February Newsletter

Welcome to tranScrip’s monthly newsletter where we share with you the latest news and views from across the organisation.

This edition includes:

• A Message from our Chief Commercial Officer
• tranScrip New Joiners
• Rare Disease Day
• Regulatory Updates
• AMR Conference Roundup
• Upcoming Conferences and Events

A Message from our Chief Commercial Officer

Dear readers,

Welcome to February’s newsletter. I am delighted to share the exciting news that this month, we welcomed three new leaders to our team: John Ivory, Rosemarie Delaney, and Sally Taylor. Their extensive expertise and visionary leadership will not only strengthen our cross-functional teams but also drive innovative solutions that align with our core purpose, to expedite the development and commercialisation of products for the benefit of patients worldwide.

With their leadership, we are broadening our Medical Affairs and Commercialisation services, ensuring that we continue to deliver best-in-class support to our clients. These expanded services will work in tandem to enhance value creation across the product lifecycle, ultimately benefiting the patients we all serve.

At tranScrip, our commitment to excellence remains unwavering, and I am confident that these strategic appointments will reinforce our ability to navigate the evolving healthcare landscape with agility and impact. We look forward to an exciting year ahead and to working together to drive meaningful advancements in the industry.

Best regards,

Rob Fox, Chief Commercial Officer

Welcoming our New Joiners

John Ivory

SVP, Head of Commercialisation

John brings over 25 years of industry experience in Sales, Marketing, and Senior Leadership, having contributed to renowned pharmaceutical companies including AstraZeneca, Elan, Servier, Genzyme, and Sanofi. His proven track record in launching innovative drugs, managing P&Ls, and steering strategic change initiatives across Europe and beyond perfectly aligns with our commitment to delivering integrated, cross-functional support across the product lifecycle. John’s leadership will be pivotal as we continue to enhance our commercialisation services and build new global partnerships.

Rosemarie Delaney

VP, Head of Market Access

Rosemarie, with over 25 years of senior industry experience, has held key roles across pharmaceuticals, vaccines, and medical devices at UK, European, and Global Director levels. Her background at organisations such as Indivior, Bristol Myers Squibb, Sanofi Pasteur, MSD, and Servier Laboratories, along with interim positions at Norgine, Eisai, and Pfizer, has equipped her with deep expertise in global market access strategy, pricing, reimbursement, and value proposition development. Rosemarie’s appointment reinforces our dedication to advancing patient access to breakthrough treatments.

Sally Taylor

SVP, Head of Medical Affairs

With 19 years of extensive experience in Medical Affairs and Clinical Research, Sally is a Fellow of the Faculty of Pharmaceutical Medicine and has led teams across the UK, Europe, Canada, and North America. Her impressive career spans a wide range of therapeutic areas including Vaccines, Oncology, Immunology, Respiratory, Allergy, Dermatology, Osteoporosis, and Cardiovascular Disease. Sally’s proven skills in transformation, restructuring, and change management make her ideally suited to lead our Medical Affairs team into its next chapter. Her leadership, along with that of John and Rosie, underscores our integrated approach to delivering maximum value to our clients and the patients they serve.

Be a Part of Our Success Story – Join the tranScrip Team

At tranScrip, we’re driven by passion, innovation, and excellence. We are searching for talented professionals ready to make a meaningful impact in the world of healthcare and life sciences. If you’re seeking a career where your expertise will make a difference, we’d love to hear from you.

View our current job vacancies > Vacancy Page

Rare Disease Day 2025

Rare but Not Alone: Accelerating Drug Development for Rare Diseases

This week, tranScrip launched a special campaign to raise awareness of rare diseases for #RareDiseaseDay on Friday 28^th February and the challenges in bringing life-changing treatments to patients.

• Over 300 million people worldwide live with a rare disease.
• 95% of rare diseases have no approved treatment.
• Drug development for rare diseases faces funding, regulatory, and accessibility hurdles—but solutions exist.

We are sharing insights, engaging in discussions, and taking action to drive innovation in the rare disease space.

What to expect this week:

• A poll on the biggest barriers to rare disease treatment
• Awareness on challenges & opportunities in orphan drug development
• tranScrip’s contributions & real-world impact
• A call to action—because 1 Rare Action = 1 Rare Impact

Follow along, engage with us, and help amplify the voices of rare disease patients. Together, we can make a difference!

Regulatory updates

EU Clinical Trials Regulation (CTR)

As of 31 January 2025, all EU clinical trials must comply with the EU CTR and be managed via the Clinical Trials Information System (CTIS).

With the end of the transition period all EU trials must now:

• Be submitted and managed via CTIS, adapting to any changes as the system evolves and is updated
• Undergo a harmonised scientific/regulatory review together with a national ethical review

Read full article here > EU CTR – end of three-year transition period

UK Clinical Trials Regulation (SI)

An updated Clinical Trial Statutory Instrument (SI) was laid before parliament in December 2024, once the SI is finalised there will be a 12-month transition period before the SI comes into force, likely in early 2026.

Some notable changes:

• Embedding of a Clinical Trial Notification process which allows for expedited review of trials that meet specific criteria
• The concept of Type B substantial modifications would be introduced For Type B modifications, ones that meet specific criteria, the need for review by MHRA would be waived

• Embedding transparency requirements into UK law

• Development of guidance around diversity and inclusion in clinical trials

Read full article here > UK CTA: What Lies Ahead for 2025?

Impact & Next Steps

Both EU and UK regulations are evolving, requiring sponsors to adapt quickly. For guidance, tranScrip’s experts can help navigate these changes and ensure compliance > Contact Us

AMR Conference Roundup

This week, tranScrip’s Rienk Pypstra attended the AMR Conference, moderating the dynamic session “Clinical Endpoints: Fit-for-Purpose?”. Leading experts challenged conventional thinking, debating whether current endpoints truly reflect meaningful patient outcomes, or if it’s time for a rethink.

The expert panel featured:

• Clare Nasmyth-Miller (Roche) – Offering real-world insights, she questioned whether current endpoints capture the full spectrum of clinical benefits.
• Dr. Radu Botgros (European Medicines Agency) – Providing a regulatory lens, he explored why existing endpoints are supported while sparking debate on what should stay and what’s missing.
• Marc Bonten (Ecraid) – he showcased its role in selecting and validating improved endpoints for the future.

The discussion underscored the need for innovation in endpoint selection, paving the way for more effective clinical evaluations in antimicrobial resistance.

Upcoming Conferences and Events

Our Head of Market Access, Rosemarie Delaney PhD, will be attending the World EPA Congress in Amsterdam on March 5–6.

We’re excited to explore the latest market access developments and connect with industry leaders.

If you’ll be there too, let’s connect! We’d love to discuss key insights, trends, and opportunities. Reach out to schedule a chat > https://transcrip-group.com/contact-us/

Looking forward to engaging discussions and meaningful connections.

Thank you for reading this month’s edition of tranScrip’s newsletter. Feel free to share your feedback in the comments.

To learn more about tranScrip’s services and how we can support you, connect with us.

Best regards, The tranScrip Team