Pharm Exec profiles AstraZeneca and MedImmune’s Bahija Jallal, this year’s winner of the Healthcare Businesswomen’s Association Woman of the Year award, whose career-long passion for drug discovery and translational science has taken her on a bold and winding path from cancer researcher to leading a big pharma biotech engine.

	Casablanca in the 1970s offered women few educational and professional opportunities. For many young girls at the time, like Bahija Jallal, the bustling Moroccan city may have represented a dead end. But this would not be the case for Jallal, raised by a strong mother who instilled in her early on that she could be whatever she wanted. Today, Jallal is executive vice president of AstraZeneca, head of MedImmune, the pharma giant’s biologics R&D arm, and an active, outspoken supporter of women’s rights. The pharma leader and PhD holder has vast experience in translational science and has helped usher to market a portfolio of successful drugs. 

	The Healthcare Businesswomen’s Association (HBA) selected Jallal as its 2017 Woman of the Year. She will be honored at HBA’s 28th annual event on May 11 in New York City. 

	While quite the milestone in Jallal’s career journey,  the timeworn phrase of “she’s come a long way” does not fit. Given Jallal’s lifelong insatiable curiosity and tireless drive, it seems the world has finally caught up to her.  

	Jallal’s root inspiration for a deep desire to learn and understand can be firmly pinned to an early tragedy. When she was nine years old, her father went to a clinic in pain with a suspected kidney stone. He never came back; his family learned he died from medical error. “If I want to put my finger on when I decided to pursue this quest, if you will, of discovering, that is it,” says Jallal. Her mother raised five daughters and two sons by herself. “I give her a lot of credit for pushing us into believing in ourselves and believing that there are no barriers,” she says. 

	After finishing her secondary education, Jallal, who speaks French, Arabic, German, and English, left Morocco for France. She earned her master’s degree in biology from the Université Paris Diderot, a multidisciplinary university known as Paris 7. After that, Jallal pursued her doctorate in physiology at University of Pierre and Marie Curie in Paris. It wasn’t until her postdoctoral research that she discovered her passion for cancer research. 

	As a postdoctoral researcher at the Max Planck Institute of Biochemistry in Martinsried, Germany, Jallal worked in the lab of Axel Ullrich, who had himself rejoined academia after working at Genentech. In the mid-1990s, Ullrich and his team were testing anti-cancer agents on a then-newfangled premise of targeted therapy. They were interested in the human epidermal growth factor receptor 2 (HER2) protein in breast cancer. “That’s where my passion for cancer and for understanding the targets of therapy started,” says Jallal. This interest forms an unbroken thread throughout her career. 

	After Jallal left Max Planck, she faced a decision newly minted researchers still struggle with today: stay in academia or make the leap into biotech. Jallal decided to try biotech-still in its infancy as an industry-and signed on as a group leader at a cancer research lab in Sugen, a then-subsidiary of Pharmacia, which was acquired by Pfizer in 2003. One day, a patient requested to speak with the Sugen scientists who were involved in the development of Sutent (sunitinib malate), a receptor protein-tyrosine kinase inhibitor approved in 2006 for metastatic kidney cancer. The patient described her experience of taking the drug and how grateful she was. 

	“I vividly remember walking out from that conference room with the patient and saying to myself, ‘This is what I want to do. I will never go back to academia,’” says Jallal. 

	After rising to the role of senior director of research at Sugen just seven years after joining the company, Jallal left in 2003 to become senior director of drug research and translation at Chiron Corporation, a multinational biotech based at the time in Emeryville, California. Her task at Chiron was herculean. She needed to set up a translational science hub that would streamline the company’s pipeline, with a particular focus on cancer drugs. Again, Jallal had acquired skills and experience within a then cutting-edge concept: she relied on translational science approaches and techniques to improve the bottom line. 

	“In translational science, we focus on how to harness the patient population that is most likely to succeed,” she says. To get to that point, a series of research questions need to be investigated. According to Jallal, one of the most important-but sometimes overlooked-questions to ask first is does the drug hit its target? Second, which biomarkers can be monitored in experiments, or created if they do not exist yet? Finally, she encourages her team members to test the drug in a specific, focused patient population, and not in all-comers. 

	“It behooves us for the sake of patients and time that we get our answers about the drug soon,” says Jallal, adding that “a good drug declares itself early.” At Chiron, Jallal was a core member of a new management team created to generate ideas and orchestrate the change involved in the $5.1 billion acquisition by Novartis in 2006. She helped expedite a new drug application and five investigational new drug filings during her three years there. 

	In 2006, Jallal got a call from MedImmune, which a year later would be acquired by AstraZeneca. Would she be interested in starting up the group’s translational 

science division? “What attracted me [about MedImmune] was an innovative and entrepreneurial spirit,” says Jallal. Faced with a diverse portfolio of drugs, Jallal took a page from her translational science playbook in oncology and applied it as a strategy to develop potential new medicines.

	“I thought that bringing an understanding of oncology, which was more advanced at the time, to other areas would be a great idea,” she says. First, Jallal put her knowledge of targeted therapeutic approaches behind an up-and-coming autoimmune disease agent. Jallal’s team developed an interferon signature that allowed them to identify the patients for whom the therapy was more likely to work. The drug is now in Phase III clinical trials for lupus.

	JoAnn Suzich, vice president of infectious disease and vaccines research at MedImmune, still remembers interviewing Jallal for her first role at the company. “After speaking with her, I remember saying, ‘We’ve finally found our person,’” says Suzich. The two women have worked together at MedImmune since 2006 and Jallal now serves as Suzich’s supervisor. 

	Suzich was impressed by Jallal’s detailed plan of how the new translational science center would bridge research and clinical. “Her willingness to be audacious was memorable,” says Suzich. “She had a clear idea about all of the parts that needed to be in place for a center, even if they wouldn’t be built right away.” Over the years, Suzich has relied on Jallal for guidance on scientific conundrums related to her work. “She always tells me, ‘You will fix this immediate problem. But let’s go beyond that and think about what will happen once it’s fixed,’” says Suzich. 

	Beginning in 2007, Jallal, working with team members, launched a bold 10-year vision for MedImmune. The goal? Build up the pipeline in order to submit one new biologics license application (BLA), on average, each year. The team accomplished that in 2015 when the company filed for the psoriasis drug Siliq (brodalumab) in partnership with Valeant Pharmaceuticals. It was subsequently approved by FDA this year. Last year, AstraZeneca submitted BLAs for durvalumab, a treatment for bladder cancer, and benralizumab, a monoclonal antibody for asthma. FDA granted a breakthrough therapy designation for durvalumab with a Prescription Drug User Fee Act (PDUFA) date in the second quarter of 2017. Earlier this year, the regulatory submission for benralizumab was accepted for review in severe, uncontrolled asthma. MedImmune is on track to file another BLA this year; biologics make up 50% of AstraZeneca’s pipeline. 

	Under Jallal’s leadership, MedImmune has made significant strides into China’s biologics market. In 2012, the company partnered with a local Chinese biotech, WuXi AppTec, to create novel biologics and get them to local patients quickly. “Late last year, we announced that our multinational-local corporate venture became the first of its kind to earn approval of a biologic investigational new drug in China,” says Jallal, referring to an anti-IL-6 antibody for rheumatoid arthritis and other autoimmune disorders. The China FDA approved it as a class I biologic and gave the green light for Phase I clinical trials. 

	Jallal has also worked hard to create-both physically and culturally-an open work environment where innovation can thrive. Starting at the leadership level, MedImmune broke down walls and physical barriers in offices. Now the entire Maryland campus works in an open floor plan. “We also have a rich cultural diversity,” says Jallal. “Groups of employees host special events like a celebration of Chinese New Year or a happy hour sponsored by our Persian colleagues.” MedImmune’s emphasis on nurturing different perspectives is “exemplified not only in our robust, innovative pipeline, but also in the large number of high-impact journals in which our scientists have published,” says Jallal. 

	Since becoming head of MedImmune in 2013, Jallal says she has learned the importance of setting the tone and leading by example. A typical day for her starts at 5 a.m., but she has always made it a priority-and encourages this among team members-to have dinner together with family. Jallal and her husband have two daughters, ages 19 and 23. By rising through the ranks at MedImmune, Jallal says she appreciates the broader perspective she has gained as part of the senior executive team-and helping AstraZeneca CEO Pascal Soriot  turn around the

	Through it all, Jallal has nurtured three bedrock qualities in her leadership: visionary, entrepreneurial, and collaborative. “I always say to my team, ‘Anyone can manage, but few can truly lead,’” she says. 

	To inspire others, a leader must set a bold, long-term vision and then chart a course that keeps employees engaged. Jallal says that her fearlessness in taking risks is a trait she encourages in fellow employees. “This industry isn’t for the faint of heart, but the reward is delivering potentially lifesaving medicines for patients,” she says. 

	Jallal’s fierce determination and encouraging leadership style has been praised far outside the pharmaceutical industry, too. In 2015, Jallal was recognized by 

 as one of 16 women of integrity. In that story, Jallal channeled her mother: “Ever since my daughters were children, I have told them never to apologize for being smart and to always seek knowledge.” 

is a freelance health writer. She can be reached at 

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For Bahija Jallal, chosen this year's Healthcare Businesswomen’s Association Woman of the Year, a passion for translational science has been the central guide in a career rise from cancer researcher to leading a big pharma biotech engine.

HBA's Woman of the Year 2017

The need to start now to meet compliance deadlines for the Drug Supply Chain Security Act is critical. Facing new mandates, one industry pilot study has demonstrated the value of a standards-based solution in prescription drug traceability.

	Legislation is transforming the pharmaceutical supply chain to improve patient safety by requiring traceability of prescription drugs. Industry members are preparing to go live with the Drug Supply Chain Security Act (DSCSA) serialization requirements for 2017, and beginning to plan for the journey to the item-level traceability requirement that lies ahead.

	Johnson & Johnson Supply Chain (JJSC) and AmerisourceBergen Corporation (ABC) recently collaborated on a pilot program testing a standards-based solution to meet the 2017 DSCSA mandate. The pilot results were published in a collaborative case study by GS1 US, the information standards organization, confirming actionable and repeatable results that offer valuable lessons for the entire industry.

	Manufacturers, wholesalers, repackagers and pharmacies have been required to implement lot-level management since 2015. In phase two of DSCSA implementation starting in November 2017, manufacturers and repackagers must serialize packages of drug products using a product identifier (GS1 Global Trade Item Number® [GTIN®] or FDA National Drug Code [NDC]), serial number, lot number and expiration date, and embed this information in a DataMatrix barcode. 

	Beginning in November 2019, wholesalers must accept only serialized products and must verify unique product identifiers; pharmacists must meet the same requirements by November 2020. Finally, by November 2023, they will be required to make available information that would allow supply-chain partners to trace the ownership back to the initial manufacturer or repackager.

	Meeting the DSCSA compliance deadlines will require significant industry collaboration to implement a common, interoperable solution affording all stakeholders clear vision throughout the supply chain. The industry is already using the GS1 standard of GTINs for product identification to comply with the first phase of DSCSA requirements. Many companies are also leveraging Electronic Product Code Information Services (EPCIS) in preparation for serialization and item-level traceability, which allows trading partners to exchange and synchronize data with products’ movement through the supply chain. 

	ABC, as a major participant operating throughout the supply chain, was eager to lead a unit-level traceability pilot with JJSC that involved serialization of individual products. “This pilot was an opportunity to not only help develop the industry solution, but also provide insights that may help our patients and customers use it and leverage it beyond compliance,” says Matt Sample, senior director for secure

	JJSC seized the opportunity to participate. “Our collaboration with AmerisourceBergen highlights the importance of having a robust, well-implemented serialization platform-one that opens up a host of future supply chain and commercial capabilities enabling the delivery of a reliable supply of high-quality products and other services to our customers,” says Mike Rose, vice president of supply chain visibility, JJSC. 

	ABC and JJSC are  long-term members of the 

, the voluntary industry group implementing global standards to address patient safety and deliver supply-chain efficiencies. The companies realize that using the common language of GS1 standards would make it easier to achieve interoperable traceability in compliance with DSCSA. The trading partners have also been active participants as subject matter experts in the Rx Secure Supply Chain workgroup, which developed the 

GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability

	ABC and JJSC decided on a four-week pilot program in a live production setting. Beginning at the point of manufacture, a DataMatrix barcode was applied that contained a serialized GTIN, batch/lot number and expiration date to each lowest saleable unit. These units were packed into cases, and a logical relationship between the “children” and “parent” was established via aggregation. 

	Product cases were then loaded onto a pallet or other logistics units, establishing yet another level of the aggregated hierarchy. At supply-chain points downstream, automated vision systems or manual barcode scanners read the DataMatrix barcode to capture the GTIN, serial number, batch/lot number and product expiration date. GS1 EPCIS was used to record business events associated with the serialized GTIN at various critical points along the supply chain, including commissioning, packing and shipping, followed by receiving and unpacking by the buyer. 

	Products were moved from manufacturing to distribution as in the past, with the addition of the serialized information. After the wholesaler placed an order and the truck departed, JJSC issued an EPCIS message containing the serialized GTINs and hierarchies contained in the shipment. This provided the ABC distribution center with the details of the specific products that were on their way.

	When the shipment arrived, the EPCIS data allowed ABC to confirm receipt-without opening a single case-of every single item that had begun its journey at the manufacturing site. “Using EPCIS message standards provides for a more streamlined process, in that systems are established with similar data file expectations across the supply chain,” explains Jeffery Denton, senior director of ABC’s global secure supply chain. “Most failures experienced during past pilots are avoidable if manufacturers provide DSCSA-compliant EPCIS v1.1 files that include master data for material attributes as well as valid GLNs (global location numbers) and GTINs.” 

	“We have a solid playbook on how to run a pilot with more than just one manufacturer and more than just one product. We have a good repeatable process for future pilots,” says Sample.

	Serialization and traceability can bring value to the respective businesses, beyond compliance. 

	“We see this as more than just a regulatory compliance effort,” says Chris Reed, JJSC’s lead for product serialization and traceability. “Leveraging GS1 standards is also intended to improve patient safety, and helps provide a means to investigate counterfeit and diverted products. It improves our internal and external supply-chain integrity.” 

	“With the implementation of serialization and traceability, we will have the opportunity to trace a serialized product from a specific wholesaler to the end customer,” continues Reed. “We can use these capabilities to further ensure that our patients and customers receive quality, genuine products. We also believe serialization and traceability will provide additional benefits to our business, like the ability to more effectively manage and verify returns.” 

	He adds, “With GS1 standards, specifically the use of GLNs and GTINs, identification of a product and its unit of measure will become clearer to the entire supply chain. In the future, there’s also immense value in utilizing GTINs for ordering processes.” 

	JJSC is a strong believer in conducting pilot tests. “We continue to discover ways to improve our design and processes through pilots. The pilot with ABC enabled us to validate and challenge our end-to-end business processes and architecture that grew, with significantly more internal and external manufacturing sites, regional requirements and IT complexity, since our last round of EPCIS exchange,” says Rosemary Hampton, IT manager, supply chain business systems, Johnson & Johnson Information Technology. 

	“To facilitate just this relatively small pilot, our enterprise resource planning operations, warehouse management system and traceability processes needed to perform in unison,” says Reed. “We found that products were arriving on ABC’s loading docks before product data arrived, because of the way we had batched our data transmissions between these three large systems. This led us to challenge and reconfigure our old way of thinking. The pilot was a reminder of how many processes and IT systems we have in play.”

	According to Reed, a missing element of data-whether it’s a dosage form or a letter in the description of the product-may seem trivial, but it can drastically impact the efficiency of the pharmaceutical supply chain, potentially leading to disruption for patients. A strong emphasis on cleansing existing master data and establishing robust data governance is critical, he says.

	Sample agrees: “Data formatting issues-how others were encoding data using GS1 standards-is important. You have to test it thoroughly with the right amount of volume in production.”

	 Something as seemingly simple as labeling requires careful consideration. Each case displays multiple labels-a Healthcare Distribution Alliance (HDA) label, a two-dimensional (2D) matrix label, and another applied by transport and logistics, among others. This can cause confusion at stops along the supply chain. Glare resulting from shrink wrap and flashing lights can also impede automated code capture; damage to cases can compromise label readability. 

	“We found we were putting the 2D barcodes in the most vulnerable spot on the packaging, so we had to change that,” says Sample. As a result of the pilot, JJSC and ABC are working with GS1 US and HDA to update labeling guidelines. “Don’t treat this as a side IT project; it’s not a casual exercise,” he warns. “It’s a business transformation project, so don’t underestimate its importance.” 

	The ABC-JJSC pilot and others  have confirmed that industry technological and business process implementations in the supply chain are sound, but the business-to-business exchange of data requires fine-tuning in the real world. 

	“It may take 25% more time to receive serialized cases, and about 30% more time to pick serialized products,” says Sample, pointing to a need for a better understanding of exceptions-how often they occur, how to deal with them and what will be deemed acceptable by FDA. “Exceptions are a reality, especially with niche products, and we need to know how to deal with them.” 

	Transparency is key as well. “It’s a unique situation: you’ve got all of these manufacturers and wholesalers and we’re all competitors,” says Sample. “But we have a constructive opportunity to collaborate in working on standardization of these traceability issues.”

	Building stronger communications channels will be vital to this effort, executives point out.   

	“For this initiative to be successful, trading partners up and down the supply chain must collaborate and communicate,” says Reed. “If we keep the lines of communication open and continue to develop and refine industry standards together, we will all be prepared for the DSCSA requirements and continue to provide safe and effective medicines to our patients.” 

	Heather Zenk, vice president of ABC’s secure supply chain, sums up the companies’ pilot in this way: “The key to success in meeting any instance of regulatory compliance really comes down to collaboration. It all rests on the willingness of our industry partners across the supply chain to work toward consensus and then drive to adoption.” 

	In addition to assuring compliance and continued product access for patients and customers, serialization can potentially enable the investigation of counterfeit and diverted products, affording brand owners additional supply-chain integrity and security. End-to-end visibility means that recalls, where necessary, can be executed efficiently. As the foundational standard, the GTIN helps to automate all processes and minimize errors, ultimately increasing patient safety. 

	The pilot program demonstrated that the GS1 GTIN has value to enhance ordering processes and reduce unit-of-measure ambiguity in the future, and that clean, quality data is imperative. 

	By starting now, life sciences companies can build the systems needed for successful transition to the DSCSA traceability requirements, and reap the full benefits of an electronic, interoperable system for identification and tracing of prescription drugs. The pilot confirmed the importance of treating this as the business transformation that it is, and assigning proper resources. This industry revolution presents the unusual opportunity of sharing best practices among partners, customers and even competitors. 

is Vice President, Healthcare, at GS1 US. He can be reached at 

Pilot study affirms the value of a standards-based solution for prescription drug traceability-and the need to start now to meet compliance deadlines for the Drug Supply Chain Security Act.

Bracing for Drug Tracing Mandate

	eyeforpharma’s annual Barcelona event has been running (initially in different European locations) for 16 years. During that time it has grown from a sales force effectiveness (SFE) summit to Europe’s largest commercial pharma meeting, attracting more than 1,000 industry delegates. These days, sales force effectiveness as a concept itself, as well as other aging terms such as multi-channel marketing, change management, and customer relationship management, are generally absent from the event’s agenda, as are those promises of old that offered to help attending companies “deliver big profits,” “increase sales,” and “target the most profitable customers.” 

	The conference is now populated with sessions on gender-parity concerns, healthcare ecosystems, and advice on how to “adapt your organization to the patient,” of all which are of course welcome and indeed 

in today’s more technologically sophisticated and socially democratic age. 

	But fueled partly by nostalgia (and more by a keenness to discover how the field is changing in the advancing digital and patient-centric era), 

zoned in on the event’s 2017-style “sales force effectiveness” offerings, which now occupy less of a prominent position in a multi-themed approach that comprises commercial innovation, patient centricity, and stakeholder collaboration. There were some rich pickings, nonetheless. Some of the sessions featured observations that might be disruptive to evolving notions of sales force strategy, such as Nestlé Nutrition Global Head of Performance Dirk Abeel’s assertion that face-to-face detailing is still the most effective means of promotion, and Miller Heiman Group Partner Harry Dunklin’s comment that “70% of all major change initiatives fail because of lack of leadership alignment and consistent messaging.”

	But there were plenty of new ideas in line with the changing demographic, technological and commercial landscape, not least Dunklin’s reminder that pharma is gradually losing its “Gen-Xers” to the rise of the Millennials, who are predicted to reach 50% of the workforce by 2020, and 75% by 2025. While this statistic might not be overly surprising, Dunklin offered an insight about how the behavior and attitudes of the new generation will affect the sales workforce. Millennials, said Dunklin, favor a “culture of inclusivity,” with research showing that employees in an inclusive culture report above-average levels of “engagement” and “empowerment.” This could be critical in terms of performance; Dunklin pointed to a recent study that stated organizations with high numbers of engaged employees outperform others by more than 200%. 

	This glimpse of the near future paved the way for Colleen Schuller, head of global selling excellence at GlaxoSmithKline, to talk about the drugmaker’s ongoing commitment to the removal of individual sales rep targets. GSK announced this approach some years ago, although the catalyst was as much a reaction to scandal as a concern for employee engagement and empowerment. It came in the wake of bribery allegations against GSK in China in 2013, prompting then-CEO Andrew Witty to overhaul the existing compensation scheme with one geared to encouraging reps to provide information to doctors more “clearly, transparently, and without any perception of conflict of interest.” 

	But Schuller’s explanation that “the intrinsic motivation for a salesperson is more important than extrinsic factors” still has a radical ring to it, so it was interesting to see how the company was faring under this philosophy. Schuller confirmed that neither sales nor the turnover of reps have been adversely affected by the scrapping of targets. GSK sales rep motivation now comes from an opportunity for autonomy and to “master their craft.” 

	Whether the rest of big pharma finds this convincing, or whether small and medium-sized companies will ever be able to introduce similar incentives, is open to question. But given Dunklin’s view of the future of the workforce, what seems radical now could be more widespread in a decade. And it all goes to show that sales force effectiveness-or however it will labeled in the encroaching era of the Millennial-is a subject that still offers plenty to talk about.

’s European and Online Editor. He can be reached at 

Columns

A review of some of the sales strategy insights on offer at last month’s eyeforpharma Barcelona event.

Sales Force Effectiveness, Millennial Style

	Pharmacovigilance’s influence has begun to encompass more than regulatory compliance, as can be seen by the number of trends identified by those on the front line. The most fundamental of them is a growing emphasis on quality. “Inspections are increasing,” says Julia Appelskog, qualified person for pharmacovigilance (QPPV) and head of pharmacovigilance at Bluefish Pharmaceuticals. Although that presents challenges, she says, it also prompts firms to achieve better systems and better processes, “because the leadership now understands how important pharmacovigilance is and is allocating more resources.”

	There’s a balance to be struck, however. “It can feel as though we’re feeding a hungry compliance animal rather than focusing on patient safety,” says David Ferguson, head of international pharmacovigilance at Shire Pharmaceuticals. 

	Breaking down global silos and establishing closer collaboration between pharmacovigilance and quality operations is becoming an increasing priority. “Inspectors expect to see a good quality system and a good pharmacovigilance system and that those systems’ processes are in alignment,” says Lesia Tontisakis, director of pharmacovigilance at Allergan.

	Such cooperation is also essential for maintaining a high-level perspective, says Mariska Kooijmans, head of drug safety and pharmacovigilance international and European Union (EU) QPPV at Amicus Therapeutics. “The quality group needs to be part of pharmacovigilance decision-making and vice versa,” she explains.

	Quality requirements can be particularly challenging for small companies, according to Laura Dalsasso, regulatory affairs office and pharmacovigilance manager at E-Pharma. The evaluation of a company’s pharmacovigilance system tends to be outsourced, which

 creates its own set of complications. “You have to audit your partners, spending time preparing agreements with each,” she says. E-Pharma markets only a limited number of packages so it can avoid a sunset clause, but it must still maintain a full pharmacovigilance system for evaluating the safety data of those products, which is resource intensive. 

	So, who’s responsible for pharmacovigilance? Ferguson says a pharmacovigilance system can touch almost any department in a pharma organization-as well as affiliates. “It’s a system for which others have responsibility as well,” he says, though that message can be a challenge to convey.

	A growing emphasis on balancing the risk–benefit ratio requires companies to consider any benefit in terms of what it means to patients. “For example, a cholesterol drug might demonstrate that it lowers cholesterol levels, but determining the benefit means asking, do patients live longer? What’s the cost? And does your drug work better than others currently out there?” says Ferguson.

	The risk–benefit profile isn’t static, either, which adds tasks to the workload. Beyond the point of clinical trials, any new data is almost exclusively safety data, says Lesley Wise, managing director of Wise Pharmacovigilance and Risk Management, suggesting that pharmacovigilance or medical safety should be driving the risk–benefit discussion. 

	The more comprehensive the picture that pharmacovigilance activities develop, the greater the value to the business. Tontisakis says  companies today are increasingly bringing in safety experts at the earliest stages of potential acquisitions in order to help them assess the matter. “It doesn’t make sense to bring in a product that isn’t safe and would cost in the long run.”

	It’s surprising, then, that pharmacovigilance doesn’t usually have a full seat during the due diligence process. “It’s often assumed that it will be all right-until you hear it’s not,” says Ferguson. 

	At Bluefish, senior management seeks advice from pharmacovigilance before deciding to initiate a new product registration. “We’re asked what the implications will be for risk minimization activities, will a post-authorization safety study be required, and what are the potential costs,” says Appelskog.

	One commercially interesting trend is the potential to use safety as a differentiator against other brands. Kooijmans used to work at Biogen, which recently had its first product approved for an orphan indication (nusinersen, for spinal muscular atrophy) because the drug’s safety profile was better than that of the already approved  product for the indication, thereby leading to a superior risk–benefit profile. Amicus, her current company, meanwhile, has been granted approval for an oral drug, Galafold (migalastat), for treating Fabry disease. Galafold was found to be easier to tolerate and had fewer side effects compared with already approved and marketed intravenous treatments. “For companies focused on ‘me-too’ products, having a safety focus would be a good approach,” says Kooijmans. “If you aren’t developing targeted, personalized medicine, you need to think about the two other areas to make your drugs stand out: better and safer-or both.”

	When a company is looking to differentiate itself in the area of safety, such activities will be part of the clinical development plan, says Wise. This is typically managed by clinical rather than by safety, especially in smaller or mid-sized companies. In larger companies, medical safety-as distinct from the operational aspects of pharmacovigilance-is firmly embedded in clinical development. “Using safety as a differentiator is an argument in a product’s risk–benefit profile,” says Wise. “If your risk–benefit ratio is positive because your risks are lower-but the benefits are the same-that’s an important thing to know.”

	The European Medicine Agency’s (EMA) good pharmacovigilance practices (GVPs) are being actively considered by other regional markets. They are likely to adopt many of the same principles in time-but with their own individual emphases, thereby creating more work for global players. Appelskog pointed out the importance of good, ongoing dialogue, which is well established within the EMA. “I’m concerned that in Eurasia and the Middle East, GVP will be brought in without discussion or willingness to adapt,” she says. “A lot still has to happen to agree on standards.”

	Other complexities include the requirement to have a responsible person for pharmacovigilance, even in markets in which a product might not be marketed. “Shire works in the area of rare diseases, and it might be that we don’t have even a single patient in a small country such as, say, Cyprus, but because we have Europe-wide marketing authorization, which is applicable to all EU member states, we’re legally obliged to have a responsible person for pharmacovigilance in that market,” says Ferguson. 

	Finally, there are skills issues to consider, stresses Wise. For instance, pharmacovigilance leaders will have to possess certain new business skills if they’re to play full roles in clinical risk–benefit decision-making. They’ll also need strategic skills in order to support the evolution of a pharmacovigilance department that has an integral role to play in R&D. 

	For Kooijmans, the role of the QPPV has evolved too; here, quality assurance has become the chief concern. “When I started out in a QPPV role, the focus was more on discussing the minimal safety side with regulators,” she says. “Now it’s much more on being ready for inspections, making sure your system works, and keeping the pharmacovigilance system master file up-to-date. All of those things serve to attract different kinds of people to pharmacovigilance.”

	The management of affiliates has become another priority for pharmacovigilance heads, adds Ferguson. In the past, in the hiring of a safety person in an emerging market, those roles would have focused on operational activities such as receiving adverse event data, doing the translation, entering the data into the database, and making sure the events were reported to the authorities on time. “Now I’ve brought those operational activities into the center and hired third parties to manage them,”  says Ferguson. “The skill set I need now from someone at the affiliate has changed from in the past; now I look for people with pharmacovigilance and quality experience. I need people who can ensure compliance, who are familiar with all of the regulations, and who know how those regulations affect everything we do.”

	A further development is that the QPPV, traditionally a European role, has become a requirement in more and more markets, says Wise. “That raises questions as to who that QPPV is going to be, because on one hand, few QPPVs would be willing to take responsibility in markets outside Europe, given the legal liabilities. But, because on the other hand there’s only one pharmacovigilance system, it doesn’t make sense for a global company to have multiple QPPVs.” 

	It’s too early to tell how these new developments in pharmacovigilance will pan out, but these are interesting times for a fast-evolving discipline. 

is Head of Practice PV Platform Services/Principal Medic at ProductLife Group. She can be reached at 

Experts debate the practice’s rise up the life sciences agenda.

The Lengthening Arm of Pharmacovigilance

	Seven Years. That’s the average time it takes an individual to get a correct diagnosis for a rare disease in the United States. In a story of a rare disease that should have been discovered by a screening that went awry, it took four months, parents unwilling to accept their doctor’s colic diagnosis, and a work-up at CHOP to save a four-month-old heading into liver failure from tyrosinemia type I, a hereditary disorder found in one in 100,000 to 120,000 births worldwide. This disease can be discovered through a newborn blood screening and treated with drugs. The mission of the parents of this story-whose son lived-is to make sure all newborns are screened and then have access to these drugs, no matter the geographic location or cost.

	Thus begins the journey of many patients, parents and loved ones to support others affected by a disease that has forever changed their lives.

	The definition of rare disease in the United States is one that occurs in less than 200,000 Americans at a given time. In Europe, a disease is characterized as rare when it affects fewer than one in 2,000. 

	We know that even “common” diseases such as breast cancer have phenotypes or subtypes. A drug for cystic fibrosis only works in a subpopulation of those diagnosed with a certain gene. And people that take statins who have a certain genetic profile are at increased risk to die from muscular waste. 

	I learned this at a conference from a researcher who specializes in genomics. He said that if he mapped each person’s genetic code in that room (about 250) and one of their children, that would stretch from the Earth to Mars. While the human genome has been mapped, each person’s genetic profile is unique. So in another example of an 18-month-old girl, the researcher took the code from both parents and child and discovered, via computer analysis in about 50 hours, she had a single gene variant that was causing her muscle degeneration.

	Fortunately, that too was cured by addressing the specific gene’s mechanism.

	Research and technology continue down this road every day, as does the resolve of patients and loved ones diagnosed with yet another rare disease. But as we think this through, that means each of us has a variant. Be it a drug on the market that has a me-too, but one works better for your variant, or a drug that you should not be taking because of the variant, or a disease that is discovered because of the variant. All the individualized variants are rare, but then the rare becomes the norm. 

	However, there remain many barriers to discovering and treating rare diseases. Julian Upton’s 

 on the International Rare Diseases Research Consortium discusses the barriers and how it is working with pharma and others to break through them.  

	What else that was once rare and now is more common with time, investment and commitment is women working in professional positions. As a group, women clearly have made strides in the professional world in the last 50 years and hold executive positions in many fields. But we do know that women participating in the STEM professions is still low, and that representation of female executives in pharma is still rare.

recognizes each year the Healthcare Businesswomen’s Association choice for Woman of the Year. This year’s honoree is Bahija Jallal, PhD, executive vice president, AstraZeneca, and head of MedImmune.

	Jallal’s story is moving, and as you’ll 

, she had the full support of a mother who believed in all of her children and their abilities and letting them know there were no barriers to their success. Jallal recently spoke at the second annual International Day of Women and Girls in Science conference at the United Nations Headquarters in New York, and is president of the board of directors of the Association of Women in Science.

	Some may believe that the time it has taken for rare disease research to advance is too long, as some argue that it still is taking too long for women to break glass ceilings. Each group, rare disease and women get their own recognition day just 10 days apart-Rare Disease Day is February 28 and International Women’s Day, which focuses on women’s rights, is March 8. 

	With time, investment and commitment, it may soon come to pass that these days won’t need to be recognized because they will move from needing attention to just being a common occurrence. 

From the Editor

Two topics in Pharm Exec this month-rare disease research and women in healthcare leadership-share a "common" thread.

When Rare Becomes Common

	The International Rare Diseases Research Consortium (IRDiRC) was launched in 2011 to facilitate cooperation and collaboration on a global scale among the many stakeholders active in rare diseases research, and to maximize the output of rare diseases R&D efforts around the world. 

 spoke to Dr. Christopher Austin, chair of the IRDiRC Consortium Assembly-who also serves as director of the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH)-about what 

 is doing to realize its ambitious goals: to deliver 200 new therapies for rare diseases and the means to diagnose most rare diseases by 2020.

Can you outline the work IRDiRC is doing in order to realize its goals?

To guide its work, IRDiRC developed a set of policies and guidelines, which are the principles that IRDiRC members agree to follow, focused on the following areas: data sharing and standards, ontologies, diagnostics, biomarkers, patient registries, biobanks, natural history, therapeutics, models, publication and intellectual property, and communications about the Consortium. Coordination of efforts that address common roadblocks is key to maximizing the collective impact of global investments in rare diseases research and accelerating progress. To that end, barriers and gaps in rare diseases research were identified, and task forces were set up to address some of these

 gaps through policy recommendation and/or technical solutions; the work has been guided by three scientific committees-diagnostics, interdisciplinary, and therapies-and three constituent committees-funders, companies, and patient advocacy-which also play important advisory role on the Consortium Assembly. 

As we move closer to 2020, are the IRDiRC’s two main objectives, to deliver 200 new therapies for rare diseases and the means to diagnose most rare diseases by that time, still realistic?

Last year, the goal to deliver 200 new therapies was achieved, four years earlier than expected. The goal to deliver the means to diagnose most rare diseases has made significant strides, with over 3,600 tests available for the diagnosis of rare genetic diseases, compared to 2,200 in 2010. Overall, it is estimated that diagnostic possibilities increased from 10% to 30-50% in the last five years. Efforts are ongoing to deliver more diagnostic tests. In light of these successes, IRDiRC is currently setting new goals for the next decade that are expected to be even more ambitious, and will contribute to further diagnostic and therapeutic progress.

What kind of success has IRDiRC had since its establishment six years ago?

 IRDiRC has brought forth awareness to the importance of principles laid out in its policies and guidelines, and promotes the adherence of these principles in research projects funded by its members. The Therapies Scientific Committee further developed recommendations to guide policies and funding strategies so as to reach its goal of 200 new therapies by 2020, based on the IRDiRC Polices and Guidelines. 

	IRDiRC task forces have produced guidelines and recommendations for policy change in specific areas, including the guidelines for data mining and repurposing, patient-centered outcome measures, and small population clinical trials. IRDiRC also worked on developing standards for interoperability among databases for human phenotypes. 

	In collaboration with the Global Alliance for Genomics and Health, three task forces were set up, working on rare diseases gene discovery through a federated network of 

genotype and rare phenotype databases called Matchmaker Exchange, tackling the barrier of data sharing through interpretation of consent and condition of data use through Automatable Discovery and Access Matrix, and setting out the development of ethical, legal, and technical requirements of privacy-preserving participant identifiers in rare diseases research. 

	Additional task forces are due to commence shortly to address approaches for investigating unsolved diagnostic cases in non-coding genomic regions, bottlenecks and barriers to clinical data sharing, and best practices for patient engagement in rare disease research.

	IRDiRC also created a quality label, “IRDiRC Recognized Resources,” to highlight standards, guidelines, tools and platforms which, if more broadly used, would contribute toward IRDiRC goals-and encourage the research community to adopt interoperable data standards while promoting data sharing.

Have you seen any advance in combating the lengthy diagnosis time associated with rare diseases?

 According to patient surveys conducted in Western Australia, Canada, and Europe, the average time of diagnosis for a rare disease is five to six years. It is thought that this time will be decreased to two to three years if a patient has access to new diagnostics methods such as next-generation sequencing, but this has yet to be confirmed by systematic surveys. IRDiRC is planning to collect data on this, as decreasing diagnosis time for rare diseases is integral to progress and the aim is to enable all patients living with a rare disease to receive diagnosis within one year of coming to medical attention.

Can you outline what involvement IRDiRC has with the pharma/biotech community and how you work together?

 A dozen or so companies  that meet membership criteria-investment of at least 10 million US dollars over five years on rare diseases research-are IRDiRC members, and participate in the Companies Constituent Committee to identify common roadblocks to efficient execution of research in the industry space that IRDiRC should address. 

	They also nominate experts to task forces who share their experience and knowledge, and, unsurprisingly, in the spirit of collaborative work, some members have also teamed up in their research and development efforts.

We recently had Rare Disease Day. How has the evolution of this event advanced the thinking around issues of rare disease?

 Worldwide Rare Disease Day events have helped create more awareness of and support for research collaborations that are bringing hope to patients. For more information, contact 

National Organization of Rare Diseases (NORD

, National Center for Advancing Translational Sciences

Six years in, Pharm Exec looks at the progress of the International Rare Diseases Research Consortium-an ambitious global effort focused on accelerating orphan disease diagnosis, and ultimately enabling better treatment options for these underserved patient populations.

Advancing Rare Disease R&D: A Mission Update

	“Close the wall up with our English dead,” King Henry V urged his troops during the British siege of the French port of Harfleur in 1415. As the UK government plunges headlong into another battle on what it still appears to regard as enemy territory, it is hard to resist the sensation that the rhetoric of that Shakespearean hero is informing much of the Brexit thinking in Westminster. 

	Certainly, for medicines supply, the current prospects of Brexit are alarming. And if the prospect of “English dead” is not yet on the horizon, the negative implications for patients are evident if Theresa May and her nationalistic cohort pursue their present course. The now-public plan to go for a so-called “hard Brexit” (with the even more radical fallback that “no deal is better than a bad deal”) automatically condemns the UK to outsider status in political, economic and trade terms with the 27 countries that will continue to function as the European Union (EU). 

	The revelation in mid-March by the principal minister for Brexit, David Davis, that he has done no planning for a “no-deal” scenario, underlines just how feckless the government approach is.

	For patients, taking the UK out of the EU’s single market, and out of the arrangements that allow goods and people to flow across it, will make it harder for UK health services to import the many medicines that are not produced domestically. It will make it harder for UK drug companies to export their products-hitting not only UK trade and business activity, but also the UK’s attractions as a place to invest and locate. 

	The UK departure also means cutting it off from the networks of life science collaboration-to say nothing of a lot of EU research funding-that make it so successful in developing new medicines. Add to that the disincentive that companies and research institutes will face with new barriers in recruiting and retaining highly-qualified staff from the pool of the 500 million citizens who will remain in the EU.

	Losing the European Medicines Agency (EMA) will be another blow, because the agency’s presence in London since it came into operation 20 years ago has kept the UK at the center of European regulatory thinking, and given UK regulators, researchers and companies unrivaled access to the best and brightest as regulatory science has converged across the world. The EMA’s impending relocation also powerfully symbolizes the isolation that UK regulators and companies will suffer as marketing authorizations that once had pan-EU force are invalidated. Companies everywhere face being obliged to obtain separate authorizations for the UK through a new system-a system that has to be created from scratch in a timetable measured in months.

	The list of challenges grows longer as the survey of the Brexit implications for medicines becomes more detailed. There is no meaning in the government’s empty boast about making Britain “one of the best places in the world for science and innovation” if there is no plan as to how to do it. Simplistic ideas about UK membership of the European Economic Area or similarly imprecise off-the-peg solutions merely demonstrate-as Mogens Peter Carl, an EU negotiator for 30 years, expressed it recently-”the degree of ignorance about Brexit.” And vague reassurances from officials and ministers about transitional arrangements and continued regulatory cooperation remain nothing more than aspirations.

	In the current heady atmosphere as the May government heads unchecked and unchallenged into negotiations, the chances of those aspirations being met are more and more remote. Because any arrangements to soften the inevitable blow of Brexit depend not on the confidence of the UK 

negotiators, but on the willingness of 27 other countries to offer concessions to the EU. The central dynamic of this process is not that the EU wants to leave the UK, but that the UK has chosen to leave the EU. 

	The Brussels view is firmly that it is for the UK, as the instigator of the process, to plead for arrangements to ease its pain, and not for the EU to volunteer remedies for ills of the UK’s own making. As the UK legislation enabling withdrawal from the EU was adopted in London, a senior Commission official remarked: “Brexit means Brexit. It does not mean the new relationship with the EU, to use Mrs. May’s quote.”

	The hard-line Brexiteers are, nevertheless, evidently still inebriated by the spirit of an earlier age, and are doubtless quoting approvingly to one another:

“Now set the teeth and stretch the nostril wide,

Hold hard the breath and bend up every spirit

To his full height. On, on, you noblest English.”

	But to avert the worst-case scenario-what might inelegantly be described as the UK falling flat on its face and shooting itself in the foot by overplaying its hand-the UK government needs to start exploring accommodations with its negotiating partners on cross-border trade, on regulatory alignment, on freedom of movement of researchers, on maintenance of patent and trademark protection, and on a dozen other key issues. 

	And if that means some acceptance of unwelcome constraints in the broader interests of patients, then the government should have the maturity to act accordingly. To preserve anything like normal service, the UK needs to make deals, and making deals means some readiness to make concessions, to recognize that not everything can work out precisely as the UK wants it.

	That is why medieval rhetoric has little place in the current predicament. Theresa May is perhaps susceptible to those ringing phrases of that long-departed (and ultimately unsuccessful) king:

“When the blast of war blows in our ears,

Disguise fair nature with hard-favour’d rage;

	But we are not in a time of war-and nor should anyone wish for that. Instead, the government would do well to pay heed to Henry’s other injunction: 

In peace there’s nothing so becomes a man

	And UK cabinet papers relating to Brexit should be required to carry a banner heading, reading: “The earlier instructions about setting the teeth and stretching the nostril wide, etc. are no longer to apply to our approach to Brexit negotiations.” 

It is hard to resist the sensation that the rhetoric of Shakespeare's Henry V is informing much of the Brexit thinking in Westminster, writes Reflector.

Brexit Threatens UK’s Drug Supply... And More

	A top priority for FDA this year has been to gain speedy Congressional approval of new user fee reauthorization bills. Now, White House proposals to slash funding for federal health agencies and to boost FDA reliance on medical product fees makes that task more critical, and more difficult. The administration’s budget “blueprint” calls for boosting

 industry fees by $1 billion in 2018 in order to reduce appropriated funds for pre-market review:  “In a constrained budget environment, industries that benefit from FDA’s approval can and should pay for their share,” states the “America First” budget plan. 

	It’s not clear, though, just how the administration would double FDA user fees. The agency already is scheduled to collect $2 billion in a variety of fees this year, as it did in 2016, about $860 million of that authorized by the Prescription Drug User Fee Act (PDUFA). Yet, these fees are intended to supplement, and not replace, appropriated funds. And doubling current drug fees would involve renegotiating the PDUFA VI package in just a few weeks, a perilous undertaking at this stage in the process. 

	An added complication in moving forward on user fee reauthorization is the expected host of “add-on” proposals to any user fee package. There’s growing enthusiasm on Capitol Hill for measures that facilitate patient access to experimental therapies under compassionate use programs. Drug pricing also is a hot issue, and FDA legislation may include proposals in this area, despite agency efforts to keep out of the pricing fray. Both Democrats and some Republicans support measures that permit Americans to purchase drugs at lower prices from Canada, and possibly other countries. The administration and most Democrats still want to authorize Medicare to negotiate prices of covered drugs. 

	More agreeable to industry are proposals to revise how Medicare Part B reimburses for medicines administered in doctors’ offices and to change Medicaid policies that discourage pharma development of value-based reimbursement models. Transparency in drug pricing practices is another popular theme, with legislation proposed to open up the rebate and discounting process. 

	Transparency is an important issue for Scott Gottlieb, who is slated to head FDA. He has expressed interest in legislation that authorizes FDA release of complete response letters, and user fee legislation could seek to clarify FDA authority to disclose that and other confidential information. Gottlieb also backs strategies to facilitate FDA approval of generic drugs to inject more competition in prescription drug markets. He has urged changes in FDA rules to facilitate testing 

and approval of complex generics, and there’s support in Congress for ensuring generic drug maker access to brand comparators.

	User fees are just one item on the FDA commissioner’s ever-expanding “to-do” list. There are tight deadlines for implementing the 21st Century Cures legislation, including measures designed to streamline clinical testing and to spur development of new medical products. Other hot-button, non-drug issues also will demand attention, including FDA regulation of clinical laboratory tests, cellular and gene therapies, food from gene-edited animals, genetic testing clinics, digital health applications, and blood supply safety, to name a few. 

	It will be no surprise to see Gottlieb move quickly to further clarify and moderate FDA rules on marketer communication of truthful information related to unapproved product uses. Earlier this year, FDA issued two important draft guidances in this area, one providing more leeway for sponsors to present healthcare economic information (HCEI) to payers, formulary committees, and other knowledgeable parties. The other document clarifies how companies may present data and information not in a product’s approved label, but “consistent with the FDA-required labeling”-or CFL, a new abbreviation. These proposals have generated so much discussion that FDA extended the formal comment period to April 19. They will be considered along with an agency memorandum on how FDA regulation of commercial speech impacts public health and safety and innovation.

	The HCEI guidance goes further than marketers expected by permitting the presentation of information to payers on investigational drugs and medical devices. Formulary committees and insurers have pressed for such advance communications to help them anticipate when an important new product is coming to market and would see coverage and formulary placement. Here, marketers need to clearly state that the product is under investigation; any hint that a product is FDA-approved is “not appropriate,” stated Elaine Hu Cunningham, senior advisor in FDA’s Office of Prescription Drug Promotion (OPDP), at the DIA advertising and promotion regulatory affairs conference in February.

	In its CFL document, FDA clarifies that added information has to be truthful and non-misleading and meet a three-factor analysis described by the agency. The aim is for FDA to help sponsors provide prescribers and health professionals (not consumers) with new information outside the product label that could enhance 

patient care. CFL information has to involve similar conditions of use and relate to the same indications and patient population in the approved labeling. New information that is 

 CFL includes product use at different disease stages, in different strengths or dosage forms, through different routes of administration, or to treat different medical conditions. But falling in the gray area of information that 

 be CFL is new data on long-term safety, additional adverse events, certain added patient subgroups, patient-reported outcomes on approved uses, more convenient dosing schedules, and comparisons to other products. 

	While marketers applauded the new guidances, they convinced FDA to go back to the drawing board with a new final rule on how to interpret “intended use” of a regulated product. FDA said it never intended to change its policy, but has put off further consideration of the issue until March 2018.

	These documents provide a clear starting point for Gottlieb to orchestrate a fresh approach to FDA regulation of commercial speech that addresses long-held industry concerns about agency curbs on a range of communications and marketing practices that raise free speech issues. FDA, as with other federal agencies, has been instructed to eliminate outmoded and overbearing regulations, along with redundant or unjustified functions. 

’s Washington Correspondent. She can be reached at 

Jill Wechsler outlines how the new FDA commissioner tasked with curbing regulation, speeding approvals-and collecting more fees to do it.

A Faster, More Flexible, and Frugal FDA?

recently spoke with Tommy Fanning, head of biopharmaceuticals and food at IDA Ireland, about the measures his organization is taking to bolster foreign direct investment by corporations in Ireland’s life sciences industry. The UK’s Brexit vote last year to pull out of the European Union may be a potential boost for the Irish biopharma market. The European Medicines Agency (EMA) is vacating its London headquarters in search of a new home, resulting in IDA Ireland ramping up efforts to attract the drug regulator to Ireland. At the same time,  IDA Ireland, which acts as a

 non-commercial, semi-state body, is busy continuing to promote the country as a manufacturing base for international life sciences companies in search of a strong source of talent.  

 was founded in 1949 as the Industrial Development Authority. The organization partners with potential and existing investors to help them establish or expand their operations in Ireland. Its major goal is to encourage investment by foreign-owned companies. Fanning’s background and experience are heavily involved in business strategy, development, and marketing. He’s held multiple business roles across IDA’s Irish and overseas operations.

Can you outline your personal journey in the life sciences space?

I’ve always been in the foreign direct investment area, working for IDA Ireland for more than 30 years in multiple sectors-with financial services companies, software and digital media companies, as well as with engineering and biopharmaceutical companies. When I was based in Tokyo, I worked with Asian companies to urge them to invest in Ireland. The two largest Japanese pharmaceutical companies, Takeda Pharmaceutical Co. and Astellas Pharma, operate two plants each in Ireland today, both API (active pharmaceutical ingredients) and final finished product. 

	I’ve been in my current position for about two years. My job involves running our biopharma department that promotes investment while working with the major pharmaceutical companies that have manufacturing facilities for small molecule pharmaceuticals and large molecule biologics. The companies manufacture both drug substance/API and also final finished product. Nine of the top 10 global drug companies have manufacturing activities in Ireland. There is quite a depth of knowledge and experience in the Irish pharmaceutical industry-an excellent skill base.  

What are the key changes you’ve seen in the pharma space in the last 10 years? 

We have a truly globalized economy in Ireland, so things that happen in the broader pharma market also happen here in Ireland. Up until the early 2000s, we were seeing a lot of pharmaceutical small molecule investment. But the last decade has really seen biologics take off. In the last 10 years in Ireland, we’ve seen an investment of more than $10 billion in biopharma facilities. Today, we have about 20 biologics manufacturing facilities dotted around the country. We are also seeing a lot of European supply chain operations. And more recently, we’ve attracted biopharma-specific services, including regulatory affairs, medical writing, pharmacovigilance, and pharmacoeconomics operations. 

	Over the years, the biopharma industry has sold products using very large sales forces. But that’s starting to change as we see companies build more targeted teams around digital sales platforms, so they can obtain analytics data about a product to see how it is succeeding in the marketplace against the competition. 

A conversation with Tommy Fanning, head of biopharma at IDA Ireland, about the country’s growth as a manufacturing powerhouse-and its bid to attract UK-based EMA post-Brexit.

Pharmaceutical Executive-04-01-2017