Risk Management Thought Leader

Shashwata Prosad Das

Deerfield, Illinois *****, USA +1-224-***-**** **************@*****.*** linkedin.com/in/shashwata-p-931a602a (Shashwata Prosad Das LinkedIn)

Highly analytical and results-driven ethics, risks and compliance thought leader with US and global experience in cultivating ethical and compliance frameworks, ensuring adherence to compliance standards across enterprise governance and compliance requirements in life science and broader healthcare industry. In depth experience in Commercial, Medical, Access, Advocacy, R&D, GMP and GCP governance, compliance, standards and systems; in depth knowledge and experience across rare diseases, ATMP, Oncology, Specialty care and mass market life science business governance and compliance strategies and programs. Thought leader in organizational culture development with built in risk awareness, along with data integrity & governance, QHSE and ESG fundamentals and core deliverables.

GOVERNANCE AND COMPLIANCE THOUGHT LEADER

IN

I ETHICS, RISKS & COMPLIANCE I ENTERPRISER AND 3RD PARTY RISKS MANAGEMENT I RWE AND HEOR EXCELLENCE I MEDICAL AND ACCESS EXCELLENCE I ASSURANCE, MONITORING AND INTERNAL AUDIT I

Visionary orchestration of Ethics, Risks and Compliance, powered with influential thought leadership and strategic guidance to establish enterprise mindset and governance. Bringing totality of the healthcare eco-system in the thought and decision-making process enabling outside in perspective to forecast external risks, internal issues and operational levers to manage business criticalities to bring and scale solutions. Expertise in streamlining governance processes to enhance operational efficiency and reduce time-to-market for healthcare solutions. Proven success in championing compliance strategies. Specialized in Ethics and Compliance leadership in today’s complex healthcare eco-system, compliance and assurance programs, risk management, privacy management, team empowerment, and leadership development. Adept at developing and implementing compliance programs, streamlining clinical operations, and medical governance. Astute at ensuring robust tracking of Corporate Integrity Agreement (CIA) deliverables to uphold adherence to the US compliance program.

Areas of Expertise

● Effective Compliance Program

● Managed Access Programs (MAP)

● GCP, GMP & Clinical Operations

● Team Training & Leadership

● Privacy management (HIPPA, GDPR, etc.)

● Good Manufacturing Practices (GMP)

● Enterprise Risk Management

● Medical Governance

● Audit & Operational Risk Management

● Third party risk management

● Project Management

● Health Economics & Outcome Research

● Strategic Business Partnerships

● Governance and Compliance Processes

● Early Access Requests (EAR)

● Corporate Governance

● Global commercialization

● Market Research

Signature Accomplishments

Impactful Leadership: Honored as the most impactful functional leader in Novartis Gene Therapies, celebrated for exceptional leadership and strategic vision in advancing the company's therapeutic initiatives. Rewarded as part of the leading team and governance leader for Novartis Gene Therapies integration into the parent organization.

Leadership in Acquisition and Integration: Steered the seamless integration of Alcon and Avexis (Novartis key acquisitions) into Novartis Gene Therapies, receiving accolades for both projects and ensuring their successful incorporation into the broader Novartis framework.

Compliance Leadership and Excellence: Achieved expertise through extensive work across GCP, Medical Governance, alongside Ethics and Compliance Areas. Had opportunity to be author and/or reviewer of multiple standards across cross border treatment, publication standards, RWE processes, medical writing and publication support decision making, Data governance and sharing, systems connectivity, GxP validation of systems, etc.

Talent Development: Developed and mentored many associates over time and many of them are at senior leadership positions across the world.

Professional Experience

Novartis Gene Therapies (GTx), Bannockburn, IL

Executive Director, Ethics Risks and Compliance

December 2021 — June 2024

Led the US ERC team to foster an environment of team collaboration and continuous improvement. Developed and implemented forward looking compliance program and standards enabling short to long term business success. Invested in team development and ensured 360-degree learning environment to enable faster business decision-making processes, robust risk management and overall, an assurance driven business management culture. Ensured effective collaboration with cross-functional team and leaders to align priorities and resources to address business & compliance risks, and company issues to meet the expectations of the regulators and external stakeholders both near and long terms, manage assurance program (monitoring, testing, systems), training, and updating of company's code and compliance policies and standards.

●Ensured systems and processes to effectively communicate compliance policies, procedures and standards across the company, drove learning and training programs in a systematic manner to ensure optimum awareness of business processes and risks, and eventually enabling the organization to make informed and credible business decisions. Ensured successful governance path for rare and ATMP business model.

●Developed team with forward looking capabilities and skillsets, aligning with the evolving requirements of the life science eco-systems, business acumen, regulatory and operational risks, data science and governance, digital and AI evolution to manage data and systems, Privacy management and compliance in programs & data collection processes, and ensure effective business partnering supporting and aligning with key business leaders in a rapidly changing regulatory environment.

●Championed systematic and hands on approaches to manage compliance training, regular touch points with field colleagues’ questions and confusions, billing and ordering matters with key accounts team and bridging overall operational compliance matters.

●Guided and solved medical and commercial access programs properly vetting Medicare and Medicaid compliance and Office of Inspector General (OIG) governance and regulations, Pharmacy access programs (specialty care program, 340B, etc.).

●Streamlined clinical operations, Health Economics and Outcomes Research (HEOR) management, Real-World Evidence (RWE) platforms, Managed Access Programs (MAP), Early Access Requests (EAR) and third-party governance on data management.

●Ensured robust tracking of Corporate Integrity Agreement (CIA) deliverables aligned with the US compliance program and defined a forward-looking governance path.

Global operation of Ethics, Risk & Compliance

Directed the GTx worldwide ERC team to foster skill development and build a high-performing and cohesive unit. Cultivated a highly motivated team through strategic coaching, development, and empowerment. Established forward-looking compliance programs to enable informed business decisions and prepare team members for future leadership roles. Oversaw and ensured adherence to compliance policies, procedures, systems, and transparency reporting.

●Spearheaded compliance initiatives to fortify business partnerships, enhance assurance programs, and optimize risk management. Ensured absolute clarity of roles and responsibilities of the team to be effectively involved in the assigned areas with empowerment and accountability.

●Developed a 360-degree and well-connected compliance and governance program across GCP governance, general compliance, enterprise risk management, and assurance exercises.

●Consistently evaluate overall culture generating programs consisting of ESG, Enterprise risk management, corporate policies and standards and external benchmarking cum regulatory and reporting requirements.

●Resolved regulatory issues by collaborating with internal auditors and representing the organization to external auditors and regulatory officials.

Novartis Pharma AG, Switzerland. February 2019 – November 2021

Business Franchise ERC Director

Advised the Global Marketing and Value Access team to optimize the delivery and implementation of global projects. Established clear governance pathways and standardized documentation to support initiatives, such as Implementation Science and partnerships with health authorities, including population health and entry agreements during registration. Collaborated with a high-performing team to simplify company standards and procedures, including managing Patient-Oriented Programs (POP), Market Research, and differentiating non-interventional studies across Health Economics and Outcome Research (HEOR).

●Ensured a mature, business focused and forward-looking risk-based compliance program in place, while partnering with business teams as an advisor and thought leader. Directed team in the same spirit.

●Refined regulatory processes by developing and implementing access models, including pre-approval paths. Steered the creation of cross-border treatment guidelines, Overall GCP governance for RWE, MAP, EAR and publication excellence paths to enhance market research projects.

●Enabled business transformation while forging strong business and technology partnerships, effectively collaborating with peer executives, and senior leaders across the enterprise demonstrating the ability to use compliance and business acumen to guide prioritization and planning processes.

●Build, mature, and maintain a collaborative enterprise risk management function, executed through a matrix of enterprise functions providing insight, trends, best practices, and practical guidance.

●Drove continuous improvement initiatives by coordinating with the internal audit team, leveraging technology, data analytics, machine learning, and digital approaches.

Novartis Singapore PTE LTD, Singapore

Head of Compliance, Singapore & Asian Emerging Markets

June 2015 — January 2019

Established and directed the compliance and risk team for Singapore and Asian emerging markets. Designed and implemented efficient compliance programs to fortify business partnerships, manage risks, and support the operational models of various business units.

●Developed assurance methodologies and promoted governance across markets by collaborating with Internal Audit team.

●Constructed governance and assurance models for diverse business units, including mass-market generics, innovative pharmaceuticals, and oncology products.

●Led GCP governance and study management for development and medical affair studies out of Singapore.

●Championed compliance with regulatory standards and optimized operational processes by overseeing distributor market governance frameworks.

Novartis Pharma Services AG, Sri Lanka

Country Manager, Sri Lanka and Maldives

September 2012 — May 2015

Led all aspects of General Management while overseeing cross-functional teams and P&L accountability. Cultivated key leadership talent for self-pay and tender-driven markets to drive strategic initiatives, drive business growth, and optimize market penetration.

●Enhanced operational efficiency by streamlining processes and optimizing resource allocation.

●Drove revenue growth by conducting market analysis and implementing sales strategies.

Novartis Pharma AG, Switzerland

Regional Brand Lead, Ophthalmology & ALCON Integration Manager

August 2011 — August 2012

Served as the Ophthalmology Brand Lead for Asia Pacific, Australia, Middle East, and Africa. Developed and implemented commercial strategies and drove market growth. Led the seamless integration of Alcon into Novartis operations to foster regional alignment and transition.

●Streamlined brand management and accelerated market penetration by cultivating strong stakeholder relationships.

●Partnered with cross-functional teams to implement strategic initiatives and optimize brand performance.

Novartis Asia Pacific, Singapore (Based out of Bangladesh)

Cluster Brand Lead

January 2010 — July 2011

Managed a strategic brand within the Metabolic portfolio across nine markets in the Asia Pacific region while delivering leadership and support to in-country brand teams. Developed and implemented brand strategies to improve market positioning and messaging. Coordinated cross-functional efforts to align sales, marketing, and medical affairs following regional objectives.

●Drove regional success of the brand by fostering collaboration among sales, marketing, and medical affairs teams.

●Increased brand visibility and market share through strategic planning and execution.

Additional Experience

Novartis Bangladesh PVT LTD Head Business Franchise, Senior Portfolio Manager, Portfolio Manager (May 2003 – July 2011)

Square Pharmaceuticals LTD, Bangladesh Senior Product Executive, Product Executive, Sales (Dec 2000 – April 2003)

Clinical and Retail Pharmacist Part-time involvement during final year master’s in pharmacy (1998 – 2000)

Market Research Field Agent Field work for a market research agency during hons in pharmacy (1996 – 1998)

External Involvement

Speaker at Business & Compliance Forums & Conferences: Delivered presentations on topics, such as Artificial Intelligence (AI) and Generative Artificial Intelligence (GAI) in rare disease ecosystems, governance of Advanced Therapy Medicinal Products (ATMP) including gene and cell therapies, radio ligand therapies (RLT), and siRNA.

Publication Contributor: Authored articles on the impact of AI and GAI in rare disease spaces and ATMP, contributing to the body of knowledge in advanced fields.

Education

Master of Science (MS) in Health Administration

Institute of Health Sciences, Colombo, Sri Lanka

Master in business administration (MBA)

University of Dhaka, Dhaka, Bangladesh

M’Pharm (Masters in Pharmacy)

University of Dhaka, Dhaka, Bangladesh

B’Pharm (Hons’ in Pharmacy)

University of Dhaka, Dhaka, Bangladesh

Professional Development

Business Finance II

Harvard Business School, Boston MA, USA

Post-Graduation in Leadership Capability

Glasgow Caledonian University, Glasgow, UK

Certified Compliance Officer

Ethics and Compliance Initiative (ECI), USA

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