List of recent past events by AAPS-BADG
March 8th, 2018 6-9 pm
Pharmaceutical Innovation in Academia
Speaker: Howard Maibach, MD, UCSF
Real-time GMP Manufacture of Injectable Formulations for Clinical Development: Where the Requirements of Science and Quality Meet
Speaker: Kevin M Kane, PhD, Quotient Sciences
October, 25th 2017 6-9 pm
Systemic Concentrations Can Limit the Oral Absorption of Poorly Soluble Drugs: An Investigation of Non-Sink Permeation Using Physiologically Based Pharmacokinetic Modeling
Defining in-vitro-in-vivo Relationships for Orally Inhaled and Nasal Drug Products
Back to the Future: Aerosol Treatment and Prevention of Tuberculosis
Speaker: Anthony J Hickey, Ph.D.,RTI International, RTP, NC
Bio and Abstract
Tuberculosis remains a serious and globally prevalent disease causing between 1.5 and 2.0 million deaths annually. The increasing incidence of multiple and extensively drug resistant tuberculosis has created urgency that cannot easily be addressed by new drug and vaccine development approaches. Repurposing existing drugs or drugs that cannot be delivered by conventional routes of administration for aerosol delivery to the lungs is not a new concept. It was first employed in the early 1950s as a response to streptomycin resistant tuberculosis. However, we are presently much better equipped to pursue lung delivery of drugs and vaccines than we were at any other point in history.
3-D Printed Pharmaceutical Dosage
Speaker: Xiaoling Li, Ph.D., University of the Pacific, Stockton, CA
Bio and Abstract
As 3D printing technology is becoming more accessible and the first 3D printed drug product was approved by the FDA in August 2015, using 3D printing technology to develop pharmaceutical products has gained significant interest in the pharmaceutical industry and academia. Various furture applications of 3D printed pharmaceutical products have been projected in the news reports. Application of 3D printing technology to produce pharmaceutical products involves many areas including materials sciences, specialized 3D printers and so on. In this presentation, an overview of the development of 3D printed pharmaceutical dosage forms will be reviewed. The design and the fabrication technology to produce pharmaceutical dosage forms with unique architeture will be discussed. The versatile release modes, flexibility, and on-demand nature of 3D printed pharmaceutical dosage forms offer unprecedented opportunity for controlled release and customized dosing of pharmaceutical agents to meet various clinical needs. Hence, 3D printed pharmaceutical products will have its role for mass production of dosage forms with unique release mode and kinetice, and also play an important role in precision medicine and personalized medicine.
Characterization of Polymorphs, Amorphous Solid Dispersions, and Proteins in Lyophilized Formulations Using Solid-State NMR Spectroscopy.
Speaker: Dr. Eric Munson, Professor in Pharmaceutical Sciences,
“Systems based Pharmaceutics: Leveraging Mechanistic Process Modeling Tools to Meet Regulatory Requirements”
Speaker: Dan Briado Senior Technical Consultant, Process Systems Enterprise Ltd.
“Developing Palatable Drug Products: It’s More than Yuck and Yum”
Speaker: David A. Tisi, Technical Director, Senopsys LLC
“Understanding Complex Systems: The Map is Not the Territory”
Speaker: Dr. Rasmus Gronfeldt Winther, Associate Professor of Philosophy, UC Santa Cruz.
“PKPD Considerations for the Preclinical Development of Antibody-Drug Conjugates”
Speaker: Dr. Shraddha Sadekar, Senior Scientist, DMPK and Disposition, Merck Research Laboratories, Palo Alto.
“Pediatric Drugs – A Review of Commercially Available Oral Drug Products”
Speaker: Dr. Robert Strickley, Principal Scientist, Gilead Sciences Inc.
“Strengthening Weaker Joints: Discovery of a New Drug Candidate for Trasnthyrethin-Folding Diseases”
Speaker: Dr. Mamoun Alhamadsheh, Dept. of Pharmaceutics & Medicinal Chemistry, University of the Pacific.
“Overcoming the Cold-Chain: Designing a Novel Freeze-Stable Vaccine”
Speaker: Aryo Sorayya, President, Engimata Inc.
“Models and Their Utility in the Drug Development Process”
Speaker: Dr. Toufigh Gordi, President of PK/PD and Clinical Pharmacology Services, Rose & Co LLC.
“Protein Particulates and Immunogenicity”
Speaker: Dr. Valerie Quarmby, Principal Scientist and Director, Genentech: “Immunogenicity in Biotherapeutic Development.”
Speaker: Dr. Hanns-Christian Mahler, Head Pharmaceutical Development & Supplies, F. Hoffmann-LaRoche Ltd., Pharmaceutical Division, Pharma Technical Development Biologics Europe: “To See or Not to See? – Particulates in Protein Pharmaceuticals”
“Formulation Development of Monoclonal Antibodies”
Speaker: Dr. Steve Shire, Staff Scientist, Late Stage Pharmaceutical Development, Genentech: “Challenges in the Development of Formulations for the Delivery of Monoclonal Antibody Therapeutics.”
Speaker: Dr. Mitra Mosharraf, Chief Scientific Officer, HTD Biosystems: “Strategies to Improve Dissolution Rate of Lyophilized High Dose Protein Formulations in Dual Chamber Syringes.”
“Oxidative Degradation of Pharmaceuticals”
Speaker: Dr. Christian Schoneich, Takeru Higuchi Distinguished Professor and Chair, Dept. Pharmaceutical Chemistry, Univ. of Kansas: “Oxidative degradation of pharmaceuticals: mechanisms and commonalities between small molecules, peptides, and proteins.”
Speaker: Dr. Andrea Ji, Senior Scientist, Late Stage Pharmaceutical Development, Genentech: “Oxidative degradation of pharmaceutical excipients.”
“Solving Drug Metabolism Challenges”
Speaker: Cyrus Khojasteh, PhD, Group Leader, DMPK Genentech
Speaker: Jason Halladay, PhD, Scientist, DMPK Genentech
“New Approaches of Drug Delivery: from Particulates to Cells”
Speaker: Xin Guo, PhD: “Design of biocompatible pH-sensitive liposomes for drug and gene delivery”
Speaker: Kevin Healy, PhD: “Bioinspired Approaches for Drug Delivery and Tissue Engineering”
“The Development of Biosimilar Drugs, Opportunities and Challenges”
SPEAKER: YING-FEI WEI, PH.D.
Why aren’t there more parenterally administered nanocarrier drug products? Speaker: Francis C. Szoka, PhD
Recent Innovations of liposomal products in drug development Speaker: Rajiv Nayar, PhD
Pharmaceutical Excipients – Adding Functionality to Product Development
(joint event with CACO)
Antibody Drug Conjugate/The Prospect of Therapeutic Antibodies
Speakers: Shrikant Deshpande, PhD/Xiaodong Yang, MD PhD
Risk Management and Protein Formulation in Drug Development
Speakers: Vijay Chiruvolu, PhD, Tim Kamerzell, PhD
Poorly Soluble Drugs-Pharmaceutical Development Strategies and
Approaches for Pre Clinical Applications (joint event with CACO)
Speakers: Ram Nyshadham, Karthik Nagapudi, Sreekanth Nadkarni, Sesha Neravennan