Key Sessions

Richard Korsmeyer, Ph.D.

Opening Keynote - Thirty-Five Years of Drug Delivery: Successes, Failures, and Next Challenges

Korsmeyer Consulting, LLC; Pfizer (retired)

1月22日
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5:00pm - 6:00pm

Cocktail Reception

8:15am - 9:00am 45 mins
Registration and Breakfast
8:15am - 2:00pm 345 mins
20+ Hours of partneringONE® Meeting Potential in 2018
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You need more time for meetings with partners, customers and clients. Last year, 400+ meetings wasn't enough, so DDP 2018 will offer more than 20+ hours of partnering time through EBD Group's partneringONE®. Leverage partneringONE® to identify and qualify technology leads and close the deal that expands your product lifecycle.

It's easy as...

  1. Request meetings. 
  2. Accept or decline requests from others.
  3. Arrive on site and meet.
9:00am - 9:15am 15 mins
Chairpersons' Opening Remarks
  • Chairperson Ann L. Daugherty, Ph.D. - Senior Manager, Drug Delivery, Pharmaceutical Development, Genentech Inc.
  • Chairperson Richard Korsmeyer, Ph.D. - Independent Consultant, Korsmeyer Consulting, LLC; Pfizer (retired)
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9:15am - 9:45am 30 mins
Opening Keynote - Thirty-Five Years of Drug Delivery: Successes, Failures, and Next Challenges
  • Keynote Speaker Richard Korsmeyer, Ph.D. - Independent Consultant, Korsmeyer Consulting, LLC; Pfizer (retired)
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Over the past 35 years, we've seen the field of drug delivery progress from an exotic specialty to a relatively mainstream discipline, particularly within the pharmaceutical industry. Early products met with mixed successes, but some eventually achieved blockbuster status, focusing attention on a previously neglected field. Despite advances in science and technology, achieving the right combination of active molecule, therapeutic target, delivery technology, and commercial market remains challenging.  This talk will present the speaker's personal perspective on success and failure in the field and on the challenges of delivering newer therapeutic modalities to create products that can revolutionize our approach to treating human diseases.

9:45am - 10:30am 45 mins
Opening Panel - Marry to Market: Making the Most of Partnerships
  • Moderator Jeannie Joughin, Ph.D. - Vice President, Corporate Development, Enable Injections, Inc.
  • Panelist Neil Mathias, Ph.D. - Research Fellow, Drug Delivery, Bristol-Myers Squibb
  • Panelist Keith Horspool, Ph.D. - Vice President Pharmaceutics, Boehringer Ingelheim
  • Panelist Napoleon Monroe - Managing Director, New Directions Technology Consulting, LLC
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10:30am - 11:00am 30 mins
Morning Refreshment Break
11:00am - 11:30am 30 mins
Enabling Drug Development for Genetic Diseases:Artificial Intelligence, Phenotypes and Genomics Integrated for Precision Medicine
  • Barry Frankel - Senior Advisor Strategy, FDNA
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Precision medicine is a major focus to improve the productivity, cost, time and yield in bio/pharmaceutical development. FDNA is the leader in using artificial intelligence for deep and accurate phenotyping ("next-generation phenotyping") combined with genomic information to affect drug discovery, development, and commercialization. This presentation will describe how this technology links clinical phenotypes to the genetic variants that cause them for drug target discovery and biomarker development, provides access to curated databases and a researcher-shared forum for novel trial designs, and enables earlier patient diagnosis for trial recruitment and access to treatment. Case studies will be utilized. Established as a leader in the genetic disorder space, the platform has applications across the broader bio/pharmaceutical industry.

11:30am - 12:15pm 45 mins
Special Populations and Rare Diseases
  • Moderator Cornell Stamoran, Ph.D. - Vice President of Corporate Strategy, Catalent Pharma Solutions
  • Panelist Judith Beizer, PharmD, BCGP, FASCP, AGSF - Clinical Professor, College of Pharmacy and Health Sciences, St. John's University
  • Panelist Edmund Pezalla, M.D., MPH - Founder and CEO, Enlightenment Bioconsult, LLC
  • Panelist Rachel Meyers, PharmD, BCPS - Clinical Associate Professor, Ernest Mario School of Pharmacy, Rutgers University
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12:15pm - 12:45pm 30 mins
Late Breaking Presentation
  • Speaker Constantin Coussios, Ph.D. - Statutory Chair of Biomedical Engineering, University of Oxford
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(Invited)

12:45pm - 2:00pm 75 mins
Networking Luncheon
2:00pm - 2:15pm 15 mins
Track 1: Drug Delivery Technologies to Watch I
Presentation Title TBA
2:00pm - 2:30pm 30 mins
Track 2: Drug Delivery Technologies to Watch II
Improving medication adherence: linking patients with technology and development capabilities
  • Paolo Golfetto - Director of Technical & Business External Relations, Stevanato Group
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Today, it is not anymore enough to make safe and efficient drugs: payers are forcing everyone in the "healthcare value chain" to cut the costs of "non adherence". This has a tremendous impact on how we conceive and design our drug delivery devices, forcing developers to put in place cohesive strategies to meet the needs of complex biopharmaceuticals and simplified delivery technologies, all of this within an evolving regulatory framework. In this paper, we will illustrate how a device developer with a range of integrated technological capabilities can help in the definition of very efficient product and process solutions for wearable injection systems. A particular set of capabilities can also fuel initiatives to improve patient adherence and quality of life, especially for chronic conditions: a snapshot of such initiatives will be also provided.

2:00pm - 3:30pm 90 mins
Workshops
Using Human Factors Engineering to Create Better Products and Increase Patient Satisfaction
  • Moderator Lee Leichter - President, P/L Biomedical Consulting
  • Christina Mendat - Partner and Senior Technical Director, Human Factors MD
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Human Factors Engineering is not only Design Validation. It can be integral in characterizing and identifying your user's needs, critical in ensuring that the product meets and exceeds their expectations, as well as required to validate the design and achieve regulatory approval. The session will provide guidance from industry experts as to how HFE can benefit your products and your business. Access to the experts will be available in a panel session to address all of your HF questions.

The Key Takeaways:

  • Understand the different phases and tools that are part of HFE and how to use them
  • Learn how to truly know your users through early HF research
  • Integrate HFE during product design to achieve the best product for you customer
  • Appreciate the keys to success in designing and executing Usability studies


2:00pm - 5:00pm 180 mins
partneringONE®
partneringONE® Meetings
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Leverage partneringONE® to identify and qualify technology leads and close the deal that expands your product lifecycle.

2:15pm - 2:30pm 15 mins
Track 1: Drug Delivery Technologies to Watch I
The Credence Companion Addresses Multiple Challenges Facing the Delivery of Biologics
  • John Merhige - Chief Commercial Officer, Credence MedSystems, Inc
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By removing the glue that is conventionally used to affix a staked-in needle, Credence presents a platform of syringe-based delivery systems that addresses significant patient and drug product risks while continuing to provide integrated, passive needle retraction and reuse prevention.

2:30pm - 2:45pm 15 mins
Track 1: Drug Delivery Technologies to Watch I
Transforming the Patient Experience with a Needle- Free Drug Delivery Device
  • Patrick A. Anquetil, Ph.D. - CEO and Co-Founder, Portal Instruments, Inc.
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Delivering high viscosity, high concentration biologics is a challenge for the biopharma industry. Injections are slow, painful, and patients dislike needles, leading to sub-par adherence rates for these treatments. Portal is transforming this patient experience with a needle-free device that is computer-controlled, easy to use, and fits into the patient's life. The device platform is viscosity agnostic and can be used seamlessly across a vast portfolio of injectables. The cartridge is pre-filled with standard fill/finish lines.

2:30pm - 2:45pm 15 mins
Track 2: Drug Delivery Technologies to Watch II
Late Breaking Presentation by Surefire
2:45pm - 3:15pm 30 mins
Track 1: Drug Delivery Technologies to Watch I
Late Breaking Presentation by Haselmeier
  • Terrence O'Hagan - General Manager, Haselmeier, Inc.
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2:45pm - 3:15pm 30 mins
Track 2: Drug Delivery Technologies to Watch II
Late Breaking Presentation by West Pharma
3:15pm - 3:30pm 15 mins
Track 1: Drug Delivery Technologies to Watch I
Showcase Session TBA
3:15pm - 3:30pm 15 mins
Track 2: Drug Delivery Technologies to Watch II
Smart Inhalers - Improving Patient Adherence and Reducing Healthcare Costs
  • James Shears - Director, New Market Development, Presspart
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Global health data confirms that poor patient adherence to long-term therapies, such as asthma and COPD, contribute significantly to rising healthcare cost. Smart Inhalers are emerging which enable more effective monitory of patient compliance and adherence, including remotely. Clinical studies using smart devices have demonstrated improvements and translate directly to a reduction in healthcare cost. Smart Inhalers face numerous challenges, from a wide range of stakeholder, for successful adoption on a global scale.

3:30pm - 4:00pm 30 mins
Track 1: Drug Delivery Technologies to Watch I
Refreshment Break
3:30pm - 4:00pm 30 mins
Track 2: Drug Delivery Technologies to Watch II
Refreshment Break
3:30pm - 4:00pm 30 mins
Workshops
Refreshment Break
4:00pm - 4:30pm 30 mins
Track 1: Drug Delivery Technologies to Watch I
Showcase Session TBA
4:00pm - 4:30pm 30 mins
Track 2: Drug Delivery Technologies to Watch II
Showcase Session TBA
4:00pm - 5:00pm 60 mins
Workshops
Late Breaking Workshop by BD
4:30pm - 5:00pm 30 mins
Track 1: Drug Delivery Technologies to Watch I
Showcase Session TBA
4:30pm - 5:00pm 30 mins
Track 2: Drug Delivery Technologies to Watch II
Showcase Session TBA
5:00pm - 6:00pm 60 mins
Cocktail Reception

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。