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Michael Pollock: Good afternoon, everyone. Welcome to the first ever patient-focused medical product development meeting to explore depression. My name is Michael Pollock. I’m the chief executive officer for the Depression and Bipolar Support Alliance, also known as DBSA. On behalf of the board of directors and the staff who have joined us here today, we are grateful to all the peers and their supporters who have traveled to Silver Spring to share their perspectives and to those who are participating virtually through our live webcasts. DBSA has a vision to transform the definition of wellness throughout the entire healthcare ecosystem, to achieve treatment outcomes that reflect what’s important to people who live with mood disorders. Today’s meeting is a major step towards realizing that goal. We are grateful to FDA staff, medical product developers, and researchers who are in attendance. Over the next four hours through polling and guided discussion, peers and their supporters will be sharing the impact depression has had on their life and the demands it can place on their whole health, as well as identifying current treatment options that are making a difference and sharing their personal outcome goals. It is our hope that by better understanding the impacts, burden on whole health, identified treatment options that are working, and treatment outcomes sought by peers, we will highlight the need for continued innovation in research and development among the industry and with regulators. Before we begin, I want to take a moment to thank our partners and our sponsors who made today’s meeting possible, and they are listed here on the screen. Please join me in giving them a round of applause. Today’s meeting is facilitated by Jane Axelrod. With more than 25 years’ experience at the FDA, Jane is now a consultant focused on regulatory policy, oversight, and compliance issues affecting the FDA. As the FDA’s Center for Drug Evaluation and Research associate director for policy and director of the Office of Regulatory Policy, Jane led multidisciplinary teams of scientists, technical experts, and attorneys in addressing complex, regulatory policy issues. She was a member of the FDA’s negotiating team for four reauthorizations of the ● ● ● ● Prescription Drug User Fee Act, or PDUFA, including PDUFA V, in which the patient-focused drug development initiative, of which this meeting is an example, originated. Join me in welcoming Jane. Jane Axelrod: Thank you. I’m very pleased to be here today—help facilitate this important meeting, to hear from you about what’s important in living with and managing depression. Before we get started I’m going to go over a couple of housekeeping duties. The agenda for the meeting is in your program. As you’ll see from the agenda we’re going to be taking about a 15-minute break at 2:30, but if you need to get up and walk and go outside, feel free to do that. The restrooms are down the hall. Right outside this door is one of them, and around the corner by the registration desk is the other. To begin the meeting I’d like to start by introducing Dr. Mitchell Mathis and invite him to give some opening remarks from FDA’s perspective. For six years, Dr. Mathis has directed the Division of Psychiatry Products in FDA Center for Drug Evaluation and Research with experience developing efficient clinical trial designs and leading a team of scientists and physicians to regulate US psychiatric drug development. He trained in psychiatry and family medicine after graduating from the Uniformed Services University of the Health Sciences. He’s a veteran of the US Air Force and Public Health Service. Dr. Mathis: Thank you, Jane—Jane says, my name is Mitch Mathis, and I run the Division of Psychiatry Products, where they approve drugs for psychiatric indication. Very happy to be here today to tell you how we have incorporated the patient voice into the business that we do in the division, and what we’ve learned from meetings like this and what we hope to learn from this one. I think the government actually has a lot of good ideas—a few are great ideas. One of the great ideas in my view is when we decided along with industry, along with academia to make what we do as clinically relevant as we possibly can. When we develop drugs, it’s an aseptic environment. It’s not reflective necessarily of exactly the patients we treat, but it’s the best we can do. We try to hold everything steady. We move one thing at a time, and then we see if we can statistically see a difference between drug and placebo a couple of times. In clinical practice that’s not what we do, and I think PFDD groups are moving that sterile environment into more of what we do in clinical practice. I’m a clinician. I’ve been taking care of patients for a long, long time. A lot of the people I work with at FDA also maintain patient populations that they’ve been taking care of a long time. Psychiatrists are a little different than other physicians. Maybe we’re similar to primary care, but a patient can come see a psychiatrist for many, many years. ● ● ● ● The reason is—because unlike other medical conditions where you might have a drug that can cure the patient or a procedure that can fix them and they don’t need the doctor anymore, we don’t have that yet. We have—our medications and our therapy reduce symptoms. They don’t cure anything, and we’re pushing of course towards that and one day we will get there. I hope that today I get to see in the mean time we have to work with meds that treat patients symptomatically. When I take care of patients in my office—I’ve been taking care of them for quite a long time and I talk to them. I know them and I know what parts of depression matter to them. I think that that relationship of knowing the patient is at least as potent as the medications that we’re using. When you combine that, you get the best result, in my view. Patient-focused drug development does this at a level that can have some regulatory significance. We come here to learn and to unlearn, if there’s something we need to unlearn, and to take that information back and to do a better job at regulating medications. The point is that the reason this is one of my favorite things to do is because it’s very much like clinical practice and I think that’s what makes it the most useful. Phyllis asked me to give a couple of examples of incorporating the patient voice and to psychiatric drug development, so I brought two examples. I only have 10 minutes, sorry. One was a PFD meeting—patient-focused drug development meeting much like this, for patients with autism or autism spectrum disorders. I learned a great deal from that meeting. I’ve been taking care of patients with ASD for a long time, but it’s a different dynamic to put a bunch of people struggling with the disease in a room with the regulators to tell us what we’re doing right and what we’re doing wrong—what they need. They support each other, a different attitude comes out, and that was extremely productive for me and I’ll give you a couple of examples. One thing I knew already but it solidified in my mind and something that I had to unlearn. Almost universally the patients with ASD and autism said that the thing that bothered them the most was the lack of social interaction with other human beings. That’s a diagnostic criteria. Everybody knows that. It should probably be a drug target, but I didn’t realize that most people would say that that was on their top three list of things they need to get fixed. That’s one of the things that they would like new drugs to be developed for. When we learn something like that, when you see it so universally and you believe it, what it means to me as a regulator is that now I can understand the patient group better in the sense that we don’t have a drug, as I said, that will cure ASD, but if we had a drug that would increase the social interaction and allow people to engage other human beings, that would be a legitimate drug ● ● ● ● target because it’s obviously important to patients. I think that’s the point. If it’s important to patients and it’s clinically relevant, then it should be considered a legitimate drug target. One of the things I had to unlearn—patients with ASD, as many of you might know, self stimulate as a way to dissipate the psychic anxiety, one patient told me. They have repetitive body movements. They oftentimes will rock or flap their hands or move their head or their eyes, and we as external observers who are designing clinical trials I know have looked at that and said, “If we find a medication that might reduce that self-stimming, that would be a good move, because that’s obviously distressing to the patient.” Couldn’t have been further off the mark from the PFD meeting. There was one lady who said, “Please keep your hands off my stimming. That’s what makes me feel better, and in fact, when I’m really ill, when I feel really bad, I can’t even muster a good self stimming.

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