Part 2: Trial Designs and Regulatory Considerations for SC Development Paths

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Description

3:00 PM – 5:00 PM (EST) Part 2: Trial Designs and Regulatory Considerations
for SC Development Paths

3:00 PM – 3:05 PM
Introduction and Welcome
Ryan Nolan, Ph.D., Halozyme

3:05 PM – 3:35 PM
Ultralong Acting Injectables for HIV Treatment and Prevention: Clinical Pharmacology Consideration for Developing the Next Generation of Therapeutics
Andrew Webber, MS, ViiV Healthcare

Recent progress in the HIV therapeutic field has led to injectable products supporting monthly dosing intervals, with next generation therapeutics in development targeting 3-6 months or longer. This talk will introduce and summarize the progress in the field as well as the modalities which may support these medicines. The development paths and challenges of long-acting regimens will be discussed, followed by an overview of several tools which enable the next generation of therapeutics and can be used to more efficiently support clinical development and regulatory pathways. Strategies to be discussed include the use of recombinant human hyaluronidase (rHuPH20) to support large volume injections, oral bridging strategies, concentration-QT (C-QT) and drug-drug interaction (DDI) analysis, and in vitro-in vivo correlation.

3:35 PM – 4:00 PM
Developing Subcutaneous Dosing Alternatives to High-Dose
Intravenous Infusions for Monoclonal Antibodies - Clinical Bridging Approach
Beate Bittner, Ph.D., F. Hoffmann - La Roche

The presentation describes the pharmacokinetic-based clinical bridging approach from intravenous to subcutaneous administration for high-dose monoclonal antibodies. Different intravenous versus subcutaneous launch scenarios are discussed future focus areas are introduced.

4:00 PM – 4:55 PM
Moderated Panel: Trial Designs and Regulatory Considerations for SC Development Paths including Role of Virtual Data in Successful Bridging Studies
Kaoutar Abbou Oucherif, Ph.D., Eli Lilly
Beate Bittner, Ph.D., F. Hoffmann - La Roche
Ramesh Kashi, Ph.D., Bristol-Myers Squibb
Yow-Ming Wang, Ph.D., US Food and Drug Administration (FDA)
Andrew Weber, MS, ViiV Healthcare

4:55 PM - 5:00 PM
Closing Remarks
Ryan Nolan, Ph.D., Halozyme

Contributors

Ryan Nolan, Ph.D.

Ryan is currently a Senior Director of Nonclinical Sciences and Clinical Pharmacology at Halozyme Therapeutics. Prior to joining Halozyme, Ryan held various roles across mulitple disciplines in large and small Pharma companies, all with a focus on applying quantitative modeling and simulation to inform and optimize scientific and business strategies.
Kaoutar Abbou Oucherif, Ph.D.

Kaoutar Abbou Oucherif is a Senior Director in the Bioproduct Research & Development group at Eli Lilly. Kaoutar has over 8 years of industry experience in drug and process development of both small and large molecules. At Lilly, Kaoutar leads two teams, one based at Lilly’s headquarters in Indianapolis and one at the Lilly Institute for Genetic Medicine in Cambridge, MA. Her teams are responsible for the development of Lilly’s parenteral drug product formulations covering monoclonal antibodies, nucleic acids, peptides, and novel modalities. Kaoutar obtained her B.S. in Chemical Engineering from New Mexico Tech and her Ph.D in Chemical Engineering from Purdue University.
Beate Bittner, Ph.D.

In her role as Global Head Product Optimization, Beate drives the development of strategic options and the commercial value assessment for product optimization opportunities across the Roche portfolio (i.e. improved administration route & frequency, innovative drug delivery technologies, formulation & device line extensions). Activities include leading global cross-company strategic initiatives in matters relating to product optimization (i.e. drug administration strategy, fixed dose combinations, subcutaneous drug delivery, global device strategy, cross-therapeutic area technology platform strategy).
Beate joined Roche in 1998 and held numerous positions of increasing responsibility including Preclinical DMPK Project Leader, Laboratory Head Preformulation, Clinical Pharmacologist, Clinical Team Leader, Global Development Team Leader, Global Project Leader, Portfolio Strategy Director, and Product Optimization Franchise Leader. Since 2012 Beate is a Lecturer at the Baden-Wuerttemberg Cooperative State University in the field of Personalized Health Care, Developing New Drugs, and Pharmacology.
Beate is trained as a Pharmacist with a PhD in Pharmaceutical Technology & Biopharmaceutics from the University of Marburg, Germany, and holds a Diploma in European Market Access from the Aix-Marseille University, France.
Yow-Ming Wang, Ph.D.

Dr. Yow-Ming Wang is currently the Associate Director for Biosimilars and Therapeutic Biologics and leading Therapeutic Biologics Program in the Immediate Office of Office of Clinical Pharmacology at CDER, FDA. From 2011 to September 2017, Dr. Wang served as the team leader of Biologics Team in Division III of Clinical Pharmacology; her team was responsible for reviewing submissions of therapeutic biologics in three clinical divisions. Prior to joining the FDA, she worked in the pharmaceutical industry with experience in small molecules and large molecules which included at Amgen from 2004 to 2011, and for 11 years at Vertex Pharmaceuticals and at Parke-Davis Pharmaceutical Research combined. She received her PhD degree from The Ohio State University College of Pharmacy with a research focus on Pharmacokinetics and Biopharmaceutics.
Andrew Weber, Ph.D.

Andrew Weber (M.S. Chemical Engineering) is a Director of Systems Pharmacology at ViiV Healthcare. In this position, he supports clinical pharmacology strategy for the development and discovery long acting injectable and HIV cure focused assets. He has also been active in supporting the development of novel injectable technologies and understanding translational pharmacology for injectable modalities. Prior to ViiV, he has over 10 years of drug discovery and development at GlaxoSmithKline supporting discovery and development of both biologic and small molecule assets. His broad-based experience spans molecular discovery, lead optimization, preclinical development, CMC, and clinical development.

Thank you

Description

Contributors

Ryan Nolan, Ph.D.

Kaoutar Abbou Oucherif, Ph.D.

Beate Bittner, Ph.D.

Yow-Ming Wang, Ph.D.

Andrew Weber, Ph.D.