OR WAIT null SECS
Andy Studna is an assistant editor for Pharmaceutical Executive and Applied Clinical Trials. He can be reached at firstname.lastname@example.org.
Following the announcement of his new role, Pharm Exec had the chance to speak with Daniel Schroen, PhD about his past experience as well as the landscape of the therapeutic development industry.
Following Fingerpaint’s announcement of Photo 51, a consultancy focused solely on advanced therapeutics such as cell and gene therapies, in June, the agency announced on Oct. 15 the appointment of Daniel Schroen, PhD as head of Photo 51.
Schroen, who will lead the strategic consulting teams at Photo 51, brings a background in strategic business development, product management, and multichannel marketing in the biotechnology and pharmaceutical industries to the consultancy. Over the past decade, he has held management positions at companies including Reveal Biosciences, WuXi Advanced Therapies, and Thermo Fisher Scientific. Schroen completed his doctorate in cell biology and immunology at Illinois State University. His postdoctoral fellowships at the Geisel School of Medicine at Dartmouth and the University of Massachusetts Medical School both involved research in the areas of oncology and rheumatology.
Following this announcement, Pharm Exec had the chance to speak with Schroen about his past experience, what he hopes to accomplish in his new role, as well as his thoughts on the therapeutic development industry as a whole.
PE: After gaining a lot of experience in education and research from your fellowships at Dartmouth and the University of Massachusetts, you’ve transitioned more into the business side of advanced therapeutics. What was the driving force behind that transition for you?
Daniel Schroen: For the seeds that planted my initial interest in the commercial side of life sciences, we’d have to go back even a bit further to my senior college year. By then I had already participated in a few projects under the guidance of professors in various science concentrations. A sponsorship through an undergraduate research program offered the opportunity to attend an early meeting of the Human Genome Project. In 1989, still relying to a great degree on manual and analog technology, the effort was expected to take the better part of a decade at a cost of billions of US dollars, both of which came to fruition. The full extent of applications arising from a complete map of human DNA could only be speculated at the time. But it was clear such an accomplishment would profoundly advance our knowledge of what makes us “us,” and importantly which chromosomes, genes, and specific regions of DNA are tied to genetic diseases, metabolic disorders, and cancers, both inherited and spontaneous. Doctoral training in cellular immunology, followed by post-docs in molecular gene expression, extended my interest in ways to address debilitating conditions like rheumatoid arthritis and deadly tumor cell invasion during metastasis.
When attending and presenting at scientific conferences toward the end of my second fellowship, I found myself gravitating to the vendor trade floor, company presentations, and talks relying on pharmaceutical collaborations with universities and medical centers. It became clear that closer industry ties to basic research could propel the pace of scientific discovery, drug development, and clinical transition. So, since 1998, I’ve been with companies, large and small, that provide products, equipment, tools, or services that support cell- and gene-based research and drug development. Starting in applications and product management, I gradually moved into strategic marketing and business development with clients including biotech, pharma, contract manufacturers, major hospitals, and clinical research organizations.
PE: What were the most valuable experiences or lessons you can take away from your time in research that have helped you in your transition toward product development?
Schroen: Working in the lab during those early years definitely strengthened my knowledge of cell and molecular biology, and looking back I recognize unique insights and learning moments that supported the move from research to industry.
As a way to illustrate these transferable skills, here are some traits I look for when joining organizations:
The road from then to now has surely had its hard lessons, trials, errors, and learning by doing. One of my biggest mistakes as a young product manager was to rely on that solitary, do-it-alone approach familiar to research. In contrast, successfully moving ideas and projects through the business opportunity pipeline requires teamwork, group effort, and buy-in from key stakeholders. A poignant lesson, but those are the ones that really stick!
PE: What are you hoping to accomplish with Photo 51?
Schroen: It would be great for Photo 51 to be top-of-mind when clients look for full-service, strategic consulting, marketing, communications, and launch services focused on serving the unique needs of the advanced therapies industry.
For biotech, pharma, and contract biomanufacturers, from emerging and mid-size players to established leaders, I would hope we apply committed, dedicated resources, laser-focused to help them develop new, forward-thinking services to the industry. The same level of attention goes for healthcare providers, care partners, physicians, payers, and patients.
Goals would include overcoming complex scientific and operational obstacles to bring bio-based drugs to market faster and better with improved treatment outcomes. We’ll need to provide personalized, responsive collaboration to support fast-paced industry needs and offer a unique value story for each patient population and therapy.
Characteristics and strategies that exemplify Photo 51 should therefore include customized solutions and personal touch tailored to each client’s exclusive needs with dedicated project leadership and support teams. We’ll strive to solve challenges early and throughout the life cycle, from early-stage R&D to late-stage therapies, commercialization, and post-launch, with adaptability for diverse, evolving product scenarios.
Fingerpaint and 1798 already bring a proven track record, a loyal customer base, deep experience, data-led decision-making, and agency awards to the table. This strong foundation will act as a springboard for Photo 51’s success.
We should also hold ourselves accountable to look at new ways to support the cell and gene therapy market, such as serving contract development and manufacturing organizations (CDMOs) and clinical trial outfits, in addition to biotech and pharma. Attention should also be placed on startups, R&D outfits, preclinical, and early clinical stage companies. By coming alongside from the outset, we can create a solid relation and value stream early. We could even consider serving industries that supply supporting products, tools, services, instruments, and biomaterials to the advanced therapies market. It’s never wise to work in isolation, so it will be imperative for Photo 51 to engage key opinion leaders, adding expert eyes to emerging opportunities.
PE: During your past experiences in product development, what have you found to be the most important elements needed to focus on effectively bringing a therapy to market?
Schroen: If you ask biopharma companies and CDMOs what keeps them up at night, common themes emerge. These pain points include turnaround time, timeline accuracy, communication channels, readiness and ease of obtaining information, the availability of personalized attention, project cost, logistics, and supply chain. As promising drug candidates move forward in the pipeline, concerns shift to tech transfer, scale-up, toxicity profiles, analytic testing, animal and human studies, and continued efficacy with acceptable side effect profiles. Closer to regulatory approval and release to the clinical market, pricing, education, training, marketing, and payer relations become paramount.
There are additional areas where outsourcing and consulting can help a biotech or pharma enhance the success rate and speed of clinical development. Smaller, early stage companies may especially benefit from professional guidance in navigating the regulatory environment, selecting the most suitable CRO to manage their clinical trial, or even helping them highlight their company and technology through effective web, collateral, digital, marketing, and positioning materials.
PE: What are some of the commercialization and access issues that face gene and cell therapy companies? How do you plan on addressing them in your new role with Photo 51?
Schroen: Some of these cell- and gene-based therapies involve single-dose treatments, meant to permanently correct an aberration, leading to sustained cure. Price tags or such bio-based drugs can range into the hundreds of thousands of dollars, even over 1 million US dollars. Convincing the payers and public to absorb such seemingly exorbitant fees will be new territory, relying on education for this new model.
As opposed to personalized small-batch and typically pricey autologous therapies, large-scale, off-the-shelf allogeneic therapies will be an ever increasing target goal and focal point.
Cell therapy is expanding so rapidly that the industry has experienced a shortage of manufacturing and testing. Construction of new facilities continues at a robust pace, so helping clients find adequate infrastructure will be another opportunity.
PE: How has the COVID-19 pandemic affected the development of a product’s life cycle? What adjustments need to be made to adhere to any changes the pandemic may have brought about?
Schroen: When I take in the collective impact to the biopharm industry since the COVID-19 outbreak began earlier this year, my sense is that what’s possible for development timelines will forever change. With the advanced tools at hand and concerted effort, multiple different COVID-19 treatments and vaccines are showing promise in unprecedented time.
Complimentary industries came together, offering solutions that further supported this massive effort. As just one example, a digital pathology outfit where I worked began supplying COVID-19-infected tissue slides, which became crucial to examine virus pathological effects in lung and other organ systems. With consolidated timelines will come an increasing demand for accuracy and efficiency across all aspects of the drug development spectrum.
PE: What do you think the future holds for the gene and cell therapy market knowing where it stands in the present?
Schroen: It’s clear that now is the time for cell, gene, and other advanced therapies. The industry is rapidly expanding, more biologic therapies are closer to approval, and opportunities remain to address challenges unique to the industry. That’s where Photo 51 will help, coming alongside clients to improve efficiency, turnaround time, success rate, and product uptake.
For the full press release from Fingerpaint on the hiring of Schroen, click here.
Andy Studna is an Assistant Editor for Pharm Exec. He can be reached at email@example.com.