September 15, 2017 PAP-Q3-17-RT-001
Ashleigh Wake, Director of Biological Services, Intertek Pharmaceutical Services
A: Success in international markets is fundamental to the progression and growth of our pharmaceutical business. This demographic is driven by the geography of the market itself, in terms of current global pharmaceutical consumption and predicted regional growth, as well as the regulatory requirement for regional testing to support global and local product registration.
Key to driving this success across multiple international locations are the partnerships we develop with internationally based clients and sponsors, where communication is critical to a successful project.
We also value international relationships inside our Intertek team encompassing globally located project teams and experts. In terms of our customer and supply base, we are increasingly supplying solutions to global clients and sourcing equipment or materials from international partners as we look for innovative approaches to meet the growing analytical challenges and increasing regulatory requirements that are encountered by our clients who are developing evermore complex products.
Kai Sievert, Director Global Marketing, BASF Pharma Solutions
A: Ever-increasing pressure on healthcare cost, a prevalent patent cliff, disharmonization of regulatory systems, increasing insolubility of new APIs, growing importance of generic and emerging market trends, etc. — the pharmaceutical industry is facing a variety of major challenges. We at BASF acknowledge the responsibility, which the pharmaceutical industry holds in curing and keeping a growing and aging population healthy. Therefore, working together across value chain steps and company borders gains more and more importance to develop reliable, sustainable and risk-mitigated solutions in a cost-effective and fast way. BASF has a long and successful history of actively partnering across company borders. An example is BASF’s multi-level cooperation with Catalent. On the one hand, in the field of omega-3 fatty acid, Catalent offers custom encapsulation of the purest, high-quality molecules with best-in-class oxidation stability. On the other hand, the development of new, more effective and patient-compliant dosage forms for pharmaceutical and nutritional use is part of joint developments. BASF helps to develop solutions that support Catalent’s goals to bring high-performance, cutting-edge products cost-efficiently to the market. International and domestic partnership will remain more than ever a key to the success of this industry.
Erik Haeffler, Vice President, Manufacturing Services, Head of CSR, Recipharm
A: Working with an aim to foster strong partnerships with suppliers, service providers and other business parties makes it possible to standardize concepts and simplify the set-up and implementation of global projects.
One key example for Recipharm is our global project in implementing the new regulatory requirements for product integrity and serialization. This is a large project, extending over 15 locations and including installations on close to 100 packing lines. Here we have chosen to run the project globally and work with single partners for machine equipment and software solutions. This has clearly helped to deliver project objectives and has made it possible to work both faster and in a more cost-efficient way. For example, when setting up a user requirement specification for machine equipment, only one standard document has been required, with just a few exceptions. The project is very clear for people working internally, but it has also shown benefits when presenting the project to customers. Serialization requires a lot of engagement with our customers and, by having a standardized approach, partnering with our suppliers; it makes the whole customer interface a lot more efficient.
A: International partnerships and collaborations are certainly critical for the success of Almac. Our customers are worldwide, with our business more or less evenly split between Europe, North America and Asia. Our suppliers are worldwide also. As an example, we are managing a diverse biocatalysis business that uses enzymes developed at Almac to produce multi-tons of chiral building blocks, complex advanced intermediates and APIs. These projects require both a supply of raw materials delivered to Ireland and REACH compliance. We have built an audited and reliable network of partners throughout continental Europe and in India for supply of raw materials and for manufacture of early synthesis steps. A recent project involved a six-step process including an evolved lipase enzyme. To meet customer timelines and to utilize Almac reactor capacity most efficiently, the first step of the process was tech transferred to our Indian partner. An Almac chemist went to India to ensure the process was tech transferred seamlessly and the Step 1 product was delivered to Ireland, where it was then forward processed. This business model of using an evolved enzyme developed at Almac combined with manufacturing in India, Ireland and the UK provides our customers compelling economics for chiral building block and API supply.
A: In order to constantly serve its clients better and meet their ever-evolving needs, SGS Clinical Research has set up R&D partnership agreements with hospitals across Europe to enable access to relevant patient populations and therapeutic expertise. Under these agreements, dedicated clinical pharmacology units are established within a hospital’s facility to conduct phase I inpatient clinical trials, which are undertaken by a permanent dedicated on-site SGS team. This team works in close collaboration with hospital physicians, trial experts and investigators to ensure solid patient recruitment capacity and rapid subject enrollment, and maintain high-quality data collection and on-time study delivery. These partnerships are beneficial in keeping the “partner hospitals” at the cutting edge of applied R&D, enabling their staff to gain greater expertise in early phase clinical trials, but most importantly, patients benefit by having access to new therapeutic solutions as early as possible.
A: For Polpharma Biologics, international partnerships are key to building up our own capacities in development and production, and to becoming visible within the contract development and production arena. In our industrial set-up, we are working with internationally recognized engineering companies, which not only have the knowledge to construct state-of-the-art and efficient production platforms, but are also aware of regulatory framework requirements. Our core target markets are EMA, FDA and PMDA regulated territories. With this knowledge, we are able to provide tailor-made solutions to fully satisfy the needs of the market and the regulators. Our presence is already a pan-European one, with subsidiaries in Poland, the Netherlands and Germany. We have established a global network for work on our global clinical trials programs that connects with potential codevelopment partners and with customers interested in our one-stop-shop offering: from cell line development through production of clinical trials material and large-scale production for drug substance, as well as formulated drug product.
A: As a provider of medicines that are destined to over 100 countries around the world, it is clear we increasingly operate in a global pharmaceutical market. While drug development has been traditionally concentrated in North America and Europe, emerging markets have grown considerably in recent years, particularly for commercial medicines. This has certainly changed the scope of our operations. Similarly, clinical investigational studies are increasingly global in nature; we rely on expert logistical partners around the world to get clinical materials to investigational sites reliably and safely. From a plant and manufacturing perspective, we have been fortunate to be supported by excellent world class and yet localized material suppliers, alternatively supported by more global equipment manufacturers who are largely concentrated in regional centers of excellence, including geographies such as Europe, often Germany and Italy, with companies such as Bosch, GEA and Gerteis in drug manufacturing and Uhlmann, IMA and Marchesini in packaging. We also see excellent companies thriving in the US, companies such as Micron Pharmaworks, MGS and many others. With the advent of serialization as a market requirement, we have been very fortunate to partner with Italian companies Antares Vision and Marchesini as we rapidly expand our global capacity in advance of the November deadline.
A: SSCI provides best-in-class solid-state and analytical services for over 250 global clients annually that are engaged in developing new life-saving medicines and require release testing of commercial product. Given the global registration strategy of these products, our laboratory is regularly audited by various regulatory authorities and has maintained an exemplary record of regulatory compliance with current Good Manufacturing Practices (cGMP).
Over the past quarter century, our reputation has been built on providing exceptional customer service and the highest- quality data. To maintain this standard, SSCI has sought leading multinational vendors, including Malvern (United Kingdom), Mettler Toledo (Switzerland), PANalytical B.V. (Netherlands) and Rigaku Corporation (Japan), that share these same core values. We value vendors that are truly committed to the design and support of their technologies over its service life cycle, which allows us to provide a consistent and reliable service offering. In cases where analytical methods are transferred to other testing laboratories, there is additional confidence gained in working with multinational vendors that maintain the technology at the receiving laboratory to the same high standard. Use of these technologies in a cGMP environment, and the heightened expectation on software and data integrity by global regulatory authorities, make the collaborations with our existing vendors and the selection of new vendors even more important.
A: Collaboration and partnership are key to business success, regardless of the industry. Companies pursue international strategic partnerships since they consider it will lead to synergy and, therefore, economic benefits. It is an important strategy that offers benefits without adding costs.
For example, in a partnership between a pharma company and a CRO, some of these benefits are:
A: The development path for University College London’s (UCL) magacizumab highlights Abzena’s integrated offering that enables its partner to progress from discovery to manufacturing utilizing Abzena’s international capabilities across its sites in the UK and US. UCL supplied a novel sequence for an antibody therapeutic candidate, magacizumab, for the treatment of neovascular age-related macular degeneration. Starting in Cambridge, UK, Abzena’s protein engineering group utilized Composite Human Antibody Technology™ to generate antibody sequences devoid of significant T-cell epitopes. Abzena’s cell line development group then cloned the optimized lead variant sequence into a vector system and transfected it into Abzena’s Composite CHO™ cell line. Research cell banks of the best performing cell lines were then assessed for use in bioreactors to identify the best cell line to move forward to Abzena’s San Diego cGMP manufacturing facility. The qualified candidate research cell bank of the highest producing cell line is currently in the process of being used to produce a GMP Master Cell Bank ready for cGMP manufacturing. Abzena’s integrated platform allows customers to accelerate and de-risk their development process by allowing manufacturing expertise to feed into early product development to address any manufacturing concerns and select the best cell line for production in their facility early on.
A: Today’s challenges in the industry are as complex and daunting as ever. Perhaps it’s speed to market for a new product candidate, operations and quality management of an existing facility in the face of downward pressure on its cost of goods, implementation of first-in-kind technologies and approaches without a precedent of regulatory approval, or loss of skilled resources to the robust labor market and baby boomer retirement.
Whether it’s a long-term relationship with a core client, a strategic alliance with a trusted service provider or a turnkey engagement with a proven vendor, partnerships have frequently provided compelling, value-added solutions to the industry’s problem statements and associated project opportunities.
With partnerships come shared successes and risks, which begs the question of who makes a good partner. From experience, good partnerships are about alignment of core values and culture, a shared vision for the desired outcomes, an agreed-upon means to measure progress and a value proposition whose worth is greater than the sum of its parts, to name a few. Furthermore, identifying the “best” partner(s) requires a constant understanding and pulse of the ever-dynamic marketplace.
A: Charles Darwin may have said it best: “Those who learned to collaborate and improvise most effectively have prevailed.” Partnerships are more easily formed and can effectively multiply talent, versus adding capabilities through development or acquisition, making them critical to responding quickly to changing markets and efficiently delivering “best in class” customer solutions.
SP Scientific has earned a reputation for line of sight scale-up in freeze drying technology and equipment, and partnerships with thought leaders and those with complementary technologies such as TDLAS have been instrumental to our success. For large projects such as new pharmaceutical production lines, the ability to work collaboratively is imperative and usually assumed. SP often works with companies such as engineering firms who are integrating equipment from a number of suppliers to deliver a turnkey customer solution. SP’s aseptic processing equipment portfolio allows us to deliver key elements, such as the sterile fill and finish capability, while other partners may provide isolators or bioreactors for production of a biological drug that are not currently within our portfolio.
A: International Partnerships are of the utmost importance for Grifols Partnership, mainly because these partnerships offer us a global understanding of the CDMO market, which is where we are focused, and consequently help us to provide the best service or solution for any request.
Identifying the right provider, supplier or firm is a critical factor to success. It is equally important to take the time to understand what each partner wants from the partnership. All companies receive approaches from prospective partners, and while this may lead to a positive and mutually beneficial relationship, it is also important to be proactive and identify your own preferred partners. As Grifols Partnership operates mainly at the international level, working with international suppliers allows us to be more agile, and accelerate time-to-market especially regarding a regulatory standpoint. Partnerships also help us accomplish international quality accreditations.
Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.
.svg)
