Off-Label presents candid conversations about the drug development industry from an insider perspective. We discuss trending topics and new developments alongside industry experts. Whether you’re drug development-curious or a seasoned veteran, enjoy as we peel back the label.
EP5: The Business of Biotech: Science, Funding, and What Comes Next
What does it really take to build a successfulbiotech? From addressing unmet medical needs, securing investor backing and reaching critical value inflection points, to navigating acquisitions and building a company positioned for long-term success, there’s a delicate balance to strike between science and finance.
On the latest Off-Label With Altasciences, host Lisa Sanford is joined by James Mackay, President, Chief Executive Officer, and Co-Founder of Crystalys Therapeutics Inc., to unpack where biotech stands today—and what could define its next chapter.
With James’ takes on the pressures of fundraising, growing impact of AI, and realities of leadership, it’s time to peel back the label on the business of biotech.
(00:00) - Introduction: The state of biotech
(01:15) - Meet James Mackay: From scientist to biotech CEO
(03:04) - The motivation behind bringing drugs to patients
(05:47) - Is the biotech industry rebounding?
(10:57) - The reality of biotech funding
(15:32) - What investors look for in a biotech
(19:22) - Reaching critical value inflection points
(23:40) - Finding the right investors and partners
(27:43) - Innovation, competition, and choosing where to play
(32:38) - The revival of biotech M&A
(34:39) - The patent cliff and its impact on biotech
(41:11) - How AI could accelerate drug development
(43:15) - What happens after a biotech is acquired?
(46:50) - Lightning Round: biotech, leadership, and career lessons
(50:04) - What the ciotech industry needs next
(50:35) - Supporting innovation through the Connect Foundation
(54:58) - Bold predictions for the future of biotech
(55:53) - AI-native biotech and the next 5–10 years
(58:06) - Closing thoughts
16 Jun 2026
EP4: The Science of "What If?": A Deep Dive Into MIDD ft. Certara
Model-informed drug development (MIDD) capitalizes on past data points with predictive modeling to accelerate timelines and address challenges earlier. It also presents a slew of other potential advantages, such as shrinking the data-access gap between large pharma and small biotechs, and reducing study subjects in both nonclinical and clinical trials. So, what does this mean for the drug development industry as we know it? What separates "thoughtful acceleration" from "careless" acceleration? And why isn’t everyone using MIDD?
Host Lisa Sanford is joined by Patrick Smith, former SVP, Translational Science, at Certara, as they unpack the innovation of MIDD, its ongoing potential, and resulting shifts in the industry.
(00:00) - Introduction
(00:55) - Meet Dr. Patrick Smith
(03:30) - Bringing modeling and simulation to biotech
(06:00) - What Is model-informed drug development?
(10:15) - Transforming drug development decisions
(15:45) - Regulatory adoption and industry acceptance
(21:45) - From skepticism to standard practice
(26:30) - Better data, faster development
(32:15) - Optimizing clinical trials and dosing
(37:45) - Reducing risk, cost, and trial burden
(43:00) - The role of AI in drug development
(48:45) - When is MIDD not a good Idea?
(54:00) - Patient perspectives on AI
(59:30) - Certara & Altasciences partnership
(1:04:35) - Bold predictions for the future
(1:06:20) - Closing remarks
30 Mar 2026
EP3: The Future of Sampling Is Here—Almost
Host Lisa Sanford is joined by Neil Spooner (PCSIG), Katty Wan (Pfizer), Enaksha Wickremsinhe (Gates Medical Research Institute), and Jeff Plomley (Altasciences) to discuss microsampling and the role it plays in a patient-centric sampling approach.
With reduced sample volume, as well as the ability to provide additional options and convenience to patients, this episode showcases the “big” potential and impact of this innovative “small” technique. From training, logistical, and implementation challenges, to regulations and device dependency, learn more about the building momentum in both bioanalytical and clinical applications.
3 Dec 2025
EP2: A Changing Drug Development Paradigm
Automation? Personalized medicine? A shifting talent pool? Dive into the rapidly changing world of drug development and listen to experts give their boldest predictions for the future of CROs.
Host Lisa Sanford is joined by colleagues from Altasciences, Marie-Hélène Raigneau, CEO; Steve Mason, Co-COO; and Dr. Gaetano Morelli, Executive Vice President Medical Affairs and Chief Medical Officer; as they take a wide-angle look at the forces reshaping drug development today and predict what’s coming next for CROs, sponsors, and patients. From emerging AI applications to organ-on-a-chip technology, shifting talent dynamics, changes in day-to-day operations, and the possible rise of personalized medicine, their discussion explores how innovation is unfolding across the industry.
About Off-Label With Altasciences:
Off-Label presents candid conversations about the drug development industry from an insider perspective. We discuss trending topics and new developments alongside industry experts. Whether you’re drug development-curious or a seasoned veteran, enjoy as we peel back the label.
30 Sept 2025
EP1: Multi-Site, Multi-Insight: Strategic Site Identification and Expanded Patient Access in Clinical Trials
Learn about the multiple benefits that incorporating a multi-site approach can provide in early-phase clinical research, the “red and green flags” to look out for when working with a CRO, the importance of the “non-data stuff.”
Host Lisa Sanford is joined by Kat Connors, Director, Multi-Site Clinical Trial and Strategic Operations at Altasciences, as they discuss the momentum growing behind using a multi-site strategy, with a notable uptick in demand in the last few years. With multi-site solutions enabling access to more robust trial data, access to an expanded patient network, the opportunity to simultaneously work with specialty and healthy population branches, as well as improved trial efficiency, there is certainly more than one reason to tune in to this episode and hear more from their conversation!
About Off-Label With Altasciences:
About Off-Label With Altasciences:Off-Label presents candid conversations about the drug development industry from an insider perspective. We discuss trending topics and new developments alongside industry experts. Whether you’re drug development-curious or a seasoned veteran, enjoy as we peel back the label.
14 Aug 2025
Introducing Off-Label With Altasciences
We’ve got some exciting news to share… We’re launching a new podcast called Off-Label! Host Lisa Sanford is peeling back the label on drug development to discuss trending topics and new advancements alongside industry experts—offering a candid insider’s perspective.Coming soon!
Reach and audience
Public platform figures. Ratings count people who left a rating, not total listeners.
Apple Podcasts (US)
5.0 / 5
1 ratings
Spotify
5.0 / 5
2 ratings
Contact Off-Label With Altasciences
Guest appearances
Books guests
Based on episode analysis; this does not confirm that the show is currently accepting guests.
Host of Off-Label With Altasciences?
Claim your podcast to manage its listing and keep your show details accurate.
Pod Engine is an independent podcast discovery and analytics service and is not affiliated with or endorsed by this podcast. Artwork and show content belong to their owners. Full legal notice.
Explore this show Podcast research with Pod Engine
