Compounding Interest

Amy Summers
  • 0.0 (0)
  • Medicine
  • Series

Welcome to Compounding Interest: The Business of Personalized Medicine, the podcast exploring what it takes to build, scale, and safeguard high-performing operations in the rapidly evolving world of personalized medicine. Hosted by Amy Summers, PharmD, BCSCP, FAPC - a nationally recognized authority in pharmacy compounding and 503B outsourcing operations - and backed by the expert team at Restore Health Consulting, this show features insightful conversations with healthcare innovators, compliance executives, and life science operators who are rethinking what it means to deliver specialized care in a highly scrutinized landscape. Each episode examines the rigorous regulatory frameworks, quality systems design, and strategic leadership approaches that help organizations elevate their operations far beyond basic compliance. Through real-world insights and field-tested strategies, guests share how they navigate complex guidelines, optimize 503A and 503B facilities, and transform strict quality controls into an organizational strength. Drawing from a deep portfolio of enterprise-level operational transformations and proven industry playbooks, the show explores how an unwavering dedication to clinical and operational excellence can become a powerful differentiator when organizations intentionally design businesses built to scale.

  1. Episode 2

    What Compounding Pharmacies Cannot Say About Safety & Effectiveness in Medicine – Darshan Kulkarni

    The personalized medicine and compounding pharmacy industry is evolving rapidly as patient demand, regulatory scrutiny, and technological innovation continue to collide. In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Darshan Kulkarni to explore the legal and ethical challenges facing compounding pharmacies today. From FDA advertising rules and promotional claims to USP 797, 503A vs. 503B pharmacies, peptides, and the future of personalized medicine, this conversation examines where innovation meets regulation and where the industry's biggest gray areas remain. Darshan Kulkarni, PharmD, MS, Esq., is a pharmacist, attorney, educator, author, and founder of Kulkarni Law Firm, where he advises FDA-regulated industries on complex regulatory and compliance matters for the Life Sciences. His expertise spans pharmacy compounding, medical devices, advertising compliance, clinical research, and FDA law. His multidisciplinary background provides a unique perspective on balancing patient access, innovation, and regulatory responsibility. Key Takeaways Why patient safety, efficacy, affordability, and access must all be balanced in personalized medicine.The legal boundaries surrounding advertising and promotional claims for compounding pharmacies.How FDA regulations, USP 797, and 503A/503B distinctions impact pharmacy operations.The regulatory challenges surrounding peptides, compounded medications, and personalized therapies.Practical guidance for pharmacies navigating compliance while continuing to serve patients effectively. Timestamps [00:00:00] - Introduction to Darshan Kulkarni and Personalized Medicine: Amy introduces Darshan and discusses how his pharmacy and legal background shapes his perspective. [00:05:15] - The Purpose and Evolution of Pharmacy Compounding: A discussion on FDA oversight, drug shortages, the NECC tragedy, and the growth of modern compounding. [00:09:53] - Common Compliance Mistakes in FDA-Regulated Industries: Darshan explains the regulatory issues he sees most often across healthcare companies. [00:14:09] - Marketing Rules for Compounding Pharmacies: Which advertising claims pharmacies should avoid and how they can market responsibly. [00:21:59] - Why Disclaimers Cannot Replace Regulatory Compliance: Understanding the limits of disclaimers in pharmaceutical advertising. [00:26:01] - Peptides and the Ongoing Regulatory Debate: A discussion on safety, efficacy, patient access, and the legal concerns surrounding peptide products. [00:31:13] - Buying a Compounding Pharmacy: Darshan shares advice on finding acquisition opportunities through networking, brokers, and industry relationships. [00:32:55] - Closing Thoughts and Final Takeaways: Amy wraps up the conversation by reflecting on the importance of thoughtful debate in personalized medicine. Follow Darshan Kulkarni: LinkedIn: https://www.linkedin.com/in/darshankulkarni/Website (Company): https://kulkarnilawfirm.com/LinkedIn (Company): https://www.linkedin.com/company/kulkarnilaw/ X (Company): https://x.com/kulkarnilawfirmYouTube: www.youtube.com/@DarshanTalks Follow the Host: Amy Summers: https://www.linkedin.com/in/amy-summers-pharmd-bcscp-fapc-20b04a93/Restore Health Consulting: https://www.restorehealthconsulting.com/ Follow The Podcast: YouTube: https://www.youtube.com/@RestoreHealthConsultingSpotify: https://open.spotify.com/show/033F4FRUbjSrN1oNbfozhD?si=caf30ccfd2ba49b6Apple Podcasts: https://podcasts.apple.com/in/podcast/compounding-interest/id6784679391

    What Compounding Pharmacies Cannot Say About Safety & Effectiveness in Medicine – Darshan Kulkarni

  2. Episode 3

    The Future of Personalized Medicine for Patients to Improve Healthcare Access with Jesse Vidrine

    Compounding pharmacies have rapidly moved from a niche corner of healthcare into the national spotlight, driven largely by the demand for GLP-1 medications and growing interest in personalized medicine. In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Jesse Vidrine, President of Boudreaux's New Drugstore and Vidrine Pharmaceutical Group, to discuss how compounding is evolving, the regulatory landscape, the future of hormones, peptides, telehealth, AI, and what it will take to make personalized medicine more accessible for patients. Jesse Vidrine is the President of Vidrine Pharmaceutical Group, the parent company of Boudreaux's New Drugstore, a nationally licensed 503A compounding pharmacy based in South Louisiana. With decades of experience in hormone replacement therapy and personalized medicine, Jesse is focused on expanding patient access to customized therapies while advancing quality, compliance, automation, and innovation within the compounding pharmacy industry. Key Takeaways Why compounding pharmacies have become significantly more visible over the past few years.What the GLP-1 movement revealed about drug pricing, access, and the broader healthcare system.How hormones, peptides, telehealth, and testing are shaping the future of personalized medicine.The regulatory challenges facing compounding pharmacies and why compliance is becoming more important than ever.How AI, automation, and technology can improve patient care while maintaining clinical quality. Timestamps [00:00] – Episode Preview [01:35] – Meet Jesse Vidrine [02:35] – How Compounding Went Mainstream [05:48] – What GLP-1s Revealed About Healthcare [13:09] – The Future of Personalized Medicine [17:46] – Hormones, Individualized Care & Clinical Need [20:01] – Customization vs. Commercial Medicine [27:16] – Peptides, Regulation & Industry Responsibility [33:30] – Telehealth, AI & Pharmacy Innovation [39:27] – Testing, Long-Term Vision & Closing Thoughts Follow Jesse Vidrine: LinkedIn: https://www.linkedin.com/in/jesse-vidrine-377a4b6b/Website (Company): https://vpgrx.com/ Follow the Host: Amy Summers: https://www.linkedin.com/in/amy-summers-pharmd-bcscp-fapc-20b04a93/Restore Health Consulting: https://www.restorehealthconsulting.com/ Follow The Podcast: YouTube: https://www.youtube.com/@RestoreHealthConsultingSpotify: https://open.spotify.com/show/033F4FRUbjSrN1oNbfozhD?si=caf30ccfd2ba49b6Apple Podcasts: https://podcasts.apple.com/in/podcast/compounding-interest/id6784679391

    The Future of Personalized Medicine for Patients to Improve Healthcare Access with Jesse Vidrine

  3. Episode 4

    Personalized Medicine Cannot Scale Without Automation for Pharmacies with Adam P. Crandall

    As personalized medicine continues to expand; from GLP-1 therapies and peptides to hormone replacement therapy, the demand placed on compounding pharmacies has never been greater. While personalized care has traditionally relied on manual sterile compounding, increasing regulatory expectations, workforce shortages, and production demands are driving a major shift toward automation. In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Adam P. Crandall to discuss how automation is transforming sterile compounding, why both 503A and 503B facilities are beginning to adopt automated filling technologies, and what pharmacy owners should consider when evaluating automation solutions. Adam P. Crandall is the Chief Revenue Officer at Addtronics, where he leads sales, marketing, and business development across multiple healthcare technology companies. One of those companies, Körber Pharma (formerly Cozzoli/Körber compounding solutions discussed in the episode), develops automated fill-finish equipment for pharmaceutical manufacturers and compounding pharmacies. Adam works closely with 503A and 503B facilities to help implement automation technologies that improve efficiency, product quality, regulatory compliance, and patient safety. Key Takeaways Why automation is rapidly becoming essential for both 503A and 503B compounding pharmacies.How automation helps reduce contamination risk while improving consistency and quality.The differences between semi-automated tabletop systems and larger pharmaceutical filling lines.How pharmacies can evaluate the ROI of automation beyond simple labor savings.What pharmacy owners should consider before investing in automated filling equipment. Timestamps [00:00] – Episode Preview [02:59] – Why Compounding Pharmacies Are Embracing Automation [05:06] – Labor Challenges & The Need for Automation [10:47] – Solving Real Pharmacy Bottlenecks [13:48] – Choosing the Right Level of Automation [21:49] – ROI Beyond Labor Savings [26:45] – Regulations, Compliance & Preparing for Future Growth [32:19] – Facility Planning & Cleanroom Requirements [44:46] – Measuring Return on Investment [48:20] – The Future of Personalized Medicine Follow Adam P. Crandall: LinkedIn: https://www.linkedin.com/in/adampcrandall/Website (Company): https://addtronics.com/LinkedIn (Company): https://www.linkedin.com/company/addtronics/YouTube (Company): www.youtube.com/@addtronicsrobotics Follow the Host: Amy Summers: https://www.linkedin.com/in/amy-summers-pharmd-bcscp-fapc-20b04a93/Restore Health Consulting: https://www.restorehealthconsulting.com/ Follow The Podcast: YouTube: https://www.youtube.com/@RestoreHealthConsultingSpotify: https://open.spotify.com/show/033F4FRUbjSrN1oNbfozhD?si=caf30ccfd2ba49b6Apple Podcasts: https://podcasts.apple.com/in/podcast/compounding-interest/id6784679391 "Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

    Personalized Medicine Cannot Scale Without Automation for Pharmacies with Adam P. Crandall

  4. Episode 5

    How a Pharmacy Technician Became a Director of Compounding with Ashley Barton

    What does a career in compounding pharmacy look like when you start as a technician and refuse to see that title as a ceiling? In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Ashley Barton to explore the evolving role of pharmacy technicians in compounding. Ashley shares how she progressed from working as a technician during college to directing compounding operations across multiple locations, and the lessons that helped her move into leadership. Ashley Barton is the Director of Compounding Operations for Peoples Pharmacy in Austin, Texas. She began her pharmacy career as a technician while attending the University of Texas and ultimately recognized that the opportunities available to her in pharmacy extended far beyond the compounding lab. The conversation goes beyond career advancement to tackle some of the biggest operational challenges facing compounding pharmacies today: technician recruitment and retention, building productive teams, improving non-sterile compounding throughput without sacrificing quality, and using smarter workflows and technology to scale. From sharing firsthand patient experiences to speaking with legislators, she makes the case that technicians have an important voice in shaping the future of pharmacy. Key Takeaways How technicians can build a leadership career in compounding pharmacy by identifying problems, proposing solutions, and actively pursuing new responsibilities.Why technician recruitment and retention have become challenging and how externships, colleges, and healthcare training programs can create a stronger talent pipeline.How to improve non-sterile compounding productivity without compromising quality, including batching, lab layout, dosage-form sequencing, and better planning.Where automation could transform compounding pharmacy, from prescriber portals and AI-assisted prescription entry to automated capsule machines and 3D-printed dosage forms.Why technicians should have a voice in pharmacy advocacy and how their firsthand experiences with patients, reimbursement, and access can help inform policy. Timestamps [00:00] - Episode Teaser [01:25] - From Pharmacy Technician to Compounding Leader [03:54] - Problem-Solving as a Path to Leadership [07:04] - Breaking Through the Technician Career Ceiling [10:37] - Solving Technician Recruitment and Retention Challenges [13:26] - What Makes a Great Non-Sterile Compounder? [15:20] - Balancing Productivity, Profitability, and Quality [17:23] - Improving Compounding Throughput and Workflow [22:49] - Quality Safeguards When Increasing Production [25:14] - Scaling Compounding Through Automation and AI [27:15] - Advocacy, Patient Access, and the Technician's Voice [31:34] - Closing Thoughts Follow Ashley Barton: LinkedIn: https://www.linkedin.com/in/ashley-barton-b6845841/Website (Company): https://peoplesrx.com/Facebook (Company): https://www.facebook.com/PeoplesRx/Instagram (Company): https://www.instagram.com/peoples_rx/ Follow the Host: Amy Summers: https://www.linkedin.com/in/amy-summers-pharmd-bcscp-fapc-20b04a93/Restore Health Consulting: https://www.restorehealthconsulting.com/ Follow The Podcast: YouTube: https://www.youtube.com/@RestoreHealthConsultingSpotify: https://open.spotify.com/show/033F4FRUbjSrN1oNbfozhD?si=caf30ccfd2ba49b6Apple Podcasts: https://podcasts.apple.com/in/podcast/compounding-interest/id6784679391 "Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

    How a Pharmacy Technician Became a Director of Compounding with Ashley Barton

  5. Episode 6

    Can Modern Pharmacy Keep Up with Telehealth and Personalized Medicine? with Christian Stella

    In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with fourth-generation pharmacist Christian Stella to explore how compounding has evolved from the neighborhood pharmacies of the early 1900s into a technology-enabled industry serving telehealth companies and patients at scale. Christian draws parallels between the pharmaceutical industrialization his great-grandfather experienced and today's convergence of telehealth, personalized medicine, GLP-1 therapies, changing regulations, and new fulfillment models. Christian Stella is a PharmD, fourth-generation pharmacist, and CEO of Precision Medicine. Pharmacy has been part of Christian's life from the beginning. He grew up around his family's pharmacies, progressing from stocking shelves and making neighborhood deliveries to attending pharmacy school and eventually building a compounding operation of his own. Today, his focus includes scalable pharmacy infrastructure, technology integrations, quality and compliance, personalized formulations, innovative dosage forms, and long-term partnerships with telehealth companies. Expect to Learn How compounding pharmacy is evolving alongside telehealth, personalized medicine, and changing patient expectations.What telehealth companies need from pharmacy partners to deliver medications efficiently at scale.Why quality and compliance must remain central as a compounding pharmacy grows.How long-term risk shaped Precision Medicine’s decision to step away from GLP-1 compounding.Why saying no to certain revenue opportunities can create room for innovation and sustainable growth. Timestamps [00:00] - Episode Teaser [01:10] - Four Generations of Pharmacy [02:33] - Why Compounding Pharmacy Is Changing Again [05:38] - Growing Up in the Family Pharmacy [07:39] - Building the “Garage Band” of Compounding Pharmacy [10:31] - Building Pharmacy Infrastructure for Telehealth [17:42] - Scaling Without Sacrificing Quality or Compliance [19:21] - Evaluating Telehealth Partners Like Investments [21:40] - Walking Away From the GLP-1 Opportunity [26:30] - Diversification and Dosage-Form Innovation [38:21] - Quality, Necessary Endings, and Preparing for California Follow Christian Stella: LinkedIn: https://www.linkedin.com/in/christianstellaprecision/Website (Company): https://precisionmeds.com/LinkedIn (Company): https://www.linkedin.com/company/precisionmedicine211/home/Facebook (Company): https://www.facebook.com/precisionmedicine1/ Follow the Host: Amy Summers: https://www.linkedin.com/in/amy-summers-pharmd-bcscp-fapc-20b04a93/Restore Health Consulting: https://www.restorehealthconsulting.com/ Follow The Podcast: YouTube: https://www.youtube.com/@RestoreHealthConsultingSpotify: https://open.spotify.com/show/033F4FRUbjSrN1oNbfozhD?si=caf30ccfd2ba49b6Apple Podcasts: https://podcasts.apple.com/in/podcast/compounding-interest/id6784679391 "Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

    Can Modern Pharmacy Keep Up with Telehealth and Personalized Medicine? with Christian Stella

  6. Episode 7

    Can a 160-Year-Old Pharmacy Shape the Future of Personalized Medicine? with Rosemary Mihalko

    What happens when one of Pittsburgh’s oldest pharmacies combines more than 160 years of history with modern personalized medicine? In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Rosemary Mihalko, owner of Hieber’s Pharmacy. Rosemary shares how she has preserved the pharmacy’s historic roots while transforming it into a modern compounding operation offering sterile, non-sterile, hazardous, and non-hazardous preparations. Rosemary Mihalko is the owner of Hieber’s Pharmacy, Pittsburgh’s oldest pharmacy. She has owned the business for more than seven years and is both its first female owner and its first owner with a Doctor of Pharmacy degree. From bringing back the traditional pharmacy soda fountain to creating customized medications for people and pets, Rosemary explains why the future of independent pharmacy can sometimes look surprisingly similar to its past. Expect to Learn How Rosemary took stewardship of a pharmacy with more than 160 years of history and balanced preserving its legacy with modernizing the business.Why Hieber’s brought back the traditional pharmacy soda fountain and the surprising connection between pharmacists, chemistry, and the origins of popular soft drinks.How personalized compounding can adapt dosage forms, flavors, strengths, and delivery methods around the needs of individual patients and even pets.What goes into operating sterile and non-sterile compounding labs, including the infrastructure, procedures, transparency, and patient education involved.How Rosemary hopes Hieber’s can remain more than a place to pick up medication by becoming a lasting community gathering place for Pittsburgh. Timestamps [00:00] - Episode Teaser [01:32] - Meet Rosemary Mihalko and Hieber’s Pharmacy [04:25] - Bringing a Historic Pharmacy Back Home [06:37] - Making the Old New Again [08:34] - Why Pharmacists and Soda Fountains Belong Together [13:55] - Jonas Salk, Polio and Hieber’s Oral History [16:57] - Meet Gummy and the Modern Pharmacy Soda Fountain [23:32] - Inside Hieber’s Compounding Capabilities [24:39] - Personalizing Medicine Around the Patient [28:36] - LDN, Ménière’s Disease and Specialized Preparations [32:45] - Sterile Eye Drops, Safety and the Future of Hieber’s Follow Rosemary Mihalko: LinkedIn: https://www.linkedin.com/in/rosemary-sassic-mihalko-9a94bb2b/Website (Company): https://www.hiebers.com/LinkedIn (Company): https://www.linkedin.com/company/hieber's-pharmacy-inc-/home/Facebook (Company): https://www.facebook.com/hieberspharmacy/Instagram (Company): https://www.instagram.com/hieberspharmacy Follow the Host: Amy Summers: https://www.linkedin.com/in/amy-summers-pharmd-bcscp-fapc-20b04a93/Restore Health Consulting: https://www.restorehealthconsulting.com/ Follow The Podcast: YouTube: https://www.youtube.com/@RestoreHealthConsultingSpotify: https://open.spotify.com/show/033F4FRUbjSrN1oNbfozhD?si=caf30ccfd2ba49b6Apple Podcasts: https://podcasts.apple.com/in/podcast/compounding-interest/id6784679391 "Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

    Can a 160-Year-Old Pharmacy Shape the Future of Personalized Medicine? with Rosemary Mihalko

  7. Episode 8

    How Telehealth Founders Can Market Their Care When Clinical Skills Aren't Enough with Joel Gajewski

    In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Joel Gajewski to explore the business side of compounding pharmacy. Drawing on more than 20 years in advertising and sales, Joel shares how lessons in scaling teams, adapting to change, specializing in profitable niches, and delivering exceptional customer service helped MediVera expand from a regional pharmacy serving 12 states into an operation reaching nearly the entire country. Joel Gajewski is the director of sales & strategic partnerships at MediVera Compounding Pharmacy, bringing an unconventional background to the compounding pharmacy industry. Before entering pharmacy, Joel spent more than two decades in nationwide advertising sales, including helping scale Gas Station TV from roughly 40 locations to more than 20,000 locations across the United States. The conversation also moves to the telehealth startup ecosystem. Joel explains the infrastructure founders need before launching, from provider networks and EMR technology to pharmacy partnerships, compliance, insurance, and patient acquisition and why simply offering the lowest price is rarely a sustainable strategy. Expect to Learn How lessons from scaling a national advertising company can translate to building a nationwide compounding pharmacy.Why specialization in areas such as urology and hormone replacement therapy helped Medeva create a more scalable business model.How customer service, fulfillment speed, regulatory awareness, and operational reliability can differentiate one compounding pharmacy from another.The essential pieces of the telehealth ecosystem, including provider networks, telehealth technology, EMRs, pharmacy partners, insurance, compliance, and payment infrastructure.Why new telehealth founders often underestimate startup timelines, marketing expenses, and patient acquisition costs and what they should think through before launching. Timestamps [00:00] - Episode Teaser [01:31] - Meet Joel Gajewski: From Advertising to Compounding Pharmacy [05:49] - Bringing a Sales and Marketing Perspective to Pharmacy [08:30] - Scaling Medeva From a Regional to National Operation [11:28] - From a Small Medical-Office Pharmacy to a 56,000-Square-Foot Facility [15:32] - Why Specialization and Customer Service Became Growth Drivers [17:03] - The Operational Challenges of Running a National Compounding Pharmacy [20:18] - Who Is Starting Telehealth Companies and What Founders Get Wrong [26:29] - The Four Essential Pieces of Building a Telehealth Business [30:55] - Technology, Compliance, Pharmacy Partnerships, and the True Cost of Growth [38:46] - Evaluating Telehealth Partners and Final Takeaways Follow Joel Gajewski: LinkedIn: https://www.linkedin.com/in/joelgajewski/Website (Company): https://mediverarx.com/LinkedIn (Company): https://www.linkedin.com/company/mediverarx/ Facebook (Company): https://www.facebook.com/mediverarx/Instagram (Company): https://www.instagram.com/mediverarx Follow the Host: Amy Summers: https://www.linkedin.com/in/amy-summers-pharmd-bcscp-fapc-20b04a93/Restore Health Consulting: https://www.restorehealthconsulting.com/ Follow The Podcast: YouTube: https://www.youtube.com/@RestoreHealthConsultingSpotify: https://open.spotify.com/show/033F4FRUbjSrN1oNbfozhD?si=caf30ccfd2ba49b6Apple Podcasts: https://podcasts.apple.com/in/podcast/compounding-interest/id6784679391 "Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

    How Telehealth Founders Can Market Their Care When Clinical Skills Aren't Enough with Joel Gajewski

  8. Episode 9

    How a Cash-Pay Pharmacy Owner Thinks About Drug Pricing

    In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Ndidiamaka “Didi” Okpareke, pharmacist, president and owner of Olive Tree Compounding Pharmacy, and congressional candidate in New Mexico, for an inspiring conversation about entrepreneurship, healthcare policy, leadership, and the courage to pursue unexpected opportunities. From her family's journey to America after surviving the Nigerian Civil War to building a successful independent compounding pharmacy, Didi shares how her personal and professional experiences shaped her decision to run for Congress. The conversation explores the challenges facing independent pharmacies, rising prescription medication costs, healthcare access in rural communities, and why having healthcare professionals involved in policymaking matters. Expect to Learn How Didi's parents' immigration journey shaped her beliefs about opportunity, perseverance, and service.What compounding pharmacy reveals about patients' individual needs and the limitations of one-size-fits-all healthcare.How drug pricing, pharmacy benefit managers (PBMs), and regulations affect independent pharmacies and patient access to medications.What inspired Didi to run for Congress and how owning a pharmacy prepared her for a new kind of leadership.How Didi balances motherhood, business ownership, and public service while encouraging others to pursue opportunities they never imagined possible. Timestamps [00:00] - Episode Preview [01:26] - Meet Ndidiamaka Okpareke, Pharmacist and Congressional Candidate [02:40] - The American Dream: Family, Immigration, and Opportunity [05:02] - An Unexpected Career in Pharmacy and Finding a Passion for Healthcare [09:23] - What Patient Care Teaches Us About Healthcare Policy and Medication Costs [12:36] - The Power of Compounding Pharmacy and Personalized Patient Care [14:08] - Raising Three Boys, Building a Business, and Inspiring the Next Generation [20:21] - Why Didi Decided to Run for Congress and the Importance of Civic Engagement [27:21] - Bringing a Pharmacist's Perspective to Government and Healthcare Reform [28:57] - Rural Healthcare Access, Independent Pharmacies, and a Vision for New Mexico [35:02] - Final Advice: Overcoming Self-Doubt and Finding Your Place to Serve Follow Ndidiamaka Okpareke: LinkedIn: https://www.linkedin.com/in/ndidiamaka-okpareke-pharmd-rph-a55254aa/Congressional Campaign: https://www.didiforcongress.com/ Follow Olive Tree Compounding Pharmacy: Website: https://www.olivetreecompounding.com/LinkedIn: https://www.linkedin.com/company/olivetreecompoundingpharmacy/My Olive Tree School: https://www.myolivetreeschool.com/Olive Tree Skin: https://www.olivetree.skin/ Follow the Host: Amy Summers: https://www.linkedin.com/in/amy-summers-pharmd-bcscp-fapc-20b04a93/Restore Health Consulting: https://www.restorehealthconsulting.com/ Follow The Podcast: YouTube: https://www.youtube.com/@RestoreHealthConsultingSpotify: https://open.spotify.com/show/033F4FRUbjSrN1oNbfozhD?si=caf30ccfd2ba49b6Apple Podcasts: https://podcasts.apple.com/in/podcast/compounding-interest/id6784679391 "Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

    How a Cash-Pay Pharmacy Owner Thinks About Drug Pricing

  9. Episode 10

    How 503A Compounding Pharmacies Support Clinical Trials Beyond Making Study Drugs

    In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Viral Jani, Chief Operating Officer of Town & Country Compounding Pharmacy, to explore an often-overlooked opportunity for compounding pharmacies: supporting clinical research. The conversation examines the operational realities of clinical trial support, including formulation development, stability testing, blinding, pharmacy manuals, and the challenges of unpredictable study timelines. Viral also explains why meticulous documentation, qualified suppliers, and consistent processes are essential to protecting the integrity of clinical research. Viral Jani is the Chief Operating Officer of Town & Country Compounding Pharmacy, a 503A compounding pharmacy based in Ramsey, New Jersey, specializing in sterile and nonsterile compounding, including hazardous preparations. With experience spanning retail operations, sterile compounding, and regulatory compliance, Viral brings a systems-focused perspective to pharmacy practice. His approach emphasizes reproducibility, documentation, and quality control as foundational elements of successful compounding and clinical research. Expect to Learn Why 503A pharmacies can be valuable partners for Phase 1 and Phase 2 studies, including investigational formulations, dose escalation, pediatric preparations, and supportive therapies.What happens between the first researcher inquiry and dispensing the first study drug, including feasibility assessments, protocol reviews, pilot batches, testing, and pharmacy manuals.How API traceability, manufacturer records, regulatory documentation, and supply chain consistency can determine whether a study succeeds or encounters costly setbacks.How pharmacies develop formulations, conduct stability testing, create matching placebos, maintain blinding, and manage inventory across changing enrollment timelines.How USP standards, 503A requirements, drug accountability, quality systems, and beyond-use dating influence a pharmacy's role in clinical research. Timestamps [00:00] - Episode Trailer [01:27] - Meet Viral Jani: From Retail Pharmacy to Compounding Leadership [03:06] - Town and Country Pharmacy and the Opportunity in Early-Phase Clinical Trials [06:36] - Who Needs Clinical Trial Compounding? Researchers, CROs, and Biotech Companies [10:25] - From Initial Inquiry to Investigational Product: Protocols, Approvals, and Pharmacy Manuals [17:49] - Understanding Pharmacy Capabilities, Study Size, and Phase I vs. Phase II Trials [21:48] - Managing Unpredictable Timelines, API Sourcing, and Supply Chain Documentation [27:24] - Formulation Development, Pilot Batches, and Stability Testing [30:16] - Placebo Blinding, Clinical Trial Labeling, and Study Funding [34:47] - 503A Compliance, USP , Beyond-Use Dating, and Final Takeaways Follow Viral Jani: LinkedIn: https://www.linkedin.com/in/viral-jani-a124b3100/Website (Company): https://tccompound.com/LinkedIn (Company): https://www.linkedin.com/company/town-country-compounding-pharmacy/Instagram (Company): https://www.instagram.com/tccompound/YouTube (Company): http://www.youtube.com/@tccompound Follow the Host: Amy Summers: https://www.linkedin.com/in/amy-summers-pharmd-bcscp-fapc-20b04a93/Restore Health Consulting: https://www.restorehealthconsulting.com/ Follow The Podcast: YouTube: https://www.youtube.com/@RestoreHealthConsultingSpotify: https://open.spotify.com/show/033F4FRUbjSrN1oNbfozhD?si=caf30ccfd2ba49b6Apple Podcasts: https://podcasts.apple.com/in/podcast/compounding-interest/id6784679391 "Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

    How 503A Compounding Pharmacies Support Clinical Trials Beyond Making Study Drugs

  10. Jun 26

    New Episode Coming Soon!

    Are you overwhelmed by complex compliance codes and shifting regulatory standards? Do you worry that your quality management systems are just checking boxes instead of truly safeguarding your operations? You don't have to navigate the high-stakes landscape of sterile compounding and personalized medicine alone. Introducing Compounding Interest: The Business of Personalized Medicine! Brought to you by Amy Summers - a nationally recognized authority in 503A and 503B operations - and the expert team at Restore Health Consulting. Backed by proven playbooks and a nationwide consulting network, they help businesses build, scale, and restore their infrastructure to maximum capacity. In each episode, you will gain executive-level insights, field-tested risk mitigation strategies , and inspection-ready solutions that help organizations move past minimum standards and achieve true operational excellence. If you are a pharmacy operator, life sciences executive, or medical spa innovator, this is your essential guide. Compounding Interest is coming soon to your favorite podcast platform. Subscribe now so you don't miss the very first episode!

  11. Jul 3

    The Peptide Therapy Crisis for Patients Losing Access to Life-Changing Treatments with Melissa Stefko

    The future of peptide compounding is at a critical crossroads. As the FDA prepares for its upcoming Pharmacy Compounding Advisory Committee (PCAC) meeting, compounders, prescribers, patients, and industry advocates are facing important decisions that could shape access to peptide therapies for years to come. In this episode, Amy Summers sits down with Melissa Stefko of Wells Pharmacy Network to discuss why these regulatory decisions matter. Together they explore the intersection of personalized medicine, patient access, regulatory oversight, and public safety. Melissa Stefko is the senior VP of regulatory affairs at Wells Pharmacy Network with extensive experience in pharmacy compounding and FDA policy. She has been actively involved in peptide nominations for FDA review and works closely with industry organizations advocating for safe, regulated access to compounded therapies. Melissa brings a practical perspective on how evolving regulations impact pharmacies, physicians, and patients seeking personalized medicine. Key Takeaways Why the upcoming FDA PCAC meeting could significantly impact peptide compounding.How peptide therapy fits into the growing movement toward personalized medicine.The safety concerns surrounding the expanding gray market for peptides.The difference between FDA enforcement discretion and state board pharmacy regulations.How pharmacists, physicians, and patients can contribute meaningful comments before FDA review. Timestamps [00:00] - Introduction to the episode [04:07] - Why peptides have become a major healthcare and regulatory topic [08:08] - Clinical uses for peptides and the original FDA nominations [11:05] - FDA's preliminary recommendations and industry concerns [15:16] - Gray market peptides versus regulated pharmacy compounding [18:35] - Understanding FDA oversight and state board enforcement [22:24] - How pharmacies, physicians, and patients can support the FDA review process [26:08] - What meaningful FDA docket comments should include [28:19] - Possible outcomes after the PCAC meeting [33:10] - Final recommendations and how stakeholders can get involved Follow Melissa Stefko: LinkedIn: https://www.linkedin.com/in/melissa-stefko-70234415/Website (Company): https://wellsrx.com/LinkedIn (Company): https://www.linkedin.com/company/wellspharmacynetwork/Facebook (Company): https://www.facebook.com/wellsrxInstagram (Company): https://www.instagram.com/wellspharmacynetwork/X (Company): https://x.com/wellsrxTikTok (Company): https://www.tiktok.com/@wellspharmacynetwork Follow the Host: Amy Summers: https://www.linkedin.com/in/amy-summers-pharmd-bcscp-fapc-20b04a93/Restore Health Consulting: https://www.restorehealthconsulting.com/ Follow The Podcast: YouTube: https://www.youtube.com/@RestoreHealthConsultingSpotify: https://open.spotify.com/show/033F4FRUbjSrN1oNbfozhD?si=caf30ccfd2ba49b6Apple Podcasts: https://podcasts.apple.com/in/podcast/compounding-interest/id6784679391

    The Peptide Therapy Crisis for Patients Losing Access to Life-Changing Treatments with Melissa Stefko
See All (11)

About

Welcome to Compounding Interest: The Business of Personalized Medicine, the podcast exploring what it takes to build, scale, and safeguard high-performing operations in the rapidly evolving world of personalized medicine. Hosted by Amy Summers, PharmD, BCSCP, FAPC - a nationally recognized authority in pharmacy compounding and 503B outsourcing operations - and backed by the expert team at Restore Health Consulting, this show features insightful conversations with healthcare innovators, compliance executives, and life science operators who are rethinking what it means to deliver specialized care in a highly scrutinized landscape. Each episode examines the rigorous regulatory frameworks, quality systems design, and strategic leadership approaches that help organizations elevate their operations far beyond basic compliance. Through real-world insights and field-tested strategies, guests share how they navigate complex guidelines, optimize 503A and 503B facilities, and transform strict quality controls into an organizational strength. Drawing from a deep portfolio of enterprise-level operational transformations and proven industry playbooks, the show explores how an unwavering dedication to clinical and operational excellence can become a powerful differentiator when organizations intentionally design businesses built to scale.

Information

  • Creator
    Amy Summers
  • Years Active
    2026
  • Episodes
    11
  • Rating
    Clean
  • Copyright
    © Copyright 2026 Amy Summers
  • Show Website
    Compounding Interest