RARE - Shekhar Natarajan

For this episode, Laura Hulley, Principal Consultant at SciPro had the pleasure of speaking with Shekhar Natarajan, a seasoned biotech leader with nearly 30 years of experience in drug development, regulatory strategy, market entry, quality and compliance with a special focus on life threatening conditions and rare diseases. 

Shekhar combines regulatory expertise and commercial acumen in driving geographical expansion and portfolio development and is actively involved in EU Industry Association activities in driving innovation and accelerated regulatory pathways.

On this episode, Shekhar shared his career highlights and discussed organisational differences between small-medium sized companies versus big pharma and how he feels this impacts business operations.

 

 

Career Highlights

Shekhar began his career in quality before transitioning to regulatory affairs, working across therapeutic areas with leading companies like Shire, GW Pharmaceuticals, and is currently working at Dyne Therapeutics as VP Head of EU and International Regulatory Affairs. Currently, he focuses on rare muscular diseases such as Duchenne Muscular Dystrophy and Myotonic Dystrophy, where no approved therapies exist in the EU or UK so there is clearly a huge unmet medical need.

 

Big Pharma vs Startups

Drawing from his experience in both large and small companies, Shekhar highlighted:

• Large Companies: Often offer established systems and resources but may lack agility.
• Startups/SMEs: Provide learning opportunities and flexibility, often requiring team members to take on diverse responsibilities. These companies focus intensively on a few product candidates, enabling innovative approaches despite often limited resources.

 

Impact of Small Companies on Rare Diseases

Shekhar noted that smaller companies often lead the way in rare disease therapies by adopting innovative clinical and regulatory strategies, conducting extensive advisory engagements, and prioritising quality over speed when faced with complexities in trial design.

 

Advice for Aspiring Regulatory Professionals

Shekhar encouraged exploring resources like TOPRA, RAPS, and regulatory agency websites (EMA, FDA, MHRA) for guidance and networking opportunities. Conferences and introductory courses offer invaluable insights into the field.

Shekhar’s passion for rare diseases and his dedication to regulatory innovation demonstrate the critical role biotech leaders play in advancing treatments for underserved conditions. His reflections serve as an inspiration for professionals looking to make a meaningful impact in the life sciences industry.

Thank you Shekhar for taking the time to feature on RARE!

 

Resources mentioned linked below:

https://www.topra.org/

https://www.raps.org/

https://www.ema.europa.eu/en/homepage

https://www.fda.gov/

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

 

Views expressed in this interview are those of Shekhar and do not represent those of any organisation to which he is currently or previously associated.