Traditional Biotech/Pharma Pioneers the Medical Cannabis Clinical Research Industry
Featuring Christina DiArcangelo Puller
Christina DiArcangelo Puller is an international woman entrepreneur with a world-class reputation in the Biotechnology and Pharmaceutical industry. Born to Albert J DiArcangelo Sr., a prominent Teamsters shop steward from Chester County PA, you might say that Christina was born to succeed in this sector. The “homegrown gifts” of learning about alliance-building and leadership were part of her Dad’s core curriculum. According to Christina, these core skills combined with 21 years of experience in clinical research, legal, and biopharma industries have prepared her for “negotiating the varied interests at play in the burgeoning medical cannabis space.”
From 1994-1996 Christina attended the Lansdale School of Business to pursue her Associate Specialized Business Degree which held a focus on Business and Paralegal. She continued her education in 2001-2003 by attending Eastern University where she received her BA in Organizational Management. Since then Christina has held some powerful positions such as overseeing clinical trials on a global scale. Check out her career experience below!
- Contract/Financial Administrator at Covalent Group
- Senior Contracts Analyst/R&D Global Contracting at Centocor
- Manager of Clinical Vendor Contracts at PDL BioPharma
- Associate Director of Clinical Contracts Management at Threshold Pharmaceuticals
- Associate Director of Clinical Contracts and Outsourcing for Fibrogen, Inc
- CEO of Armonia Clinical Research, LLC
- CEO of Affinity BioCeuticals LLC
- CEO, Founder, and President of the Board at Affinity Patient Advocacy
- CEO and Founder of Affinity Bio Partners LLC
So you may be asking yourself, why is a cannabis centric website covering the story of an entrepreneur within the pharmaceutical industry? If so, just think about it for just a minute. One of the biggest arguments against the legalization of cannabis is that there isn’t enough research. Despite there being many anecdotal stories and research studies surrounding the efficiency of cannabis at treating a plethora of different ailments, the number of studies and clinical trials coming out of the U.S. is minimal. This is something that Christina hopes to help change as she truly believes in the potential of medical cannabis.
While Christina acknowledges that getting clinical trials underway in the United States will mean overcoming many different hurdles she has an innovative approach and is currently in the process of raising Series A funding for the first study under the oversight of her medical cannabis Biotech company known as Affinity BioCeuticals, LLC. She stated the following in regards.
“Medical Cannabis is still considered a Class I drug 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. This is not the standard way of operating in a clinical trial setting. Additionally, for us to be able to find patients to enroll in our clinical trials, we will utilize our tech partner, HCXP’s, Artificial Intelligence Patient Recruitment and Retention technology.”
Affinity BioCeuticals which was founded by Christina is the first Cannabis Biotech company in the state of Pennsylvania. Their research and development is focused on cannabinoid-based therapies with a focus on CBD. Affinity BioCeuticals is looking to sponsor clinical studies in both the US and globally.
When I asked Christina about the goals and mission of Affinity BioCeuticals, she stated the following.
“Affinity BioCeuticals would like to develop formulations for CBD, manufacture and obtain an IND (Investigational New Drug) application through the FDA. Our hope is to develop CBD products that will help unmet medical needs for patients with pain management, PTSD, mental health, palliative care for cancer patients, neurological disorders and the list goes on. More clinical research needs to be performed to show safety and efficacy worldwide, especially in the US and that’s what we are going to do. Additionally, we would like to develop strains of medical cannabis and then perform clinical research. I am very passionate about Affinity BioCeuticals which is helping patients with unmet medical needs. Medical Cannabis and CBD once studied through clinical research should demonstrate both to be safe and efficacious for many different therapeutic areas and indications. My patient-forward, patient-first motto is not always apparent in the biotech/pharma industry. I speak to people often who are suffering and who are looking for guidance with respect to how to use Medical Cannabis. 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’s focus in the medical cannabis industry isn’t just on clinical trials but also on changing the “misconceptions as to what professionals are truly doing in the medical cannabis industry by helping to raise the professionalism and collaborative spirit.”
Christina’s passion for helping medical cannabis patients stems from her father Albert who fell ill with stage IV liver, lung, and stomach cancer in 2015. Since then her focus has shifted to the “human facet of her work,” promoting her to become the founder of Affinity Patient Advocacy which is a nonprofit that provides resources to families struggling with cancer and provides advocacy at no cost to patients. Christina’s experience allowed her to easily look into clinical trials that her father would qualify for based on specific inclusion/exclusion criteria which allowed her to get him the best hospice care with a dedicated team. This is something Christina feels that every patient deserves and why her head and heart are fully aligned and devoted to serving unmet patient needs. This is when it was clear to Christina that it was inevitable that her focus gravitated towards the groundbreaking frontier of medical cannabis.
The backbone of Affinity Patient Advocacy and Affinity BioCeuticals is a Clinical Research Organization (CRO) known as Affinity Bio Partners. According to Christina, this CRO “works closely with pharma, biotech, medical cannabis and CBD companies in providing clinical research services assisting our clients to the market. Our role includes study design/protocols and implementation, clinical operations, safety, contract negotiations, outsourcing, patient recruitment and global compliance. My 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 I see my 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. “
Affinity Bio Partners has offices in the San Francisco Bay Area as well as corporate headquarters based out of Spring City, PA. Christina was also excited to announce that they would soon be launching the latest company in the Affinity family, Affinity MedCan Advocacy which will “provide programmatic education, lobbying, and advocacy in the medical cannabis industry.”
To learn more about Christina and her endeavors follow her on LinkedIn.
Article by Ashley Priest