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Life Sciences Industry Overview, Challenges and Opportunities

Life Sciences industry is at the throes of innovation and transformation.  Targeted therapeutic approaches for cancer and rare diseases and rapidly evolving genomics and molecular medicine approaches are translating into Precision medicine and individualized therapeutic protocols. Gene therapy and Gene editing are beginning to transform the industry at a fundamental level. Decentralized Clinical Trials (DCT) are aiding the transformation, facilitating a patient-centric approach and leveraging a variety of digital technologies.  Recent application of mRNA-based platforms, expeditious trials and submission have led to the approval of highly effective vaccines for COVID-19.  These new approaches provide increased confidence to the life sciences industry and the patient population in the potential of next generation treatments. 

 

Multiple operational levers are being evaluated, leveraging "Digital Clinical" infrastructure and associated processes and trained staff and applied to increase the efficiency of clinical trials: 

  • ​Adaptive designs, patient-centric and Real-World Evidence (RWE) based.

  • Operational agility to conduct decentralized clinical trials (DCT), remote monitoring of sites, remote patient engagement and leveraging a variety of digital technologies (e.g., m-Health devices).  

  • Define and implement better data standards and deliver improved data quality.

  • Establish "Best In Class" governance to enable sharing of real time insights across functions internally and externally (e.g., CROs, regulators and other industry peers) to drive better collaboration and improved outcomes for patients.

  • Ensure enterprise-wide adoption of digital, AI, machine learning and cloud technologies to accelerate time to market and achieve real transformation  

 

As industry pursues a diverse set of global and submissions, there is added pressure on Pharmacovigilance, Regulatory affairs and other functions to improve their operational agility, digital technology capabilities and understanding regional regulatory agencies' requirements for successful submissions.  Hence the need for business transformation and a dependable set of external providers that offer scalable, flexible and high quality services for a variety of “Future-ready” operating models has become a critical. 

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LS-SACS approach to assisting clients in their Transformation efforts

Life Sciences Sourcing Advisory and Consultancy Services (LS-SACS) is committed to assisting and driving the transformation of the industry.  We offer advisory and consulting services in two main areas of transformation in the industry - Clinical operations transformation and Strategic Sourcing and Outsourcing.   Our proven approach will enable our clients to become more efficient, reduce clinical development cycle time and cost of operations, while ensuring highest quality, patient safety and satisfaction. 

  • ​Strategic Sourcing / Outsourcing Advisory Services:  We provide "end to end" sourcing services from strategy through RFP process followed by post contract implementation and governance. We ensure established contracts and agreements with the optimal set of global and regional CRO, FSP and Technology vendors that fits your needs. Service areas include  

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  • Clinical monitoring / operations

    • Clinical data services (e.g., CDM, Biostatistics / programming, data standards / conversions)

    • PV / drug safety

    • Complaints management 

    • Regulatory affairs

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  • Business Transformation across Clinical, Pharmacovigilance and Regulatory Operations: We bring proven frameworks, experience, and expertise to help you define your clinical, PV or regulatory operations future vision that is aligned with industry trends.  We help redesign internal processes and align technologies. We assist in refining the skills and redesign of the roles and responsibilities of staff across clinical operations, clinical data services, pharmacovigilance, regulatory affairs and other areas. 

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We bring the Ideal combination of strategic sourcing experience with all types of engagement models and the diverse domain / functional expertise needed to enable transformation.

 LEADERSHIP 
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DR. KRISHNAN RAJAGOPALAN, PH. D.,

President, LS-SACS 

Dr. Krishnan Rajagopalan has 25+ years of experience in management consulting, global services delivery (CRO, FSP and IT services) and sourcing / outsourcing advisory services to the Life Sciences industry (Pharma, biotech, medical devices, and generics).  He advised and provided services to more than 120 small, medium, and large (8/10 top Pharma) life sciences organizations across research, clinical development, and commercial functions.  Prior to setting up Life Sciences Transformation Group, Krishnan was an advisor and global practice leader at Navitas Life Sciences, Cognizant, PA Consulting, Infosys and Mitchell Madison Group

Krishnan has extensive experience in establishing and delivering functional (FSP), IT and CRO services using a 24x7 integrated operating model from India, China, US, EU, and Latin America.   The range of services delivered include

  • Phase I-IV studies (CRO)

  • Clinical Data Management, Biostatistics and Programming, and Medical Writing

  • PV / drug safety

  • Quality / complaints management.

 

He was involved in the design and implementation of multiple contracting and commercial models, including Time & Material, fixed price, unit / deliverables /outcomes-based and risk-reward.

 

As a strategic sourcing advisor and management consultant, Krishnan delivered transformative solutions to C-Suite leadership and functional leaders across R&D and commercial areas.  Some of the core solutions included:

  • Best practice business and IT strategy, operating models and governance 

  • BPM / BPR

  • Digital strategy and governance

  • End to End sourcing and outsourcing

  • PMO and organizational change and communications management

  • Analytical and automation capabilities for improved productivity. 

Dr. Rajagopalan has a Ph.D., in Bio organic chemistry from the University of Kentucky and was a NCI Cancer Research Fellow at the Harvard Medical School and Massachusetts General Hospital.  He has more than 20 peer reviewed publications and presentations and a US Patent

TEAM
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LS-SACS leverages a broad network of industry leaders and SMEs across clinical operations, clinical data sciences, pharmacovigilance, regulatory operations, procurement and other areas.  The network includes an extended team of business process transformation, operating model and redesign, staffing roles and responsibilities and training, organizational change and communications and digital, AI / ML technology  experts.  

CONTACT US

Life Sciences - Sourcing Advisory and Consultancy Services (LS-SACS)

Edison, New New Jersey, USA

Email: krishnan.rajagopalan@ls-sacs.com

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