Program 2021

September 13th - 14th, Boston, MA

For speaking opportunities, contact Ahmed Osman on ahmed.osman@markallengroup.com.

7:40 AM - 8:40 AM

Registration & Refreshments

8:40 AM - 8:50 AM

Chair’s Opening Remarks

8:50 AM - 9:25 AM - Keynote

Technology & Innovation

9:30 AM - 10:05 AM - Case Studies

Small Molecules

Mechanistic Pathways and Tools for Minimizing Drug Precipitation

Ajit Narang, Senior Scientist, Genentech

Biologics

Disruptive Technologies for Rapid Vaccine Development

Abstract TBC

Device Development

The Challenges and Opportunities of Development of Combination Inhalation Products for Non-Pulmonary Diseases

Mick  Hurrey, Fellow Vice President, Product Development, InCarda Therapeutics

Many challenges exist when developing inhalation products, all of which are combination products. However, when you try to change an undesirable effect, systemic delivery of an active, into a feature there are additional hurdles that need to be considered. In addition, since the patient population and the health care professionals treating these non-pulmonary diseases are often not familiar with pulmonary devices, additional usability concerns arise. This talk will present some case studies that address these concerns.

10:10 AM - 10:45 AM - Solution Spotlights

Small Molecules

Solution Spotlight by Quotient Sciences

Biologics

Solution Spotlight by WL Gore

Device Development

Solution Spotlight by Sensile Medical

10:45 AM - 11:35 AM

1-to-1 Meetings & Networking Break

11:35 AM - 12:10 PM - Case Studies

Small Molecules

Nanoparticle Drug Delivery for Tumour Targeting

  • Reviewing passive and active targeting
  • Nanoparticle stabilisation 
  • Nanoparticle formulations challenge

Biologics

Exploring the Future of Biologics Delivery

  • Reviewing latest regulatory updates
  • Is the demand for biologics growing?
  • Challenges in the biologics world

Device Development

Software Applications (Apps), the New Medical Devices?

  • When do mobile apps become devices? The regulations.
  • Allowing apps to make recommendations on treatments or medical consultations
  • Role of AI and responsibility of app designers vs medical clinicians

12:15 PM - 12:50 PM - Case Studies

Small Molecules

Recent Advances in Modified and Controlled Release Formulations

Arul Joseph, Senior Director, Pharmaceutical Development and Clinical Supply Chain, Avanir Pharmaceuticals

Discussion of new formulation technologies and trends in modified and controlled release formulations

12:50 PM - 1:50 PM

Lunch Break

1:35 PM - 2:10 PM - Solution Spotlights

Small Molecules

Solution Spotlight by Foster Delivery Science

Abstract TBC

Biologics

Solution Spotlight by TBC

Device Development

Solution Spotlight by TBC

2:15 PM - 2:50 PM - Case Studies

Small Molecules

DepoFoam® Technology: A Controlled-Release Lipid-Based Drug Delivery Platform

Soroush Ardekani, Manager, Pacira Biosciences

  • Formulation features/characteristics and commercial applications of multivesicular liposomes (MVLs)
  • Drug delivery system for non-opioid post-surgical pain management

Biologics

Topic TBC (BMS)

Device Development

Wearable Insulin Delivery Devices

  • Sweat based glucose monitoring
  • Closed loop systems for glucose measurement and dosage setting
  • Data collection and deep learning

2:50 PM - 3:40 PM

1-to-1 Meetings & Networking Break

3:40 PM - 4:55 PM - Solution Spotlights

Small Molecules

Solution Spotlight by Cydex Pharmaceuticals

Biologics

Solution Spotlight by TBC

Device Development

Solution Spotlight by TBC

5:00 PM - 5:45 PM - Panel Discussion

Technology & Innovation

Preparing for Patient-Centric Drug Development Regulations

  • What do the recent FDA Guidelines on Patient-Focused Drug Development (PFDD) mean to us?
  • Why do we need more patient focussed thinking and design of drug products, medical devices and combination products?
  • How will become more patient focussed shake up the industry and make us more competitive

5:45 PM - 5:50 PM

Chair’s Closing Remarks

8:00 AM - 8:45 AM

Registration & Refreshments

8:45 AM - 8:50 AM

Chair’s Opening Remarks

9:30 AM - 10:05 AM - Case Studies

Small Molecules

Drug Delivery Systems for Proteolysis Targeting Chimera that Improve Tumour Accumulation and Therapeutic Index

Vijay Anand Sethuraman, Senior Scientific Manager, Genentech

The Proteolysis targeting chimera (PROTAC) is a promising new technology in the field of oncology. There are several oncology targets that are being pursued by this technology. For many of these targets the pharmacology is driven by AUC over a certain inhibitory concentration and for some targets the therapeutic index (TI) may be very narrow. One way to improve the TI is to deliver the PROTAC via a sustained delivery system like the liposomes.

Two drug delivery systems were developed by incorporating the PROTACs in liposomes. In the first delivery system the PROTAC was incorporated into liposomes via a conventional approach where in the liposomes were formed by mixing the lipids in organic phase and PROTAC in aqueous phase. In another system the lipids were in organic phase and the PROTAC was pre-dissolved in cyclodextrin at very concentration and liposomes were formed. These liposomes were further purified by size exclusion chromatography or dialysis filtration.

In a Rat PK/PD study at 20 mg/kg, the cyclodextrin liposomes had 25X higher plasma concentration and 2.6X higher tumour concentration compared to conventional formulation. This improvement in plasma and tumour concentration could potentially improve the TI for the PROTAC.

A liposomal drug delivery system seems promising based on the above results. Optimization of the liposomes could further improve the tumour concentration and improve the overall TI. This delivery technology may be well suited to bring novel PROTACs into clinic.

Biologics

Oral Delivery of Peptides

Puneet Tyagi, Senior Scientist, AstraZeneca

Abstract TBC

Device Development

Topic TBC (Novel Device Development)

Geoff Wise, Senior Manager Device Development

10:10 AM - 10:45 AM - Solution Spotlights

Small Molecules

Solution Spotlight by Nanoform

Biologics

Solution Spotlight by TBC

Device Development

Solution Spotlight by TBC

10:45 AM - 11:35 AM

1-to-1 Meetings & Networking Break

11:35 AM - 12:10 PM - Case Studies

Small Molecules

Optimizing Conventional Formulations for Continuous Manufacturing

  • Improving material science, API and process robustness for continuous manufacturing
  • Ensuring you have fully automated controls to realize true end-to-end pharma production
  • Breakthrough technologies poised to revolutionize formulation and manufacturing

Biologics

Exploiting Synthetic Peptides in Generic Development

  • Update on status of synthetic peptide formulations 
  • Improving peptide stability and formulations

Device Development

Challenges and Opportunities in Combination Product Design, Development and Use

  • Designing devices and drugs in unison
  • Main challenges of designing user friendly devices

12:15 PM - 12:50 PM - Solution Spotlights

Small Molecules

Solution Spotlight by TBC

Biologics

Solution Spotlight by TBC

Device Development

Solution Spotlight by TBC

12:50 PM - 1:50 PM

Lunch Break

1:35 PM - 2:10 PM - Case Studies

Small Molecules

Achieving better Success Rate at Developing CNS targeted drugs

  • How to overcome the stumbling block of pharmacokinetics/pharmacodynamics
  • Choosing the correct dosage

Biologics

QbD and Process Scale Up Considerations

  • Biological continuous manufacturing
  • Making sense of regulatory guidelines
  • Formulating drugs with manufacturing in mind

Device Development

Medical Apps and a New Combination Products

  • Making an app/device work well together: considerations
  • Putting the patient first
  • Data protection

2:15 PM - 2:50 PM - Solution Spotlights

Small Molecules

Solution Spotlight by TBC

Biologics

Solution Spotlight by TBC

Device Development

Solution Spotlight by TBC

2:50 PM - 3:40 PM

Networking Break

3:40 PM - 4:55 PM - Case Studies

Technology & Innovation

Topic TBC (Opthalmic delivery)

Device Development

Ophthalmic Drug Delivery

  • Avoiding drug loss through thermoresponsive polymer formulation
  • in-vitro evaluation of ophthalmic drug release
  • Performance characteristics of ophthalmic drug delivery

5:00 PM - 5:45 PM - Panel Discussion

Device Development

What Does the Future Hold for Novel Drug Delivery and Combination Products?

  • What are the current and anticipated hurdles to novel drug delivery?
  • What are the current biggest challenges to developing new combination products and how will this affect LCM?
  • How will new technology change current products (special focus on apps and connectivity)

5:45 PM - 5:55 PM

Poster Presentation Award

5:55 PM - 6:55 PM

Chair’s Closing Remarks