“Our collaboration has been nothing short of exceptional”
Working with Innovaderm was an absolute pleasure. Their expertise and commitment were particularly evident when data or analysis related challenges arose. Innovaderm consistently provided multiple solutions and well thought out strategies to handle these complex situations. Their team's quality of work, flexibility, and straightforward communication made our partnership and workstreams smooth and efficient. We appreciated the lack of unnecessary back-and-forth, with most cases being resolved without the need for lengthy email threads. This efficiency enabled us to achieve our desired timelines with high-quality deliverables. Overall, our experience with Innovaderm was highly positive. I have had the opportunity to work closely with Innovaderm teams on several projects over the past few years. We would definitely collaborate with them again and wholeheartedly recommend their Biometrics services.
Turning the Tide: A Remarkable Turnaround in Phase 2 Trial Results
The Challenge
A client shared disappointing phase 2 trial results and FDA’s stern comments on phase 3 protocol (developed by another CRO).
Our Solutions
We meticulously reviewed phase 2 study data and conducted post-hoc analysis, identified phases 2 and 3 design flaws and completely revamped phase 3 statistical portion of protocol and statistical analysis plan (SAP).
The Results
Our rigorous re-evaluation yielded significant phase 2 results, surpassing expectations. We helped overcome hurdles, instilling renewed confidence in the drug’s potential to phase 3.
Therapeutic knowledge and experience
Deep biometrics insights into a wide range of therapeutic areas
Over 3 decades of unparalleled biometrics services
45+ Skilled Biometrics Professionals
Pina D’Angelo
VP, Biometrics
Diane Potvin
Senior Statistical Advisor
Eric Hardy
Senior Director Biometrics
Edith Simeon
Associate Director Biostatistics
Rolland Gaudet
Principal Biostatistician
01
Memberships
02
Accreditations
03
Publications
Potvin D, D’Angelo P, Bennett S, Jankicevic J, Bissonnette R. Adaptive designs in dermatology clinical trials: Current status and future perspectives. J Eur Acad Dermatol Venereol. 2024;00:1–10. https://doi.org/10.1111/jdv.20030
R. Bissonnette, L. F. Eichenfield, E. Simpson, D. Thaçi, K. Kabashima, J. P. Thyssen, E. Guttman-Yassky, F. P. Nunes, M. Gamalo, F. Ahmad, M. Kuligowski, K. Sun, C. Pipper, A. W. Christensen, P. D'Angelo, M. Milutinovic, A. Guettner, J. I. Silverberg. Estimands for atopic dermatitis clinical trials: Expert opinion on the importance of intercurrent events. J Eur Acad Dermatol Venereol. 2023 May;37(5):976-983.
Kollmannsberger C, Hurwitz H, Bazhenova L, Cho BC, Hong D, Park K, Reckamp KL, Sharma S, Der-Torossian H, Christensen JG, Faltaos D, Potvin D, Tassell V, Chao R, Shapiro GI. Phase I Study Evaluating Glesatinib (MGCD265), An Inhibitor of MET and AXL, in Patients with Non-small Cell Lung Cancer and Other Advanced Solid Tumors. Target Oncol. 2023 Jan;18(1):105-118.
Stambler BS, Plat F, Sager PT, Shardonofsky S, Wight D, Potvin D, Pandey AS, Ip JE, Coutu B, Mondésert B, Sterns LD, Bennett M, Anderson JL, Damle R, Haberman R, Camm AJ. First Randomized, Multicenter, Placebo-Controlled Study of Self-Administered Intranasal Etripamil for Acute Conversion of Spontaneous Paroxysmal Supraventricular Tachycardia (NODE-301). Circ Arrhythm Electrophysiol. 2022 Dec;15(12):e010915.
DiLiberti CE, Bon C, D’Angelo P, Gallicano K, Potvin D. Suggestions for Streamlining and Optimizing Clinical End‐Point Bioequivalence Studies for US Abbreviated New Drug Application Submissions. Clin Pharmacol Ther 2019 Feb;105(2):310-312.
Brimhall BD, Petri N, D’Angelo P. Relative Bioavailability of a Single 4-mg Dose of Somatropin Administered by Subcutaneous Injection or by Needle-free Device and Coadministered With the Growth Hormone Inhibitor Octreotide Acetate in Healthy Adult Subjects. Clin Ther 2018 May;40(5):741-751.
Xu J, Audet C, DiLiberti CE, Hauck WW, Montague TH, Parr AF, Potvin D, and Schuirmann DJ. Optimal adaptive sequential designs for crossover bioequivalence studies. Pharmaceutical Statistics 2016;15:15-27.
Lee L, D’Angelo P, Verbel D, Martinez G, Aluri J, Brimhall D. A Randomized, Three-Treatment, Three-Period, Six- Sequence-Crossover, Single-Center, Bioequivalence Study to Evaluate the Impact of Different 10-mg Crystalline Forms on the Pharmacokinetics of Lenvatinib in Healthy Volunteers. Int J Clin Pharmacol Ther 2015 Feb;53(2):190-8.
Barchuk WT, Salapatek AM, Ge T, D'Angelo P, Liu X. Proof-of-Concept Study of the Effect of a Novel H3-Receptor Antagonist in Allergen-Induced Nasal Congestion. J Allergy Clin Immunol 2013 Oct;132(4):838-46.e1-6.
Creticos PS, Esch R, Couroux P, Gentile DA, D’Angelo P, Whitlow B, Alexander M, Coyne TC. Randomized, Double- Blind, Placebo-Controlled Trial of Standardized Ragweed Sublingual-Liquid Immunotherapy for Allergic Rhinoconjunctivitis. J Allergy Clin Immunol 2014 May;133(5):1502.
D’Angelo P. Adaptive Study Designs and Assessment Approaches for Bioequivalence: Interim Analyses and Type I Error in Bioequivalence Studies. Invited speaker, American Association of Pharmaceutical Statistics, Oct 2012.
Bernstein JA, Salapatek AM, Lee JS, Nelson V, Wilson D, D'Angelo P, Tsitoura D, Murdoch R, Patel D. Provocation of Non-Allergic Rhinitis (NAR) Patients in Response to Simulated Weather Conditions Using an Environmental Exposure Chamber (EEC) Model. Allergy Asthma Proc 2012 Jul-Aug;33(4):333-40.
Colucci P, D'Angelo P, Mautone G, Scarsi C, Ducharme MP. Pharmacokinetic Equivalence of a Levothyroxine Sodium Soft Capsule Manufactured Using the New Food and Drug Administration Potency Guidelines in Healthy Volunteers Under Fasting Conditions. Ther Drug Monit. 2011 Jun;33(3):355-61.
Montague TH, Potvin D, DiLiberti CE, Hauck WW, Parr AF, and Schuirmann DJ. Additional Results for ‘Sequential Design Approaches for Bioequivalence Studies with Crossover Designs’. Pharmaceutical Statistics (online publishing 2011).
Salapatek A, Lee J, Patel D, D'Angelo P, Liu J, RO Zimmerer J, et al. Solubilized nasal steroid (CDX-947) when combined in the same solution nasal spray with an antihistamine (CDX-313) provides improved, fast-acting symptom relief in patients with allergic rhinitis. Allergy Asthma Proc 2011; 32:221-9.
Salapatek A, Wilson D, Liu J, Song Y, D'Angelo P, Patel P, et al. The Non-Allergic Rhinitis (NAR) Environmental Exposure Chamber (EEC) Model Evokes Consistent and Significant Nasal Symptoms in NAR Patients but not in Healthy Normal Volunteers (HNV). Allergy 2010; 65:34.
Lee J, Wilson D, Patel D, D'Angelo P, Liu J, Song Y, et al. The Non-Allergic RhinoConjunctivitis (NARC) Environmental Exposure Chamber (EEC) Model Induces Significant Ocular Symptoms Specifically in NARC Patients. Ann Allergy Asthma Immunol 2010; 105:A13.
Salapatek AM, D'Angelo P, Liu J, McCue S, R Z, J P. Novel Solubilization of Azelastine and Budesonide with Captisol in a Convenient Combination Nasal Spray Format Provides Faster and Greater Nasal Symptom Relief than Either Captisol- Enabled-Budesonide or a Marketed Budesonide Product Alone: A Meta-Analysis of Two Environmental Exposure Chamber (EEC) Studies. Allergy 2009; 64:596.
Salapatek A, D'Angelo P, Bates M, Patel D, Patel P, Pipkin J, et al. Novel Combination Product Captisol-Enabled® Budesonide+Azelastine HCl Provides Fast, Long-lasting Relief of Allergic RhinitisSymptoms (Total Nasal Symptom Score (TNSS) and Individual Nasal Symptoms Scores (NSS)) in Ragweed Allergic Patients Studied in an Environmental Exposure Chamber (EEC) Model. J Allergy Clin Immunol 2009; 123:S130.
Patel P, Salapatek A, D'Angelo P, Bates M, Patel D, Zimmer R, et al. The Combination Product Captisol-Enabled® Budesonide+Azelastine HCl Nasal Spray Provides Significant, Long-lasting Relief of Ocular Allergy Symptoms in Ragweed Allergic Patients Studied in an Environmental Exposure Chamber (EEC) J Allergy Clin Immunol 2009; 123:s130.
Patel P, Bates M, Liu J, D’Angelo P, Salapatek AM. Trials in an Environmental Exposure Chamber (EEC) can be performed In- or Out- of the natural pollen season: A randomized, double-blind, placebo-controlled, two-way crossover study in patients with SAR indicates no difference in efficacy outcomes In- or Out- of the pollen season. Ann Allergy Asthma Immunol 2009; 102:A12.
Lee J, Wilson D, Patel D, Bernstein J, D'Angelo P, Salapatek A. The use of an environmental exposure chamber (EEC) model for challenging non-allergic rhinitis (NAR) patients to irritant triggers. Ann Allergy Asthma Immunol 2009; 103:A26.
Lee J, Wilson D, Patel D, Bernstein J, D'Angelo P, Salapatek A. Objective and subjective response to simulated weather changes in non-allergic rhinitis (NAR) patients using a novel environmental exposure chamber (EEC) model. Ann Allergy Asthma Immunol 2009; 103:A25.
Zimmerer, R.O., D'Angelo, P, Liu, J, Pipkin, JD, Salapatek, AM. Nasal administration of Captisol-enabled budesonide solution significantly reduces total ocular symptom scores (TOSS) of ragweed allergic patients in an environmental exposure chamber (EEC) model. American Association of Pharmaceutical Sciences, APSJ, 2008.
Potvin D, DiLiberti CE, Hauck WW, Parr AF, Schuirmann DJ, Smith RA. Sequential design approaches for bioequivalence studies with crossover designs. Pharm Stat. 2008 Oct-Dec;7(4):245-62.
Dr. Christian Marsolais
Senior Vice President and Chief Medical Officer Theratechnologies www.theratech.com
“We achieved our oncology research goals with Diane Potvin’s creative and robust statistical solutions”
In our long-standing collaboration with Diane Potvin (Senior Statistical Advisor, Innovaderm), she has proven to be a very professional, innovative, and capable biostatistician. Her support and expertise in biostatistics and oncology have been invaluable in moving our phase I clinical oncology program forward. She is always very adaptable and responsive to our requests, works well with our Thera team, and was able to quickly provide sound advice on how to develop a novel dose-escalation algorithm, supported by the binomial distribution, that was readily accepted by the FDA. Her input allowed Thera to seamlessly explore different dosing schedules/strategies in the ongoing phase I trial. We look forward to a continued partnership with Diane.
Over 30 years of experience in meeting sponsor expectations with consistency, dependability, and quality of the biometrics services.
Precision
CRF forms library and EDC edit checks meticulously flagging discrepancies. Intricately planned study design, SAP, and randomization schedules.
Collaboration
45+ DM and Biostatistics team members working closely, ensuring seamless data transition, quality, and timely delivery of study results.
Expertise
Experts in navigating complicated study designs in every trial phase, from study design to regulatory submissions and using innovative data analysis techniques and methodology.
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