GHP Q4 2019

GHP / Q4 2019 13 , Balancing the disparate needs of pharmaceutical companies and pregnant women, the teamat Pregistry have a great deal of responsibility on their shoulders. Curious about how theymanage it, we caught up with the company’s CEO, Dr DiegoWyszynski, to find out more. Best Pregnancy & Lactation Information Platform 2019 “Our mission is to fill a major gap in information about the risks of medi- cines and vaccines during pregnancy and lactation to help women and their health care providers make informed, evidence-based health care decisions that optimize maternal and infant outcomes.” This is the mission of Pregistry, one of the world’s largest platforms for pregnant and nursing women, and the mission of Dr Diego Wyszyn- ski, CEO of Pregistry. The aim is to conduct observational research on the safety of medicines and vaccines used during pregnan- cy. Over 600,000 pregnant and nursing women are in Pregistry’s ever-growing pool, drawn in by the useful and practical information and tools that are offered online and free of charge. Ultimately, this means that Pregistry is in the perfect position to send out surveys, analyse the responses, and communicate the findings on behalf of pharmaceutical compa- nies, academia, and regulators. Pregistry has an interesting business model. It exists simul- taneously for the benefit of the pharmaceutical industry and, more specifically, for companies that have products that will likely be used by women of childbearing potential, and for pregnant women who receive useful information and tools. “Usually, we get in- volved during the drug’s phase III activities,” says Diego, “although it is not uncommon for us to be asked to consult during phase II of development. Predictably, most large studies we conduct, such as pregnancy exposure registries and analyses of administrative databases, occur when the drug is already on the market.” The biggest appeal of Pregistry comes from the partnership it has cultivated with pregnant women. Pregistry is, above all, a trusted name. “For the last six years, we have worked extensively to develop and offer a large amount of information and tools free of charge, including expert reports on thousands of medications, exposures, and medical condi- tions.” With over 40 pregnancy specialists, covering a range of clinical, preclinical, safety, regula- tory, marketing, and IT needs, the focus is on making sure that both mother and baby are healthy and safe and that prescribers have the information needed to be able to explain the potential benefits and risks of medications during pregnancy and lactation. This symbiotic relationship works to the advantage of both parties, and Pregistry is able to help both learn about the other. “There are millions of women using medica- tions of unknown safety during pregnancy every single day,” states Diego. He says this be- cause, of the approximately 80 mil- lion pregnant women in the world, about 50-75% will take at least one prescription medication during pregnancy, of which less than 10% have been studied in pregnant women. “Since about half of the pregnancies are unplanned, many of these women will be using un- studied medications during the first trimester of gestation, when most of the vital organs are develop- ing,” Diego explains. “This should be of great concern to all of us.” Fortunately, Diego and the team at Pregistry care deeply about this issue and encourage their partners in the pharmacy industry to take a proactive approach to proceed- ings. “As a result, we encourage pharmaceutical and biotech companies to proactively discuss this topic during phases II and III of development to see how they can be best positioned at the time of drug approval.” Committed to getting ahead of developments, Pregistry is constantly thinking of potential new study designs and strategies to analyse data. Currently, one of the company’s most interest- ing activities is a project under development for a mid-size biotech company. They want to have a Pregnancy Surveillance Program (PSP) for all its market- ed products used by women of childbearing potential. The PSP is a pharmacovigilance system to meticulously evaluate reports of exposed pregnant women and their offspring. “It relies on the proactive identification and follow-up of exposed pregnan- cies, the collection and evaluation of exposures, a careful medical assessment of outcomes, and the use of a variety of available reference populations to quickly identify potential safety signals. It is a great hypothesis-generation tool that can be incorporated into the company’s Pharmacovigi- lance department at low cost,” Diego adds. With development of several pro- jects underway and an ever-grow- ing pool of pregnant women across the world to conduct stud- ies, Pregistry’s value proposition is unique. Conducting research based on sensitive information can be challenging but, for Pregistry, it does not seem to be a problem as they have already gained the respect and trust of many pregnant women and health care professionals over the years and are showing no signs of slowing down anytime soon. Contact: Diego Wyszynski Company: Pregistry Website: www.pregistry.com