13^th International Conference on Biologics and Biosimilars October 24-25, 2018 Boston, USA

Biography:

Francois-Xavier Frapaise, M.D has over 30 years of international drug development experience at major pharmaceutical companies including Sanofi, Bayer, Boehringer, Merck, and Abbott; he has held multiple C- level positions (CSO, CMO, CEO) in different pharmacies in the US and Europe. He has extensive experience of biosimilars development (Boehringer-Ingelheim, Pfenex, Merck KGaA) and is currently heading a biosimilar consulting company. He has been the CSO and SVP of Optimer, has served as the CEO of Asphelia Pharmaceuticals, Inc. VP R&D and corporate officer of TAP, CMO of Ocera Therapeutics, VP of Scientific Affairs at Abbott International, Head of Medical Affairs at Bayer Europe, Medical Director at Bayer France, VP of R&D at Delagrange, Head of Anti-thrombotics Strategic Marketing at Sanofi, Medical Director at Choay. He holds an M.D. degree from Faculté of Medecine and holds an academic position at the Thrombosis Research Center at the Loyola Medical Center in Maywood (IL).

 

Abstract:

In his book, “The End of History?”, published in the National Interest in 1992, Fukuyama argues that the advent of western liberal democracy may signal the endpoint of humanity's sociocultural evolution and the final form of human government. In the same vein, based on recent development of sophisticated analytical methods and evolution of regulatory guidance, one should discuss the relevance of the current clinical development model for biosimilars and raise the following long-term questions: is it the end of clinical trials in biosimilar development,” or more realistically, “could we, in the foreseeable future, drastically reduce the financial and operational burden of biosimilars clinical trials?” It is well known that proteins have unique structural organisation patterns and even those that are chemically identical may have different biological effects due to structural folding differences, without mentioning the effect of post-translational modifications. However, with the current exponential development of multiple sophisticated analytical methods enabling comparability assessment between originators and candidate biosimilars both structurally (orthogonal methods) and functionally (compound-dependent), considering the lack of sensitivity of many clinical models to detect meaningful differences between follow-on biologics and reference compounds, and the recent evolution of regulators perspective on this matter, the relevance of the current clinical development model should be legitimately questioned. Even if this is not ready for prime time, we observe, through the interaction with regulators, that current trends are compatible with this possible long-term perspective, namely: the reliance on healthy volunteer PK/PD studies only to support some biosimilar compounds registration (without testing the candidate biosimilar in oncology patients), wider acceptance by the FDA/EMA of extrapolation from one indication to all other approved indications of the reference compound (e.g. infliximab), and agencies’ willingness, if not encouragement, to test clinical biosimilarity in non- approved indications of the originator compound! When one considers the financial and operational burden of running pivotal trials based on clinical endpoints (skeletal-related events) in some indications (e.g. osteoporosis, metastatic prostate cancer), the likely acceptability of surrogate markers (BMD in osteoporosis), one can predict that clinical trial designs and endpoints for biosimilars are likely to significantly evolve in the coming years. However, one important question remains open, at least for immunogenic compounds (e.g. adalimumab), namely the opportunity to predict immunogenicity based on non-clinical models.

Biography:

Peter H Kalinka is Chairman and Principal Consultant at Longmore 60 Biotech Inc. He possesses in-depth knowledge of drug development and directed numerous development projects including Therapeutic Proteins, Monoclonal Antibodies, and Fusion Proteins. His experience in overall development spans cloning, process development, scale-up, (e-coli, CHO, Hybridoma etc.) analytical development, bioassays, pre-clinical, clinical Phases, to manufacturing and regulatory affairs. Working with more than 20 companies worldwide, he has directed all or spearheaded parts of development programs for Biosimilars, Biobetters, and Biologics. 

 

Abstract:

Peter H Kalinka is Chairman and Principal Consultant at Longmore 60 Biotech Inc. He possesses in-depth knowledge of drug development and directed numerous development projects including Therapeutic Proteins, Monoclonal Antibodies, and Fusion Proteins. His experience in overall development spans cloning, process development, scale-up, (e-coli, CHO, Hybridoma etc.) analytical development, bioassays, pre-clinical, clinical Phases, to manufacturing and regulatory affairs. Working with more than 20 companies worldwide, he has directed all or spearheaded parts of development programs for Biosimilars, Biobetters, and Biologics. 

 

Biography:

Candida is a Founder and President of BBCR consulting. Leveraging extensive experience leading early clinical development and developing regulatory strategy, BBCR consulting is a valuable asset for a company requiring advisory related to life science product development; specifically, pipeline and clinical plan assessments, clinical trials, GTM strategy, safety, or biomarker. BBCR team areas of expertise include rare diseases, immune-oncology, immunology, inflammation, risk-benefit management, regulatory compliance, and FDA issues. BBCR team is a specialized in orphan, autoimmune, oncology, and CNS indications for an innovator, biosimilar, and repurposing products. BBCR team has contributed innovative clinical regulatory strategies and trial design for products directed to regulatory compliance across international government entities for drug, device, and combination products. BBCR team leads evidence-based trial strategies, cost-effective solutions reduces risks and facilitate patient centricity, recruitment, and retention she is an accomplished Senior Executive MD with more than 25 years of success spanning biotechnology, pharmaceuticals, and device. She led market approval for five major products, improved endpoint achievability, and designed Natural History studies and registry protocols. An industry leader, she is a sought-after speaker presenting at international industry summits. Candida attained her MD and a higher degree in Immunology and trained at The Johns Hopkins University and The Harvard University. 

Abstract:

Rare diseases hugely need moderate treatment choices. Vagrant medications have been ignored by the biosimilar business for quite a while. Patient’s advocates that people with rare diseases have access to safe and effective biologic and biosimilar medicines. Worldwide, 350M people are estimated to suffer from a rare disease, including 25-30M US and 30M EU residents. With >60% biologics represent most of the worldwide vagrant medication advertise. A noteworthy issue with protein-based therapeutics is their immunogenicity.Forms of an immune response are the activation of B cells, and T-cells, which help to activate B cells. The T-cells react in a typical response to a fake protein remedial as though it were outside since it is unique in relation to the imperfect, common protein. A T-cell reaction confound like this occasionally happens on account of the protein FVIII. Virtually all therapeutic proteins (biologics) evoke an insusceptible reaction with the resulting creation of hostile to medicate antibodies (ADA). The ADA to therapeutic monoclonal antibodies (mAbs) that are coordinated against the antigen-binding site of the therapeutic mAb is neutralizing. This nature of the ADA reaction explains why fully human antibodies can still be exceedingly immunogenic. Biosimilars have to be tested for their immunogenicity as it is impossible to predict if they will induce an immunogenicity similar to the one manifested by the corresponding innovator biologics. Infusion-related reactions (IRRs) include hypersensitivity reactions and cytokine release syndromes. Hypersensitivity reactions have classically been partitioned into type I, II, III, and IV reactions; type I and III reactions are those regularly observed following administration of biologics. The infusion-related reaction is defined as a disorder characterized by an adverse reaction to the infusion of pharmacological or biological substances and as a disorder characterized by nausea, headache, tachycardia, hypotension, rash, and shortness of breath and caused by the release of cytokines. Infusion-related reactions are common and timely related to drug administration and have been reported as anaphylaxis, anaphylactoid reactions, and cytokine release syndrome, among other terms used. Animal toxicology studies are neither predictive of severe IRRs nor of hypersensitivity in human. With respect to intravenous (IV) administration, the SC route offers more convenience to patients, flexibility in dosing, and potential to lessen medicinal services costs. There is a perception that SC organization can represent a higher immunogenicity hazard than IV administration for a given protein.However, a recent comparative clinical study of sc vs iv administration of abatacept showed that the efficacy and immunogenicity are comparable between the two routes of administration.

 

Biography:

Thomas J Webster is the Chemical Engineering Department Char and Art Zafiropoulo Chair at Northeastern. Prof. Webster has graduated 144 students. His lab group published 9 textbooks, 48 book chapters, 403 articles, and 32 provisional/full patents. He has received numerous honors: 2012, Fellow, American Institute for Medical and Biological Engineering; 2013, Fellow, Biomedical Engineering Society; 2015, Wenzhou 580 Award; 2015, Zheijang 1000 Talent Program; 2016, Fellow, Biomaterials Science and Engineering; and 2016, Acta Biomaterialia Silver Award. He also frequently appears on the BBC, NBC, ABC, Fox, and other news outlets talking about science.

 

Abstract:

Nanotechnology has already revolutionized disease prevention, diagnosis, and treatment, as evidenced by a significant number of FDA, approved materials. In fact, many studies have indicated that nanoparticles can act as drugs and even replace pharmaceutical agents. This talk will first cover advances in the use of nanoparticles as improved drug agents to treat cancer, infections, and grow tissues. Moreover, this talk will highlight how the development of nanoparticles has influenced traditional drug discovery and development. There has been a noted increase in combined nanoparticle – drug approaches but some believe the development of nanoparticles has decreased efforts in traditional drug discovery and delivery. This talk will also highlight FDA approved nanoparticles and what is necessary for the field to continue to grow.

 

Biography:

Leigh-Ann M Durant, Esq., is a senior legal and business executive with more than 24 years of experience in the global biopharmaceutical industry.  She is currently the Head lawyer for all R&D activities in the US at EMD Serono, Inc., the US affiliate of Merck KGaA, Darmstadt, Germany. She also serves as an independent director on a privately-held biotech company. Earlier in her career, she was a trial lawyer and Partner at Nixon Peabody LLP and law clerk for Chief Justice Weisberger of the Rhode Island Supreme Court. Recipient of the national Top 30 Emerging Leaders in the Pharmaceutical Industry Award, Woman of the Year in Law Award and Top 10 Women Lawyers in Massachusetts Award, for over two decades she has served on a variety of boards and executive committees, has led various legal and non-profit organizations as President, and speaks nationally on a variety of topics.

 

Abstract:

Statement of the Problem: Biopharma’s 50-year old drug development model – which focuses on products and healthcare providers, rather than patients and health outcomes – is failing to meet modern-day stakeholders needs. Technology-driven patients and providers, evidence-focused regulators, and cost-conscious payors are demanding more data, more innovation, improved health outcomes, and answers to questions that matter most to patients, all of which are inspiring a radical shift in our drug development paradigm. A patient-centric drug development model offers solutions to these challenges. This paper provides an overview of some of the latest developments in this new model and paradigm shift, including conceptual definitions, widely adopted patient-centric activities, new regulatory guidance, and a novel approach to estimating financial value of patient engagement, all of which provide opportunities to maximize innovation.

Methodology and Theoretical Orientation: This paper was developed from a systematic literature review of peer-reviewed and gray literature using PubMed and Google and a synthesis of peer-reviewed literature, reports, FDA guidance documents, recommendations, findings and observations from regulators, academic research centers, patient advocacy organizations, non-profit coalitions, and commentators.

Findings:  Despite wanting to meet stakeholder needs and an eagerness to embrace patient-centricity, adoption of patient-centered drug development has been challenging for biopharma. Some of the latest developments in this area provide additional justification and validation for embracing this paradigm shift, however, new strategies, organizational structures, and enterprise-wide culture change are also needed to ensure wholesale organizational adoption and permanence.

Conclusion and Significance:  Latest developments further support that patient-centered drug development reduces development timelines, improves data quality, increases probabilities of technical and regulatory success, and increases return on investment. However, changes in strategies, structures, and culture must occur to disrupt and supplant the existing product-focused drug development model and transition successfully and permanently to the new patient-centric model, enabling biopharma to maximize innovation.

 

Biography:

Aruna Dontabhaktuni is an internationally renowned pharmaceutical professional with 23 years of experience across all phases of drug development. She received her Pharmacy degree from Karnataka Pharmacy College, India and PhD from Long Island University, New York City. She is the founder and CEO of PharmaPro consulting, her company specializes in clinical pharmacology, and regulatory submissions. She also serves on the scientific board for several pharmaceutical and biotech companies as a subject matter expert in clinical pharmacology. In her carrier, she has supported 30+ compounds from early, to late-stage of drug development, in oncology & immunology, other rare diseases including breakthrough therapy designations application for Olaratumab (LARTRUVO™). She has played the pivotal role in mentoring the next generation of scientists, thorough her managerial responsibilities. Her 50+ publications including posters, manuscripts and conference presentations as a keynote speaker at national and international conferences, are a clear testament to her achievements.

 

Abstract:

What does it take to qualify for the expedited FDA Drug approval? What is the breakthrough therapy designation application and how is it impacting the global drug development? In 2012, Congress created the breakthrough-therapy designation to expedite the testing and approval by the FDA, of medications with the potential to provide the substantial improvement over existing treatments. “Breakthrough Therapy designation” is improved to hasten the growth and evaluation that are meant to treat the serious condition and introductory clinical proof indicates that the drug may reveal considerable increment over an available therapy on a clinically significant endpoint. To control whether the advancement over available therapy is considerable is a matter of discernment and depends on both the magnitude of the treatment effect, which could include the duration of effect and the elevation of an observed clinical outcome. In general, the primary clinical proof should show a clear advantage over available therapy. How the recent trends in globalization and the complexity of drug development have resulted in the possibility that expedited programs in one country may now influence drug development in another.