Pharmaceutical Processing created a questionnaire to learn more about Catalent Pharma Solutions, their technologies, and some of the upcoming trends they are seeing in the industry. Catalent is an exhibitor at INTERPHEX 2016. Elliott Berger, VP Global Marketing & Strategy at Catalent, answers our questions.
Below are the edited responses to this exclusive Q&A.
Q: Tell us a little bit about your company—what do you do and what are some of the areas that you specifically excel in?
Berger: Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,700 people, including over 1,000 scientists, at 31 facilities across five continents, and in fiscal 2015 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J.
Q: What don’t most people realize about your company?
Berger: Because of the company’s extensive capabilities, many don’t recognize our deep expertise in product development. We help our customers take products to market faster, including nearly half of new drug products approved by the FDA in the last decade. Some of our brands often ‘steal the limelight,’ such as Zydis® orally disintegrating tablets and RP Scherer softgel technologies. It’s not always the case that we are recognized for the multiple touch points we have either, from pre-clinical assessment and optimization of molecules and formulations to match drug delivery technologies for pre-clinical testing, to comparator sourcing, clinical supply, and an array of drug delivery technologies, including proprietary technologies, in biologics, inhalation, parenterals, and (of course) oral drug delivery.
Q: What is one of the biggest successes of your company?
Berger: We’re very proud to be a trusted supplier of the drugs, biologics, and consumer health products that help people live longer, healthier lives. We have longstanding, extensive relationships with leading pharmaceutical and biotechnology customers. In fiscal 2015, we did business with 82 of the top 100 branded drug marketers, 19 of the top 20 generics marketers, 40 of the top 50 biologics marketers, and 23 of the top 25 consumer health marketers globally, as well as with nearly 1,000 other customers, including emerging and specialty companies, which are often more reliant on outside partners as a result of their more virtual business models.
Our team of over 1,000 talented scientists has supported nearly half of innovative drug and biologic approvals since 2005, and we have more than 500 active development programs for new customer products. We have 20 R&D teams in 10 countries to help develop better treatments and from over 30 global sites. Catalent serves over 1,000 customers and supplies around 70 billion doses annually.
Our significant intellectual property includes over 1,400 patents and patent applications.
Q: What are some of the biggest challenges in your industry?
Berger: One of the key challenges in our industry is the increasingly complex molecules coming through development pipelines. These potential treatments are challenging in terms of formulation, optimizing bioavailability, and their therapeutic delivery profiles, as well as in terms of developing differentiated treatments that are not only effective for patients, but appreciated by doctors and purchasers.
Q: What is one of the biggest areas of growth your industry has seen in recent years?
Berger: A decade ago, the world’s top 10 selling medicines were all small molecules. In 2014, just half of the ten biggest sellers were small molecules, with four monoclonal antibodies and a modified form of insulin.
With drugs for the ‘easier’ targets available and many now adequately served with generic medicines, pharma and biotech companies have become more creative. Biologics have become an important part of the fight against disease, and the challenges facing the medicines market are how to make safer, more efficacious drugs, exploring innovative combination therapies, and developing more efficient manufacturing processes. Antibody–drug conjugates (ADCs) are one example of how combining a biologic’s targeting mechanism action with the potency of a chemotherapeutic toxin can have significant benefits.
Q: Where do you see the industry going in the next 10 years? Your area of expertise?
Berger: Globally, the pharma industry is still fragmented and continues to consolidate, so we would expect the pharma services sector to do the same. There is increased demand for specialized outsourced services, including global solutions as well as customized and full service options. We have seen an increase in the demand for complex products requiring drug delivery expertise as well as specialty handling services including scheduled storage, cold chain logistics, and handling of DEA-licensed drugs and potent and cytotoxic compounds.
We continue to respond to the industry’s increasing demand for a full service partner across the product life cycle to save our clients making costly investments, allowing them to focus on bringing their products to market faster. We have invested significantly in differentiated technologies such as SMARTag™ ADC for next generation bioconjugates and GPEx® for high-titer vector for stable cell lines, antibody combination therapy, latest analytical technologies, and process development for biologics. Another example of R&D investment is our award winning OptiShell® softgel technology that allows for high-temperature encapsulation of semi-solid fill material within a non-gelatin, plant-based shell.
Q: What would you consider to be a major achievement for the industry in the near future?
Berger: The industry needs to bring more and better drugs to market that have a genuine impact on patient health for both prevalent and rare diseases, with improved drug delivery technologies key to accelerating this process.
Q: Will you be exhibiting any new products at the show? If so, tell us about them!
Berger: Alongside our expansions in consumer health and biologics, we will be introducing our fixed price OptiForm® Solution Suite to the INTERPHEX attendees for the first time. This platform integrates superior technologies to match the best, most innovative, drug delivery technologies to each developmental molecule, with the goal of providing optimal animal PK materials in just twelve weeks.
Q: What are you most looking forward to at INTERPHEX this year?
Berger: INTERPHEX is always a great place to network with existing and potential customers as well seeking out innovative technologies and partnering opportunities.
Pharmaceutical Processing is a platinum sponsor of INTERPHEX.
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