Pre-Conference Workshop Day – Tuesday, August 27th, 2019
12:00pm – 2:30pm
WORKSHOP A: Recent Advances in 3D Printing of Large & Small Molecule Drug Products
Recent Advances in 3D Printing of Large & Small Molecule Drug Products
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Industrial and academic researchers have recently examined the use of 3D printing technologies to overcome the limitations associated with conventional manufacturing processes. These technologies involved fabrication of three-dimensional structures through additive joining of materials in a layer-by-layer manner. This workshop will review recent developments in 3D printing technologies for processing large and small molecule drug products into artificial tissues as well as biosensors, drug delivery devices, and medical instruments. Several topics related to 3D printing, including processing of radiographic images, development of computer models, novel 3D printing technologies, and novel materials for use in 3D printing, will be discussed. This workshop will create collaboration and discussion among the many groups involved in the development and use of 3D printing technologies, including drug development enghineers, medical device manufacturers, and clinicians. We anticipate that this workshop will facilitate future research activities, including industry-university collaborations, involving 3D printing of large and small molecule drug for use in medicine, surgery, and dentistry. |
Xiaoling Li, PhD
Professor and Associate Dean/CSO, University of the Pacific / Triastek
Jae Yoo, PhD
Chief Technology Officer, Aprecia Pharmaceuticals
3:00pm – 5:30pm
WORKSHOP B: Oral Controlled Release Solid Dosage Forms
Oral Controlled Release Solid Dosage forms
During this intensive workshop, examples from industry will cover developing new product and technology offerings for modified release drug delivery, types of modified release and formulation aspects and considerations. Additionally, the workshop will cover hot melt extrusion focused on engineering aspects, manufacturing considerations, type of polymers and how things are analyzed.
Nasrin Mahmoudi, PhD
Pharmaceutical Application TS&D Manager, DuPont Nutrition & Health
Tony Listro
Vice President, Technical Business Development, Foster Delivery Science
Main Summit Day One – Wednesday, August 28th, 2019
7:30am – 8:55am
Registration Opens & Continental Breakfast for Summit Participants
8:55am – 9:05am
Collaboration is King! Ice Breaker
For today’s drug manufacturer, the idea of collaboration is one that should never leave the table. Successful organizations will ensure that their internal departments are working hand-in-hand with one another. And, even more successful companies know that there could be huge benefits to reap by collaborating with others across the healthcare ecosystem. To instill this idea of collaborating for success, we are going to play a fun little ice-breaker game.
9:05am – 9:10am
Welcome and Chairperson’s Introduction & Opening Remarks
Rakesh Dixit, PhD
Vice President, R&D, Head Biologics Safety Assessment, AstraZeneca
9:10am – 9:50am
Developing Advanced Drug Delivery Systems to Better Harness effects of Cancer Immunotherapy
Michael Mitchell, PhD
Skirkanich Assistant Professor of Innovation, University of Pennsylvania
9:50am – 10:30am
DEP Drug Delivery: Developing Enhanced Therapies
David Owen, PhD
Vice President, Research, Starpharma
10:30am – 11:00am
Morning Networking & Refreshment Break in Exhibit Hall
11:00am – 11:40am
Examining Microsphere Drug Release and Impact of Formulation and Process Factors
Daniel Wu, PhD
Senior Director, Technical Operations, Bausch Health
11:40am – 12:20pm
Selection fo Clinically Relevant Forms & Formulations using In Vitro Analysis & Pre-Clinical Models
Phillip Snyder, PhD
Associate Director, Preclinical and Pharmaceutical Sciences, Vertex Pharmaceuticals
12:20pm – 12:50pm
PANEL SESSION: Exploring Innovative Collaborations to Support The Next Generation of Drug Products
Rakesh Dixit, PhD
Vice President, R&D, Head Biologics Safety Assessment, AstraZeneca
Xiaoling Li, PhD
Professor and Associate Dean/CSO, University of the Pacific / Triastek
Laszlo Otvos, PhD
Professor, Semmelweis Medical School
David Owen, PhD
Vice President, Research, Starpharma
Scott Shandler, PhD
Founder & Chief Executive Officer, Longevity Biotech
12:30pm – 2:00pm
Networking Lunch in the Exhibit Hall
6th Controlled & Modified Drug Release Stream
4th Peptide Drug Design & Delivery Stream
2:00pm – 2:45pm
Combining In-Vivo Animal Models with Physiologically Based Pharmacokinetics (PBPK) Modeling to Optimize Oral Controlled Release Dosage Forms
Wen Lin, PhD
Senior Director, Senior Investigator I, Novartis
Nanomedicines: Innovations in Delivery of Anti-Cancer Biologics
Rakesh Dixit, PhD
Vice President, R&D, Head Biologics Safety Assessment, AstraZeneca
2:45pm – 3:30pm
Nanoparticle Formulation Modalities: Light-Scattering Tools for Screening and Characterization
Daniel Some, PhD
Principle Scientist, Marketing, Wyatt Technology
Fast Forward to Clinic with an Optimized Adiponectin Receptor Agonist Peptide
Laszlo Otvos, PhD
Professor, Semmelweis Medical School
3:30pm – 4:00pm
Afternoon Networking & Refreshment Break in Exhibit Hall
4:00pm – 4:45pm
Modeling Zero-order Drug Release Kinetics in Controlled Release Oral dosage forms
Kamal Jonnalagadda, PhD
Professor & Director, Pharmaceutics Graduate Program, Philadelphia College of Pharmacy, USciences
Non-Clinical Peptide Product Development: Regulatory Aspects with a focus on Toxicology
Mayur Mitra, PhD
Senior Scientist, Toxicologist and Pharmacology Sub-team Leader, Safety Assessment, Genentech
4:45pm – 5:30pm
Nucleic Acid Delivery for Enabling MRNA: Enabling the next Generation of Therapeutics
Venkata Krishnamurthy, PhD
Associate Principal Scientist, AstraZeneca
Nanoparticle and Microparticle Formulations of Peptides and other Biologics through Flash NanoPrecipitation
Robert Pagels, PhD
Lead Scientist, Optimeos Life Sciences
5:35pm
Chair’s Closing Remarks, Drinks Reception and End of Day One
Main Summit Day Two – Thursday, August 29th, 2019
8:00am – 8:55am
Continental Breakfast for Conference Participants
9:05am – 9:10am
Chairperson’s Introduction & Opening Remarks
9:00am – 9:45am
Utilizing Biopharmaceutical Modeling for Particle size Specification of Oral Extended Release Products
Dabing Chen, PhD
Principal Scientist, Boehringer Ingelheim
9:45am – 10:30am
In Situ Forming Injectable Hydrogel Formulations for Controlled Delivery of Peptides and Proteins
Yingkai Liang, PhD
Senior Research Scientist, Formulation Development, Merck & Co.
10:30am - 11:00am
Morning Networking & Refreshment Break in Exhibit Hall
11:00am – 11:40am
Protein Stabilization in Solid Dose Formulations
Eric Munson, PhD
Dane O. Kildsig Chair in Industrial and Physical Pharmacy, Department Head, Department of Industrial and Physical Pharmacy, Purdue University
11:40am – 12:20pm
Preclinical Studies of an Intranasal Prodrug/Enzyme Formulation to Treat Seizure Emergencies
Ronald Siegel, PhD
Professor, Department of Pharmaceutics, University of Minnesota
12:20pm – 1:00pm
Advances in 3D Manufacture of Sustained Release Oral Drug Products
Xiaoling Li, PhD
Professor and Associate Dean/CSO, University of the Pacific / Triastek
1:00pm – 2:00pm
Networking Lunch in the Exhibit Hall
2:00pm – 2:40pm
Drug Release Simulations and Advanced Characterization of Long Acting Implants
Daniel Skomski, PhD
Senior Scientist, Merck & Co.
2:40pm – 3:20pm
Enabled Formulations Bridging Discovery and Development for Modified Release Drug Products
Ruchit Trivedi, PhD
Associate Director, Formulation, Bioduro
3:20pm – 3:40pm
Afternoon Networking & Refreshment Break in Exhibit Hall
3:40pm – 4:10pm
PANEL: Developing Metabolically Stable Peptide-Like Therapeutics with Unique Molecular Biology Properties
Laszlo Otvos, PhD
Professor, Semmelweis Medical School
Rakesh Dixit, PhD
Vice President, R&D, Head Biologics Safety Assessment, AstraZeneca
Scott Shandler, PhD
Founder & Chief Executive Officer, Longevity Biotech
4:10pm – 4:40pm
Advances in 3D Printing and Bioprocessing for Tissue Engineering
Mahima Singh, Pharm.D
Pharmaceutical Sciences Researcher, University of the Sciences
4:40m – 5:10pm
Expediting Peptide Product Development for Precision Medicine
Chong-Hui Gu, PhD
Head of CMC, Agios Pharmaceuticals
5:10pm
Chair’s Wrap-up & Conference Concludes