Agenda • BioTech Pharma Summit 2021

1. Antibody Engineering & Therapeutics

2. Inhalation & Respiratory Drug Delivery

3. Pharmacovigilance & Drug Safety

4. Pre-filled Syringes & Injectables

5. Gut-Brain Axis

6. Probiotics, Human & Skin Microbiome

7. Aseptic Processing Technology

8. Drug/Device Combination Products

Antibody Engineering & Therapeutics Agenda

Agenda is being produced and will be announced soon.

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Day 1

Day 2

Day 1 | 08:00 - 08:20

IRDD Registration & Welcome Coffee

Day 2 | 08:00 - 08:20

Registration and Coffee

Day 1 | 08:20 - 08:30

Chairman's Opening Address

Day 2 | 08:20 - 08:30

Chairman's Opening Address

Part I: The challenges of developing inhalation drugs

Part V: New Approaches to Treating Respiratory Diseases

Day 1 | 08:30 - 09:00

Science base and challenges of therapeutic equivalence of respiratory products.

Jörg Schiewe, Head of Global CMC Experts at Boehringer Ingelheim Pharma GmbH & Co. KG

Day 2 | 08:30 - 09:00

Topic to announce

Masahiro Sakagami, Professor of Pharmaceutics at Virginia Commonwealth University School of Pharmacy

Day 1 | 09:00 - 09:30

IRDD Speed Networking

An innovative approach to maximize networking capabilities through two minute periods, where delegates can meet their peers and exchange business cards before rotating to the next company representative.

Day 2 | 09:00 - 09:30

Shared Decision Making to Improve Adherence in Severe Asthma

Tonya Winders, President and Chief Executive Officer at Allergy & Asthma Network

Day 1 | 09:30 - 10:00

The biological barriers to consider for the development of inhaled biotherapeutics

Nathalie Heuzé-Vourc'h, Research Professor at INSERM, Research Centre for Respiratory Diseases

Day 2 | 09:30 - 10:00

Inhalation therapy for pulmonary arterial hypertension, a pulmonary vascular disease

Fakhrul Ahsan, University Distinguished Professor in the Department of Pharmaceutical Sciences at the TTUHSC

Day 1 | 10:00 - 10:30

Early Phase Clinical Trials for Inhaled Drugs - Challenges and Opportunities

Aernout van Haarst, PhD Director, Scientific Affairs at Celerion

Day 2 | 10:00 - 10:30

Optimising surrogate outcome measures for respiratory trials

Peter Robbins Professor of Physiology at the University of Oxford

10:30 - 11:00

Morning Coffee & Networking Break

Part VI: New analytical insights into dry powder formulations for inhalation

Day 1 | 11:00 - 11:30

Accurate dosimetry predictions for evolving liquid aerosol delivery

Arkadiusz Kuczaj, PhD, Manager Aerosol Research and Dosimetry at Philip Morris International Research and Development

Day 2 | 11:00 - 11:30

Topic to announce

Wayland Rushing, Director, Scientific Affairs at Eurofins BioPharma Product Testing

Part II: Inhalation Formulation Solutions & Technology

Day 1 | 11:30 - 12:00

Formulation and Spray Drying Process Development of Inhaled Biopharmaceuticals

Diana Fernandes, Inhaled Biopharmaceutical Development Scientist at Hovione

Day 2 | 11:30 - 12:00

Speaking Sponsorship Available - Have your talk here

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Day 1 | 12:00 - 12:30

Administration of high dose antibiotic DPI: formulation/device combination for a cystic fibrosis patient-centric product

Francesca Buttini, Associate Professor at University of Parma, Italy

Day 2 | 12:00 - 13:00

Panel Discussion

Future directions in inhalation and respiratory drug delivery research

Day 1 | 12:30 - 13:00

Musings on High Dose Powder Delivery

Jeffry Weers, Ph.D. Chief Technical Officer at Respira Therapeutics, Inc.

13:00 - 14:00

Lunch Break

Day 1 | 14:00 - 14:30

Increasing the drug load in capsule based DPI drug delivery systems

Prof. Dr. Sven Stegemann, Professor of patient centric drug design and manufacturing at the Graz University of Technology, Austria

Day 2 | 14:00 - 14:30

TOP-5 Poster Presentations (5min. On Stage)

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Part V: New Approaches to Inhalation Product Development and Production

Day 1 | 14:30 - 15:00

Formulation Development Challenges and Pitfalls When Developing Dry Powder Inhalers

Martin Wing-King, Director of Project Management at Quotient Sciences

Day 2 | 14:30 - 15:00

Topic to be announced (Development and commercialization of inhaled therapeutic products)

Michael Castagna, Chief Executive Officer at MannKind Corporation

15:00 - 15:30

Afternoon Coffee & Networking Break

Part IV: Regulatory pathways for inhaled therapies

Day 1 | 15:30 - 16:00

Paving the way towards respiratory medicine using Functional Respiratory Imaging and AI.

Jan De Backer, PhD, CEO at FLUIDDA

Day 2 | 15:30 - 16:00

Development of an Integrated Digital Health Product (Digihaler^TM)

Mark Milton-Edwards Head of Product & Health Solutions - Digital Health at Teva Pharmaceuticals

Day 1 | 16:00 - 16:30

Speaking Sponsorship Available - Have your talk here

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Day 2 | 16:00 - 16:30

Use of 3d printing, Computational fluid dynamics and customised engineering in inhalation pre-clinical development

Simon Moore, Global Lead of Inhalation Science and Engineering at Covance

Day 1 | 16:30 - 17:00

Get it right first time: Inhaler technology and manufacturing

Marco Laackmann, Director Inhalation Technology at Harro Höfliger

Day 2 | 16:30

Chairman's closing remarks & End of the IRDD Event

Part III: Regulatory pathways for inhaled therapies

Day 1 | 17:00 - 17:30

Using a New Human Realistic Approach to In Vitro Characterization to Better Predict In Vivo Performance of Inhaled Aerosols

Dino Farina, Founder and CEO at Proveris Scientific

Day 1 | 17:30 - 18:00

Panel Discussion

Asthma inhalers: what next for the drug delivery tech?

DAY 1 | 20:00 - 22:30

Monday night business dinner

The BioTech Pharma Summit 2021: Gala Dinner

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IRDD_Gala_Dinner_New_York_Inhalation_Drug_Delivery

Pharmacovigilance & Drug Safety Agenda

Agenda is being produced and will be announced soon.

If you would like to speak at this event please click here

Pre-filled Syringes & Injectables Agenda

Agenda is being produced and will be announced soon.

If you would like to speak at this event please click here