2023 has been a year of highs and lows for the gene therapy field. On one hand the FDA have begun to brace for a wave of approvals, with significant green-lights for Vyjuvek, Roctavian and Elevidys; we have seen a 190% increase in clinical trial initiation between H1 of 2022 and H1 of 2023, and significant investments are being made to scale up manufacturing capabilities. On the flipside, companies continue to grapple with core clinical, regulatory, manufacturing, and commercial challenges facing their pipelines, reflected by a trend of later-stage programs being prioritised. 

In the context of these challenges, research with industry decision makers tells us they remain uncertain over the reliability of service provisions available to help their gene therapy programs. In particular, drug developers are seeking expert help in the following: 

• • Scaling up manufacturing processes and providing logistical support, including cleanroom provision, bioanalytics, and cGMP capabilities 
  • Clinical development and operations support, including end-to-end CRO services, genetic testing, and medical communications 

• Regulatory affairs, supporting strategic and technical advice for IND clearance, clinical development, regulatory CMC, and post-marketing needs 
• Pricing, reimbursement, and market access challenges 

Can your services add value to any of these conversations? 

If so, we offer a variety of bespoke networking, branding, and speaking opportunities to help our partners build vital relationships, showcase their solutions, and generate new business leads for 2024 and beyond. 

Act now to stay ahead of the curve and establish yourself as leaders in the gene therapy field. 

Email sponsor@hansonwade.com for more information on the partnership opportunities we offer, bespoke and tailorable to your business goals for hitting commercial objectives for 2024 and beyond.