Shekhar Natarajan | Forttuna Council Member

Skills

Regulatory Affairs & Global Pharmaceutical Policy Rare Disease Drug Development & Clinical Lifecycle Strategy Biotech Leadership, Compliance & Industry Advocacy

About

Seasoned Biotech Leader | Vice President | Chair of IRDiRC Therapies Scientific Committee (TSC) | Chair of EUCOPE R&D Group | British Pharmacopoeia Commission’s Expert Advisory Group (EAG)
Shekhar is currently Vice President- Regulatory Affairs and Policy at Dyne Therapeutics, a Boston, USA based biotech company specializing in rare muscle diseases. Within Dyne...

Company details

Dyne Therapeutics

Company Bio

Dyne Therapeutics is a clinical-stage biotechnology company focused on developing life-transforming therapies for people living with genetically driven neuromuscular diseases. Headquartered in Waltham, Massachusetts, the company is dedicated to advancing innovative treatments designed to address the root causes of serious muscle disorders and improve the lives of patients and their families.

The company’s research is centered on its proprietary FORCE™ platform, which enables targeted delivery of therapeutics to muscle and the central nervous system. Through this technology, Dyne is developing therapies aimed at delivering meaningful functional improvement for individuals affected by rare neuromuscular conditions.

Dyne Therapeutics is advancing a robust pipeline of programs targeting diseases such as Duchenne muscular dystrophy (DMD), myotonic dystrophy type 1 (DM1), facioscapulohumeral muscular dystrophy (FSHD), and Pompe disease. Several of these programs are currently progressing through clinical trials as the company works toward bringing new treatment options to patients with significant unmet medical needs.

Driven by a mission to transform the future for people living with serious muscle diseases, Dyne Therapeutics combines scientific innovation, patient-focused research, and collaborative partnerships to accelerate the development of next-generation therapies that can deliver lasting impact for individuals, families, and communities worldwide.

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About

Seasoned Biotech Leader | Vice President | Chair of IRDiRC Therapies Scientific Committee (TSC) | Chair of EUCOPE R&D Group | British Pharmacopoeia Commission’s Expert Advisory Group (EAG)

Shekhar is currently Vice President- Regulatory Affairs and Policy at Dyne Therapeutics, a Boston, USA based biotech company specializing in rare muscle diseases. Within Dyne, Shekhar is responsible for developing regulatory strategies for rare disease portfolio of products.

Shekhar has close to three decades of pharma/biotech industry experience covering regulatory affairs, quality and compliance supporting entire life cycle of the product (i.e. pre-clinical, clinical and commercialization). Shekhar is very passionate about his efforts in the healthcare space and has been a strong advocate for Rare Diseases where there is huge unmet need.

Shekhar has been very active in the EU Industry Association forums like EFPIA (European Federation of Pharmaceutical Industries and Associations) and EUCOPE (European Confederation of Pharmaceutical Entrepreneurs) and has been supporting global Health Authorities as industry volunteer in their scientific and technical initiatives.

During his time at EFPIA, Shekhar chaired the India Regulatory Network for several years. As chair of the India Regulatory Network, he represented EFPIA in meetings between European Commission (EC)/European Medicines Agency (EMA) and Indian Ministry of Health (MoH) on emerging and regulatory topics impacting the pharmaceutical industry.

He is well recognized for his efforts in the field of Healthcare and Regulatory Affairs and was awarded Fellowship of Royal Society of Chemistry (FRSC) and Fellowship of The Organisation for Professionals in Regulatory Affairs (FTORPA). Shekhar is a member of the Expert Advisory Group (EAG) of the British Pharmacopoeia Commission (BPC). He was also recently appointed by EUCOPE as Chair of the R&D Focus Group and by the International Rare Disease Research Consortium (IRDiRC) as Chair of Therapeutic Scientific Committee (TSC).