A New Industry for Leaders of Outsourced Services and Customers
As the pharmaceutical industry undergoes unprecedented levels of change, there are significant opportunities for the development and formulation of breakthrough medicines that can dramatically improve patient lives. To convert those opportunities into successful new drug products, however, numerous obstacles have yet to be overcome.
There is a real need in the industry for innovative dialogue and content around these issues that can drive toward practical and effective solutions. Conventional trade shows and conferences do not create an environment and atmosphere that can truly foster deep communication. To meet this need, That’s Nice has created Nice Symposium, an event designed to bring together pharmaceutical professionals from all stages of the drug commercialization cycle (discovery, development, formulation, manufacturing and packaging) so they can learn about and exchange technical knowledge with like-minded and innovative peers and supplier partners.
The first Nice Symposium event is tentatively scheduled for January 31 and February 1, 2017 in Durham, North Carolina and will focus on the challenges associated with oral solid dose formulation. The novel format, which includes a nontraditional open floor plan, is ideally suited for the refurbished American Tobacco Company complex, a unique venue that is itself a new resource in Durham, close to Research Triangle Park and easily accessible.
Oral Solid Dose Formulation Challenges
Oral delivery, when possible, is the preferred route of administration because it is the easiest method for patients and has the highest compliance rates. Oral formulations also tend to be the least costly, and there are many different dosage form options (tablets, capsules, gels, liquids, etc.).1 As a result, oral solid dose forms are attractive not only for new drug candidates, but the reformulation of existing products to extend patent protection or introduce improved generic versions.
Advances in combinatorial chemistry and highthroughput screening (HTS) technologies, while allowing the rapid synthesis of vast numbers of new potential drug candidates, have also resulted in the identification of candidates with promising mechanisms of action but that suffer from poor solubility and bioavailability. These active ingredients present significant formulation challenges and are driving the development of new techniques related to particle manipulation, hot-melt extrusion (HME), spray drying, co-crystal formation and the use of lipidic vehicles.1
Many new chemical entities (NCEs) are also highly potent — approximately 25% of drugs on the market today are formulated with HPAPIs, and the overall HPAPI market is predicted to be growing at around 10%/year.2 These compounds, many of which are solids, require special handling (facilities, equipment, procedures, training) to protect workers and the environment from unintended exposure. They also often are formulated at very low dosages that require specialized formulation technologies to ensure uniform incorporation into the solid drug product.3
Growing Interest In Outsourcing
In 2016, the contract manufacturing market size for solid dosage forms is anticipated to be $24.5B;4 the propensity to outsource oral solid dosage forms continues to grow modestly. Nice Insight’s 2016 CDMO Outsourcing Survey results indicated that for small-molecule drug substance services, small-molecule API commercial scale manufacturing was more popular than large-molecule API commercial scale manufacturing, at 33% and 30%, respectively.5 Similarly, for small-molecule drug product services, 76% of respondents indicated that they outsourced their drug product solid dose manufacturing (clinical scale) and 65% indicated they outsourced their drug product solid dose manufacturing (commercial scale).5 Both were higher compared to outsourcing of drug product semi-solid and liquid dose manufacturing (62% for clinical and 60% at commercial scale).5
Tackling Tough Topics
The first Nice Symposium event will tackle the tough issues associated with oral solid dosage formulation, including overcoming poor solubility and bioavailability, working with high-potency compounds, selecting appropriate excipients, coating design and application and meeting the needs of different patient populations.
Other topics that will be addressed include managing clinical trials, improving manufacturing efficiency and productivity, overcoming logistics challenges, and regulatory compliance. Tableting and encapsulation, release control, inhalation and other technologies will be covered. Effective brand/ product control, patient efficacy, supply chain transparency, fraudulent/counterfeit medicines and lifecycle management will also be raised.
Six panels comprising supplier companies and their invited customers will focus on the following topics:
- The Composition and Functioning of the Oral Solid Dose Supply Chain
- Worldwide Demand at All Stages in the Oral Solid Dose Supply Chain
- Capsule Technology and Patient Adherence
- Outsourcing Challenges and Opportunities, Including Sponsor Needs, Partner Models and Project Management Approaches
- Counterfeiting and Meeting Serialization Requirements
- Collaboration Across the Entire Oral Dose Supply Chain – Best Practices
NonTraditional Industry Event
In addition to the panel discussion designed to incorporate perspectives of all sides of supplier-customer partnerships, the nontraditional open floor plan of the venue is designed to encourage increased interaction and engagement between all attendees involved in oral solid dosage delivery from clinical to commercial, including sourcing, manufacturing, quality and executive leaders of API and excipient suppliers, processing and packaging equipment manufacturers and large-to-emerging (bio)pharmaceutical companies.
Event sponsors each have their own “value stations,” or unique configurations of kiosks, tables and chairs with lounge areas and flat screens. Sponsors also receive a 15-minute presentation slot and custom invitations to the event for their top customers and prospects, who are also invited to participate on the panels (invited attendees pay no entrance fee). They also have the opportunity for a one-on-one interview with an editor of Pharma’s Almanac that will be featured on www.PharmasAlmanac.com for one month, published in a special chalsection of the hard copy of Pharma’s Almanac (on- and offline distribution of 97,000) and available as a PDF for the sponsor’s own use.
Several networking and partnership opportunities will be provided over the two-day event, including breakfast and lunches on both days and a dinner and social mixer on the first night. All meals are included. Participants will also have the opportunity to provide direct feedback on their experience at the first Nice Symposium, including valuable learning, as well as areas for improvement.
After the show, sponsors will also be provided with a contact list of all customer and peer participants and a Workshop Report on oral solid dosage formulation, including an exclusive “first look” at the Nice Insight Annual Survey results for Top CDMOs in OSD.
Energizing And Supportive
The new Nice Symposium offers pharmaceutical professionals a place to come together to discuss important issues facing the industry in an energizing format designed to facilitate communication and in-depth knowledge sharing. It is also designed to support the growing importance of preferred partnerships between suppliers and their customers, whether contract service providers and drug innovators or equipment suppliers and generics manufacturers.
For more information
Contact Nigel Walker at +1 212 366 4455 or [email protected]
References
- Tiene, Guy. “Formulation Challenges Driving Interest in CDMOs.” Manufacturing Chemist.13 Jan. 2016. Web.
- HPAPIs and Cytotoxic Drugs Manufacturing Market (2nd Edition), 2016 – 2026. Rep. Roots Analysis. 9 Mar. 2016. Web.
- Tiene, Guy. “Targeted, Highly Potent Therapies: Big Growth Driver for the CDMO Market.” Speciality Chemicals. Aug. 2016. Web.
- Manufacturing of Solid Dosage Forms – Transformation in Manufacturing Concepts and Expanding Contract Manufacturers’ Production Capacity May Force Regulatory Bodies to Re-Design Guidelines on Quality Standards. Rep. Research and Markets. Feb. 2011. Web.
- The 2016 Nice Insight Contract Development & Manufacturing Survey.