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Pre-Conference Workshop – Monday, January 27th, 2020

3:00pm

WORKSHOP: 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.
Tony Listro

Tony Listro

Vice President, Technical Business Development

Foster Delivery Science

5:30pm

Workshop Concludes
Main Conference Day One – Tuesday, January 28th, 2020
7:30am
Registration Opens & Continental Breakfast for Conference Attendees (Liberty C)

8:45am

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.

8:55am

Chairperson’s Day One Welcome and Opening Remarks
Rakesh Dixit, PhD

Rakesh Dixit, PhD

President & Chief Executive Officer

Bionavigen

9:00am

Assessing the Advantages and Limitations of Supersaturation Based Formulations to Enable the Oral Drug Development of Poorly Soluble Drug Candidates
John Morrison, PhD

John Morrison, PhD

Senior Research Investigator, Discovery Pharmaceutics

Bristol Myers Squibb

9:35am

Structure-guided Selection of Solid Forms to Drive Oral Bioavailability of Protease Inhibitors
Phillip Snyder, PhD

Phillip Snyder, PhD

Associate Director, Preclinical and Pharmaceutical Sciences

Vertex Pharmaceuticals

10:10am
Maximizing Exposure for New Oral Compounds in Early Formulation Development
Ildiko Terebesi, PhD

Ildiko Terebesi, PhD

Head, Early Formulation Development

Bayer
10:45am
Morning Networking & Refreshment Break
11:15am
Nanomedicines: Innovations in Bioavailability Enhancement & Delivery of Anti-Cancer Biologics
Rakesh Dixit, PhD

Rakesh Dixit, PhD

President & Chief Executive Officer

Bionavigen
11:50am
PANEL DISCUSSION: Bridging the Gap - Strategies for the Rapid Transition from Development to Commercial Manufacturing
Rakesh Dixit, PhD

Rakesh Dixit, PhD

President & Chief Executive Officer

Bionavigen
Douglas Nesta, PhD

Douglas Nesta, PhD

Senior Director, Biopharmaceutical Product Sciences

GlaxoSmithKline
Rick Panicucci, PhD

Rick Panicucci, PhD

Senior Vice President, CMC

QED Therapeutics

John Morrison, PhD

John Morrison, PhD

Senior Research Investigator, Discovery Pharmaceutics

Bristol Myers Squibb
Celal Albayrak, PhD

Celal Albayrak, PhD

Chief Executive Officer & Co-Founder

Pasen
12:30pm
Networking Lunch

1:40pm

Improving Product Bioavailability via Prodrug Approach
  • Intrinsic solubility improvement by prodrug
  • Permeability enhancement-Permeability enhancer vs. prodrug
  • Improving drug delivery via metabolism of the prodrug
  • Passive targeting delivery of nanoparticles via the enhanced permeability and retention (EPR)
Dedong Wu, PhD

Dedong Wu, PhD

Senior Scientist, Pharmaceutical Science

AstraZeneca

2:10pm

Food Effect Projections via Physiologically Based Absorption Modeling for Orally-dosed Drug Products
Binfeng Xia, PhD

Binfeng Xia, PhD

Senior Manager, Pharmacokinetics, Dynamics, and Metabolism

Sanofi

2:40pm

Advances in Bioavailability Enhancement Strategies for Parenterals and Macromolecules
Douglas Nesta, PhD

Douglas Nesta, PhD

Senior Director, Biopharmaceutical Product Sciences

GlaxoSmithKline

3:10pm

The BioDuro Solution Engine: Solubility Enhancement Screening for Formulation Development
Ruchit Trivedi, PhD

Ruchit Trivedi, PhD

Associate Director of Pharmaceutics

BioDuro

3:40pm

Afternoon Networking & Refreshment Break in Exhibit Hall

4:10pm

Use of Imaging to Assess Drug Delivery via Targeted Biologics
Andy Boswell, PhD

Andy Boswell, PhD

Senior Scientist

Genentech

4:45pm

Prediction of Clinical Pharmacokinetics via Biopharmaceutics M&S: Case Studies on Amorphous Solid Dispersion and Long-Acting Implant Formulations
Wei Zhu, PhD

Wei Zhu, PhD

Associate Principal Scientist, Biopharmaceutics and Specialty Dosage Forms

Merck & Co.

5:20pm-
6:45pm

Chair’s Closing Remarks, Drinks Reception in Exhibit Hall and End of Day One
Main Conference Day Two – Wednesday, January 29th, 2020

8:00am

Continental Breakfast for Conference Participants
8:55am
Chair’s Welcome and Morning Remarks

9:00am

Redispersibility of Nanosolids: Challenges and Opportunities
Dina Zhang, PhD

Dina Zhang, PhD

Director, Pharmaceutical Sciences

Merck & Co.

9:40am
Increasing Bioavailability of Solid Oral Dosage with an Integrated Development and Manufacturing Approach
Bei Chen, PhD

Bei Chen, PhD

Principal Research Engineer, Operations Science & Technology

Abbvie
10:20am
Evaluating the Utility of Gastrointestinal Systems in predicting Drug Performance: Focus on Tiny-TIM
Karthik Nagapudi, PhD

Karthik Nagapudi, PhD

Senior Principal Scientist

Genentech

11:00am

Morning Networking & Refreshment Break

11:30am

Enhancing Small Molecule Oral Bioavailability via Amorphous Nanoparticle Engineering
Kurt Ristroph, PhD

Kurt Ristroph, PhD

NSF Graduate Research Fellow

Princeton University

12:05pm

Computer-Aided Formulation Development for Small-Molecule Drugs and Biologics
John Shelley, PhD

John Shelley, PhD

Schrodinger Fellow

Schrodinger
12:40pm

Networking Lunch

2:00pm
Advances 3D Printing in Pharmaceutical Manufacturing for Biopharmaceuticals
Joseph Della Rocca, PhD

Joseph Della Rocca, PhD

Senior Scientist

Merck & Co.
2:35pm
Impact of Enabling Drug Delivery Approaches on PK performances
  • Importance of Enabling Drug Delivery Approaches for different therapeutic areas
  • Drug Product Design and Development strategy to achieve desired PK performances
  • Case studies on Melt extrusion, Nanoparticles and Transdermal Drug Delivery systems
  • Impact of Life Cycle Management on Drug Delivery approaches
Indrajit Ghosh, PhD

Indrajit Ghosh, PhD

Senior Principal Scientist, Pharmaceutical Science and Technology

Celgene

3:10pm

Afternoon Networking & Refreshment Break

3:30pm
Small Molecule Oral Bioavailability Enhancement via Stability and Formulation Design
Celal Albayrak, PhD

Celal Albayrak, PhD

Chief Executive Officer & Co-Founder

Pasen

4:05pm

PBPM Applications in Drug Development and Dissolution Specification
Wen Lin, PhD

Wen Lin, PhD

Senior Research Investigator

Novartis

4:40pm

Chair’s Closing & 2020 Summit Concludes

Attend

Attend and walk away with 2 YEARS worth of new product development strategies, formulation approaches, delivery technologies and regulatory updates while decreasing drug product time-to-market in just 2 days!

Sponsorship

Take advantage of the unique opportunity to engage your direct target audience face-to-face, and help them overcome their product challenges in 2 full interactive days!

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