Rupal Sood, B.Pharm, Mba

RUPAL SOOD Pharma and Life Sciences Strategy Consultant Service and Capability Deck ©Rupal Sood | Confidential and for business use only About Rupal Rupal is a market intelligence and insights professional who has been serving blue-chip pharma companies at premier agencies for 12+ years. Through her expertise in data analysis and market intelligence she supports customer engagement strategies, HCP and patient need gap analysis, digital health, and transformation programs. Rupal has served clients like large pharma players including Novartis, Roche, Merck, CSL Behring, Sandoz and Novo Nordisk. She also supports innovative health tech companies developing solutions to improve treatment outcomes in hard-to-treat indications like obesity, Rupal Sood A talented researcher with training in pharmacology and the business of healthcare infertility and postpartum depression. Rupal graduated as a pharmacist from one of India’s premier schools, University of Delhi and has an MBA from a national institute dedicated to pharmaceutical sciences. Through her advisory work at both agency and pharma side, she aims to build a solid, multinational strategic consulting practice within the Biopharma sector. ©Rupal Sood | Confidential and for business use only Service offerings and capabilities ©Rupal Sood | Confidential and for business use only Core Service Offerings For COMPETITIVE the INTELLIGENCE MARKET INSIGHTS o Market Assessment o Consumer and HCP surveys o Pipeline and Portfolio Analysis o Treatment guidelines and payor analysis o Competitor monitoring and insights o Go to market strategy INNOVATION INTELLIGENCE o Clinical trial intelligence o Epidemiology and access CONFERENCE COVERAGE DIGITAL TRANSFORMATION o Ecosystem and landscape analysis o Patient/HCP insights o Digital leaders research o HCP / consumer preferences DUE DILIGENCE RESEARCH o Technological, business and regulatory research and analytics o Live Session Coverage o Market share and competitive positioning o Benchmarking R&D strategies o Primary Intelligence o Prospects and growth o Manufacturing Intelligence o Competitor Tracking o Conference Analysis and Insights ©Rupal Sood | Confidential and for business use only o Reputation Check Sector know-how and areas of expertise Therapy Area Expertise Sector Proficiency  BioPharma and Innovative Drugs Rare Diseases Respiratory  MedTech and Devices  Blood derivatives and plasma therapies Oncology Neurology  Diagnostics and Screening  Digital Therapeutics  Biosimilars and Generics Immunology Gene Therapy  Drug Manufacturing &CDMOs  Consumer Health and OTC ©Rupal Sood | Confidential and for business use only 360-degree Know-How  Early development and Clinical trials  Manufacturing and complex formulations  New Launch and lifecycle mgmt.  Delivery and access Market Know-How  Global Markets: USA, EU-7  APAC and SE Asia  Middle East And Africa Case Studies and Samples ©Rupal Sood | Confidential and for business use only Case Study 3 : Enabling a virtual care partner to develop rare disease capabilities CHALLENGE  A mid-size virtual care provider in the US wanted player to foray into rare disease segment  With no prior experience in rare diseases, they wanted to understand the segment and identify opportunities for growth and potential collaboration APPROACH To meet the client’s needs, we provide the following approach  Prepare a Rare Disease Landscape Analysis to upskill the client on the new segment  Provide Rare Disease selection guidance so that the company can focus its efforts towards relevant segments SOLUTION  Market Assessment Report which covered sector trends, key indications and top players  Defining a list of key attributes that made a rare disease a good fit for the platform based on epidemiology, treatment guidelines, approved treatments etc.  Prioritized list of rare disease indications along with in-depth profiling of each of covering existing patient journeys and how digital interventions at various inflection points can improve patient outcomes  Case Studies and examples of industry collaborations in the Rare disease space to guide future collaborations RESULTS  The client was provided with highly actionable intelligence that they used to develop unique capabilities to enter the rare disease segment ©Rupal Sood | Confidential and for business use only Case Study 1 : Ensuring high Patient and HCP demand through digital partnerships CHALLENGE SOLUTION  A large pharma player wanted to increase access to high quality medical care in areas of chronic disease focus in Australia  Traditional, off-line only approaches were limiting the pace and scale in which a revolutionary first in class therapy was able to bring in meaningful change to patient’s lives  We proposed that through effective partnerships with organizations sharing similar ambitions, with distinct digital health competencies, we partner in increasing access for patients in Australia o The pharma player will bring deep expertise, global presence, local influence, and world-class therapies. o While the partners bring proficiency in connecting with, and engaging with, patients and healthcare professionals  Dependent on partner competencies, the pharma company can contribute in several ways to assist the partner ambitions APPROACH  Diagnoses: understanding the landscape, consumer, drivers, and IT options  Partner Selection: Based on desk research, a Long List of telehealth operators in Australia that met the most essential criteria was made which was shortlisted with stricter criteria based on players online presence, telehealth modalities, geographic reach, established pharmacy channel partners and delivery options  Technology Assessment: potential SaaS platforms were based on criteria- delivery, data assurance, types of reporting, compliance etc.  Commercial / Value Creation: partners were evaluated on their expertise in funnel design and effective application of data to grow their efficiency and customer conversion  Commercial Assistance Program: A high degree of enthusiasm and strong desire to align with the pharma companies' goals and expressed efforts toward partnering was seen as a driving factor RESULTS  Based on criteria mentioned above, two partners were selected as being the best fit for the goal  Due diligence supported early impressions that the selected players would provide great opportunity with low reputational risk  Once introductions were made to the pharma company, and several conversations confirmed a unanimous agreement for progressing, the Steering Committee gave an go-ahead to craft agreements ©Rupal Sood | Confidential and for business use only Mapping Existing Patient Journeys in Rare Indications Good awareness in physicians related to BP diagnosis, however, no significant advancement happened in a last decade BP is the most frequent blistering disease of the skin (and mucosa) affecting typically the elderly (>65 years), but can occur at any age and in any race. Blood test for antibodies and skin biopsy are common test for confirmatory diagnosis of BP Current treatment approaches focus on the symptomatic relief and no disease modifying therapy currently approved . Oral or topical corticosteroids are the treatment mainstay. The long-term high dose corticosteroids leads to infection risk in BP patients Presentation Diagnosis Current Treatment Goals Standard of Care • Decrease blister formation • Promote healing of blisters and erosions • Determine the minimal dose of medication necessary to control the disease process • Oral corticosteroids – for immunosuppression • Antibiotics – reduce infection risk or management • Other topics ointments for skin rash or irritation • Off-label use to biologic immunotherapies (i.e., rituximab) Urticarial like skin rash Fluid filled blisters Direct immunofluorescence study Key takeaway Key takeaway Unmet Needs/Issues Key takeaways • In both man or women, after age of 70 the BP incidence significantly increase • Large blisters that don’t easily rupture at touch with eczema or rash • Good BP awareness observed in dermatologists and geriatrics • Blood test for circulating IgG autoantibodies • DIF tests in patients with bullous pemphigoid usually demonstrate IgG and complement C3 deposition in a linear band at the dermalepidermal junction • The diagnosis is not complicated or expensive process • Patients may require 6 – 60 months of treatment cycle due to remissions of BP. • Most of the old patients suffer from other chronic conditions such as hypertension, diabetes, COPD etc. • ~50% patients develop severe form of a disease that require high dose OCS • High mortality in severe patient primarily happens due to secondary complications (i.e. infection) due to treatment ©Rupal Sood | Confidential and for business use only Designing a NextGen PSP program that uses digital strategies to enhance patient onboarding and compliance ©Rupal Sood | Confidential and for business use only Competitor Landscape and Pipeline Intelligence Six Oral therapies have been approved in the last one year for Multiple Sclerosis Phase II ALS Therapy BrainStorm Cell Therapeutics GDNF agonist ATX-MS 1467 Apitope Immunostimulant BCD-132 Biocad CD 20 Antagonist IV SC IV Natalizumab BS Bioeq IP IL2 agonist Expected Launch: FY 2023-24 Expected Launch: FY2021 Vafidemstat Oryzon Demethylase 1 inhibitors; MAO inhibitor Evobrutinib* Merck KGaA BTK Inhibitor BCD 054 Biocad biotechnology IL2 agonist Expected Launch: FY 2024-25 Expected Launch: FY2021-22 Vidofludimus Immunic Dihydroorotate dehydrogenase inhibitor GA Depot-Once Monthly Mapi Pharma Ltd. Myelin basic protein stimulant IV Amiselimod Mitsubishi Tanabe Pharma S1P receptor antagonist CNM-Au8 Clene Nanomedicine Elezanumab AbbVie RGMc Inhibitor Amantadine ER/ ADS 5102 Adamas Pharma NMDA Receptor Antagonist Temelimab GeNeuro MSRV Inhibitor IV Pre-Registration Phase III RHB 104 RedHill Biopharma Antibiotic Combination IM IM Ofatumumab GSK/Novartis CD20 antagonist Expected Launch: 2025-26 Masitinib AB Science DGF, tyrosine kinase, FGFR3, c-kit, Lyn and Fyn tyrosine kinases inhibitor Ublituximab Ildong Pharma CD 20 Antagonist Expected Launch: FY 2024-25 Expected Launch: FY2021-22 IV Ibudilast MediciNova PPD 4 Inhibitor NeuroVax Immune Response BioPharma T Cell inhibitor INT-131 Coherus Biosciences PPAR gamma agonist Ponesimod Actelion Sphingosine 1-phosphate 1 agonist Ozanimod Bristol-Myers Squibb Sphingosine 1-phosphate 1 agonist Expected Launch: H1 2021 Expected Launch: H2 2020 Recent Launches Mayzent®; 2019 Novartis IV Baclofen Sun Pharma GABA B receptor agonist Opicinumab Biogen LINGO-1 Antagonist Sphingosine 1-phosphate 1 modulator Vumerity®; 2019 Biogen / Alkermes Nrf2 Stimulant Mavenclad-2019 J&J/Merck Immunosuppressants Key Insights ATL-1102 SC Antisense Therapeutics Alpha4beta1 integrin antagonist IM BAFIERTAM Banner Life Sciences Transcription factor Nrf2 stimulant Expected Launch: H2 2020 Expected Launch: FY2023-24 HLCM-051 Athersys Allogeneic stem cell SC Expected Launch: Q1 2021 SAR-442168* Sanofi BTK Inhibitor Expected Launch: FY 2022-23 *Phase III trials announced 1,2 IV Registered IV Merck had a head start in BTKi’s with Evobrutinib and Sanofi/Principia Biopharma’s SAR442168 followed it. Currently both the molecules are positioned exactly the same as far as the development status are concerned ©Rupal Sood | Confidential and for business use only Oral Injectable (IV or SC or IM) Inhaled BTK Inhibitors Disease Overview and Treatment Landscapes The primary treatment goal is to relieve the pain and reduce the next RCE episode RCE Treatment Options1,2 First line of treatment Lubrication: preservative-free artificial tears and ointment Second line of treatment Autologous serum tears and cyclosporine 0.05%, Antibiotics and pain relievers Acute episodes of corneal erosion Above All + Patching & cycloplegia To reduces the frequency of RCE Inhibitors of matrix metalloproteinase-9 & topical corticosteroids Other therapies for specific cases Conservative Treatment : Bandage Contact Lens and Punctal Occlusion Surgery : Anterior Stromal Micropuncture, Diamond Burr Polishing and Excimer Laser Phototherapeutic Keratectomy (PTK) Treatment Management1,2 • The two primary therapeutic goals for RCE are to facilitate rapid re-epithelialization and relieve pain. A secondary goal is to prevent future occurrences of erosion. • The basic principle of treatment of RCES is to increase the adhesion of the epithelium to the underlying stroma. This may be due to the increase of hemidesmosomes and anchoring fibrils or due to the promotion of fibrosis. Bandage Contact Lens ©Rupal Sood | Confidential and for business use only Punctal occlusion with the FCI ready set punctum plugs Market Trends and Sector Intelligence The sector will keep moving towards specialized chronic care spaces, addressing the specific combination of needs in these areas Telehealth is here to stay Telehealth 2.0 : Focus on Chronic Diseases Telehealth industry is becoming more mature and is shifting away from urgent care to specialized care Integrated, unified, comprehensive experience Personalized t/t Plans Mental Health Certified Chronic Care Professionals 13 -17% of visits are virtual Telehealth use overall has leveled off at levels 38 times higher than before the pandemic, ranging from 13% to 17% of visits across all specialties Diabetes Hypertension Obesity Behavior Change Tools Health Coaching Evidence-based Programs Agile Approach Connected Devices Emergency Outreach Industry Speak “The big telehealth players to start to build out specialized virtual clinics for high-cost conditions like kidney disease, MSK pain or migraines to keep up with startups flooding the market” - Jeff Becker, principal healthcare analyst at CB Insights Sources in Slide Notes “In 2022, entrepreneurs and investors will expand telemedicine into more chronic care spaces like cardiology. Today, someone in the U.S. suffers a heart attack every 40 seconds and heart disease costs the U.S. about $219 billion a year” - Bill Taranto, founding partner, Merck Global Health Innovation Fund ©Rupal Sood | Confidential and for business use only Drug Development and Mfg. Intelligence PORTFOLIO FOCUS Research and Development 3# Manufacturing, Quality & Logistics 2# Monitoring & Self Management 1# Treatment & Decision Support 4# Digital Initiatives Related To Drug Development Name of the Initiative Focus Description Highly Orchestrated Supply Network (HOSuN) - Supply Chain Manufacturing, Quality and Logistics Pfizer plan to use this network to help identify medicine demand throughout the world, and especially for biologic and vaccine products that may require manufacturing lead times of 9-15 months so that medicine demands are met1 Cortex - Drug Development Process Research and Development Cortex helps to categorize particle shapes based on partial microscopic images of a drug substance2 PCMM (Portable Continuous Miniature & Modular) - Manufacturing Platform Manufacturing, Quality and Logistics PCMM shortens the manufacturing process from weeks to minutes. One marketed oncology product and three other clinical candidates are being manufactured on the PCMM platform in Groton, Connecticut, and Freiburg, Germany. Pfizer estimates that 70% of its solid oral dose portfolio will be manufactured on PCMM in the next 10 years1 Innovative Medicines Initiative (IMI2) - Data and Evidence network project - Clinical trials Research and Development European Health Data & Evidence Network (EHDEN) is an IMI 2 consortium with 23 partners operating in Europe. EHDEN conducts a large-scale analysis of health data in Europe to generate insights and evidence from real-world clinical data at scale3 Augmented-reality technology - Manufacturing Platform Research and Development Augmented reality technology diagnose, maintain, and repair lab and production equipments with minimal human contact. Helps in maintaining real-time monitoring of shipments and temperatures anywhere in the world4 ©Rupal Sood | Confidential and for business use only Target Profiling and Insights Vyxeos is a fixed-combination of chemotherapy drugs (HOSPITAL USE ONLY) daunorubicin and cytarabine. Drug MOA Licensee/Originator Dosage Targeted Indication RINVOQ® (daunorubicin and cytarabine liposome for injection) Antineoplastic Jazz Pharmaceuticals Intravenous Infusion Acute Myeloid Leukemia Targeted Patient Profile  Adults with newly diagnosed therapyrelated acute myeloid leukemia (tAML) or acute myeloid leukemia (AML) with myelodysplasia-related changes (AML-MRC) Key USP Global Status Australia Fixed dose combination, showed better efficacy vs SOC; Marketed Approved since June 2022 Serious Adverse Effects Hemorrhage Adverse Events that require physician monitoring/ prescreening  v Cardiotoxicity Copper Overload Tissue Necrosis Vyxeos initially faced payor issues in the US, including disease-code reimbursements that incentivize lower-cost treatments. Facilities “thus tend to be cautious on using expensive products” ©Rupal Sood | Confidential and for business use only 15 Target Profiling and Insights Form Health Funding $15.4M Valuation N/A Founded 2019 Form Health is a telemedical weight loss company that focuses on individuals dealing with obesity Select Investors NextView Ventures, SignalFire, M13 Similar Companies $215.9M $218M $188M ©Rupal Sood | Confidential and for business use only Sources : Company Websites and HPR Analysis Physician Survey and Market Research Most docs want to access telehealth through their current practice Use or interest in virtual consult modalities* Physicians are sceptical about DTC medicine start-ups, as 54% feel patients will not receive an adequate standard of care through DTC medicine 67% Through my current practice 20% Through an external organization including pharmacies 29% Through a DTC telemedicine company ©Rupal Sood | Confidential and for business use only 18 LET’S STAY IN TOUCH https://www.linkedin.com/in/rupal-sood-aba67920/ - Hyderabad, INDIA - ©Rupal Sood | Confidential and for business use only https://twitter.com/Biopharma_intel