What the Future of the Pharma Industry Holds - Boris Reznik, BioRASI LLC


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Boris Reznik of BioRASI LLC, a solution provider at the marcus evans Evolution Summit 2013, on the latest trends in the pharmaceutical industry.
Interview with: Boris Reznik, Chairman, BioRASI LLC

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What the Future of the Pharma Industry Holds - Boris Reznik, BioRASI LLC

  1. 1. What the Future of the Pharma Industry HoldsInterview with: B o r i s R e z n i k ,Chairman, BioRASI LLCMaximizing the probability of clinicaltrial success is key, as pharmaceuticalcompanies are increasingly pressured toreduce the time and cost of clinicaldevelopment, without compromising onquality, says Boris Reznik, Chairman,bioRASI LLC.A contract research organization (CRO)joining the marcus evans EvolutionSummit 2013, in Palm Beach, Florida,May 8-10, as a solutions provider,bioRASI LLC’s Reznik highlights thelatest trends in the industry.What trends do you see in thepharmaceutical industry globally?The growth of emerging consumermarkets worldwide is promptingpharmaceutical companies to takedeliberate steps for adhering toregulatory requirements of not only theUS Food and Drug Administration (FDA)and the European Medicines Agency(EMA) but also other jurisdictions even ifrollout to those markets is notimmediately planned. For example,including Russia into pivotal trialgeographies assures eligibility of thedrug for future registering there.The industry is also experiencingmounting pressure to reduce overallcosts of bringing new drugs to market.With clinical development being one ofthe most expensive components of thisprocess, the accepted paradigm ofoutsourcing specialized services to CROscontinues to climb. CROs are nowaccountable for maximizing theprobability of trial success andmaintaining high service levels whileminimizing both the time and cost ofdevelopment. This trend is causing thepharma industry to re-evaluate theirexclusive relationships with multi-billiondollar CROs and in certain cases to shiftalignment to small and mid-size CROswho might be better at fulfilling theentire spectrum of these requirements.Additionally, sponsors are increasinglylooking to CROs to provide a scientificangle, not only in development ofprotocols or clinical trial designs, butalso in running them with the aim ofoptimization. Agile CROs are respondingto this challenge by augmenting theirprofessional talent pool with MDs andPhDs trained in particular areas ofspecialty.Leading CROs are progressing beyondmere global presence to fully integratingtheir geographic capabilities, the bestworldwide medical facilities, supply chainmanagement and e-clinical technologies.Strong partnerships between pharmacompanies and CROs optimize thefulfillment of global regulatoryrequirements eliminating the necessityto duplicate trials.Another trend is associated with anincreasing number of expiringblockbuster drug patents. This isopening up new areas of opportunitiesfor pharma and biotech companies.Building upon existing successful smallmolecule drugs, companies aredelivering to the market both genericdrugs and enhanced 505(b)(2) versions.Similarly, biologics going off patentcreate tremendous opportunities withfollow-on biologics, from biosimilars tobio-betters and soon to inter-changeables. Pharma companies aresearching for CROs that havedemonstrated experience in these areasto avoid pitfalls that have been known toderail biosimilar development. Notsurprising, companies are eager topursue simultaneous approvals fromFDA, EMA and other jurisdictions forcostly biosimilar drug developments.In the wake of this trend some CROs areemerging as experts in follow-onbiologics. The concept of inter-changeability presents even greaterpotential; biosimilars would require adirect-to-physician sales force, which isexpensive. Interchangeable biosimilars,however, can be sold directly to majordistributors and pharmacy chains,because they can be substituted at thoselevels, providing a far more cost-e ffe c tive s trate gy f or ma rke tpenetration.How can pharmaceutical companiesachieve the highest probability ofsuccess?Trial success requires a close partnershipbetween the sponsor and CRO inadvance of project design. Withcollective focus on optimization, they candetermine the relative importance to beplaced on crucial trial variables. Focusingon factors as if they are independentleads to unintended consequences, forexample increasing the number ofpatients naturally increases the trialpower, but also increases costs andtime. Since all program requirementsare in fact interconnected, solutionsmust be developed with simultaneousmultidimensional considerations in mind.This demands using a more scientificapproach when designing studies andleads to a higher probably of success.For example, selecting precise endpointsmeasurements and reducing trial-induced variability provides for a studywith a given number of patients havinghigher power, or for the same trialpower but with fewer patients. This iswhere novel principal investigator (PI)interactive training reduces intra- andinter-rater variability. Taking that a stepfurther, you can apply similar techniquesfor training study subjects to minimizeinter- and intra-subject variability.These types of scientifically designed,and more importantly validatedmethods, are exactly what the industryleaders use.Any final comments?Billions of dollars have been needlesslywasted on trials that have failed to reachsuccess or need to be repeated forapprovals in different jurisdictions. Theindustry is moving toward leveragingappropriate expertise, normallyassociated with CROs, in the areas oftrial design and conduct to increase theoverall probability of success andeliminate rerunning the studies.Manybillionsof dollarshave beenwastedon trials
  2. 2. The Pharma Network – marcusevans Summits group deliverspeer-to-peer information onstrategic matters, professionalt r e n d s a n d b r e a k t h r o u g hinnovations.Please note that the Summit is aclosed business event and thenumber of participants strictlylimited.About the Evolution Summit 2013This unique forum will take place at The Ritz-Carlton, Palm Beach, Florida, May8-10, 2013. Offering much more than any conference, exhibition or trade show, thisexclusive meeting will bring together esteemed industry thought leaders andsolution providers to a highly focused and interactive networking event. TheSummit includes presentations on improving trial performance, establishingstrategic alliances, site selection and e-recruitment.www.evolutionsummit.comContactSarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, SummitsDivisionTel: + 357 22 849 313Email: press@marcusevanscy.comFor more information please send an email to info@marcusevanscy.comAll rights reserved. The above content may be republished or reproduced. Kindlyinform us by sending an email to press@marcusevanscy.comAbout BioRASI LLCAs a full service global CRO, bioRASI delivers “Clinical Research Optimized”. bioRASI provides expertise in the design and executionof large complex clinical trials, supporting Specialty, Innovative and Biopharmaceutical companies bioRASI accelerates drugdevelopment by optimally leveraging global resources and proficiency across a broad range of therapeutic indications, maximizingquality, service levels, regulatory and industry acceptance, while minimizing time and cost.www.biorasi.comAbout marcus evans Summitsmarcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discussstrategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity toindividually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings.For more information, please visit: www.marcusevans.comUpcoming EventsDiscovery Summit (Europe) - www.discovery-summit.comEvolution Summit (Europe) - www.evolution-summit.comTo view the web version of this interview, please click here: www.evolutionsummit.com/BorisReznik