COMPANY PROFILE

Summary

Adare Pharma Solutions is a global technology-driven CDMO providing end-to-end integrated services, from product development through commercial manufacturing and packaging, with expertise focusing on small molecule oral dosage forms. Adare’s specialized technology platforms provide taste masking, controlled release, solubility enhancement, and patient-centric dosing solutions. With a proven history in drug delivery, Adare has developed and manufactures more than 45 products sold by customers worldwide.

Key Leadership

• Tom Sellig, Chief Executive Officer

Tom Sellig brings more than 30 years of global experience in the life sciences industry to Adare, including experience scaling organizations and driving growth in the CDMO and Pharma Services space.

From 2019 to 2021 Tom served as Chief Executive Officer of LabConnect, a clinical trial laboratory services organization. Under his leadership, the company more than doubled in revenue and underwent significant team expansion.

Prior to LabConnect, Tom was Chief Commercial Officer at ConnectiveRx, where he was responsible for all commercial and customer-facing activity at the patient support and patient access company. Earlier, Tom was Senior Vice President of Global Sales at Patheon, where he played an integral role in the company’s sale to and integration with Thermo Fisher. Previously, he served as the Global Vice President of Sales and Client Services at Covance.

Tom received his bachelor’s degree in Economics from Vanderbilt University and an MBA from New York University.

Vivek Sharma, Executive Chairman

Vivek brings over 25 years of global leadership experience in North America, Europe, and Asia. The last 15 years have been spent in the pharmaceutical industry, including contract manufacturing, critical care, and healthcare insights, data and AI. He was formerly CEO at Piramal Critical Care (Global Inhalation Anesthesia company), Piramal Pharma Solutions (Global CDMO) and Decision Resources Group (Global Healthcare Insights and Data and Analytics company). Prior to this Vivek was Managing Director with Boston based Private Equity firm Thomas H. Lee Partners.

Michael Ryan, Chief Financial Officer and Chief Operations Officer

Mike brings over 20 years of global experience in finance, operations, and mergers & acquisitions, including significant experience operating in a private equity-backed environment.

Mike previously served as President and Chief Operating Officer of the Commercial Division at Syneos Health, where he was responsible for running the day-to-day operations of the division, as well as the oversight and delivery of all the material strategies and commitments to key stakeholders.

Mike began his career with Arthur Andersen working in their public accounting practice. He holds a Bachelor of Science in Business Administration from the University of Notre Dame and is a Certified Public Accountant.

Vipan Dhall, Chief Scientific Officer

Vipan brings over 25 years of global experience in the development of formulations and drug delivery technologies. At Adare, he is responsible for global R&D organization comprising of pharmaceutical development, technical operations, regulatory affairs and project management with a focus on developing NCEs, Generics and Innovative Generics. Prior to joining Adare, Vipan has held leadership positions with SGS (North America), Piramal, Dr. Reddys Labs, NPS Pharmaceuticals, where he has led drug discovery, product development and clinical services.

Vipan received his Masters and Ph.D. in Pharmaceutical Sciences from India.

Giuseppe Di Vincenzo, Chief Strategy Officer

Giuseppe leads our strategy and internal pipeline development teams.

He was previously Vice President, Strategic and Commercial Development at Adare where he was responsible for commercial strategy, marketing, business development and internal pipeline development activities. Prior to that, he was Vice President Global Sales and Strategy at Aptalis Pharmaceutical Technologies. Before joining Aptalis, he held several senior positions at Eurand. He also held roles with Élan Corporation and Arthur D. Little.

Giuseppe holds a degree in Biology from the University Federico II of Naples and a MBA from the London Business School.

Kristin Berkinsky, Chief Human Resources Officer

Kristin Berkinsky has more than 20 years in global human resources experience across life sciences and pharmaceuticals, manufacturing, and business services. Kristin joined Adare from Conduent, where she served in a Global Vice President of Human Resources position. Previously, she served as CHRO at Argo Turboserve, a global manufacturing and supply chain services organization. Earlier, Kristin worked in the CDMO industry as Global Head of Human Resources for Piramal Healthcare and CHRO at Halo Pharmaceuticals.

Kristin earned her BA in Philosophy from Pennsylvania State University.

https://adarepharmasolutions.com/about/our-leadership/

Key Capabilities and Services:

Product Development: Experienced Staff of close to 100 Experts dedicated to your product development needs:

• Pre-formulation

• QbD Principles applied with formulation development

• Support including physical characterization

• Analytical method development & validation

• IMPD manufacture and QP release

• Technology transfer

• ICH stability programs at all conditions

• Small scale non-GMP and GMP development capability

• Double blinding for placebo-controlled OSD projects

• Pediatric formulations for oral delivery

• Solvent dispersion and coating capabilities with Nanotech drug delivery platform

• 505(b)2 Product Concepts / Development of Lifecycle Products

Commercial Manufacturing Capabilities:

• Standard Offerings

• Granulation and mixing

• Roller Compaction

• Fluid bed processing & Drying

• Wurster

• Top Spray

• Oven drying

• Pan coating

• Blending (Bin and Static)

• Tableting

• Tablet Printing & Inspection

• Capsule filling

• Small scale GMP manufacturing

• Tech Transfer

• Warehousing & distribution

Specialized Offerings:

• Microencapsulation of solids and liquids

• Orally disintegrating tablets (ODT)

• Dry syrup/ suspensions

• MMTS TM Minitabs

• Enzyme formulation

• DEA Controlled substances: - Manufacturing registration authorized for classes II-V - Analytical Labs authorized for I–V

• Fixed-dose combination manufacturing

• Liquid filling in hard-shell capsules with banding

• Solvent granulation and coating processes

• Food sprinkle dosage forms

• High Potency 1 mcg/m3 and above

Packaging Capabilities:

• High-speed bottle filling - Low count - High count - Short run

• Blister Packaging - Thermo and Cold Forming

• Serialization Competent - Aggregation Capable

• Specialty Packaging - Clinical Supply Services - Stick pack and cartoning operations - Powder-in-bottle filling capabilities

ADARE’S SPECIALIZED TECHNOLOGIES

Parvulet® technology is a patient-centric dosage solution that enables a solid powder or tablet to convert to a semi-solid in the presence of water within thirty seconds. The final dosage is easily administered, as a soft food like texture, ideal for pediatric and geriatric populations (including those with dysphagia).

AdvaTab® Orally Disintegrating Tablets (ODTs) incorporates coated or uncoated drug particles that are uniformly dispersed in a low-moisture, rapidly disintegrating matrix. Each ODT is formulated to achieve an acceptable taste and desired release profile. AdvaTab® technology is ideal for patients who have difficulty swallowing, pediatric, geriatric, and dysphagic patients. This technology can be combined with Microcaps® and Diffucaps® to create immediate release or controlled release ODTs.

Diffucaps® Customized Release Technology has the flexibility to incorporate functional, release-controlling polymers or protective coatings onto drug-layered cores, granules, or crystals. This allows for easy adjustment of both dosage strength and dissolution profile to achieve the desired in vivo pharmacokinetic profile. Beads can have different release profiles, different active ingredients, or both—all in one product.

Microcaps® Taste Masking and Modified Release Technology achieves uniform and efficient coating of drug particles by coacervation (phase separation) to build polymeric membranes of varying porosity and thickness. The result is a free-flowing powder containing microencapsulated API (or API substrate) in a wide range of particle sizes. The Microcaps technology can be applied to multiple dosage forms for both immediate and modified-release profiles

MMTSTM Multi Mini Tablet System Customized Release technology combines the simplicity of a tablet formulation with the flexibility of multiparticulate dosage forms with high drug-loading capability. Adare has developed Ultra Microtablets—a smaller standard of tablets targeting diameters in the range of 1.2 mm to even 1.0 mm. The small size facilitates the development of products that can offer multiple drugs or varying release profiles within a single capsule.

DIFFUTAB® technology is an effective solution for targeted drug delivery through customized and sustained release. The technology assists the development of high-dosage and sustained release products for once-daily administration. A matrix tablet is coated with functional polymers, followed by a blend of hydrophilic and hydrophobic polymers. Layered erosion and diffusion of the drug matrix tablet result in a controllable release.

Precision Particle Fabrication™ technology produces uniform microspheres and microcapsules with narrow size distribution and precise control over particle structure. The platform technology is flexible and customizable to accommodate a broad range of active ingredients, including small molecules, peptides and proteins. The technology uses two physical processes simultaneously to create uniform droplets piezoelectric vibration and a co-flowing non-solvent “carrier” stream. For any given mass flow rate, droplet size can be reduced simply by increasing the frequency of vibration. The technology includes three platforms: Optimμm®, for oral delivery; StratμmTM, for injectable delivery; and Unisun®, for otic delivery.

Optimµm® technology creates microspheres with high drug loading suitable for taste masking, enteric coatings, and extended-release oral applications. The technology is capable of producing single- or double-layer particles in a one manufacturing step, lending to cost-effective creation of palatable dosage forms that mimic traditional tablets, pills, and capsules. The Optimµm® technology allows for unprecedented control in release rate and dosage form properties. This technology is ideal for oral small molecules, nutraceuticals, agricultural applications, flavorings, and heat stable molecules.

Stratµm™ technology, for injectable delivery, allows for precise control of particle size and composition enabling predictable injectable performance, which is critical for self-administration, extended release, and modified release applications with a narrow therapeutic index. Unlike other encapsulation techniques, Stratμm® is capable of producing single- or double-layer particles in a one manufacturing step, lending to creation of next-generation “pulsatile” release formulations or extended-release formulations. This technology is ideal for injectable small molecules, proteins, peptides, vaccines, and heat-labile molecules and requires lyophilization.

Unisun® technology combines the use of encapsulated or free drug, along with a fast-film forming agent, which allows for low-cost, long-acting intratympanic delivery of a therapeutic. The technology allows for less frequent administrations than current therapies and is capable of sustaining drug levels in the inner ear cochlea for weeks. The technology can be used to inject and set up highly concentrated depots of a drug and is ideal for small molecules, proteins, peptides and vaccines.

Adaptdose™, Adare’s unique commercialized approach to adaptive formulation design, is a highly flexible, multi-delivery platform tool that eliminates the need for post Phase 1 trial reformulations and facilitates the creation of custom oral delivery systems. Adaptdose provides the ability to combine 2-3 active ingredients or 3-4 delivery rates in a single capsule using minitablets, granules and liquid.

Duragran™ allows for more uniformity and precise control of targeted particle sizes while providing production time and cost savings. It eliminates the need for extrusion and spheronization for high API-loaded drug particulates by using fluid bed processing technology that combines the particle sizing and coating processes. This creates controlled-release beads/granules of uniform and narrow particle size range.

CAT.oneSM minimizes the potential for abuse by ensuring that drug products are evaluated for all potential routes of misuse. Adare’s experts integrate abuse-deterrent testing by replicating basic and multi-step methods that an abuser may use to prepare the product for recreational misuse or abuse. Our CAT.one laboratory scientists possess the expertise and knowledge of current FDA Guidance on the evaluation of abuse-deterrent and manipulation-resistant formulations, allowing us to efficiently handle all your category 1 in-vitro testing needs.

Contact

1200 Lenox Drive, Suite 100, Lawrenceville, NJ 08648

609-450-1312