Kevin Bittorf Email & Phone Number

SCxCMC Solutions has assembled a highly skilled group of consultants to help bring our pharmaceutical client’s molecules to the clinic efficiently while exceeding expectations and timelines. Our talented group of consultants include experts in Formulation Development, Chemical Development, Chemistry, Quality Assurance, Project Management, Supply Chain Management, and other critical support functions needed for any small to medium Pharmaceutical companies and Biotechs.

CMC Consultant experience in wide rage of dosage forms: Tablets, Softgets, Emulsions, sprays, nano-particles and solutionsHighly experienced in working with CMO and CRO in attaining clinical trial material and commercial material.

The Advancing Drug Development Forum - Making the Impossible Possible, builds on positive momentum and energy from our past meetings. Our Next form is Dec 12th, 2019 in Boston MA,The form attracts and stimulates dialogue among key opinion leaders within biotech and pharma, executive leaders, senior directors, consultants, and a close network of CROs and CDMOs to further explore novel solutions, and promising technology breakthroughs. Together we will learn from entrepreneurial industry experts about how they are introducing and incorporating novel approaches in small molecule drug development; changing timelines and ROIs. Hear for yourself, how you can speed up your timelines and improve your product quality. For the agenda please goto www.AdvDrug.org

Founding President of an organization to examine pharmaceutical compactions. Simulation/replication of tablet compression is an increasingly important part of product development, allowing investigation of tableting properties earlier in development and material/cost sparing studies supporting scale-up and registration. Now widely used in the pharmaceutical industry and in academia, simulators have a central role in pursuing Quality by Design as a time- and cost-efficient complement to on-press experimentation.www.compactionsimulation.com

Greenbrae, California, Us

At NP2, a non-profit dedicated to reducing the cost of life-saving generic drugs in the U.S., I led the strategic effort to bring affordable oncology medications to market, specifically targeting injectable generic drugs that have seen significant price increases in recent years. I provided leadership in identifying CDMO partners for a challenging-to-manufacture cytotoxic drug and significantly boosted NP2's social media presence, doubling our outreach within a short period.I played a key role in identifying and securing potential commercialization partners and distributors, and I provided the strategic roadmap to position NP2 for a successful ANDA (Abbreviated New Drug Application) filing. My efforts helped advance NP2's mission of delivering cost-effective, life-saving treatments to those in need.

Lexington, Massachusetts, Us

In my role as Acting Head of CMC, I was responsible for preparing all active assets for commercialization while ensuring the continuous supply of clinical trial materials for both large and small molecule programs. I led the CMC team in successfully managing critical operational and strategic initiatives to advance Curis' portfolio.Key accomplishments included collaborating closely with the CFO to align CMC activities with a stringent start-up budget, completing due diligence on a biologics program, and identifying and negotiating with key commercial drug product and drug substance vendors. Additionally, I implemented an IRT system to streamline clinical trial operations and defined the CMC-QA strategy to ensure regulatory compliance and quality control.

Charlestown, Ma, Us

As the Scientific Fellow and Head of Formulation Development at Flatley Discovery Lab, I spearheaded the development of a complex formulation for a combination product targeting cystic fibrosis. I led the end-to-end formulation process, from initial development through manufacturing, to ensure the successful delivery of clinical trial materials. This involved collaborating closely with cross-functional teams to navigate the unique challenges of combining multiple active pharmaceutical ingredients.In addition, I defined and managed the clinical supply chain, ensuring timely and efficient delivery of all clinical supplies across multiple trial phases. My leadership in operational logistics, coupled with a deep technical understanding of formulation science, was critical in advancing the product's clinical development and supporting its path toward commercialization.

As Vice President at Trek Therapeutics, I held comprehensive responsibility for all pharmaceutical development (CMC), supply chain management, business development, and intellectual property activities. This included spearheading in-licensing deals and managing legal aspects of IP and contracting. I developed the strategic framework for Trek’s business development, focusing on delivering unique value propositions to potential partners, which became central to the company's deal-making process.I played a key role in Series A investor meetings, contributing to securing critical funding. Within my first three months, I secured an agreement for Trek’s first corporate asset and led the negotiation and contracting of all assets related to Trek’s Hepatitis C treatment, a cornerstone of our product portfolio.Key accomplishments include:• Developed and led the virtual pharmaceutical development (CMC) network of CMOs and CROs to ensure efficient development and manufacturing of clinical and commercial materials.• Provided the operational framework for financial and project management functions, ensuring seamless execution of development strategies.• Successfully negotiated terms and managed contracts for all of Trek’s assets, forming the foundation of our Hepatitis-C treatment program

As the Industrial Chair and Advisory Board Member, I provide strategic leadership and guidance to advance the organization's mission of fostering innovation and collaboration within the biopharmaceutical sector. In this role, I act as a bridge between industry and academia, ensuring that research initiatives align with real-world challenges and opportunities in biopharmaceutical manufacturing.I work closely with key stakeholders, including manufacturers, system suppliers, and raw material providers, to drive the development of next-generation biopharmaceutical processes. My efforts are focused on facilitating partnerships, shaping the research agenda, and providing insights to accelerate the commercialization of safe, effective biopharmaceutical therapeutics.Key contributions:• Led the formation of strategic industry-academic partnerships, enhancing the consortium's impact on biopharmaceutical innovation.• Advised on the development of cutting-edge biomanufacturing technologies to improve product robustness and safety.• Facilitated industry engagement, securing funding for research projects and new infrastructure developments that support advanced biopharmaceutical science.

Boston, Ma, Us

I was responsible for expanding overall understanding of Living proof’s products and processes. Completing this thought a quality by design (QbD) framework and developing advanced analytical technologies to assist in understanding both chemical and physical analytical mechanisms in the hair and skin lines. Responsible for product quality assurance and developed qualtiy systems. key accomplishments• Reduced release time for products by over 90%• Reduced batch failure by over 80%• Developed a formal project management system

Boston, Ma, Us

Develop Assets in Emerging Markets• Developed and directed a virtual Chemistry Manufacturing and Control (CMC), group • Key contributor to Vertex’s creation of a network model to develop novel compounds through partnershipsAssess and Implement Novel Technologies for Pharmaceutical Development: Continuous Processing• Initiated the continuous processing initiative for Vertex Pharmaceuticals’ products; all of Vertex’s products will be manufactured in this manner. Completed the technical and financial justification to move all project to a continuous processing platform. • Led Pharmaceutical Development innovation teams to identify future processing technologies in the areas of biotransformations, finite element analysis, continuous processing, and process analytical technology (PAT)

Boston, Ma, Us

Led the formulation development for Vertex’s anti-viral compounds including, Incivek, Vertex’s oral treatment for hepatitis C (HCV). CMC Core Team Leader for HCV programs. Key accomplishments:• Developed a “Quality by Design” (QbD) framework for our contract manufactures• Introduced multiple real-time process analytical technologies (PAT) into the laboratory and commercial manufacturing• Identified CMOs and transferred entire CMC activities to new manufacturers

Dublin, County Dublin, Ie

Technical Operations Engineer•Validated over 30 products and intermediates in a cGMP environment at various CMOs• Developed solid dosage forms with various methods including: blending, compression, coating, soft-gel encapsulation, and gelatin coating processes

Dk-2740 Skovlunde, Dk

Developer, consultant and sales representative for Computational Fluid Dynamics designed to solve industrial mixing problems.

Phd, Chemical Engineering

Mba

B.Sc., Chemical Engineering