< PreviousQ&A20Pharma Business International www.pbiforum.netYour lead investigationaltherapeutic candidate has a NewDrug Application and MarketingAuthorisation Application underreview with the US Food andDrug Administration andEuropean Medicines Agency(EMA) respectively. What potentialdoes this treatment have?We believe lutetium 177Luoxodotreotide represents a significantopportunity. This treatment is for anorphan indication called neuroendocrinetumours, or NETs. The Committee forMedicinal Products for Human Use(CHMP) of the European MedicinesAgency (EMA) recommended agastroenteropancreatic, or GEP-NETindication, which is similar to the labelwe requested from the FDA. Based onhistorical incidence and prevalence data,a rough estimate of the GEP-NETpopulation in the US and EU combined isaround 240,000 people. We expect thatour drug will be used as a second-linetherapy, which is how Peptide ReceptorRadionuclide Therapy (PRRT) is currentlyreflected in GEP-NET treatmentguidelines published by the EuropeanSociety for Medical Oncology (ESMO)and European Neuroendocrine TumorSociety (ENETS). AAA positions themselves asbridging the gap betweenscientific findings and theirpractical use as life enhancingapplications. How important is itfor the science and medicinesectors to work alongsideregulators?Collaboration with regulators is crucialin bringing new innovations to themarket. For example, lutetium 177LuPRRT has had a long-documentedhistory of thousands of patients beingtreated since 2000. We identified a needto make PRRT more widely available,and initiated the regulatory process aswell as committed to developing a robustcommercial manufacturing process andconducting a randomised Phase III study,allowing for full market approval to beachieved. In fact, even though it is notyet approved, regulators allowed theadministration of lutetium (177Lu)oxodotreotide in more than 1,800patients on a compassionate use andnamed patient basis for the treatment ofNETs and other tumours over-expressingsomatostatin receptors in ten Europeancountries and in the US under anExpanded Access Program (EAP).There’s been much debate overthe future of Britain’s lifesciences and the EMA post-Brexit. What are your thoughtson the subject?The UK has a strong heritage in drivingmedical innovation, and the importanceof the life sciences sector to the UKeconomy post-Brexit is well recognisedwithin discussions. Creating a world-leading offer for pharmaceuticalinvestment and employment translates toan environment where research anddevelopment, reimbursement, and uptakeof medicines are well aligned. We are pleased that the Association ofthe British Pharmaceutical Industry (ABPI)is actively campaigning to support theindustry, and we feel that there is anacceptance by UK policy makers that oursector should receive sufficientprioritisation to mitigate any significantchanges to market dynamics post-Brexit,such as those regarding import tariffs forexample. Having founded AAA in 2002,how would you say thelandscape has changed, and doyou think developing nuclearmedicines is easier now?The nuclear medicine sector hasevolved significantly since 2002, and isnow providing a much wider variety ofproducts for functional imaging in cancer,neurology, infectious disease and otherareas. Development of these diagnosticmedicines may be somewhat easier thanwhen we started, because functionalimaging techniques have gained wide-spread validation and adoption, andclinicians and regulators understand theirvalue. However, significant advances inthe therapeutic side of the nuclearQ&AStefano BuonoPharma Business International recently sat down with Stefano Buono, CEO ofradiopharmaceutical company Advanced Accelerator Applications (AAA), to discuss nuclearmedicines, the effect of Brexit on Britain’s life sciences and future developments. 20-21_Layout 1 07/08/2017 11:11 Page 1Pharma Business International 21www.pbiforum.netQ&Amedicine industry are just now beginningto emerge.Are there any future plans ordevelopments you can tell usabout?We have positioned AAA as the firsttheragnostic nuclear medicine companyin oncology - merging therapeutic anddiagnostic technologies to advance theearly detection, treatment and monitoringof disease. We believe this approach isthe future of nuclear medicine and willultimately lead to a greater use of nuclearmedicine therapies in oncology. We are developing a pipeline oftheragnostic pairings for oncologyindications. Our theragnostic platforminvolves radiolabelling a single targetingmolecule with either gallium Ga-68 fordiagnostic use, or lutetium Lu-177 fortherapy. Therefore, molecular imagingand diagnosis of the disease can beeffectively followed by personalisedtreatment utilising the same moleculartargeting compound.Lutetium 177Lu oxodotreotide is thetherapeutic part of our first pairing forNETs. The diagnostic parts of the pairing,SomaKit TOC™ in Europe andNETSPOT® in the US are approved forlocalisation of NET lesions. Since theyshare the same targeting molecule aslutetium 177Lu oxodotreotide, thediagnostics may also be used to selectpatients for PRRT treatment.20-21_Layout 1 07/08/2017 11:11 Page 2PROCUREMENT22Pharma Business International www.pbiforum.netMany pharmaceutical companies relyon procurement as a major incomesource. Operations such as the NHSin the UK have a purchasingpower far greater than any otherorganisation so winningcontracts can have a hugeimpact on the company’sbottom line.Yet as procurementprocesses are changing, thishasn’t always gone hand inhand with changes to the waycompanies alter theirprocedures. Tendering isbeginning to dominateprocurement and it is vital thatcompanies are well-placed to respondin an effective fashion. The NHS, for one,has this summer published a report toreview their procurement capability. TheNational Audit Office identified thepotential for £500 million in savings byembracing better procurement policies,so it’s likely that changes in the way theymanage procurement and liaise withsuppliers are in the air.A survey conducted by Model N andtechnology partner Feedback ProcessiLogici suggests the companies hoping towin tenders will need to change theirapproach to take advantage of the newstreamlined methods. The survey invitednearly a hundred top-level managers toprovide insight into their tendermanagement priorities and practices anddiscovered that almost three quarters ofproviders to the Life Sciences market arefailing to proactively engage all keystakeholders.That’s certainly a smaller number thanhas been the case in previous years.Indeed, James Robinson, Director ofIndustry Solutions at Model N, says,“Two years ago, the number of firmsadopting a centralised approach wouldhave been much lower. However, muchmore needs to be done if providersare not to miss vital opportunitiesto increase their tenderconversion rates.“With more than two thirdsof businesses lackingautomated processes andwith no senior managementbuy-in, it’s clear that theimportance of effectivetendering has still to take itsrightful place in today’sboardrooms, despite increasingmarket pressures. Disconnected,manually-based processes result inhighly damaging gaps in the tendermanagement lifecycle between offers,administration and award management.This creates unnecessary revenueleakage and reduced profitability.”The NHS Procurement DevelopmentProgramme is among those thatadvocate the use of competition toensure value. Peter Harrison, SiemensHealthcare’s UK Managing Director, says,“Effective procurement will befundamental to addressing the NHSfunding gap and every party within thesupply chain must be prepared toProcuringcontracts Procurement is a complex task within the pharma industry and sometimes it’s easy to getbogged down with your own procurement strategy. It is worth, however, looking at yourmajor competitor’s procurement strategies as well.24 Á© Shutterstock / chrisdorney22-25_Layout 1 07/08/2017 11:11 Page 1© Shutterstock / Monkey Business Images22-25_Layout 1 07/08/2017 11:11 Page 2PROCUREMENT24Pharma Business International www.pbiforum.net“Effective procurement will befundamental to addressing the NHSfunding gap and every party within thesupply chain must be prepared todemonstrate their value.”Peter Harrison, Siemens Healthcare’s UK Managing Director22-25_Layout 1 07/08/2017 11:11 Page 3Pharma Business International 25www.pbiforum.netPROCUREMENTdemonstrate their value. This includes procurementintermediaries such as framework operators. We are pleased tosee the report promises to explore opportunities to increasetransparency of procurement data, and we believe there shouldbe much greater transparency of business transacted throughprocurement framework operators. There are clear benefits tobe derived from the effective use of frameworks, such as thereduced cost of the procurement process, and leverage ofdemand discounts.”The Model N survey suggests that only 14% of thosesurveyed recognise tendering as an opportunity to differentiatethe business on value rather than price, so there is an obviousopportunity for companies to illustrate their ability to provide thefull package. James Robinson says, “Bearing in mind thefundamental importance of ensuring legal compliance at everystep in a highly-regulated tendering environment, the relativelack of concern found by the survey is both a surprise and aconcern.”Procurement isn’t just a question of maximum value at theminimum price – as these projects can also play a major role todrive innovation. There are myriad opportunities for innovativecompanies to engage with the public sector to solve specificproblems, most notably in schemes such as the UK’s SBRIwhich enables the public sector to engage with industry duringthe early stages of development, supporting projects throughthe stages of feasibility and prototyping.Standing for the Small Business Research Initiative, the SBRIaims to match business ideas to government challengesthrough a simple procurement process. The benefit forbusinesses is that the public sector organisations take the leadcustomer role, helping to develop and de-risk innovativesolutions for which it might be the potential future customer.The process starts with a government department or otherpublic body identifying a specific challenge, which is thenturned into an open competition for new technologies andideas. Companies with potentially interesting technologiessubmit an application, and those judged to be the mostpromising are awarded development contracts. This firstfeasibility phase lasts generally two to six months, withcontracts typically being up to a maximum of £100,000.Following a second assessment stage, a subset of theseideas may be awarded a second phase contract which can befor up to two years and a maximum of a million pounds, and willgenerally be for the development of a prototype ordemonstrator. After this, companies are expected tocommercialise the result which is taken to market and open tocompetitive procurement. Any intellectual property remains withthe company and 100% of the funding is provided through acontract not a grant.These changes could affect many within the pharmaceuticalindustry, and the results of studies like this could determinemarketing and targeting strategies for some time.© Shutterstock / Monkey Business Images22-25_Layout 1 07/08/2017 11:11 Page 4LABORATORIES26Pharma Business International www.pbiforum.netWorking tostandardLaboratory practice is important to ensurevalidity and minimise risk. One of the mostwell-known documents on this is the GoodLaboratory Practice code, or GLP. 26-29_Layout 1 07/08/2017 11:12 Page 1Pharma Business International 27www.pbiforum.netLABORATORIESResearch and developmentremains key to the progress of manypharmaceutical firms, and also thefuture of the human race. In an erawhere pathogens are becomingincreasingly resistant to commonmedicine, it is important that suchcontinues. Many pharma giants runnumerous research laboratoriesaround the globe, and there are alsoplenty of independent labs who seekto sell any finished product orresearch to pharma companies.Good laboratory practice (or GLPas it is known) is obviously veryimportant. In most cases it refers to aquality system of controls andmanagement for laboratories, whichhelps to make sure that there is acertain reliability and integrity to anyresults. This involves a number ofrequirements, as any good non-clinical research must be consistent,reliable and above all reproducible. GLP was born in 1972 in NewZealand and Denmark, but onlyspread to the US in 1978 following aBioTest Labs scandal. TheOrganisation for Economic Co-operation and Development (OECD)helped to spread the principles ofGLP to many other countries, andnow it is common around the world. Obviously GLP does not refer tothe basic safety necessities of labhealth and safety, such as gloves,glasses and PPE. These are basicrequirements that should come asstandard in every way. GLP is split into many differentcategories, all of which carry equalimportance in the eyes of the OECD.The responsibilities of individualpersonnel and their roles are clearlydefined, as is the need for thesemembers of a team if any are notpresent. The guidelines are mostly brokendown into the different stages of© Shutterstock / Tonhom100929 Á26-29_Layout 1 07/08/2017 11:12 Page 2LABORATORIES28Pharma Business International www.pbiforum.net© Shutterstock / PowerUp26-29_Layout 1 07/08/2017 11:12 Page 3Pharma Business International 29www.pbiforum.netLABORATORIESresearch, including test facilityorganisation and personnel – whichlooks into the responsibilities of theStudy Director, Principal Investigatorand Study Personnel. These aim toensure that studies are carried out ina way that aligns with conductrequirements expected of thepositions. There are also guidelines toindicate and set up expectations forthe recording, documenting andarchiving process. Following after that is QualityAssurance programmes, including theresponsibilities of QA Personnelwithin the lab. Facilities in general,which involves not just test systemfacilities but also facilities for handlingtests and archiving. Waste disposal isalso covered, particularly with thehazardous s and dangerous nature ofmany by-products created in the lab. When it comes to study plans andreports, the GLP lays out requiredcontent for the study plan in terms ofaims and goals, details of the sponsorand any additional test facilitiesinvolved in the tests, and much more.The goal here is to ensure that anyand all transparency is observedwhen it comes to looking over orpublishing the results of any tests.Scandals in past years have shownthat labs sponsored by individualcompanies may find results thatbenefit those companies to thedetriment of scientific protocol. GLPcan help reduce this, or at least putsafeguards into place that allowinvestigators to look back over theprocess and identify if this might bethe case.GLP has always been referenced assomething of a guideline, but formany countries certain aspects – orthe entirety – of it have been put intolaw. The European Union adopted twobasic Directives and a Decisionrelating to the application of the GLPprinciples in 1987, while somechanges were made to this in 2004,much of it still does apply. Theseinclude compulsory audits andinspections to ensure that lab facilitiesconform to GLP rules and regulations. There are a number of Non-OECDmember countries who do notconform to GLP standards in labs. Itis worth noting that this does notdiscount the validity of their results,and in fact many interestingdevelopments have come fromcountries who do not follow GLP.OECD regulations do not guaranteegood science or correct results, butrather then ensure that any resultsgathered can be easily reproduced ina control environment to ascertain thevalidity. Results generated in Non-OECD locations might not have thesame easily-followed paper trail,which can make reproducing the trialsto ensure validity almost impossible. Though some have criticised theGLP as being prohibitively expensiveto follow, mainly due to itsrequirement for certain experiencedstaff members, it is no exaggerationto say its implementation has helpedthe pharmaceutical industry expand ata rate far beyond its cost. Ultimatelythese practices have provenworthwhile and achievable for manyacross the world, so the validity ofthose who say it cannot be followedcould be drawn into question. 26-29_Layout 1 07/08/2017 11:12 Page 4Next >