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5th Controlled & Modified Drug Release Summit

November 28 - 29, 2018 | Marriott Philadelphia Downtown Hotel, Philadelphia, PA
REGISTER TODAYEVENT GUIDE

Pre-Conference Workshop Day – Tuesday, November 27th, 2018

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2:45pm – 3:00pm

Registration for Workshop Attendees

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3:00pm – 5:00pm

Pre-Conference Workshop: 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.

True Rogers, PhD

True Rogers, PhD

Pharma Technologies Leader, Technology & Innovation, DuPont Nutrition & Health

Tony Listro

Tony Listro

Vice President, Technical Business Development, Foster Delivery Science

Day One – Wednesday, November 28th, 2018

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7:45am – 9:00am

Registration and Continental Breakfast for Conference Attendees

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9:00am – 9:15am

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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9:15am – 9:20am

Welcome and Chairperson’s Introduction & Opening Remarks

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9:20am – 10:00am

REGULATORY UPDATE: Global Guidance on Pharmacokinetics and Clinical Evaluation of Modified Release Dosage Forms

Pavel Farkas, PhD

Pavel Farkas, PhD

Senior Director Biopharmaceutics/Clinical Development, Teva

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10:00am – 10:40am

Decreasing Time-to-Market via Synchrotron Utilization to Discover Stable Formulation

Steve Byrn, PhD

Steve Byrn, PhD

Charles B. Jordan Professor of Medicinal Chemistry, Purdue University

Pamela Smith, PhD

Pamela Smith, PhD

Chief Operating Officer, Improved Pharma

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10:40am – 11:10am

Morning Networking & Refreshment Break in Exhibit Hall

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11:10am – 11:50am

Alternative Therapeutic Fields for Inhalation Drug Development

David Cipolla, PhD

David Cipolla, PhD

Vice President, Research, Insmed

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11:50am – 12:30pm

PANEL DISCUSSION: Exploring Innovative Collaborations to Support The Next Generation of Drug Products

Laszlo Otvos, PhD

Laszlo Otvos, PhD

Adjunct Professor, Semmelweis Medical School

Amit Joshi, PhD

Amit Joshi, PhD

Senior Manager, Advanced Sourcing & Innovation, Johnson & Johnson

Dana Ault-Riche, PhD

Dana Ault-Riche, PhD

Chief Executive Officer, Reflexion Pharmaceuticals

Mike de Leeuw, PhD

Mike de Leeuw, PhD

Founder & CEO, OncoLize BV

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12:30pm – 1:30pm

Networking Lunch in the Exhibit Hall

5th Controlled & Modified Drug Release Stream

3rd Peptide Drug Design & Delivery Stream

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1:30pm – 2:05pm

Evolution of Nanoparticle Delivery: Targeted Approaches in Oncology Drug Development

Piotr Grodzinski, PhD

Piotr Grodzinski, PhD

Director, NCI Office of Cancer Nanotechnology Research, NCI / NIH

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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2:05pm – 2:40pm

Comparing Pharmacokinetic Performance of an Osmotic Tablet against a Matrix Tablet in Beagle dogs: Case Study of a BCS class II Molecule

Mikolaj Milewski, PhD

Mikolaj Milewski, PhD

Principal Scientist, Oral Biopharmaceutics/Drug Absorption, Merck & Co

Next Generation Product Development: Developing and Commercializing D-Amino Acid Proteins and the Opportunities for Industry

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

Dana Ault-Riche, PhD

Dana Ault-Riche, PhD

Chief Executive Officer, Reflexion Pharmaceuticals

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2:40pm – 3:15pm

Nucleic Acid Delivery: Enabling the Next Generation of Therapeutics

Luis Santos, PhD

Luis Santos, PhD

Scientist II, Dosage Form Design & Development (DFDD), MedImmune

Improving the Pharmacokinetic Properties of Peptide-Based Drug Products

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

Tarik Soliman, PhD

Tarik Soliman, PhD

Founder & CEO, Extend Biosciences Inc.

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3:15pm – 3:50pm

Afternoon Networking & Refreshment Break in Exhibit Hall

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3:50pm – 4:25pm

Gene Editing in vivo with Cas9 RNP and Donor DNA Complexed to Gold Nanoparticles

Niren Murthy, PhD

Niren Murthy, PhD

Professor, Bioengineering, UC Berkley

Delivery and Controlled Release from Nanoparticles for Drug Delivery & Imaging

Robert Prud’homme, PhD

Robert Prud’homme, PhD

Professor, Department of Chemical & Biological Engineering, Princeton University

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4:25pm – 5:00pm

Design and Evaluation of Sustained Ocular Delivery Systems

Viral Kansara, PhD

Viral Kansara, PhD

Vice President of Discovery, Clearside Biomedical

Towards the Use of ADP355: First-in-Class Adiponectin Receptor Agonist Peptide in NASH

Laszlo Otvos, PhD

Laszlo Otvos, PhD

Adjunct Professor, Semmelweis Medical School

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5:00pm – 5:35pm

Solution Engine Screening for Rapid Identification of Controlled Release Matrices

Blair West, PhD

Blair West, PhD

Chief Scientific Officer, Global CMC Solutions, BioDuro

Enabling Oral Delivery of Peptides with Novel Approaches to Mature Technology

Jasmine Musakhanian, PhD

Jasmine Musakhanian, PhD

Scientific and Marketing Director, Pharmaceutical Division, Gattefossé USA

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5:35pm

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

Day Two – Thursday, November 29th, 2018

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8:00am – 8:55am

Continental Breakfast for Conference Participants

5th Controlled & Modified Drug Release Stream

3rd 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

Intra-Tumoral Drug Delivery: Novel Formulations, Technologies and Development Strategies

Dhaval Patel, PhD

Dhaval Patel, PhD

Senior Research Investigator, Bristol Myers Squibb

Epitope-Based Vaccine Design Yields Fusion Peptide-Directed Antibodies that Neutralize Diverse Strains of HIV-1

Kai Xu, PhD

Kai Xu, PhD

Senior Scientist, Vaccine Research Center (VRC), NIAID, NIH

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9:35am – 10:10am

Oral Modified Release Drug Products: Applications and Considerations for Selection

Grace Okoh, PhD

Grace Okoh, PhD

Associate Principal Scientist, Merck & Co.

Using Peptides for Targeted-Cancer Therapy: A Novel Strategy for Improving Stability and Half-Life

Mamoun Alhamadsheh, PhD

Mamoun Alhamadsheh, PhD

Associate Professor of Pharmaceutical Chemistry, University of the Pacific

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10:10am – 10:45am

An Erosion-Based Approach to Oral Drug Delivery

Carol Thompson, PhD

Carol Thompson, PhD

Chief Executive Officer, BDD Pharma

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

Scott Shandler, PhD

Scott Shandler, PhD

Founder & Chief Executive Officer, Longevity Biotech

Dana Ault-Riche, PhD

Dana Ault-Riche, PhD

Chief Executive Officer, Reflexion Pharmaceuticals

Amit Joshi, PhD

Amit Joshi, PhD

Senior Manager, Advanced Sourcing & Innovation, Johnson & Johnson

Laszlo Otvos, PhD

Laszlo Otvos, PhD

Adjunct Professor, Semmelweis Medical School

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10:45am – 11:15am

Morning Networking & Refreshment Break in Exhibit Hall

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11:15am – 11:50am

Nanotechnology Approaches for Localized and Targeted Treatment of Lung Diseases

Tamara Minko, PhD

Tamara Minko, PhD

Distinguished Professor and Chair, Rutgers University

Peptide Microarrays as a Drug Discovery Platform Technology

Chris Diehnelt, PhD

Chris Diehnelt, PhD

Assistant Research Professor, Biodesign Center for Innovations in Medicine, Arizona State University

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11:50am – 12:25pm

Utilizing Intrinsic Properties of Pressure Sensitive Adhesive for Transdermal and Oral Controlled Release

Gaurav Tolia, PhD

Gaurav Tolia, PhD

Senior Lead Scientist, Mylan

Localized Ocular Delivery of Peptides for Enhanced Exposure

Susan Crowell, PhD

Susan Crowell, PhD

Senior Scientist, PKPD, Genentech

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12:25pm – 1:30pm

Networking Lunch in the Exhibit Hall

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1:30pm – 2:05pm

Evaluating Disintegration Mechanisms that Improve Bioavailability from Immediate Release Tablets using FBRM

Lilly Roy, PhD

Lilly Roy, PhD

Scientist II, Vertex Pharmaceuticals

Degradants in Peptides

Yogita Krishnamachari, PhD

Yogita Krishnamachari, PhD

Principal Scientist, Peptide Product Development, Merck Research Laboratories

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2:05pm – 2:40pm

Impact of Enabling Drug Delivery Approaches on PK Performances

Indrajit Ghosh, PhD

Indrajit Ghosh, PhD

Senior Principal Scientist, Pharmaceutical Science and Technology, Celgene

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

Mrinmoy Saha, PhD

Mrinmoy Saha, PhD

Senior Scientist, Abzena

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2:40pm – 2:55pm

Afternoon Networking & Refreshment Break in Exhibit Hall

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2:55pm – 3:30pm

Affordable Targeted Delivery of Tumor-Based Drug Products

Mike de Leeuw, PhD

Mike de Leeuw, PhD

Founder & CEO, OncoLize BV

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3:30pm – 4:00pm

Formulation and Processing Strategies for Continuous Twin-Screw Granulation of a Thermally Labile Drug

Tony Listro

Tony Listro

Vice President, Technical Business Development, Foster Delivery Science

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3:30pm – 4:00pm

Targeted Peptide Delivery via Novel Routes of Administration Whilst Maintaining Stability

Sandhya Girish, PhD

Sandhya Girish, PhD

Director/Senior Scientist, Global Head Oncology, Clinical Pharmacology Development Sciences, Genentech

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4:00pm – 4:30pm

Multiparticulate Drug Delivery Systems (MDDS) for Oral Modified Release (MR)

 

  • Understanding key criteria needed to building lasting relationships with your key customer segments
  • Examining customer variables including age, sex, race, location and more to understand how you can target these within one multi-channel approach
  • Identifying fundamental customer needs: What do each customer segment require in order to nurture their interest in your campaign?
  • Collaborating this data into a multi-channel digital marketing plan
  • Discussing successful multi-channel marketing campaigns through strategic consumer engagement

 

Sree Nadkarni, PhD

Sree Nadkarni, PhD

Senior Director, Small Molecule Manufacturing, Seattle Genetics

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4:30pm

Chair’s Wrap-up & Conference Concludes

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