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Thursday, May 4, 2017
7:30-8:30 AM - Registration & Networking Continental
8:30-8:45 AM - Welcoming & Opening
Ralph Vitaro, Publisher & President, Drug Development
Josef Bossart, Executive Editor, PharmaCircle LLC
Donald Sebastian, PhD, President & CEO, New Jersey Innovation Institute & Senior Vice President, Technology & Business Development, New Jersey Institute of Technology
The New Jersey Innovation Institute (NJII) is a new model for business innovation. It is a non-profit corporation of New Jersey Institute of Technology following industry-led agendas to assume the risk of advanced technology development as a proprietary client service, platform technology development for industry sectors, and innovation across supply chains. NJII features Innovation Labs (iLabs) that focus on: Healthcare Delivery Systems, Bio-Pharmaceutical Production, Civil Infrastructure, Defense & Homeland Security, and Financial Services. It also conducts NJIT's economic development mission through Economic Cluster Development, Applied Education and Training, Entrepreneurship, and Enterprise Development. The Institute launches with roughly $40M in programmatic activity.
Laurie Smaldone, MD, COO & CSO, NDA Group AB
How Integrated Global/Market Access Drug Development Strategies Add Value in Early Development
Abstract: Understanding the market access and global regulatory landscape is critical in drug development decision making. Many companies are working in areas of targeted therapy, rare disease, and highly specialized technologies that challenge the traditional pathways to commercialization. We will explore considerations to optimize value and bring patients access to novel therapies that require more holisitc ways to generate evidence that is not only required for approval, but also for reimbursement. Case studies will be discussed that highlight challenges and opportunities along the path to the market.
Tom Johnson, Senior Director, Life Science Solutions, Exostar
(SI)2 - Pairing Scientific Innovation With Security Innovation
Abstract: Scientific innovation represents a life science company’s future, and it must be protected from malicious cyber threats targeting the company and its diverse network of external partners. Threat sophistication and persistence, coupled with an extended attack surface, requires security solutions whose innovations match the science. In this presentation, Exostar’s Tom Johnson will highlight the security-based technologies life science companies must include in their repertoire, including identity and access management with multi-factor authentication, multi-tenant collaboration with digital rights management, electronic/digital signatures, and continuous risk assessment/management solutions.
10:15-10:45 Networking & Morning Break
Scott Brown, MS, Executive
Director, Device Development, Merck
Avoiding the Pitfalls in
Device Development & Commercialization
Abstract: This presentation will go over the common sources of
failure in delivery device development and how to systematically avoid them
while optimizing the likelihood of a successful product approval and launch.
Emphasis is placed upon design integrity and simplicity and effectively meeting
the needs of patients and healthcare professionals.
Cornell Stamoran, PhD, Vice President, Strategy for Catalent, Inc., & Co-Chair, Catalent Applied Drug Delivery Institute
The Patient-Focus Imperative: Formulating & Delivering Better Patient Outcomes
Abstract: This session will review the current state of patient-focused drug formulation and drug product design, with research, regulatory, and real-world perspectives. The session will also include a look at the near-term future of patient-focused design, and discuss practical ways to accelerate patient focus during the development process.
Keith Horspool, PhD, VP of Material & Analytical Sciences, Boehringer Ingelheim
Pharmaceutical Development White Noise & Dark Matter
Abstract: Traditional development has relied on practices and processes that have generally been successful for many years. However, it is not uncommon for “standard development” to suffer challenges that affect the overall effectiveness and efficiency of a project in terms of time and resources. In many cases, issues encountered lead to extensive root cause analyses that could be prevented by better mechanistic and materials understanding of the drug substance, its isolation, and the formulation composition. By developing deeper material science perspectives, it is possible to accelerate programs based on smart risk-taking and by prescient avoidance of problems that are likely to be experienced in later development.
12:15-1:30 PM - Networking & Lunch
Kurt Nielsen, PhD, President, Lupin
Indispensable Principles of Rx & Gx Product Selection & Portfolio Management: Debunking Myths & Demystifying the Decision-Making
Abstract: All too often, the indispensable principles of a business process are not universally understood and only known to a few leaders in an organization. There is additional complexity and uncertainty that must be dealt with by existing and potential partners and vendors. We will identify and define the core principles of Rx and Gx product selection and portfolio management business process for small, medium, and large cap companies. There will be a focus on the under-articulated beliefs and often misunderstood decision-making while dispelling widespread myths that lead to failed programs and unrealizable expectations in today's value-driven pharmaceutical markets in the US.
Finn Bauer, PhD, Director of R&D & Head of Solid Formulations, MilliporeSigma
Alternative Technologies to Overcome Solubility & Bioavailability Challenges
Abstract: Most active pharmaceutical ingredients (API) lack aqueous solubility during pharmaceutical drug product development, and one in three drug candidates offers poor bioavailability in the preclinical stage. Various strategies are commonly used to enhance drug bioavailability, and carriers can improve the aqueous solubility of drug candidates. Inorganic carriers, such as porous silica-based particles, are advantageous, as the material is safe (GRAS) and can easily be formulated into a final oral dosage form (tablet or capsule). The presentation discusses the proof-of-concept, formulation strategy, and manufacturing scale-up for silica-based drug carriers, exemplified by different case studies of poorly soluble drug candidates.
Mathias Romacker, MA, Senior Director, Device Strategy, Pfizer
Global Market Trends for Injection Devices – A Brief Overview
Abstract: This presentation will review the latest industry news in injectable drug delivery and discuss new product launches and business announcements and what could be next. Furthermore, the presentation will look at selected device technology advancements and how those may better address new needs.
Conrad F. Mir , President & CEO of Calmare Therapeutics
Dilution or Death? The Cost of Just One More Day in the Microcap World
Abstract: Innovative medical technologies are often encased in publicly traded companies. Their flagship technologies are usually featured as “The next billion dollar breakthrough!” And then comes the big takeaway: The company is in various stages of chaos and hopes it can last just one more day. So, this begs the questions: How much does one more day cost; and, how can we make this work? Please join me in discussing three financial structures that are afforded to publicly traded companies and can help make one more day last just enough.
Nila Das, PhD, Senior Research Investigator, Bristol-Myers Squibb
Antibody-Drug Conjugates & Their Unique Challenges
Abstract: In the past couple of decades, antibody-drug conjugates (ADCs) have experienced significant interest in their application for cancer treatment. However, the development of ADCs is complicated by their unique challenges, such as extremely potent payloads, and physicochemical behavior, such as DAR, unconjugated drug, and unconjugated mAb. This presentation will highlight these challenges in context to a case study.
Jeffrey Bacha, MBA, Chairman & CEO, DelMar Pharmaceuticals
The Importance of Strategic Collaborations With Universities & Organizations to Further Develop a Technology
Abstract: Developing innovative pharmaceutical therapies and technologies in a cost-effective manner is often a challenge for emerging companies. For this reason, many companies find it beneficial to establish research relationships with leading academic medical research centers, enabling them access to leading minds in their respective field and world-class infrastructure while maintaining expenditures at a manageable level. These often long-standing relationships with researchers and key investigators is often based on mutual interest or expertise described in their published research, making them an idea partner for any company.
4:30-6:00 PM - Cocktails
& Hors d’oeuvres Networking Reception
Friday, May 5, 2017
8:00-9:00 AM - Networking & Continental Breakfast
9:00-9:15 AM - Opening Remarks
Peter Pekos, MSc, President & CEO, Dalton Pharma Services
Form, Fit & Function…All Are Critical for Drug Development Success With a CDMO
Abstract: The current marketplace has a plethora of established and emerging CDMOs (Contract Development and Manufacturing Organizations) offering a wide variety of production capabilities, expertise, and value-added services. Selecting the best CDMO can be very challenging for the small/medium-size biopharma company, yet it is one of the most critical decisions when investing in drug development. While technical expertise, quality, reliability, and timeliness are important, choosing a CDMO that provides the best fit can be even more crucial for success. Large contractors can add bureaucracy to a project, putting at risk the agility that a small/medium biopharma company needs to advance quickly and adapt to project changes. On the other hand, CDMOs that are too small may not have the depth or resources on demand that is necessary for optimum service, relationships, and performance. The best-fit CDMO will operate as an extension of their clients’ business and project team, and will be able to vertically integrate as much of the project scope as possible to streamline vendor management for the client. Relationships that build on interaction with the clients’ staff across various functions prevent project silos, and develop a partnership in which trust and commitment are paramount. This discussion will reflect on the characteristics of the best-fit CDMO, review case studies, and provide tools for enhancing the drug development program using a CDMO.
David Harris, PhD, Fellow, Merck Research Laboratories
Pediatric Formulation Development & Patient-Focused Design Principles
Abstract: U.S. and EU regulations require sponsors to develop pediatric formulations and labeling for all new chemical entities that are expected to be used in pediatric patients. Pediatric formulation development presents several challenges, including the need for dose flexibility and the need to accommodate the varying abilities of children to take conventional oral dosage forms. Swallowability and palatability – both elements of patient-focused product development – are critical considerations in pediatric medicine. This presentation will review the challenges associated with pediatric formulation development, the most commonly used formulation approaches, and the compromises inherent in pediatric formulation selection. It will also review the extension of these design principles and formulation approaches to geriatric medicine.
Lilli Zakarija, MSME, MBA, Co-Founder/President, EdgeOne Medical
Device Design Controls When the Combination Product Uses an Off-the-Shelf Device Versus Custom Developed Device
Abstract: The integrated development approach between the two constituents (drug/biologic and device) of a combination product are now the norm, yet organizations still struggle with understanding device design controls and level of effort appropriate for their development program. Understanding key aspects of the device design control process and what is necessary to comply with CP regulations is helpful to an organization as they consider appropriate device(s) for their program as well as understanding when key attributes of the drug/biologic are necessary to the device activities.
Martin Eastgate, PhD, Director, Chemical & Synthetic Development, Bristol-Myers Squibb
Design, Development & Implementation of New Routes to Promising Clinical Candidates
Mahen Gundecha, MBA, Head of Alliance Management, Sandoz Inc. (Novartis Group)
Building Alliance Management Into a Value-Enhancing Capability Throughout Your Organization
Abstract: Strategic alliances are becoming critical to the growth, profitability and future sustainability of today’s health care organizations. Companies are driving growth through R&D and commercial collaborations. They are managing costs and infrastructure by outsourcing product development, manufacturing, supply chain and administrative functions. Effective alliance management can drive the operational and financial success of these business collaborations. However, turning business collaborations into strategic partnerships does not come without challenges. In this interactive session, we will discuss approaches to build effective alliances across your enterprise and also create a sustainable alliance management culture.
Ronald L. Smith, PhD, Scientific Assoc. VP, Pharmaceutical Sciences, Merck Research Laboratories
Transformative Innovations in Drug Product Science & Technology
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