TrialSite recently interviewed a group of new leaders at the white-hot, decentralized clinical trial venture called Medable. The Silicon Valley-based decentralized trials platform announced strong momentum in the first half of 2020, as clinical trials sponsors pivot to digital platforms in response to COVID-19. Led by co-founder and CEO Michelle Longmire, the new hires were recruited based on the accelerating demand for Medable products. These new team members include sales and marketing, strategy, partnership, and eClinical implementation-related experience, with a combined 150 years of experience and prior roles with Novartis, Abbot, Covance, PPD, Medidata, Oracle, IBM, ERT, Medimmune, and Otsuka. They impressed the TrialSite founder.
Medable Emerging as a Leader
TrialSite has monitored the evolution of this startup, including Joseph Constance’s piece, “Virtual Trials Offer a Lifeline Amidst COVID, but more than Just Flipping a Switch.” Medable seeks to work with clinical trials sponsors, depending on specific needs, with tailored, emerging industry-standard models including fully virtual trials and hybrid studies in a bid to facilitate remote engagement of patients and sites, while ultimately collecting and unifying clinical trials data from recruitment to close-out.
Mendable has added a number of leaders including the following:
- Mary Costello, Head of Site and Investigator Network: Mary has 30+ years of healthcare and clinical experience, including leadership roles at Covance, Fisher Clinical Services, eClinical Solutions and Elligo Health Research. She is a founder of BioAustin.
- Rasmus Hogreffe, VP of Decentralized Trial Innovation: Rasmus is a serial entrepreneur and virtual trials advocate who has been involved in more than 60 clinical trials. He most recently served as head of virtual trials at LEO Innovation Lab.
- Steve Lesser, VP of Partner Strategy: Steve is an experienced solutions consultant and partner relationship manager with 20+ years’ experience including Medidata and IBM. Steve is also a stand-up comic who holds a Ph.D. in neurobiology from Duke.
- Heidi Pfefferkorn, Decentralized Solutions Leader: Heidi is a scientist and technical operations leader with 25+ years’ experience in clinical development, from clinical supply design to quality assurance and most recently DCT methodologies at Novartis.
- Eric Peper, Executive VP of Sales: Eric has nearly 25 years of sales experience in healthcare and clinical trials, the last 16 at ERT, most recently as global vice president of Cardiac, Imaging, and Respiratory Sales.
- David Swanger, Senior VP of Marketing: David is an accomplished SaaS marketing leader with more than 15 years’ experience at Medidata, Oracle, IBM and Rackspace.
- Ching Tian, Senior VP of Strategy & Solutions: Ching is a clinical data and digital expert with more than 25 years’ experience including Novartis, PPD, Medimmune, and Otsuka.
Dr. Michelle Longmire, CEO and co-founder of Medable recently shared, “We’re thrilled to add more smart, experienced and driven leaders to work closely with our customers and partners around the world.” The Silicon Valley physician and entrepreneur continued, “While COVID-19 has clearly accelerated the shift to decentralized trials, we expect the pace to continue as digital platforms become a foundation for all trials—making them much more accessible for patients while cutting the time it takes to bring innovative therapies to market.”
TrialSite’s founder, Daniel O’Connor, conducted a 30-minute interview with the Medable team. O’Connor, critical by nature, asked the team a range of what were at times sharp and challenging questions about impediments and obstacles to decentralized trials, as well as ongoing industry challenges such as health inequities and how some demographic groups may not trust health systems or for that matter, pharmaceutical companies. David Swanger, the company’s new VP of Marketing, highlighted the collective sentiment amongst the team: that Medable is a unique company, in a unique market and importantly operating in a unique set of circumstances given the challenges with COVID-19. Swanger told the TrialSite publisher that the industry is actively rethinking processes all around, from protocols to site visits.
With two decades of experience, Swanger is a seasoned technology product marketer with tours at IBM, Oracle, Rackspace and Medidata. An impressive character, intelligent and charismatic yet grounded and humble, the product-marketing maven emphasized that the movement to patient-centric studies represents an incremental, progressive evolution rather than a revolution.
Hence, he emphasized, the importance of Medable’s decentralized trial readiness framework: a program and portfolio of artifacts that will help clinical trials sponsors embrace decentralized clinical trials in a progressive and incremental approach, helping them best capitalize on adaptions such as Medable’s platform.
VP of Partner Strategy Steven Lesser, Veteran of Medidata
Steven Lesser, VP of Partner Strategy, knows a little about the eClinical space having spent 12 years at Medidata. Lesser added color and clarity to a number of points in the discussion. When it comes to the biopharmaceutical industry embracing decentralized clinical trials, Lesser sees some comparable elements to how the industry ultimately adapted to fully capitalize on the use of electronic data capture (EDC). That process didn’t happen overnight, nor will the industry fully capitalize on the trend to patient-centric trials overnight—it will take time, emergence of best practices, industry consensus, and even some standards.
On the topic of industry-wide full adoption, Lesser, Swanger and others concurred with O’Connor that the terms associated with decentralized clinical trials, or virtual trials, are not yet harmonized.
Meaning that different groups, companies and vendors need to work together toward a true operationalization of terms so that the concepts mean the same thing to all stakeholders involved in clinical research. Medable leadership will continue to actively engage sponsors, CROs, regulators, and of course patients in the quest to establish itself as a thought leader and value-added contributor to the ongoing march to better clinical research safety, quality, and productivity.
Awareness of Need for Diversity in Research
TrialSite’s Founder raised the topic of diversity and the underrepresented in clinical research, wondering what the Medable perspective would be on this touchy subject. The group exhibited a depth, sophistication, and even wisdom infused into their expressed understanding of these challenges. Onboarded as Senior VP of Strategy & Solutions, Ching Tian has spent nearly three decades working in the clinical trials field with both CRO (PPD) and industry, most recently serving Novartis as General Manager for Data and Digital. Ms. Tian shared what is certainly evidence of a deep understanding of some of the equity challenges in healthcare generally and clinical trials specifically. She emphasized some of the efforts in Novartis to use data and digital engagement to help break down barriers.
Ms. Tian suggested that as decentralized trials expand, enabling greater patient-centricity, clinical trials will actually become more responsive, flexible and accessible, hence overcoming barriers that have hindered trial participation in the past.
Tian shared that many patients cannot afford to spend a day driving to trial site that could be hours away; many have to work or care for children. She softly and intelligently revealed a wisdom and insight that will most certainly contribute greatly to Medable’s endeavors.
Medable Patient Advisory Council
On the concept of patient centricity, Rasmus Hogreffe, VP of Decentralized Trial Innovation, mentioned the Medable Patient Advisory Council, a nationwide network of expert patient advocates, advisors, and caregivers with a diverse background in patient engagement and a strong understanding of patient preferences.
An impressive concept, evidencing Medable’s holistic thinking about the incremental yet ultimately revolutionary transformation of biomedical research toward decentralized, patient-centric scenarios.
Also on the call was Heidi Pfefferkorn, originally a scientist at Novartis and now Medable’s new Decentralized Solutions Leader. Ms. Pfefferkorn, bringing impressive pharmaceutical research experience, spent 27 years working her way progressively in different roles there. Ms. Pfefferkorn and Ms. Tian worked together at Novartis, and they bring their energies to helping Medable transform the industry.
Medable is making some great moves, in bringing in a diverse, experienced and eclectic group of talent which happens to represent the key to software company success. And on that front Ms. Longmire is building something very special. As the company grows, industry expertise, combined with pragmatic business experience, critical thinking, and a dose of humility helps the firm avoid the negative attributes, such as over-confidence and overly domineering personalities that can take hold in a rapidly growing concern. Ms. Longmire and team are to be commended for their progress and the great group of people they’re hiring. TrialSite’s O’Connor was impressed with the team.
Medable is on a mission to get effective therapies to patients faster by transforming clinical drug development with disruptive technologies. The company offers a flexible digital platform for decentralized trials, replacing siloed systems with integrated tools, data, and interfaces to streamline design, recruitment, retention, and data quality. Medable connects patients, sites, and clinical trial teams to improve patient access, experience, and outcomes. Medable is a privately held, venture-backed company headquartered in Palo Alto, California. For more information, visit www.medable.com and follow @Medableinc on Twitter.