Registration & Breakfast
Registration hosted by
Chair’s Opening Remarks
Barbara Lueckel, PhD
Head of Research and Technologies Partnering, Roche
Opening Keynote Address
New Ways to Deliver Drugs and Cells
Robert Langer, PhD
David H. Koch Institute Professor, MIT
Genome Engineering – Delivery and Testing
George Church, PhD
Professor of Genetics, Harvard Medical School
Networking Break & Partnering Meetings, Exhibits Open
Exploring Creative Partnering Models to Support Tomorrow’s Healthcare Innovations
While big pharma continues to make investments that have a defined pay-out, there is far less enthusiasm to fund adventurous initiatives that are high-risk investments at a very early stage. This panel will explore novel partnering models to create opportunities to develop the future healthcare innovations of tomorrow while mitigating risk.
Richard Korsmeyer, PhD
Executive Director, Advanced External Projects, Technology & Innovation Group, Pfizer
Founder, President and CEO, Alcyone Lifesciences
Co-Founder and CEO, Cyta Therapeutics
Stephen Gerrard, PhD
Program Officer, Chemistry, Manufacturing and Controls, Global Health / Integrated Development, Bill and Melinda Gates Foundation
Founder and President, Institute for Pediatric Innovation
Director of Innovation Impact, Pacific Northwest National Laboratory
Partnering Case Study featuring Pfizer and AstraZeneca
In this session, pharma and biotech representatives will discuss lessons learned from forging successful drug delivery partnerships.
Barbara Lueckel, PhD
Head of Research and Technologies Partnering, Roche
VP, Business Development, Starpharma
Denis Patrick, PhD
Executive Director, Head External R&D Innovation, Oncology Research Unit, Pfizer, Inc
Adam McNulty, MBA
Scientific Partnering & Alliances, AstraZeneca
VP, Nanomedicine Development & Manufacturing, Pfizer, Inc
Drug Delivery - The Year in Review
Josef Bossart, PhD
Executive Editor, PharmaCircle LLC
Lunch & Partnering Meetings
Drug Delivery Technology Presentations in Three Tracks
Brief Break from 3:45 – 4:00 pm
Track 1: Injectable Formulation Technologies
Ann Daugherty, PhD
Senior Manager, Drug Delivery, Genentech
Companies are presenting injectable formulation technologies, such as nanoparticles, microspheres, liposomes, drug conjugates, sustained release depots and implants.
Innovative Nanomedicines for Enhanced Therapeutic Performance
Cristal Therapeutics develops innovative nanomedicines for an enhanced therapeutic performance. Preliminary promising results on the clinical evaluation of CriPec® docetaxel will be presented.
Cristianne Rijcken, MD
Founder and Chief Scientific Officer, Cristal Therapeutics
Oakwood Labs, Chroniject™ Technology
Oakwood’s patented sustained-release injectable microsphere technology, called Chroniject™, and Oakwood’s clinical and commercial manufacturing capabilities.
Tracy Richey MD, PhD
Principal Scientist, Formulation Development, Oakwood Labs
The ENHANZE Platform
Reducing the patient and healthcare burden by potentially enabling subcutaneous delivery of therapeutics with greater speed and volumes with reduced frequency and variability.
Kenneth Schultz, MD
VP of Innovation, Strategy, and Business Development, Halozyme Therapeutics
DEP Dendrimers in Drug Delivery
Starpharma’s patented DEP™ technology exploits the benefits of clinically validated polylsine dendrimers to deliver a therapeutic payload in a precise way to achieve desired therapeutic goals.
VP, Business Development, Starpharma
SynBiosys Sustained Release Microspheres for Parenteral Drug Delivery
Demonstrating excellent safety, control over release kinetics and effective preservation of drug integrity, InnoCore’s SynBiosys biodegradable polymeric drug delivery platform exhibits all requirements to develop complex parenteral sustained release microsphere formulations for all classes of drug molecules.
Rob Steendam, PhD
Chief Technology Officer, InnoCore Pharma
Creating Value with the BEPO Technology Combined with a Non-traditional Collaborative Model
The presentation will focus on long-acting injectables benefits and opportunities and on BEPO specific features including improved patient compliance, efficacy and safety aspects, as well as, versatility, formulation development and manufacturing costs aspects.
Chief Technology Officer, Medincell
POZ – The Next Generation in Polymer Drug Delivery
Serina Therapeutics, Inc is a pharmaceutical research and development company that has developed a proprietary, patented polymer technology platform for drug development (POZTM) based upon poly(oxazoline).
Randall Moreadith, MD, PhD
CEO, Serina Therapeutics
Novel, Sustained-release, Micro-suspension to Reduce Repeated Epidural Steroid Injections
SpineThera has developed a novel, sustained-release, corticosteroid micro-suspension that we believe will provide durable pain relief from a single epidural injection.
Delivering More Drug Where It’s Needed
Safer, yet more effective treatment is a key goal in oncology drug delivery. Intezyne’s IVECT nanoparticle platform achieves this objective by delivering more drug to the tumor and reducing damage to healthy tissue.
Kevin Sill, PhD
CEO, Intezyne Technologies
Silica Matrix for Controlled Drug Release
DelSiTech’s technology is a biodegradable, biocompatible silica-based controlled /extended release platform for non-oral dosage forms.
Cora Griffin, PhD
Business Development Director, DelSiTech
Engineering Uniform Particles to Improve Drug Performance
Liquida has developed a simple, scalable solution to improve medicines by molding uniform drug particles at the micro and nanoscale.
Kevin Herlihy, PhD
Principal Scientist, PRINT Formulation, Liquidia
Use of Next Generation Sequence Modified Albumin Variants for Improving Drug Half-life, Delivery, and Payload Capacity
Albumedix has developed next generation sequence modified albumin variants with both improved half-life and API payload capacity that show enhanced performance in various animal models.
Daniel Shelly, PhD, MBA
Director, Business Development, Albumedix
AnestaGel Matrix BioHydrogel
InSitu Biologics researches, develops, tests and manufactures implantable time release products composed of its proprietary tunable, bio-polymeric hydrogel, Matrix™BioHydrogel.
CEO, InSitu Biologics
Novel Long Lasting Intravenous Analgesic Formulations for the Treatment of Postoperative Pain with Opioid Sparing
Here we report the development of novel injectable NSAID and COX II products formulated using Altus micellar SmartCelle technology. Along with the benefits to patients and cost of treatment of reduced injection frequency, we propose that such increased exposure to sustained drug levels will have a significant opioid sparing effect in a multimodal regimen.
Damon Smith, PhD
CEO, ALTUS FORMULATION
Track 2A: Non-Injectable Technologies - Oral
Mark Wilson, PhD
Director, PTS, R&D, GSK
Companies are presenting oral drug delivery technologies, such as controlled release, bioavailability-
enhancing and solubility technologies.
What Do You Do When Spray Drying and Melt Extrusion Fail to Solve Your Poorly Soluble Drug’s Problems?
Three case studies illustrating the application of KinetiSol® to produce optimum drug products with highly challenging insoluble compounds.
VP, R&D, Dispersol
Polymer-free Materials for Truly Controllable Drug Delivery – Introduction to Applications for Oral and Long Acting Injectable Formulations
Discussion of the opportunities for using materials for enhancing drug delivery; both injectable and oral formulations, and both small and large molecules.
Healthcare Business Manager, Lucideon
Addressing Adherence Challenges for Drugs Having pH-dependent Solubility
Creating sustainable acidic or basic pH microenvironments within coated beads to optimize pharmacokinetics and create patient-centric formulations.
Anthony Recupero, PhD
Senior Director, Business Development, Adare Pharmaceuticals
MicroJetReactor Technology: A Novel Approach for Nanotechnology-based Reformulation of Poorly Water-soluble Drugs
Presentation of MicroJet Reactor Technology: A Novel Approach for Nanotechnology Reformulation of poor water-soluble drugs (BCS II/IV).
Elke Horstkotte, PhD
Senior Project Manager, leon-nanodrugs
Oral Absorption Benefits of Eligen® Technology
Emisphere’s Eligen® Technology has been proven to enhance the oral delivery of molecules that are not normally permeable through gastro-intestinal membranes. Peptides, proteins, and other molecules that have been successfully delivered orally will be discussed.
Lead Chemist, Emisphere
Nanoporous Silica for Advanced Drug Delivery
Nanologica’s nanoporous silica technology is a versatile drug delivery platform with a key feature of stabilizing drugs in their amorphous form. Clinical benefits of NLAB Silica ™ technology will be demonstrated in case studies.
Paulina Paszkiewicz, MD
Business Developer, Drug Delivery, Nanologica
EUDRATEC® PEP – Switching Biologics from Parenteral to Oral Administration
Multi-unit oral dosage forms with EUDRATEC® PEP for oral delivery of macromolecules and poorly permeable small molecule drugs. The platform technology offers the synergistic combination of modules for bioavailability enhancement with a tailored release profile in the gastrointestinal tract.
Hans Baer, MSc
Senior Project Manager, Drug Delivery Services, Pharma Polymers & Services, Nutrition & Care, Evonik
Track 2B: Non-Injectable – Oral, Mucosal, Transdermal
Companies are presenting a variety of non-injectable technologies, such as transdermal patches, microneedle patches, mucosal technologies, and oral delivery systems.
RapidFACT: Reducing the Time and Cost for Optimizing Drug Product Formulations
What is Translational Pharmaceutics and what are the benefits? RapidFACT – accelerated screening and optimization of formulations based upon clinical data. Applications and case studies – solubility enhancement and modified release formulation optimization.
Kieran Crowley, PhD
Senior Scientific Director, North America, Quotient Clinical
Molded Polymer Dosage Forms – Current and Future Applications in Women’s Health
Molded and extruded polymeric dosage forms for long-term drug delivery have found a number of significant applications in the field of women’s health.
James Arps, PhD
Director of Pharma Services, Promed Pharma
Bioavailability Optimization Technology(TM) the Next Generation in Micronization
CritiTech’s Bioavailability Optimization Technology(TM) represents the next generation in micronization, providing unique, excipient free nanoparticles with an exponential increase in surface area and dissolution rate.
Chief Commercial Officer, CritiTech
Advances in “Drug in Adhesive” Transdermal Patches
Medherant has developed a superior novel adhesive for use in transdermal patches which allows higher drug loading without compromising adhesion, delivers more drug through the skin and therefore can achieve higher transdermal drug dosing over sustained time periods.
Commercial Director, Medherant Ltd
IntraTab™ Presents: Sublingual Drug Delivery Technology™ (SDDT™) Our Proprietary Platform for Transmucosal Delivery
SDDT™ is the first and only patented delivery technology that transports APIs which are not natively amenable to transmucosal delivery. SDDT™ allows for API’s normally administered via inhalation, injection or transdermally to be rapidly administered orally with no First Pass Effect.
President, IntraTab Labs
Applicator-free Microneedle Patch Technology for Skin Delivery
Micron Biomedical is a clinical stage company that is developing a novel, proprietary, applicator-free, painless microneedle patch technology to improve and simplify the delivery of injectable drugs and vaccines. Micron Biomedical’s technology, capabilities and partnering strategy will be discussed.
Sebastien Henry, MS, MBA
VP, Program Management, Micron Biomedical
Protection or Absorption? What is Your Focus in the Oral Delivery of Large Molecules; Perhaps We Should Focus on Both.
Entera Bio is currently focused on developing an oral formulation of PTH 1-34 (Teriparatide). By focusing on both protection of the molecule and GI absorption, Entera has been able to significantly reduce interpatient and intrapatient variability. This short presentation will focus on some of data generated from multiple Phase 1 and Phase 2 studies in hypoparathyroidism.
Phillip Schwartz, PhD
CEO, Entera Bio
Track 3: Drug Delivery Device Technologies
Head, Academics & Innovation, Sanofi
Companies are presenting device technologies, such as wearable drug delivery systems, needle-free devices, pre-filled syringes, auto-injectors, and other enabling devices.
Improving Adherence by Optimizing the Patient Experience
By improving the delivery experience, pharmaceutical companies and their device partner can provide greater adherence and improved clinical outcomes.
VP, Business Development, Drug Delivery, Insulet
The Intuitiveness, Ergonomics and Usability of the Credence Companion® Safety Syringe: A Formative Study
Credence will share results from the latest User Study, which explored intuitiveness of use and user preference.
Chief Commercial Officer, Credence Medsystems
Tailoring the Autoinjection with SAFELIA®
Safelia autoinjectors allow large possibility of design tailoring for optimizing self-injection. Based on 1ml and 2.25ml prefilled syringes injections, Safelia adapts to administer rapidly, through thinner needles, high volumes, high viscosities.
Strategy Director, Nemera
Next Generation Needle Free Drug Delivery Device
What if there was a way to inject high viscosity biologics, without the pain, anxiety, and risks of handling needles? We will introduce Portal Instruments’ revolutionary drug delivery system.
CEO, Portal Instruments
Improving Outpatient Drug Delivery Compliance
The drive toward improving outpatient drug delivery starts with the primary container.
Senior Director Combinational Products, Stevanato Group
Patient Centric Shift- challenges and Trends in Drug Delivery
Discussion of the current trends and challenges for biologics overall and specific to integrated containment systems.
Director, Market Development, West Pharma
Smart Devices are Reshaping the Drug Delivery Landscape – But How to Efficiently Drive Their Adoption?
Smart drug delivery devices are now a reality – but what does “smart” really mean? How these innovations can fit in regulatory, industrial, and data privacy constraints?
Eric Dessertenne, PharmD, MBA
Head of Business Development and Commercial Operations, Biocorp
Insights into Providing Integrated Drug Delivery Solutions to Address the Challenge of Higher Volume and High Viscosity Biologics
During this talk, we will highlight Bespak’s newest auto injector line Syrina™ as well as the cutting edge powerpack system Vapoursoft™.
Global Business Development Lead, Bespak
Micro-Pump Delivery Systems: Patchpumps vs. Belt-worn Devices
Micro-pumps offer new options for drug delivery, opening up new and improved treatments. This presentation explores the pros and cons of each option – depending on patient needs, therapy options and drug requirements.
Gerhard Mayer, PhD
VP, Business Development, Sensile
Assuring Adherence with a Microchip-based Drug Delivery Implant
Microchips Biotech is fulfilling the promise of implantable drug delivery and disease management systems to transform people’s lives and the way healthcare is delivered.
Cheryl Blanchard, PhD
President and CEO, Microchips Biotech
DCI – A Reconstitution Platform Technology
A novel reconstitution platform that combines proven, industry-standard drug containers to deliver enhanced drug separation integrity and improved human factors.
Dave Seaward, MD
Projects Director, 3P Innovation
Quantex Single-use Micro-pump for Drug Delivery
Overview of novel design and test results based on a rotary fixed-displacement pumping principle which exhibits low running torque, high output pressure (>30psig) and insensitivity to fluid viscosity.
Connectivity as an Overall Brand Strategy
Connected devices offer value beyond the delivery of a drug. The data provides the opportunity to measure and improve real-world drug performance, driving success in a value-based environment.
Co-founder and CEO, Quio
Addressing Challenges in Biologic Drug Delivery through Innovations in Lubricious Barrier Coatings
Advances in Omniflex fluoropolymer barrier coating technology at Datwyler allow manufacturers of injection devices to dramatically reduce silicone-oil-based subvisible particles and achieve highly consistent delivery forces.
Susan Dounce, PhD
Senior Manager, Business Development & Innovation, Injection Systems, Datwyler
Making Innovation Investment Count
Cambridge Design Partnership is on a mission to improve innovation ROI. In this talk we’ll highlight some of the counter-intuitive lessons we’re learning along the way and the principles, approaches and tools that we’ve found can reduce risk, reduce time to market and deliver innovation with improved ROI.
Front End Innovation Leader, Cambridge Design Partnership
Continental Breakfast in Exhibit Hall and Partnering Meetings
Barbara Lueckel, PhD
Head of Research and Technologies Partnering, Roche
Opening Keynote Presentation
Innovations in Healthcare
Mir Imran, MS
Chairman & CEO, InCube Labs
Keynote Presentation: How Biogen Thinks about Next Generation Biologics Manufacturing
Jorg Thommes, PhD
SVP, Technical Development, Biogen
Device Strategies and Solutions for High Volume / High Viscosity Drugs
A significant number of drugs are high volume and/or highly viscous and pose delivery challenges. This panel will engage in a discussion focused on practical strategies and solutions for delivering high volume/high viscosity drugs.
Shawn Davis, PhD
Principal Engineer of Device Strategy and Advanced Technology, Amgen
Director, Device Development, Biogen
David Haase, MBA
Senior Manager, Device Development, Genentech, Inc
Chief Technology Officer, Phillips-Medisize
Consumer Industrial and Medical, BattelleMike Hooven
President and CEO, Enable Injections
Networking Break in Exhibit Hall and Partnering Meetings
6th Annual Company Spotlights
In this session, three pharmaceutical companies will present their partnering philosophy, current needs and scouting interests, as related to drug delivery.
Head, Combination Product Device Development, R&D
James Cunningham, PhD
Director, Ocular Drug Delivery
Marta Corcoran, PhD
Senior Scientist, Drug Delivery and Device Development
Associate Director Device Development
Luncheon Roundtable Session & Partnering Meetings
The PODD Luncheon Roundtable session is open to all delegates and features a dedicated moderator. Roundtables are an excellent way to engage in in-depth discussions and meet colleagues with similar interests. Be sure to pick up a Grab-and-Go lunch to enjoy during the roundtable discussion.
Intrathecal and Brain Drug Delivery
Principal Scientist and Group Leader, Protein Pharmaceutical and Device Development, Biogen
Vishwesh Patil, PhD
Scientist II, Technical Development, Biogen
Principal Engineer, Technical Development, Biogen
Improving Therapeutic Outcomes using Digital Drug Delivery
Technology and medicine are converging to bring digital therapeutics to the market. There are a number of new products incorporating electronics and connectivity to improve compliance, adherence and monitoring of drug therapy. The panel will discuss important issues in this emerging field:
- Emerging products and opportunities – “smart” pills, microchip-based implants, digital inhalers
- Potential benefits of digitally-enabled drug delivery products
- User-interface and patient experience
- Can data collection improve outcomes?
EVP and Chief Technology Officer, Microchips Biotech, Inc
Christopher Bettinger, PhD
Associate Professor, Departments of Biomedical Engineering & Materials Science, Carnegie Mellon University
Christopher Coletta, PhD
Independent Consultant / Former Director of Drug Delivery Innovation, Amgen
Eric Elenko, PhD
EVP, Science and Technology, PureTech
Christoph Klaus, MBA
CEO, Balda US
Yuri Maricich, MD
VP of Clinical Development, Pear Therapeutics
DDS Technology Soapbox@PODD sponsored by Pfizer
The DDS Soapbox is specifically designed for inventors and early-stage companies to give a 5-minute “pitch” or presentation to the audience. This session is open to start-ups, emerging companies, entreprene
urs, licensing officers and university researchers.
David Chen, PhD
Principal Scientist, Novel Delivery Technologies, Pfizer Inc
Cam Med LLC
Evopump: The First Truly Bandage-like Patch Pump
Cam Med LLC is developing the Evopump, a bandage-like, actively controllable patch pump for delivering one or multiple injectable medications.
Co-founder and CEO
Carnegie Mellon University
Edible Electronics: Materials & Structures for Ingestible Medical Devices
This talk will describe recent advances in bioinspired materials for potential use in edible devices. Recent discoveries include the use of melanin-based pigments as biocompatible materials for on-board energy storage.
Christopher Bettinger, PhD
Associate Professor, Departments of Biomedical Engineering & Materials Science
Spherical Nucleic Acids as Potent Immune Modulatory Agents
Exicure is developing Spherical Nucleic Acids. The results of our Phase I trial in psoriasis patients and our pre-clinical TLR9 immuno- oncology work with Spherical Nucleic Acids will be discussed.
David Giljohann, PhD
CNS Drug Delivery
NEUWAY Pharma presents its proprietary CNS Drug Delivery Technology which allows the transport of different types of drugs to the cells of the CNS. The technology is based on a protein which forms capsules whose lumen can be filled with different types of molecules.
Heiko Manninga, PhD
Managing Director and Chief Scientific Officer
Matrix-Binding Fusions for Local Drug Delivery and Sustained Retention
Potential therapeutics will not be effective if they are unable to reach their targeted tissue and remain there long enough for activity, especially in poorly vascularized tissues with densely packed matrix. ProteoThera solves this problem with a proprietary matrix-binding peptide that allows for optimal transport into tissues and extended residence time while maintaining activity of the therapeutic cargo.
Parth Patwari, MD, ScD
Chief Scientific Officer
The ‘LyoKit’ Drug Reconstitution System
Recon Therapeutics’s patent-pending device simplifies at-home injections in the men’s health, fertility, and hormone replacement markets. By keeping drug and diluent separate until the patient is ready to inject, the device increases shelf-life for pharmaceutical products, eliminates the need for refrigeration, and ensures safe, accurate dosing.
R&D, Koch Institute for Integrative Cancer Research, Harvard-MIT Division of Health Sciences and Technology
Oral Biotherapeutics Drug Delivery
Converting injectable drugs is often described as the “holy grail” of drug delivery. Although many companies have tried and failed, Rani Therapeutics believes it has cracked the code with its novel approach – the “robotic pill” – that delivers biologics directly into the intestinal wall. Hear from Mir Imran about Rani’s unique technology and his plans to drastically improve the lives of millions of patients suffering from diabetes, osteoporosis rheumatoid arthritis, multiple sclerosis, and many other chronic conditions.
Mir Imran, MS
Chairman and CEO
Innovate in a Meaningful Way
This talk will cover how iO’s global, risk-managed approach and user-centric process for product design and engineering delivers faster time-to-concept at considerable value with high user satisfaction.
Founder & CEO
Partnering to Deliver Next-Generation Diabetes Products
Panelists will discuss the current drug delivery needs for diabetes management, as well as current licensing interests related to formulation and device technologies. Technology evaluation criteria and partnering models will also be covered.
Associate VP, Medical Device Development, Sanofi
VP, Drug Delivery/Device R&D Innovation, Eli Lilly
Anand Subramony, PhD
VP, Drug Delivery & Device Development, MedImmuneCarsten Weber
Head of Pharmaceutical Science Operations, Sanofi
Enabling Technologies to Overcome Oral Small Molecule Delivery Challenges
Developing the optimal oral dosage form of a small molecule drug can be challenging, as a large number of these molecules have poor bioavailability, solubility and / or sub-optimal pharmacokinetics properties. Technologies that offer extended and enhanced oral exposure are currently of high interest. This panel will discuss enabling delivery technologies and strategies to address critical formulation issues encountered during small molecule formulation development.
- Which technologies are working?
- Solid dispersions
- Lipid-based systems
- Oral sustained release systems
- What are the advantages and limitations of these technologies?
- What have we learned and how do we fill the gaps?
- How do we rationally select the right technology for the right compound? What kind of data is needed for the selection process?
Director, Discovery Pharmaceutical Sciences, Merck
Zhengming (Jimmy) Chen, PhD
Senior Director, Pharmaceutical Sciences, Shionogi Inc
Keith Horspool, PhD
VP, Material and Analytical Sciences, Boehringer Ingelheim
Ajit Narang, PhD
Senior Scientist, SMPS, Genentech, Inc
Manuel Sanchez-Felix, PhD
Senior Fellow, Novel Drug Delivery Technologies, Novartis Institutes for Biomedical Research
- Which technologies are working?