8:30 am
Keith Horspool
Keith Horspool
Vice President Pharmaceutics
Boehringer Ingelheim

8:45 am

The drug delivery landscape continues to rapidly evolve with advancements in personalized medicine and pharmaceutical development. As the industry continues to see a growing role of biotherapeutics in commercial and clinical phases, new opportunities and challenges arise for novel drug delivery methods of biologics. Hear first-hand on where the industry is heading as we move into a new era of medicine and explore the future trends of biologics and drug delivery to develop strategic plans for a biologics portfolio.

  • Explore opportunities and challenges in novel drug delivery methods for biologics
  • Evaluate strategic partnerships to aid with building a robust biologics portfolio
  • Assess the continuing M&A activity in the pharmaceutical industry and its implications on your organizations strategic growth plans
Rakesh Dixit
Rakesh Dixit, PhD, DABT
Vice President, Research and Development, Global Head, Biologics Safety Assessment- Translational Sciences, Medimmune
Astrazeneca

Didier Pertuy
Didier Pertuy
Vice President, Global Head of Drug Device Integrated Development & Device Strategy
SANOFI

9:45 am

The use of biologics is on the rise and novel delivery approaches for chronic health conditions is shifting the role of the patient. As biologics are highly concentrated and require specific dosages, challenges to deliver consistent dosages impacts patient adherence. As the role of the patient is transforming to have more independence and control of their treatment, wearable drug delivery technology is projected to improve the user experience, drive adherence, and ensure patient engagement. In this session, discover how to provide patients with novel approaches to drug delivery through the use of connected health devices.

  • Ensure consistent dosage administration for patients with chronic diseases
  • Leverage connected drug delivery devices to ensure patient adherence and convenience
Matthew James Clemente
Matthew James Clemente
Chief Technology Officer, Connected Product Solutions, Delivery and Device Research & Development
Eli Lilly

Paul Upham
Paul Upham
Senior Principal
Genentech

11:00 am

By 2020, analysts expect the worldwide biosimilar market to reach 25-35 billion dollars and they are projected to save the industry up to 250 billion dollars over the next 10 years. As biosimilar products start to gain momentum in the market, manufactures are interested in understanding the future implications of biosimilars on the drug delivery landscape. This session will provide first hand insight on how the industry is developing and using biosimilars in the future and what you should be preparing for in today’s volatile market.

  • Assess the legislative and reimbursement landscape of biosimilars
  • Determine the best strategy and approach for manufacturing both biologics and biosimilars
  • Understand how to prepare for the impact biosimilars will have on the drug delviery landscape
11:45 am

Biologics that are formed with short plasma half-lives require more frequent administration, therefore making it more difficult for patients to comply with their regimens. Although these drugs have advantages over conventional drugs in that they are more selective, effective, and have limited side effects, manufacturers face a lack of adherence and compliance to these drugs due to the design of the drug and mode of delivery. Manufacturers will have to address these challenges in the drug development process, and inform patient focused drug development initiatives with insights from patients and payers. As payers are heavily focused on outcomes, what payers perceive to be valuable, thus, guiding reimbursement decisions has become more critical today than ever before. In this session, we will discuss how improve formulation strategies to enhance patient convenience and adherence to improve patient outcomes, establish more convenient methods of delivery, and improve payer partnerships.

  • Build R&D efforts based on patient, care giver, and payer insights
  • Drive patient focused biologics formulation development to improve patient outcomes, payer reimbursement and novel technology efforts
  • Evaluate the present reimbursement landscape to inform superior drug formulation and development strategies
  • Understand how to employ pre-formulation development strategies to improve patient convenience
  • Leverage devices and analytical tools to develop patient centered biologics drugs and integrate devices in early development
Advait Badkar
Advait Badkar
Senior Director New Technologies
Pfizer

12:30 pm

Join your peers for interactive roundtable discussions to explore opportunities in biologics drug formulation and delivery. Facilitators will lead the discussion and ensure key learning and takeaways from each topic.

Transdermal Drug Delivery

Pulmonary Drug Delivery

Drug Delivery

Human Factors

Combination Products

Nanotechnology

Wearable Devices

1:45 pm

Big data, analytics, precision medicine, and artificial intelligence is transforming research and development. Advancements in technology has created the opportunity to leverage big data from patients and utilize artificial intelligence technologies for biological insights. The use of big data as well as molecular and clinical data paves the way for predictive modeling to identify molecules that can be developed into biologics. Discover how to develop strategies to leverage the evolution of big data and artificial intelligence is transforming the drug delivery landscape to develop

  • Identify opportunities to use big data for predictive modeling
  • Establish safe and effective biological targets through the use of molecular and clinical data
  • Discover how to leverage Artificial intelligence to gain biological insights and improve the targeting and delivery of biologics
Derek Mathers
Derek Mathers
Director Advanced Development
Worrel Design for Healthcare

2:30 pm

The competition in the biologics market is increasing and successful product development requires a number of good decisions to be made with respect to the product concept, formulation, delivery device and intellectual property. Whilst there is a need for platform technologies to standardize the development process, new products will not succeed without constant innovation. Discover how innovative formulation technology can be combined with delivery technologies to enable next generation products.

  • Convenience and patient adherence are key to success in many therapeutic areas
  • Formulation and drug delivery patents are increasing in importance
  • Innovation in formulation and delivery technologies has become critical to achieve competitive products
Jan Jezek
Jan Jezek
Chief Scientific Officer
Arecor

3:45 pm

Most pharmaceutical and bio-pharmaceutical drugs are designed to work systemically via the circulatory system, and are thus formulated for direct injection or to be systemically absorbed in the stomach or small intestine. On the other hand, medicines that are intended to work locally, within the gastrointestinal (GI) tract, must be formulated to prevent or minimize systemic absorption. Both of these products were designed to work locally in the GI tract, and thus required enteric protection and the desired release profile. This presentation will describe the design and rationale for the formulation developed for each product, and discuss the challenges and possible solutions of delivering medicines to the gut for their desired local activity.

  • Understand how to improve biological delivery to achieve delivery and targeting of biologics to the GI tract location
  • Develop delivery strategies to ensure modified release of formulations to multiple GI target sites
  • Examine excipient selection to ensure non-absorbed localized activity
Andrew Bristol
Andrew Bristol
Vice President, Research and Development
Synthetic Biologics

4:15 pm

The key to improving the therapeutic effects of a biologic and extending the lifecycle of a drug is to develop partnerships between pharmaceutical and biotech companies and novel drug delivery companies to improve safety, efficacy, and effectiveness. Learn how to develop partnerships to establish innovative drug delivery systems and employ new technologies.

  • Discover the importance of partnering to advance the use of new drug delivery technologies that aid in business development goals
  • Discover take-away learnings from successful deals to develop beneficial partnerships and collaborations
  • Apply key learnings from partnerships to advance programs and facilitate scale-up and clinical development
Mary Gardner
Mary Gardner
Former Director of Technology Assessment, Hospira, Pfizer
Chief Executive Officer, DelNova

Jan Jezek
Jan Jezek
Chief Scientific Officer
Arecor

Moderator:
Patrick Lim Soo
Patrick Lim Soo
Senior Principal Scientist
Pfizer