EXECUTIVE INTERVIEW – Catalent Applied Drug Delivery Institute: Helping to Get Better Drugs to Waiting Patients, Encouraging the Adoption of Advanced Delivery Technologies

Headquartered in Somerset, NJ, Catalent Pharma Solutions is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics, and consumer health products. With over 75 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable product supply. Catalent employs approximately 8,500 people, including more than 1,000 scientists, at nearly 30 facilities across 5 continents and generates more than $1.7 billion in annual revenue. In 2012, Catalent launched the Applied Drug Delivery Institute to promote innovation, knowledge-sharing, and collaboration between industry leaders, academic experts, customers, and regulators to enhance understanding of available, emerging, and future drug delivery technologies and improve patient care. Kurt Nielsen, PhD, Senior Vice President of Research and Development, and Founding Institute Board Member, recently spoke with Drug Development & Delivery about the Institute, its goals, structure, and activities.

Q: What is the vision behind the Catalent Applied Drug Delivery Institute, and what mission does the Catalent Institute aspire to achieve?

A: Our industry is facing an ever-increasing challenge delivering effective medicines to patients due to the increasing technical challenges of new molecules going through the development process. We believed we really needed to work more collaboratively by bringing together the best minds from across both industry and academia to share all of their combined expertise, insights, and experiences. We owe that to patients, doctors, and our shareholders.

So, we established The Catalent Applied Drug Delivery Institute in 2012, with the aim of promoting innovation, knowledge-sharing, and collaboration between industry leaders, academic experts, customers, and regulators to enhance understanding of available, emerging, and future drug delivery technologies and improve patient care.

We believed that earlier introduction of drug delivery technology into the development process would really help advance more molecules through the development process by improving their bioavailability, therapeutic profiles, and delivery mechanisms. Our mission is to bring better treatments to market by advancing the development and adoption of applied drug delivery technologies. By harnessing the knowledge of some of the world’s leading experts in drug development, delivery, and formulation, the Institute aims to cultivate leadership and excellence in drug development through education, training, and innovation.

As part of that mission, the Catalent Applied Drug Delivery Institute serves as a link between industry and academia by providing guidance, counsel, and resources on major issues pertaining to drug development, delivery, and formulation. We will continue to develop programs that facilitate mutually beneficial collaborations, increase communication, and shed light on regulatory issues affecting drug developers and researchers. The Institute also pursues a multi-tiered approach of seed funding, strategic counsel, and educational programs to advance the adoption of emerging technologies.

Ultimately, our goal is to help develop better treatments for patients by advancing the application, adoption, and innovation of applied drug delivery technologies.

Q: Who are the founding members of the executive board of the Catalent Institute, who are the advisory board members, and why were they chosen to help support the mission?

A: The Executive Board of the Catalent Institute was formed to facilitate its strategy and governance. The members include leaders from R&D, Strategy, Licensing, Marketing, and Corporate Development. We selected the members of the Advisory Board based on their broad expertise in drug delivery and experience in bringing pharmaceutical innovation to patients.

Founding members of the Board include me and some senior colleagues from the Catalent organization, including Dr. Cornell Stamoran, Vice President of Corporate Development and Strategy; Dr. Julien Meissonnier, R&D Platform Director; Terry Robinson, who is the Institute’s Executive Director; Akan Oton, Director of Business Development, Technology Licensing; and Elliott Berger, Vice President of Marketing and Strategy.

We also have an Advisory Board for the Institute, which is made up of our own R&D Director Dr. Craig Davies-Cutting, plus two relatively new recruits from outside the Catalent organization, Dr. Ralph Lipp and Prof. Claus-Michael Lehr, both of whom we are delighted to have on board.

Dr. Lipp is a well-known pharmaceutical industry executive and inventor who brings over 20 years of industry and academic experience to the Institute, having previously served as Vice President, Pharmaceutical Sciences R&D at Eli Lilly and Company, and in R&D leadership roles at Schering AG.

Prof. Lehr is a world-renowned scientist in drug delivery and a Professor of Pharmaceutical Science who is actively engaged in transdermal, pulmonary, and GI drug delivery innovation as head of the Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) Department of Drug Delivery (DDEL) at Saarland University in Germany.

We have also established a collaborative Key Opinion Leader network composed of leading academics from around the world to help bring diverse expertise to fulfilling our mission.

Q: How does this team plan to achieve their mission of promoting innovation, knowledge-sharing, and collaboration between industry leaders and academic experts?

A: Since the launch of the Institute in November 2012, our team has made great progress in connecting scientists from academia and industry through a number of key initiatives and programs.

First, we have begun rolling out a series of collaborative Global Symposia focused on real-world drug delivery challenges facing R&D teams today. Our initial events, which we held recently in New Jersey, and at the Royal Society of Chemistry’s London headquarters, featured speakers from Catalent, 3M, Bend

Research, BASF, Formac Pharmaceuticals, University of Bath and The New Jersey Institute of Technology were very successful and generated some great feedback. Together they attracted more than 150 registrants from major pharmaceutical companies and leading universities, with attendees ranging from Vice Presidents and Directors to Principal Scientists and Graduate Students.

We believe that expanding this program of educational days in both Europe and North America, for industry professionals and academia, is crucial to achieving the Institute’s objectives.

A further initiative we are employing is the publishing of educational resources and reference guides, such as our recent Oral Drug Delivery Guide, which has been extremely well received. The aim of the guide is to provide both academia and industry with an informative balance of underlying pharmaceutical sciences and insights from real-world product development experts. It covers key topics in oral drug delivery, including Predicting Drug Absorption, Solving Problems of API Degradation, Drug Delivery Technology Solutions, Criteria for Use, and Patient Population-Focused Drug Delivery Technology Strategies.

In addition to making these resources available for free download on the Institute’s website, we will be printing and distributing them at our own events and also at major industry tradeshows, such as the AAPS (The American Association of Pharmaceutical Scientists) and CPhI Annual Meetings.

Our Annual Drug Delivery Landscape Survey, is now in its second year and surveys formulation scientists involved with oral product development in pharmaceutical companies in the United States, Canada, and Europe to understand their key concerns on drug delivery issues.

We are constantly looking to expand our collaborations with leading drug delivery experts, associations, and foundations like AAPS, the Geriatric Medicines Society, Faster Cures, the APGI (Association de Pharmacie Galénique Industrielle), and also academic institutions, such as the New Jersey Institute of Technology and St. John’s University.

Another important initiative of the Institute is our annual Academic Competition for Future Life Science Leaders, where graduate students have the opportunity to win cash prizes and a one-year membership with the AAPS. Last year’s competition drew some exceptionally high-quality original review articles, addressing a wide range of topics, including drug development, delivery technologies, improving therapeutic profiles and bioavailability, preformulation, and pediatric drugs. This year, we are delighted to announce that the Catalent Institute plans to partner with AAPS to cosponsor the 3rd Annual Global Academic Competition and the submission site will be open later this fall in 2013. This partnership is important as it shows our joint commitment to raising awareness of drug delivery technologies as a means to improve patient care and our encouragement of the next generation of students to demonstrate their academic excellence, while creating real-world opportunities for continued advanced research and practical industry experience.

Finally, the Institute is currently focused on research efforts with clinicians to identify drug targets in need of optimization and understanding patients’ unmet needs in medication delivery. We are also establishing a consortium focused on Non-Invasive Macromolecules.

Q: You mention the Drug Delivery Landscape Survey, can you share a few highlights and findings?

A: It is a fact that a high percentage of poorly soluble compounds never reach human clinical studies. Better understanding of the chemistry of the drug, solubilizers, such as polymers, surfactants, and lipids, and the various salt/crystal forms can get more drug candidates through the preclinical testing phase. Our survey results confirmed this, and the two top problems identified by respondents when working with poorly soluble drugs were optimizing the drug-release profile (71% of respondents cited) and stability (66% cited). More than half (58%) the respondents cited difficulties in identifying excipients with optimal properties, while 49% identified excipient – API interactions as a concern. As expected, permeability and absorption in the gastrointestinal tract were also key issues.

In addition, a food effect was frequently encountered (93%) by respondents. A clinically significant food effect occurs frequently with poorly soluble drugs, resulting in more complicated dosage and administration instructions for the product. Drug delivery technologies that eliminate food effects, like lipid-based systems or amorphous mixtures, can eliminate it, simplifying the dosing instructions and improving ease of use for patients.

Lastly, many respondents rated many technologies as “good” (approx. 50%). However, for highly experienced formulators, particle engineering, amorphous mixtures, and lipid-based systems received top scores for excellent performance. A formulator’s experience and expertise with the right drug delivery tool kit can help successfully develop more products and better treatments.

Q: The Academic Competition is an interesting program to reach out to future scientists, can you tell us a little more?

A: Sure. The academic competition aims to identify emerging scientific talent, foster drug delivery education, and reward academic excellence. It also reflects the Institute’s commitment to fostering education, collaboration, and adoption of drug delivery technologies to develop better treatments for patients.

This year’s winners were chosen from leading US and European universities with graduate programs in pharmaceutical science, including St. John’s University, Rutgers University, New Jersey Institute of Technology, University of North Carolina at Chapel Hill, Purdue University, and Heinrich Heine University of Düsseldorf, Germany.

The 2012/13 grand prize of $5,000 was awarded to James Byrne of the University of North Carolina at Chapel Hill, whose winning submission focused on Treating Human Autoimmunity With Immunotherapy. His article provided a discussion of targeted immunotherapies and innovation in the form of a novel microneedle-based immunotherapy drug delivery technology strategy.

Additionally, each of the following students was awarded a first place prize of $2,000 for their thought-provoking submissions:

Shashank Jain, St. John’s University: Rationale for Selection of Solubility & Dissolution Enhancement Strategies focused on formulation strategies to improve solubility and dissolution of new APIs, including salt formation, co-crystals, particle size reduction, amorphous solids, solid dispersions, co-solvents, and pro-drugs.

Maxim Osipovs, Heinrich Heine University of Düsseldorf: Challenges for the Oral Delivery of Macromolecules provided commentary on the applications of dry polymer controlled-release drug delivery technologies on the particulate scale. The major insights of the article discuss enabling a broader range of controlled-release application to dose forms, such as film strips, solid oral dispersible tablets, and liquid oral suspensions.

Maxx Capece, New Jersey Institute of Technology (NJIT): Modified Release of Dry-Polymer Coated Active Pharmaceutical Ingredients discussed bioavailability as the main challenge in oral protein and peptide drug delivery and a number of strategies to overcome these challenges, mainly nanoparticulate, as this option has increased versatility and could present more opportunities for marketable formulations.

Q: Finally, how can the Institute help get better drugs to waiting patients?

A: At the core of the Institute’s vision is encouraging dialogue and depth of understanding of drug delivery technologies throughout industry and academia and bringing these parties together to provide optimal delivery solutions. We are taking a similar approach currently being used by universities, non-profit organizations, and industry to knock-down the collaboration and communication hurdles in translational medicine. Through collaboration, we aim to address key issues in drug delivery, such as solubility and bioavailability enhancement, to produce more efficacious drugs. By applying advanced drug delivery technologies to essential medicines, we have already witnessed significant value for patients globally.

By disseminating greater knowledge of existing delivery technologies, and creating novel technologies through collaboration, we aim to provide a significant contribution in bringing the next generation of important and effective medicines to patients more quickly.