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Pre-Conference Workshop Day – Tuesday, August 27th, 2019

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9:55am – 10:00am

 

Registration Opens for Workshop Day Participants

 

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10:00am – 1:00pm

WORKSHOP A: Recent Advances in 3D Printing of Large & Small Molecule Drug Products

 

Recent Advances in 3D Printing of Large & Small Molecule Drug Products

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

Xiaoling Li, PhD

Professor and Associate Dean/CSO, University of the Pacific / Triastek

Jae Yoo, PhD

Jae Yoo, PhD

Chief Technology Officer, Aprecia Pharmaceuticals

Derrick Smith, PhD

Derrick Smith, PhD

Senior Specialist, 3D Technologies, Merck & Co (*Invited)

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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.

 

 

Main Summit Day One – Wednesday, August 28th, 2019

 

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7:30am – 8:55am

 

Registration Opens & Continental Breakfast for Summit Participants

 

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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.

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9:05am – 9:10am

Welcome and Chairperson’s Introduction & Opening Remarks

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9:10am – 9:50am

KEYNOTE: Precision Medicine & Healthcare Delivery: Making Precision Medicine a Reality via Novel Technology Advancements

Di Bei, PhD

Di Bei, PhD

Senior Clinical Pharmacologist, Bristol-Myers Squibb

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9:50am – 10:30am

KEYNOTE: Innovating Bioactive Materials: The Cross Section of Drug Delivery and Nano-Surface Therapeutics

Vincent	Ling, PhD

Vincent Ling, PhD

Senior Director, Advanced Technologies, Drug Product Development, Takeda

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10:30am – 11:00am

Breakthrough Innovations in the Next Generation of Inhalation Drug Delivery: Alternative Therapeutic Fields for Drug Development

Charles Oh, PhD

Charles Oh, PhD

Senior Vice President Clinical Development, Acorda Therapeutics

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11:00am – 11:30am

Morning Networking & Refreshment Break in Exhibit Hall

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11:30am – 12:10pm

Development of Accelerated Methods to Predict Long-Term Peptide Release and Polymer Degradation of a 4-6 Month Extended Release Formulation

Mohammad Al-Sayah, PhD

Mohammad Al-Sayah, PhD

Senior Scientist, Small Molecule Analytical Chemistry, Genentech

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12:10pm – 12:50pm

PANEL SESSION: Accelerating Time to Market Through Innovation in Formulation Design and Drug Delivery

Rakesh Dixit, PhD

Rakesh Dixit, PhD

Vice President, R&D, Head Biologics Safety Assessment, AstraZeneca

Xiaoling Li, PhD

Xiaoling Li, PhD

Professor and Associate Dean/CSO, University of the Pacific / Triastek

Vincent	Ling, PhD

Vincent Ling, PhD

Senior Director, Advanced Technologies, Drug Product Development, Takeda

Mohammad Al-Sayah, PhD

Mohammad Al-Sayah, PhD

Senior Scientist, Small Molecule Analytical Chemistry, Genentech

Scott Shandler, PhD

Scott Shandler, PhD

Founder & Chief Executive Officer, Longevity Biotech

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12:50pm – 2:00pm

Networking Lunch in the Exhibit Hall

6th Controlled & Modified Drug Release Stream

4th Peptide Drug Design & Delivery Stream

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2:00pm – 2:35pm

Combining In-Vivo Animal Models with Physiologically Based Pharmacokinetics (PBPK) Modeling to Optimize Oral Controlled Release Dosage Forms

Tycho Heimbach, PhD

Tycho Heimbach, PhD

Senior Director, PK Sciences, PBPK and Biopharmaceutics, Novartis

What’s Next for Peptide Product Development? Effective Strategies for Customizing Existing Delivery Platforms for New Products

Rakesh Dixit, PhD

Rakesh Dixit, PhD

Vice President, R&D, Head Biologics Safety Assessment, AstraZeneca

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2:35pm – 3:10pm

Nanoparticle Formulation Modalities: Light-Scattering Tools for Screening and Characterization

Daniel Some, PhD

Daniel Some, PhD

Principle Scientist, Marketing, Wyatt Technology

Examining Futuristic Platforms for the Discovery of New Peptide Therapeutic Advancements

Any medical device marketer will tell you that showcasing case studies is a vital ingredient to marketing and sales success; yet very few actually master the art of writing a killer case study that doesn’t make people tune out. In this interactive, hands-on session we will:

  • Identify the “right” topic for a great story line
  • Select the “right” client
  • Understand the elements of a great case study and how to combine emotion and the business value to the story
  • Learn how to interview a subject – know which questions you need to ask
  • Craft the story for the “right” audience

Tina Grogan, Vice President Marketing, Acelity

Robert Prud’homme, PhD

Robert Prud’homme, PhD

Professor, Department of Chemical & Biological Engineering, Princeton University

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3:10pm – 3:40pm

Afternoon Networking & Refreshment Break in Exhibit Hall

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3:40pm – 4:15pm

Improving Adherence with Pediatric Dosage Forms - Oral Controlled Modified Release Formulations via Minitablet Development

Biplop Mitra, PhD

Biplop Mitra, PhD

Principal Research Scientist, Drug Product Development, Celgene Corporation

Non-Clinical Peptide Product Development: Regulatory Aspects with a focus on Toxicology

Mayur Mitra, PhD

Mayur Mitra, PhD

Senior Scientist, Toxicologist and Pharmacology Sub-team Leader, Safety Assessment, Genentech

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4:15pm – 4:50pm

DEP Drug Delivery: Developing Enhanced Therapies

David Owen, PhD

David Owen, PhD

Vice President, Research, Starpharma

Overcoming Drug Delivery Barriers for Peptide-Based Drug Products: Approaches and Strategies

Umar Maharoof, PhD

Umar Maharoof, PhD

Associate Director, Dosage Form Design & Development, Medimmune

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4:50pm – 5:30pm

Improving Adherence with Patient-Centric Modified Release Formulations: Transforming Oral Delivery Challenges into Proprietary Product Solutions

Peptide based Complement Therapeutics:The Compstatin Case

John Lambris, PhD

John Lambris, PhD

Professor, University of Pennsylvania and Founder of Amyndas Pharmaceuticals

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5:35pm

Chair’s Closing Remarks, Drinks Reception and End of Day One

 

Main Summit Day Two – Thursday, August 29th, 2019

 

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8:00am – 8:55am

Continental Breakfast for Conference Participants

6th Controlled & Modified Drug Release Stream

4th Peptide Drug Design & Delivery Stream

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8:55am – 9:00am

Chairperson’s Introduction & Opening Remarks

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9:00am – 9:35am

Using PBPK Modeling to justify Drug Product Size IVIVC and Release Mechanism

Dabing Chen, PhD

Dabing Chen, PhD

Principal Scientist, Boehringer Ingelheim

Next Generation Injectable Peptide Drug Products: Glucose Sensing and Triggered Delivery: Innovations in Insulin Delivery

Vladimir Malinin, PhD

Vladimir Malinin, PhD

Senior Director, Research, Insmed

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9:35am – 10:10am

Delivery and Controlled Release from Nanoparticles for Drug Delivery & Imaging

Developing Metabolically Stable Peptide-Like Therapeutics with Unique Molecular Biology Properties

Scott Shandler, PhD

Scott Shandler, PhD

Founder & Chief Executive Officer, Longevity Biotech

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10:10am – 10:40am

Morning Networking & Refreshment Break in Exhibit Hall

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10:40am – 11:15am

Newly Developed Controlled Release Subcutaneous Formulations for Long Acting Implants for HIV

Daniel Skomski, PhD

Daniel Skomski, PhD

Senior Scientist, Merck & Co.

Improving the Pharmacokinetic Properties of Peptide-Based Drug Products

Robert Pagels, PhD

Robert Pagels, PhD

Lead Scientist, Optimeos Life Sciences

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11:15am – 11:50am

Chong-Hui Gu, PhD

Chong-Hui Gu, PhD

Head of CMC, Agios Pharmaceuticals

Expediting Product Development for Precision Medicine

Developing Regulatory CMC Strategies for Peptide Delivery System Combination Products

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11:50am – 12:25pm

Recent Advances in the Commercialization of Sustained Release Ocular Drug Delivery Systems

Matrix-Binding Peptides for Targeted Delivery to Tissues

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12:25pm – 1:30pm

Networking Lunch in the Exhibit Hall

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1:30pm – 2:05pm

In Situ Forming Injectable Hydrogel Formulations for Controlled Delivery of Peptides and Proteins

Yingkai Liang, PhD

Yingkai Liang, PhD

Senior Research Scientist, Formulation Development, Merck & Co.

Business Drivers for Orphan Drug Development: Strategies and Challenges for Peptide-Based Products

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2:05pm – 2:40pm

How do you Build In Vivo – In Vitro Correlation to Develop your Release Performance?

Ruchit Trivedi, PhD

Ruchit Trivedi, PhD

Associate Director, Formulation, Bioduro

Peptide-Based Novel APIs for Preparation of Antibody Drug Conjugates (ADCs)

Victor Hruby, PhD

Victor Hruby, PhD

Regents Professor in the Department of Chemistry, University of Arizona

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2:40pm – 3:00pm

Afternoon Networking & Refreshment Break in Exhibit Hall

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3:00pm – 3:35pm

Using Solid-State Characterization to Study Amorphous Drug-Excipient Interactions

Roxana Schlam, PhD

Roxana Schlam, PhD

Principal Scientist, Bristol-Myers Squibb

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3:35pm – 4:10pm

Utilizing Novel Modified Release Technologies for the Future of Patient-Centered Drug Delivery

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4:10pm – 4:45pm

New Modified-Release Technology & Role of Physico-Chemical Properties of Polymers in Hot Melt Extrusion

Eric Munson, PhD

Eric Munson, PhD

Dane O. Kildsig Chair in Industrial and Physical Pharmacy, Department Head, Department of Industrial and Physical Pharmacy, Purdue University

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4:45pm

Chair’s Wrap-up & Conference Concludes

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