receiving a PhD in molecular biology form Université de Montréal in 1998 (honor’s list), he received a Graduate Diploma in Management from HEC Montréal. He performed an industrial post-doctoral fellowship at Angiogene where he eventually became project leader. Dr Guy invented and developed a cell and gene therapy approach to treat heart failure, a technology that was patented and licensed. At AccelLAB, he established the scientific program for the preclinical evaluation of medical device in the fields of cardiology, ENT, orthopedics and others. He developed an expertise in bioabsorbable scaffolds, authored many articles in this field, presented for sponsors in scientific meetings and was invited as preclinical expert at a work shop at the FDA and a biodegradable metal symposium. Dr. Guy is an active member of the Society of Toxicology (SOT).

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James Oberhauser is Senior Director of Device Development and Clinical Packaging Engineering. Dr. Oberhauser joined Gilead in 2015 to build a team responsible for developing medical devices to meet the needs of a growing injectable drug pipeline. His growing team is driving innovative device solutions for complex parenteral formulations for long-acting therapies. Dr. Oberhauser’s team is also chartered with developing primary and secondary packaging solutions that ensure product stability and promote adherence and persistence with Gilead’s therapies.

Prior to joining Gilead, Dr. Oberhauser led a team at Abbott Vascular that developed the world’s first bioresorbable polymer stent to treat symptoms of coronary artery disease. In 2013, he was recognized with the Innovation Team Award from the Abbott Laboratories Volwiler Society. Dr. Oberhauser also served over six years on the faculty of the Department of Chemical Engineering at the University of Virginia, studying structure-property relationships in polymer blends and composite systems. He holds 47 issued patents and has authored 22 peer-reviewed journal publications.

Dr. Oberhauser received his B.S. from the University of California, Davis, M.S. from Stanford University, and Ph.D. from the University of California, Santa Barbara, all degrees in chemical engineering. He also conducted postdoctoral research at the California Institute of Technology.

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Paul L. Feldman joined Glaxo Pharmaceuticals, Research Triangle Park, North Carolina in 1987 after receiving his PhD from the University of California, Berkeley. From 1987-1995 Paul worked on a variety of drug discovery programs one of which led to the discovery of the marketed ultrashort-acting analgesic opioid agonist remifentanil (Ultiva). In addition, he and academic collaborators worked on the biochemistry of nitric oxide production and first demonstrated that N-hydroxyarginine is an intermediate in the biosynthesis. From 1995-2000 Paul’s department worked on the discovery of antiviral agents for treatment of HIV and HSV. One of the highlights during this period was the discovery of the marketed HIV protease inhibitor, fosamprenavir (Lexiva/Telzir). In 2000 Paul became Vice President of Chemistry for the Metabolic and Viral Diseases for GlaxoSmithKline (GSK) Pharmaceuticals. His group discovered three assets, the HIV integrase inhibitor dolutegravir (Tivicay and component of Triumeq) approved in 2013 (Tivicay) and 2014 (Triumeq) for HIV treatment, cabotegravir, currently in the regulatory submission phase for HIV treatment and in phase 3 for HIV prevention, and the ultrashort-acting benzodiazepine, remimazolam (outlicensed, Paion), currently under regulatory review in the United States, Japan, and China. In 2010 Paul was named Senior Vice President and his responsibilities included leading the Enteroendocrine Discovery Performance Unit, part of GSK’s Metabolic Pathways Cardiovascular Unit, and leader of GSK’s R&D Medicinal Chemistry Center of Excellence. The Enteroendocrine Unit focused on the discovery and early stage development of optimized combination peptide hormones, luminally restricted small molecules, and GRAS potentiators to treat diabetes and obesity. Several of these agents advanced into phase 2 clinical studies. In 2015 Paul left GSK and helped co-found and was CEO of the biotechnology company, Phoundry Pharmaceuticals, Inc. which was focused on discovering peptide hormone therapeutics. In September, 2015 Phoundry was acquired by Intarcia Therapeutics, Inc. Paul currently is Head of Discovery and Translational Medicine and part of the executive management team of Intarcia. His Intarcia Discovery and Translational Medicine team is providing scientific and regulatory support for the investigational type 2 diabetes medication ITCA 650, a GLP-1 agonist, exenatide, delivered every 3 to 6 months via an osmotic mini-pump. Additionally, his team is progressing Intarcia’s pipeline assets in the following therapy areas: metabolic and HIV (Pre-Exposure Prophylaxis in the developing world with the Bill and Melinda Gates Foundation).

Paul is a member of Abbvie’s Chemistry Advisory committee (2018-present), has served as an adjunct Professor of Chemistry, Duke and North Carolina State Universities, chair of Heterocyclic Compounds Gordon Research Conference (2000), member at large (2000-2003) and alternate councilor (2012-2014) to the Executive Committee in the Division of Organic Chemistry of the American Chemical Society, and chair of the Division of Organic Chemistry Fellowship Evaluation Committee (2003). In 2014 Paul received the North Carolina Section of the American Chemical Society’s Distinguished Lecturer award. Paul served as an editor for Organic Reactions from 2014-2018. Paul has >100 scientific disclosures including scientific articles, invited lectures, book chapters, patents, and poster presentations.

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Vladimir Bantseev is a Sr. Scientist/Toxicologist in the Department of Safety Assessment – Toxicology at Genentech. In this capacity, he serves as project toxicologist across three therapeutic indications, Ophthalmology, Neuro and Immuno-Oncology supporting programs from target identification through post-marketing. He is now serving as the Toxicology Therapeutic Area Leader for Ophthalmology. Dr. Bantseev is a Fellow of the American Academy of Optometry, SOT member and an elected board member of the Ocular Toxicology Sub Specialty. He is also an active member of ARVO. He has presented and published extensively in the area of ophthalmic drug development, ocular anatomy, physiology and toxicology.

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Dr. Christopher A. Rhodes is CEO and founder of Drug Delivery Experts, a contract services product development CDMO specializing in solution through complex injectables and small molecules through biologics with capabilities from formulation through clinical supplies and stability. Dr. Rhodes is a pharmaceutical scientist with over 25 years of experience in product development of complex formulations and delivery systems including long-acting injectable, pulmonary, nasal, transdermal, and oral formulations for peptides, proteins, antibodies, oligonucleotides, and small molecules. He played a key role in the development of the commercial products Byetta, Lusedra, Bydureon, Myalept, and Afrezza, was an R&D leader at Amydis Diagnostics, SKS Ocular, Amylin, Guilford, and Mannkind, and was drug development team leader for a propofol prodrug, an NCE for peripheral neuropathy, and led translational research on delivery systems for exenatide, including nasal, pulmonary, oral, and transdermal microporation technologies. He is a founder of Sensulin, CASS Pharmaceuticals, and Baywind Bioventures, companies developing drug delivery enabled pharmaceutical assets. He has a PhD in chemistry (UCLA), a BS in chemistry (NYU), and was a Post Doc at Yale.

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Dr. Mark A. Bush has 20 years of experience in drug development with a focus on clinical pharmacology, pharmacokinetics and pharmacometrics. Mark received his PhD in Drug Delivery and Disposition from the University of North Carolina at Chapel Hill (1999) where he specialized in pharmacokinetics and mechanisms of opioid tolerance. After receiving his PhD, Mark joined the pharmacokinetics team at Chiron in the Bay Area. While at Chiron, he supported the development of multiple large and small molecule drugs during the nonclinical and early clinical stages of development. In 2001 Mark transitioned to a role in the Clinical Pharmacology group at GlaxoSmithKline where he supported multiple development programs from candidate selection through regulatory submission. After leaving GSK in 2011, Mark joined Nuventra where he currently serves as Vice President of Clinical Pharmacology and Pharmacokinetics. While at Nuventra Mark has provided scientific and strategic consulting for a wide range of therapeutic targets and drug types including small molecules, therapeutic proteins, and antibodies (including bispecific antibodies). During his time at GSK and Nuventra Mark has provided pharmacokinetics, modeling, and simulation analyses to guide development and optimization of multiple drug/device combination products.


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