DRUG    DELIVERY20/20 Pharma
case studies                JiM VaUghan, Vice President and general Manager of 3m Drug Delivery Systems Division,         ...
case studies                                                                                                              ...
case studies                “a kEy aDVanTagE oF 3m’S miCro   4                  rEPLiCaTED SySTEm iS ThaT wE              ...
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Drug delivery

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Jim VaUghan, Vice President and General Manager of 3m Drug Delivery Systems ivision,
discusses some of the manufacturing challenges in the life-cycle of a product and bringing a new product to market.

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Drug delivery

  1. 1. DRUG DELIVERY20/20 Pharma
  2. 2. case studies JiM VaUghan, Vice President and general Manager of 3m Drug Delivery Systems Division, discusses some of the manufacturing challenges in the life-cycle of a product and bringing a new 2 product to marketManufacturing Ph: What delivery options does 3M Drug De- body. additionally, we have developed a hollow pharmaceutical firms in emerging markets, helping livery Systems currently offer, and what are the microstructured transdermal system that allows liq- them develop their drugs into our dosage forms. key advantages and applications of each? uid forms of these drugs to be delivered, which will We are seeing many new small, research-driven JV: 3M’s chief drug delivery technologies are in further expand the range of medications that can pharmaceutical companies, particularly in asia, the areas of inhalation and transdermal delivery. be delivered transdermally, which is a very exciting thanks to the increasing level of scientific talent inhalation drug delivery is very popular for the innovation. Those are the two main areas in drug outside of america and the u.K., and we consider treatment of conditions such as asthma, chronic delivery systems that we focus on at 3M. these companies to be important partners in our Obstructive Pulmonary disease, and other diseases offerings to new markets. We can also provide assis- of the respiratory tract. 3M has a history of over 50 Ph: Emerging markets are presenting im- tance with navigating regulatory requirements as years in the inhalation category, and our contribu- portant opportunities in the pharmaceutical larger firms look to expand into new territories, as tions include the development of the first metered- industry. What is 3M doing to position itself in well as provide manufacturing services to produce dose inhaler and the first cfc- free propellant this area? the large volumes necessary to help companies pressurized Metered-dose inhaler, autohaler, and JV: 3M, as you know, is a big multinational firm; meet the demand for their products. some novel valves and adaptors that we have to we are in many countries. as the world gets smaller offer to our customers. and countries are generating more wealth, emerg- Ph: Bringing a new product to market involves as we know, inhalation has fundamental ing markets are investing more in helping people significant work beyond pairing the drug and advantages for respiratory diseases, due to the fact have healthier, and hopefully longer, lives. This is the delivery system. Manufacturing is a signifi- that it is target-specific. drugs that are adminis- important to drug delivery systems, because un- cant challenge as well. What additional services tered by inhalation minimize systemic absorption fortunately with industrialization comes pollution, does 3M offer to customers, and how can out- and adverse effects compared with drugs that must bringing with it an increase in disease states. Our sourcing those services benefit companies? travel through the gastrointestinal tract. inhala- delivery systems help relieve those disease states JV: Most people are familiar with tablets and cap- tion is a growing market and it continues to evolve with the right drugs, allowing people to have a bet- sules, and those are the predominant dosage forms and expand to larger molecules, such as proteins ter quality of life. for delivering drugs that we know today. Because and peptides. We believe that inhalation has the These systems include inhalers for asthma of that, many pharmaceutical companies already potential to become the delivery route of choice and chronic Obstructive Pulmonary disease, have the equipment to manufacture those dosage for a wide variety of therapies, for both local and along with the transdermal delivery systems for a forms. However, when a company finds a drug systemic drug delivery. variety of molecules. These platforms enable ef- that is good for respiratory treatment—chronic applications for transdermal therapies are ficient administration of drugs to treat some of the Obstructive Pulmonary disease or allergies, and so expanding rapidly. 3M has been in the “sticky- most common diseases that arise with increasing on — and they believe that the best way to deliver stuff ” within the transdermal area for over 30 years industrialization. additionally, they also enable fast the drug is through the lungs using either dry — both in the formulation and development, as delivery of vaccines, an important component of powder inhalation or metered-dose inhalers, many well as expertise in films and adhesives. currently improving public health in emerging markets. firms do not have that infrastructure, equipment we offer transdermal systems and components for an important consideration when developing or knowledge to manufacture those dosage forms. small molecules, proteins or peptides. drugs for emerging markets is the issue of trans- This is where 3M can help. We have a reach and the transdermal delivery has a number of advan portation and storage. a key advantage of 3M’s ability to produce for our customers’ needs, with tages over other routes of administration, includ- micro replicated system is that we have seen sev- facilities to manufacture inhalers in the u.s., the ing its ability to avoid the first-pass metabolic eral molecules that we can manufacture and then u.K. and south america. additionally, we have the effects of the liver. it also provides steady, sus- dry onto the microneedles in such a manner that capability of developing those dosage forms in our tained release of the drug, and helps ensure the drug doesn’t require cold storage. if you can laboratories in singapore, the u.s. and the u.K. compliance. 3M has developed a method of solid eliminate the need for cold storage, the distribu- 3M’s inhalation manufacturing capabili- microstructuredtransdermalsystemmicroneedle tion and access to that drug or that dosage form can ties include both pressure-fill and cold-fill for delivery that expands the range of medications that be widened quickly, because it can be distributed a metered-dose inhaler manufacturing, and we can can be delivered transdermally to patients, using lot faster, and less expensively. also provide custom micronizing or particle size re- biocompatible, polymeric microneedles to bypass On top of our dosage platforms, 3M has manu- duction to obtain particles in the respirable range. the barrier properties of the stratum corneum facturing and research and development facilities additionally, we have filling capabilities for projects and deliver previously undeliverable molecules, in most regions around the world, and we have just in sizes ranging from clinical to commercial supply. including vaccines, proteins and peptides into the opened a brand new laboratory in singapore. These 3M is one of the only Mdi component suppliers to locations give us the ability to work with many manufacture both valves and canisters, so we can 20/20 Pharma
  3. 3. case studies 3 Manufacturingoptimize these components simultaneously with customize and meet their requirements. in addition pharmaceutical firm partners the greatest value inthe convenience of a single source, which helps to manufacturing, we offer services including contract manufacturing services.ensure their compatibility. analytical work, regulatory help and compilation of Likewise with transdermal delivery, 3M offers documents for submission to get a drug approved. Ph: Life cycle management is an importantmanufacturing services for the transdermal sys- We offer a full spectrum of services to assist our part of the pharmaceutical business. how doestems and components, which include backings, customers in getting their drugs registered and 3M work with customers to address life cyclemembranes, liners and tapes. We are able to assist ready for approval, distribution and sales. We use management needs?with transdermal manufacturing needs, includ- this partnership approach to help assure a smooth JV: as we know, the continuing increase in prod-ing aqueous and solvent coating, converting and process from start to finish, which can help im- uct development costs means pharmaceuticalpackaging. as with inhalation, our transdermal prove a product’s chances for success. companies are under increasing pressure to findmanufacturing facilities are capable of handling Manufacturing is a service at which we are ways to increase revenues from existing marketedcapacities ranging from lab scale, pilot scale or well-practiced. 3M is very experience in manu- fac- products, and also to ensure protection from salescommercial scale. We have an extensive array of turing thousands of products for sale in more than erosion after the launch of generic equivalents.scientists who bring over 30 years of experience in 60 countries, and we also have the network and Many companies have found that delivering exist-this area. infrastructure to handle even the most complex ing molecules via new delivery routes can improve By working with 3M for their manufactur- supply chains. Our 50-year track record of compli- patient compliance, or the drug’s overall thera-ing needs, pharmaceutical firms can be assured of ance with multiple global regulatory bodies, includ- peutic benefits. reformulating drugs for deliveryreliable product delivery with our expert supply ing the fda, can give our pharmaceutical partners via the lungs or through transdermal means canchain management and global facilities that are additional peace of mind. sometimes result in improvements to the currentcurrent good manufacturing practice compliant, as these points illustrate, by combining our dosage form and response in the patients, includingas well as capable of large scale production. We use formulation expertise, state-of-the-art technology, fewer side effects, greater and/or faster onset ofa collaborative approach to planning and execu- and our strict compliance to regulatory guidelines action and also longer action. This reformulationtion, and we work very closely with our partners to with multiple filling capabilities, 3M can provide its can be undertaken both as a method of life cycle 20/20 Pharma
  4. 4. case studies “a kEy aDVanTagE oF 3m’S miCro 4 rEPLiCaTED SySTEm iS ThaT wE haVE SEEn SEVEraL moLECuLESManufacturing ThaT WE CAn MAnUFACTURE AnD THEn DRy onTo THE MICRonEE- DLES In SUCH A MAnnER THAT THE DRUg DoESn’T REqUIRE CoLD SToRAgE.” management or as a general improvement to the and this is an area in which 3M’s manufacturing transdermal systems can lower costs in shipping drug to help with issues such as compliance, side services can be helpful. another effective way of and storing, and total delivery costs will be signifi- effects and so on. controlling costs is to reduce a new drug’s time to cantly lower. from a commercial perspective, formulating market, and this can be achieved by making certain furthermore, in terms of pharmaco econom- drugs for new delivery routes can extend the life a firm has the necessary chemistry, manufacturing ics, using inhalation or transdermal delivery to of successful products and also protect them from and controls system data packages to allow fast allow patients to self-administer medications is a generic substitution. alternatively, it may enable approval through the regulatory bodies. With 3M’s much more cost-effective method of delivery than pharmaceutical companies to enter a new market experience of over 50 years in the industry, we having professional healthcare providers delivering utilizing their existing technologies or by partner- have a record of approval the first time through for injections. ing with drug delivery companies to enter a mar- regulatory bodies for both inhalation and transder- We understand that the challenging economy ket of strategic importance. to help our customers mal dosage forms. and we’re proud to say we have has caused both healthcare companies and determine if their candidate molecules may be suit- gained approval the first time through in our last consumers to examine the value of the services able for transdermal, inhalation or nasal drug deliv- three submissions. This kind of efficiency can be a available to them, and we are confident that 3M can ery, 3M offers a free-of-charge, no obligation paper significant help in controlling costs. offer increased efficiency and value to both groups. feasibility service which explores the likelihood of another aspect of cost controls is in dosage By providing pharmaceutical firms with a range of a product’s success using these delivery routes. forms, and 3M’s offerings can play a role here as services to help them develop new delivery meth- well. specifically, a metered-dose inhaler is one of ods, gain approval, and manufacture their products, Ph: Controlling costs is an important issue in the cheapest dosage forms per dose that you can we can help them reduce their time to market the pharma industry and healthcare in general. administer to a patient. Likewise, with transdermal and increase their internal efficiency. and in the how does 3M help its customers address delivery systems some drugs can be developed in range of our delivery systems, we are helping offer this challenge? a seven-day patch, which is a very cost-effective patients cost-effective and precise dosing of drugs JV: One of the most effective ways for pharma- way of delivering certain medicines to the patient. that can allow them to efficiently self-administer ceutical companies to control costs is to reduce the additionally, as previously discussed, the ability to their medications. amount of money that they have in manufacturing, eliminate cold storage for some microstructured JimVaughn became Vice President and general manager of 3m Drug Delivery Systems Division (DDSD) in 2007, having held the general manager position since 2005. Prior to his present appointment, he served in Europe as Busi- ness Director for Pharma- ceuticals & DDSD, and prior was Business Director for Personal Care Division. in his 33 year tenure with 3m, mr. Vaughan’s various positions in the company include Technical and manufacturing manager for 3m Selvi Pharmaceuticals, italy; Quality assurance manager; Plant manager for northridge, Calif., u.S.; Supply Chain man- ager for DDS, and general Sales & marketing manager for Europe. 20/20 Pharma

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