Issue:July/August 2015
INDUSTRY PERSPECTIVES - The Future of the Pharma & Biotech Industries: Your Colleague’s Perspectives
Drug Development & Delivery’s Global Formulation Report in this issue has provided some notable facts, figures, and comments on what has been happening in the industry in a number of key sectors these past 18 months. As such, we thought it would be intriguing for our readers to hear what some of your colleagues believe will have a significant impact on the pharmaceutical and biotechnology industries throughout the next 5 to 10 years. We allowed the participants only a brief comment or two, and as expected, the responses were varied and thought-provoking.
“CDMOs of the future will have in-house drug substance and active pharmaceutical ingredient (API) manufacturing capability, drug product development, and commercial manufacturing capability of small molecule, large molecule, and biologics in a variety of dosage forms. APIs can be developed with improved properties for the drug product manufacturing, reducing the time required for formulating drugs in a suitable delivery system. There also will be a consolidation of the drug and device industry, which will prove beneficial when better devices to deliver dugs can be screened in the preclinical and early clinical phase of drug development. Understanding the site of efficacy in NCEs, the optimum site of absorption to better target delivery, and the use of better devices to deliver drugs will enhance success in drug delivery by reducing patient-to-patient variability and ensuring drugs are delivered to the target site to elicit clinical efficacy.” – Anil Kane, PhD, Executive Director, Global Head of Formulations, Pharmaceutical Development Services, Patheon
“As the economy has recovered, we seem to have come full circle and are now back to the point at which speed is the most critical factor in developing formulations. For a period of time, keeping costs down was the most important factor even if things took longer to get done. Now, formulators are being pressed to do more with less. In the early formulation development work, API is very precious and in a lot of cases, available amounts for formulation work are minimal. Companies that will be the most successful will be the ones that have the expertise to develop formulations with as little API as possible and will accomplish the formulation development work utilizing the principles of Quality-by-Design. In the next decade, it will be a necessity for formulations that are submitted in regulatory filings to be the product of a process that follows Quality-by-Design. It will no longer be a ‘nice to have,’ it will be a requirement.” – Paul Skultety, PhD, Vice President, Pharmaceutical Development Services, Xcelience
“One of the leading sources of drug candidate failures will be due to unsuitable GMP ingredients that are part of the final dosage formulations. With the high cost of development and delivery, the Pharmaceutical industry should rely more on their Excipient and API manufacturers to ensure the products being supplied are suitable for their intended end use to accomplish their desired development outcomes.”– Tom Donnelly, Director of Sales & Marketing, BioSpectra
“Fixed dose combinations (FDCs) will have a significant impact in multiple dosage forms throughout the next several years. The US Food and Drug Administration recently issued new guidance giving some additional exclusivity for filings with at least one new drug in the FDC product. A ‘new’ drug could mean either an NCE (New Chemical Entity) or a different dose of a previously approved drug, and such exclusivity offers market appeal for drug sponsors. At the same time, FDC products also appeal to patients because they provide a convenient and compliant means of dosing two drugs often taken together.”– Brad Gold, PhD, Vice President of Pharmaceutical Development, Metrics Contract Services
“We are living in the era of transformation. Formulations using ‘nanoparticles’ as a part of targeted drug delivery are expected to enter the market in the next 5 to 10 years. Nanoparticles can help in the controlled release of a drug, and may also deliver two different types of drugs at the same time, to give a stronger combination therapy, thereby increasing the efficacy of the drug.”– Dr. Siddharth Dutta, Frost & Sullivan Life Sciences & Healthcare Industry Manager
“The trend in the industry today is compatibility of both the active ingredients of a drug as well as its method of administration, ie, it must be ‘patient friendly.’ This is a direct reflection of a rapidly aging population and the rise in the home healthcare sector. In order to control costs and avoid cost-intensive therapies in a hospital or doctor’s office setting, there is pressure to develop medicines that will enable more procedures in a private setting such as the home. Additionally, there is a rapid rise in therapies focused on conditions with small patient populations. These therapies, often ‘Orphan Drugs,’ are by US definition, drugs developed for treating conditions affecting fewer than 200,000 persons.”– Claudia Roth, Vice President, Innovation Management, Vetter Pharma International
“High-throughput solubility screening along with advanced thermodynamic modeling can help predict the solubility behavior of APIs. This creates an opportunity to perform dosage form selection in the early phases of drug development.” – Irena McGuffy, MS, PharmD, Director, Formulations Development, Catalent Pharma Solutions
“The advent of personalized healthcare, the desire to control healthcare costs, and the intelligence and curiosity of the patient population will collectively have the most dominant impact on the pharmaceutical and biotechnology industry in the coming years. This will result in the need for the industry to trend toward the design and development of smarter and more flexible medical products. The scaling of these products will require specialized platforms, including a synergistic overlay of more selective chemical matter, sophisticated diagnostics, specialized delivery devices, and targeted formulation platforms and dosage forms, which include novel functional excipient materials.”– David Vodak, Vice President, Bend Research, a division of Capsugel Dosage Form Solutions
“Today many of the top-selling drugs as well as the majority of drugs in development are biologics based. In parallel to this development, Drug Delivery (DD) and Formulation will continue to evolve throughout the next decade to better meet the needs of patients and clinicians for such drugs. This suggests we will see continuing improvements and refinements in patient-friendly injection device designs and configurations that could handle larger volume formats and as well as viscous drug formulations through subcutaneous injection. Many of these future drugs will be marketed with compliance tracking solutions and incorporate such patient-friendly technologies right from the beginning. Within the next decade, advancements will also include formulation and delivery device solutions for targeted delivery by both local as well as systemic administration.”– Tugrul Kararli, PhD, MBA, President & Founder, PharmaCircle
“I believe that the ability to conveniently administer drug subcutaneously with a programmable dose profile will fundamentally alter the trajectory of drug formulation, enabling companies to move from discovery into development faster, and increasing the probability of success in a clinical program.”– Michael Graffeo, Vice President, Business Development, Drug Delivery, Insulet Corporation
“Future innovation should be centered around improving patient outcomes by enhancing formulation and delivery technologies. For example, New Therapeutic Entities (NTEs) offer a huge upside, but for patients to see the benefits in access and cost efficiency, formulators need a clearer path to regulatory approval to spur innovation. By streamlining these guidelines, we can combine existing molecules with ‘smart’ delivery technologies and achieve the primary goal of patient compliance and improved health.”– Cindy R. Kent, MBA, VP & General Manager, 3M DDS
“Significant reduction in drug development timelines are predicted thanks to the emergence of in silico/computational models that analyze drug solubility, dispensability, and compatibility in one or more excipient systems; in vitro analytical models that predict bioavailability better; improved understanding of the transporter-mediated absorption; and elucidation of the biopharmaceutical role of excipients in drug delivery. Solid dispersion and continuous manufacturing technologies will be taking center stage, but the biggest, perhaps the most revolutionary change will result from shifting paradigms that demand rethinking of how drugs are selected and ultimately developed.”– Jasmine Musakhanian, Scientific & Marketing Director, Pharmaceutical Division, Gattefossé USA
“I believe we will see new excipients designed and engineered for specific delivery purposes as well as more “intelligent” device-mediated drug delivery technologies. Dow recently announced the launch of new HPMC polymers called Affinisol that were designed and engineered for hot melt extrusion applications, specifically for solid dispersions of poorly soluble drugs. Additionally, there are several companies developing devices that can provide real-time feedback to monitor a condition, control and regulate drug release, or respond to a biomarker.”– Michael Crowley, President, Theridian Technologies, LLC
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