EP2: A Changing Drug Development Paradigm

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

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 remarksAbout 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.About Altasciences:Altasciences is a drug development organization dedicated to safely accelerating early-phase development for biotech, biopharmaceutical, and pharmaceutical companies. By combining the scale and expertise of a large CRO/CDMO with the flexibility and personalized approach of a mid-size partner, Altasciences delivers unified solutions across nonclinical, clinical, bioanalytical, formulation, and manufacturing services. Through intentional integration and true collaboration, the company removes barriers from lead candidate selection to clinical proof of concept—helping sponsors save time, reduce complexity, and make confident, data-driven decisions that enable earlier returns on investment. Guided by over 30 years of experience and a commitment to quality, integrity, and partnership, Altasciences enables clients to reach critical milestones faster and with greater confidence. Altasciences… Drug Development, Reimagined.™

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.(00:00) - Introduction: The rise of patient-centric sampling(00:53) - Meet the microsampling panel(01:24) - What Is microsampling?(03:00) - Advances driving microsampling forward(06:44) - Which assays are compatible with microsampling?(08:55) - Putting patient choice at the center(11:40) - How COVID-19 accelerated at-home sampling(14:05) - Barriers to widespread adoption(15:25) - Training patients for at-home collection(18:45) - Navigating logistics and sample returns(22:35) - Regulatory challenges across global studies(26:30) - Device variability and sample quality(32:30) - Building patient-centric sampling into clinical trials(35:40) - Expanding at-home sampling beyond PK(39:10) - How the industry can drive adoption(42:15) - Education, collaboration, and the patient-centric sampling community(46:40) - The future of microsampling technology(50:07) - Bold predictions for patient-centric sampling(55:28) - Closing thoughtsAbout 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.About Altasciences:Altasciences is a drug development organization dedicated to safely accelerating early-phase development for biotech, biopharmaceutical, and pharmaceutical companies. By combining the scale and expertise of a large CRO/CDMO with the flexibility and personalized approach of a mid-size partner, Altasciences delivers unified solutions across nonclinical, clinical, bioanalytical, formulation, and manufacturing services. Through intentional integration and true collaboration, the company removes barriers from lead candidate selection to clinical proof of concept—helping sponsors save time, reduce complexity, and make confident, data-driven decisions that enable earlier returns on investment. Guided by over 30 years of experience and a commitment to quality, integrity, and partnership, Altasciences enables clients to reach critical milestones faster and with greater confidence. Altasciences… Drug Development, Reimagined.™

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.About Altasciences:Altasciences is a drug development organization dedicated to safely accelerating early-phase development for biotech, biopharmaceutical, and pharmaceutical companies. By combining the scale and expertise of a large CRO/CDMO with the flexibility and personalized approach of a mid-size partner, Altasciences delivers unified solutions across nonclinical, clinical, bioanalytical, formulation, and manufacturing services. Through intentional integration and true collaboration, the company removes barriers from lead candidate selection to clinical proof of concept—helping sponsors save time, reduce complexity, and make confident, data-driven decisions that enable earlier returns on investment. Guided by over 30 years of experience and a commitment to quality, integrity, and partnership, Altasciences enables clients to reach critical milestones faster and with greater confidence. Altasciences… Drug Development, Reimagined.™

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!(00:00) - Introduction: Patient access and diversity in early phase trials(01:30) - Meet Kat Connors and her clinical research journey(03:54) - What sponsors should expect entering the clinical phase(05:44) - Why speed and flexibility matter in early development(06:57) - Combining healthy volunteer and patient cohorts(09:28) - Building a patient recruitment strategy early(11:36) - Expanding patient access through a multi-site network(13:02) - Competing for specialty patient populations(15:29) - How site feasibility and selection work(18:35) - Live feasibility and engaging sites before study award(20:05) - Using site expertise to strengthen study design(21:50) - Healthy volunteer vs. patient recruitment(23:07) - Accelerating site startup, contracting, and IRB review(25:41) - The role of project management in multi-site trials(28:07) - When does a multi-site strategy make sense?(28:44) - Case Study: adding a patient arm mid-study(30:47) - Managing risk and consistency across multiple sites(32:39) - The early phase CRO difference(35:48) - Green flags when choosing a clinical partner(37:43) - Incorporating sponsors’ preferred sites(40:39) - The “non-data” side of successful clinical trials(41:59) - Maintaining quality across external sites(44:48) - Managing budgets and avoiding surprise costs(47:02) - The future of early phase patient trials(48:18) - Closing thoughtsAbout 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.About Altasciences:Altasciences is a drug development organization dedicated to safely accelerating early-phase development for biotech, biopharmaceutical, and pharmaceutical companies. By combining the scale and expertise of a large CRO/CDMO with the flexibility and personalized approach of a mid-size partner, Altasciences delivers unified solutions across nonclinical, clinical, bioanalytical, formulation, and manufacturing services. Through intentional integration and true collaboration, the company removes barriers from lead candidate selection to clinical proof of concept—helping sponsors save time, reduce complexity, and make confident, data-driven decisions that enable earlier returns on investment. Guided by over 30 years of experience and a commitment to quality, integrity, and partnership, Altasciences enables clients to reach critical milestones faster and with greater confidence. Altasciences… Drug Development, Reimagined.™

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!