AMMG Does a Deep Dive Into Peptides
Jeff Morris
Peptides are the hottest topics in medicine and aesthetics, and at this October’s Age Management Medicine Conference in Las Vegas, AMMG is delving into peptides in a big way. The conference will feature a full-day workshop on Essential Knowledge of Peptide Therapy and a follow-up workshop on Advanced Peptide Clinical Strategies, as well as a workshop on using peptides in Regenerative Aesthetics.
These workshops will be especially timely, as progress is being made every day in understanding and accepting the role of peptides in longevity medicine, with this week’s decisions by an FDA advisory panel evidence of how quickly the landscape is changing. By October, there will be much more information for practitioners to absorb.
What are they?
For those unfamiliar, peptides are the building blocks of proteins that play key roles for health. They are short chains of amino acids that can have a range of effects on the body. For example, peptides help orchestrate hormone activity, immune defense, tissue repair and growth, control of inflammation, and digestion. You can think of them as smaller and simpler versions of proteins, which are made of longer chains of amino acids. The body can make countless types of peptides by stringing together different amino acids. Each combination of amino acids produces unique — and very specific — functions.
Recent research indicates that some types of peptides could have a beneficial role in slowing down the aging process, reducing inflammation, and destroying microbes. A growing number of people are also using peptide injections and supplements to enhance their health and fitness.
Various types of peptides and their uses have been discussed extensively by sources as diverse as Harvard and Columbia Schools of Medicine, the Mayo Clinic, Cleveland Clinic, and popular news and health sites. All make the point that more research and clinical studies need to be done to determine both effectiveness and possible side effects, and that patients should discuss peptides with their doctors before use.
That’s where you come in. Where can you get the latest thorough and reliable information on peptide therapy? That’s where AMMG comes in.
Reliable information you can use
AMMG is devoting two whole-day workshops to teach about peptides, along with a regenerative aesthetics workshop that will focus largely on peptides.
The workshop on Wednesday, Oct. 17 is Part 1 of Essential Knowledge in the Clinical Use of Peptides for Age Management Medicine, and completion of a post-workshop exam will qualify attendees for certification in this area. It is presented in conjunction with the Clinical Peptide Society, founded in 2008 and the preeminent professional society dedicated to advancing clinical applications of therapeutic peptides in medicine. The co-founders and teachers of this course, Dr. Edwin Lee and Dr. Luis Martinez, have taught hundreds of health care providers on the clinical use of peptides for many years.
Dr. Lee is an endocrinologist, author and international speaker. He is board certified in Internal Medicine, Endocrinology, Diabetes and Metabolism, and has completed special training in Regenerative and Functional Medicine. He is a graduate of the Medical College of Pennsylvania and finished his fellowships at the University of Pittsburgh. He has lectured about peptides across the world and prescribes peptides in his medical practice.
Dr. Martínez is a Regenerative Medicine, Anti-aging and Cell Therapy specialist, clinical researcher and biomedical consultant. He earned his medical degree at the Ponce School of Medicine and completed his residency training at the University of Pennsylvania. He is actively involved in educating and training physicians in multiple aspects of Regenerative and Age Management Medicine; his current focus is on the therapeutic use of novel peptides, particularly as they relate to immune function and aging.
The Wednesday workshop is an 8-hour class of essential knowledge about peptide therapy. It will be followed on Thursday, October 8 with Part 2: Advanced Peptide Clinical Strategies—Protocols, Dosages, Case Discussion. This Advanced Clinical Peptide Workshop is an intensive, physician-focused educational program designed for clinicians seeking deeper expertise in evidence-informed peptide therapeutics and integrative regenerative medicine.
There is a prerequisite requirement: attendees must have completed an AMMG Full Day Initial Peptide Course and/or Peptide Certification. The Peptide Certification on Wednesday October 7th will satisfy this requirement as would any previous AMMG peptide full day course.
“Interest in peptide therapy continues to grow among both healthcare professionals and the public,” said Dr. Lee. “To help clinicians understand the current scientific evidence and apply peptides responsibly in clinical practice, the Clinical Peptide Society offers the Essential Knowledge of the Clinical Use of Peptides course. The program reviews the available scientific literature, proposed clinical protocols for each peptide, safety considerations, and numerous real-world clinical case examples. As one of the first organizations to develop a comprehensive peptide certification program, the Clinical Peptide Society is committed to promoting evidence-based education and the safe, ethical use of peptide therapies.”
Aesthetics in focus
For those already certified or more interested in aesthetic applications, Wednesday will also feature the workshop Foundations of Regenerative Aesthetics: Essential Techniques for Starting and Growing Your Aesthetic Practices. The course will address the evolving regulatory landscape surrounding peptides and topical regenerative products, helping providers better understand compliant integration strategies while navigating current industry considerations.
Ideal for physicians, aesthetic providers, nurses, medical spas, and practices looking to strengthen their understanding of regenerative aesthetics, smart skin renewal, peptides, and combination therapies designed to support both exceptional clinical outcomes and sustainable business growth, this program includes live demonstrations and audience interaction.
Some key sessions in the Aesthetics workshop include Over the Counter Peptides: Are they Effective & How to Use Them, and How to Incorporate and Combine Aesthetics with Peptides for a Viable Financial Return, both taught by Nora Addam; and The Use of Peptides, How They Affect the Patient and Impact Aesthetic Appearance, taught by H. William Song, M.D.
Dealing with a changing landscape
The use of certain peptides is in a state of flux. As of September 2023, the FDA had banned a list of 22 peptides from being produced by 503A compounding pharmacies in the U.S.—while peptides are used in some FDA-approved medications to treat diabetes, obesity, certain endocrine disorders, and other health conditions. Injectable insulin for blood sugar control is a peptide. So are GLP-1 medications that treat obesity and type 2 diabetes (among other diseases), including semaglutide (Ozempic, Wegovy) and tirzepatide (Zepbound, Mounjaro).
It is against this complicated backdrop that AMMG is offering the latest research and updates. Further hearings took place this week regarding the use of other peptides.
A positive step
Dr. Lee worked with the FDA’s Pharmacy Compounding Advisory Committee (PCAC) preparation team leading up to PCAC’s July 23-24 meeting. Over the two-day session, the PCAC reviewed seven peptides — BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon, and emideltide (DSIP) — for potential inclusion on the FDA’s Section 503A Bulk Drug Substances List, which governs what licensed compounding pharmacies may prepare for individual patients under a valid prescription. The committee recommended six of the seven: BPC-157, KPV, and TB-500 each passed 8–6 with one abstention; MOTS-c passed 7–5 with two abstentions; and Semax and Epitalon passed 8–5 and 7–5, respectively. Emideltide was the panel’s sole rejection, voted down 6–7.
On July 27, AMMG and the Clinical Peptide Society issued a joint press release applauding the favorable recommendation on therapeutic peptides, calling the outcome “a milestone for responsible, evidence-based peptide medicine.”
“This is a meaningful step toward a more rational, evidence-driven regulatory framework for peptide therapeutics,” the organizations said in their statement. “Independent scientific and medical experts examined the safety and efficacy record for these compounds and, for six of the seven, recommended a legal pathway for licensed pharmacies to prepare them under physician prescription. That is a genuine win for patients and for clinicians who have long sought clearer, safer standards in this space.”
Much more to come
Dr. Lee noted this decision addresses whether compounding pharmacies can legally make these substances with a prescription, not formal FDA drug approval. This vote is a nonbinding recommendation sent to the FDA leadership for a final ruling.
AMMG and CPS were also careful to note, in their statement, what the vote does — and does not — mean. They said PCAC’s recommendation is advisory; the FDA is not obligated to adopt it, and formal rulemaking, including a Notice of Proposed Rulemaking and public comment period, is still required before any of the six peptides may be officially compounded, a process that typically takes six to twelve months or more. None of the peptides reviewed is an FDA-approved drug, and the vote does not extend to 503B outsourcing facilities. “We see this as real momentum, not a finish line,” the statement continued. “Building rigorous clinical standards, sound manufacturing practice, and honest patient education around these compounds is ongoing work — and it’s exactly why our two organizations exist.”
“It is very important that physicians understand newly FDA panel supported peptides, and the reason is simple: these therapies are about to reshape how clinicians diagnose, treat, and manage a wide range of conditions,” said Dr. Lee. “These newly FDA-reviewed peptides affect safety, legality, treatment options, and patient outcomes.”
Both organizations framed the outcome as further evidence that peptide medicine is moving toward the same rigor and accountability long expected of hormone replacement therapy — grounded in documented physiology and honest evidence, rather than unregulated, gray-market use.
Prior to the decision, Dr. Lee noted that, although Secretary of Health and Human Services Robert F. Kennedy Jr. has publicly expressed support for peptide therapies—including discussing peptides favorably during his appearance on The Joe Rogan Experience—the ultimate scientific review of these seven peptides was conducted through the FDA’s established regulatory process, with recommendations made by the PCAC.
In addition to helping obtain published Russian literature on Epitalon and Semax, as well as numerous scientific publications supporting the evidence base for several of the peptides under review, Dr. Lee also introduced the developers and leading researchers associated with MOTS-c and BPC-157 to the team preparing for the meeting.
One of the major challenges facing these peptides, said Dr. Lee, is the FDA’s emphasis on evidence generated through the Investigational New Drug (IND) pathway. While most of the seven peptides have published preclinical and, in some cases, human clinical data, relatively few have completed the traditional Phase 1, Phase 2, and Phase 3 clinical trials typically associated with drug development and FDA approval.
“While relatively few of the seven peptides under review have completed the traditional Phase 1 through Phase 3 clinical trial process, many have accumulated published evidence supporting their biological activity, safety, and potential therapeutic benefits,” explains Dr. Lee. “Consequently, clinicians and patients are faced with the challenge of balancing an expanding scientific literature against a regulatory framework that generally emphasizes evidence generated through the IND pathway.”
Dr. Lee has published three human studies evaluating BPC-157 that were conducted outside the Investigational New Drug (IND) pathway. Following a three-week FDA inspection of his peptide research, the FDA issued a Form FDA 483 that included observations regarding the conduct of clinical investigations without an IND and other infractions in doing a clinical study. As a result of the inspection and subsequent communications with the FDA, Dr. Lee has not published additional peptide studies outside the IND process and understands that future prospective clinical investigations intended for publication need to be conducted under an IND.
For further information on the AMMG conference and to register for these pre-conference workshops, go to agemed.org.