Clinical Research Pioneer Takes on MMJ: Christina DiArcangelo Puller Pulls No Punches
Medical Cannabis is the talk of the town since Pennsylvania passed resolution 116 in the spring of 2017, and Christina DiArcangelo Puller is at the forefront of that conversation.
Christina helms the growing Affinity family of companies, a biopharma empire that includes Affinity Bio Partners, Affinity Patient Advocacy, Affinity BioCeuticals and Affinity MedCan Advocacy. Currently, Affinity’s clinical research and advocacy efforts are poised to lead the charge to legalizing Medical Cannabis.
At an exclusive conference she organized this winter at the Sofitel in Philadelphia, Christina shared her vision with a room full of growers, physicians, researchers, lawyers, venture capitalists and other business hopefuls who want to see PA become a center for Medical Cannabis research and innovation in the US. (The way the law is written in PA, special provisions are given to growers and dispensaries to partner with major universities for the purposes of medical research on Medical Cannabis.)
“If we are going to see prohibition end in this country, we need these clinical trials, and we are going to do them.” Standing at the podium, and one of only a half-dozen women in the room, Christina is unflappable.
The daughter of a prominent Teamsters shop steward from Chester County, Christina grew up learning about leadership and alliance-building, which were part of her Dad’s core curriculum.
These homegrown gifts, combined with 21 years in the legal, clinical research, pharmaceutical and biopharma industries, has prepared her for negotiating the varied interests at play in the burgeoning Medical Cannabis space.
“There’s a lot going on and people are moving in many different directions. There are a lot of misconceptions as to what professionals are truly doing in the Medical Cannabis industry. The level of professionalism and collaborative spirit really needs to be raised. We are hoping to be able to raise the bar and be a positive element of change.”
The bedrock of Christina’s Affinity family is Affinity Bio Partners, a clinical research organization, or “CRO”, which works closely with biotech and pharma companies in the process of their clinical development to help get them to market. Their role includes study design/protocols and implementation, clinical operations, safety, contract negotiations, outsourcing, patient recruitment and global compliance.
Christina’s staff of clinical research professionals is highly experienced, having contributed research on over 30 major, FDA-approved pharmaceuticals and devices on the market today. But she sees her company’s competitive advantage stemming from the deep consideration it gives to the patient experience: “We are frequently rescuing studies from other CROs to revitalize patient recruitment with our detailed, proven recruitment strategies. Biotech and pharma companies need to think about the patients that they are trying to recruit when they are developing their protocols.”
With additional offices in the San Francisco Bay Area, Affinity’s East Coast corporate headquarters is in Phoenixville, a community with deep roots for Christina. It was there that she grew up under the guidance of her father, Albert J. DiArcangelo, Sr., former president of the local steelworkers’ union, a steelworker for Phoenix Steel Company until it closed its doors and shop steward for the Teamsters of the PA Turnpike Commission for 25 years.
When he fell ill with Stage IV liver, lung and stomach cancer in 2015, Christina’s focus shifted to the human face of her work, prompting her to found Affinity Patient Advocacy. The nonprofit provides resources to families struggling with cancer and in need of advocates at no cost. “For my dad, I was able to look into clinical trials that he might have met the inclusion/exclusion criteria for very easily, liaise with the various physicians and get him into the best hospice with a dedicated team. Everyone deserves the best treatment that’s right for them.”
With her head and heart fully aligned and devoted to serving unmet patient needs, it was inevitable that Christina would gravitate toward the groundbreaking frontier of Medical Cannabis. And she hasn’t looked back.
Affinity BioCeuticals, which she founded in 2017, is a first-of-its-kind biotech company that will focus exclusively on clinical research into the effects of Medical Cannabis. “More clinical research needs to be performed to show safety and efficacy worldwide, especially in the US,” she says. “That’s what we are going to do.”
To aid in that effort, Christina formed a sister company, Affinity MedCan Advocacy, to provide programmatic education, lobbying, Medical Cannabis justice and advocacy.
When talking about public perception of Medical Cannabis, Christina urges: “Continued education is key.” In addition to the symposiums it sponsors—the next one is on February 21, 2018 in Philadelphia—Affinity is proactive about sponsoring events as well as attending and supporting other Medical Cannabis groups.
The effort, however, is not without its challenges. Medical Cannabis is still considered a Class I narcotic by the federal government. “Right now, it is very difficult to run clinical trials in the US when you have to understand each of the state’s regulations that have voted to approve Medical Cannabis, and you have to be able to develop a unique and innovative way of enrolling those clinical patients,” she says. “This is not the standard way of operating in a clinical trial setting.”
As a clinical research professional, Christina’s pet peeve is bad data: “There are companies out there now that are collecting information—anecdotally, of course—not in any way that meets with real research standards, and then they are selling it back to companies who are new to the market. That’s crazy. How can we do the work we need to do to change people’s minds about cannabis without real data?”
Above all, Christina’s approach is patient-forward, patient-first: “I speak to people every day who are suffering and who are looking for guidance with respect to how to use Medical Cannabis,” she says. “It would be ideal to get these people into our studies so we can really understand, in a clinical, science-driven environment, how we can help them.”
Christina DiArcangelo Puller is the founder and CEO of Affinity Bio Partners located at 20 E. Bridge St., Ste. 301, Spring City, PA 19475. For more information, call 610-933-6578, email Info@AffinityBioPartners.com or visit www.AffinityBioPartners.com.